August 2025
Dosage guidance:
Safety: Evaluate need to administer age-appropriate vaccines according to immunization guidelines prior to initiation; immunization with live vaccines is not recommended during treatment due to transient reduction in IgG levels. Delay administration in patients with active infection until the infection is resolved.
Missed dose: Administer missed dose as soon as possible and resume dosing every 2 weeks thereafter.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
No dosage adjustment necessary.
No dosage adjustment necessary.
Refer to adult dosing.
(For additional information see "Nipocalimab: Pediatric drug information")
Myasthenia gravis, generalized: Note: For use in patients with antiacetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase (MuSK) antibody positive generalized myasthenia gravis.
Children ≥12 years and Adolescents:
Initial: IV: 30 mg/kg/dose once. Begin maintenance dosing 2 weeks after initial dose.
Maintenance: IV: 15 mg/kg/dose every 2 weeks.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Altered kidney function:
Children ≥12 years and Adolescents: IV: No dosage adjustment necessary.
Children ≥12 years and Adolescents: IV: No dosage adjustment necessary.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported for adults, unless otherwise noted.
>10%:
Cardiovascular: Peripheral edema (12%)
Endocrine & metabolic: Hypercholesterolemia (24%), increased LDL cholesterol (11%)
Immunologic: Antibody development (children, adolescents, adults: 48%; neutralizing: 39%)
Infection: Infection (43%; serious infection: 7%)
Neuromuscular & skeletal: Muscle spasm (12%)
Respiratory: Respiratory tract infection (18%)
1% to 10%:
Cardiovascular: Hypertension (5%)
Endocrine & metabolic: Decreased HDL cholesterol (5%)
Gastrointestinal: Abdominal pain (8%), diarrhea (7%), infection of mouth (5%), nausea (5%)
Genitourinary: Urinary tract infection (6%)
Hematologic & oncologic: Anemia (6%)
Hypersensitivity: Hypersensitivity reaction (8%; including anaphylaxis, angioedema)
Infection: Herpes simplex infection (≤6%), herpes zoster infection (≤6%)
Nervous system: Dizziness (5%), insomnia (5%)
Neuromuscular & skeletal: Back pain (8%)
Respiratory: Cough (7%)
Miscellaneous: Fever (7%)
Frequency not defined: Hypersensitivity: Infusion-related reaction (including chills, erythema of skin, fatigue, flu-like symptoms, headache, skin rash)
Serious hypersensitivity reactions (eg, anaphylaxis, angioedema) to nipocalimab or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity reaction: Hypersensitivity reactions, including angioedema, anaphylaxis, rash, urticaria, and eczema, may occur; mild to moderate reactions usually occurred within 1 hour to 2 weeks of administration. Hypersensitivity reactions have led to discontinuation of therapy. If a hypersensitivity reaction occurs during administration, discontinue infusion and administer appropriate supportive measures.
• Infection: Risk of infection, including serious infections and latent viral infections (eg, herpes zoster, Epstein-Barr virus), may be increased. Delay administration in patients with active infection until the infection is resolved. If a serious infection occurs, treat appropriately and consider withholding nipocalimab until resolution of infection. Evaluate need to administer age-appropriate vaccines according to immunization guidelines prior to initiation.
• Infusion reaction: Infusion-related reactions, including chills, dizziness, erythema, fatigue, headache, influenza-like illness, nausea, and rash, may occur; mild to moderate reactions usually occurred within 1 hour to 2 days of administration. If a severe infusion reaction occurs during administration, discontinue infusion and administer appropriate supportive measures. Consider risks and benefits of readministration in patients with a severe infusion-related reaction. If a mild to moderate infusion-related reaction occurs, a rechallenge may be considered with premedication, slower infusion rates, and close monitoring.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Ref). Thrombocytopenia, ascites, pulmonary deterioration, and kidney and liver failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Ref). See manufacturer's labeling.
Other warnings/precautions:
• Immunizations: Nipocalimab causes a reduction in humanized monoclonal antibody (IgG) levels; avoid the use of live vaccines in patients undergoing nipocalimab treatment. Evaluate need to administer age-appropriate vaccines according to immunization guidelines prior to initiation. For infants exposed to nipocalimab in utero, passive immunity may be reduced for ≥6 months; vaccine efficacy may also be reduced. Consider risks and benefits of administering live vaccines and monitor for development of infection in these infants.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Imaavy: Nipocalimab-aahu 1,200 mg/6.5 mL (6.5 mL) [contains polysorbate 80]
No
Solution (Imaavy Intravenous)
1200MG/6.5ML (per mL): $2,304.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: Administer as IV infusion only. Dilute prior to administration. Administer diluted solution 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). Administration sets must be made of either polybutadiene, polyethylene, polyurethane, polypropylene, or polyvinylchloride. If diluted solution is refrigerated prior to administration, allow solution to adjust to room temperature (do not use a heat source) prior to infusion. Other medications should not be added to or simultaneously infused through the same IV line. Administer as follows:
Initial dose: Infuse over ≥30 minutes.
Maintenance dose: Infuse over ≥15 minutes.
If adverse effects occur during administration, slow or stop the infusion. Monitor patient for 30 minutes following completion of infusion for signs/symptoms of infusion-related or hypersensitivity reaction.
Parenteral: IV infusion: If diluted solution is refrigerated prior to administration, allow solution to adjust to room temperature (do not use a heat source) prior to infusion. Administer diluted solution using an infusion set with an in-line or add-on, sterile, nonpyrogenic, low protein-binding filter made of polyethersulfone or polysulfone (pore size ≤0.2 micrometers). Administration sets must be made of either polybutadiene, polyethylene, polyurethane, polypropylene, or PVC. Other medications should not be added to or simultaneously infused through the same IV line. Administer as follows:
Initial dose: Infuse over ≥30 minutes.
Maintenance doses: Infuse over ≥15 minutes.
Rate adjustment for infusion-related reactions: For mild to moderate reactions, may rechallenge with premedication, slower infusion rates, and close clinical observation. For severe reactions, discontinue and initiate appropriate therapy; consider risks and benefits before reinitiating.
Myasthenia gravis, generalized: Treatment of generalized myasthenia gravis in adult and pediatric patients ≥12 years of age who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Fc Receptor-Binding Agents: Nipocalimab may decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Nipocalimab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Ref).
Outcome data following maternal use of nipocalimab during pregnancy are limited (Ref).
Patients exposed to nipocalimab may be enrolled in a pregnancy safety study (1-800-526-7736 or https://www.IMAAVY.com).
Nipocalimab is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Immunization status (prior to treatment); weight (prior to treatment and periodically thereafter); signs and symptoms of hypersensitivity reaction (during infusion and for 30 minutes after infusion completion), infusion reaction, and infection.
Nipocalimab-aahu is a human IgG1 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG levels.
Distribution: Vd: 2.67 L.
Metabolism: Expected to be degraded by proteolytic enzymes into small peptides and amino acids.
Half-life elimination: 29.3 hours.
Excretion: Clearance: 0.0627 L/hour.
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