Complera (Tenofovir Disoproxil Fumarate, Emtricitabine, Rilpivirine Hydrochloride)

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Complera (Tenofovir Disoproxil Fumarate, Emtricitabine, Rilpivirine Hydrochloride) Dosage and Side Effects

COMPLERA is used as a complete regimen to treat people with HIV infection.

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

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 reactions have been reported with COMPLERA. If you develop a rash, along with any of the following symptoms, stop taking COMPLERA and contact your doctor right away: blisters, mouth sores, swelling of the face, lips, tongue, mouth, or throat, swollen eyes (pink eye), or fever, dark urine, or pain on the right side of the stomach-area.

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. Graves' 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 doctor right away.

Other common sides effects reported for EMTRIVA and VIREAD are:

  • Inflammation of the pancreas
  • Shortness of breath
  • Allergic reaction

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.

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 DFcaused 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 breast-feed: 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 breast-feed 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.

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, EMTRIVA, GENVOYA, STRIBILD, TRUVADA, 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.

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.

Other related products

The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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