Details for: PMS-TENOFOVIR
Company: PHARMASCIENCE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02453940 | PMS-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
- pms-TENOFOVIR is a type of medicine called a nucleotide analog reverse transcriptase inhibitor (NRTI).
- Use in the Treatment of HIV-Infection:
pms-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). pms-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: pms-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 pms-TENOFOVIR, your healthcare professional should be prescribing pms-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, pms-TENOFOVIR helps to block HIV reverse transcriptase (enzyme) that is needed for HIV to multiply. pms-TENOFOVIR lowers the amount of HIV in the blood (called viral load).
- pms-TENOFOVIR does not cure HIV infection or AIDS. The long-term effects of pms-TENOFOVIR are not known at this time. People taking pms-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, pms-TENOFOVIR works by interfering with the normal working of enzymes (HBV DNA polymerase) that are essential for the HBV virus to reproduce itself. pms-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 pms-TENOFOVIR may help your hepatitis. Sometimes, viruses change in your body and medicines no longer work. This is called drug resistance.
pms-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 pms-TENOFOVIR if you are allergic to pms-TENOFOVIR or any of its ingredients (see What the non-medicinal ingredients are).
What the medicinal ingredient is
Tenofovir disoproxil fumarate
What the non-medicinal ingredients are
FD&C Blue # 2 Aluminum Lake, Hydroxy Propyl Cellulose, Hypromellose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate, Titanium Dioxide and Triacetin.
What dosage form it comes in
Tablets: 300 mg
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 pms-TENOFOVIR. Some patients treated with tenofovir disoproxil fumarate (a component of pms-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 pms-TENOFOVIR. Do not stop taking pmsTENOFOVIR without your healthcare professional’s advice. If you stop taking pms-TENOFOVIR, tell your healthcare professional immediately about any new, unusual or worsening symptoms that you notice after stopping treatment. After you stop taking pms-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 pms-TENOFOVIR belong (NRTIs) can cause a condition called lactic acidosis (buildup 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 tenofovir disoproxil fumarate 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 pms-TENOFOVIR. If you notice these symptoms, stop taking pmsTENOFOVIR 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 pms-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 pms-TENOFOVIR if you have not already discontinued treatment with HEPSERA®.
BEFORE you use pms-TENOFOVIR talk to your healthcare professional if:
- You are pregnant or planning to become pregnant: Pregnant mothers should not take pms-TENOFOVIR unless specifically directed by the healthcare professional. If you take pms-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 pms-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®). Tenofovir disoproxil fumarate (pms-TENOFOVIR) may increase the amount of VIDEX® in your blood. You may need to be followed more carefully if you are taking pms-TENOFOVIR 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), EPCLUSA® (sofosbuvir/velpatasvir), or VOSEVITM (sofosbuvir/velpatasvir/voxilaprevir) may increase the amount of tenofovir disoproxil fumarate (pms-TENOFOVIR) in your blood, which could result in more side effects. You may need to be followed more carefully if you are taking pms-TENOFOVIR together with REYATAZ®, KALETRA®, PREZISTA®, HARVONI®, EPCLUSA®, OR VOSEVITM. pms-TENOFOVIR may decrease the amount of REYATAZ® in your blood. If you are taking pms-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
pms-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 pms-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
pms-TENOFOVIR and become harder to treat.
If you are taking pms-TENOFOVIR to treat your HIV or if you
have HIV and HBV coinfection and are taking
pms-TENOFOVIR, always take pms-TENOFOVIR in
combination with other anti-HIV medicines. pms-TENOFOVIR
and other products like pms-TENOFOVIR may be less likely to
work in the future if you are not taking pms-TENOFOVIR with
other anti-HIV medicines because you may develop resistance to
those medicines.
If you have HBV only (without HIV), pms-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 pms-TENOFOVIR for
chronic hepatitis B.
Only take medicine that has been prescribed specifically for
you. Do not give pms-TENOFOVIR to others or take medicine
prescribed for someone else.
Usual Adult Dose:
- The usual dose of pms-TENOFOVIR is one 300 mg tablet orally (by mouth) once a day.
- pms-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 pms-TENOFOVIR tablet once daily orally.
- pms-TENOFOVIR may be taken with or without a meal.
Overdose
Missed Dose
- If you miss a dose of pms-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 tenofovir disoproxil fumarate 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
pms 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 pms-TENOFOVIR, contact your healthcare
professional.
How to store
- Keep pms-TENOFOVIR and all other medications out of reach and sight of children.
- pms-TENOFOVIR should be stored between 15ºC and 30ºC (59-86ºF). 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 3 ways:
- Report online at www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada.html
- 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, Ontario
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 plus the full product monograph, prepared for
health professionals, can be obtained by contacting
Pharmascience Inc. at 1-888-550-6060.
This leaflet was prepared by
Pharmascience Inc.
Montréal, Canada
H4P 2T4
www.pharmascience.com
Last revised: October 10, 2018
ATRIPLA®, COMPLERA®, DESCOVY®, EMTRIVA®,
EPCLUSA®, GENVOYA®, HARVONI®, HEPSERA®,
ODEFSEY™, SOVALDI®, STRIBILD®, TRUVADA®,
VEMLIDY™, VIREAD®, and VOSEVI™ are trademarks of
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Inc. is not affiliated with and does not endorse Pharmascience Inc.
or its products.
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