Tembexa: Uses, Side Effects and Dosage

What is TEMBEXA used for?

TEMBEXA is used to treat smallpox disease in adults, children and infants.

Limitations of Use:

Tembexa is not approved for the treatment of diseases other than smallpox disease.

How does TEMBEXA work?

Smallpox disease is caused by type of virus called variola virus. TEMBEXA is an antiviral medicine that acts against variola virus. It prevents the virus from replicating.

What are the ingredients in TEMBEXA?

Tablet:

Medicinal ingredients: brincidofovir

Non-medicinal ingredients: 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.

Serious Warnings and Precautions

An increase in death was seen when TEMBEXA was studied in patients who were treated for longer periods of time.

See “Other warnings you should know about” for more information.

“HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR ADULT AND PEDIATRIC PATIENTS FOR TREATMENT OF SMALLPOX DISEASE BASED ON LIMITED CLINICAL TESTING IN HUMANS.”

Oral Suspension:

Medicinal ingredients: brincidofovir

Non-medicinal ingredients: 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 comes in the following dosage forms:

Tablets: 100 mg

Oral Suspension: 10 mg/mL

Do not use TEMBEXA if:

• You are allergic to brincidofovir.
• You are allergic to any of the other ingredients in TEMBEXA or to a component of the container.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEMBEXA. Talk about any health conditions or problems you may have, including if you:

• are immunocompromised, which means you have problems with your immune system.
• have kidney problems.
• have recently received or plan to receive a smallpox vaccination.

Other warnings you should know about:

Talk to your doctor or pharmacist before taking TEMBEXA.

Increased risk of death when used for longer periods:

An increase in death was seen when TEMBEXA was studied in patients with another disease. These patients were treated for longer periods of time. An increased risk of death is possible if TEMBEXA is used for longer than the recommended two doses. Therefore, TEMBEXA should only be used as recommended, with one dose on Day 1 and one dose on Day 8.

Liver testing and problems:

Your healthcare professional should perform blood tests to check your liver before you start taking TEMBEXA and while you are taking it. Contact your healthcare professional right away if you have any symptoms of liver problems. These include: stomach pain, right upper stomach area pain or swelling, dark urine, yellowing of your skin or the whites of your eyes, flu like symptoms, swelling of the belly, nausea, vomiting, throwing up of blood, extreme tiredness, confusion, abnormal liver blood testing results provided by your doctor.

Women - Preventing pregnancy:

Before you take TEMBEXA, tell your healthcare professional if you are pregnant, think you might be pregnant, or plan to become pregnant. TEMBEXA can harm your unborn infant. Tell your healthcare provider if you become pregnant or think you may be pregnant while you are taking TEMBEXA.

Your healthcare professional will check to see if you are pregnant before you start taking TEMBEXA.

Your healthcare professional may use another medicine to treat your smallpox disease if you are pregnant. You must use effective birth control while you are taking TEMBEXA and for 2 months after you stop taking it. Talk to your healthcare professional for more information on effective birth control methods.

Men - Preventing pregnancy in female partners and fertility:

TEMBEXA may harm your sperm. If you are sexually active with a woman you must use condoms while you are taking TEMBEXA and for 4 months after you stop taking it. TEMBEXA can also affect your fertility and ability to conceive children. This may not be reversible.

Breastfeeding:

Tell your healthcare professional if you are breastfeeding or plan to breastfeed. You should not breastfeed when you have smallpox disease. This is because of the risk of passing the smallpox virus to your infant through your breastmilk. Before you take TEMBEXA, talk to your healthcare professional on how best to feed your infant while you are taking TEMBEXA.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with TEMBEXA

• Cidofovir, used to treat eye infections.
• Medicines called protease inhibitors, used to treat human immunodeficiency virus (HIV) or hepatitis C virus (HCV).
• Clarithromycin, erythromycin and rifampin, antibiotics used to treat infections.
• Gemfibrozil, used to treat heart disease.
• Cyclosporine, used to treat organ rejection in transplant patients.

How to take TEMBEXA:

• Always take TEMBEXA exactly as your healthcare professional has told you.
• Check with your healthcare professional if you are not sure.
• Take TEMBEXA once a week for 2 doses in total (on Day 1 and Day 8).

• Take TEMBEXA tablets on an empty stomach or with a low-fat, low calorie meal (around 300 calories, with approximately 5% calories from fat). Talk to your healthcare professional for examples of foods that you can eat for a low-fat meal.

• Swallow tablet whole with water. Do not crush, break, or divide them.
• Take TEMBEXA oral suspension on an empty stomach.
• Shake the oral suspension bottle well before each use. Use an oral dosing syringe to correctly measure your dose. Ask your pharmacist for an oral dosing syringe if you do not have one. Only take the amount prescribed to you. Throw away any unused portion after completion of 2 prescribed doses.

• For people who are not able to swallow: You may give TEMBEXA oral suspension through a naso-gastric or gastrostomy tube to someone who is not able to swallow. Use the following instructions:

  • Draw up the prescribed dose of TEMBEXA oral suspension using a catheter-tip syringe with mL markings on it.
  • Give the dose through the naso-gastric tube or gastrostomy tube.
  • Refill the catheter-tip syringe with 3 mL of water and shake the syringe. Give the contents of the syringe through the naso-gastric tube or gastrostomy tube.
  • Flush with water before and after administration.
• Stay under the care of your healthcare professional during treatment with TEMBEXA.
• If you touch TEMBEXA, wash your hands very well with soap and water. If you get TEMBEXA in your eyes, rinse your eyes well with water.

Usual dose:

The usual dose of TEMBEXA is based on your weight and your ability to swallow tablets. Your healthcare professional will tell you how much TEMBEXA to take.

Overdose:

Missed Dose:

If you miss the second and final dose of TEMBEXA, take it as soon as possible.

What are possible side effects from using TEMBEXA?

These are not all the possible side effects you may have when taking TEMBEXA. If you experience any side effects not listed here, tell your healthcare professional.

• Nausea
• Diarrhea
• Vomiting
• Decreased appetite
• Rash

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store TEMBEXA tablets and oral suspension at room temperature (15°C to 30°C).
• Do not freeze TEMBEXA oral suspension.

Keep out of reach and sight of children.

If you want more information about TEMBEXA:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), or by calling Emergent BioDefense Operations Lansing LLC at 1-877-246-8472.