Imaavy (nipocalimab-aahu)

No dosing information is available for this tab.

Nipocalimab-aahu is administered via IV infusion only. The injection is available as an injection concentrate that requires further dilution prior to administration.

Administer the diluted solution through an IV line containing a sterile, in-line or add-on, non-pyrogenic, low protein-binding filter made of polyethersulfone or polysulfone and having a pore size of <=0.2 micrometer. Use administration sets with polybutadiene, polyethylene, polyurethane, polypropylene, or polyvinyl chloride tubing.

Do not infuse other medications via the same IV line as nipocalimab-aahu.

Store unopened vials of nipocalimab-aahu at 2--8degreesC in their original container to protect from light. Do not freeze or shake. The diluted solution should be administered immediately after preparation. If immediate administration is not possible, the diluted solution may be stored at 2--8degreesC for no more than 24 hours protected from light; do not freeze. If the diluted solution has been refrigerated, allow it to come to room temperature prior to administration; do not use external heat sources. After preparation or removal of the drug from the refrigerator, use or discard the diluted solution within 12 hours, including infusion time. During these 12 hours, store under ambient light at 15-30degreesC.

No dosing information is available for this tab.

No formal drug interaction studies have been conducted with nipocalimab-aahu. Since nipocalimab-aahu is not metabolized by cytochrome P-450 (CYP) enzymes, interactions with medications that are substrates, inhibitors, or inducers of CYP enzymes are not expected. Nipocalimab-aahu undergoes degradation by proteolytic enzymes into small peptides and amino acids.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Selected Immunosuppressive Agents/Live Vaccines; Live Bcg

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) The US manufacturer of sibeprenlimab-szsi states live vaccines should not be given within 30 days prior to initiation or during treatment with sibeprenlimab-szsi.(15)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Igg Antibodies And Derivatives/Efgartigimod-Alfa

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)

Nipocalimab-Aahu/Igg Antibodies And Derivatives

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Neonatal Fc Receptor Inhibitors/Insulin Efsitora Alfa

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Insulin efsitora alfa is fused to IgG2. When bound to FcRn, degradation of insulin efsitora alfa is inhibited, reducing its renal clearance and prolonging its action.(3) FcRn inhibitors bind to FcRn and may decrease systemic exposure of other ligands of FcRn, like insulin efsitora alfa.(3)

CLINICAL EFFECTS: The effectiveness of insulin efsitora alfa may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of insulin efsitora alfa states that if an FcRn inhibitor is required, an alternative basal insulin should be considered.(3)

DISCUSSION: FcRn inhibitors may decrease concentrations of insulin efsitora alfa.(3)

*History of serious hypersensitivity reaction to nipocalimab or any product excipients.

There are no contraindication contraindications for this drug.

• Infection

There are no moderate contraindications for this drug.

The most common adverse reactions experienced in 10% or more of patients with generalized myasthenia gravis receiving nipocalimab-aahu include respiratory tract infections, peripheral edema, and muscle spasms.

There are no severe adverse reactions for this drug.

More Frequent

• Muscle spasm
• Peripheral edema
• Upper respiratory infection

Less Frequent

• Acute abdominal pain
• Anemia
• Back pain
• Cough
• Dental abscess
• Diarrhea
• Dizziness
• Fever
• Herpes simplex infection
• Herpes zoster
• Hyperlipidemia
• Hypersensitivity drug reaction
• Hypertension
• Influenza
• Injection site sequelae
• Insomnia
• Lower respiratory infection
• Nausea
• Oral candidiasis
• Skin and skin structure infection
• Urinary tract infection

No enhanced messaging available.

Safety and effectiveness of nipocalimab-aahu for the treatment of generalized myasthenia gravis in pediatric patients <12 years of age have not been established. In 7 adolescents, 12-18 years of age, administration of an IV dose of nipocalimab-aahu resulted in observed steady-state serum concentrations that were within the range observed for adult patients with generalized myasthenia gravis.

There are limited data on the use of nipocalimab-aahu during pregnancy to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, doses of 0, 100, or 300 mg/kg of nipocalimab-aahu administered to monkeys weekly from the end of organogenesis through parturition, which are 6 and 20 times the recommended human maintenance dose of 15 mg/kg, resulted in placental ischemia, fetal loss, and decreased levels of IgG in the offspring. IgG levels returned to normal in the offspring with no adverse effects at 6 months.

Since monoclonal antibodies increasingly cross the placenta as pregnancy progresses and the largest amount crosses in the third trimester, transmission of nipocalimab-aahu from the mother to the developing fetus may occur. Because maternal IgG antibodies are expected to be reduced with nipocalimab-aahu, a reduction in fetal passive protection is anticipated. Prior to administration, consider the risks and benefits of vaccine use in infants who were exposed to nipocalimab-aahu in utero.

A pregnancy exposure registry monitors outcomes in pregnant women exposed to nipocalimab-aahu. Clinicians and patients may enroll in the registry by calling 1-800-526-7736 or visiting https://www.imaavy.com/generalized-myasthenia-gravis/.

Data are available from 13 women who were administered nipocalimab-aahu during pregnancy. Nipocalimab-aahu is excreted into human colostrum and breastmilk. The effects on the breastfed infant and milk production are unknown. Consider the benefits of breastfeeding along with the mother's clinical need for nipocalimab-aahu and any potential adverse effects on the breastfed infant from the drug or the mother's underlying maternal condition.

The manufacturer makes no specific dosage recommendations in geriatric patients.

Clinical studies of nipocalimab-aahu did not include sufficient numbers of patients 65 years of age and older to determine whether there are differences in response from younger adult patients. The pharmacokinetics of nipocalimab-aahu were not affected by age in a population pharmacokinetic analysis.