Consumer Information for: AURO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR
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
Auro-Efavirenz-Emtricitabine-Tenofovir contains 3 medicines, efavirenz, emtricitabine and tenofovir disoproxil fumarate, combined in one pill. EMTRIVA and VIREAD are HIV (human immunodeficiency virus) nucleoside/nucleotide analog reverse transcriptase inhibitors (NRTIs) and efavirenz is an HIV non-nucleoside analog reverse transcriptase inhibitor (NNRTI). VIREAD and EMTRIVA are components of TRUVADA®. Auro-Efavirenz-Emtricitabine-Tenofovir can be used alone as a complete regimen or in combination with other medications to treat people with HIV infection. Auro- Efavirenz-Emtricitabine-Tenofovir is for adults age 18 and older. Efavirenz/Emtricitabine/Tenofovir has not been studied in children under age 18 or adults over age 65.
What it does
Auro-Efavirenz-Emtricitabine-Tenofovir helps block HIV reverse transcriptase, a chemical in your body (enzyme) that is needed for HIV to multiply. Auro-Efavirenz-Emtricitabine- Tenofovir 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 immune deficiency syndrome (AIDS) develops. Auro-Efavirenz- Emtricitabine-Tenofovir may also help to increase the number of T cells (CD4+ cells).
Auro-Efavirenz-Emtricitabine-Tenofovir does not cure HIV infection or AIDS. The long-term effects of Auro-Efavirenz- Emtricitabine-Tenofovir are not known at this time. People taking Auro-Efavirenz-Emtricitabine-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. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections. It is very important that you see your doctor regularly while taking Auro-Efavirenz-Emtricitabine-Tenofovir.
Auro-Efavirenz-Emtricitabine-Tenofovir has not been shown to reduce the risk of passing HIV 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
Together with your doctor, you need to decide whether Auro- Efavirenz-Emtricitabine-Tenofovir is right for you.
Do not take Auro-Efavirenz-Emtricitabine-Tenofovir if:
- you are taking any medication that is listed in this pamphlet under “Drugs that must not be taken with Auro-Efavirenz- Emtricitabine-Tenofovir” (see INTERACTIONS WITH THIS MEDICATION).
- you have or are at known risk for any type of bone disease or bone-related problems and have not discussed this with your doctor.
- you are allergic to Auro-Efavirenz-Emtricitabine-Tenofovir or any of its ingredients. The medicinal ingredients are efavirenz, emtricitabine and tenofovir DF (see: What the important nonmedicinal ingredients are).
What the medicinal ingredient is
Efavirenz, emtricitabine, tenofovir disoproxil fumarate (tenofovir DF)
What the non-medicinal ingredients are
Croscarmellose Sodium, Low-substituted Hydroxypropyl Cellulose, Microcrystalline Cellulose, Hydroxypropyl Cellulose, Sodium Lauryl Sulfate, Hypromellose, Magnesium stearate and Opadry II Pink 85F94172.
What dosage form it comes in
Auro-Efavirenz-Emtricitabine-Tenofovir is available as tablets. Each tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate as active ingredients. Pink colored, oval shaped, biconvex, film coated tablets debossed with ‘K14’ on one side and plain on the other side. Each bottle contains 30 tablets and a silica gel desiccant and is closed with a child-resistant closure.
Warnings and precautions
Serious Warnings and Precautions
The class of medicines to which emtricitabine and tenofovir DF, two of the components of Auro-Efavirenz-Emtricitabine- Tenofovir, belongs (NRTIs) can cause a condition called lactic acidosis, together with an enlarged liver. This rare but serious side effect has occasionally been fatal.
- The symptoms of lactic acidosis include: feeling very weak, tired or uncomfortable; unusual or unexpected stomach discomfort; feeling cold; feeling dizzy or lightheaded; suddenly developing an irregular heartbeat. Lactic acidosis occurs more often in women, particularly if they are very overweight. You should consult your doctor immediately if such symptoms occur while you are receiving Auro-Efavirenz-Emtricitabine- Tenofovir.
- Non-specific symptoms of liver problems may include nausea, vomiting, stomach pain and yellowing of the skin and eyes.
If you notice these symptoms of lactic acidosis or liver problems, stop taking Auro-Efavirenz-Emtricitabine-Tenofovir and consult a doctor immediately.
- “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 Auro-Efavirenz-Emtricitabine- Tenofovir. Do not stop taking Auro-Efavirenz- Emtricitabine-Tenofovir without your doctor’s advice. If you stop taking Auro-Efavirenz-Emtricitabine-Tenofovir, tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment. After you stop taking Auro-Efavirenz-Emtricitabine-Tenofovir, your doctor will still need to check your health and take blood tests to check your liver. Auro-Efavirenz-Emtricitabine-Tenofovir is not approved for the treatment of hepatitis B virus infection.
- 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 Auro-Efavirenz-Emtricitabine-Tenofovir. Some patients treated with tenofovir DF (a component of Auro-Efavirenz- Emtricitabine-Tenofovir) 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.
- Tenofovir DF, a component of Auro-Efavirenz-Emtricitabine-Tenofovir, caused harm to the bones of animals. 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 supplementation with your doctor. The effect of supplementation with calcium and/or vitamin D is unknown.
- Patients who experience dizziness, trouble concentrating or drowsiness should avoid driving or operating machinery.
- Women should not become pregnant while taking Auro-Efavirenz-Emtricitabine-Tenofovir and for 12 weeks after stopping it. Serious birth defects have been seen in animals and women treated with efavirenz (a component of Auro-Efavirenz-Emtricitabine-Tenofovir) during pregnancy. It is not known whether efavirenz caused these defects. A reliable form of barrier contraception must always be used even if you or your partner are using other methods of contraception such as the pill or other hormonal therapy (e.g. implants, injections). Auro-Efavirenz-Emtricitabine-Tenofovir may remain in your blood for a time after therapy is stopped. Therefore, you should continue use of a reliable form of contraception for 12 weeks after stopping treatment with Auro-Efavirenz-Emtricitabine-Tenofovir. If you are pregnant or become pregnant while taking Auro-Efavirenz- Emtricitabine-Tenofovir, your doctor may register you in the Antiretroviral Pregnancy Registry. The Registry monitors fetal outcomes in pregnant women using antiretroviral medicines.
- A small number of patients taking efavirenz, one of the components of Auro-Efavirenz-Emtricitabine-Tenofovir, have had severe depression, strange thoughts, or angry behavior. Some patients have had thoughts of suicide and a few patients have actually committed suicide. These problems tend to occur more often in patients with a history of mental illness. You should contact your doctor immediately if you think you are having these symptoms, so your doctor can decide whether you should continue to take Auro-Efavirenz-Emtricitabine-Tenofovir.
- Consult your doctor if you have a rash, since some rashes may be serious.
BEFORE you use Auro-Efavirenz-Emtricitabine-Tenofovir (efavirenz/ emtricitabine/tenofovir DF) talk to your doctor or pharmacist:
If you have ever had a previous life threatening skin reaction (e.g. Stevens-Johnson syndrome).
If you are breast-feeding or plan to breast-feed: Do not breast- feed if you have HIV or are taking Auro-Efavirenz- Emtricitabine-Tenofovir. HIV can be passed to your baby in your breast milk. All components of Auro-Efavirenz-Emtricitabine-Tenofovir (efavirenz, emtricitabine and tenofovir DF) can be passed to your baby in your breast milk and may cause harm to your baby. Talk to your doctor about the best way to feed your baby.
If you have other medical conditions: Let your doctor know if you have other medical conditions, especially liver or kidney problems, pancreatitis (inflammation of the pancreas), seizures or mental illness, or have or are at risk for bone disease or bone-related problems.
If you have or have had a heart rhythm disorder such as:
If you are taking other medicines: Some medicines can interact when taken together, including prescription and non-prescription medicines, herbal products and dietary supplements (see INTERACTIONS WITH THIS MEDICATION).
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
No drug interaction studies have been done with efavirenz/emtricitabine/tenofovir disoproxil fumarate. Drugs that must not be taken with Auro-Efavirenz- Emtricitabine-Tenofovir:
- Propulsid™ (cisapride)*, Versed® (midazolam), Halcion® (triazolam), ergot medications (for example Wigraine® and Cafergot®), Hismanal (astemizole)*, Seldane® (terfenadine)*, Vascor® (bepridil)* or Orap® (pimozide). Taking these medications with Auro-Efavirenz-Emtricitabine-Tenofovir could create the potential for serious or life-threatening side effects.
- Zepatier® (elbasvir/grazoprevir), since Zepatier® may lose its effect.
- Vfend® (voriconazole), since it may lose its effect or may increase the chance of having side effects from Auro- Efavirenz-Emtricitabine-Tenofovir.
- Do not take Auro-Efavirenz-Emtricitabine-Tenofovir if you are taking St. John’s wort (Hypericum perforatum), or products containing St. John’s wort. St. John’s wort is an herbal product sold as a dietary supplement. Taking St. John’s wort may decrease Auro-Efavirenz-Emtricitabine- Tenofovir levels and may lead to increased viral load and possible resistance to efavirenz or resistance to the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs).
*Not marketed in Canada.
It is also important to tell your doctor if you are taking any of the following:
- Auro-Efavirenz-Emtricitabine-Tenofovir should not be used with 3TC®, Combivir®, COMPLERA®, DESCOVY®, EMTRIVA, GENVOYA®, Heptovir®, HEPSERA®, Kivexa®, ODEFSEY®, Triumeq®, Trizivir®, TRUVADA®, STRIBILD®, VEMLIDY® or VIREAD. Auro-Efavirenz- Emtricitabine-Tenofovir also should not be used with Sustiva® unless your doctor decides a dose adjustment is needed (e.g. with rifampin).
- Do not take Auro-Efavirenz-Emtricitabine-Tenofovir if you are on other medications that may affect your kidneys and you have not discussed this with your doctor. Auro- Efavirenz-Emtricitabine-Tenofovir should not be used at the same time or shortly after cidofovir, ganciclovir, vancomycin or aminoglycosides as this may harm the kidneys.
- Reyataz® (atazanavir sulfate), Fortovase®* or Invirase® (saquinavir); these medicines need to be replaced with another medicine when taken with Auro-Efavirenz- Emtricitabine-Tenofovir. If your doctor does prescribe Reyataz and Auro-Efavirenz-Emtricitabine-Tenofovir, you may need to be monitored more carefully for side effects.
- Biaxin® (clarithromycin). Biaxin may interact with Auro- Efavirenz-Emtricitabine-Tenofovir to affect the electrical activity of your heart. Biaxin needs to be replaced with another medicine when taken with Auro-Efavirenz- Emtricitabine-Tenofovir.
- Celsentri® (maraviroc).
- Crixivan® (indinavir), methadone, Mycobutin® (rifabutin), Zoloft® (sertraline), Wellbutrin® SR, Wellbutrin® XL, or Zyban® (bupropion); these medicines may need to have their dose changed when taken with Auro- Efavirenz-Emtricitabine-Tenofovir.
- Videx® or Videx EC ® (didanosine); tenofovir DF (a component of Auro-Efavirenz-Emtricitabine-Tenofovir) may increase the amount of didanosine in your blood, which could result in more side effects. You may need to be monitored more carefully if you are taking Auro- Efavirenz-Emtricitabine-Tenofovir and didanosine together. Also, the dose of didanosine may need to be changed.
- Kaletra® (lopinavir/ritonavir) or HARVONI® (ledipasvir/sofosbuvir) may increase the amount of tenofovir DF (a component of Auro-Efavirenz- Emtricitabine-Tenofovir) in your blood, which could result in more side effects. You may need to be monitored more carefully if you are taking Auro-Efavirenz-Emtricitabine-Tenofovir and Kaletra together or Auro-Efavirenz- Emtricitabine-Tenofovir and HARVONI together. Also, the dose of Kaletra may need to be changed.
- EPCLUSA® (sofosbuvir/velpatasvir) or VOSEVI™ (sofosbuvir/velpatasvir/voxilprevir) should not be used with Auro-Efavirenz-Emtricitabine-Tenofovir as it is expected to decrease the amount of velpatasvir (a component of EPCLUSA and VOSEVI) and voxilaprevir (a component of VOSEVI) in your blood, which may reduce the effectiveness of EPCLUSA or VOSEVI.
- Maviret® (glecaprevir/pibrentasvir) is not recommended when taking Auro-Efavirenz-Emtricitabine-Tenofovir.
- Medicines for seizures [for example, Dilantin® (phenytoin), Tegretol® (carbamazepine), or phenobarbital]; your doctor may want to switch you to another medicine or check drug levels in your blood from time to time.
- Sporanox® (itraconazole) and Posanol® (posaconazole) may need to be replaced by another medicine when taken with Auro-Efavirenz-Emtricitabine-Tenofovir.
- The cholesterol-lowering medicines Lipitor® (atorvastatin), Pravachol® (pravastatin sodium), and Zocor® (simvastatin).
- Rifadin® (rifampin) or the rifampin-containing medicines Rofact® and Rifater®.
- Calcium channel blockers such as Cardizem® or Tiazac® (diltiazem), Covera HS®, Isoptin® SR or Tarka® (verapamil), and others.
- Immunosuppressants such as Neoral® (cyclosporine), Advagraf® or Prograf® (tacrolimus), Rapamune® or Torisel® (sirolimus).
- Hepatitis C antiviral agents such as Galexos® (simeprevir).
- Antimalarials such as Coartem®* and Riamet®* (artemether/lumefantrine). These medicines may interact with Auro-Efavirenz-Emtricitabine-Tenofovir to affect your heart. Malarone® (atovaquone/proguanil) (an antimalarial).
- The effect of combining alcohol or recreational (street, illicit) drugs with efavirenz has not been studied. Because they may interact with each other, speak with your doctor before you combine Auro-Efavirenz-Emtricitabine-Tenofovir with these drugs.
*Not marketed in Canada.
These are not all the medicines that may cause problems if you take Auro-Efavirenz-Emtricitabine-Tenofovir. Be sure to tell your doctor about all the medicines you take.
Keep a complete list of all the prescription and nonprescription medicines as well as any herbal medicines that you are taking, how much you take and how often you take them. Make a new list when medicines or herbal medicines are added or stopped, or if the dose changes. Give copies of this list to all your doctors and pharmacists every time you visit them or fill a prescription. This will give your doctor a complete picture of the medicines you use. Then he or she can decide the best approach for the situation.
Proper use of this medication
Stay under a doctor’s care when taking Auro-Efavirenz- Emtricitabine-Tenofovir. Do not change your treatment or stop treatment without first talking with your doctor.
Take Auro-Efavirenz-Emtricitabine-Tenofovir every day exactly as your doctor prescribed it. Follow the directions from your doctor, exactly as written on the label. Set up a dosing schedule and follow it carefully.
When your Auro-Efavirenz-Emtricitabine-Tenofovir supply starts to run low, get more from your doctor or pharmacy. 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 Auro-Efavirenz- Emtricitabine-Tenofovir and become harder to treat.
Only take medicine that has been prescribed specifically for you. Do not give Auro-Efavirenz-Emtricitabine-Tenofovir to others or take medicine prescribed for someone else.
Do not use if seal over bottle opening is broken or missing.
Usual Adult Dose
- The usual dose of Auro-Efavirenz-Emtricitabine- Tenofovir is one tablet orally (by mouth) once a day.
- Auro-Efavirenz-Emtricitabine-Tenofovir should be taken on an empty stomach. Taking Auro-Efavirenz-Emtricitabine-Tenofovir at bedtime may make some side effects less bothersome.
Overdose
If you think you have taken too much Auro-Efavirenz- Emtricitabine-Tenofovir, 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 Auro-Efavirenz-Emtricitabine-Tenofovir, take it as soon as you remember that day. Do not take more than 1 dose of Auro-Efavirenz-Emtricitabine-Tenofovir in a day. Do not take 2 doses at the same time. Call your doctor or pharmacist if you are not sure what to do.
Side effects and what to do about them
The most common side effects of Sustiva, EMTRIVA and VIREAD are:
Nervous system symptoms such as dizziness, trouble sleeping, drowsiness, trouble concentrating, unusual dreams
- Headache
- Diarrhea
- Nausea
- Vomiting
- Rash
- Flatulence (intestinal gas)
- Tiredness
- Itching
- Allergic reaction (including swelling of the face, lips, tongue or throat)
- Abdominal pain
Other side effects may include pancreatitis (inflammation of the pancreas) and shortness of breath.
Skin discoloration (small spots or freckles) may also happen with Auro-Efavirenz-Emtricitabine-Tenofovir.
A small number of patients taking efavirenz, one of the components of Auro-Efavirenz-Emtricitabine-Tenofovir, have had severe depression, strange thoughts, or angry behavior. Some patients have had thoughts of suicide and a few patients have actually committed suicide. These problems tend to occur more often in patients with a history of mental illness. Contact your doctor immediately if you think you are having these symptoms so your doctor can decide whether you should continue to take Auro-Efavirenz-Emtricitabine-Tenofovir. Changes in body fat have been seen in some patients taking antiretroviral therapy. 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.
Some patients have experienced serious liver problems including liver failure, resulting in transplantation or death. Most of these serious side effects occurred in patients with a chronic liver disease such as a hepatitis infection, but there have also been a few reports in patients without any existing liver disease.
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 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 to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
Effect: Serious psychiatric events Symptoms:
|
✔ | ||
| Uncommon | |||
Effect: Serious psychiatric events Symptoms:
|
✔ | ||
Effect: Severe skin rash Symptoms:
|
✔ | ||
| Rare | |||
Effect: Lactic acidosis Symptoms:
|
✔ | ||
Effect: Hepatotoxicity (severe liver problems) with hepatomegaly (liver enlargement) and steatosis (fat in the liver) Symptoms:
|
✔ | ||
Effect: Kidney problems Symptoms:
|
✔ | ||
| Very Rare | |||
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 Auro-Efavirenz-Emtricitabine-Tenofovir, for a long time.
Muscle pain, muscle weakness, bone pain and softening of the bone (infrequently contributing to fractures) have also been reported due to tenofovir DF (a component of Auro-Efavirenz- Emtricitabine-Tenofovir).
There have been other side effects in patients taking Sustiva, EMTRIVA or VIREAD. This is not a complete list of side effects. If you have questions about side effects, ask your doctor, nurse, or pharmacist. You should report any new or continuing symptoms to your doctor right away. Your doctor may be able to help you manage these side effects.
How to store
- Keep Auro-Efavirenz-Emtricitabine-Tenofovir and all other medications out of reach and sight of children.
- Auro-Efavirenz-Emtricitabine-Tenofovir should be stored at 15–25 °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 Auro-Efavirenz-Emtricitabine-Tenofovir in its original container and keep the container tightly closed, protect from light and moisture. Dispense only in original container. Do not use if seal over bottle opening is broken or missing.
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 for information on how to report online, by mail or by fax; or
- Call 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 Auro-Efavirenz- Emtricitabine-Tenofovir:
- Talk to your doctor or pharmacist.
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website; the manufacturer’s website, or by calling 1-855-648-6681.
This leaflet was prepared by
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision: May 29, 2020
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| SUPEUDOL 10 | 00443948 | SANDOZ CANADA INCORPORATED | OXYCODONE HYDROCHLORIDE 10 MG |
| SUPEUDOL 5 | 00789739 | SANDOZ CANADA INCORPORATED | OXYCODONE HYDROCHLORIDE 5 MG |