TPOXX INJECTION Dosage & Rx Info

Tpoxx Injection Generic Name & Formulations

Legal Class

General Description

Tecovirimat 200mg/vial; soln for IV infusion after dilution; contains hydroxypropyl-β-cyclodextrin.

Pharmacological Class

Antiviral.

How Supplied

Caps—42; Single-dose vial (20mL)—7

Manufacturer

SIGA Technologies

Generic Availability

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 Injection 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 Injection Dosage and Administration

Adults and Children

Determine creatinine clearance prior to initiation; monitor during treatment. Give by IV infusion over 6hrs via an infusion pump. 3–<35kg: 6mg/kg every 12hrs; 35–<120kg: 200mg every 12hrs; ≥120kg: 300mg every 12hrs. All: treat for 14 days. For ≥13kg: switch to oral caps as soon as it can be tolerated; give first oral dose at the time of and in place of the next scheduled IV dosing.

Tpoxx Injection Contraindications

Contraindications

IV: severe renal impairment (CrCL <30mL/min).

Tpoxx Injection Boxed Warnings

Not Applicable

Tpoxx Injection 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 Injection Pharmacokinetics

Metabolism

Hydrolysis, UGT1A1, UGT1A4.

Elimination

Oral: renal (73%), fecal (23%); IV: not available. Half-life: 19 hours (oral); 21 hours (IV).

Tpoxx Injection Interactions

Interactions

May potentiate repaglinide; monitor for hypoglycemia. May antagonize midazolam; monitor efficacy.

Tpoxx Injection Adverse Reactions

Adverse Reactions

Headache, nausea, abdominal pain, vomiting. IV: infusion site reactions.

Tpoxx Injection Clinical Trials

See Literature

Tpoxx Injection Note