Tembexa (BRINCIDOFOVIR)
Tembexa (BRINCIDOFOVIR) is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: Tembexa; Generic name: BRINCIDOFOVIR; Manufacturer: Emergent BioDefense Operations Lansing LLC.
| Brand name | Tembexa |
|---|---|
| Generic name | BRINCIDOFOVIR |
| Manufacturer | Emergent BioDefense Operations Lansing LLC |
| Used for | 1 INDICATIONS AND USAGE TEMBEXA is an orthopoxvirus nucleotide analog DNA polymerase inhibitor and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. ( 1.1 ) Limitations of Use: • TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease. ( 1.2 ) • The effectiveness of TEMBEXA 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 ) • TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune defici |
| Dosage | 2 DOSAGE AND ADMINISTRATION • Testing: Before initiation and during treatment with TEMBEXA perform hepatic laboratory testing and pregnancy testing. ( 2.1 ) • See full prescribing information for details on important administration instructions. ( 2.2 ) • Adult and pediatric patients weighing 48 kg or above: 200 mg (two 100 mg tablets or 20 mL oral suspension for patients who cannot swallow tablets) once weekly for 2 doses. ( 2.3 ) • Adult and pediatric patients weighing 10 kg to less than 48 kg |
| Warnings | WARNING: INCREASED RISK FOR MORTALITY WHEN USED FOR LONGER DURATION An increased incidence of mortality was seen in TEMBEXA-treated subjects compared to placebo-treated subjects in a 24-week clinical trial when TEMBEXA was evaluated in another disease [see Warnings and Precautions ( 5.1 )] . WARNING: INCREASED RISK FOR MORTALITY WHEN USED FOR LONGER DURATION See full prescribing information for complete boxed warning. An increased incidence of mortality was seen in TEMBEXA-treated subjects compa |
| Active ingredient(s) | BRINCIDOFOVIR |
| Route | ORAL |
| Official label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0784838e-00bd-4b14-9b7e-653b7fbb7eea |