Viread (Tenofovir Disoproxil Fumarate)

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 doctor may monitor your kidney function before beginning and while receiving VIREAD. Some patients treated with tenofovir disoproxil fumarate (a component of VIREAD) 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 VIREAD. Do not stop taking VIREAD without your doctor's advice. If you stop taking VIREAD, tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment. After you stop taking VIREAD, your doctor will still need to check your health and take blood tests to check your liver for several months.
• The class of medicines to which VIREAD 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 VIREAD 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 doctor immediately if such symptoms occur while you are receiving VIREAD. If you notice these symptoms, stop taking VIREAD and consult a doctor 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 doctor. If you have bone problems, you may wish to discuss calcium and/or vitamin D supplements with your doctors.
• Changes in body fat have been seen in some patients taking antiretroviral therapy for the treatment of HIV infection. These changes may include increased amounts of fat in the upper back and neck (“buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long term health effects of these conditions are not known at this time.

• Do not take VIREAD if you are already taking TRUVADA, ATRIPLA, COMPLERA or STRIBILD because VIREAD is one of the active ingredients in these products.
• Do not take VIREAD if you have not already discontinued treatment with HEPSERA.

BEFORE you use VIREAD talk to your doctor or pharmacist if:

• You are pregnant, planning to become pregnant: Pregnant mothers should not take VIREAD unless specifically directed by the doctor.
• You are breastfeeding or planning to breastfeed: Do not breastfeed if you are taking VIREAD. 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 doctor about the best way to feed your baby.
• You have other medical conditions: Let your doctor know if you have other medical conditions, especially hepatitis (inflammation of the liver), pancreatitis (inflammation of the pancreas), 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.

The most common side effects of VIREAD 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 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.

Drugs that contain didanosine (Videx, Videx EC). Tenofovir disoproxil fumarate (VIREAD) may increase the amount of Videx in your blood. You may need to be followed more carefully if you are taking VIREAD and Videx together. Also, the dose of didanosine may need to be reduced.

Reyataz (atazanavir sulfate), Kaletra (lopinavir/ritonavir), Prezista (darunavir) or HARVONI (ledipasvir/sofosbuvir) may increase the amount of tenofovir disoproxil fumarate (VIREAD) in your blood, which could result in more side effects. You may need to be followed more carefully if you are taking VIREAD together with Reyataz, Kaletra, Prezista or HARVONI. VIREAD may decrease the amount of Reyataz in your blood. If you are taking VIREAD and Reyataz together, you should also be taking Norvir (ritonavir).

Stay under a doctor's care when taking VIREAD. Do not change your treatment or stop treatment without first talking with your doctor.

Carefully follow the directions and dosing schedule prescribed by your doctor.

When your VIREAD supply starts to run low, see your doctor or pharmacist 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 VIREAD and become harder to treat.

If you are taking VIREAD to treat your HIV or if you have HIV and HBV coinfection and are taking VIREAD, always take VIREAD in combination with other anti-HIV medicines. VIREAD and other products like VIREAD may be less likely to work in the future if you are not taking VIREAD with other anti-HIV medicines because you may develop resistance to those medicines.

If you have HBV only (without HIV), VIREAD can be prescribed as a single drug treatment for HBV.

Talk to your doctor about taking an HIV test before you start treatment with VIREAD for chronic hepatitis B.

Only take medicine that has been prescribed specifically for you. Do not give VIREAD to others or take medicine prescribed for someone else.

Usual adult dose:

• The usual dose of VIREAD is one 300 mg tablet orally (by mouth) once a day.
• VIREAD 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 VIREAD tablet once daily orally.
• VIREAD may be taken with or without a meal.

Overdose:

In case of drug overdose, contact your healthcare practitioner (e.g. doctor), hospital emergency department or regional poison care centre, even if there are no symptoms.

Missed dose:

• If you miss a dose of VIREAD, take it as soon as possible and then take your next scheduled dose at its regular time.
• Do not double the next dose.