Nipocalimab
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Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Recommended Dosage for gMG Dilute IMAAVY prior to administration. Administer via intravenous infusion only [see Dosage and Administration ] . [See table below.]
Recommended Dosage for wAIHA Dilute IMAAVY prior to administration. Administer via intravenous infusion only [see Dosage and Administration ] . [See table below.]
Missed Doses If a scheduled infusion is missed, administer the dose of IMAAVY as soon as possible. Resume dosing, maintaining the treatment interval.
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 , 2.3) ] . 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 Dilute total volume withdrawn of IMAAVY by adding to an infusion container containing 0.9% Sodium Chloride Injection to a final volume of: 250 mL for patients who weigh 40 kg or more, or 100 mL for patients who weigh less than 40 kg.
Only use infusion containers made of polyolefin, polypropylene, or polyvinylchloride. Gently invert the infusion container at least 10 times to mix the solution. Do not shake. Verify that a uniform solution has been achieved by visual inspection. Do not use if particulate matter or discoloration is present. Storage Conditions of the Diluted Solution Administer the diluted IMAAVY solution immediately after preparation.
If the diluted IMAAVY solution is not used immediately: Protect from light. Store refrigerated at 2 °C to 8 °C (36 °F to 46 °F) for no more than 24 hours. Do not freeze. After preparation or removal from the refrigerator, use or discard the IMAAVY diluted solution within 12 hours, including infusion time. During these 12 hours, store under ambient light at 15 °C to 30 °C (59 °F to 86 °F).
Administration If the diluted solution is refrigerated prior to administration, allow to warm to room temperature. Do not use external heat sources to warm IMAAVY. Administer the diluted solution by intravenous infusion only using an infusion set with an in-line or add-on, sterile, non-pyrogenic, low protein-binding filter made of polyethersulfone or polysulfone (pore size 0.2 micrometer or less).
Administration sets must be made of either polybutadiene, polyethylene, polyurethane, polypropylene, or polyvinylchloride. Do not infuse IMAAVY concomitantly in the same intravenous line with other agents. Administer IMAAVY infusion intravenously over at least 30 minutes for the initial dose and at least 15 minutes for subsequent doses [see Dosage and Administration (2.2 , 2.3) ] .
If an adverse reaction occurs during administration of IMAAVY, the infusion may be slowed or stopped at the discretion of the healthcare professional. Monitor the patient for 30 minutes after each infusion for signs or symptoms of an infusion-related or hypersensitivity reaction [see Warnings and Precautions (5.2 , 5.3) ].
| Initial dosage | Maintenance dosage |
|---|---|
| 30 mg/kg administered once via intravenous infusion over at least 30 minutes. | Two weeks after the initial dose administer a maintenance dose of 15 mg/kg via intravenous infusion over at least 15 minutes. Continue the maintenance dose every two weeks thereafter. |
| Initial dosage | Subsequent dosage |
|---|---|
| 30 mg/kg administered once via intravenous infusion over at least 30 minutes. | Four weeks after the initial dose administer a subsequent dose of 30 mg/kg via intravenous infusion over at least 15 minutes. Continue the subsequent dose every four weeks thereafter. |
Drug interactions
Check nipocalimab against a medication listLabel text (2 paragraphs)
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. ( 7.1 )
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-aahu 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-aahu or to any of the excipients in IMAAVY. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for nipocalimab. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
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 .
Data 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 immunoglobulin (IgG) in the offspring at both doses tested. IgG levels in offspring returned to normal levels and no adverse effects on immune function were evident by 6 months after birth.
Mean systemic exposures achieved at the doses tested were 5- and 24-times the population PK model simulated mean steady state exposure at the recommended human maintenance dose for gMG (15 mg/kg) and 5.5- and 28-times the population PK model simulated mean steady state exposure at the recommended human maintenance dose for wAIHA (30 mg/kg) on an AUC basis.
Breastfeeding (LactMed)
Maternal nipocalimab injections produce low levels in colostrum and breastmilk. Because adalimumab is a large protein molecule, it is likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Nipocalimab was undetectable in the serum of some breastfed infants. No special precautions appear to be required.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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