Generic name: TECOVIRIMAT 10mg in 1mL
Dosage form: capsule
Drug class: Miscellaneous antivirals
Medically reviewed by Drugs.com. Last updated on Jul 18, 2022.
2.1 Important Dosing Instructions
It is recommended that patients 13 kg and above initiate oral treatment with TPOXX capsules if possible. If patients are unable to take oral TPOXX capsules or Drug-Food Preparation, treatment may be initiated with TPOXX injection as a 6 hour intravenous (IV) infusion. If IV treatment is necessary, conversion from IV to oral TPOXX is recommended as soon as oral treatment can be tolerated [see Dosage and Administration (2.3)]. In patients receiving an IV infusion, the first dose of oral treatment should be given at the time of and in place of the next scheduled IV dosing.
In patients receiving an oral treatment who subsequently 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.
Take TPOXX capsules within 30 minutes after a full meal containing moderate or high fat.
If a dose of oral TPOXX is missed, the patient should take the dose as soon as possible and anytime up to 8 hours prior to the next scheduled dose. If less than 8 hours remain before the next scheduled dose, do not take the missed dose, and resume dosing at the next scheduled dose.
Administer TPOXX injection by IV infusion over 6 hours via an infusion pump. Must dilute TPOXX Injection prior to use [see Dosage and Administration (2.5)].
2.2 Testing Before Initiating and During Treatment with TPOXX Injection
Determine creatinine clearance in all patients before starting TPOXX injection and monitor while receiving TPOXX injection as clinically appropriate [see Dosage and Administration (2.4), Contraindictions (4), Warnings and Precautions (5.2) and Use in Specific Populations (8.4, 8.6)].
2.3 TPOXX Oral Dosage for Pediatric Patients Weighing at Least 13 kg and Adults
The recommended dosage of TPOXX capsules in pediatric patients weighing at least 13 kg and adults is displayed in Table 1 below.
aTPOXX capsules should be taken within 30 minutes after a full meal containing moderate or high fat [see Clinical Pharmacology (12.3)]
|Body Weight||Oral Dosage for 14 Daysa|
|Dosage (Number of Capsules)||Drug Food Preparation for Patients Who Cannot Swallow Capsules|
|13 kg to less than 25 kg||200 mg (1 capsule) every 12 hours||Carefully open the required number of capsules and mix contents of capsule(s) of TPOXX with 30 mL of liquid (e.g., milk, chocolate milk) or soft food (e.g., apple sauce, yogurt). The entire mixture should be administered within 30 minutes of its preparation.|
|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|
2.4 Renal Impairment
TPOXX injection is contraindicated in patients with creatinine clearance below 30 mL per minute [see Contraindictions (4)].
2.5 Dosage and Administration of TPOXX Injection for Intravenous Infusion
The recommended dosage of TPOXX injection in pediatric patients weighing at least 3 kg and adults is displayed in Table 2 below.
TPOXX injection is supplied in a single-dose clear glass vial containing 200 mg/20 mL (10 mg/mL). Parenteral drug products must be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. To administer:
- Use aseptic technique when preparing TPOXX injection.
- Withdraw the quantity of TPOXX injection (Table 2), add this volume to the syringe then dilute with two equal parts of either 0.9% (w/v) sodium chloride injection (normal saline) or 5% (w/v) dextrose injection in a syringe of suitable size. Injection with diluents other than 0.9% sodium chloride or 5% dextrose solution has not been studied. NOT FOR IV BOLUS INJECTION. Do not use prefilled infusion bags for product preparation and administration.
- The diluted TPOXX injection may be stored refrigerated (2°C - 8°C) for up to 24 hours or at room temperature (15°C - 25°C) for up to 4 hours.
- Gently swirl the syringe of in-use solution prior to inserting into the syringe pump and infuse over 6 hours every 12 hours for 14 days.
- Do not re-use the single-dose vial once it has been punctured.
aPatients weighing at least 13 kg should be switched to TPOXX Capsules to complete the 14 day treatment course as soon as oral therapy can be tolerated.
b10 mg/mL TPOXX solution containing 40% hydroxypropyl betadex (8 g per vial) with water for injection [see Dosage Forms and Strengths (3)]
cDiluent is either 0.9% (w/v) sodium chloride injection or 5% (w/v) dextrose injection solution.
dDepending on size of syringe available with syringe pump system, two separate syringes may be needed for each 6 hour administration.
|Body Weight||Dosage for up to 14 days||Volume of TPOXX Injectionb||Volume of Diluentc|
|3 kg to less than 35 kg||6 mg/kg every 12 hours by intravenous infusion over 6 hoursa||0.6 mL/kg||1.2 mL/kg|
|35 kg to less than 120 kg||200 mg every 12 hours by intravenous infusion over 6 hours||20 mL||40 mL|
|120 kg and aboved||300 mg every 12 hours by intravenous infusion over 6 hours||30 mL||60 mL|
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