Enter drug's generic or brand name below. Results will appear here. Note: all drug related information obtained on this page is provided by RX List.
Using the RX LIST database:
(1) Enter the drug name in the search box below and hit ENTER
(2) The rx list web site will open here with the drug search completed. Next, scroll down the page to locate the link to the drug you are searching for and then click on the link.
WARNING
SERIOUS INFECTIONS and MALIGNANCY
Patients treated with AMJEVITA are at increased risk for developing serious infections that may lead to hospitalization or death [see WARNINGS AND PRECAUTIONS]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue AMJEVITA if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with AMJEVITA prior toinitiating therapy in patients with chronic or recurrent infection.
Monitor patients closely for the development of signs and symptoms of infection during and after treatment with AMJEVITA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products [see WARNINGS AND PRECAUTIONS]. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adultmales.
Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see WARNINGS AND PRECAUTIONS].
AMJEVITA (adalimumab-atto) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). AMJEVITA was created using recombinant DNA technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.
AMJEVITA™ (adalimumab-atto) Injection is supplied as a sterile, preservative-free solution of adalimumab-atto for subcutaneous administration. The drug product is supplied as either a single-use, prefilled SureClick® autoinjector, or as a single-use, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-use, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2.
Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2.
Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2.
The following clinically significant adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reaction with adalimumab was injection site reactions. In placebo-controlled trials, 20% of patients treated with adalimumab developed injection site reactions (erythema and/or itching, hemorrhage, pain or swelling), compared to 14% of patients receiving placebo. Most injection site reactions were described as mild and generally did not necessitate drug discontinuation.
The proportion of patients who discontinued treatment due to adverse reactions during the double-blind, placebo-controlled portion of studies in patients with RA (i.e., Studies RA-I, RA-II, RA-III and RA-IV) was 7% for patients taking adalimumab and 4% for placebo-treated patients. The most common adverse reactions leading to discontinuation of adalimumab in these RA studies were clinical flare reaction (0.7%), rash (0.3%) and pneumonia (0.3%).
In the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, Ps, HS and UV, the rate of serious infections was 4.3 per 100 patient-years in 7973 adalimumab-treated patients versus a rate of 2.9 per 100 patient-years in 4848 control-treated patients. Serious infections observed included pneumonia, septic arthritis, prosthetic and post-surgical infections, erysipelas, cellulitis, diverticulitis, and pyelonephritis [see Warnings and Precautions (5.1)].
Tuberculosis and Opportunistic Infections
In 52 global controlled and uncontrolled clinical trials in RA, PsA, AS, CD, UC, Ps, HS and UV that included 24,605 adalimumab-treated patients, the rate of reported active tuberculosis was 0.20 per 100 patient-years and the rate of positive PPD conversion was 0.09 per 100 patient-years. In a subgroup of 10,113 U.S. and Canadian adalimumab-treated patients, the rate of reported active TB was 0.05 per 100 patient-years and the rate of positive PPD conversion was 0.07 per 100 patient-years. These trials included reports of miliary, lymphatic, peritoneal, and pulmonary TB. Most of the TB cases occurred within the first eight months after initiation of therapy and may reflect recrudescence of latent disease. In these global clinical trials, cases of serious opportunistic infections have been reported at an overall rate of 0.05 per 100 patient-years. Some cases of serious opportunistic infections and TB have been fatal [see Warnings and Precautions (5.1)].
In the rheumatoid arthritis controlled trials, 12% of patients treated with adalimumab and 7% of
placebo-treated patients that had negative baseline ANA titers developed positive titers at week 24. Two patients out of 3046 treated with adalimumab developed clinical signs suggestive of new-onset lupus-like syndrome. The patients improved following discontinuation of therapy. No patients developed lupus nephritis or central nervous system symptoms. The impact of long-term treatment with adalimumab products on the development of autoimmune diseases is unknown.
There have been reports of severe hepatic reactions including acute liver failure in patients receiving TNF-blockers. In controlled Phase 3 trials of adalimumab (40 mg SC every other week) in patients with RA, PsA, and AS with control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 × ULN occurred in 3.5% of adalimumab-treated patients and 1.5% of control-treated patients. Since many of these patients in these trials were also taking medications that cause liver enzyme elevations (e.g., NSAIDs, MTX), the relationship between adalimumab and the liver enzyme elevations is not clear. In a controlled Phase 3 trial of adalimumab in patients with polyarticular JIA who were 4 to 17 years, ALT elevations ≥ 3 × ULN occurred in 4.4% of adalimumab-treated patients and 1.5% of control-treated patients (ALT more common than AST); liver enzyme test elevations were more frequent among those treated with the combination of adalimumab and MTX than those treated with adalimumab alone. In general, these elevations did not lead to discontinuation of adalimumab treatment. No ALT elevations ≥ 3 × ULN occurred in the open-label study of adalimumab in patients with polyarticular JIA who were 2 to < 4 years.
In controlled Phase 3 trials of adalimumab (initial doses of 160 mg and 80 mg, or 80 mg and 40 mg on Days 1 and 15, respectively, followed by 40 mg every other week) in adult patients with CD with a control period duration ranging from 4 to 52 weeks, ALT elevations ≥ 3 × ULN occurred in 0.9% of adalimumab-treated patients and 0.9% of control-treated patients. In the Phase 3 trial of adalimumab in pediatric patients with Crohn’s disease which evaluated efficacy and safety of two body weight based maintenance dose regimens following body weight based induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 × ULN occurred in 2.6% (5/192) of patients, of whom 4 were receiving concomitant immunosuppressants at baseline; none of these patients discontinued due to abnormalities in ALT tests. In controlled Phase 3 trials of adalimumab (initial doses of 160 mg and 80 mg on Days 1 and 15, respectively, followed by 40 mg every other week) in adult patients with UC with control period duration ranging from 1 to 52 weeks, ALT elevations ≥ 3 × ULN occurred in 1.5% of adalimumab-treated patients and 1.0% of control-treated patients. In controlled Phase 3 trials of adalimumab (initial dose of 80 mg then 40 mg every other week) in patients with Ps with control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 × ULN occurred in 1.8% of adalimumab-treated patients and 1.8% of control-treated patients. In controlled trials of adalimumab (initial doses of 160 mg at Week 0 and 80 mg at Week 2, followed by 40 mg every week starting at Week 4), in subjects with HS with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3% of adalimumab-treated subjects and 0.6% of control- treated subjects. In controlled trials of adalimumab (initial doses of 80 mg at Week 0, followed by 40 mg every other week starting at Week 1) in adult patients with uveitis with an exposure of 165.4 PYs and 119.8 PYs in adalimumab-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of adalimumab-treated patients and 2.4% of control-treated patients.
Rheumatoid Arthritis Clinical Studies
The data described below reflect exposure to adalimumab in 2468 patients, including 2073 exposed for 6 months, 1497 exposed for greater than one year and 1380 in adequate and well-controlled studies (Studies RA-I, RA-II, RA-III, and RA-IV). Adalimumab was studied primarily in placebo-controlled trials and in long-term follow up studies for up to 36 months duration. The population had a mean age of 54 years, 77% were female, 91% were Caucasian and had moderately to severely active rheumatoid arthritis. Most patients received 40 mg adalimumab every other week [see Clinical Studies (14.1)].
Table 1 summarizes reactions reported at a rate of at least 5% in patients treated with adalimumab 40 mg every other week compared to placebo and with an incidence higher than placebo. In Study RA-III, the types and frequencies of adverse reactions in the second year open-label extension were similar to those observed in the one-year double-blind portion.
Table 1. Adverse Reactions Reported by ≥ 5% of Patients Treated with Adalimumab During Placebo-Controlled Period of Pooled RA Studies (Studies RA-I, RA-II, RA-III, and RA-IV)
| Adalimumab 40 mg subcutaneous Every Other Week |
Placebo | |
| (N = 705) | (N = 690) | |
| Adverse Reaction (Preferred Term) | ||
| Respiratory | ||
| Upper respiratory infection | 17% | 13% |
| Sinusitis | 11% | 9% |
| Flu syndrome | 7% | 6% |
| Gastrointestinal | ||
| Nausea | 9% | 8% |
| Abdominal pain | 7% | 4% |
| Laboratory Tests* | ||
| Laboratory test abnormal | 8% | 7% |
| Hypercholesterolemia | 6% | 4% |
| Hyperlipidemia | 7% | 5% |
| Hematuria | 5% | 4% |
| Alkaline phosphatase increased | 5% | 3% |
| Other | ||
| Headache | 12% | 8% |
| Rash | 12% | 6% |
| Accidental injury | 10% | 8% |
| Injection site reaction ** | 8% | 1% |
| Back pain | 6% | 4% |
| Urinary tract infection | 8% | 5% |
| Hypertension | 5% | 3% |
| * Laboratory test abnormalities were reported as adverse reactions in European trials ** Does not include injection site erythema, itching, hemorrhage, pain or swelling |
||
Other infrequent serious adverse reactions that do not appear in the Warnings and Precautions or Adverse Reaction sections that occurred at an incidence of less than 5% in adalimumab-treated patients in RA studies were:
Body As A Whole: Pain in extremity, pelvic pain, surgery, thorax pain
Cardiovascular System: Arrhythmia, atrial fibrillation, chest pain, coronary artery disorder, heart arrest, hypertensive encephalopathy, myocardial infarct, palpitation, pericardial effusion, pericarditis, syncope, tachycardia
Digestive System: Cholecystitis, cholelithiasis, esophagitis, gastroenteritis, gastrointestinal hemorrhage, hepatic necrosis, vomiting
Endocrine System: Parathyroid disorder
Hemic And Lymphatic System: Agranulocytosis, polycythemia
Metabolic And Nutritional Disorders: Dehydration, healing abnormal, ketosis, paraproteinemia, peripheral edema
Musculo-Skeletal System: Arthritis, bone disorder, bone fracture (not spontaneous), bone necrosis, joint disorder, muscle cramps, myasthenia, pyogenic arthritis, synovitis, tendon disorder
Neoplasia: Adenoma
Nervous System: Confusion, paresthesia, subdural hematoma, tremor
Respiratory System: Asthma, bronchospasm, dyspnea, lung function decreased, pleural effusion
Special Senses: Cataract
Thrombosis: Thrombosis leg
Urogenital System: Cystitis, kidney calculus, menstrual disorder
In general, the adverse reactions in the adalimumab-treated patients in the polyarticular juvenile idiopathic arthritis (JIA) trials (Studies JIA-I and JIA-II) [see Clinical Studies (14.2)] were similar in frequency and type to those seen in adult patients [see Warnings and Precautions (5), Adverse Reactions (6)]. Important findings and differences from adults are discussed in the following paragraphs.
In Study JIA-I, adalimumab was studied in 171 patients who were 4 to 17 years of age, with polyarticular JIA. Severe adverse reactions reported in the study included neutropenia, streptococcal pharyngitis, increased aminotransferases, herpes zoster, myositis, metrorrhagia, and appendicitis. Serious infections were observed in 4% of patients within approximately 2 years of initiation of treatment with adalimumab and included cases of herpes simplex, pneumonia, urinary tract infection, pharyngitis, and herpes zoster.
In Study JIA-I, 45% of patients experienced an infection while receiving adalimumab with or without concomitant MTX in the first 16 weeks of treatment. The types of infections reported in adalimumab-treated patients were generally similar to those commonly seen in polyarticular JIA patients who are not treated with TNF-blockers. Upon initiation of treatment, the most common adverse reactions occurring in this patient population treated with adalimumab were injection site pain and injection site reaction (19% and 16%, respectively). A less commonly reported adverse event in patients receiving adalimumab was granuloma annulare which did not lead to discontinuation of adalimumab treatment.
In the first 48 weeks of treatment in Study JIA-I, non-serious hypersensitivity reactions were seen in approximately 6% of patients and included primarily localized allergic hypersensitivity reactions and allergic rash.
In Study JIA-I, 10% of patients treated with adalimumab who had negative baseline anti-dsDNA antibodies developed positive titers after 48 weeks of treatment. No patient developed clinical signs of autoimmunity during the clinical trial.
Approximately 15% of patients treated with adalimumab developed mild-to-moderate elevations of creatine phosphokinase (CPK) in Study JIA-I. Elevations exceeding 5 times the upper limit of normal were observed in several patients. CPK concentrations decreased or returned to normal in all patients. Most patients were able to continue adalimumab without interruption.
In Study JIA-II, adalimumab was studied in 32 patients who were 2 to < 4 years of age or 4 years of age and older weighing < 15 kg with polyarticular JIA. The safety profile for this patient population was similar to the safety profile seen in patients 4 to 17 years of age with polyarticular JIA.
In Study JIA-II, 78% of patients experienced an infection while receiving adalimumab. These included nasopharyngitis, bronchitis, upper respiratory tract infection, otitis media, and were mostly mild to moderate in severity. Serious infections were observed in 9% of patients receiving adalimumab in the study and included dental caries, rotavirus gastroenteritis, and varicella.
In Study JIA-II, non-serious allergic reactions were observed in 6% of patients and included intermittent urticaria and rash, which were all mild in severity.
Adalimumab has been studied in 395 patients with psoriatic arthritis (PsA) in two placebo-controlled trials and in an open-label study and in 393 patients with ankylosing spondylitis (AS) in two placebo-controlled studies [see Clinical Studies (14.3, 14.4)]. The safety profile for patients with PsA and AS treated with adalimumab 40 mg every other week was similar to the safety profile seen in patients with RA, adalimumab Studies RA-I through IV.
Adults: The safety profile of adalimumab in 1478 adult patients with Crohn’s disease (CD) from four placebo-controlled and two open-label extension studies [see Clinical Studies (14.5)] was similar to the safety profile seen in patients with RA.
Pediatric Patients 6 Years to 17 Years: The safety profile of adalimumab in 192 pediatric patients from one double-blind study (Study PCD-I) and one open-label extension study [see Clinical Studies (14.6)] was similar to the safety profile seen in adult patients with CD.
During the 4-week open-label induction phase of Study PCD-I, the most common adverse reactions occurring in the pediatric population treated with adalimumab were injection site pain and injection site reaction (6% and 5%, respectively).
A total of 67% of children experienced an infection while receiving adalimumab in Study PCD-I. These included upper respiratory tract infection and nasopharyngitis.
A total of 5% of children experienced a serious infection while receiving adalimumab in Study PCD-I. These included viral infection, device related sepsis (catheter), gastroenteritis, H1N1 influenza, and disseminated histoplasmosis.
In Study PCD-I, allergic reactions were observed in 5% of children which were all non-serious and were primarily localized reactions.
Adults: The safety profile of adalimumab in 1010 adult patients with ulcerative colitis (UC) from two placebo-controlled studies and one open-label extension study [see Clinical Studies (14.7)] was similar to the safety profile seen in patients with RA.
Adalimumab has been studied in 1696 subjects with plaque psoriasis (Ps) in placebo controlled and open-label extension studies [see Clinical Studies (14.8)]. The safety profile for subjects with Ps treated with adalimumab was similar to the safety profile seen in subjects with RA with the following exceptions. In the placebo-controlled portions of the clinical trials in Ps subjects, adalimumab-treated subjects had a higher incidence of arthralgia when compared to controls (3% vs. 1%).
Adalimumab has been studied in 727 subjects with hidradenitis suppurativa (HS) in three placebo-controlled studies and one open-label extension study [see Clinical Studies (14.9)]. The safety profile for subjects with HS treated with adalimumab weekly was consistent with the known safety profile of adalimumab.
Flare of HS, defined as ≥25% increase from baseline in abscesses and inflammatory nodule counts and with a minimum of 2 additional lesions, was documented in 22 (22%) of the 100 subjects who were withdrawn from adalimumab treatment following the primary efficacy timepoint in two studies.
Adalimumab has been studied in 464 adult patients with uveitis (UV) in placebo-controlled and open-label extension studies [see Clinical Studies (14.10)]. The safety profile for patients with UV treated with adalimumab was similar to the safety profile seen in patients with RA.
The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of adalimumab or of other adalimumab products.
There are two assays that have been used to measure anti-adalimumab antibodies. With the ELISA, antibodies to adalimumab could be detected only when serum adalimumab concentrations were < 2 mcg/mL. The ECL assay can detect anti-adalimumab antibody titers independent of adalimumab concentrations in the serum samples. The incidence of anti-adalimumab antibody (AAA) development in patients treated with adalimumab are presented in Table 2.
Table 2. Anti-Adalimumab Antibody Development Determined by ELISA and ECL Assay in Patients Treated with Adalimumab
| Indications | Study Duration | Anti-Adalimumab Antibody Incidence by ELISA (n/N) | Anti-Adalimumab Antibody Incidence by ECL Assay (n/N) | ||
| In all patients who received adalimumab | In patients with serum adalimumab concentrations < 2 mcg/mL | ||||
| Rheumatoid Arthritisa | 6 to 12 months | 5% (58/1062) | NR | NA | |
| Juvenile Idiopathic Arthritis (JIA) | 4 to 17 years of ageb | 48 weeks | 16% (27/171) | NR | NA |
| 2 to 4 years of age or ≥ 4 years of age and weighing < 15 kg | 24 weeks | 7% (1/15)c | NR | NA | |
| Psoriatic Arthritisd | 48 weekse | 13% (24/178) | NR | NA | |
| Ankylosing Spondylitis | 24 weeks | 9% (16/185) | NR | NA | |
| Adult Crohn’s Disease | 56 weeks | 3% (7/269) | 8% (7/86) | NA | |
| Pediatric Crohn’s Disease | 52 weeks | 3% (6/182) | 10% (6/58) | NA | |
| Adult Ulcerative Colitis | 52 weeks | 5% (19/360) | 21% (19/92) | NA | |
| Plaque Psoriasisf | Up to 52 weeksg | 8% (77/920) | 21% (77/372) | NA | |
| Hidradenitis Suppurativa | 36 weeks | 7% (30/461) | 28% (58/207)h | 61% (272/445i | |
| Non-infectious Uveitis | 52 weeks | 5% (12/249) | 21% (12/57) | 40% (99/249)j | |
|
n: number of patients with anti-adalimumab antibody; NR: not reported; NA: Not applicable (not performed) a In patients receiving concomitant methotrexate (MTX), the incidence of anti-adalimumab antibody was 1% compared to 12% with adalimumab monotherapy |
|||||
Rheumatoid Arthritis and Psoriatic Arthritis: Patients in Studies RA-I, RA-II, and RA-III were tested at multiple time points for antibodies to adalimumab using the ELISA during the 6- to 12-month period. No apparent correlation of antibody development to adverse reactions was observed. With monotherapy, patients receiving every other week dosing may develop antibodies more frequently than those receiving weekly dosing. In patients receiving the recommended dosage of 40 mg every other week as monotherapy, the
ACR 20 response was lower among antibody-positive patients than among antibody-negative patients. The long-term immunogenicity of adalimumab products is unknown.
The following adverse reactions have been identified during post-approval use of adalimumab products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to adalimumab products exposure.
Gastrointestinal disorders: Diverticulitis, large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, pancreatitis
General disorders and administration site conditions: Pyrexia
Hepato-biliary disorders: Liver failure, hepatitis
Immune system disorders: Sarcoidosis
Neoplasms benign, malignant and unspecified (including cysts and polyps): Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin)
Nervous system disorders: Demyelinating disorders (e.g., optic neuritis, Guillain-Barré syndrome), cerebrovascular accident
Respiratory disorders: Interstitial lung disease, including pulmonary fibrosis, pulmonary embolism
Skin reactions: Stevens Johnson Syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all sub types including pustular and palmoplantar), alopecia, lichenoid skin reaction
Vascular disorders: Systemic vasculitis, deep vein thrombosis
Adalimumab has been studied in rheumatoid arthritis (RA) patients taking concomitant methotrexate (MTX). Although MTX reduced the apparent adalimumab clearance, the data do not suggest the need for dose adjustment of either AMJEVITA or MTX [see Clinical Pharmacology (12.3)].
In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF-blockers with anakinra or abatacept, with no added benefit; therefore, use of AMJEVITA with abatacept or anakinra is not recommended in patients with RA [see Warnings and Precautions (5.7, 5.11)]. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF-blocker. There is insufficient information regarding the concomitant use of AMJEVITA and other biologic products for the treatment of RA, PsA, AS, CD, UC, Ps, HS and UV. Concomitant administration of AMJEVITA with other biologic DMARDs (e.g., anakinra and abatacept) or other TNF-blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions.
Avoid the use of live vaccines with AMJEVITA [see Warnings and Precautions (5.10)].
The formation of CYP450 enzymes may be suppressed by increased concentrations of cytokines (e.g., TNFa, IL-6) during chronic inflammation. It is possible for products that antagonize cytokine activity, such as adalimumab products, to influence the formation of CYP450 enzymes. Upon initiation or discontinuation of AMJEVITA in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.
Included as part of the PRECAUTIONS section.
The concomitant use of a TNF-blocker and abatacept or anakinra was associated with a higher risk of serious infections in patients with rheumatoid arthritis (RA); therefore, the concomitant use of AMJEVITA and these biologic products is not recommended in the treatment of patients with RA [see Warnings and Precautions (5.7, 5.11) and Drug Interactions (7.2)].
Treatment with AMJEVITA should not be initiated in patients with an active infection, including localized infections. Patients 65 years of age and older, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Consider the risks and benefits of treatment prior to initiating therapy in patients:
Cases of reactivation of tuberculosis and new onset tuberculosis infections have been reported in patients receiving adalimumab products, including patients who have previously received treatment for latent or active tuberculosis. Reports included cases of pulmonary and extrapulmonary (i.e., disseminated) tuberculosis.
Evaluate patients for tuberculosis risk factors and test for latent infection prior to initiating AMJEVITA and periodically during therapy.
Treatment of latent tuberculosis infection prior to therapy with TNF blocking agents has been shown to reduce the risk of tuberculosis reactivation during therapy. Prior to initiating AMJEVITA, assess if treatment for latent tuberculosis is needed; and consider an induration of ≥ 5 mm a positive tuberculin skin test result, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG).
Consider anti-tuberculosis therapy prior to initiation of AMJEVITA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab products. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient.
Strongly consider tuberculosis in the differential diagnosis in patients who develop a new infection during AMJEVITA treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment with AMJEVITA, including the development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. Tests for latent tuberculosis infection may also be falsely negative while on therapy with AMJEVITA.
Discontinue AMJEVITA if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with AMJEVITA, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.
If patients develop a serious systemic illness and they reside or travel in regions where mycoses are endemic, consider invasive fungal infection in the differential diagnosis. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection.
Consider appropriate empiric antifungal therapy, taking into account both the risk for severe fungal infection and the risks of antifungal therapy, while a diagnostic workup is being performed. To aid in the management of such patients, consider consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections.
Consider the risks and benefits of TNF-blocker treatment including AMJEVITA prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing a TNF-blocker in patients who develop a malignancy.
In the controlled portions of clinical trials of some TNF-blockers, including adalimumab products, more cases of malignancies have been observed among TNF-blocker-treated adult patients compared to control-treated adult patients. During the controlled portions of 39 global adalimumab clinical trials in adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), plaque psoriasis (Ps), hidradenitis suppurativa (HS) and uveitis (UV), malignancies, other than non-melanoma (basal cell and squamous cell) skin cancer, were observed at a rate (95% confidence interval) of 0.7 (0.48, 1.03) per 100 patient-years among 7973 adalimumab-treated patients versus a rate of 0.7
(0.41, 1.17) per 100 patient-years among 4848 control-treated patients (median duration of treatment of 4 months for adalimumab-treated patients and 4 months for control-treated patients). In 52 global controlled and uncontrolled clinical trials of adalimumab in adult patients with RA, PsA, AS, CD, UC, Ps, HS and UV, the most frequently observed malignancies, other than lymphoma and NMSC, were breast, colon, prostate, lung, and melanoma. The malignancies in adalimumab-treated patients in the controlled and uncontrolled portions of the studies were similar in type and number to what would be expected in the general U.S. population according to the SEER database (adjusted for age, gender, and race).1
In controlled trials of other TNF-blockers in adult patients at higher risk for malignancies (i.e., patients with COPD with a significant smoking history and cyclophosphamide-treated patients with Wegener’s granulomatosis), a greater portion of malignancies occurred in the TNF-blocker group compared to the control group.
Non-Melanoma Skin Cancer
During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, Ps, HS and UV, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, and in particular patients with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment for the presence of NMSC prior to and during treatment with AMJEVITA.
Lymphoma and Leukemia
In the controlled portions of clinical trials of all the TNF-blockers in adults, more cases of lymphoma have been observed among TNF-blocker-treated patients compared to control-treated patients. In the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, Ps, HS and UV, 2 lymphomas occurred among 7973 adalimumab treated patients versus 1 among 4848 control-treated patients. In 52 global controlled and uncontrolled clinical trials of adalimumab in adult patients with RA, PsA, AS, CD, UC, Ps, HS and UV, with a median duration of approximately 0.7 years, including 24,605 patients and over 40,215 patient-years of adalimumab, the observed rate of lymphomas was approximately 0.11 per 100 patient-years. This is approximately 3-fold higher than expected in the general U.S. population according to the SEER database (adjusted for age, gender, and race).1 Rates of lymphoma in clinical trials of adalimumab cannot be compared to rates of lymphoma in clinical trials of other TNF-blockers and may not predict the rates observed in a broader patient population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma, even in the absence of TNF-blockers. Post-marketing cases of acute and chronic leukemia have been reported in association with TNF-blocker use in RA and other indications. Even in the absence of
TNF-blocker therapy, patients with RA may be at a higher risk (approximately 2-fold) than the general population for the development of leukemia.
Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blockers (initiation of therapy ≤ 18 years of age), of which AMJEVITA is a member. Approximately half the cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months of therapy (range 1 to 84 months). Most of the patients were receiving concomitant immunosuppressants. These cases were reported post marketing and are derived from a variety of sources including registries and spontaneous post-marketing reports.
Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF-blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF-blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with the immunosuppressants azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF-blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF-blocker or a TNF-blocker in combination with these other immunosuppressants. The potential risk with the combination of azathioprine or 6-mercaptopurine and AMJEVITA should be carefully considered.
Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of AMJEVITA and institute appropriate therapy. In clinical trials of adalimumab, hypersensitivity reactions (e.g., rash, anaphylactoid reaction, fixed drug reaction, non-specified drug reaction, urticaria) have been observed.
Use of TNF-blockers, including AMJEVITA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to HBV reactivation. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF-blocker therapy. Exercise caution in prescribing TNF-blockers for patients identified as carriers of HBV. Adequate data are not available on the safety or efficacy of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-blocker therapy to prevent HBV reactivation. For patients who are carriers of HBV and require treatment with TNF-blockers, closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, stop AMJEVITA and initiate effective anti-viral therapy with appropriate supportive treatment. The safety of resuming TNF-blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of AMJEVITA therapy in this situation and monitor patients closely.
Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome. Exercise caution in considering the use of AMJEVITA in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of AMJEVITA should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders.
Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents. Adverse reactions of the hematologic system, including medically significant cytopenia (e.g., thrombocytopenia, leukopenia) have been infrequently reported with adalimumab products. The causal relationship of these reports to adalimumab products remains unclear. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on AMJEVITA. Consider discontinuation of AMJEVITA therapy in patients with confirmed significant hematologic abnormalities.
Concurrent use of anakinra (an interleukin-1 antagonist) and another TNF-blocker, was associated with a greater proportion of serious infections and neutropenia and no added benefit compared with the TNF-blocker alone in patients with RA. Therefore, the combination of AMJEVITA and anakinra is not recommended [see Drug Interactions (7.2)].
Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF-blockers. Cases of worsening CHF have also been observed with adalimumab products. Adalimumab products have not been formally studied in patients with CHF; however, in clinical trials of another TNF-blocker, a higher rate of serious CHF-related adverse reactions was observed. Exercise caution when using AMJEVITA in patients who have heart failure and monitor them carefully.
Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with AMJEVITA, discontinue treatment [see Adverse Reactions (6.1)].
In a placebo-controlled clinical trial of patients with RA, no difference was detected in anti-pneumococcal antibody response between adalimumab and placebo treatment groups when the pneumococcal polysaccharide vaccine and influenza vaccine were administered concurrently with adalimumab. Similar proportions of patients developed protective levels of anti-influenza antibodies between adalimumab and placebo treatment groups; however, titers in aggregate to influenza antigens were moderately lower in patients receiving adalimumab. The clinical significance of this is unknown. Patients on AMJEVITA may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products.
It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating AMJEVITA therapy. Patients on AMJEVITA may receive concurrent vaccinations, except for live vaccines.
The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants [see Use in Specific Populations (8.1, 8.4)].
In controlled trials, the concurrent administration of TNF-blockers and abatacept was associated with a greater proportion of serious infections than the use of a TNF-blocker alone; the combination therapy, compared to the use of a TNF-blocker alone, has not demonstrated improved clinical benefit in the treatment of RA.
Therefore, the combination of abatacept with TNF-blockers including AMJEVITA is not recommended [see Drug Interactions (7.2)].
Long-term animal studies of adalimumab products have not been conducted to evaluate the carcinogenic potential or its effect on fertility.
Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Inform patients that AMJEVITA may lower the ability of their immune system to fight infections. Instruct patients of the importance of contacting their doctor if they develop any symptoms of infection, including tuberculosis, invasive fungal infections, and reactivation of hepatitis B virus infections [see Warnings and Precautions (5.1, 5.2, 5.4)].
Counsel patients about the risk of malignancies while receiving AMJEVITA [see Warnings and Precautions (5.2)].
Advise patients to seek immediate medical attention if they experience any symptoms of severe hypersensitivity reactions.
Advise patients to report any signs of new or worsening medical conditions such as congestive heart failure, neurological disease, autoimmune disorders, or cytopenias. Advise patients to report any symptoms suggestive of a cytopenia such as bruising, bleeding, or persistent fever [see Warnings and Precautions (5.5, 5.6, 5.8, 5.9)].
Inform patients that the first injection is to be performed under the supervision of a qualified health care professional. If a patient or caregiver is to administer AMJEVITA, instruct them in injection techniques and assess their ability to inject subcutaneously to ensure the proper administration of AMJEVITA [see Instructions for Use]
Instruct patients to dispose of their used needles and syringes or used prefilled autoinjector in a FDA-cleared sharps disposal container immediately after use. Instruct patients not to dispose of loose needles and syringes or prefilled autoinjector in their household trash. Instruct patients that if they do not have a FDA-cleared sharps disposal container, they may use a household container that is made of a heavy-duty plastic, can be closed with a tight-fitting and puncture-resistant lid without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container.
Instruct patients that when their sharps disposal container is almost full, they will need to follow their community guidelines for the correct way to dispose of their sharps disposal container.
Instruct patients that there may be state or local laws regarding disposal of used needles and syringes. Refer patients to the FDA’s website at https://www.fda.gov/safesharpsdisposal for more information about safe sharps disposal, and for specific information about sharps disposal in the state that they live in.
Instruct patients not to dispose of their used sharps disposal container in their household trash unless their community guidelines permit this. Instruct patients not to recycle their used sharps disposal container.
Doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
No information provided
Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab products also lyse surface TNF expressing cells in vitro in the presence of complement. Adalimumab products do not bind or inactivate lymphotoxin (TNF-beta). TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated concentrations of TNF are found in the synovial fluid of patients with RA, JIA, PsA, and AS and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased concentrations of TNF are also found in psoriasis plaques. In Ps, treatment with AMJEVITA may reduce the epidermal thickness and infiltration of inflammatory cells. The relationship between these pharmacodynamic activities and the mechanism(s) by which adalimumab products exert their clinical effects is unknown.
Adalimumab products also modulate biological responses that are induced or regulated by TNF, including changes in the concentrations of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 × 10-10M).
After treatment with adalimumab, a decrease in concentrations of acute phase reactants of inflammation (C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]) and serum cytokines (IL-6) was observed compared to baseline in patients with rheumatoid arthritis. A decrease in CRP concentrations was also observed in patients with Crohn’s disease, ulcerative colitis, and hidradenitis suppurativa. Serum concentrations of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodeling responsible for cartilage destruction were also decreased after adalimumab administration.
The pharmacokinetics of adalimumab were linear over the dose range of 0.5 to 10 mg/kg following administration of a single intravenous dose (adalimumab products are not approved for intravenous use). Following 20, 40, and 80 mg every other week and every week subcutaneous administration, adalimumab mean serum trough concentrations at steady state increased approximately proportionally with dose in RA patients. The mean terminal half-life was approximately 2 weeks, ranging from 10 to 20 days across studies. Healthy subjects and patients with RA displayed similar adalimumab pharmacokinetics.
Adalimumab exposure in patients treated with 80 mg every other week is estimated to be comparable with that in patients treated with 40 mg every week.
The average absolute bioavailability of adalimumab following a single 40 mg subcutaneous dose was 64%. The mean time to reach the maximum concentration was 5.5 days (131 ± 56 hours) and the maximum serum concentration was 4.7 ± 1.6 mcg/mL in healthy subjects following a single 40 mg subcutaneous administration of adalimumab.
The distribution volume (Vss) ranged from 4.7 to 6.0 L following intravenous administration of doses ranging from 0.25 to 10 mg/kg in RA patients.
The single dose pharmacokinetics of adalimumab in RA patients were determined in several studies with intravenous doses ranging from 0.25 to 10 mg/kg. The systemic clearance of adalimumab is approximately 12 mL/hr. In long-term studies with dosing more than two years, there was no evidence of changes in clearance over time in RA patients.
Rheumatoid Arthritis and Ankylosing Spondylitis: In patients receiving 40 mg adalimumab every other week, adalimumab mean steady-state trough concentrations were approximately 5 mcg/mL and 8 to 9 mcg/mL, without and with MTX concomitant treatment, respectively. Adalimumab concentrations in the synovial fluid from five rheumatoid arthritis patients ranged from 31 to 96% of those in serum. The pharmacokinetics of adalimumab in patients with AS were similar to those in patients with RA.
Psoriatic Arthritis: In patients receiving 40 mg every other week, adalimumab mean steady-state trough concentrations were 6 to 10 mcg/mL and 8.5 to 12 mcg/mL, without and with MTX concomitant treatment, respectively.
Plaque Psoriasis: Adalimumab mean steady-state trough concentration was approximately 5 to 6 mcg/mL during adalimumab 40 mg every other week treatment.
Adult Uveitis: Adalimumab mean steady concentration was approximately 8 to 10 mcg/mL during adalimumab 40 mg every other week treatment.
Adult Hidradenitis Suppurativa: Adalimumab trough concentrations were approximately 7 to 8 mcg/mL at Week 2 and Week 4, respectively, after receiving 160 mg on Week 0 followed by 80 mg on Week 2. Mean steady-state trough concentrations at Week 12 through Week 36 were approximately 7 to 11 mcg/mL during adalimumab 40 mg every week treatment.
Adult Crohn’s Disease: Adalimumab mean trough concentrations were approximately 12 mcg/mL at Week 2 and Week 4 after receiving 160 mg on Week 0 followed by 80 mg on Week 2. Mean steady-state trough concentrations were 7 mcg/mL at Week 24 and Week 56 during adalimumab 40 mg every other week treatment.
Adult Ulcerative Colitis: Adalimumab mean trough concentrations were approximately 12 mcg/mL at Week 2 and Week 4 after receiving 160 mg on Week 0 followed by 80 mg on Week 2. Mean steady-state trough concentrations were approximately 8 mcg/mL and 15 mcg/mL at Week 52 after receiving a dose of adalimumab 40 mg every other week and 40 mg every week, respectively.
Rheumatoid Arthritis: A trend toward higher apparent clearance of adalimumab in the presence of anti-adalimumab antibodies was identified.
Hidradenitis Suppurativa: In subjects with moderate to severe HS, antibodies to adalimumab were associated with reduced serum adalimumab concentrations. In general, the extent of reduction in serum adalimumab concentrations is greater with increasing titers of antibodies to adalimumab.
Geriatric Patients: A lower clearance with increasing age was observed in patients with RA aged 40 to 75 years.
Pediatric Patients:
Juvenile Idiopathic Arthritis:
Pediatric Crohn's Disease: Adalimumab mean ± SD concentrations were 15.7±6.5 mcg/mL at Week 4 following 160 mg at Week 0 and 80 mg at Week 2, and 10.5±6.0 mcg/mL at Week 52 following 40 mg every other week dosing in patients weighing ≥ 40 kg. Adalimumab mean ± SD concentrations were 10.6±6.1 mcg/mL at Week 4 following dosing 80 mg at Week 0 and 40 mg at Week 2, and 6.9±3.6 mcg/mL at Week 52 following 20 mg every other week dosing in patients weighing < 40 kg.
Male and Female Patients: No gender-related pharmacokinetic differences were observed after correction for a patient’s body weight. Healthy subjects and patients with rheumatoid arthritis displayed similar adalimumab pharmacokinetics.
Patients with Renal or Hepatic Impairment: No pharmacokinetic data are available in patients with hepatic or renal impairment.
Rheumatoid factor or CRP concentrations: Minor increases in apparent clearance were predicted in RA patients receiving doses lower than the recommended dose and in RA patients with high rheumatoid factor or CRP concentrations. These increases are not likely to be clinically important.
Methotrexate: MTX reduced adalimumab apparent clearance after single and multiple dosing by 29% and 44%, respectively, in patients with RA [see Drug Interactions (7.1)].
MEDICATION GUIDE
AMJEVITA™ (am-jeh-vee'-tah)
(adalimumab-atto)
injection, for subcutaneous use
Read the Medication Guide that comes with AMJEVITA before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment.
What is the most important information I should know about AMJEVITA?
AMJEVITA is a medicine that affects your immune system. AMJEVITA can lower the ability of your immune system to fight infections. Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections.
You should not start taking AMJEVITA if you have any kind of infection unless your doctor says it is okay.
Before starting AMJEVITA, tell your doctor if you:
|
|
After starting AMJEVITA, call your doctor right away if you have an infection, or any sign of an infection. AMJEVITA can make you more likely to get infections or make any infection that you may have worse.
Cancer
What is AMJEVITA?
AMJEVITA is a medicine called a Tumor Necrosis Factor (TNF)-blocker. AMJEVITA is used:
What should I tell my doctor before taking AMJEVITA?
AMJEVITA may not be right for you. Before starting AMJEVITA, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your doctor if you use:
Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
How should I take AMJEVITA?
What are the possible side effects of AMJEVITA?
AMJEVITA can cause serious side effects, including:
ee “W hat is the most important information I should know about AMJEVITA?”
|
|
|
|
|
|
|
|
|
|
Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with AMJEVITA may be stopped.
The most common side effects with AMJEVITA include:
These are not all the possible side effects with AMJEVITA. Tell your doctor if you have any side effect that bothers you or that does not go away. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store AMJEVITA?
Keep AMJEVITA, injection supplies, and all other medicines out of the reach of children.
General information about the safe and effective use of AMJEVITA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AMJEVITA for a condition for which it was not prescribed. Do not give AMJEVITA to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about AMJEVITA. If you would like more
information, talk with your doctor. You can ask your doctor or pharmacist for information about AMJEVITA that is written for health professionals.
What are the ingredients in AMJEVITA? Active ingredient: adalimumab-atto
Inactive ingredients: glacial acetic acid, polysorbate 80, sucrose and Water for Injection. Sodium hydroxide is added as necessary to adjust the pH to 5.2.
 |
AMJEVITA™(adalimumab-atto)
Manufactured by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799 U.S.A
U.S. License Number 1080
© 2022–2023 Amgen Inc. All rights reserved.1xxxxxx – v6
For more information call 1-800-77-AMGEN (1-800-772-6436).
This Medication Guide has been approved by the U.S. Food and Drug Administration
INSTRUCTIONS FOR USE
AMJEVITA™(am-jeh-vee'-tah)
(adalimumab-atto)
injection, for subcutaneous use
20 mg/0.2 mL
40 mg/0.4 mL
80 mg/0.8 mL
single-dose prefilled syringe
This Instructions for Use contains information on how to inject AMJEVITA with a prefilled syringe.
If your healthcare provider decides that you or a caregiver may be able to give your injections of AMJEVITA at home, you should receive training on the right way to prepare and inject AMJEVITA. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse.
The medicine in the AMJEVITA prefilled syringe is for injection under the skin (subcutaneous injection). See the AMJEVITA Medication Guide for information about AMJEVITA.
Getting to know your prefilled syringe
 |
1. Important Information You Need to Know Before Injecting AMJEVITA
Dosing:
 |
Important: Keep the syringe and sharps disposal container out of the sight and reach of children.
Frequently asked questions:
For additional information and answers to frequently asked questions, visit www.amjevita.com.
Where to get help:
If you want more information or help using AMJEVITA:
2. Storing and Preparing to Inject AMJEVITA
 |
Dosing:
2a Refrigerate the syringe carton until you are ready to use it.
Important: Keep the syringe out of the sight and reach of children.
 |
2b Grasp the syringe by the body and remove it from the carton.
 |
2c Wait 15 to 30 minutes for the syringe to reach room temperature.
 |
2d You may keep AMJEVITA at room temperature for up to 14 days, if needed.
Important: Place the syringe in a sharps disposal container if it has reached room temperature and has not been used within 14 days.
 |
2e Gather and place the following items for your injection on a clean, flat, and well-lit surface:
3. Getting Ready for Your Injection
 |
3a Inspect the medicine. It should be clear and colorless to pale yellow.
Important: If the medicine is cloudy, discolored, or has flakes or particles, or if the syringe is damaged or expired, call 1-800-77-AMGEN (1-800-772-6436).
 |
3b Check the expiration date (Exp.) and inspect the syringe for damage.
 |
3c Inject into 1 of these locations.
Important: Avoid areas with scars or stretch marks, or where the skin is tender, bruised, red, or hard.
 |
3d Wash hands thoroughly with soap and water.
 |
3e Clean the injection site with an alcohol wipe.
4. Injecting AMJEVITA
Important: Only remove the needle cap when you can inject right away (within 5 minutes) because the medicine can dry out. Do not recap.
 |
4a Pull the needle cap straight off while holding the syringe body.
Important: Never put the needle cap back on to avoid accidental needlestick injury.
 |
4b Place the needle cap in the sharps disposal container.
 |
4c Pinch the skin around the injection site before injection.
Important: Continue to pinch the skin until the injection is complete.
INSERT
 |
4d Insert the needle into the pinched skin at a 45-degree angle.
INJECT
 |
4e Slowly press the plunger rod all the way down until it reaches the bottom of the syringe to inject the medicine.
5. Disposing of AMJEVITA and Checking the Injection Site
Important: Never put the needle cap back on.
 |
5a Place the used syringe in an FDA-cleared sharps disposal container right away after use.
Important: Do not throw away the syringe in your household trash.
 |
5b Check the injection site.
Additional information about your sharps disposal container
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
Disposing of sharps disposal containers:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
There may be state or local laws about how you should throw away used needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at:
https://www.fda.gov/safesharpsdisposal
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
Do not recycle your used sharps disposal container.
For more information or help call 1-800-77-AMGEN (1-800-772-6436).
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
AMJEVITA (adalimumab-atto)
Manufactured by:
|
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
US License Number 1080
©202X Amgen Inc. All rights reserved.
INSTRUCTIONS FOR USE
AMJEVITA™ (am-jeh-vee'-tah)
(adalimumab-atto)
injection, for subcutaneous use
40 mg/0.4 mL
single-dose prefilled SureClick® autoinjector
This Instructions for Use contains information on how to inject AMJEVITA with a SureClick autoinjector.
If your healthcare provider decides that you or a caregiver may be able to give your injections of AMJEVITA at home, you should receive training on the right way to prepare and inject AMJEVITA. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse.
The medicine in the AMJEVITA autoinjector is for injection under the skin (subcutaneous injection). See the AMJEVITA Medication Guide for information about AMJEVITA.
Getting to know your prefilled autoinjector
 |
1. Important Information You Need to Know Before Injecting AMJEVITA
Important: Keep the autoinjector and sharps disposal container out of the sight and reach of children.
Frequently asked questions:
For additional information and answers to frequently asked questions, visit www.amjevita.com.
Where to get help:
If you want more information or help using AMJEVITA:
2. Storing and Preparing to Inject AMJEVITA
 |
2a Refrigerate the autoinjector carton until you are ready to use it.
Important: Keep the autoinjector out of the sight and reach of children.
|
2b Wait 15 to 30 minutes for the autoinjector to reach room temperature.
|
2c You may keep AMJEVITA at room temperature for up to 14 days, if needed.
Important: Place the syringe in a sharps disposal container if it has reached room temperature and has not been used within 14 days.
 |
2d Inspect the medicine. It should be clear and colorless to pale yellow.
Important: If the medicine is cloudy, discolored, or has flakes or particles, or if the autoinjector is damaged or expired, call 1-800-77-AMGEN (1-800-772-6436).
 |
2e Check the expiration date (Exp.) and inspect the autoinjector for damage.
3. Getting Ready for Your Injection
 |
3a Gather and place the following items for your injection on a clean, flat, and well-lit surface:
|
3b Inject into 1 of these locations.
Important: Avoid areas with scars or stretch marks, or where the skin is tender, bruised, red, or hard.
|
3c Wash hands thoroughly with soap and water.
|
3d Clean the injection site with an alcohol wipe.
4. Injecting AMJEVITA
Important: Only remove the yellow cap when you can inject right away (within 5 minutes) because the medicine can dry out. Do not recap.
 |
4a Grasp the autoinjector so you can see the window. Pull the yellow cap straight off. You may need to pull hard.
 |
4b Pinch the skin to create a firm surface at the injection site. Place the cream safety guard straight against he pinched skin.
PUSH
and hold against skin
 |
4c Firmly push the autoinjector down until the cream safety guard stops moving. Hold the autoinjector down, do not lift.
PRESS
light blue start button
 |
4d Keep pushing the autoinjector down and press the light blue start button to start the injection.
WATCH and CONFIRM
that the window turns fully yellow
 |
4e Keep pushing the autoinjector down. When the window is fully yellow, the injection is complete.
Important: If the window has not turned fully yellow, or it looks like the medicine is still coming out, you have not received a full dose. Call your healthcare provider right away.
5. Disposing of AMJEVITA and Checking the Injection Site
 |
5a Place the used autoinjector and yellow cap in an FDA-cleared sharps disposal container right away after use.
Important: Do not throw away the autoinjector in your household trash.
|
5b Check the injection site.
Additional information about your sharps disposal container
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
Disposing of sharps disposal containers:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
There may be state or local laws about how you should throw away used needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at:
https://www.fda.gov/safesharpsdisposal
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
Do not recycle your used sharps disposal container.
For more information or help call 1-800-77-AMGEN (1-800-772-6436).
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
AMJEVITA (adalimumab-atto)
Manufactured by:
|
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
US License Number 1080
©202X Amgen Inc. All rights reserved.
