TECOVIRIMAT CAP,ORAL
Clinical Criteria Summary
Indications & Patient Selection
- JYNNEOS (Vaccine for Prevention)
- Indicated for pre- or post-exposure prophylaxis against monkeypox and smallpox in adults at high risk.
- Pre-exposure prophylaxis (PrEP): Recommended for laboratory workers handling orthopoxviruses; broader vaccination may be recommended when supply increases.
- Post-exposure prophylaxis (PEP): Indicated after high-risk exposure to monkeypox virus; ideally given within 4 days of exposure to prevent infection. Between 4–14 days post-exposure may be less effective. Beyond 14 days, benefits may outweigh risks in specific clinical situations (e.g., severely immunosuppressed patient with recent confirmed partner).
- Not expected to provide benefit if administered after onset of signs or symptoms of monkeypox.
- PEP++ (Enhanced PEP) criteria: Multiple sexual partners in the past 14 days in a jurisdiction with known monkeypox transmission.
- TPOXX / TECOVIRIMAT (Treatment)
- FDA approved for treatment of smallpox based on animal models; available under EA-IND protocol for non-variola orthopoxvirus infections including monkeypox during an outbreak.
- Consider for patients with severe disease: hemorrhagic disease, confluent lesions, sepsis, encephalitis, or conditions requiring hospitalization.
- Consider for persons at 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 or presence of atopic dermatitis or other exfoliative skin disorders.
- Consider for monkeypox virus aberrant infections: accidental implantation in eyes, mouth, genitals, or anus.
Dosing & Administration
- JYNNEOS
- Standard (FDA-approved) regimen: 2 subcutaneous (SQ) doses of 0.5 mL each, 4 weeks apart, into fatty tissue over the triceps in the upper arm. Minimum interval is 28 days; may be given up to 4 days before or 7 days after. If delayed >7 days, administer ASAP without restarting series.
- Alternative (EUA) regimen: 0.1 mL administered intradermally (ID) on the volar surface of the forearm, second dose 28 days later. Preferred in VHA for most patients to maximize supply.
- Interchangeability: Adults who received standard SQ dosing may receive the second dose ID if no history of keloid development.
- TPOXX / TECOVIRIMAT
- Oral (Preferred): 600 mg every 12 hours for 14 days. Increase to 600 mg every 8 hours for patients weighing ≥120 kg. Must be given within 30 minutes of a full moderate or high fat meal.
- Intravenous (If unable to tolerate oral): Dilute with 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 diluted into prefilled infusion bags or given as IV bolus. Administer over 6 hours every 12 hours via syringe pump.
- Duration: 14 days. Modifications to dose, frequency, and duration may be necessary based on clinical condition, disease progression, therapeutic response, or clinical judgment (consult CDC EOC/FDA).
Contraindications
- JYNNEOS: History of a severe allergic reaction (e.g., anaphylaxis) after a previous dose.
- TPOXX / TECOVIRIMAT INJECTION: Severe renal impairment (CrCl < 30 mL/min). No contraindications to oral tecovirimat.
Precautions & Warnings
- JYNNEOS
- History of severe allergic reaction (anaphylaxis) following gentamicin or ciprofloxacin (contains trace amounts).
- History of severe allergic reaction (anaphylaxis) to chicken or egg protein AND currently avoiding exposure to all chicken/egg products.
- Moderate to severe acute illness with or without fever (defer until improved).
- Immunocompromised patients may have a diminished immune response.
- Appropriate medical treatment must be available to manage possible anaphylactic reactions; weigh risk of severe reaction against disease risk.
- TPOXX / TECOVIRIMAT
- Use with caution in mild or moderate renal impairment (injection due to reduced clearance of hydroxypropyl-β-Cyclodextrin vehicle).
- Hypoglycemia when co-administered with repaglinide.
- Weak inducer of CYP3A and weak inhibitor of CYP2C8/CYP2C19; effects not clinically relevant for most substrates except increased repaglinide and decreased midazolam concentrations.
Storage, Handling & Monitoring
- JYNNEOS
- Frozen: Thaw to room temperature before use. Use vials before date marked on carton. Once thawed, store refrigerated (36–46°F) for up to 8 weeks. Do not re-freeze.
- Room Temperature: Unpunctured vials up to 6 consecutive hours (46–77°F). Punctured vials must be stored refrigerated and discarded within 8 hours of first puncture.
- Monitoring: Observe after vaccination for immediate adverse reactions including syncope. Observation duration is 30 minutes for persons with history of anaphylaxis to gentamicin, ciprofloxacin, or chicken/egg protein (and avoiding exposure); 15 minutes for all others.
- TPOXX / TECOVIRIMAT
- Diluted IV solution: Store refrigerated up to 24 hours, or 4 hours at room temperature.