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Axatilimab-csfr is a CSF-1R–blocking antibody. Axatilimab-csfr is a humanized IgG4 (kappa light chain) monoclonal antibody produced in Chinese hamster ovary cells. Axatilimab-csfr has an approximate molecular weight of 150 kDa.
NIKTIMVO (axatilimab-csfr) injection is a sterile, preservative-free, slightly opalescent, pale brownish yellow solution for intravenous use. The solution is free from visible particles.
Each single-dose vial contains 50 mg of axatilimab-csfr in 1 mL of solution. Each mL contains 50 mg of axatilimab-csfr, citric acid monohydrate (3.6 mg), glycine (9.38 mg), polysorbate 80 (0.5 mg), sodium citrate (8.49 mg), sucrose (42.79 mg) and Water for Injection, USP. The pH is 5.0.
NIKTIMVO is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
For patients weighing at least 40 kg, administer NIKTIMVO 0.3 mg/kg, up to a maximum dose of 35 mg, as an intravenous infusion over 30 minutes every 2 weeks until progression or unacceptable toxicity.
Monitor aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatine phosphokinase (CPK), amylase, and lipase prior to the start of NIKTIMVO therapy, every 2 weeks for the first month, and every 1 to 2 months thereafter until abnormalities are resolved.
For recommended NIKTIMVO dosage modifications due to adverse reactions, see Table 1.
Table 1: Recommended NIKTIMVO Dosage Modifications for Adverse Reactions
| Adverse Reaction | Severitya | Dosage Modification |
| Infusion-related reactions [see WARNINGS AND PRECAUTIONS] | Grade 1 or 2 |
|
| Grade 3 or 4 | Permanently discontinue NIKTIMVO. | |
| Elevation of AST or ALT (on the day of dosing) [see ADVERSE REACTIONS] | Grade 3 with total bilirubin ≤ Grade 1 | Withhold NIKTIMVO until recovery to Grade 2, then resume NIKTIMVO at 0.2 mg/kg (maximum 23 mg) every 2 weeks. |
| Elevation of AST or ALT (regardless of the time of the reaction) [see ADVERSE REACTIONS] | ALT or AST ≥ 3 times ULN with total bilirubin ≥ 2 times ULN and ALP < 2 times ULN | Withhold NIKTIMVO and investigate for drug-induced liver injury. If confirmed, permanently discontinue NIKTIMVO. |
| Grade 4 | Permanently discontinue NIKTIMVO. | |
| Elevation of CPK, amylase, or lipase [see ADVERSE REACTIONS] | ≥ Grade 3 |
|
| Symptomatic ≥ Grade 3 | Permanently discontinue NIKTIMVO. | |
| Other Nonhematologic Adverse Reactions [see ADVERSE REACTIONS] | Grade 3 | Withhold NIKTIMVO until recovery to Grade 2:
|
| Grade 4 | Permanently discontinue NIKTIMVO. | |
| AST = aspartate aminotransferase; ALT = alanine aminotransferase; ULN = upper limit of normal; ALP = alkaline phosphatase; CPK = creatine phosphokinase. a Graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5. |
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OR
Injection: 50 mg/mL slightly opalescent, pale brownish yellow solution in a single-dose vial.
NIKTIMVO (axatilimab-csfr) injection is a slightly opalescent, pale brownish yellow solution. It is supplied in a carton containing one single-dose vial of:
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.
Manufactured by: Incyte Corporation, Wilmington, DE 19803. Revised: Aug 2024.
The following 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 safety of NIKTIMVO was evaluated in 79 adult and pediatric patients with cGVHD treated with NIKTIMVO 0.3 mg/kg intravenously every 2 weeks in the AGAVE-201 trial [see Clinical Studies]. The median duration of treatment was 10.3 months (range: 0.5 to 28.6 months), and 73.4% were treated for more than 6 months.
Serious adverse reactions occurred in 44% of patients who received NIKTIMVO. Serious adverse reactions in more than 2 patients included infection (pathogen unspecified), viral infection, and respiratory failure. Permanent discontinuation of NIKTIMVO due to an adverse reaction occurred in 10% of patients and dose reduction due to adverse reaction occurred in 8% of patients. Dose interruptions due to an adverse reaction occurred in 44% of patients. The adverse reactions leading to dose interruption in more than 2 patients were viral infection, infection (pathogen unspecified), bacterial infection, musculoskeletal pain, and pyrexia.
The most common (≥ 15%) adverse reactions, including laboratory abnormalities, were increased AST, infection (pathogen unspecified), increased ALT, decreased phosphate, decreased hemoglobin, viral infection, increased gamma glutamyl transferase (GGT), musculoskeletal pain, increased lipase, fatigue, increased amylase, increased calcium, increased CPK, increased ALP, nausea, headache, diarrhea, cough, bacterial infection, pyrexia, and dyspnea.
Table 2 summarizes the nonlaboratory adverse reactions in AGAVE-201.
Table 2: Adverse Reactions in ≥ 10% of Patients With cGVHD Who Received NIKTIMVO in AGAVE-201
| Adverse Reaction | NIKTIMVO 0.3 mg/kg intravenously every 2 weeks (N = 79) |
|
| All Grades (%) | Grades 3-4 (%) | |
| Infections and infestations | ||
| Infection (pathogen unspecified)a | 57 | 14 |
| Viral infectionb | 43 | 15 |
| Bacterial infectionc | 15 | 8 |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal paind | 35 | 3 |
| General disorders and administration site conditions | ||
| Fatiguee | 32 | 4 |
| Pyrexia | 15 | 1 |
| Edemaf | 13 | 1 |
| Gastrointestinal disorders | ||
| Nauseag | 23 | 3 |
| Diarrheah | 18 | 5 |
| Nervous system disorders | ||
| Headachei | 20 | 1 |
| Dizzinessj | 11 | 0 |
| Respiratory, thoracic and mediastinal disordersCoughk180 | ||
| Dyspneal | 15 | 3 |
| Immune system disorders | ||
| Drug hypersensitivitym | 13 | 3 |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 11 | 4 |
| Vascular disorders | ||
| Hemorrhagen | 11 | 1 |
| Skin and subcutaneous tissue disorders | ||
| Rasho | 10 | 0 |
| Graded according to NCI CTCAE v5.0. a Includes abscess jaw, atypical pneumonia, bacteremia, bronchitis, conjunctivitis, cystitis, device-related infection,enterocolitis infectious, gastroenteritis, gastrointestinal infection, groin abscess, hordeolum, liver abscess,nasopharyngitis, otitis media, otitis media acute, pneumonia, respiratory tract infection, rhinitis, sepsis, sinusitis,tooth infection, upper respiratory tract infection, urinary tract infection, and wound infection. b Includes adenoviral upper respiratory infection, BK virus infection, COVID-19, coronavirus infection, enterovirus infection, gastroenteritis astroviral, gastroenteritis viral, herpes simplex, herpes zoster, influenza, metapneumovirus bronchiolitis, metapneumovirus infection, norovirus infection, oral viral infection, parainfluenza viral bronchitis, parainfluenza virus infection, respiratory syncytial virus infection, rhinovirus infection, viral infection, and viral upper respiratory tract infection. c Includes bacterial diarrhea, bacterial vaginosis, campylobacter gastroenteritis, campylobacter infection, cellulitis, clostridium difficile colitis, clostridium difficile infection, enterococcal infection, erysipelas, hemophilus infection, lower respiratory tract infection bacterial, pseudomonal skin infection, staphylococcal bacteremia, staphylococcal infection, stenotrophomonas infection, streptococcal infection, and urinary tract infection enterococcal. d Includes arthralgia, back pain, flank pain, musculoskeletal pain, myalgia, pain in extremity. e Includes asthenia, fatigue, and malaise. f Includes localized edema and peripheral edema. g Includes nausea and vomiting. h Includes colitis and diarrhea. i Includes headache and migraine. j Includes dizziness and dizziness postural. k Includes cough and productive cough. l Includes dyspnea and dyspnea exertional. m Includes bronchospasm, flushing, hot flush, hypersensitivity, infusion-related hypersensitivity reaction, infusionrelated reaction, and urticaria. n Includes contusion, epistaxis, hematochezia, hematoma, and vaginal hemorrhage. o Includes dermatitis bullous, dermatitis exfoliative generalized, rash, and rash maculo-papular. |
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Clinically relevant adverse reactions in < 10% of patients who received NIKTIMVO included:
Table 3 summarizes the laboratory abnormalities in AGAVE-201.
Table 3: Selected Laboratory Abnormalities in Patients with cGVHD Who Received NIKTIMVO in AGAVE-201
| Laboratory Abnormality | NIKTIMVO 0.3 mg/kg intravenously every 2 weeks (N=79) |
|
| All Gradesa (%) |
Grade 3 or 4a (%) |
|
| Hematology | ||
| Decreased hemoglobin | 48 | 4 |
| Chemistry | ||
| Increased aspartate aminotransferase | 61 | 5 |
| Increased alanine aminotransferase | 51 | 3 |
| Decreased phosphate | 51 | NA |
| Increased gamma glutamyl transferase | 39 | 4 |
| Increased lipase | 34 | 3 |
| Increased amylase | 32 | 0 |
| Increased calcium | 31 | 1 |
| Increased alkaline phosphatase | 28 | 0 |
| Increased creatine phosphokinase | 25 | 0 |
| NA = not applicable. a The denominator used to calculate the rate varied from 78 to 79 based on the number of patients with at least1 post-treatment value |
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Immunogenicity: Anti-Drug Antibody–Associated Adverse Reactions
In 276 patients with cGVHD who received NIKTIMVO in clinical trials, among the patients who developed anti-drug antibodies (ADAs), hypersensitivity reactions occurred in 26% (13/50) of patients with neutralizing antibodies (NAb) and in 4% (2/45) of those without NAb [see CLINICAL PHARMACOLOGY].
No Information Provided
Included as part of the "PRECAUTIONS" Section
NIKTIMVO can cause infusion-related reactions. Infusion-related reactions, including hypersensitivity reactions, occurred in 18% of patients who received NIKTIMVO in the clinical trial (AGAVE-201), with Grade 3 or 4 reactions in 1.3% [see ADVERSE REACTIONS].
Premedicate with an antihistamine and an antipyretic for patients who have previously experienced an infusion-related reaction to NIKTIMVO [see DOSAGE AND ADMINISTRATION].
Monitor patients for signs and symptoms of infusion-related reactions, including fever, chills, rash, flushing, dyspnea, and hypertension. Interrupt or slow the rate of infusion or permanently discontinue NIKTIMVO based on severity of the reaction [see DOSAGE AND ADMINISTRATION].
Based on its mechanism of action, NIKTIMVO may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with NIKTIMVO and for 30 days after the last dose [see Use In Specific Populations].
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).
Advise patients and caregivers that reactions related to the infusion may occur during NIKTIMVO treatment. Inform patients and caregivers of the signs and symptoms of infusion-related reactions and to seek medical care should signs and symptoms occur [see WARNINGS AND PRECAUTIONS].
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy. Advise females of reproductive potential to use effective contraception during treatment with NIKTIMVO and for 30 days after the last dose [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].
Advise women not to breastfeed during treatment and for 30 days after the last dose of NIKTIMVO [see Use In Specific Populations].
No studies have been performed to assess the potential of axatilimab-csfr for carcinogenicity or genotoxicity.
Dedicated fertility studies have not been conducted with axatilimab-csfr. Administration of axatilimab-csfr to sexually mature cynomolgus monkeys in a 3-month toxicology study had no effect on menstrual cyclicity in females, sperm parameters (morphology, motility, or number) in males, and produced no histopathologic findings in female and male reproductive organs, indicating that axatilimab-csfr did not adversely affect reproductive function. Targeted deletion of CSF-1R or CSF-1 in rodent models resulted in impairment of fertility.
Based on its mechanism of action, NIKTIMVO may cause fetal harm when administered to pregnant women [see CLINICAL PHARMACOLOGY]. There are no available data on the use of NIKTIMVO in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with axatilimab-csfr.
Targeted mutation of CSF-1R or CSF-1 in rodent models results in prenatal and perinatal death, deficits in growth, and pleiotropic impact on multiple organ systems, including skeletal and reproductive. Regulation by CSF-1R on non-mononuclear phagocytic cells and macrophages plays a role in the innate immune protection of the fetus and in pregnancy maintenance and embryo-fetal development. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, NIKTIMVO has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
There are no data on the presence of axatilimab-csfr in human milk or the effects on the breastfed child or milk production. Maternal IgG is known to be present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 30 days after the last dose of NIKTIMVO.
NIKTIMVO may cause fetal harm when administered to a pregnant woman [see Pregnancy].
Verify pregnancy status in females of reproductive potential prior to initiating NIKTIMVO [see Pregnancy].
Females
Advise females of reproductive potential to use effective contraception during treatment with NIKTIMVO and for 30 days after the last dose of NIKTIMVO.
The safety and effectiveness of NIKTIMVO for the treatment of cGVHD after failure of at least two prior lines of systemic therapy have been established in pediatric patients weighing at least 40 kg. Use of NIKTIMVO in pediatric patients weighing at least 40 kg is supported by evidence from clinical trials that included 3 children (ages 6 to less than 12 years old) and 5 adolescents (ages 12 to less than 17 years old) [see Clinical Studies]. The safety and effectiveness of NIKTIMVO have not been established in pediatric patients weighing less than 40 kg.
Compared to adult and pediatric patients weighing 40 kg and above, patients weighing less than 40 kg had lower maximum concentration, trough concentration, and average concentration at the same weight-based dosage.
Based on findings of thickening of the growth plate and metaphysis and/or degeneration of the growth plate in the femur in animals, monitor bone growth and development in pediatric patients [see Nonclinical Toxicology].
Of the 79 patients with cGVHD treated with NIKTIMVO, 21 (26.6%) were 65 years and older, and 2 (2.5%) were 75 years and older [see Clinical Studies]. No overall differences in the safety or effectiveness of NIKTIMVO have been observed between patients 65 years of age and older and younger patients.
No Information Provided
None.
Axatilimab-csfr is a monoclonal antibody that binds to colony stimulating factor-1 receptors (CSF-1R) expressed on monocytes and macrophages. Blocking CSF-1R with axatilimab-csfr reduces the levels of these circulating proinflammatory and profibrotic monocytes and monocyte-derived macrophages, as demonstrated by a reduction of nonclassical monocyte counts in nonclinical studies with axatilimab-csfr, and inhibits the activity of pathogenic macrophages in tissues.
Axatilimab-csfr caused a dose-dependent increase from 0.15 mg/kg to 6 mg/kg (0.5 to 20 times the approved recommended dosage) in CSF-1 and interleukin (IL)-34 concentrations and a dose-dependent reduction in the levels of nonclassical monocytes in peripheral blood.
Axatilimab-csfr pharmacokinetics are presented as geometric mean (coefficient of variation [%CV]) in adult patients with cGVHD following axatilimab-csfr 0.3 mg/kg (maximum 35 mg) every 2 weeks, unless otherwise specified. Axatilimab-csfr AUC increased in a greater than dose-proportional manner following single-dose administration of axatilimab-csfr over a dose range of 0.15 mg/kg to 3 mg/kg (0.5 to 10 times the approved recommended dosage) in healthy subjects.
There was no axatilimab-csfr systemic accumulation following the approved recommended dosage.
Axatilimab-csfr volume of distribution is 6.06 L (16.3% CV).
Axatilimab-csfr total clearance is 0.07 L/h (38.8% CV). The median (5th to 95th percentile) time to 97% reduction from Cmax after the end of infusion is 4.0 (2.3 to 7.2) days following axatilimab-csfr 0.3 mg/kg (maximum 35 mg).
The total clearance of axatilimab-csfr is composed of linear and non-linear components such that axatilimab-csfr clearance decreased from 2.32 mL/h/kg to 0.21 mL/h/kg and mean terminal halflife increased from 10.7 hours to 108 hours following single-dose administrations of axatilimabcsfr over a dose range of 0.15 mg/kg to 3 mg/kg (0.5 to 10 times the approved recommended dosage).
Metabolism
Axatilimab-csfr is expected to be metabolized into small peptides by catabolic pathways.
No clinically meaningful differences in the exposure of axatilimab-csfr were observed in adult and pediatric patients based on age (12 to 81 years), sex, body weight (40 to 151 kg), race (White, Black, or Asian), mild to moderate renal impairment (estimated creatinine clearance 30-89 mL/min by the Cockcroft-Gault equation), or mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin 1 to ≤ 1.5 times ULN and any AST) following the approved recommended dosage of 0.3 mg/kg (maximum 35 mg) every 2 weeks.
The effect of severe renal impairment (estimated creatinine clearance 15-29 mL/min, Cockcroft-Gault equation) and moderate to severe hepatic impairment (total bilirubin > 1.5 times ULN and any AST) on axatilimab-csfr pharmacokinetics is unknown.
Axatilimab-csfr exposures in pediatric patients weighing 40 kg and above are comparable to those in adults following the approved recommended dosage of 0.3 mg/kg (maximum 35 mg) every 2 weeks.
The observed incidence of ADAs is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADAs in the studies described below with the incidence of ADAs in other studies, including those of NIKTIMVO or of other axatilimab products.
ADAs were assessed in 276 patients with cGVHD who received NIKTIMVO. The incidence of axatilimab-csfr treatment-emergent ADAs was 33.7% (93/276) following a median exposure time of 7.8 months. NAb were detected in 47 of 93 cGVHD patients with treatment-emergent ADAs. There was no clinically meaningful effect of anti–axatilimab-csfr antibodies or NAb on the pharmacokinetics, pharmacodynamics, or effectiveness of NIKTIMVO. The presence of NAb correlated with the occurrence of hypersensitivity reactions [see ADVERSE REACTIONS].
In a 6-month chronic toxicity study in sexually immature cynomolgus monkeys, axatilimab-csfr was administered once weekly at doses of 10, 30, or 100 mg/kg/week via intravenous injection. The primary findings included periorbital swelling, widespread accumulation of basophilic material, and effects on bone at doses ≥ 10 mg/kg/week. Alterations in bone included decreases in bone markers, thickening of the growth plate and metaphysis and/or degeneration of the growth plate in the femur. In a 3-month toxicity study in sexually mature monkeys, intravenous administration of axatilimab-csfr at doses of 10, 30, or 100 mg/kg/week resulted in decreases in bone biomarkers at doses ≥ 30 mg/kg/week.
The efficacy of NIKTIMVO was evaluated in AGAVE-201 (NCT04710576), a randomized, open-label, multicenter study in adult and pediatric patients with recurrent or refractory cGVHD who had received at least 2 lines of systemic therapy and required additional treatment. Patients with platelet count ≥ 50 × 109/L, absolute neutrophil count ≥ 1 × 109/L, ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN if liver cGVHD was present), total bilirubin ≤ 1.5 × ULN, and creatinine clearance ≥ 30 mL/minute were eligible. Patients with uncontrolled infections were not eligible.
Treatment consisted of NIKTIMVO 0.3 mg/kg administered intravenously every 2 weeks until disease progression, lack of efficacy by 9 months, or unacceptable toxicity. Continued treatment with GVHD prophylaxis and standard care systemic cGVHD therapies were permitted as long as the patient had been on a stable dose for at least 2 weeks prior to study. Initiation of new systemic cGVHD therapy while on study was not permitted.
Demographics and baseline characteristics of the 79 patients treated with NIKTIMVO 0.3 mg/kg every 2 weeks in AGAVE-201 are summarized in Table 4.
Table 4: Demographics and Baseline Characteristics of Patients With cGVHD
| NIKTIMVO 0.3 mg/kg every 2 weeks (N = 79) |
|
| Median age, years (range) | 50 (7, 76) |
| Age ≥ 65 years, n (%) | 21 (27) |
| Male, n (%) | 46 (58) |
| Race, n (%) | |
| White | 67 (85) |
| Asian | 4 (5) |
| Black | 2 (3) |
| Other | 1 (1) |
| Not reported | 5 (6) |
| Median (range) time (months) from cGVHD diagnosis | 47 (4, 211) |
| ≥ 4 Organs involved, n (%) | 45 (57) |
| Median (range) number of prior lines of therapy | 4 (2, 12) |
| Number of prior lines of therapy, n (%) | |
| 2 | 11 (14) |
| 3 | 14 (18) |
| 4 | 17 (22) |
| ≥ 5 | 37 (47) |
| Prior cGVHD treatment with ibrutinib, n (%) | 27 (34) |
| Prior cGVHD treatment with ruxolitinib, n (%) | 57 (72) |
| Prior cGVHD treatment with belumosudil, n (%) | 16 (20) |
| Refractory to last therapy, n (%) | 37 (47) |
| Severe cGVHD, n (%) | 63 (80) |
| Median (range) Global Severity Rating | 7 (2, 10) |
| Median (range) modified Lee Symptom Scale Score at baseline | 24 (4, 55) |
| Median (range) corticosteroid dose at baseline (PE/kg)a | 0.21 (0.04, 2.12) |
| a Prednisone equivalents/kilogram/day. | |
The efficacy of NIKTIMVO was based on overall response rate (ORR) through Cycle 7 Day 1, where overall response included complete response or partial response according to the 2014 NIH Consensus Development Project on Response Criteria. The ORR results from AGAVE-201 for the 0.3 mg/kg every 2 weeks dosage regimen are presented in Table 5. The median time to first response was 1.5 months (range, 0.9 to 5.1 months). The median duration of response, calculated from first response to progression, death, or new systemic therapies for cGVHD, was 1.9 months (95% CI: 1.6, 3.5). In patients who achieved response, no death or new systemic therapy initiation occurred in 60% (95% CI: 43, 74) of patients for at least 12 months since response.
Table 5: Efficacy Results From AGAVE-201
| Endpoint | NIKTIMVO 0.3 mg/kg every 2 weeks (N = 79) |
| Overall response rate, n (%) | 59 (75%) |
| 95% CI | 64, 84 |
| Complete response, n (%) | 0 (0%) |
| Partial response, n (%) | 59 (75%) |
| CI = confidence interval | |
ORR results were supported by exploratory analyses of patient-reported symptom bother which showed at least a 7-point decrease in the modified Lee Symptom Scale score through Cycle 7 Day 1 in 56% (95% CI: 44, 67) of patients.
NIKTIMVO™
(nik tim voe)
(axatilimab-csfr) injection, for intravenous use
What is NIKTIMVO?
NIKTIMVO is a prescription medicine used to treat adults and children who weigh at least 88.2 pounds (40 kg) with chronic graft-versus-host disease (cGVHD) after you have received at least 2 prior treatments (systemic therapy) and they did not work.
It is not known if NIKTIMVO is safe and effective in adults and children weighing less than 88.2 pounds (40 kg).
Before receiving NIKTIMVO, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive NIKTIMVO?
What are the possible side effects of NIKTIMVO?
NIKTIMVO may cause serious side effects, including:
The most common side effects of NIKTIMVO include:
These are not all the possible side effects of NIKTIMVO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Incyte Corporation at 1-855-463-3463.
General information about the safe and effective use of NIKTIMVO.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider for information about NIKTIMVO that is written for health professionals.
What are the ingredients in NIKTIMVO?
Active ingredient: axatilimab-csfr
Inactive ingredients: citric acid monohydrate, glycine, polysorbate 80, sodium citrate, sucrose, and Water for Injection.
