Drug Guide
Ocrelizumab
Classification
Therapeutic: Immunosuppressant, Monoclonal Antibody
Pharmacological: Anti-CD20 Monoclonal Antibody
FDA Approved Indications
- Relapsing Multiple Sclerosis (RMS)
- Primary Progressive Multiple Sclerosis (PPMS)
Mechanism of Action
Ocrelizumab selectively targets CD20-positive B cells, leading to their depletion, which reduces inflammation and central nervous system damage in multiple sclerosis.
Dosage and Administration
Adult: For RMS and PPMS, 600 mg IV every 6 months, administered as two 300 mg infusions separated by 2 weeks.
Pediatric: Not approved for pediatric use.
Geriatric: No specific dosage adjustment, but monitor renal function and signs of infection.
Renal Impairment: No specific adjustment recommended; monitor closely.
Hepatic Impairment: No specific data; use caution and monitor.
Pharmacokinetics
Absorption: Administered intravenously, so absorption is immediate.
Distribution: Widely distributed; volume of distribution approximately 4.8 L.
Metabolism: Metabolized through protein catabolism pathways.
Excretion: Not eliminated via urine; cleared via cellular mechanisms.
Half Life: Approximately 26 days.
Contraindications
- Hypersensitivity to ocrelizumab or any of its components.
Precautions
- Increased risk of infections, including serious and opportunistic infections.
- Reactivation of hepatitis B virus.
- Vaccinations should be given prior to initiation; live vaccines should be avoided during treatment.
Adverse Reactions - Common
- Infusion reactions (fever, chills, rash, SOB) (Common)
- Upper respiratory tract infections (Common)
- Headache (Common)
Adverse Reactions - Serious
- Infections (pneumonia, herpes zoster) (Uncommon)
- Progressive Multifocal Leukoencephalopathy (PML) (Rare)
- Hypersensitivity and anaphylactic reactions (Rare)
Drug-Drug Interactions
- Other immunosuppressants, live vaccines, vaccines that may be affected by immunosuppression
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor for signs of infection, infusion reactions, and PML.
Diagnoses:
- Risk for infection
- Risk for delayed infusion reactions
Implementation: Pre-medicate with corticosteroids, antihistamines, and antipyretics prior to infusion; monitor vital signs during and after infusion.
Evaluation: Assess for adverse reactions, efficacy of MS symptom control, and monitor for infections.
Patient/Family Teaching
- Report any signs of infection or allergic reactions immediately.
- Avoid live vaccines during treatment and for 6 months following the last infusion.
- Maintain regular follow-up appointments.
Special Considerations
Black Box Warnings:
- Risk of PML
Genetic Factors: N/A
Lab Test Interference: May affect immunoglobulin levels and lymphocyte counts, which should be monitored.
Overdose Management
Signs/Symptoms: N/A for specific overdose; monitor for infusion reactions and signs of infection.
Treatment: Supportive care; corticosteroids or antihistamines for infusion reactions; no specific antidote.
Storage and Handling
Storage: Store in a refrigerator between 2°C and 8°C. Do not freeze.
Stability: Stable until the expiration date printed on the vial when stored properly.