Details for: AG-EMTRICITABINE / TENOFOVIR DISOPROXIL FUMARATE
Company: ANGITA PHARMA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02496356 | AG-EMTRICITABINE / TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE | 300 MG; 200 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
AG-Emtricitabine / Tenofovir Disoproxil Fumarate is a type of
medicine called an HIV (human immunodeficiency virus)
nucleoside analog reverse transcriptase inhibitor (NRTI). AGEmtricitabine / Tenofovir Disoproxil Fumarate contains 2
medicines, Emtricitabine and Tenofovir disoproxil fumarate
combined in one pill.
AG-Emtricitabine / Tenofovir Disoproxil Fumarate is used:
- To treat HIV-1 Infection when used with other anti-HIV medicines in adults.
- To help reduce the risk of getting HIV-1 infection when
used with safer sex practices in:
- HIV-1 negative men who have sex with men, who are at high risk of getting infected with HIV-1 through sex.
- Male-female sex partners when one partner has HIV-1infection and the other does not.
This is sometimes called Pre-Exposure Prophylaxis or PrEP. - AG-Emtricitabine / Tenofovir Disoproxil Fumarate is for adults age 18 and older. AG-Emtricitabine / Tenofovir Disoproxil Fumarate is not indicated in children under age 18 or adults over age 65.
What it does
- Use of AG-Emtricitabine / Tenofovir Disoproxil Fumarate to treat HIV-1 infection:
AG-Emtricitabine / Tenofovir Disoproxil Fumarate lowers the amount of HIV in the blood (viral load). Lowering the amount of HIV in the blood lowers the chance of infections that happen when your immune system is weak (opportunistic infections).
HIV infection destroys CD4+ (T) cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immunedeficiency syndrome (AIDS) develops. AG-Emtricitabine / Tenofovir Disoproxil Fumarate may also help to increase the number of T cells (CD4+ cells).
AG-Emtricitabine / Tenofovir Disoproxil Fumarate does not cure HIV-1 infection or AIDS. If you have HIV-1 infection, you must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.
People taking AG-Emtricitabine / Tenofovir Disoproxil Fumarate 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. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections.
- Use of AG-Emtricitabine / Tenofovir Disoproxil
Fumarate to reduce the risk of HIV-1 infection (PrEP
indication):
When used with safer sex practices, AG-Emtricitabine / Tenofovir Disoproxil Fumarate may help to reduce the risk of getting HIV-1 infection:- AG-Emtricitabine / Tenofovir Disoproxil Fumarate works better to reduce the risk of getting HIV-1 when the medicines are in your bloodstream before you are exposed to HIV1.
Considerations when AG-Emtricitabine / Tenofovir Disoproxil Fumarate is used for PrEP:
- Together with your healthcare professional, you need to decide whether AG-Emtricitabine / Tenofovir Disoproxil Fumarate is right for you.
- AG-Emtricitabine / Tenofovir Disoproxil Fumarate can only help reduce your risk of getting HIV-1 before you are infected.
- Do not take AG-Emtricitabine / Tenofovir Disoproxil
Fumarate to help reduce your risk of getting HIV-1 if:
- you already have HIV-1 infection. If you are HIV-1 positive, you need to take other medicines with AG-Emtricitabine / Tenofovir Disoproxil Fumarate to treat HIV-1. AGEmtricitabine / Tenofovir Disoproxil Fumarate by itself is not a complete treatment for HIV-1.
- you do not know your HIV-1 infection status. You may already be HIV-1 positive. You need to take other HIV-1 medicines with AGEmtricitabine / Tenofovir Disoproxil Fumarate to treat HIV-1.
- Your healthcare professional will run tests to determine that you are HIV- negative before starting PrEP treatment.
When it should not be used
Do not use AG-Emtricitabine / Tenofovir Disoproxil Fumarate if:
- You are allergic (hypersensitive) to any of the ingredients in this formulation (see: What the medicinal ingredients are; What the important nonmedicinal ingredients are)
- Do not use AG-Emtricitabine / Tenofovir Disoproxil Fumarate to reduce the risk of getting HIV if you already have HIV or do not know your HIV status.
Do NOT take AG-Emtricitabine / Tenofovir Disoproxil Fumarate if:
- you are on other medications that may affect your kidneys and have not discussed this with your healthcare professional.
- you have or are at known risk for any type of bone disease or bone related problems and have not discussed this with your healthcare professional.
- you are allergic to AG-Emtricitabine / Tenofovir Disoproxil Fumarate or any of its ingredients. The medicinal ingredients are emtricitabine and tenofovir disoproxil fumarate (see: What the important nonmedicinal ingredients are).
- you are already taking 3TC® (lamivudine), ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate), Combivir® (lamivudine/zidovudine), COMPLERA® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), DESCOVY® (emtricitabine and tenofovir alafenamide), EMTRIVA® (emtricitabine), GENVOYA® (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide), ODEFSEYTM (emtricitabine / rilpivirine / tenofovir alafenamide), Heptovir® (lamivudine), Kivexa® (abacavir sulfate and lamivudine), STRIBILD® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate), Triumeq® (abacavir sulfate/dolutegravir sodium/lamivudine), Trizivir® (abacavir sulfate/lamivudine/zidovudine), VEMLIDYTM (tenofovir alafenamide) or VIREAD® (tenofovir disoproxil fumarate) because these medicines contain the same or similar active ingredients.
- you are also taking HEPSERA (adefovir dipivoxil) to treat your HBV infection
Changes in your immune system (Immune Reconstitution
Inflammatory Syndrome) can happen when an HIV-1 infected
person starts 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.
What the medicinal ingredient is
emtricitabine tenofovir disoproxil fumarate
What the non-medicinal ingredients are
croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose FD&C Blue #2/Indigo carmine aluminum lake, hydropropylmethylcellulose 2910, lactose monohydrate, titanium dioxide, and triacetin.
What dosage form it comes in
AG-Emtricitabine / Tenofovir Disoproxil Fumarate is available as tablets. Each tablet contains 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (which is equivalent to 245 mg of tenofovir disoproxil), as active ingredients. The tablets are blue, capsule-shaped, film- coated, debossed with “LA49” on one side and plain on the other side. Each bottle contains 30 tablets and 90 tablets and a desiccant (silica gel canister) and is closed with a child- resistant closure.
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 AG-Emtricitabine / Tenofovir Disoproxil Fumarate. Some patients treated with tenofovir disoproxil fumarate(a component of AGEmtricitabine / Tenofovir Disoproxil Fumarate) 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 are also infected with the Hepatitis B Virus, “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 AG-Emtricitabine / Tenofovir Disoproxil Fumarate. Do not stop taking AGEmtricitabine / Tenofovir Disoproxil Fumarate without your healthcare professional’s advice. If you stop taking AG-Emtricitabine / Tenofovir Disoproxil Fumarate, tell your healthcare professional immediately about any new, unusual or worsening symptoms that you notice after stopping treatment. After you stop taking AGEmtricitabine / Tenofovir Disoproxil Fumarate, your healthcare professional will still need to check your health and take blood tests to check your liver for several months. AG-Emtricitabine / Tenofovir Disoproxil Fumarate is not approved for the treatment of Hepatitis B Virus infection.
- The class of medicines to which AG-Emtricitabine / Tenofovir Disoproxil Fumarate belongs (NRTIs) can cause a condition called lactic acidosis, together with an enlarged liver. Non-specific symptoms such as nausea, vomiting and stomach pain might indicate the development of lactic acidosis. This rare but serious side effect has occasionally been fatal. Lactic acidosis occurs 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 AG-Emtricitabine / Tenofovir Disoproxil Fumarate. The symptoms that may indicate 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. If you notice these symptoms, stop taking AG-Emtricitabine / Tenofovir Disoproxil Fumarate 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, or 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.
- AG-Emtricitabine / Tenofovir Disoproxil Fumarate should only be used for the PrEP indication if you are HIVnegative before and during treatment. Discuss with your healthcare professional if you have had a recent flu-like illness. Your healthcare professional will run tests to confirm that you are HIV negative before and during AGEmtricitabine / Tenofovir Disoproxil Fumarate treatment.
Before taking AG-Emtricitabine / Tenofovir Disoproxil
Fumarate to reduce your risk of getting HIV-1 infection
(PrEP indication):
You must get tested to be sure you are HIV-negative. It is
important that you also get tested at least every 3 months as
recommended by your healthcare provider while taking AGEmtricitabine / Tenofovir Disoproxil Fumarate. Do not take AGEmtricitabine / Tenofovir Disoproxil Fumarate to reduce the
risk of getting HIV (PrEP) unless you are confirmed to be
HIV-negative.
Tell your healthcare provider if you have any of the following
symptoms within the last month before you start taking AGEmtricitabine / Tenofovir Disoproxil Fumarate or at any time
while taking AG-Emtricitabine / Tenofovir Disoproxil
Fumarate:
- tiredness
- fever
- sweating a lot (especially at night)
- rash
- vomiting or diarrhea
- joint or muscle aches
- headache
- sore throat
- enlarged lymph nodes in the neck or groin
These may be signs of HIV infection and you may need to have a
different kind of test to diagnose HIV. If you are already taking
AG-Emtricitabine / Tenofovir Disoproxil Fumarate to prevent
HIV-1 infection (PrEP), your healthcare provider may tell you to
stop taking AG-Emtricitabine / Tenofovir Disoproxil Fumarate
until an HIV test confirms that you do not have HIV-1 infection.
Just taking AG-Emtricitabine / Tenofovir Disoproxil
Fumarate may not keep you from getting HIV. AGEmtricitabine / Tenofovir Disoproxil Fumarate does NOT
always prevent HIV.
You must still practice safer sex at all times. Do not have any
kind of sex without protection. Always practice safer sex by
using a latex or polyurethane condom to lower the chance of
sexual contact with semen, vaginal secretions, or blood.
You must also use other prevention methods to keep from
getting HIV.
- Know your HIV-1 status and the HIV-1 status of your partners.
- While taking AG-Emtricitabine / Tenofovir Disoproxil Fumarate, get tested at least every 3 months for HIV, as recommended by your healthcare provider. Ask your partners to get tested.
- If you think you were exposed to HIV-1, tell your healthcare provider right away. They may want to do more tests to be sure you are still HIV-negative.
- Get tested for other sexually transmitted infections such as syphilis and gonorrhea. These infections make it easier for HIV to infect you.
- Get information and support to help reduce risky sexual behavior.
- Have fewer sex partners.
- Do not miss any doses of AG-Emtricitabine / Tenofovir
Disoproxil Fumarate. Missing doses may increase your risk
of getting HIV-1 infection.
BEFORE you use AG-Emtricitabine / Tenofovir Disoproxil Fumarate (emtricitabine/tenofovir DF) talk to your healthcare professional:
If you are pregnant or planning to become pregnant: Pregnant mothers should not take AG-Emtricitabine / Tenofovir Disoproxil Fumarate unless specifically directed by the healthcare professional.
If you are a female who is taking AG-Emtricitabine / Tenofovir Disoproxil Fumarate to prevent HIV infection (PrEP) and you become pregnant while taking AG-Emtricitabine / Tenofovir Disoproxil Fumarate, talk to your healthcare provider about whether you should continue taking AG-Emtricitabine / Tenofovir Disoproxil Fumarate.
Pregnancy Registry. There is a pregnancy registry for women who
take antiviral medicines during pregnancy. The purpose of this
registry is to collect information about the health of you and your
baby. Talk to your healthcare provider about how you can take part
in this Antiretroviral Pregnancy Registry.
If you are breastfeeding or planning to breastfeed: Do not
breastfeed if you are taking AG-Emtricitabine / Tenofovir
Disoproxil Fumarate or have HIV. Emtricitabine and
tenofovir DF, the two components of AG-Emtricitabine /
Tenofovir Disoproxil Fumarate, pass to your baby in your
breast milk. You should not breastfeed because of the risk of
passing HIV to your baby. Talk to your healthcare professional about the best way to feed your baby.
If you have other medical conditions: Let your healthcare
professional know if you have other medical conditions,
especially liver, bone and kidney problems.
If you are taking other medicines: Some medicines can
interact when taken together, including prescription and nonprescription medicines and dietary supplements (see
INTERACTIONS WITH THIS MEDICATION).
If you are taking didanosine: Taking didanosine and AGEmtricitabine / Tenofovir Disoproxil Fumarate may cause
serious reactions including lactic acidosis (too much acid in
the blood), pancreatitis (inflamed pancreas) and nerve damage
(neuropathy) (see INTERACTIONS WITH THIS
MEDICATION and SIDE EFFECTS AND WHAT TO
DO ABOUT THEM).
AG-Emtricitabine / Tenofovir Disoproxil Fumarate should not
be used with or soon after cidofovir, acyclovir, valacyclovir,
ganciclovir, valganciclovir, aminoglycosides, or nonsteroidal
anti-inflammatory drugs (NSAIDS), due to potential harm to
the kidneys.
It is a good idea to keep a complete list of all the medicines
that you take. Make a new list when medicines are added or
stopped. Give copies of this list to all of your healthcare
providers every time you visit your healthcare professional or
fill a prescription.
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
Let your healthcare professional know if you are taking these or any other medications:
- Drugs that contain didanosine (Videx, Videx EC). Tenofovir disoproxil fumarate (a component of AGEmtricitabine / Tenofovir Disoproxil Fumarate) may increase the amount of Videx in your blood. You may need to be followed more carefully if you are taking AG-Emtricitabine / Tenofovir Disoproxil Fumarate and Videx together. Also, the dose of didanosine may need to be reduced. Reyataz (atazanavir sulfate), Kaletra (lopinavir/ritonavir), Prezista® (darunavir), HARVONI (ledipasvir/sofosbuvir), EPCLUSA (sofosbuvir/velpatasvir) or VOSEVI™ (sofosbuvir/velpatasvir/voxilaprevir). These medicines may increase the amount of tenofovir disoproxil fumarate (a component of AG-Emtricitabine / 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 AG-Emtricitabine / Tenofovir Disoproxil Fumarate together with Reyataz (atazanavir sulfate), Kaletra (lopinavir/ritonavir), Prezista (darunavir), HARVONI (ledipasvir/sofosbuvir), EPCLUSA (sofosbuvir/velpatasvir) or VOSEVI (sofosbuvir/velpatasvir/voxilaprevir). AG Emtricitabine / Tenofovir Disoproxil Fumarate may decrease the amount of Reyataz (atazanavir sulfate) in your blood. If you are taking AG-Emtricitabine / Tenofovir Disoproxil Fumarate and Reyataz (atazanavir sulfate) together, you should also be taking Norvir (ritonavir).
- Non-steroidal anti-inflammatory drugs.
Proper use of this medication
Stay under a healthcare professionals care when taking
AG-Emtricitabine / Tenofovir Disoproxil Fumarate. Do
not change your treatment or stop treatment
without first talking with your healthcare
professional.
Take AG-Emtricitabine / Tenofovir Disoproxil Fumarate exactly
as your healthcare professional prescribed it. Follow the
directions from your healthcare professional, exactly as written
on the label. Set up a dosing schedule and follow it carefully.
When used to treat HIV-1 infection, AG-Emtricitabine /
Tenofovir Disoproxil Fumarate is always used with other HIV-1
medicines.
If you take AG-Emtricitabine / Tenofovir Disoproxil Fumarate to
reduce your risk of getting HIV-1:
- you must also use other methods to reduce your risk of getting HIV.
- take AG-Emtricitabine / Tenofovir Disoproxil Fumarate every day, not just when you think you have been exposed to HIV-1.
Avoid doing things that can increase your risk of getting HIV infection or spreading HIV infection to other people:
- Do not re-use or share needles or other injection equipment.
- Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
- Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vagina secretions, or blood.
Ask your healthcare provider if you have any questions on how
to prevent getting HIV infection or spreading HIV infection to
other people.
When your AG-Emtricitabine / Tenofovir Disoproxil Fumarate
supply starts to run low, get more from your healthcare
professional. 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 AGEmtricitabine / Tenofovir Disoproxil Fumarate and become
harder to treat.
Only take medicine that has been prescribed specifically for you.
Do not give AG-Emtricitabine / Tenofovir Disoproxil Fumarate
to others or take medicine prescribed for someone else.
Do not use if seal over bottle opening is broken or missing.
Usual Adult Dose:
For the treatment of HIV-1 infection:
- The usual dose of AG-Emtricitabine / Tenofovir Disoproxil Fumarate is one tablet orally (by mouth) once a day, in combination with other anti-HIV medicines.
- AG-Emtricitabine / Tenofovir Disoproxil Fumarate may be taken with or without a meal.
- The usual dose of AG-Emtricitabine / Tenofovir Disoproxil Fumarate is one tablet orally (by mouth) once a day.
- AG-Emtricitabine / Tenofovir Disoproxil Fumarate may be taken with or without a meal.
Overdose:
If you think you have taken too much AG-Emtricitabine / Tenofovir Disoproxil Fumarate contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose
It is important that you do not miss any doses. If you miss a dose of AG-Emtricitabine / Tenofovir Disoproxil Fumarate and it is less than 12 hours from the time you usually take AGEmtricitabine / Tenofovir Disoproxil Fumarate, then take the dose. If more than 12 hours has passed from the time you usually take AG-Emtricitabine / Tenofovir Disoproxil Fumarate, then wait until the next scheduled daily dose. Do not take more than 1 dose of AG-Emtricitabine / Tenofovir Disoproxil Fumarate in a day. Do not take 2 doses at the same time. Call your healthcare professional if you are not sure what to do.
Side effects and what to do about them
The most common side effects of AG-Emtricitabine / Tenofovir Disoproxil Fumarate are:
- Diarrhea
- Nausea
- Vomiting
- Dizziness
- Headache
Other side effects include:
- Stomach pain
- Indigestion
- Inflammation of the pancreas
- Sleeping problems
- Abnormal dreams
- Weakness
- Pain
- Shortness of breath
- Allergic reaction (including swelling of the face, lips, tongue or throat)
- Rash
- Flatulence (intestinal gas)
- Skin discoloration (small spots or freckles) may also happen with AG-Emtricitabine / Tenofovir Disoproxil Fumarate
| 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 AG-Emtricitabine /
Tenofovir Disoproxil Fumarate, for a long time.
Muscle pain, muscle weakness, bone pain and softening of the
bone (infrequently contributing to fractures) have also been
reported.
There have been other side effects in patients taking
Emtricitabine Tablets or Tenofovir disoproxil fumarate Tablets.
This is not a complete list of side effects. If you have questions
about side effects, ask your healthcare professional. You should
report any new or continuing symptoms to your healthcare
professional right away. Your healthcare professional may be
able to help you manage these side effects.
How to store
- Keep AG-Emtricitabine / Tenofovir Disoproxil Fumarate and all other medications out of reach and sight of children.
- AG-Emtricitabine / Tenofovir Disoproxil Fumarate should be stored at 15–30 °C. It should remain stable until the expiration date printed on the label.
- Do not keep your medicine in places that are too hot or cold.
- 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.
- Keep AG-Emtricitabine / Tenofovir Disoproxil Fumarate in its original container and keep the container tightly closed.
Reporting side effects
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 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 AG-Emtricitabine /Tenofovir Disoproxil Fumarate:
- 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.html; or by contacting the sponsor, Angita Pharma Inc., at:1-450-449-9272.
This leaflet was prepared by Angita Pharma Inc. 1310 rue Nobel, Boucherville, Québec, J4B 5H3 Last revised: February 17, 2020