Consumer Information for: MYLAN-TENOFOVIR DISOPROXIL
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
- Mylan-Tenofovir Disoproxil is a type of medicine called a nucleotide analog reverse transcriptase inhibitor (NRTI).
- Use in the Treatment of HIV-Infection: Mylan-Tenofovir Disoproxil 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). Mylan-Tenofovir Disoproxil 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: Mylan-Tenofovir Disoproxil 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 Mylan-Tenofovir Disoproxil, your doctor should be prescribing Mylan-Tenofovir Disoproxil 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, Mylan-Tenofovir Disoproxil helps to block HIV reverse transcriptase (enzyme) that is needed for HIV to multiply. MylanTenofovir Disoproxil lowers the amount of HIV in the blood (called viral load).
- Mylan-Tenofovir Disoproxil does not cure HIV infection or AIDS. The long-term effects of Mylan-Tenofovir Disoproxil are not known at this time. People taking Mylan-Tenofovir Disoproxil 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, Mylan-Tenofovir Disoproxil works by interfering with the normal working of enzymes (HBV DNA polymerase) that are essential for the HBV virus to reproduce itself. Mylan-Tenofovir Disoproxil 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 Mylan-Tenofovir Disoproxil 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 Mylan-Tenofovir Disoproxil if you are allergic to Mylan-Tenofovir Disoproxil or any of its ingredients (See: What the important nonmedicinal ingredients are).
- Do not take Mylan-Tenofovir Disoproxil if you are already taking TRUVADA®, ATRIPLA®, or COMPLERA®, or STRIBILD® because MylanTenofovir Disoproxil is one of the active ingredients in these products.
- Do not take Mylan-Tenofovir Disoproxil if you have not already discontinued treatment with HEPSERA®.
What the medicinal ingredient is
Tenofovir disoproxil fumarate (TDF)
What the non-medicinal ingredients are
Croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The film coating contains: FD&C Blue #2, hypromellose, lactose monohydrate, titanium dioxide and triacetin.
What dosage form it comes in
Mylan-Tenofovir Disoproxil is available as tablets.
Each tablet contains 300 mg of tenofovir DF, which is equivalent
to 245 mg of tenofovir disoproxil. Mylan-Tenofovir Disoproxil
300 mg tablets are light blue film-coated, almond shaped,
biconvex tablets debossed with “M” on one side of the tablet and
‘TN300’ 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 MylanTenofovir Disoproxil. Some patients treated with TDF (a component of Mylan-Tenofovir Disoproxil) have had kidney problems. Your doctor 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 Mylan-Tenofovir Disoproxil. Do not stop taking Mylan-Tenofovir Disoproxil without your healthcare professional’s advice. If you stop taking Mylan-Tenofovir Disoproxil, tell your healthcare professional immediately about any new, unusual or worsening symptoms that you notice after stopping treatment. After you stop taking MylanTenofovir Disoproxil, 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 Mylan-Tenofovir Disoproxil 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 heart beat. This rare but serious side effect has occasionally been fatal.
- Severe liver problems can happen in people who take
Mylan-Tenofovir Disoproxil 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 Mylan-Tenofovir Disoproxil. If you notice these symptoms, stop taking MylanTenofovir Disoproxil 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 Mylan-Tenofovir Disoproxil 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 Mylan-Tenofovir Disoproxil if you have not already discontinued treatment with HEPSERA®.
BEFORE you use Mylan-Tenofovir Disoproxil talk to your healthcare professional if:
- You are pregnant or planning to become pregnant: Pregnant mothers should not take Mylan-Tenofovir Disoproxil unless specifically directed by the healthcare professional. If you take Mylan-Tenofovir Disoproxil while you are pregnant, talk to your doctor 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 Mylan-Tenofovir Disoproxil. 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 (Mylan-Tenofovir Disoproxil) may increase the amount of Videx in your blood. You may need to be followed more carefully if you are taking MylanTenofovir Disoproxil and Videx together. Also, the dose of didanosine may need to be reduced.
- Reyataz® (atazanavir sulfate) Kaletra® (lopinavir/ritonavir). Prezista® (darunavir), HARVONI ® (ledipasvir /sofosbuvir) or EPCLUSATM (sofosbuvir/velpatasvir), or VOSEVITM (sofosbuvir/velpatasvir/voxilaprevir) may increase the amount of TDF (Mylan-Tenofovir Disoproxil) in your blood, which could result in more side effects. You may need to be followed more carefully if you are taking Mylan-Tenofovir Disoproxil together with Reyataz, Kaletra, Prezista, HARVONI, EPCLUSA or VOSEVI. Mylan-Tenofovir Disoproxil may decrease the amount of Reyataz in your blood. If you are taking MylanTenofovir Disoproxil and Reyataz together, you should also be taking Norvir® (ritonavir).
Proper use of this medication
Stay under a healthcare professional’s care when taking MylanTenofovir Disoproxil. 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 Mylan-Tenofovir Disoproxil 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 Mylan-Tenofovir Disoproxil and become harder to
treat.
If you are taking Mylan-Tenofovir Disoproxil to treat your HIV or
if you have HIV and HBV coinfection and are taking MylanTenofovir Disoproxil, always take Mylan-Tenofovir Disoproxil in
combination with other anti-HIV medicines. Mylan-Tenofovir
Disoproxil and other products like Mylan-Tenofovir Disoproxil
may be less likely to work in the future if you are not taking
Mylan-Tenofovir Disoproxil with other anti-HIV medicines
because you may develop resistance to those medicines.
If you have HBV only (without HIV), Mylan-Tenofovir
Disoproxil 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 Mylan-Tenofovir Disoproxil for
chronic hepatitis B.
Only take medicine that has been prescribed specifically for you.
Do not give Mylan-Tenofovir Disoproxil to others or take medicine prescribed for someone else.
Usual Dose
Usual Adult Dose:- The usual dose of Mylan-Tenofovir Disoproxil is one 300 mg tablet orally (by mouth) once a day.
- Mylan-Tenofovir Disoproxil 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 MylanTenofovir Disoproxil tablet once daily orally.
- Mylan-Tenofovir Disoproxil may be taken with or without a meal
Overdose
Missed Dose
- If you miss a dose of Mylan-Tenofovir Disoproxil, 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 tenofovir DF 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-Barre 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 doctor 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 talk with your doctor or pharmacist |
|---|---|---|---|
| Rare Effect: Kidney problems Symptoms |
|||
| Increased or decreased urination as well as increased thirst | ✔ | ||
| Swelling of legs and feet | ✔ | ||
| Feeling listless and tired | ✔ | ||
| Rare Effect: Lactic acidosis Symptoms |
|||
| Feeling very weak or tired | ✔ | ||
| Unusual muscle pain | ✔ | ||
| Stomach pain with nausea and vomiting | ✔ | ||
| Feeling cold especially in arms and legs | ✔ | ||
| Feeling dizzy or lightheaded | ✔ | ||
| Fast or irregular heartbeat | ✔ | ||
| Very
Rare Effect: Hepatotoxicity (severe liver problems) with hepatomegaly (liver enlargement) and steatosis (fat in the liver) Symptoms |
|||
| Jaundice (skin or the white part of eyes turn yellow) | ✔ | ||
| Urine turns dark | ✔ | ||
| Bowel movements (stools) turn light in color | ✔ | ||
| Loss of appetite for several days or longer | ✔ | ||
| Feeling sick to your stomach (nausea) | ✔ | ||
| Lower stomach pain | ✔ | ||
| Very rare Effect: Flare-ups of hepatitis B virus infection following drug discontinuation Symptoms |
|||
| Jaundice (skin or the white part of eyes turn yellow) | ✔ | ||
| Urine turns dark | ✔ | ||
| Bowel movements (stools) turn light in color | ✔ | ||
| Loss of appetite for several days or longer | ✔ | ||
| Feeling sick to your stomach (nausea) | ✔ | ||
| Lower stomach pain | ✔ | ||
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 Mylan-Tenofovir
Disoproxil, 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 Mylan-Tenofovir Disoproxil, contact your
healthcare professional
How to store
- Keep Mylan-Tenofovir Disoproxil and all other medications out of reach and sight of children.
- Mylan-Tenofovir Disoproxil should be stored at 15ºC – 30ºC (59-86º F). 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
This document can be found at: www.mylan.ca.
The full Product Monograph prepared for health professionals can
be obtained by contacting the sponsor, Mylan Pharmaceuticals
ULC at: 1-844-596-9526
This leaflet was prepared by Mylan Pharmaceuticals ULC
Etobicoke, Ontario M8Z 2S6
Revised on: January 2, 2019
Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-844-596-9526
www.mylan.ca
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