Patient Medication Information: uses, side effects, how to take - Teva-Tenofovir

ABOUT THIS MEDICATION

What the medication is used for:

TEVA-TENOFOVIR is a type of medicine called a nucleotide analog reverse transcriptase inhibitor (NRTI).
Use in the Treatment of HIV-Infection:
TEVA-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). TEVA-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:
TEVA-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 TEVA-TENOFOVIR, your healthcare professional should be prescribing TEVA-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, TEVA-TENOFOVIR helps to block HIV reverse transcriptase (enzyme) that is needed for HIV to multiply. TEVA-TENOFOVIR lowers the amount of HIV in the blood (called viral load).
TEVA-TENOFOVIR does not cure HIV infection or AIDS. The long-term effects of TEVA-TENOFOVIR are not known at this time. People taking TEVA-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, TEVA-TENOFOVIR works by interfering with the normal working of enzymes (HBV DNA polymerase) that are essential for the HBV virus to reproduce itself. TEVA-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 TEVA-TENOFOVIR may help your hepatitis. Sometimes viruses change in your body and medicines no longer work. This is called drug resistance.

TEVA-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 TEVA-TENOFOVIR if you are allergic to TEVA-TENOFOVIR or any of its ingredients (See: What the nonmedicinal ingredients are).

What the medicinal ingredient is:

Tenofovir disoproxil fumarate

What the nonmedicinal ingredients are:

Colloidal anhydrous silica, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, FD&C Blue #2, carmine, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

What dosage forms it comes in:

TEVA-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 to blue, modified capsule-shaped film-coated tablets debossed with “93” on one side and with “7104” on the other side. Each bottle contains 30 tablets and a child-resistant cap with desiccant silica gel (3 gm.) sorbit canister.

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 TEVA-TENOFOVIR.

Some patients treated with tenofovir disoproxil fumarate (a component of TEVA-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 TEVA-TENOFOVIR. Do not stop taking TEVA-TENOFOVIR without your healthcare professional’s advice. If you stop taking TEVA-TENOFOVIR, tell your healthcare professional immediately about any new, unusual or worsening symptoms that you notice after stopping treatment. After you stop taking TEVA-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 TEVA-TENOFOVIR 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 TEVA-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 TEVA-TENOFOVIR. If you notice these symptoms, stop taking TEVA-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 TEVA-TENOFOVIR if you are already taking ATRIPLA^®(efavirenz/emtricitabine/tenofovir disoproxil fumarate), COMPLERA^®(emtricitabine/rilpivirine/tenofovir disoproxil fumarate), DESCOVY^®(emtricitabine/tenofovir alafenamide), GENVOYA^®(elvitegravir/tenofovir alafenamide (as the hemifumarate)/emtricitabine/cobicistat), ODEFSEY™ (emtricitabine/rilpivirine/tenofovir alafenamide), STRIBILD^®(elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate), TRUVADA^®(emtricitabine/tenofovir disoproxil fumarate) or VEMLIDY™ (tenofovir alafenamide).
because these medicines contain the same or similar active ingredients.
Do not take TEVA-TENOFOVIR if you have not already discontinued treatment with HEPSERA^®(adefovir dipivoxil).

BEFORE you use TEVA-TENOFOVIR talk to your healthcare professional if:

You are pregnant or planning to become pregnant: Pregnant mothers should not take TEVA-TENOFOVIR unless specifically directed by the healthcare professional. If you take TEVA-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 TEVA-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^®). TEVA-TENOFOVIR may increase the amount of didanosine (Videx^®) in your blood. You may need to be followed more carefully if you are taking TEVA-TENOFOVIR and drugs containing didanosine (Videx^®) together. Also, the dose of didanosine may need to be reduced.
Reyataz^®(Atazanavir sulfate), Kaletra^®(lopinavir/ritonavir), Prezista^®(darunavir), HARVONI^®(ledipsavir/sofosbuvir), EPCLUSA^®(sofosbuvir/velpatasvir) or VOSEVI™ (sofosbuvir/velpatasvir/voxilaprevir) may increase the amount of tenofovir disoproxil fumarate in your blood, which could result in more side effects. You may need to be followed more carefully if you are taking TEVA-TENOFOVIR together with Reyataz^®(atazanavir sulfate), Kaletra^®(lopinavir/ritonavir), Prezista^®(darunavir), HARVONI^®(ledipsavir/sofosbuvir), EPCLUSA^®(sofosbuvir/velpatasvir) or VOSEVI™ (sofosbuvir/velpatasvir/voxilaprevir). TEVA-TENOFOVIR may decrease the amount of atazanavir sulfate in your blood. If you are taking TEVA-TENOFOVIR and atazanavir sulfate together, you should also be taking ritonavir.

PROPER USE OF THIS MEDICATION

Stay under a healthcare professional’s care when taking TEVA- 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 TEVA-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 TEVA- TENOFOVIR and become harder to treat.

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

If you have HBV only (without HIV), TEVA-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 TEVA-TENOFOVIR for chronic hepatitis B.

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

Usual Adult Dose:

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

Overdosage:

In case of drug overdose, contact your healthcare professional, hospital emergency department or Regional Poison Control Centre, even if there are no symptoms.

Missed Dose:

If you miss a dose of TEVA-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 TEVA-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.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptoms / Effect	Talk with your healthcare professional	Stop taking drug and call your healthcare professional
Only if severe	In all cases
Rare
Effect: Kidney problems Symptoms Increased or decreased urination as well as increased thirst Swelling of legs and feet Feeling listless and tired		√ √ √
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

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Symptoms / Effect	Talk with your healthcare professional	Stop taking drug and call your healthcare professional

Only

severe

In all cases

problems)

with hepatomegaly (liver enlargement) and steatosis (fat in the liver)

Symptoms

Jaundice (skin or the white part of eyes turns 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

√

Effect: Flare-ups of

hepatitis B virus infection following drug discontinuation

Symptoms

Jaundice (skin or the white part of eyes turns 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 TEVA-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 effects while taking TEVA-TENOFOVIR, contact your healthcare professional.

HOW TO STORE IT

Keep TEVA-TENOFOVIR and all other medications out of reach and sight of children.
TEVA-TENOFOVIR should be stored between 15°C and 30°C. 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/adverse-reaction-reporting.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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited by:

Phone: 1-800-268-4127 ext. 3;

Email: druginfo@tevacanada.com; or

Fax: 1-416-335-4472

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Rx or OTC	Prescription (Rx)?
DIN	02403889
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Tenofovir disoproxil fumarate 300 MG
Dosage form(s)	Tablet
Route(s) of administration	Oral
Drug class (WHO ATC)	J Antiinfectives for systemic use J05 Antivirals for systemic use J05A Direct acting antivirals J05AF Nucleoside and nucleotide reverse transcriptase inhibitors J05AF07 Tenofovir disoproxil
Company	TEVA CANADA LIMITED
Current status	Marketed
Current status date	July 26, 2017

Teva-Tenofovir: Uses, Side Effects and Dosage