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Drugs & Medications

Complera

GENERIC NAME(S): EMTRICITABINE/RILPIVIRINE HCL/TENOFOVIR DISOPROXIL FUMARATE

WARNINGS:

Rarely, this medication has caused severe (sometimes fatal) liver problems and a certain metabolic problem (lactic acidosis). Tell your doctor immediately if you develop symptoms of liver problems (such as persistent nausea/vomiting, severe stomach/abdominal pain, pale stools, dark urine, yellowing eyes/skin), or of lactic acidosis (such as unusual tiredness/weakness, fast/irregular heartbeat, fast/difficult breathing, drowsiness, muscle pain, cold skin). These serious side effects may occur more often in women and obese patients.

If you have hepatitis B infection, your hepatitis symptoms may get worse or become very serious if you stop taking this medication. Talk with your doctor before stopping this medication. Your doctor will monitor liver tests for several months after you stop emtricitabine/rilpivirine/tenofovir. Tell your doctor immediately if you have symptoms of worsening liver problems.

Who should not take Complera?
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Uses

This product contains 3 different medications: emtricitabine, rilpivirine, and tenofovir. It is used to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Emtricitabine and tenofovir belong to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). Rilpivirine belongs to a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs).

Emtricitabine/rilpivirine/tenofovir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

How to use Complera

Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually once daily.

Medications which reduce or block stomach acid (such as proton pump inhibitors/PPIs, H2 blockers, antacids) may reduce the absorption of rilpivirine, making it work less well. Do not take PPIs (such as omeprazole, lansoprazole) while using this medication. If you take antacids, take the antacids at least 2 hours before or at least 4 hours after this medication. If you take H2 blockers (such as famotidine, ranitidine), take them at least 12 hours before or at least 4 hours after this medication.

It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not take less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase and/or make the infection more difficult to treat (resistant).

Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and your risk of side effects may increase.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.

Side Effects

See also Warning section.

Headache, trouble sleeping, nausea, vomiting, diarrhea, tiredness, dizziness, and skin discoloration (such as small spots/freckles, darkening of the palms of the hands/soles of the feet) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).

Tell your doctor right away if you have any serious side effects, including: change in the amount of urine, mental/mood changes (such as depression, thoughts of suicide).

Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, fainting.

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

Tenofovir may increase the risk of bone loss. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of calcium and vitamin D to reduce this side effect. If you are at risk for bone loss, your doctor may monitor your bone mineral density. Tell your doctor right away if any of the following serious side effects occur: bone pain, easily broken bones.

This medication can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking this medication, tell your doctor or pharmacist if you are allergic to emtricitabine, rilpivirine, or tenofovir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease (such as hepatitis B or C, cirrhosis), alcohol use, bone problems (such as bone disease, bone loss/osteoporosis, weak/broken bones).

Rilpivirine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using this medication, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this medication safely.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcohol.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Emtricitabine and tenofovir in this product pass into breast milk. It is unknown if rilpivirine passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: adefovir, other drugs that may be harmful to the kidneys (including aminoglycosides such as amikacin/gentamicin, NSAIDs such as ibuprofen/naproxen), proton pump inhibitors (PPIs such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole).

Do not take this medication with other products that treat HIV infection, especially products that contain didanosine, emtricitabine, rilpivirine, tenofovir, or lamivudine.

Other medications can affect the removal of rilpivirine from your body, which may affect how this medication works. Examples include dexamethasone, macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin, rifampin, rifapentine), St. John's wort, certain drugs used to treat seizures (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin), telithromycin, among others.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/irregular heartbeat, severe dizziness, fainting.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as kidney/liver function, urine glucose/protein, viral load, T-cell counts, blood mineral levels, bone density tests) should be performed before you start treatment and periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Keep all regular medical and laboratory appointments.

Missed Dose

If you miss a dose and it is within 12 hours of the time you usually take the dose, take it with a meal as soon as you remember. If it is more than 12 hours from the time you usually take the dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Store this drug in its original bottle. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised January 2014. Copyright(c) 2014 First Databank, Inc.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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