Complera

Generic Name: emtricitabine, rilpivirine, and tenofovir (Oral route)

em-trye-SYE-ta-been, ril-pi-VIR-een hye-droe-KLOR-ide, ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate

Oral route(Tablet)

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including tenofovir disoproxil fumarate, a component of emtricitabine/rilpivirine hydrochloride/tenofovir disoproxil fumarate. Not indicated for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy have not been established in patients co-infected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and HIV-1 and have discontinued emtricitabine/rilpivirine hydrochloride/tenofovir; monitor hepatic function upon discontinuation of therapy .

Commonly used brand name(s)

In the U.S.

• Complera

Available Dosage Forms:

• Tablet

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Uses For Complera

Emtricitabine, rilpivirine, and tenofovir combination is used to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients who have not received any HIV treatment in the past.

This medicine will not cure HIV infection or AIDS. It works by lowering the amount of HIV in the blood. The medicine will also help your immune system. This may help delay problems that usually result from AIDS or HIV disease. It will not keep you from spreading HIV to other people. People who receive this medicine may continue to have some of the problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Before Using Complera

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Emtricitabine, rilpivirine, and tenofovir combination is not recommended for children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of emtricitabine, rilpivirine, and tenofovir combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving emtricitabine, rilpivirine, and tenofovir combination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Carbamazepine


• Dexamethasone


• Esomeprazole


• Lansoprazole


• Omeprazole


• Oxcarbazepine


• Pantoprazole


• Phenobarbital


• Phenytoin


• Rabeprazole


• Rifabutin


• Rifampin


• Rifapentine


• St John's Wort

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adefovir Dipivoxil


• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Atazanavir


• Calcium Carbonate


• Cimetidine


• Delavirdine


• Didanosine


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Efavirenz


• Etravirine


• Famotidine


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• Nevirapine


• Nizatidine


• Ranitidine


• Telaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ketoconazole


• Lopinavir


• Methadone


• Ritonavir


• Tipranavir

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone problems, history of or


• Depression, or history of or


• Fanconi syndrome (type of kidney disease) or


• Hepatitis B infection or


• Liver disease or


• Osteomalacia (soft bones) or


• Osteoporosis (weak or brittle bones)—Use with caution. May make these conditions worse.

• Kidney disease—Should not be used in patients with this condition.

Proper Use of Complera

Take this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Keep taking this medicine for the full time of treatment, even if you begin to feel better. Do not stop taking it without checking first with your doctor. When your supply of the medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of the medicine.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

It is best to take this medicine with food.

If you are taking antacids that contain aluminum, magnesium, or calcium, take the antacid at least 2 hours before or 4 hours after this medicine.

If you are taking a stomach medicine for heartburn or ulcers (such as cimetidine, famotidine, nizatidine, ranitidine, Axid®, Pepcid®, Tagamet®, or Zantac®), take the heartburn medicine at least 12 hours before or 4 hours after this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For treatment of HIV infection:
    
    • Adults—One tablet once a day.
    
    
    • Children—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose or forget to use your medicine and it is less than 12 hours since your last dose, take it as soon as you can and take your next dose at the normal time. If you miss a dose or forget to use it, and it is more than 12 hours since your last dose, wait and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Complera

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine does not decrease the risk of transmitting HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. Also, do not share needles or equipment with anyone or use dirty needles. If you have any questions about this, check with your doctor.

This medicine may cause a rare, but serious, unwanted effect called lactic acidosis. This is a condition where the blood has too much acid. Stop using this medicine and call your doctor right away if you have more than one of these symptoms: abdominal or stomach discomfort; a decreased appetite; diarrhea; fast, shallow breathing; a general feeling of discomfort; muscle pain or cramping; nausea; shortness of breath; sleepiness; or unusual tiredness or weakness.

This medicine may cause rare, but serious, liver problems. This may occur in patients with a history of hepatitis B infection. Stop using this medicine and check with your doctor right away if you have more than one of these symptoms: clay-colored stools; dark urine; a decreased appetite; fever; headache; itching; nausea and vomiting; skin rash; stomach pain or tenderness; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

Tell your doctor right away if you start to feel depressed and have thoughts about hurting yourself. Report any unusual thoughts or behavior that troubles you, especially if they are new or get worse quickly.

This medicine may cause your bones to get thin. This could increase your risk for broken bones (fractures). Ask your doctor about this if you have any concerns.

This medicine may cause you to have extra body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from your legs, arms, or face.

When you start taking HIV medicines, your immune system may get stronger. If you already have pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight the infections. If this occurs, be sure to tell your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

This medicine should not be used together with adefovir (Hepsera®), dexamethasone (Decadron®), lamivudine (Combivir®, Epivir®, Epivir-HBV®, Epzicom™, Trizivir®), or certain seizure medicines (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, or Trileptal®).

Do not use this medicine together with medicines for tuberculosis (such as rifabutin, rifampin, rifapentine, Mycobutin®, Priftin®, Rifadin®, or Rimactane®), certain stomach medicines (such as esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, Aciphex®, Nexium®, Prevacid®, Prilosec®, or Protonix®). or St. John's wort.

The medicines in this combination tablet are also available as Atripla®, Emtriva®, Edurant®, Truvada®, and Viread®. Do not take the emtricitabine, rilpivirine, and tenofovir combination with any of these medicines.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Complera Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• 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

Less common

• Body aches or pain


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest pain


• cough


• difficulty with breathing


• ear congestion


• fever or chills


• headache


• loss of voice


• runny or stuffy nose


• shortness of breath


• sneezing


• sore throat


• tightness in the chest


• troubled breathing


• unsteadiness or awkwardness


• unusual tiredness or weakness


• weakness in the arms, hands, legs, or feet


• wheezing

Incidence not known

• 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


• decrease in amount of urine


• diarrhea


• difficulty with swallowing


• dizziness


• dry mouth


• fast heartbeat


• fast, shallow breathing


• frequent urination


• general tiredness and weakness


• headache


• hives


• hostility


• increased thirst


• indigestion


• irritability


• itching


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lethargy


• light-colored stools


• loss of appetite


• 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


• 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. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abnormal dreams


• sleeplessness


• trouble sleeping


• unable to sleep

Less common

• Acid or sour stomach


• back pain


• belching


• difficulty with moving


• heartburn


• pain in the joints


• pain or tenderness around the eyes and cheekbones


• sneezing


• stomach discomfort or upset

Incidence not known

• Lack or loss of strength

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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