Nipocalimab
FDA Drug Information • Also known as: Imaavy
- Brand Names
- Imaavy
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION Nipocalimab-aahu, a neonatal Fc receptor blocker, is a recombinant human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody, expressed in a genetically engineered Chinese hamster ovary cell line. Nipocalimab-aahu has an aglycosylated Fc region, therefore it lacks effector functions. Nipocalimab-aahu has an approximate molecular weight of 142 kilodaltons (kDa). IMAAVY™ (nipocalimab-aahu) injection is a sterile, preservative-free, colorless to slightly brownish, clear to slightly opalescent solution, supplied in a single-dose vial for intravenous infusion after dilution. Each single-dose vial contains either 300 mg/1.62 mL or 1,200 mg/6.5 mL of nipocalimab-aahu at a concentration of 185 mg/mL. In addition, each mL of solution contains arginine hydrochloride (25.35 mg), histidine (0.77 mg), L-histidine monohydrochloride monohydrate (1.07 mg), methionine (1.0 mg), polysorbate 80 (0.60 mg), sucrose (64.3 mg), and water for injection, USP, at a pH of 6.0.
What Is Nipocalimab Used For?
1 INDICATIONS AND USAGE IMAAVY is indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. IMAAVY is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for instructions on dosage, preparation, and administration. ( 2.1 , 2.2 , 2.3 ) Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of IMAAVY. ( 2.1 ) Administer via intravenous infusion only. ( 2.2 ) The recommended initial dosage is 30 mg/kg once via intravenous infusion over at least 30 minutes. Two weeks after the initial dosage, administer a maintenance dosage of 15 mg/kg via intravenous infusion over at least 15 minutes, and continue every two weeks thereafter. ( 2.2 ) Must be diluted with 0.9% sodium chloride injection prior to administration. ( 2.3 ) Administer as an intravenous infusion via a 0.2 micron in-line or add-on filter. ( 2.3 ) 2.1 Recommended Vaccination Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of IMAAVY. Because IMAAVY causes transient reduction in IgG levels, vaccination with live vaccines is not recommended during treatment with IMAAVY [see Warnings and Precautions (5.1) ]. 2.2 Recommended Dosage Dilute IMAAVY prior to administration. Administer via intravenous infusion only [see Dosage and Administration (2.3) ] . The recommended initial dosage of IMAAVY is 30 mg/kg administered once via intravenous infusion over at least 30 minutes. Two weeks after the initial dosage administer a maintenance dosage of 15 mg/kg via intravenous infusion over at least 15 minutes. Continue the maintenance dosage every two weeks thereafter. If a scheduled infusion appointment is missed, the maintenance dosage of IMAAVY should be administered as soon as possible. Resume dosing every two weeks thereafter. 2.3 Preparation and Administration Instructions Prior to administration, dilute IMAAVY single-dose vials with only 0.9% sodium chloride injection using the instructions below. For patients who weigh 40 kg or more, the total volume to be administered is 250 mL; for patients who are 12 years or older and weigh less than 40 kg, the total volume to be administered is 100 mL (see Preparation ) . Preparation Prepare the solution for infusion using aseptic technique as follows: Calculate the dosage (mg), total drug volume (mL) of IMAAVY solution required, and the number of IMAAVY vials needed, based on the patient's current weight [see Dosage and Administration (2.2) ] . Each single-dose vial of IMAAVY is at a concentration of 185 mg/mL. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Check that the solution in each vial is colorless to slightly brownish, clear to slightly opalescent, and free of visible particles. Do not use if visible particles are present or if the solution is discolored (other than colorless to slightly brownish). Gently withdraw the calculated volume of IMAAVY from the vial(s). Discard any unused portion of the vials. Dilute total...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling Infections [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Infusion-related Reactions [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥10%) in patients with gMG treated with IMAAVY were respiratory tract infections, peripheral edema, and muscle spasms. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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. Adults In Study 1 and its extension study the safety of IMAAVY was evaluated in 186 patients with gMG who received at least one dose of IMAAVY. Of those patients, 168 patients were exposed to IMAAVY every 2 weeks for at least 6 months, and 140 patients were exposed for at least 12 months. In Study 1, 98 adult patients with gMG received IMAAVY 15 mg/kg every two weeks (after 30 mg/kg initial dose) [see Clinical Studies (14) ]. Of these 98 patients, approximately 67% were female, 67% were White, 29% were Asian, and 10% were of Hispanic or Latino ethnicity. The mean age at study entry was 53 years (range 20 to 81). Adverse reactions reported in at least 5% of patients treated with IMAAVY and more frequently than placebo, are summarized in Table 1. The most common adverse reactions (reported in at least 10% of patients treated with IMAAVY) were respiratory tract infection, peripheral edema, and muscle spasms. Table 1: Adverse Reactions (≥ 5%) of Patients Treated with IMAAVY and More Frequently than in Placebo in Study 1 Adverse Reaction IMAAVY N=98 % Placebo N=98 % Includes the following reported in patients treated with IMAAVY: Infection Respiratory tract infection COVID-19 (and other related terms), pneumonia, bronchitis, pneumonia bacteria 18 13 Urinary tract infection other related terms 6 3 Herpes zoster and Herpes simplex 6 2 Oral infection glossitis, oral candidiasis, pericoronitis, pulpitis dental, tooth abscess, tooth infection 5 3 Peripheral edema 12 2 Muscle spasm 12 3 Hypersensitivity reaction angioedema, dermatitis atopic, eczema, gingival swelling, rash (and other related terms), urticaria 8 7 Abdominal pain 8 3 Back pain 8 5 Pyrexia 7 1 Diarrhea 7 3 Cough 7 3 Anemia 6 4 Dizziness 5 1 Nausea 5 2 Hypertension 5 2 Insomnia 5 2 Infections In Study 1 and its extension study, infections that occurred in patients treated with IMAAVY (n=186) included upper respiratory tract infection (46%), respiratory tract infection (28%; including pneumonia, bronchitis, COVID-19), urinary tract infection (15%), herpes (8%; including herpes simplex, herpes zoster, herpes zoster oticus), influenza (8%), oral infection (8%; including candidiasis and dental infections), and skin infection (7%; including cellulitis). Two (1%) cases of infections (cellulitis and urinary tract infection) led to discontinuation of IMAAVY [see Warnings and Precautions (5.1) ] . Hypersensitivity Reactions In Study 1 and its extension study, out of 186 patients treated with IMAAVY, 30 (16%) patients experienced hypersensitivity reactions, which occurred within one hour to two weeks of administration. One patient experienced hypersensitivity reaction (urticaria) that required discontinuation of IMAAVY [see Warnings and Precautions (5.2) ] . Infusion-Related Reactions In Study 1 and its extension study, out of 186 patients treated with IMAAVY, 20 (11%) patients experienced infusion-related reactions, which occurred within one hour to 2 days of administration. No patients experienced infusion-related reaction that required discontinuation of IMAAVY [see Warnings and Precautions (5.3) ] ....
Drug Interactions
7 DRUG INTERACTIONS Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing IMAAVY and using alternative therapies. ( 7 ) 7.1 Effect of IMAAVY on Other Drugs Concomitant use of IMAAVY with medications that bind to the human neonatal Fc receptor (FcRn) (e.g., immunoglobulin products, monoclonal antibodies, or antibody derivates containing the human Fc domain of the IgG subclass) may lower systemic exposures and reduce effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing IMAAVY, and using alternative therapies [see Clinical Pharmacology (12.3) ] .
Contraindications
4 CONTRAINDICATIONS IMAAVY is contraindicated in patients with a history of serious hypersensitivity reaction to nipocalimab or any of the excipients in IMAAVY. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.2) ] . IMAAVY is contraindicated in patients with a history of serious hypersensitivity reaction to nipocalimab or to any of the excipients in IMAAVY. ( 4 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary There are limited data on the use of IMAAVY in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There was no evidence of direct adverse effects on fetal development following administration of nipocalimab-aahu to pregnant monkeys; however, adverse effects on the placenta were associated with fetal loss at both doses tested (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There is a pregnancy safety study for IMAAVY. If IMAAVY is administered during pregnancy, or if a patient becomes pregnant while receiving IMAAVY, healthcare providers should report IMAAVY exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com Clinical Considerations Fetal/Neonatal Adverse Reactions Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Because IMAAVY reduces maternal serum IgG concentration and impedes placental IgG transfer to the fetus, passive immunity in the infant may be reduced for 6 months or more; therefore: Monitor for the development of serious infection. Effectiveness of vaccines may be reduced. Consider the risks and benefits prior to administering live vaccines to infants exposed to IMAAVY in utero . Animal Data Intravenous administration of nipocalimab-aahu (0, 100, or 300 mg/kg) to pregnant monkeys weekly from the end of organogenesis (gestation day 45) through parturition resulted in placental ischemia, associated with fetal loss and decreased levels of IgG in the offspring at both doses tested. IgG levels in offspring...
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied IMAAVY™ (nipocalimab-aahu) injection is a sterile, preservative-free, colorless to slightly brownish, clear to slightly opalescent solution for intravenous use after dilution. IMAAVY is supplied in cartons containing a single-dose vial per carton as: 300 mg/1.62 mL (185 mg/mL) NDC 57894-800-01 1,200 mg/6.5 mL (185 mg/mL) NDC 57894-801-01 Storage and Handling Unopened Vials Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Diluted Solution For storage of the diluted IMAAVY solution, see Dosage and Administration (2.3) .
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.