Starting Complera A treatment for HIV infection

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Starting Complera A treatment for HIV infection COMPLERA,

trademarks of Gilead Sciences, Inc. or its related companies.

1 Starting Complera A treatment for HIV infection COMPLERA, STRIBILD, EMTRIVA, TRUVADA, VIREAD and HEPSERA are registered trademarks of Gilead Sciences, Inc. or its related companies. ATRIPLA is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks are the property of their respective owners Gilead Sciences Canada, Inc. All rights reserved. CPL013E

COMPLERA is a prescription human immunodeficiency virus (HIV) medicine that: Is used to treat HIV in adults.

EMTRIVA and VIREAD are part of the HIV-1 class of drugs called nucleoside analog reverse transcriptase inhibitors (NRTIs), and Edurant is an HIV-1 non-nucleoside analog reverse transcriptase

Emtriva (emtricitabine) Viread (tenofovir DF) Edurant (rilpivirine) Within this guide, you will learn about Complera treatment, including how it works, precautions and possible side effects.

2 COMPLERA is a prescription human immunodeficiency virus (HIV) medicine that: Is used to treat HIV in adults. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS) Contains three medicines Pr EMTRIVA (emtricitabine), Pr Edurant (rilpivirine) and Pr VIREAD (tenofovir DF) combined in one pill. EMTRIVA and VIREAD are part of the HIV-1 class of drugs called nucleoside analog reverse transcriptase inhibitors (NRTIs), and Edurant is an HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI) What is Complera? Complera contains three different HIV medications from two different classes of treatment, combined in one pill. Emtriva (emtricitabine) Viread (tenofovir DF) Edurant (rilpivirine) Within this guide, you will learn about Complera treatment, including how it works, precautions and possible side effects. It is important to follow your doctor s instructions and take Complera exactly as prescribed. 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. This booklet is designed to help familiarize you with Complera. Please refer to the Patient Information leaflet included with your medication for more complete information. If you still have any questions, don t hesitate to speak with your doctor or other member of your health care team. They can provide answers if there is anything you are not sure of, and help you get the most out of your treatment. NRTI (nucleoside analog reverse transcriptase inhibitor) Actual size NNRTI (non-nucleoside analog reverse transcriptase inhibitor) Complera. Your HIV treatment. Pr Complera is used as a complete regimen to treat HIV infection in adults age 18 and older. Complera has not been studied in children under age 18 or adults over age

What does Complera do? Before you start Complera Complera helps treat HIV infection in two important ways: Lowers viral load Complera lowers the amount of HIV in the blood (viral load).

Increases CD4 cell count Complera may also help increase the number of CD4 cells, a type of white blood cell important to the immune system, which helps fight infection.

3 What does Complera do? Before you start Complera Complera helps treat HIV infection in two important ways: Lowers viral load 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). Increases CD4 cell count Complera may also help increase the number of CD4 cells, a type of white blood cell important to the immune system, which helps fight infection. HIV infection destroys CD4 cells and, after a large number are destroyed, AIDS can develop. Reducing the amount of HIV and increasing the CD4+ (T) cell count may help improve your immune system. This may reduce your risk of infections that can happen when your immune system is weak (opportunistic infections). People taking Complera may still get opportunistic infections or other conditions that happen with HIV infection. Complera has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination, so patients must continue to practice safe sex and must not share needles. Use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood. Complera does not cure HIV infections or AIDS. Ask your health care provider if you have any questions about how to prevent passing HIV to other people. The long-term effects of Complera are unknown at this time. Complera. Your HIV treatment. Talk to your doctor or pharmacist if you have: An eating disorder, or are following a strict diet Drug allergies A heart condition, including a heart rhythm disorder (or a family history of heart rhythm disorders or sudden [heart] death under age 50) Other conditions, especially: - Liver problems, including hepatitis B or C virus infection - Inflammation of the pancreas (pancreatitis) - Bone disease, risk of bone disease or bone-related problems - Kidney problems or are undergoing kidney dialysis treatment - Feelings of depression Important: Ask your doctor or pharmacist about medicines, herbal products or dietary supplements that should not be taken with Complera. Some medicines, including prescription and some over-the-counter medicines, can interact when taken together, and several drugs should not be taken with Complera (see page 10 for further details). 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 Antiretroviral Pregnancy Registry. 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. 3 4

How to take Complera Complera is taken as a single pill, once a day. It should be taken at the same time every day, to help maintain a steady amount of medication in your body.

If you stop taking Complera for even a short time, the amount of virus in your blood may increase, and the virus may become resistant to therapy, making it harder to treat.

4 How to take Complera Complera is taken as a single pill, once a day. It should be taken at the same time every day, to help maintain a steady amount of medication in your body. See your doctor regularly while taking Complera, and follow your doctor s directions exactly. It is very important not to miss a dose. If you stop taking Complera for even a short time, the amount of virus in your blood may increase, and the virus may become resistant to therapy, making it harder to treat. Set up a daily dosing schedule and follow it carefully, and be sure to refill your Complera prescription before your supply starts to run low. 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. Talk to your doctor about suitable food options (see daily dosing chart for examples). Do not change or stop your treatment without first talking with your doctor. Complera. Your HIV treatment. 5 6

Daily dosing chart It is important to take COMPLERA exactly as your doctor prescribed it: one pill, once a day, with food. This will help make sure the medication is absorbed into your body.

5 Daily dosing chart It is important to take COMPLERA exactly as your doctor prescribed it: one pill, once a day, with food. This will help make sure the medication is absorbed into your body. Do not change your treatment or stop treatment without first talking with your doctor. 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. Example Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Date Pill taken Time Food month / day 7:00 am 2 pieces of toast with a butter substitute, with 250 ml (8 ounces) of 2% milk and 4 ounces of apple juice Example Day 17 Day 18 Day 19 Day 20 Day 21 Day 22 Day 23 Date Pill taken Time Food month / day 7:00 am 2 pieces of toast with a butter substitute, with 250 ml (8 ounces) of 2% milk and 4 ounces of apple juice 7 This chart can help you keep track of your Complera doses during your first month of therapy. Following your regimen is easier if you make Complera treatment part of your daily routine. Obtain a refill from your doctor or pharmacy if your COMPLERA supply begins running low. When travelling, it s recommended to bring enough medicine to last beyond your intended stay, in the event of a travel delay. Day 8 Day 9 Day 10 Day 11 Day 12 Day 13 Day 14 Day 15 Day 16 Day 24 Day 25 Day 26 Day 27 Day 28 Day 29 Day 30 Day 31

6 Remember To get the most out of your treatment: Dosing Take one tablet, at the same time every day. Swallow the pill with plenty of water. Food requirements Always take Complera with food. A protein drink is not a substitute for food. Missed doses If you miss a dose of Complera within 12 hours of the time you usually take it, you should take Complera with food as soon as possible. Take the next dose at the regularly scheduled time. If you miss a dose of Complera by more than 12 hours from 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. Refills As soon as your Complera supply starts to run low, be sure to get more from your doctor or pharmacy. When travelling, it s recommended to bring enough medicine to last beyond your intended stay, in the event of a travel delay. Storage Complera should be stored out of reach of children, at C (59 86 F). Complera. Your HIV treatment. 8

7 Interactions with this medication Acid-blocking medications Proton pump inhibitors a class of medicines used to treat stomach ulcers, heartburn or acid reflux disease (e.g., omeprazole [ Pr Losec ], lansoprazole [ Pr Prevacid ], dexlansoprazole [ Pr Dexilant TM ], rabeprazole [ Pr Pariet ], pantoprazole [ Pr Pantoloc ], esomeprazole [ Pr Nexium ]) should not be taken with Complera. If you take an antacid a medicine to treat heartburn from acid reflux (e.g., aluminum hydroxide [Gaviscon ], magnesium hydroxide [milk of magnesia], calcium carbonate [Tums ]) take it at least 2 hours before or at least 4 hours after Complera. If you take an H 2 -receptor antagonist also available to treat stomach ulcers, heartburn or acid reflux disease (e.g., cimetidine, famotidine [ Pr Pepcid ], nizatidine [ Pr Axid ], ranitidine [ Pr Zantac ]) take it at least 12 hours before or at least 4 hours after Complera (e.g., taking Complera with breakfast each morning would allow you to take an H 2 -receptor antagonist 4 hours later, at lunch OR with your evening meal). Some of these medicines may be available under other names. Always carefully read the package leaflets that are provided with any medicines. If you re unsure which type of acid-blocking medication you re currently using, ask your doctor or pharmacist. 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. 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. Pr ATRIPLA (efavirenz/emtricitabine/tenofovir DF), Pr Stribild (elvitegravir/ cobicistat/emtricitabine/tenofovir DF), Emtriva, Pr Truvada (emtricitabine/ tenofovir DF), Viread, Pr Combivir (lamivudine/zidovudine), Pr 3TC or Pr Heptovir (lamivudine), Pr Kivexa (abacavir sulfate/lamivudine), Pr Hepsera (adefovir), Pr Trizivir (abacavir sulfate/lamivudine/zidovudine) or Edurant should not be taken with Complera. Do not take Complera if you are already taking any of the following drugs: Anticonvulsants (to treat epilepsy and prevent seizures [carbamazepine, oxcarbazepine, phenobarbital, phenytoin]) Antimycobacterials (rifabutin, rifampin, rifapentine) Glucocorticoids (systemic dexamethasone [more than a single dose]) Herbal products (St. John s wort [Hypericum perforatum]) Please consult the Consumer Information leaflet found in the Complera product packaging for additional information on drug interactions. 9 10

8 Potential side effects of Complera The most common side effects of Complera are abdominal pain, depression, headache, rash, and sleeping problems (including difficulty falling asleep). Other side effects may include: Abnormal dreams Allergic reaction (including skin rash, redness, irritation, swelling of the face, lips, tongue or throat, difficulty in breathing) Decreased appetite Diarrhea Dizziness Fatigue Indigestion Intestinal gas Nausea Pain Rash Skin discoloration (small spot or freckles) Sleepiness Stomach pain or discomfort Vomiting Weakness Changes in your immune system (immune reconstitution syndrome): 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 (components of Complera) are inflammation of the pancreas, shortness of breath and allergic reaction (see above). Talk to your doctor if you notice bone pain, suffer a bone fracture, or have other bone problems. You may wish to discuss calcium and/or vitamin D supplements with your doctor. 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. 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). Nonspecific 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 occur 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, arm and face may also happen. The cause and long-term health effects of these conditions are not known at this time. Reporting suspected side effects You can report any suspected adverse reactions to the Canada Vigilance Program by calling toll-free at or online at Contact your health professional if you require information related to the management of side effects

9 My notes 13 14

PATIENT INFORMATION EMTRIVA

PATIENT INFORMATION EMTRIVA EMTRIVA capsules and oral solution are for oral ingestion only. It is important to take EMTRIVA with combination therapy on a regular dosing schedule to avoid missing doses. Lactic acidosis and severe