Drug Detail:Tecovirimat (oral/injection) (Tecovirimat (oral/injection) [ tek-oh-vir-i-mat ])
Drug Class: Miscellaneous antivirals
Usual Adult Dose for Smallpox
Oral dosage by body weight:
13 kg to less than 25 kg: 200 mg (1 capsule) every 12 hours
25 kg to less than 40 kg: 400 mg (2 capsules) every 12 hours
40 kg to less than 120 kg: 600 mg (3 capsules) every 12 hours
120 kg and above: 600 mg (3 capsules) every 8 hours
Duration of therapy: 14 days
Intravenous infusion dosage by body weight:
3 kg to less than 35 kg: 6 mg/kg every 12 hours by IV infusion over 6 hours
35 kg to less than 120 kg: 200 mg every 12 hours by IV infusion over 6 hours
120 kg and above: 300 mg every 12 hours by IV infusion over 6 hours
Duration: up to 14 days
Comments:
- Patients weighing at least 13 kg should be switched to oral capsules to complete the 14-day course as soon as oral therapy can be tolerated.
- Injection formulation is NOT for IV bolus injection.
Use: Treatment of human smallpox disease caused by variola virus
Usual Pediatric Dose for Smallpox
Oral dosage by body weight:
13 kg to less than 25 kg: 200 mg (1 capsule) every 12 hours
25 kg to less than 40 kg: 400 mg (2 capsules) every 12 hours
40 kg to less than 120 kg: 600 mg (3 capsules) every 12 hours
120 kg and above: 600 mg (3 capsules) every 8 hours
Duration of therapy: 14 days
Intravenous infusion dosage by body weight:
3 kg to less than 35 kg: 6 mg/kg every 12 hours by IV infusion over 6 hours
35 kg to less than 120 kg: 200 mg every 12 hours by IV infusion over 6 hours
120 kg and above: 300 mg every 12 hours by IV infusion over 6 hours
Duration: up to 14 days
Comments:
- Patients weighing at least 13 kg should be switched to oral capsules to complete the 14-day course as soon as oral therapy can be tolerated.
- Injection formulation is NOT for IV bolus injection.
Use: Treatment of human smallpox disease caused by variola virus in pediatric patients weighing at least 3 kg
Renal Dose Adjustments
Oral capsules: No adjustment recommended
Injection:
Mild and moderate renal dysfunction: No adjustment recommended.
Severe renal impairment (CrCl below 30 mL per min): Contraindicated
Liver Dose Adjustments
No adjustment recommended
Precautions
US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides
CONTRAINDICATIONS ORAL CAPSULES: None
CONTRAINDICATIONS INJECTION:
- Patients with severe renal dysfunction (CrCl below 30 mL/min)
Consult WARNINGS section for additional precautions.
Dialysis
No adjustment recommended.
Other Comments
Administration advice:
ORAL:
- Capsules should be taken with a full glass of water within 30 minutes after a full meal containing moderate of high fat.
- For patients who cannot swallow capsules: Carefully open the required number of capsules and mix content with 30 mL of liquid such as milk, or chocolate milk, or soft food such as yogurt or apple sauce. The entire mixture should be administered within 30 minutes of its preparation.
- In patients receiving an oral treatment who afterwards require IV treatment, the first dose of IV infusion should be given at the time of and in place of the next scheduled oral dosing.
- If an oral dose is missed, the patient should take the next dose as soon as possible and anytime up to 8 hours prior to the next scheduled dose. If less than 8 hours remain, do not take the missed dose and resume dosing at the next scheduled dose.
INJECTION:
- Determine creatinine clearance in all patients before starting injection treatment with this drug and keep monitoring while in treatment.
- Administer injection by IV infusion over 6 hours via an infusion pump. Review manufacturer's instructions for preparation and dilution instructions. DO NOT administer as an IV bolus injection.
Storage requirements:
- Store capsules in the original bottle at 20C to 25C (68F to 77F), excursions permitted 15C to 30C (59F to 86F)
- The diluted injection may be stored refrigerated between 2C and 8C for up to 24 hours or at room temperature between 15C and 25C for up to 4 hours. Do not freeze.
Reconstitution/preparation techniques:
- The manufacturer product information should be consulted.
Monitoring:
- Creatinine clearance in all patients before starting injection treatment and during treatment.
- Closely monitor renal function during and after treatment in pediatric patients younger than 2 years old.
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
- Take capsules with a full glass of water (6 to 8 ounces) within 30 minutes after a full meal containing moderate of high fat.
- This drug may interact with other medications. Report all the other drugs you use to your healthcare provider.
- Do not breastfeed your infant.
Frequently asked questions
- What is TPOXX used to treat?
