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TEMBEXA is a brand name for Brincidofovir, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations • TEMBEXA should be avoided in pregnant women or in individuals of childbearing potential who think they might be pregnant. 1 Pregnancy]. 1 Pregnancy]. ” TEMBEXA (brincidofovir) Product Monograph Page 5 of 26 TEMBEXA, as clinically appropriate.
• Advise women of childbearing potential to avoid becoming pregnant and to use effective contraception during treatment with TEMBEXA and for at least 2 months after the last dose [see 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential; Contraception].
• Advise male patients of reproductive potential with female partners of childbearing potential to use condoms during treatment with TEMBEXA and for at least 4 months after the last dose [see 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential; Contraception].
• TEMBEXA efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models [see 7 WARNINGS AND PRECAUTIONS, Immune]. • Animal studies have indicated that co-administration of TEMBEXA at the same time as the live smallpox vaccine (vaccinia virus) may reduce the immune response to the vaccine.
The clinical impact of this is unknown [see 7 WARNINGS AND PRECAUTIONS, Immune]. Recommended Dose and Dosage Adjustment The recommended dosage of TEMBEXA in pediatric and adult patients is displayed in Table 1.
Table 1:
Recommended Dosage in Pediatric and Adult Patients Patient’s Weight (kg) TEMBEXA Oral Suspension (10 mg/mL) TEMBEXA Tablet (100 mg) Less than 10 kg 6 mg/kg once weekly for 2 doses (on Days 1 and 8) N/A 10 kg to less than 48 kg 4 mg/kg once weekly for 2 doses (on Days 1 and 8) N/A 48 kg and above 200 mg (20 mL) once weekly for 2 doses (on Days 1 and 8) 200 mg (two 100 mg tablets) once weekly for 2 doses (on Days 1 and 8) Patients with Renal Impairment: No dosage adjustment of TEMBEXA is required for patients with mild, moderate, or severe renal impairment or patients with end stage renal disease (ESRD) receiving dialysis [see 10 CLINICAL PHARMACOLOGY].
Patients with Hepatic Impairment:
Perform hepatic laboratory testing in all patients before starting TEMBEXA and while receiving TEMBEXA, as clinically appropriate. No dosage adjustment is required for patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C) [see 7 WARNINGS AND PRECAUTIONS, 8 ADVERSE REACTIONS, and 10 CLINICAL PHARMACOLOGY].
Reconstitution Not applicable. TEMBEXA (brincidofovir) Product Monograph Page 6 of 26 Administration Avoid direct contact with broken or crushed tablets or oral suspension. If contact with skin or mucous membranes occurs, wash thoroughly with soap and water, and rinse eyes thoroughly with water [see 7 WARNINGS AND PRECAUTIONS and 12 SPECIAL HANDLING INSTRUCTIONS].
, and 10 CLINICAL PHARMACOLOGY]. Reconstitution Not applicable. TEMBEXA (brincidofovir) Product Monograph Page 6 of 26 Administration Avoid direct contact with broken or crushed tablets or oral suspension. If contact with skin or mucous membranes occurs, wash thoroughly with soap and water, and rinse eyes thoroughly with water [see 7 WARNINGS AND PRECAUTIONS and 12 SPECIAL HANDLING INSTRUCTIONS].
TEMBEXA Tablets TEMBEXA tablets can be taken on an empty stomach or with a low-fat, low calorie meal (approximately 300 calories, with approximately 5% calories from fat). Swallow TEMBEXA tablets whole. Do not crush, break, or divide TEMBEXA tablets.
TEMBEXA Oral Suspension Take TEMBEXA oral suspension on an empty stomach. Shake oral suspension before use. Use an appropriate oral dosing syringe to correctly measure the total prescribed dose. Discard unused portion after completion of 2 prescribed doses.
For patients who cannot swallow, TEMBEXA oral suspension can be administered by enteral tube (naso-gastric or gastrostomy tubes) as follows: • Draw up prescribed dose with a calibrated catheter-tip syringe and utilize this syringe to administer the dose via the enteral tube.
• Refill the catheter-tip syringe with 3 mL of water, shake, and administer the contents via the enteral tube. • Flush the enteral tube with water before and after enteral administration. Missed Dose If you miss the second and final dose of TEMBEXA, take it as soon as possible.
5 OVERDOSAGE There is no clinical experience with overdosage of TEMBEXA. In the event of an overdose, monitor patients for adverse effects and provide appropriate supportive care. For management of a suspected drug overdose, contact your regional poison control centre.
TEMBEXA (brincidofovir) Product Monograph Page 7 of 26 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2: Dosage Forms, Strengths, Composition and Packaging TEMBEXA Tablets: TEMBEXA tablets are blue modified-oval shaped, coated tablets debossed with “BCV” on one side and “100” on the other side and packaged into blister cards.
3 Pediatrics]. 4 Geriatrics]. 2 CONTRAINDICATIONS TEMBEXA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION, AND PACKAGING. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions An increase in mortality was observed in comparison to placebo when TEMBEXA was evaluated in patients who were treated for longer durations (see 7 WARNINGS AND PRECAUTIONS).
4 DOSAGE AND ADMINISTRATION Dosing Considerations • TEMBEXA should be avoided in pregnant women or in individuals of childbearing potential who think they might be pregnant. 1 Pregnancy]. 1 Pregnancy]. ” TEMBEXA (brincidofovir) Product Monograph Page 5 of 26 TEMBEXA, as clinically appropriate.
• Advise women of childbearing potential to avoid becoming pregnant and to use effective contraception during treatment with TEMBEXA and for at least 2 months after the last dose [see 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential; Contraception].
• Advise male patients of reproductive potential with female partners of childbearing potential to use condoms during treatment with TEMBEXA and for at least 4 months after the last dose [see 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential; Contraception].
• TEMBEXA efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models [see 7 WARNINGS AND PRECAUTIONS, Immune]. • Animal studies have indicated that co-administration of TEMBEXA at the same time as the live smallpox vaccine (vaccinia virus) may reduce the immune response to the vaccine.
The clinical impact of this is unknown [see 7 WARNINGS AND PRECAUTIONS, Immune]. Recommended Dose and Dosage Adjustment The recommended dosage of TEMBEXA in pediatric and adult patients is displayed in Table 1.
TEMBEXA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION, AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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TEMBEXA Tablets TEMBEXA tablets can be taken on an empty stomach or with a low-fat, low calorie meal (approximately 300 calories, with approximately 5% calories from fat). Swallow TEMBEXA tablets whole. Do not crush, break, or divide TEMBEXA tablets.
TEMBEXA Oral Suspension Take TEMBEXA oral suspension on an empty stomach. Shake oral suspension before use. Use an appropriate oral dosing syringe to correctly measure the total prescribed dose. Discard unused portion after completion of 2 prescribed doses.
For patients who cannot swallow, TEMBEXA oral suspension can be administered by enteral tube (naso-gastric or gastrostomy tubes) as follows: • Draw up prescribed dose with a calibrated catheter-tip syringe and utilize this syringe to administer the dose via the enteral tube.
• Refill the catheter-tip syringe with 3 mL of water, shake, and administer the contents via the enteral tube. • Flush the enteral tube with water before and after enteral administration. Missed Dose If you miss the second and final dose of TEMBEXA, take it as soon as possible.
Each blister cavity contains one film-coated tablet containing 100 mg of brincidofovir. The blister card is placed in a wallet. Each wallet contains one (1) blister card with a total of 4 film-coated tablets.
TEMBEXA Oral Suspension:
TEMBEXA oral suspension is an aqueous based, preserved white to off-white opaque, lemon lime flavored suspension containing 10 mg/mL of brincidofovir packaged into a high-density polyethylene bottle with a low-density polyethylene press-in bottle adaptor (PIBA) inserted into the bottle.
Each bottle is filled to deliver 65 mL of TEMBEXA oral suspension. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General The efficacy 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.
The efficacy of TEMBEXA is based solely on efficacy studies in animal models of orthopoxvirus disease [see 14 CLINICAL TRIALS]. TEMBEXA should not be used for the treatment of other diseases besides human smallpox disease. Increased Risk for Mortality When Used for Longer Durations An increase in mortality was observed in a randomized, placebo-controlled Phase 3 trial when TEMBEXA was evaluated in another disease.
An increased risk in mortality is possible if TEMBEXA is used for a duration longer than at the recommended dosage on Days 1 and 8. In Study 301 (CMX001- 301), a total of 303 subjects received TEMBEXA (100 mg twice weekly) and 149 subjects received matching placebo for up to 14 weeks.
The primary endpoint was evaluated at Week 24. All-cause mortality at Week 24 was 16% in the TEMBEXA group compared to 10% in the placebo group. Route of Administration Dosage Form/ Strength/Composition Non-medicinal Ingredients Oral Tablet, 100 mg Colloidal Silicon Dioxide, Crospovidone, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Purified Water, Silicified Microcrystalline Cellulose, Talc and Titanium Dioxide.
Oral suspension, 10 mg/mL Citric Acid Anhydrous, Lemon Lime Flavor, Microcrystalline Cellulose and Carboxymethyl Cellulose Sodium, Purified Water, Simethicone 30% Emulsion, Sodium Benzoate, Sucralose, Trisodium Citrate Anhydrous, and Xanthan Gum.
TEMBEXA (brincidofovir) Product Monograph Page 8 of 26 Carcinogenesis and Mutagenesis TEMBEXA is considered a potential human carcinogen based on findings from animal studies in which rats administered TEMBEXA developed adenocarcinomas and carcinomas.
2 Recommended Dose and Dose Adjustment and 16 NON-CLINICAL TOXICOLOGY]. Do not divide, break, or crush TEMBEXA tablets. Avoid direct contact with broken or crushed tablets or oral suspension. If contact with skin or mucous membranes occurs, wash thoroughly with soap and water, and rinse eyes thoroughly with water [see 12 SPECIAL HANDLING INSTRUCTIONS].
Gastrointestinal During the first 2 weeks of TEMBEXA therapy in Phase 2 and 3 randomized, placebo-controlled clinical trials in 392 adult patients, a composite term of diarrhea (all grade, all cause) occurred in 40% of TEMBEXA-treated subjects compared with 25% of subjects in the placebo control group.
Treatment with TEMBEXA was discontinued in 5% of subjects for diarrhea (composite term) compared with 1% in the placebo control group. Additional gastrointestinal (GI) adverse events included nausea, vomiting, and abdominal pain [see 8 ADVERSE REACTIONS].
Monitor patients for GI adverse events including diarrhea and dehydration, provide supportive care, and if necessary, do not give the second and final dose of […]
Table 1:
Recommended Dosage in Pediatric and Adult Patients Patient’s Weight (kg) TEMBEXA Oral Suspension (10 mg/mL) TEMBEXA Tablet (100 mg) Less than 10 kg 6 mg/kg once weekly for 2 doses (on Days 1 and 8) N/A 10 kg to less than 48 kg 4 mg/kg once weekly for 2 doses (on Days 1 and 8) N/A 48 kg and above 200 mg (20 mL) once weekly for 2 doses (on Days 1 and 8) 200 mg (two 100 mg tablets) once weekly for 2 doses (on Days 1 and 8) Patients with Renal Impairment: No dosage adjustment of TEMBEXA is required for patients with mild, moderate, or severe renal impairment or patients with end stage renal disease (ESRD) receiving dialysis [see 10 CLINICAL PHARMACOLOGY].
Patients with Hepatic Impairment:
Perform hepatic laboratory testing in all patients before starting TEMBEXA and while receiving TEMBEXA, as clinically appropriate. No dosage adjustment is required for patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C) [see 7 WARNINGS AND PRECAUTIONS,