Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: SIGA Technologies Netherlands B.V., Prinsenhil 29, Breda 4825 AX, The Netherlands
Tecovirimat SIGA is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:
Tecovirimat SIGA is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4.4 and 5.1).
Tecovirimat SIGA should be used in accordance with official recommendations.
Tecovirimat treatment should be initiated as soon as possible after diagnosis (see section 4.1).
The recommended doses are described in Table 1.
Table 1. Recommended dose by body weight:
| Body Weight | Dosage | Number of Capsules |
|---|---|---|
| 13 kg to less than | 25 kg 200 mg every 12 hours for 14 days | One Tecovirimat 200 mg capsule |
| 25 kg to less than 40 kg | 400 mg every 12 hours for 14 days | Two Tecovirimat 200 mg capsules |
| 40 kg and above | 600 mg every 12 hours for 14 days | Three Tecovirimat 200 mg capsules |
If vomiting occurs within 30 minutes of taking tecovirimat hard capsules, another dose may be administered immediately. If vomiting occurs more than 30 minutes after taking tecovirimat hard capsules, no additional dose should be given and dosing should resume as usual after 12 hours.
No dosage adjustment is required (see section 5.2).
No dosage adjustment is required (see section 5.2).
No dosage adjustment is required (see section 5.2).
Tecovirimat should not be administered to children of less than 13 kg body weight. No dose recommendations have been established.
Oral use.
Tecovirimat hard capsules should be taken within 30 minutes after a meal of moderate or high fat (see section 5.2).
For patients who cannot swallow Tecovirimat hard capsules, the capsules may be opened and the contents may be mixed with approximately 30 mL of liquid (e.g. milk) or soft food (e.g. yogurt) and swallowed within 30 minutes of completing a meal (see sections 5.2 and 6.3).
In case of overdose, patients should be monitored for any signs or symptoms of adverse reactions. Haemodialysis will not significantly remove tecovirimat in overdosed patients.
5 years.
Capsules that have been opened and mixed with food or liquids, should be consumed within 30 minutes (see section 6.6).
Store below 25°C.
Store in the original package in order to protect from light.
For storage conditions after mixing the medicinal product, see section 6.3.
High-density polyethylene (HDPE) bottles with a polypropylene child-resistant cap.
Pack-size of 84 (2 bottles of 42) hard capsules.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
