Brand Name
Tpoxx
Generic Name
Tecovirimat
View Brand Information FDA approval date: May 31, 2022
Classification: Orthopoxvirus VP37 Envelope Wrapping Protein Inhibitor
Form: Injection
What is Tpoxx (Tecovirimat)?
TPOXX is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein and is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg.
Approved To Treat
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Brand Information
TPOXX (tecovirimat monohydrate)
1DOSAGE FORMS AND STRENGTHS
TPOXX Capsules
TPOXX capsules are hard gelatin with an opaque orange body imprinted in white ink with “SIGA” followed by the SIGA logo followed by “®”, and an opaque black cap imprinted in white ink with “ST-246
TPOXX Injection
TPOXX injection: 200 mg/20 mL (10 mg/mL) of tecovirimat as a clear, colorless to pale yellow solution in a single-dose vial for further dilution.
2CONTRAINDICATIONS
TPOXX Capsules:
None.
TPOXX Injection:
The excipient hydroxypropyl-β-cyclodextrin is eliminated through glomerular filtration. Therefore, TPOXX Injection is contraindicated in patients with severe renal impairment (defined as creatinine clearance below 30 mL/min)
3OVERDOSAGE
There is no clinical experience with overdosage of TPOXX. In case of overdosage, monitor patients for any signs or symptoms of adverse effects. Hemodialysis will not significantly remove TPOXX in overdosed patients.
4DESCRIPTION
TPOXX capsules and TPOXX injection contains tecovirimat, an inhibitor of the orthopoxvirus VP37 envelope wrapping protein.
TPOXX (tecovirimat) capsules, for oral use are immediate release capsules containing tecovirimat monohydrate equivalent to 200 mg of tecovirimat for oral administration. The capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shell is composed of gelatin, FD&C blue #1, FD&C red #3, FD&C yellow #6, and titanium dioxide.
TPOXX (tecovirimat) injection, for intravenous use is a sterile, colorless to pale yellow solution free of visible particles that is intended for intravenous use following dilution. Tecovirimat injection is available in a single-dose vial containing 200 mg/20 mL (10 mg/mL) of tecovirimat and 8,000 mg (400 mg/mL) of Hydroxypropyl Betadex, NF (hydroxypropyl β-cyclodextrin) and Water for Injection, USP/NF.
Tecovirimat monohydrate is a white to off-white crystalline solid with the chemical name Benzamide, N-[(3a
Tecovirimat monohydrate is practically insoluble in water and across the pH range of 2.0-6.5 (< 0.1 mg/mL).
5CLINICAL STUDIES
Overview
The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. Therefore, the effectiveness of TPOXX for treatment of smallpox disease was established based on results of adequate and well-controlled animal efficacy studies of non-human primates and rabbits infected with non-variola orthopoxviruses. Survival rates observed in the animal studies may not be predictive of survival rates in clinical practice.
Study Design
Efficacy studies were conducted in cynomolgus macaques infected with monkeypox virus, and New Zealand white (NZW) rabbits infected with rabbitpox virus. The primary efficacy endpoint for these studies was survival. In non-human primate studies, cynomolgus macaques were lethally challenged intravenously with 5 x 10
Study Results
Treatment with tecovirimat for 14 days resulted in statistically significant improvement in survival relative to placebo, except when given to cynomolgus macaques starting at Day 6 post-challenge (
6HOW SUPPLIED/STORAGE AND HANDLING
TPOXX Capsule
How Supplied
Each TPOXX capsule contains 200 mg of tecovirimat. TPOXX capsules are hard gelatin with an opaque orange body imprinted in white ink with “SIGA” followed by the SIGA logo followed by “®”, and an opaque black cap imprinted in white ink with "ST-246
Storage and Handling
Store capsules in the original bottle at 20°C to 25°C (68°F to 77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
TPOXX Injection
How Supplied
TPOXX injection is supplied in a 30 mL single-dose vial as a clear, colorless to pale yellow solution for intravenous administration containing 200 mg/20 mL (10 mg/mL) of tecovirimat (NDC 50072-010-30). This solution is intended for dilution with either 0.9% (w/v) sodium chloride injection or 5% (w/v) dextrose injection solution. The vial stopper is not made with natural rubber latex. The vials are packed in cartons of seven vials. Short-term (up to 24 hours) storage and handling at an ambient temperature is acceptable.
Storage and Handling
Store TPOXX injection in a refrigerator at 2°C to 8°C (36°F to 46°F) Do not freeze.
The diluted solution(s) of TPOXX injection with either 0.9% (w/v) sodium chloride (normal saline) or 5% (w/v) dextrose solution should be used within 4 hours of preparation if stored at room temperature or within 24 hours of preparation if stored at 2°C to 8°C
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Efficacy Based on Animal Models Alone
Inform patients that the efficacy of TPOXX is based solely on efficacy studies demonstrating a survival benefit in animals and that the effectiveness of TPOXX has not been tested in humans with smallpox disease
Important Dosage and Administration Information
Advise patients to take TPOXX capsules as directed within 30 minutes of eating a full meal containing moderate or high fat with 6-8 oz. of water
Inform patients who cannot swallow capsules to refer to the Instructions for Use
Drug Interactions
Inform patients that TPOXX may interact with other drugs. Advise patients to report to their healthcare provider the use of other prescription drugs
TPOXX injection: Hydroxypropyl-β-cyclodextrin, a required component of TPOXX injection, is eliminated through glomerular filtration. Therefore, in patients with severe renal impairment (defined as creatinine clearance below 30 mL/min), the use of TPOXX injection is contraindicated
Lactation
Instruct individuals with smallpox not to breastfeed their infant because of the risk of passing variola virus to the breastfed infant
TPOXX capsules Manufactured by:
TPOXX injection manufactured by:
Distributed by:
8PRINCIPAL DISPLAY PANEL - NDC: 50072-200-42 - 200 mg Capsule 42-count Bottle Label
9PRINCIPAL DISPLAY PANEL - NDC: 50072-010-30 - 200 mg/20 mL (10 mg/mL Vial Label)
10PRINCIPAL DISPLAY PANEL - NDC: 50072-010-01 - 7 Vial Carton Label
