Generic Name

Mavenclad

Mechanism

Mavenclad (ozanimod) is a *highly selective sphingosine‑1‑phosphate (S1P) receptor modulator*.
• Targets: S1P₁ and S1P₅ receptors on lymphocytes and CNS cells.
• Lymphocyte sequestration: Binding to S1P₁ prevents lymphocyte egress from lymph nodes → ↓ peripheral T‑ and B‑cell counts.
• Reduced CNS inflammation: Decreases autoreactive lymphocyte trafficking into the central nervous system, lowering demyelination events.
• Neuroprotection: S1P₅ activation may promote remyelination and neuronal survival.

Pharmacokinetics

• Route: Oral (tablet)
• Absorption: Peak plasma concentration (Cmax) reached 8–23 h post‑dose; food does not alter bioavailability (~65 %).
• Metabolism: Oxidative demethylation by CYP2C19 (minor) and CYP3A4 → two active metabolites with pharmacological activity.
• Elimination: 1–2 % excreted unchanged in urine; remainder via feces.
• Half‑life: Parent drug ~2 days; active metabolites ~15 days (steady‑state achieved ~4–6 weeks).
• Drug interactions: Strong CYP3A4 inhibitors (e.g., ketoconazole) ↑ serum concentrations; no significant interaction with CYP2C19 inhibitors.

Indications

• Relapsing‑Remitting Multiple Sclerosis (RRMS) in adults (≥18 yrs) who:
• Have received interferon‑β or glatiramer acetate, or
• Are unsuitable for injectable DMF or are non‑responsive to interferon‑β.
• *Note*: Clinical trials excluded patients with progressive MS forms.

Contraindications

• Contraindications
• Severe hepatic impairment (ALT/AST > 3 × ULN).
• Uncontrolled cardiac disease, recent myocardial infarction, or significant conduction abnormalities.
• Known hypersensitivity to ozanimod.
• Warnings
• Bradycardia / AV block – first‑dose observation for ≥4 h in a monitored setting.
• Liver injury – monitor LFTs; discontinue if toxic hepatitis develops.
• Serious infections – risk of opportunistic infections, especially in patients with profound lymphopenia (ANC < 200 cells/µL).
• PML – rare; screen for JC virus before initiation and periodically.
• Lipid elevation – monitor LDL/HDL; treat hyperlipidemia if needed.
• Pregnancy & lactation – insufficient data; use contraception.

Dosing

• Take with or without food.
• First‑dose monitoring: Baseline ECG, vital signs; observe for > 4 h for bradycardia/VD.
• Rescue: Treat symptomatic bradycardia with atropine or temporary pacing if needed.

Adverse Effects

Monitoring

1. Baseline: CBC with differential, LFTs, lipid profile, ECG, MRI brain.

2. During therapy:
• CBC/lymphocyte count: every 4 weeks for 6 months, then every 4–6 months.
• LFTs: at weeks 2, 4, 6, then every 3 months.
• Lipids: every 3–6 months.
• ECG: baseline and day 7 (or day 14 if abnormal).

3. Infection surveillance: Screen for TB, hepatitis B/C, JC virus DNA at baseline and annually.

4. Pregnancy test: Female of childbearing potential before dosing and periodic.

Clinical Pearls

• First‑dose safety: Always administer the initial 3 mg dose under direct medical supervision; monitor for ≥4 h in a monitored unit.
• Bradycardia vigilance: Patients with untreated A‑fib or prior AV block may need extended monitoring or avoidance.
• Switching strategy: When transitioning from natalizumab, allow a 2‑month washout to mitigate PML risk; consider EBV serology.
• Liver monitoring: Rapid LFT elevation requires dose interruption; postpone re‑initiation until transaminases < 2 × ULN.
• Opportunistic infection work‑up: Screen for latent TB and hepatitis B prior to use; treat prophylaxis if indicated.
• Cost considerations: Offer manufacturer patient assistance programs; consider pharmacy savings cards.
• Patient preference: Oral modality improves adherence compared to injectables; emphasize adherence and regular monitoring to maintain therapeutic benefit.

*These concise drug card points are designed to support quick reference for medical students and clinicians while adhering to SEO best practices for healthcare content.*