Details for: MINT-TENOFOVIR
Company: MINT PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02512939 | MINT-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
- MINT-TENOFOVIR is a type of medicine called a nucleotide analog reverse transcriptase inhibitor (NRTI).
- Use in the Treatment of HIV-Infection: MINT-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). MINT-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: MINT-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 MINT-TENOFOVIR, your healthcare professional should be prescribing MINT-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, MINTTENOFOVIR helps to block HIV reverse transcriptase (enzyme) that is needed for HIV to multiply. MINT-TENOFOVIR lowers the amount of HIV in the blood (called viral load).
- MINT-TENOFOVIR does not cure HIV infection or AIDS. The long- term effects of MINT-TENOFOVIR are not known at this time. People taking MINTTENOFOVIR 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.
- In patients with HBV infection, MINTTENOFOVIR works by interfering with the normal working of enzymes (HBV DNA polymerase) that are essential for the HBV virus to reproduce itself. MINTTENOFOVIR 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 MINTTENOFOVIR may help your hepatitis. Sometimes viruses change in your body and medicines no longer work. This is called drug resistance.
When it should not be used
- Do not take MINT-TENOFOVIR if you are allergic to MINT-TENOFOVIR or any of its ingredients (See:What the nonmedicinal ingredients are).
What the medicinal ingredient is
Tenofovir Disoproxil Fumarate (TDF)
What the non-medicinal ingredients are
Croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, magnesium stearate and Opadry II light blue (Hypromellose, titanium dioxide, triacetin and FD&C Blue #2)
What dosage form it comes in
MINT-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 coloured, almond shaped, film-coated tablets debossed with “H” on one side and “123” 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 MINTTENOFOVIR. Some patients treated with TDF (a component of MINT-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 MINT-TENOFOVIR. Do not stop taking MINT-TENOFOVIR without your healthcare professional’s advice. If you stop taking MINTTENOFOVIR, tell your healthcare professional immediately About any new, unusual or worsening symptoms that you notice after stopping treatment. After you stop taking MINT-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 MINTTENOFOVIR belongs (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 MINT-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.
- The 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 MINT-TENOFOVIR. If you notice these symptoms, stop taking MINTTENOFOVIR and consult a healthcare professional immediately.
- TDF caused harm to the bones of animals. TDF 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 MINT-TENOFOVIR if you are already taking ATRIPLA®, COMPLERA®, DESCOVY®, GENVOYA®, ODEFSEYTM, STRIBILD®, TRUVADA® or VEMLIDYTM because these medicines contain the same or similar active ingredients.
- Do not take MINT-TENOFOVIR if you have not already discontinued treatment with adefovir dipivoxil.
BEFORE you use talk to your healthcare professional if:
- You are pregnant or planning to become pregnant: Pregnant mothers should not take MINT-TENOFOVIR unless specifically directed by the healthcare professional. If you take MINT-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 MINT-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 (Videx®, Videx EC®). TDF (MINT-TENOFOVIR) may increase the amount of Videx in your blood. You may need to be followed more carefully if you are taking MINTTENOFOVIR and Videx together. Also, the dose of didanosine may need to be reduced.
- Reyataz®(atazanavir sulfate), Kaletra® (lopinavir/ ritonavir), Presizta®( darunavir),HARVONI® (ledipasvir/sofosbuvir), EPCLUSA® (sofosbuvir/velpatasvir), or VOSEVITM (sofosbuvir/velpatasvir/voxilaprevir) may increase the amount of TDF (MINTTENOFOVIR) in your blood, which could result in more side effects. You may need to be followed more carefully if you are taking MINT-TENOFOVIR together with Reyataz, Kaltera, Prezista, HARVONI, EPCLUSA or VOSEVI. MINT-TENOFOVIR may decrease the amount of Reyataz in your blood. If you are taking MINT-TENOFOVIR and Reyataz together, you should also be taking Norvir® (ritonavir).
Proper use of this medication
Stay under a healthcare professional’s care
when taking MINT-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 MINT-TENOFOVIR 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 MINTTENOFOVIR and become harder to treat.
If you are taking MINT-TENOFOVIR to treat
your HIV or if you have HIV and HBV coinfection
and are taking MINT-TENOFOVIR, always take
MINT-TENOFOVIR in combination with other
anti-HIV medicines. MINT-TENOFOVIR and
other products like MINT-TENOFOVIR may be
less likely to work in the future if you are not
taking MINT-TENOFOVIR with other anti-HIV
medicines because you may develop resistance
to those medicines.
If you have HBV only (without HIV), MINTTENOFOVIR 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
MINT-TENOFOVIR for chronic hepatitis B.
Only take medicine that has been prescribed
specifically for you. Do not give MINTTENOFOVIR to others or take medicine
prescribed for someone else.
Usual Dose:
Usual Adult Dose:
- The usual dose of MINT-TENOFOVIR is one 300 mg tablet orally (by mouth) once a day.
- MINT-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 MINT-TENOFOVIR tablet once daily orally.
- MINT-TENOFOVIR may be taken with or without a meal.
Overdose:
Missed Dose
- If you miss a dose of MINT-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 MINTTENOFOVIR 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 to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| 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 MINT-TENOFOVIR, for a long
time.
Muscle pain, muscle weakness, bone pain and
softening of the bone (infrequently contributing to
fractures) have also been reported.
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.
How to store
Keep MINT-TENOFOVIR and all other
medications out of reach and sight of children.
MINT-TENOFOVIR should be stored at 15–30
oC (59–86 oF). 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 side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about MINTTENOFOVIR:
- 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 ; the manufacturer’s website http://www.mintpharmaceuticals.com/, or by calling 1-877-398-9696.
This leaflet was prepared by Mint Pharmaceuticals Inc. Last revised: February 23, 2021