Tembexa 10 mg/mL
Brincidofovir · SUSPENSION · Emergent BioDefense Operations Lansing LLC
Tembexa is a suspension containing brincidofovir at 10 mg/mL, taken oral. Manufactured by Emergent BioDefense Operations Lansing LLC.
Key Facts
- Brand Name
- Tembexa
- Generic Name
- Brincidofovir
- NDC Code (Product)
64678-012- Manufacturer
- Emergent BioDefense Operations Lansing LLC
- Strength
- 10 mg/mL
- Dosage Form
- SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- NDA214460
- Marketing Start
- 04/20/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 deficient animals. ( 1.2 ) 1.1 Treatment of Human Smallpox Disease TEMBEXA ® is indicated for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. 1.2 Limitations of Use TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease [see Warnings and Precautions ( 5.1 , 5.2 )] . The effectiveness of TEMBEXA for the treatment of smallpox disease has not been determined in humans because adequate and well-controlle…
Dosage & Administration
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: 4 mg/kg oral suspension once weekly for 2 doses. ( 2.3 ) • Pediatric patients weighing less than 10 kg: 6 mg/kg oral suspension once weekly for 2 doses. ( 2.3 ) 2.1 Testing Before Initiating and During Treatment with TEMBEXA Perform hepatic laboratory testing in all patients before starting TEMBEXA and while receiving TEMBEXA, as clinically appropriate [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.7 )] . Perform pregnancy testing before initiation of TEMBEXA in individuals of childbearing potential to inform risk [see Warnings and Precautions ( 5.5 ) and Use in Specific Populations ( 8.3 )] . 2.2 Important Administration Instructions Avoid direct contact with br…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Concomitant use with OATP1B1 and 1B3 inhibitors increase TEMBEXA exposure which may increase TEMBEXA-associated adverse reactions. Consider alternative medication that are not OATP1B1 or 1B3 inhibitors. If concomitant use is necessary, increase monitoring for adverse reactions associated with TEMBEXA and postpone the dosing of OATP1B1 or 1B3 inhibitors at least 3 hours after TEMBEXA administration. ( 7.1 ) 7.1 Effect of Other Drugs on TEMBEXA Inhibitors for Organic Anion Transporting Polypeptide (OATP) 1B1 and 1B3 Concomitant use of TEMBEXA with OATP1B1 and 1B3 inhibitors (clarithromycin, cyclosporine, erythromycin, gemfibrozil, human immunodeficiency virus [HIV] and hepatitis C virus [HCV] protease inhibitors, rifampin [single dose]) increase brincidofovir AUC and C max which may increase TEMBEXA-associated adverse reactions [see Clinical Pharmacology ( 12.3 )] . Where possible, consider alternative medications that are not OATP1B1 or 1B3 inhibitors. If concomitant use with TEMBEXA is necessary, increase monitoring for adverse reactions associated with TEMBEXA (elevations in transaminases and bilirubin, diarrhea, or other GI adverse events) [see Warnings and Pr…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Elevations in hepatic transaminases and bilirubin [see Warnings and Precautions ( 5.2 )] • Diarrhea and other GI adverse events [see Warnings and Precautions ( 5.3 )] Common adverse reactions (occurring in at least 2% of TEMBEXA-treated subjects) were diarrhea, nausea, vomiting, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Emergent BioDefense Operations Lansing LLC at 1-877-246-8472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of TEMBEXA has not been studied in patients with smallpox disease. The safety of TEMBEXA was evaluated in 392 adult subjects aged 18 to 77 years in Phase 2 and 3 randomized, placebo-controlled clinical trials. Of the subjects who received a 200 mg total weekly dose of TEMBEXA, 54% were male, 85% were White, …
Frequently Asked Questions
What is Tembexa used for?
Tembexa contains Brincidofovir. It is a suspension taken oral. Consult your doctor for specific uses.
Is Tembexa a controlled substance?
Tembexa is not classified as a controlled substance by the DEA.
What is the generic name for Tembexa?
The generic name for Tembexa is Brincidofovir. There are no other listed brand versions of Brincidofovir.
What is the NDC code for Tembexa 10 mg/mL?
The NDC (National Drug Code) for Tembexa 10 mg/mL is 64678-012, listed by Emergent BioDefense Operations Lansing LLC.
Other Tembexa Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)