Nurses Compass
Drug Guide
Rozanolixizumab-noli
Classification
Therapeutic: Immunosuppressant / Monoclonal antibody
Pharmacological: Anti-Sclerostin antibody
FDA Approved Indications
- Treatment of generalized myasthenia gravis in adults with AChR antibody positivity
Mechanism of Action
Rozanolixizumab-noli is a monoclonal antibody that targets and inhibits the neonatal Fc receptor (FcRn), thereby reducing IgG antibody levels, which helps in conditions mediated by pathogenic IgG such as myasthenia gravis.
Dosage and Administration
Adult: Initial dose is 480 mg via subcutaneous injection, followed by 240 mg every 4 weeks.
Pediatric: Not currently approved or studied in pediatric populations.
Geriatric: No specific dosage adjustment required; evaluate renal and hepatic function.
Renal Impairment: No specific adjustments indicated.
Hepatic Impairment: No specific adjustments indicated.
Pharmacokinetics
Absorption: Subcutaneous administration; time to peak concentration approximately 3-4 days.
Distribution: Distributed primarily in the plasma; volume of distribution approximately 5 liters.
Metabolism: Metabolized via proteolytic pathways; typical monoclonal antibody catabolism.
Excretion: Excreted via catabolic pathways; not primarily renally excreted.
Half Life: Approximately 20 days.
Contraindications
- Hypersensitivity to rozanolixizumab-noli or excipients.
Precautions
- Use with caution in patients with active or chronic infections; monitor for signs of infection.
- Not studied in pregnant or breastfeeding women; risks should be considered.
Adverse Reactions - Common
- Headache (Common)
- Influenza-like illness (Common)
- Nausea (Common)
Adverse Reactions - Serious
- Serious infections (Less common)
- Hypersensitivity reactions including anaphylaxis (Rare)
Drug-Drug Interactions
- Potential increased risk of infections with other immunosuppressants.
- Immunizing with live vaccines is not recommended during therapy.
Drug-Food Interactions
- No specific interactions reported.
Drug-Herb Interactions
- Limited data; caution advised with herbal immunomodulators.
Nursing Implications
Assessment: Monitor for signs of infection, allergic reactions, and injection site reactions.
Diagnoses:
- Risk for infection
Implementation: Administer subcutaneously as prescribed; educate on infection prevention.
Evaluation: Assess for effectiveness in reducing myasthenic symptoms and adverse effects.
Patient/Family Teaching
- Report signs of infection or allergic reactions promptly.
- Do not receive live vaccines during treatment.
- Follow scheduled dosing and clinic visits.
Special Considerations
Black Box Warnings:
- Increased risk of infections, including serious infections.
Genetic Factors: None specific.
Lab Test Interference: No known interference with laboratory tests.
Overdose Management
Signs/Symptoms: Severe allergic reactions, exaggerated immunosuppression.
Treatment: Supportive care; monitor vital signs; administer epinephrine for anaphylaxis.
Storage and Handling
Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze.
Stability: Stable in refrigeration; discard if frozen.