TECOVIRIMAT CAP,ORAL
Clinical Criteria Summary
Criteria for MONKEYPOX/ SMALLPOX INJ,SUSP (JYNNEOS)
- Indication & Use: Prevention of smallpox and monkeypox in adults at high risk; pre- or post-exposure prophylaxis against monkeypox.
- Dosing & Administration:
- Standard regimen: 2 subcutaneous (SQ) doses of 0.5 mL each, 4 weeks apart (minimum interval 28 days), administered into fatty tissue over the triceps.
- Alternative EUA regimen: 0.1 mL intradermally on the volar surface of the forearm, second dose 28 days later; preferred for most patients to maximize supply.
- May be administered simultaneously with other vaccines at different anatomic sites.
- Contraindications: History of severe allergic reaction (e.g., anaphylaxis) after a previous dose.
- Precautions & Warnings:
- History of severe allergic reaction to gentamicin or ciprofloxacin (contains trace amounts).
- History of severe allergic reaction to chicken or egg protein AND currently avoiding all chicken/egg products.
- Moderate to severe acute illness with or without fever (defer until improved).
- Immunocompromised patients may have a diminished immune response.
- Safety & Monitoring:
- Observe for immediate adverse reactions: 30 minutes for patients with history of anaphylaxis to gentamicin, ciprofloxacin, or chicken/egg protein (and avoiding exposure); 15 minutes for all others.
- Adverse events include injection site pain, redness, swelling, induration, itching; systemic myalgia, headache, fatigue, nausea, chills; cardiac adverse events of special interest (asymptomatic troponin elevations). No myopericarditis reported.
- Prophylaxis Strategies:
- Pre-exposure prophylaxis: Recommended for laboratory workers handling orthopoxviruses (booster every 2 years); not generally advised for most clinicians/laboratorians currently.
- Post-exposure prophylaxis: Administer within 4 days of exposure to prevent infection; between 4-14 days may be less effective; beyond 14 days benefits may outweigh risks in specific situations (e.g., severely immunosuppressed with recent exposed partner). Not expected to benefit after symptom onset.
- Enhanced PEP (PEP++): For high-risk populations (multiple sexual partners in past 14 days in jurisdiction with known transmission, sex at commercial venues/events/areas where transmission occurs).
Criteria for TECOVIRIMAT CAP,ORAL & TECOVIRIMAT INJ,SOLN (TPOXX)
- Indication & Use: Treatment of monkeypox (non-variola orthopoxvirus infections); FDA approved for smallpox based on animal models.
- Patient Selection Criteria for Treatment:
- Severe disease (hemorrhagic disease, confluent lesions, sepsis, encephalitis, or conditions requiring hospitalization).
- High risk for severe disease: Immunocompromised; pregnant/breastfeeding women; persons with complications (secondary skin infections, gastroenteritis with severe nausea/vomiting, diarrhea/dehydration, bronchopneumonia, concurrent disease/comorbidities); history/presence of atopic dermatitis or other exfoliative skin disorders.
- Aberrant infections: Accidental implantation in eyes, mouth, genitals, or anus.
- Dosing & Administration:
- Oral: 600 mg every 12 hours for 14 days; increase to 600 mg every 8 hours for patients weighing ≥120 kg. Given within 30 minutes of a full moderate/high fat meal. Preferred route.
- IV (if unable to tolerate oral): Dilute in 0.9% sodium chloride or 5% dextrose. <120 kg: 20 mL (200 mg) + 40 mL diluent. ≥120 kg: 30 mL (300 mg) + 60 mL diluent. NOT in prefilled infusion bags. Administer over 6 hours via syringe pump every 12 hours. Change to oral formulation as soon as able.
- Duration: 14 days. Modifications to dose, frequency, and duration may be necessary based on clinical condition/response per CDC consultation.
- Contraindications & Precautions:
- Injection: Contraindicated in severe renal impairment (CrCl <30 mL/min). Use caution in mild/moderate renal impairment due to risk of hydroxypropyl-β-Cyclodextrin accumulation.
- Oral: No contraindications.
- Hepatic impairment: No dose adjustment required for mild, moderate, or severe.
- Renal impairment: No dose adjustment required for mild/moderate insufficiency.
- Safety & Monitoring:
- Oral: Headache (12%), nausea (5%). Discontinuation due to adverse events in 6/359 patients.
- IV: Headache (15%), infusion site pain, swelling, erythema, extravasation.
- Drug interactions: Weak CYP3A inducer and weak CYP2C8/CYP2C19 inhibitor. Monitor for hypoglycemia with repaglinide; monitor midazolam concentrations.
- Pregnancy/Lactation: No human data available. Excreted in breast milk in mice. Decreased fertility observed in male mice at ~24x human exposure.
- Acquisition & Regulatory:
- Available via HHS Expanded Access Investigational New Drug (EA-IND) protocol.
- Requires prospective VA R&D committee approval and IRB-approved informed consent (unless exception applies).
- Limited VA allocation; orders managed through HPoP system. Report adverse events/medication errors to CDC within 72 hours and to VAERS/VA ADERS.