Consumer Information for: COMPLERA

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

COMPLERA contains 3 medicines, EMTRIVA® (emtricitabine), Edurant® (rilpivirine) and VIREAD® (tenofovir disoproxil fumarate [tenofovir DF]), combined in one pill. EMTRIVA and VIREAD are HIV (human immunodeficiency virus) nucleotide/nucleoside analog reverse transcriptase inhibitors (NRTI) and Edurant is an HIV non-nucleoside analog reverse transcriptase inhibitor (NNRTI). VIREAD and EMTRIVA are components of TRUVADA®. COMPLERA is used as a complete regimen to treat people with HIV infection. COMPLERA is for adults age 18 and older. COMPLERA has not been studied in children under age 18 or in a sufficient number of adults over age 65 to determine whether they respond differently from adults under 65 years.

What it does

COMPLERA helps block HIV reverse transcriptase, a chemical in your body (enzyme) that is needed for HIV to multiply. COMPLERA 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). COMPLERA may also help to increase the number of T cells (CD4+ cells).

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.

COMPLERA does not cure HIV infection or AIDS. The long-term effects of COMPLERA are not known at this time. People taking COMPLERA 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 COMPLERA.

COMPLERA does not reduce the risk of passing HIV to others through sexual contact or blood contamination. Continue to practice safe sex by using a latex or polyurethane condom or other barrier to lower the chance of sexual contact with semen, vaginal secretions or blood and do not use or share needles.

When it should not be used

Together with your doctor, you need to decide whether COMPLERA is right for you.

Do not take COMPLERA if:

  • you are already taking any of the following drugs:
    Type of Drug Examples of Generic Names
    Anticonvulsants
    (to treat epilepsy and prevent seizures)    		 carbamazepine, oxcarbazepine, phenytoin, phenobarbital
    Antimycobacterials rifapentine, rifampin
    Glucocorticoids systemic dexamethasone (more than a single dose)
    Herbal products St. John’s wort (Hypericum perforatum)
    Proton Pump Inhibitors
    (to prevent or treat stomach ulcers, heartburn or acid reflux disease)    		 omeprazole, lansoprazole, dexlansoprazole, rabeprazole, pantoprazole, esomeprazole
  • you are on other medications that may affect your kidneys and have not discussed this with your doctor.
  • 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 COMPLERA or any of its ingredients. The medicinal ingredients are emtricitabine, rilpivirine and tenofovir DF (See: What the important nonmedicinal ingredients are).
  • you are already taking ATRIPLA®, BIKTARVY®, DESCOVY®, EMTRIVA, GENVOYA®, ODEFSEY®, Symtuza™, STRIBILD®, TRUVADA, VEMLIDY®, VIREAD, Combivir®, 3TC®, Heptovir®, Kivexa®, or Trizivir®, because these medicines contain the same or similar active ingredients.
  • you are also taking HEPSERA® to treat your HBV infection.
  • you are already taking Edurant unless recommended by your doctor and you are taking rifabutin with COMPLERA.
What the medicinal ingredient is

emtricitabine
rilpivirine hydrochloride
tenofovir DF

What the non-medicinal ingredients are

pregelatinized starch, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, povidone, polysorbate 20. The film coating contains polyethylene glycol, hypromellose, lactose monohydrate, triacetin, titanium dioxide, iron oxide red, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake.

What dosage form it comes in

COMPLERA is available as tablets. Each tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (which is equivalent to 27.5 mg of rilpivirine hydrochloride) and 300 mg of tenofovir DF (which is equivalent to 245 mg of tenofovir disoproxil), as active ingredients. The tablets are pink, modified capsule-shaped, film-coated, debossed with “GSI” on one side and plain-faced on the other side. Each bottle contains 30 tablets, silica gel desiccant and polyester coil 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 doctor may monitor your kidney function before beginning and while receiving COMPLERA. Some patients treated with tenofovir DF (a component of COMPLERA) 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 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 COMPLERA. Do not stop taking COMPLERA without your doctor’s advice. If you stop taking COMPLERA, tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment. After you stop taking COMPLERA, your doctor will still need to check your health and take blood tests to check your liver. COMPLERA is not approved for the treatment of hepatitis B virus infection.
  • The class of medicines to which emtricitabine and tenofovir DF, two of the components of COMPLERA, 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 heartbeat. This rare but serious side effect has occasionally been fatal.
  • Severe liver problems can happen in people who take COMPLERA or similar medicines. You may develop an enlarged liver (hepatomegaly) or a fatty liver (steatosis). Non-specific symptoms such as yellowing of skin and eyes, nausea, vomiting and stomach pain might indicate the development of liver problems. Lactic acidosis or severe liver problems 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 COMPLERA. If you notice these symptoms, stop taking COMPLERA and consult a doctor immediately.
  • Tenofovir DF caused harm to the bones of animals. Tenofovir DF 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. 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.

BEFORE you use COMPLERA (emtricitabine/rilpivirine/tenofovir DF) talk to your doctor or pharmacist:

If you have an eating disorder or are following a strict diet.

If you have any drug allergies.

If you are pregnant or planning to become pregnant: The effects of COMPLERA on pregnant women or their unborn babies are not known. Pregnant women should not take COMPLERA unless specifically directed by the doctor. If you use COMPLERA while you are pregnant, talk to your doctor about how you can be on the COMPLERA Antiviral Pregnancy Registry.

If you are breastfeeding or plan to breastfeed: Do not breastfeed if you are taking COMPLERA or have HIV. Tenofovir and emtricitabine pass into your baby in your breast milk. You should not breastfeed because of the risk of passing HIV to your baby. Talk to your doctor about the best way to feed your baby.

If you have a heart disease or a heart condition, including a heart rhythm disorder (QT prolongation) or family history of heart rhythm disorders (QT prolongation) or sudden (heart) death under 50 years of age.

If you have other medical conditions: Let your doctor know if you have other medical conditions, especially liver problems, including hepatitis B or C virus infection, pancreatitis (inflammation of the pancreas), have or are at risk for bone disease or bone related problems, have kidney problems or are undergoing kidney dialysis treatment, or have or develop feelings of depression.

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).

Interactions with this medication

Drugs that should not be taken with COMPLERA:

  • Do not take COMPLERA if you are on other medications that may affect your kidneys and have not discussed this with your doctor.
  • ATRIPLA, BIKTARVY, DESCOVY, EMTRIVA, GENVOYA, ODEFSEY, Symtuza, STRIBILD, TRUVADA, VEMLIDY, VIREAD, Combivir (lamivudine/zidovudine), 3TC or Heptovir (lamivudine), Kivexa (abacavir sulfate/lamivudine), HEPSERA, Trizivir (abacavir sulfate/lamivudine/ zidovudine) and Triumeq (dolutegravir/abacavir sulfate/lamivudine) should not be used with those medicines.
  • Edurant, unless recommended by your doctor and you are taking rifabutin with COMPLERA.

Tell your doctor if you are taking any of the following medicines. Some of these medicines may be obtained without a prescription and some of these may be available under other names. It is important that you carefully read the package leaflets that are provided with these medicines.

Type of Drug Examples of Generic Names (Brand Names)
Antacids
(to treat heartburn from acid reflux)		 aluminum
magnesium hydroxide
calcium carbonate
Antimycobacterials
(to treat some bacterial infections)		 rifabutin
Azole antifungal agents ketoconazole, fluconazole, voriconazole, itraconazole, posaconazole
Corticosteroids
(to treat inflammation or asthma)		 fluticasone propionate (Advair Diskus®, Cutivate®, Flonase®, Flovent Diskus®)
H2-Receptor Antagonists
(to treat stomach ulcers or used to relieve heartburn from acid reflux)		 cimetidine (Tagamet®)
famotidine (Pepcid®)
nizatidine (Axid AR®)
ranitidine (Zantac®)
Hepatitis C Antiviral Agents
(to treat hepatitis C)		 ledipasvir/sofosbuvir (HARVONI®)
sofosbuvir/velpatasvir (EPCLUSA®)
sofosbuvir/velpatasvir/voxilaprevir (VOSEVI®)
Macrolide Antibiotics
(to treat bacterial infections)		 clarithromycin (Biaxin®)
erythromycin (Benzamycin®, AK Mycin®, EES®-200/400, EES-600, ERYC®, Erythro-S®, Erythro-ES®, Erybid®, PCE®)
Narcotic Analgesic
(to treat bacterial infections)		 methadone (Methadol®, Metadol-D®, Cophylac® drops)

These are not all the medicines that may cause problems if you take COMPLERA. 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 COMPLERA. Do not change your treatment or stop treatment without first talking with your doctor.

Take COMPLERA 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.

Always take COMPLERA with food. COMPLERA must be taken with food which will help make sure the medicine is absorbed into your body. A protein drink is not a substitute for food. An example of suitable foods to take with COMPLERA would be 2 pieces of toast with a butter substitute, with 250 mL (8 ounces) of 2% milk and 4 ounces of apple juice. There are other food options that can be taken to achieve the food requirement. Talk to your doctor.

When your COMPLERA 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 COMPLERA and become harder to treat.

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

If you take an antacid (a medicine to treat heartburn from acid reflux such as aluminum/magnesium hydroxide, calcium carbonate), take the antacid either at least 2 hours before or at least 4 hours after COMPLERA. If you take an H2-receptor antagonist (medicines used to treat stomach ulcers, heartburn or acid reflux disease such as cimetidine, famotidine, nizatidine or ranitidine), take the H2-receptor antagonist at least 12 hours before or at least 4 hours after COMPLERA. Importantly, proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole, esomeprazole) also available for these conditions should not be taken with COMPLERA.

For patients receiving rifabutin, an additional 25 mg tablet of Edurant per day is recommended to be taken concomitantly with COMPLERA for the duration of the rifabutin coadministration.

Do not use if seal over bottle opening is broken or missing.

Usual Adult Dose

  • The usual dose of COMPLERA is one tablet orally (by mouth) once a day. Swallow with plenty of water.
  • Always take COMPLERA with food; food is important to make sure the medicine is absorbed into your body. A protein drink is not a substitute for food. See further instructions above.

Overdosage

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

As with all medicines, COMPLERA should be kept out of reach of children.

Missed Dose

It is important that you do not miss any doses. If you miss a dose of COMPLERA within 12 hours of the time it is usually taken, you should take COMPLERA with food as soon as possible. Take the next dose of COMPLERA at the regularly scheduled time.

If you miss a dose of COMPLERA by more than 12 hours of the time you usually take it, wait and then take the next dose of COMPLERA at the regularly scheduled time. Do not double the next dose to make up for a missed dose.

Side effects and what to do about them

The most common side effects of COMPLERA are abdominal pain, depression, headache, rash and sleeping problems (including difficulty falling asleep).

Other side effects include vomiting, nausea, intestinal gas, dizziness, allergic reaction (including skin rash, redness, irritation, swelling of the face, lips, tongue or throat, difficulty in breathing), sleepiness, abnormal dreams, stomach pain or discomfort, indigestion, diarrhea, skin discoloration (small spot or freckles), pain, weakness, decreased appetite, increased weight and fatigue.

Severe skin and allergic reactions have been reported with COMPLERA. If you develop a rash and any of the following symptoms, stop taking COMPLERA and contact your doctor right away:

  • swelling of the face, lips, tongue, mouth or throat, eyes (pink eye), hands or feet
  • difficulty breathing
  • blisters, mouth sores, fever
  • liver problems (hepatitis) with symptoms such as stomach pain, nausea, vomiting, yellowing of the skin and eyes (jaundice)
  • increased eosinophils (type of white blood cells) in the blood with symptoms such as reddened skin, fever, and enlarged lymph nodes

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 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.

Other common side effects reported for EMTRIVA and VIREAD are:

  • Inflammation of the pancreas
  • Shortness of breath
  • Allergic reaction (see above)
Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and call your doctor or pharmacist
Rare
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
   ✔  
Effect: Kidney problems
Symptoms
  • You may have increased or decreased urination as well as increased thirst
  • You may have swelling of your legs and feet
  • You may feel listless and tired
   ✔  
Very Rare
Effect: Hepatotoxicity (severe liver problems) with hepatomegaly (liver enlargement) and steatosis (fat in the liver)
Symptoms
  • Jaundice (skin or the white part of eyes turn 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 turn 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 COMPLERA, 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 COMPLERA).

There have been other side effects in patients taking EMTRIVA, Edurant 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 COMPLERA and all other medications out of reach and sight of children.
  • COMPLERA should be stored at 15–30 °C (59–86 °F). 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 COMPLERA in its original container and keep the container tightly closed.
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:

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the Medeffect™ Canada Web site at www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada

NOTE: Should you require information related to the management of side effects, please 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 found at: www.gilead.ca, or by contacting the sponsor, Gilead Sciences Canada, Inc., at: 1-866-207-4267

This leaflet was prepared by Gilead Sciences Canada, Inc.

Last revised: October 17, 2019

Gilead Sciences, Inc.
Foster City, CA 94404
USA

Gilead Sciences Canada, Inc.
Mississauga, ON L5N 2W3

ATRIPLA®, BIKTARVY®, COMPLERA®, DESCOVY®, EMTRIVA®, EPCLUSA®, GENVOYA®, HARVONI®, HEPSERA®, ODEFSEY®, STRIBILD®, TRUVADA®, VEMLIDY®, VIREAD®, and VOSEVI® are trademarks of Gilead Sciences, Inc. or its related companies.

All other marks referenced herein are the property of their respective owners.

©2019 Gilead Sciences, Inc. All rights reserved.

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