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Mepolizumab is a humanized IL-5 antagonist monoclonal antibody. Mepolizumab is produced by recombinant DNA technology in Chinese hamster ovary cells. Mepolizumab has a molecular weight of approximately 149 kDa.
NUCALA is supplied as a sterile, white to off-white, preservative-free, lyophilized powder for SC injection after reconstitution. Upon reconstitution with 1.2 mL of Sterile Water for Injection, USP [see DOSAGE AND ADMINISTRATION], the resulting concentration is 100 mg/mL and delivers 1 mL. Each single-dose vial delivers mepolizumab 100 mg, polysorbate 80 (0.67 mg), sodium phosphate dibasic heptahydrate (7.14 mg), and sucrose (160 mg), with a pH of 7.0.
The following adverse reactions are described in greater detail in other sections:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
A total of 1,327 patients with severe asthma were evaluated in 3 randomized, placebo-controlled, multicenter trials of 24 to 52 weeks’ duration (Severe Asthma Trials DREAM, MENSA, and SIRIUS). Of these, 1,192 had a history of 2 or more exacerbations in the year prior to enrollment despite regular use of high-dose ICS plus additional controller(s) (Severe Asthma Trials DREAM and MENSA), and 135 patients required daily oral corticosteroids (OCS) in addition to regular use of high-dose ICS plus additional controller(s) to maintain asthma control (Severe Asthma Trial SIRIUS). All patients had markers of eosinophilic airway inflammation [see Clinical Studies (14.1)]. Of the patients enrolled, 59% were female, 85% were White, and ages ranged from 12 to 82 years. Mepolizumab was administered subcutaneously or intravenously once every 4 weeks; 263 patients received NUCALA (mepolizumab 100 mg subcutaneously) for at least 24 weeks. Serious adverse events that occurred in more than 1 patient and in a greater percentage of patients receiving NUCALA 100 mg (n = 263) than placebo (n = 257) included 1 event, herpes zoster (2 patients vs. 0 patients, respectively).
The incidence of adverse reactions in the first 24 weeks of treatment in the 2 confirmatory efficacy and safety trials MENSA and SIRIUS with NUCALA 100 mg is shown in Table 2.
Table 2: Adverse Reactions with NUCALA with ≥3% Incidence and More Common than Placebo in Patients with Severe Asthma (MENSA and SIRIUS)
|
Adverse Reaction |
NUCALA |
Placebo |
|
Headache |
19 |
18 |
|
Injection site reaction |
8 |
3 |
|
Back pain |
5 |
4 |
|
Fatigue |
5 |
4 |
|
Influenza |
3 |
2 |
|
Urinary tract infection |
3 |
2 |
|
Abdominal pain upper |
3 |
2 |
|
Pruritus |
3 |
2 |
|
Eczema |
3 |
<1 |
|
Muscle spasms |
3 |
<1 |
52-Week Trial: Adverse reactions from the Severe Asthma Trial DREAM with 52 weeks of treatment with mepolizumab 75 mg intravenously (n = 153) or placebo (n = 155) and with ≥3% incidence and more common than placebo and not shown in Table 2 were: abdominal pain, allergic rhinitis, asthenia, bronchitis, cystitis, dizziness, dyspnea, ear infection, gastroenteritis, lower respiratory tract infection, musculoskeletal pain, nasal congestion, nasopharyngitis, nausea, pharyngitis, pyrexia, rash, toothache, viral infection, viral respiratory tract infection, and vomiting. In addition, 3 cases of herpes zoster occurred in patients receiving mepolizumab 75 mg intravenously compared with 2 patients in the placebo group.
Systemic Reactions, including Hypersensitivity Reactions: In the Severe Asthma Trials DREAM, MENSA, and SIRIUS described above, the percentage of patients who experienced systemic (allergic and non-allergic) reactions was 3% in the group receiving NUCALA 100 mg and 5% in the placebo group. Systemic allergic/hypersensitivity reactions were reported by 1% of patients in the group receiving NUCALA 100 mg and 2% of patients in the placebo group. The most commonly reported manifestations of systemic allergic/hypersensitivity reactions reported in the group receiving NUCALA 100 mg included rash, pruritus, headache, and myalgia. Systemic
non-allergic reactions were reported by 2% of patients in the group receiving NUCALA 100 mg and 3% of patients in the placebo group. The most commonly reported manifestations of systemic non-allergic reactions reported in the group receiving NUCALA 100 mg included rash, flushing, and myalgia. A majority of the systemic reactions in patients receiving NUCALA 100 mg (5/7) were experienced on the day of dosing.
Injection Site Reactions: Injection site reactions (e.g., pain, erythema, swelling, itching, burning sensation) occurred at a rate of 8% in patients receiving NUCALA 100 mg compared with 3% in patients receiving placebo.
Long-Term Safety: Nine hundred ninety-eight patients received NUCALA 100 mg in open-label extension studies, during which additional cases of herpes zoster were reported. The overall adverse event profile has been similar to the severe asthma trials described above.
The safety data for NUCALA is based upon 1 open-label clinical trial that enrolled 36 patients with severe asthma aged 6 to 11 years. Patients received 40 mg (for those weighing <40 kg) or 100 mg (for those weighing ≥40 kg) of NUCALA administered subcutaneously once every 4 weeks. Patients received NUCALA for 12 weeks (initial short phase). After a treatment interruption of 8 weeks, 30 patients received NUCALA for a further 52 weeks (long phase). The adverse reaction profile for patients aged 6 to 11 years was similar to that observed in patients aged 12 years and older.
A total of 407 patients with CRSwNP were evaluated in 1 randomized, placebo-controlled, multicenter, 52-week treatment trial. Patients received NUCALA 100 mg or placebo subcutaneously once every 4 weeks. Patients had recurrent CRSwNP with a history of prior surgery and were on nasal corticosteroids for at least 8 weeks prior to screening [see Clinical Studies (14.2)]. Of the patients enrolled, 35% were female, 93% were White, and ages ranged from 18 to 82 years.
Table 3 summarizes adverse reactions that occurred in ≥3% of patients treated with NUCALA and more frequently than in patients treated with placebo in the CRSwNP trial.
Table 3: Adverse Reactions with NUCALA with ≥3% Incidence and More Common than Placebo in Patients with Chronic Rhinosinusitis with Nasal Polyps
|
Adverse Reaction |
NUCALA |
Placebo |
|
Oropharyngeal pain |
8 |
5 |
|
Arthralgia |
6 |
2 |
|
Abdominal pain upper |
3 |
2 |
|
Diarrhea |
3 |
2 |
|
Pyrexia |
3 |
2 |
|
Nasal dryness |
3 |
<1 |
|
Rash |
3 |
<1 |
Systemic Reactions, including Hypersensitivity Reactions: In the 52-week trial, the percentage of patients who experienced systemic (allergic [type I hypersensitivity] and other) reactions was <1% in the group receiving NUCALA 100 mg and <1% in the placebo group. Systemic allergic (type I hypersensitivity) reactions were reported by <1% of patients in the group receiving NUCALA 100 mg and no patients in the placebo group. The manifestations of systemic allergic (type I hypersensitivity) reactions included urticaria, erythema, and rash and 1 of the 3 reactions occurred on the day of dosing. Other systemic reactions were reported by no patients in the group receiving NUCALA 100 mg and <1% of patients in the placebo group.
Injection Site Reactions: Injection site reactions (e.g., erythema, pruritus) occurred at a rate of 2% in patients receiving NUCALA 100 mg compared with <1% in patients receiving placebo.
The safety data below reflects the safety of NUCALA in adults with inadequately controlled COPD and an eosinophilic phenotype. NUCALA was evaluated in a pooled safety population that consisted of 2089 patients with COPD in 3 randomized, placebo-controlled, multicenter trials of 52 to 104 weeks duration, including MATINEE and METREX [see Clinical Studies (14.3)], and Trial 3. Trial 3 enrolled COPD adults with a peripheral blood eosinophil count ≥150 cells/µL at screening or ≥300 cells/µL in the year prior. The pooled safety population received NUCALA 100 mg (n = 1043) or placebo (n = 1046), administered subcutaneously once every 4 weeks, in addition to background triple inhaled therapies (e.g., ICS, long-acting beta agonist [LABA], and long-acting muscarinic antagonist [LAMA]).
Table 4 summarizes adverse reactions that occurred in ≥3% of patients treated with NUCALA and more frequently than in patients treated with placebo in COPD trials.
Table 4: Adverse Reactions with NUCALA with ≥3% Incidence and More Common than Placebo in Patients with Chronic Obstructive Pulmonary Disease in a Pooled Safety Population (MATINEE, METREX, and Trial 3)
|
Adverse Reaction |
NUCALA |
Placebo |
|
Back pain |
7 |
6 |
|
Diarrhea |
5 |
4 |
|
Cough |
5 |
4 |
|
Oropharyngeal pain |
4 |
2 |
|
Urinary tract infection |
4 |
3 |
|
Pain in extremity |
4 |
3 |
Herpes Zoster: In the pooled safety population, 14 (1%) patients in the NUCALA group compared to 7 (0.7%) patients in the placebo group experienced herpes zoster.
A total of 136 patients with EGPA were evaluated in 1 randomized, placebo-controlled, multicenter, 52-week treatment trial. Patients received 300 mg of NUCALA or placebo subcutaneously once every 4 weeks. Patients enrolled had a diagnosis of EGPA for at least 6 months prior to enrollment with a history of relapsing or refractory disease and were on a stable dosage of oral prednisolone or prednisone of greater than or equal to 7.5 mg/day (but not greater than 50 mg/day) for at least 4 weeks prior to enrollment [see Clinical Studies (14.4)]. Of the patients enrolled, 59% were female, 92% were White, and ages ranged from 20 to 71 years. No additional adverse reactions were identified to those reported in the severe asthma trials.
Systemic Reactions, including Hypersensitivity Reactions: In the 52-week trial, the percentage of patients who experienced systemic (allergic and non-allergic) reactions was 6% in the group receiving 300 mg of NUCALA and 1% in the placebo group. Systemic allergic/hypersensitivity reactions were reported by 4% of patients in the group receiving 300 mg of NUCALA and 1% of patients in the placebo group. The manifestations of systemic allergic/hypersensitivity reactions reported in the group receiving 300 mg of NUCALA included rash, pruritus, flushing, fatigue, hypertension, warm sensation in trunk and neck, cold extremities, dyspnea, and stridor. Systemic non-allergic reactions were reported by 1 (1%) patient in the group receiving 300 mg of NUCALA and no patients in the placebo group. The reported manifestation of systemic non-allergic reactions reported in the group receiving 300 mg of NUCALA was angioedema. Half of the systemic reactions in patients receiving 300 mg of NUCALA (2/4) were experienced on the day of dosing.
Injection Site Reactions: Injection site reactions (e.g., pain, erythema, swelling) occurred at a rate of 15% in patients receiving 300 mg of NUCALA compared with 13% in patients receiving placebo.
A total of 108 adult and adolescent patients aged 12 years and older with HES were evaluated in a randomized, placebo-controlled, multicenter, 32-week treatment trial. Patients with non-hematologic secondary HES or FIP1L1-PDGFRα kinase-positive HES were excluded from the trial. Patients received 300 mg of NUCALA or placebo subcutaneously once every 4 weeks. Patients must have been on a stable dose of background HES therapy for the 4 weeks prior to randomization [see Clinical Studies (14.5)]. Of the patients enrolled, 53% were female, 93% were White, and ages ranged from 12 to 82 years. No additional adverse reactions were identified to those reported in the severe asthma trials.
Systemic Reactions, including Hypersensitivity Reactions: In the trial, no systemic allergic (type I hypersensitivity) reactions were reported. Other systemic reactions were reported by 1 (2%) patient in the group receiving 300 mg of NUCALA and no patients in the placebo group. The reported manifestation of other systemic reaction was multifocal skin reaction experienced on the day of dosing.
Injection Site Reactions: Injection site reactions (e.g., burning, itching) occurred at a rate of 7% in patients receiving 300 mg of NUCALA compared with 4% in patients receiving placebo.
In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during post-approval use of NUCALA. 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 drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to NUCALA or a combination of these factors.
Hypersensitivity reactions, including anaphylaxis.
Formal drug interaction trials have not been performed with NUCALA.
Included as part of the PRECAUTIONS section.
Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred following administration of NUCALA. These reactions generally occur within hours of administration, but in some instances can have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, NUCALA should be discontinued [see Contraindications (4)].
NUCALA should not be used to treat acute symptoms or acute exacerbations of asthma or COPD. Do not use NUCALA to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma or COPD remains uncontrolled or worsens after initiation of treatment with NUCALA.
Herpes zoster has occurred in subjects receiving NUCALA 100 mg in controlled clinical trials [see Adverse Reactions (6.1)]. Consider vaccination if medically appropriate.
Do not discontinue systemic or inhaled corticosteroids (ICS) abruptly upon initiation of therapy with NUCALA. Reductions in corticosteroid dosage, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dosage may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Eosinophils may be involved in the immunological response to some helminth infections. Patients with known parasitic infections were excluded from participation in clinical trials. It is unknown if NUCALA will influence a patient’s response against parasitic infections. Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. If patients become infected while receiving treatment with NUCALA and do not respond to anti-helminth treatment, discontinue treatment with NUCALA until infection resolves.
Long-term animal studies have not been performed to evaluate the carcinogenic potential of mepolizumab. Published literature using animal models suggests that IL-5 and eosinophils are part of an early inflammatory reaction at the site of tumorigenesis and can promote tumor rejection. However, other reports indicate that eosinophil infiltration into tumors can promote tumor growth. Therefore, the malignancy risk in humans from an antibody to IL-5 such as mepolizumab is unknown.
Male and female fertility were unaffected based upon no adverse histopathological findings in the reproductive organs from cynomolgus monkeys receiving mepolizumab for 6 months at intravenous dosages up to 100 mg/kg once every 4 weeks (approximately 20 times the MRHD of 300 mg on an AUC basis). Mating and reproductive performance were unaffected in male and female CD-1 mice receiving an analogous antibody, which inhibits the activity of murine IL-5, at an intravenous dosage of 50 mg/kg once per week.
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Inform patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of NUCALA. Instruct patients to contact their healthcare provider if such reactions occur.
Inform patients that NUCALA does not treat acute asthma symptoms or acute exacerbations of asthma or COPD. Inform patients to seek medical advice if their asthma remains uncontrolled or COPD symptoms worsen after initiation of treatment with NUCALA.
Inform patients that herpes zoster infections have occurred in patients receiving NUCALA and where medically appropriate, inform patients that vaccination should be considered.
Inform patients to not discontinue systemic or inhaled corticosteroids except under the direct supervision of a physician. Inform patients that reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Trademarks are owned by or licensed to the GSK group of companies.
Manufactured by:
GlaxoSmithKline LLC
Philadelphia, PA 19104
U.S. License No. 1727
Distributed by:
 |
GlaxoSmithKline
Durham, NC 27701
©2025 GSK group of companies or its licensor.
There is no specific treatment for an overdose with mepolizumab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
NUCALA is contraindicated in patients with a history of hypersensitivity to mepolizumab or excipients in the formulation [see Warnings and Precautions (5.1), Description (11)].
Mepolizumab is an IL-5 antagonist (IgG1 kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Mepolizumab binds to IL-5 with a dissociation constant of 100 pM, inhibiting the bioactivity of IL-5 by blocking its binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface. Inflammation is an important component in the pathogenesis of asthma, CRSwNP, COPD, EGPA, and HES. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in inflammation. Mepolizumab, by inhibiting IL-5 signaling, reduces the production and survival of eosinophils; however, the mechanism of mepolizumab action in asthma, CRSwNP, COPD, EGPA, and HES has not been definitively established.
The pharmacodynamic response (blood eosinophil reduction) following repeat doses of mepolizumab administered subcutaneously or intravenously was evaluated in adult subjects with asthma and blood eosinophil levels >200 cells/mcL. Subjects received 1 of 4 mepolizumab treatments (administered every 28 days for a total of 3 doses): 12.5 mg subcutaneous, 125 mg subcutaneous, 250 mg subcutaneous, or 75 mg intravenous. Sixty-six of the 70 randomized subjects completed the trial. Compared with baseline levels, blood eosinophils decreased in a dose-dependent manner. A reduction in blood eosinophil levels was observed in all treatment groups by Day 3 (48 hours post-dose). On Day 84 (4 weeks post-last dose), the observed geometric mean reduction from baseline in blood eosinophils was 64%, 78%, 84%, and 90% in the 12.5-mg subcutaneous, 75-mg intravenous, 125-mg subcutaneous, and 250-mg subcutaneous treatment groups, respectively. The model-predicted subcutaneous doses providing 50% and 90% of maximal reduction of blood eosinophils at Day 84 were estimated to be 11 and 99 mg, respectively. These results, along with the clinical efficacy data from the dose-ranging exacerbation DREAM Trial in adult and adolescent subjects with severe asthma supported the evaluation of mepolizumab 75 mg intravenous and 100 mg subcutaneous in the confirmatory severe asthma trials [see Clinical Studies (14.1)]. Following subcutaneous administration of mepolizumab 100 mg every 4 weeks for 32 weeks in adult and adolescent subjects with severe asthma (MENSA Trial), blood eosinophils were reduced to a geometric mean count of 40 cells/mcL, which corresponds to a geometric mean reduction of 84% compared with placebo.
The pharmacodynamic response (blood eosinophil reduction) was also evaluated in children aged 6 to 11 years with severe asthma. Following subcutaneous administration of mepolizumab 40 mg every 4 weeks for 52 weeks, blood eosinophils were reduced to a geometric mean count of 48 cells/mcL. This corresponds to a geometric mean reduction from baseline of 85%.
The magnitude of reduction in adults, adolescents, and children with severe asthma was observed within 4 weeks of treatment and was maintained throughout the treatment periods.
Following subcutaneous administration of NUCALA 100 mg every 4 weeks (for CRSwNP or COPD), or 300 mg every 4 weeks (for EGPA or HES), blood eosinophils were reduced to a similar magnitude to that observed in patients with severe asthma compared to placebo.
For adults with CRSwNP, following subcutaneous administration of mepolizumab 100 mg every 4 weeks for 52 weeks, blood eosinophils were reduced to a geometric mean count of 60 cells/mcL. There was a geometric mean reduction of 83% compared with placebo. This magnitude of reduction was observed within 4 weeks of treatment and was maintained throughout the treatment period [see Clinical Studies (14.2)].
For adults with COPD, following subcutaneous administration of mepolizumab 100 mg every 4 weeks for 52 to 104 weeks, blood eosinophils were reduced to a geometric mean count of 50-60 cells/mcL. There was a geometric mean reduction of approximately 79% compared with placebo, and this magnitude of reduction was observed within 4 weeks of treatment and was maintained throughout the treatment period [see Clinical Studies (14.3)].
For adults with EGPA, following subcutaneous administration of mepolizumab 300 mg every 4 weeks for 52 weeks, blood eosinophils were reduced to a geometric mean count of 38 cells/mcL. There was a geometric mean reduction of 83% compared with placebo, and this magnitude of reduction was observed within 4 weeks of treatment [see Clinical Studies (14.4)].
For adults and pediatric patients aged 12 years and older with HES, following subcutaneous administration of mepolizumab 300 mg every 4 weeks for 32 weeks, blood eosinophils were reduced to a geometric mean count of 70 cells/mcL. There was a geometric mean reduction of 92% compared with placebo [see Clinical Studies (14.5)].
Following subcutaneous dosing in adult subjects with asthma, mepolizumab exhibited approximately dose-proportional pharmacokinetics over a dose range of 12.5 to 250 mg. The pharmacokinetic properties of mepolizumab observed in subjects with CRSwNP (adults), COPD (adults), EGPA (adults), or HES (adults and adolescents) were similar to the pharmacokinetic properties observed in subjects with severe asthma (adults and adolescents).
Subcutaneous administration of mepolizumab 300 mg had approximately 3 times the systemic exposure of mepolizumab 100 mg.
Following 100-mg subcutaneous administration in the upper arm of adult and adolescent subjects with asthma, the bioavailability of mepolizumab was estimated to be approximately 80%.
Following repeat subcutaneous administration once every 4 weeks, there was approximately a 2-fold accumulation at steady state.
The population central volume of distribution of mepolizumab in adult subjects with asthma is estimated to be 3.6 L for a 70-kg individual.
Following subcutaneous administration of mepolizumab in adult subjects with asthma, the mean terminal half-life (t1/2) ranged from 16 to 22 days. The population apparent systemic clearance of mepolizumab in adult and adolescent subjects with asthma is estimated to be 0.28 L/day for a 70-kg individual.
Metabolism: Mepolizumab is a humanized IgG1 monoclonal antibody that is degraded by the proteolytic enzymes widely distributed in the body and not restricted to hepatic tissue.
Racial Groups and Male and Female Patients: Population pharmacokinetics analyses indicated there was no significant effect of race and gender on mepolizumab clearance.
Age: Population pharmacokinetics analyses indicated there was no significant effect of age on mepolizumab clearance.
Pediatric Patients: Mepolizumab pharmacokinetics following subcutaneous administration in subjects aged 6 to 11 years with severe asthma was investigated in the initial 12-week treatment phase of an open-label clinical trial. Exposures (AUC) following subcutaneous administration of either 40 mg (for children weighing <40 kg) or 100 mg (for children weighing ≥40 kg) were 1.32 and 1.97 times higher, respectively, compared with that observed in adults and adolescents receiving 100 mg. Based on these results, simulation of a 40-mg subcutaneous dose every 4 weeks in children aged 6 to 11 years, irrespective of body weight, resulted in predicted exposures similar to that observed in adults and adolescents.
Patients with Renal Impairment: No clinical trials have been conducted to investigate the effect of renal impairment on the pharmacokinetics of mepolizumab. Based on population pharmacokinetic analyses, mepolizumab clearance was comparable between subjects with creatinine clearance values between 50 and 80 mL/min and patients with normal renal function. There are limited data available in subjects with creatinine clearance values <50 mL/min; however, mepolizumab is not cleared renally.
Patients with Hepatic Impairment: No clinical trials have been conducted to investigate the effect of hepatic impairment on the pharmacokinetics of mepolizumab. Since mepolizumab is degraded by widely distributed proteolytic enzymes, not restricted to hepatic tissue, changes in hepatic function are unlikely to have any effect on the elimination of mepolizumab.
No formal drug interaction studies have been conducted with mepolizumab. In population pharmacokinetics analyses of Phase 3 studies, there was no evidence of an effect of commonly coadministered small molecule drugs on mepolizumab exposure.
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 NUCALA or of other mepolizumab products.
In adult and adolescent patients with severe asthma receiving NUCALA 100 mg, 15/260 (6%) had detectable anti-mepolizumab antibodies. Neutralizing antibodies were detected in 1 patient with asthma receiving NUCALA 100 mg. Anti-mepolizumab antibodies slightly increased (approximately 20%) the clearance of mepolizumab. There was no evidence of a correlation between anti-mepolizumab antibody titers and change in eosinophil level. The clinical relevance of the presence of anti-mepolizumab antibodies is not known. In the clinical trial of children aged 6 to 11 years with severe asthma receiving NUCALA 40 or 100 mg, 2/35 (6%) had detectable anti-mepolizumab antibodies during the initial short phase of the trial. No children had detectable anti-mepolizumab antibodies during the long phase of the trial.
In patients receiving NUCALA 100 mg over 52 weeks for CRSwNP or over 52 to 104 weeks for COPD, 6/196 (3%) and 35/999 (4%) had detectable anti-mepolizumab antibodies, respectively. In patients receiving NUCALA 300 mg over 52 weeks for EGPA or over 32 weeks for HES, 1/68 (<2%) and 1/53 (2%) had detectable anti-mepolizumab antibodies, respectively. No neutralizing antibodies were detected in any of these patients. Because of the low occurrence of anti-drug antibodies, the effect of these antibodies on the pharmacokinetics, pharmacodynamics, safety, and/or effectiveness of NUCALA is unknown.
The reported frequency of anti-mepolizumab antibodies may underestimate the actual frequency due to lower assay sensitivity in the presence of high drug concentration. The data reflect the percentage of patients whose test results were positive for antibodies to mepolizumab in specific assays.
INSTRUCTIONS FOR USE
NUCALA(mepolizumab) injection, for subcutaneous use
100 mg/mL Prefilled Autoinjector
Important information
NUCALA is a prescription medicine that is injected under the skin (subcutaneous) from a single-dose prefilled autoinjector. You and your caregiver should be trained on how to prepare and perform your injection before trying to do it yourself.
The following instructions provide the information you need to correctly use the prefilled autoinjector with yellow needle guard.
Before starting your injection, it is important that you read and understand these instructions and then carefully follow them so that you complete each step successfully.
Storage information
Keep NUCALA and all medicines out of the reach of children.
Warnings
Know your prefilled autoinjector
 |
Supplies in carton
1 Prefilled autoinjector
Supplies not in carton
|
Prepare |
|
|
1. Take out the prefilled autoinjector |
|
|
|
|
2. Inspect and wait 30 minutes before use |
|
|
|
|
3. Choose your injection site |
|
|
|
|
4. Clean your injection site |
|
|
|
|
Inject |
|
|
5. Remove the clear needle cap |
|
|
|
|
6. Start your injection |
|
|
|
|
7. Complete your injection |
|
|
|
|
Dispose |
|
|
8. Throw away your used autoinjector |
|
|
Put your used autoinjector and clear needle cap in an FDA-cleared sharps disposal container right away after use. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of it. There may be state or local laws about how you should throw away used autoinjectors. 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: www.fda.gov/safesharpsdisposal.
Keep your sharps disposal container out of the reach of children. |
|
Frequently asked questions
|
For more information about NUCALA, call 1-888-825-5249 or visit our website at www.NUCALA.com.
Trademarks are owned by or licensed to the GSK group of companies.
Manufactured by:
GlaxoSmithKline LLC,
Philadelphia, PA 19104,
U.S. License No. 1727
Distributed by:
GlaxoSmithKline,
Durham, NC 27701
©2023 GSK group of companies or its licensor. NCL:4IFU-A
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: March 2023
INSTRUCTIONS FOR USE
NUCALA (mepolizumab) injection, for subcutaneous use
100 mg/mL Prefilled Syringe
Important information
NUCALA is a prescription medicine that is injected under the skin (subcutaneous) from a single-dose prefilled syringe. You and your caregiver should be trained on how to prepare and perform your injection before trying to do it yourself.
The following instructions provide the information you need to correctly use the prefilled syringe with automatic needle guard.
Before starting your injection, it is important that you read and understand these instructions and then carefully follow them so that you complete each step successfully.
Storage information
Keep NUCALA and all medicines out of the reach of children.
Warnings
Know your prefilled syringe
 |
Supplies in carton
1 Prefilled syringe
Supplies not in carton
|
Prepare |
|
|
1. Take out the prefilled syringe |
|
|
|
|
2. Inspect and wait 30 minutes before use |
|
|
|
|
3. Choose your injection site |
|
|
|
|
4. Clean your injection site |
|
|
|
|
Inject |
|
|
5. Remove the gray needle cap |
|
|
|
|
6. Start your injection |
|
|
|
|
7. Complete your injection |
|
|
|
|
Dispose |
|
|
8. Throw away your used syringe |
|
|
Put your used syringe and gray needle cap in an FDA-cleared sharps disposal container right away after use. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of it. There may be state or local laws about how you should throw away used syringe. 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: www.fda.gov/safesharpsdisposal.
Keep your sharps disposal container out of the reach of children. |
|
|
For more information about NUCALA, call 1-888-825-5249 or visit our website at www.NUCALA.com.
Trademarks are owned by or licensed to the GSK group of companies.
Manufactured by:
GlaxoSmithKline LLC,
Philadelphia, PA 19104,
U.S. License No. 1727
Distributed by:
GlaxoSmithKline,
Durham, NC 27701
©2023 GSK group of companies or its licensor. NCL:4IFU-S
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: March 2023
INSTRUCTIONS FOR USE
NUCALA (mepolizumab) injection, for subcutaneous use
40 mg/0.4 mL Prefilled Syringe
Important information
NUCALA is a prescription medicine that is injected under the skin (subcutaneous) from a single-dose prefilled syringe. You and your caregiver should be trained on how to prepare and perform your injection before trying to do it yourself.
The following instructions provide the information you need to correctly use the prefilled syringe with automatic needle guard.
Before starting your injection, it is important that you read and understand these instructions and then carefully follow them so that you complete each step successfully.
Storage information
Keep NUCALA and all medicines out of the reach of children.
Warnings
Know your prefilled syringe
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Supplies in carton
1 Prefilled syringe
Supplies not in carton
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Prepare |
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1. Take out the prefilled syringe |
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2. Inspect and wait 30 minutes before use |
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3. Choose your injection site |
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4. Clean your injection site |
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Inject |
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5. Remove the gray needle cap |
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6. Start the injection |
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7. Complete the injection |
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Dispose |
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8. Throw away the used syringe |
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Put your used syringe and gray needle cap in an FDA-cleared sharps disposal container right away after use. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of it. There may be state or local laws about how you should throw away used syringe. 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: www.fda.gov/safesharpsdisposal.
Keep your sharps disposal container out of the reach of children. |
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For more information about NUCALA, call 1-888-825-5249 or visit our website at www.NUCALA.com.
Trademarks are owned by or licensed to the GSK group of companies.
Manufactured by:
GlaxoSmithKline LLC,
Philadelphia, PA 19104,
U.S. License No. 1727
Distributed by:
GlaxoSmithKline,
Durham, NC 27701
©2023 GSK group of companies or its licensor. NCL:2IFU-S40
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: March 2023
