Tecvayli
Tecvayli
Generic Name
Tecvayli
Mechanism
- Targets the viral VP37 envelope‑protein essential for the formation of extracellular enveloped virions.
- Binds to VP37, blocking its interaction with the host cell membrane and preventing viral egress from infected cells.
- Results in a delayed release and spread of virus, effectively reducing viral titers and clinical disease duration.
---
Pharmacokinetics
| Parameter | Oral | IM (60 mg) |
| Bioavailability | 75–90 % | ~100 % |
| Peak plasma concentration (Tmax) | ~1–2 h | 30–60 min |
| Half‑life | 5–7 h (steady‑state ~15 h) | ~7 h |
| Metabolism | Minor N‑dealkylation; primarily unchanged in plasma | Same pathway as oral |
| Excretion | Renal (≈30 %) and biliary; ~45 % unchanged | |
| Food effect | Mild; no clinically significant change |
--
•
Indications
- Confirmed or suspected monkeypox infection in persons ≥12 kg.
- Virally‑exposed patients with high‑risk post‑exposure prophylaxis (e.g., close contacts).
- Smallpox prophylaxis in individuals with occupational exposure (e.g., laboratory personnel, certain military roles).
---
Contraindications
- Contraindicated in patients with known hypersensitivity to tecovirimat or any excipient.
- Warning: Not yet studied in pregnancy or lactation; use only if benefit outweighs risk.
- Caution in hepatic impairment (since biliary excretion may be altered).
- Drug interactions: Few clinically relevant interactions; do not co‑administer with strong CYP3A4 inhibitors/inducers—recommend drug‑interaction review if such agents are prescribed.
---
Dosing
| Scenario | Dose | Duration |
| Monopox‐treated | 600 mg orally twice daily (≈10 mg/kg) | 14 days |
| Monopox PEP | 600 mg orally twice daily (≈10 mg/kg) | 14 days |
| Smallpox prophylaxis | 600 mg orally twice daily (≈10 mg/kg) | 14 days |
| IM route | 60 mg IM (≈1 mg/kg) | Single dose (only if oral administration impossible or contraindicated). |
• Administration notes: Oral solution should be taken with water or non‑fat milk; can be taken with or without food. IM injection must be in a muscle (e.g., gluteal), using 1 mL syringes.
--
•
Adverse Effects
| Category | Frequency (reported in trials) | Notes |
| Common (≥5 %) | Nausea, diarrhea, headache, dizziness, fever | Usually mild/moderate |
| Serious (≤1 %) | Transient elevation in liver enzymes, severe skin rash | Monitor LFTs in high‑risk patients |
| Rare | Hypersensitivity reaction (rash, urticaria) | Immediate discontinuation if occurs |
--
•
Monitoring
- Baseline & weekly liver function tests (ALT, AST, bilirubin).
- Renal function if pre‑existing disease.
- Symptoms of hypersensitivity (rash, swelling).
- Viral load/symptom resolution is monitored clinically; repeat PCR optional in research settings.
---
Clinical Pearls
- Early initiation is key: Begin Tecvayli within 4 days of symptom onset for optimal efficacy.
- Single‑dose IM option: Handy for patients refusing oral therapy or in resource‑limited settings where medicine may degrade at high temps.
- Kidney‑poor patients: Though renal excretion is modest, avoid dose adjustment in moderate CKD; monitor creatinine.
- Drug‑interaction horizon: Though minimal, check for concomitant medications that alter CYP3A4 activity—particularly ritonavir or ketoconazole—though data are limited; clinical judgment applies.
- Packaging: Be mindful of the “stay‑in‑cold-chain” (2–25 °C) requirement; pre‑laden AMO syringes maintain potency at room temperature for up to 28 days.
---