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Tpoxx Generic Name & Formulations
Legal Class
Rx
General Description
Tecovirimat 200mg; caps.
Pharmacological Class
Antiviral.
See Also
How Supplied
Caps—42; Single-dose vial (20mL)—7
Manufacturer
Generic Availability
NO
Mechanism of Action
Tecovirimat targets and inhibits the activity of the orthopoxvirus VP37 protein (encoded by and highly conserved in all members of the orthopoxvirus genus) and blocks its interaction with cellular Rab9 GTPase and TIP47, which prevents the formation of egress competent enveloped virions necessary for cell to cell and long-range dissemination of virus.
Tpoxx Indications
Indications
Human smallpox disease caused by variola virus in patients weighing ≥3kg.
Limitations of Use
Efficacy in humans has not been determined. Efficacy may be reduced in immunocompromised patients.
Tpoxx Dosage and Administration
Adults and Children
Take within 30mins after a moderate or high fat meal. If difficulty swallowing, may open caps and mix contents in 30mL of liquid or soft food (eg, milk, apple sauce, yogurt); consume entire mixture. ≥3kg: see IV entry. 13–<25kg: 200mg (1 cap) every 12hrs; 25–<40kg: 400mg (2 caps) every 12hrs; 40–<120kg: 600mg (3 caps) every 12hrs; ≥120kg: 600mg (3 caps) every 8hrs. All: treat for 14 days. For ≥13kg: initiate with Tpoxx oral caps, if possible. If IV infusion treatment is required, give first dose of IV infusion at the time of and in place of the next scheduled oral dosing.
Tpoxx Contraindications
Contraindications
IV: severe renal impairment (CrCL <30mL/min).
Tpoxx Boxed Warnings
Not Applicable
Tpoxx Warnings/Precautions
Warnings/Precautions
IV: monitor creatinine clearance closely in patients with mild to moderate renal impairment;if renal toxicity is suspected, consider switching to Tpoxx oral caps or using alternative therapy. IV: use caution and monitor renal function after treatment in patients <2yrs. Pregnancy. Nursing mothers.
Tpoxx Pharmacokinetics
Elimination
Oral: renal (73%), fecal (23%); IV: not available. Half-life: 19 hours (oral); 21 hours (IV).
Tpoxx Interactions
Interactions
May potentiate repaglinide; monitor for hypoglycemia. May antagonize midazolam; monitor efficacy.
Tpoxx Adverse Reactions
Adverse Reactions
Headache, nausea, abdominal pain, vomiting. IV: infusion site reactions.
Tpoxx Clinical Trials
See Literature
Tpoxx Note
Not Applicable
Tpoxx Patient Counseling
See Literature
