Rx Item-TPOXX tecovirimat monohydrate 200MG 42 CAPSULES BY CATALENT PHARMA/SIGA

Smallpox

TPOXX (tecovirimat) is an orthopoxvirus-specific antiviral indicated for the treatment of human smallpox disease. 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.

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]. 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
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 13 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

TPOXX should be taken within 30 minutes after a full meal of moderate or high fat. (2.1, 2.2)
Adults: 600 mg twice daily for 14 days (2.1)
Pediatrics patients weighing 13 kg or more (2.2):
� 13 kg to less than 25 kg: 200 mg of TPOXX twice daily for 14 days
� 25 kg to less than 40 kg: 400 mg of TPOXX twice daily for 14 days
� 40 kg or more: 600 mg of TPOXX twice daily for 14 days

DOSAGE FORMS AND STRENGTHS

Capsule: 200 mg. (3)

CONTRAINDICATIONS

None (4)

WARNINGS AND PRECAUTIONS

Hypoglycemia: Co-administration with repaglinide may cause hypoglycemia. Monitor blood glucose and monitor for hypoglycemic symptoms during co-administration. (5.1)

ADVERSE REACTIONS

Common adverse reactions in healthy adult subjects (? 2%) were headache, nausea, abdominal pain, and vomiting. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact SIGA Technologies at 1-541-753-2000 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Consult the full prescribing information prior to and during treatment for potential drug interactions. (5.1, 7, 12.3)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 7/2018

Rx Item-TPOXX tecovirimat monohydrate 2
RX50072-200-42

Rx Item-TPOXX tecovirimat monohydrate 2
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