Tecovirimat

Generic name
Tecovirimat
Brand name
ATC Code
J05AX24

Tecovirimat

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The pharmacokinetics of tecovirimat have not been studied in pediatric patients. Based on a population pharmacokinetic model and simulation, the recommended pediatric dosing regimen for individuals with a body weight of at least 13 kg is expected to result in exposure similar to that in adults (SmPC)

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Smallpox, monkeypox, cowpox and complications due to virus replication after smallpox vaccination
  • Oral
    • 13 up to 25 kg
      • 400 mg/day in 2 doses.
    • 25 up to 40 kg
      • 800 mg/day in 2 doses.
    • ≥ 40 kg
      • 1.200 mg/day in 2 doses.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects

No information is present at this moment.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

The European Medicines Agency has decided to defer the obligation for the manufacturer to submit the results of studies with tecovirimat in one or more subgroups of pediatric patients for the treatment of orthopoxvirus disease (smallpox, monkeypox, cowpox
and vaccinia) 

This drug is registered under "exceptional conditions. This means that for ethical reasons it was not possible to obtain complete information on this drug.

In case of difficulty in swallowing the capsules may be opened; mix the contents with approx. 30 ml of liquid (e.g. milk) or soft food (e.g. yogurt) and swallow within 30 min after the meal.
If vomiting occurs within 30 min of ingestion, administer a second dose immediately; if vomiting occurs more than 30 min after ingestion, do not take an additional dose.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

DIRECT ACTING ANTIVIRALS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB01
J05AB12
J05AB06
J05AB16
J05AB04
J05AB11
J05AB14
Phosphonic acid derivatives
J05AD01
Protease inhibitors
J05AE08
J05AE10
J05AE07
J05AE02
J05AE04
J05AE03
J05AE01
Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF06
J05AF02
J05AF09
J05AF10
J05AF05
J05AF04
J05AF07
J05AF13
J05AF13
J05AF01
Non-nucleoside reverse transcriptase inhibitors
J05AG06
J05AG03
J05AG04
J05AG01
J05AG05
Neuraminidase inhibitors
J05AH02
J05AH01
Antivirals for treatment of HIV infections, combinations
J05AR02
J05AR20
J05AR13
J05AR25
J05AR18
J05AR19
J05AR03
J05AR09
J05AR10
Other antivirals
J05AX28
J05AX12
J05AX07
J05AX09
J05AX08
ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS
J05AR02
J05AR20
J05AR13
J05AR25
J05AR18
J05AR19
J05AR03
J05AR09
J05AR10
Integrase inhibitors
J05AJ04
Antivirals for treatment of HCV infections
J05AP54
J05AP57
J05AP51
J05AP08
J05AP55

Reference

  1. SIGA Technologies Netherlands B.V., SmPC Tecovirimat (EU/1/21/1600) 28-01-2022, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose