Details for: APO-TENOFOVIR
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02451980 | APO-TENOFOVIR | TENOFOVIR DISOPROXIL FUMARATE | 300 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
- APO-TENOFOVIR is a type of medicine called a nucleotide analog reverse transcriptase inhibitor (NRTI).
- Use in the Treatment of HIV-Infection:
APO-TENOFOVIR is a treatment for Human Immunodeficiency Virus (HIV) infection in adults and adolescents age 12 years and older and weighing at least 35 kg (77 lb). APO-TENOFOVIR is always used in combination with other anti-HIV medicines to treat people with HIV infection.
HIV infection destroys CD4+ (T) cells, which are important to the immune system. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops. - Use in the Treatment of Chronic Hepatitis B:
APO-TENOFOVIR is also used to treat chronic hepatitis B (an infection with hepatic B virus [HBV]) in adults age 18 years and older. - If you have both HIV and HBV infection and are taking APO-TENOFOVIR, your healthcare professional should be prescribing APO-TENOFOVIR in combination with other anti-HIV medicines (See: Proper Use of This Medication).
What it does
Treatment of HIV infection:
- In patients with HIV infection, APO-TENOFOVIR helps to block HIV reverse transcriptase (enzyme) that is needed for HIV to multiply. APO-TENOFOVIR lowers the amount of HIV in the blood (called viral load).
- APO-TENOFOVIR does not cure HIV infection or AIDS. The long- term effects of APO-TENOFOVIR are not known at this time. People taking APO-TENOFOVIR may still get opportunistic infections or other conditions that happen with HIV infection. Opportunistic infections are infections that develop because the immune system is weak.
Treatment of Chronic Hepatitis B:
- In patients with HBV infection, APO-TENOFOVIR works by interfering with the normal working of enzymes (HBV DNA polymerase) that are essential for the HBV virus to reproduce itself. APO-TENOFOVIR may help lower the amount of hepatitis B virus in your body by lowering the ability of the virus to multiply and infect new liver cells.
- We do not know how long APO-TENOFOVIR may help your hepatitis. Sometimes viruses change in your body and medicines no longer work. This is called drug resistance.
APO-TENOFOVIR does not reduce the risk of passing HIV or HBV to others through sexual contact or blood contamination. Continue to practice safe sex and do not use or share dirty needles.
When it should not be used
- Do not take APO-TENOFOVIR if you are allergic to APO-TENOFOVIR or any of its ingredients (See: What the important nonmedicinal ingredients are).
What the medicinal ingredient is
Tenofovir disoproxil fumarate
What the non-medicinal ingredients are
Anhydrous lactose, calcium stearate, colloidal silicon dioxide, crospovidone, FD&C Blue No. 2, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
What dosage form it comes in
APO-TENOFOVIR is available as tablets. Each tablet contains 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. The tablets are light blue, almond shaped, biconvex, film coated, and engraved “TEN” over “300” on one side, “APO” on the other side.
Warnings and precautions
Serious Warnings and Precautions
- The most serious possible side effect is harm to the kidneys, including damage to kidney cells, kidney tissue inflammation and kidney failure. Your healthcare professional may monitor your kidney function before beginning and while receiving APO-TENOFOVIR. Some patients treated with tenofovir disoproxil fumarate (a component of APO-TENOFOVIR) have had kidney problems. Your healthcare professional may need to perform additional blood tests if you have had kidney problems in the past or need to take another drug that can cause kidney problems.
- If you have Hepatitis B Virus infection or if you have HIV and HBV infection together, “flare-ups” of Hepatitis B Virus infection, in which the disease suddenly returns in a worse way than before, can occur if you stop taking APO-TENOFOVIR. Do not stop taking APO-TENOFOVIR without your healthcare professional’s advice. If you stop taking APO-TENOFOVIR, tell your healthcare professional immediately about any new, unusual or worsening symptoms that you notice after stopping treatment. After you stop taking APO-TENOFOVIR, your healthcare professional will still need to check your health and take blood tests to check your liver for several months.
- The class of medicines to which APO-TENOFOVIR belong (NRTIs) can cause a condition called lactic acidosis (build-up of acid in the blood). The symptoms that may be signs of lactic acidosis include: feeling very weak, tired or uncomfortable; unusual or unexpected stomach discomfort, feeling cold, feeling dizzy or lightheaded; suddenly developing a slow or irregular heartbeat. This rare but serious side effect has occasionally been fatal.
- Severe liver problems can happen in people who take
APO-TENOFOVIR or similar medicines. You may
develop an enlarged liver (hepatomegaly) or a fatty
liver (steatosis). Non-specific symptoms such as
yellowing of the skin and eyes, nausea, vomiting, and
stomach pain might indicate the development of liver
problems.
Lactic acidosis or severe liver problems occur more often in women, particularly if they are very overweight. You should consult your healthcare professional immediately if such symptoms occur while you are receiving APO-TENOFOVIR. If you notice these symptoms, stop taking APO-TENOFOVIR and consult a healthcare professional immediately. - Tenofovir disoproxil fumarate caused harm to the bones of animals. Tenofovir disoproxil fumarate reduced bone density in humans. If you notice bone pain, suffer a bone fracture, or other bone problem, consult your healthcare professional. If you have bone problems, you may wish to discuss calcium and/or vitamin D supplements with your healthcare professionals.
- Do not take APO-TENOFOVIR if you are already taking emtricitabine/tenofovir disoproxil fumarate, efavirenz/emtricitabine/ tenofovir disoproxil fumarate, emtricitabine/rilpivirine/tenofovir disoproxil fumarate, emtricitabine/tenofovir alafenamide, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate because these medicines contain the same or similar active ingredients.
- Do not take APO-TENOFOVIR if you have not already discontinued treatment with adefovir dipivoxil.
BEFORE you use APO-TENOFOVIR talk to your healthcare professional if:
- You are pregnant or planning to become pregnant: Pregnant mothers should not take APO-TENOFOVIR unless specifically directed by the healthcare professional. If you take APO-TENOFOVIR while you are pregnant, talk to your healthcare professional about how you can be included in the Antiviral Pregnancy Registry.
- You are breastfeeding or planning to breastfeed: Do not breastfeed if you are taking APO-TENOFOVIR. Tenofovir passes to your baby in your breast milk. You should not breastfeed because of the risk of passing HIV or HBV to your baby. Talk to your healthcare professional about the best way to feed your baby.
- You have other medical conditions: Let your healthcare professional know if you have other medical conditions, especially hepatitis (inflammation of the liver), pancreatitis (inflammation of the pancreas), and bone and kidney problems.
- You have HIV Infection.
- You are taking other medicines: Some medicines can interact when taken together, including prescription and non- prescription medicines and dietary supplements.
Other Special Warnings:
Your blood sugar levels (glucose) or levels of fats (lipids) in
your blood may increase with HIV treatment. Your doctor
may order blood tests for you.
Interactions with this medication
- Drugs that contain didanosine. Tenofovir disoproxil fumarate (APO-TENOFOVIR) may increase the amount of didanosine in your blood. You may need to be followed more carefully if you are taking APO-TENOFOVIR and didanosine together. Also, the dose of didanosine may need to be reduced.
- Atazanavir sulfate, lopinavir/ritonavir, darunavir, ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir may increase the amount of tenofovir disoproxil fumarate (APO-TENOFOVIR) in your blood, which could result in more side effects. You may need to be followed more carefully if you are taking APO-TENOFOVIR together with atazanavir sulfate, lopinavir/ritonavir, darunavir, ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir. APO-TENOFOVIR may decrease the amount of atazanavir in your blood. If you are taking APO-TENOFOVIR and atazanavir together, you should also be taking ritonavir.
Proper use of this medication
Stay under a healthcare professional’s care when taking APO-TENOFOVIR. Do not change your treatment or stop
treatment without first talking with your healthcare
professional.
Carefully follow the directions and dosing schedule prescribed
by your healthcare professional.
When your APO-TENEFOVIR supply starts to run low, see
your healthcare professional for a refill. This is very important
because the amount of virus in your blood may increase if the
medicine is stopped for even a short time. The virus may
develop resistance to APO-TENOFOVIR and become harder
to treat.
If you are taking APO-TENOFOVIR to treat your HIV or if
you have HIV and HBV coinfection and are taking APO-TENOFOVIR, always take APO-TENOFOVIR in
combination with other anti-HIV medicines. APO-TENOFOVIR and other products like APO-TENOFOVIR
may be less likely to work in the future if you are not taking
APO-TENOFOVIR with other anti- HIV medicines because
you may develop resistance to those medicines.
If you have HBV only (without HIV), APO-TENOFOVIR can
be prescribed as a single drug treatment for HBV.
Talk to your healthcare professional about taking an HIV test
before you start treatment with APO-TENOFOVIR for
chronic hepatitis B.
Only take medicine that has been prescribed specifically for
you. Do not give APO-TENOFOVIR to others or take
medicine prescribed for someone else.
Usual Adult Dose:
- The usual dose of APO-TENOFOVIR is one 300 mg tablet orally (by mouth) once a day.
- APO-TENOFOVIR may be taken with or without a meal.
Usual Adolescent (12 Years of Age and Older) Dose for HIV Infection:
- Body weight ≥ 35 kg (≥ 77 lb): Take one 300 mg APO-TENOFOVIR tablet once daily orally.
- APO-TENOFOVIR may be taken with or without a meal.
Overdosage:
Missed Dose
- If you miss a dose of APO-TENOFOVIR, take it as soon as possible and then take your next scheduled dose at its regular time.
- Do not double the next dose
Side effects and what to do about them
The most common side effects of APO-TENOFOVIR are:
- Diarrhea
- Nausea
- Vomiting
- Dizziness
Other side effects include:
- Flatulence (intestinal gas)
- Allergic reaction, including angioedema (swelling of the blood vessels) with symptoms such as skin rash, redness, swelling of the hands, legs, feet, face, lips, tongue or throat, with difficulty in breathing
- Stomach pain
- Weakness
- Inflammation of the pancreas
- Shortness of breath
- Headache
- Rash
Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time, or you could develop an autoimmune disease in which your immune system reacts against your own body [e.g. Grave's disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system) or polymyositis (which affects the muscles)] and it may develop at any time, sometimes months later after the start of HIV therapy. Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling or fatigue, or any new symptoms, contact your healthcare professional right away.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and call your healthcare professional |
|---|---|---|---|
| Rare | |||
Effect: Kidney problems
Symptoms
|
✔ | ||
Effect: Lactic acidosis
Symptoms
|
✔ | ||
| Very Rare | |||
Effect: Hepatotoxicity
(severe liver problems) with
hepatomegaly (liver
enlargement) and steatosis
(fat in the liver)
Symptoms
|
✔ | ||
Effect: Flare-ups of hepatitis
B virus infection following
drug discontinuation
Symptoms
|
✔ | ||
Lactic acidosis is a medical emergency and must be treated in
the hospital. You may be more likely to get lactic acidosis or
serious liver problems if you are very overweight (obese) or
have been taking nucleoside analog medicines, like APO-TENOFOVIR, for a long time.
Muscle pain, muscle weakness, bone pain and softening of the
bone (infrequently contributing to fractures) have also been
reported.
This is not a complete list of side effects. For any unexpected
side effects while taking APO-TENOFOVIR, contact your
healthcare professional.
How to store
- Keep APO-TENOFOVIR and all other medications out of reach and sight of children.
- APO-TENOFOVIR should be stored at controlled room temperature 15°C to 30°C, protect from moisture. It should remain stable until the expiration date printed on the label.
- Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away, make sure that children will not find them.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about APO-TENOFOVIR:
- 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/healthcanada/services/drugs-health-products/drugproducts/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800- 667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario,
M9L 1T9
All registered trademarks in this document are the property of
their respective owners.
Last revised: October 24, 2018