TPOXX- tecovirimat monohydrate injection, solution, concentrate TPOXX- tecovirimat monohydrate capsule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

TECOVIRIMAT (UNII: F925RR824R) (TECOVIRIMAT - UNII:F925RR824R)

Beszerezhető a:

SIGA Technologies, Inc.

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

TPOXX® is indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 3 kg. 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 [see Clinical Studies (14)] . TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models. 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) [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)] . Risk Summary There are no available data on the use of tecovirimat in pregnant individuals to evaluate for a

Termék összefoglaló:

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® ", containing white to off-white powder. Each bottle contains 42 capsules (NDC 50072-200-42) with an induction seal and child-resistant cap. 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 [see Dosage and Administration (2.5)] .

Engedélyezési státusz:

New Drug Application

Termékjellemzők

TPOXX- TECOVIRIMAT MONOHYDRATE INJECTION, SOLUTION, CONCENTRATE
TPOXX- TECOVIRIMAT MONOHYDRATE CAPSULE
SIGA TECHNOLOGIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TPOXX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TPOXX.
TPOXX (TECOVIRIMAT) CAPSULES, FOR ORAL USE
TPOXX (TECOVIRIMAT) INJECTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2018
INDICATIONS AND USAGE
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. (1.1)
Limitations of Use:
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. (1.2)
TPOXX efficacy may be reduced in immunocompromised patients based on
studies demonstrating
reduced efficacy in immunocompromised animal models. (1.2)
DOSAGE AND ADMINISTRATION
Pediatric and Adult Patients weighing 40 kg or more (2.3) (Oral
Dosing):
40 kg to less than 120 kg: 600 mg of TPOXX every 12 hours for 14 days
120 kg or more: 600 mg of TPOXX every 8 hours for 14 days
Pediatrics and adult patients weighing 13 kg or more and those who
cannot swallow capsules (2.3) (Oral
Dosing): TPOXX Capsules can be administered by carefully opening the
number of capsule noted below
and mixing and administering the entire contents in 30 mL of liquid
(e.g., milk, chocolate milk) or soft
food (e.g., apple sauce, yogurt):
13 kg to less than 25 kg: 200 mg (1 Capsule) of TPOXX every 12 hours
for 14 days
25 kg to less than 40 kg: 400 mg (2 Capsules) of TPOXX every 12 hours
for 14 days
40 kg to less than 120 kg: 600 mg (3 Capsules) of TPOXX every 12 hours
for 14 days
120 kg or more: 600 mg (3 capsules) every 8 hours for 14 days
Patients weighing 3 kg and above (2.5) (Intravenous Dosing):
3 kg to less than 35 k