Nurses Compass
Drug Guide
Nipocalimab-aahu
Classification
Therapeutic: Immunosuppressant; Monoclonal Antibody
Pharmacological: Anti-FcRn (neonatal Fc receptor).antibody
FDA Approved Indications
- Treatment of generalized myasthenia gravis (gMG) in adults
Mechanism of Action
Nipocalimab is a monoclonal antibody that binds to the neonatal Fc receptor (FcRn), inhibiting its function. This reduces the recycling of IgG antibodies, leading to decreased levels of pathogenic IgG autoantibodies that cause autoimmune diseases such as myasthenia gravis.
Dosage and Administration
Adult: The dosing regimen involves an initial dose followed by maintenance doses; specifics should follow FDA labeling and prescribing information.
Pediatric: Not approved for pediatric use; safety and efficacy not established.
Geriatric: No specific dosage adjustments; assess renal and hepatic function as needed.
Renal Impairment: No specific adjustments provided; monitor for increased immunosuppression risk.
Hepatic Impairment: No specific adjustments provided; use with caution.
Pharmacokinetics
Absorption: Administered via intravenous infusion; absorption not applicable.
Distribution: Widely distributed in the body; concentration data not specified.
Metabolism: Metabolized via proteolytic catabolism; specific pathways not detailed.
Excretion: Excreted through proteolytic pathways; not specifically via renal or hepatic routes.
Half Life: Approximately several days; exact half-life not specified in available sources.
Contraindications
- Hypersensitivity to nipocalimab or any component of the formulation.
Precautions
- Monitor for infusion reactions.
- Use caution in patients with active infections or immunosuppression.
- Potential risk of infections due to immune modulation.
Adverse Reactions - Common
- Infusion-related reactions (Common)
- Headache (Common)
Adverse Reactions - Serious
- Serious infections (Less common)
- Hypersensitivity reactions including anaphylaxis (Rare)
Drug-Drug Interactions
- Concomitant immunosuppressants may increase infection risk.
Drug-Food Interactions
- No significant data available.
Drug-Herb Interactions
- No specific data available.
Nursing Implications
Assessment: Monitor for signs of infection, allergic reactions, and infusion reactions.
Diagnoses:
- Risk for infection
- Type 2 immune response suppression
Implementation: Administer under supervision; monitor patient during and after infusion.
Evaluation: Assess patient response and adverse reactions regularly.
Patient/Family Teaching
- Report any signs of infection or allergic reactions immediately.
- Do not miss doses to maintain efficacy.
- Inform healthcare provider about all medications and allergies.
Special Considerations
Black Box Warnings:
- Increased risk of serious infections.
Genetic Factors: No specific genetic considerations documented.
Lab Test Interference: May alter levels of IgG and related immunoglobulin tests.
Overdose Management
Signs/Symptoms: Potential for severe immune suppression or hypersensitivity.
Treatment: Supportive care; no specific antidote. Discontinue therapy and provide symptomatic treatment as needed.
Storage and Handling
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F).
Stability: Stable under recommended storage conditions; avoid freezing.