Complera

Brand name:

Complera.

Emtricitabine, rilpivirine, and tenofovir are antiviral drugs used to treat human immunodeficiency virus (HIV) infection causing acquired immune deficiency syndrome (AIDS).

This drug is given to patients who have never taken HIV treatment before, in adult patients who have a viral load that is equal to 100,000 copies/mL or less, or in certain adult patients who have a viral load that is less than 50 copies/mL.

This drug prevents HIV cells from multiplying in the body. You can still transmit the disease after taking this drug. This drug requires a prescription.

Before taking this drug, the risks and benefits for your body should be discussed with your healthcare provider.

Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. This drug is not recommended for pediatric patients.

Studies in the elderly have not reported any geriatric-specific problems that would limit the usefulness of this drug combination.

Adjustments in the dose may be required in the elderly since they are more likely to have age-related liver, kidney, or heart problems.

Adverse effects have been reported in animals but studies in pregnant women or animals are still inadequate. Infant risk is still undetermined when taking this drug during breastfeeding.

Discuss with your healthcare professional about the risks and benefits of this drug before breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

• Amifampridine
• Clarithromycin
• Dapsone
• Dasabuvir
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Flucytosine
• Pyrazinamide
• Pyrimethamine
• Ribavirin
• Stavudine
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Acetaminophen
• Fluconazole
• Interferon Beta-1a
• Methadone
• Nelfinavir
• Probenecid
• Rifabutin
• Rifampin
• Rifapentine
• Tipranavir
• Valproic Acid

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects.

Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as blood problems, pancreatitis, Hepatitis B infection or Hepatitis C infection, kidney or liver diseases.

This drug must be taken exactly as directed by your healthcare professional. To prevent any side effects, take this drug exactly as directed on the label or as prescribed by your healthcare professional.

Follow the instructions on the label or as directed by your healthcare professional. Take this drug combination for the full time of treatment to control the viral load in your blood.

Consult with your healthcare professional before you stop taking this drug. It is recommended to take this drug with food.

Take antacids containing aluminum, magnesium, or calcium at least 2 hours before or 4 hours after taking this drug. Take the heartburn drugs at least 12 hours before or 4 hours after this drug.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed.

The dosage of this drug you take depends on the medical problem for which you are using this drug. Adults with HIV infection are given one tablet once a day with food.

Use in children is not recommended. A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.

Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs. Keep the drug in the original bottle that you were given at the pharmacy.

Your health care provider should closely monitor the effectiveness of this drug as well as check for unwanted effects. Unwanted effects can be screened by blood tests.

Check with your healthcare professional before you take any other drugs. When treatment with this drug is stopped abruptly, HIV and hepatitis B virus infections, or liver disease may worsen.

Inform your healthcare professional for any serious side effects of Zidovudine such as fever, chills, sore throat, pale skin, or unusual tiredness or weakness.

A blood transfusion may be required for these symptoms or temporarily stopping treatment with lamivudine and zidovudine combination.

If you are infected, it is recommended to avoid any sexual activity involving an exchange of body fluids with other people. Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex.

Spermicides have been shown to kill HIV in lab tests. Lubricants without oil, such as K-Y Jelly, are recommended and refrain from using oil-based jelly, cold cream, baby oil, or shortening as a lubricant as these products can cause the condom to break.

Birth control pills and diaphragms will not prevent the transmission of HIV virus. Sharing of needles or equipment with anyone is not recommended. Lactic acidosis and hepatoxicity are rare but serious reactions to this drug.

These side effects will be more common in female, very overweight, or have been taking anti-HIV drugs for a long time.

Consult with your healthcare professional immediately if you experience any symptoms of:

• abdominal discomfort or cramping
• dark urine
• decreased appetite
• diarrhea
• a general feeling of discomfort
• light-colored stools
• muscle cramping or pain
• nausea
• unusual tiredness or weakness
• trouble breathing
• vomiting
• yellow eyes or skin
• severe muscle pain
• tenderness
• weakness

Taking this drug may make your immune system stronger and you may notice new symptoms when your body tries to fight hidden infections.

Inform your healthcare professional immediately if you notice changes in your body shape, including an increased amount of body fat in the neck or upper back, face, around the chest, or stomach area as this drug may cause you or your child to have excess body fat.

You might also lose fat from your legs, arms, or face. Breastfeeding is not recommended if you have HIV infection.

Autoimmune disorders such as Graves disease, polymyositis, and Guillain-BarrГ© syndrome may also occur. Inform your healthcare professional that you are taking this drug.

Consult with your healthcare professional before you take any other prescription or nonprescription drugs, and herbal or vitamin supplements.

Side effects may vary for each individual and prompt medical attention should be given if they occur.  

Consult with your healthcare professional immediately if you experience symptoms of:

• discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• mental depression
• thoughts of killing oneself
• tiredness
• trouble concentrating
• trouble sleeping
• body aches or pain
• burning
• crawling
• itching
• numbness
• prickling
• "pins and needles" or tingling feelings
• chest pain
• cough
• the difficulty with breathing
• ear congestion
• fever or chills
• headache
• loss of voice
• runny or stuffy nose
• sneezing
• a sore throat
• tightness in the chest
• unsteadiness or awkwardness
• unusual tiredness or weakness
• weakness in the arms, hands, legs, or feet
• abdominal or stomach discomfort
• agitation
• bloating
• bloody or cloudy urine
• bone pain
• broken bones, especially the thigh bone
• changes in behavior
• confusion
• constipation
• dark urine
• decreased appetite
• the decrease in the amount of urine
• diarrhea
• the difficulty with swallowing
• dizziness
• dry mouth
• fast heartbeat
• fast, shallow breathing
• frequent urination
• general tiredness and weakness
• headache
• hostility
• increased thirst
• indigestion
• irritability
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lethargy
• light-colored stools
• muscle pain or cramps
• muscle tenderness
• wasting or weakness
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• pain in the stomach, side, or abdomen
• possibly radiating to the back
• rapid weight gain
• seizures
• skin rash
• hives
• itching
• sleepiness
• swelling of the face, ankles, hands, feet, or lower legs
• upper right stomach pain
• vomiting yellow eyes or skin

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear.

Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional.

Report any side effects to the FDA hotline at 1-800-FDA-1088.