5 WARNINGS AND PRECAUTIONS
5.1 Lactic Acidosis/Severe Hepatomegaly with Steatosis
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir DF, a component of COMPLERA, in combination with other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering nucleoside analogs to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with COMPLERA should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).
5.2 Patients Coinfected with HIV-1 and HBV
It is recommended that all patients with HIV-1 be tested for the presence of chronic hepatitis B virus before initiating antiretroviral therapy. COMPLERA is not approved for the treatment of chronic HBV infection and the safety and efficacy of COMPLERA have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued emtricitabine or tenofovir DF, two of the components of COMPLERA. In some patients infected with HBV and treated with EMTRIVA®, the exacerbations of hepatitis B were associated with liver decompensation and liver failure. Patients who are coinfected with HIV-1 and HBV should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with COMPLERA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
5.3 New Onset or Worsening Renal Impairment
Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir DF [See Adverse Reactions (6.2)].
It is recommended that estimated creatinine clearance be assessed in all patients prior to initiating therapy and as clinically appropriate during therapy with COMPLERA. In patients at risk of renal dysfunction, including patients who have previously experienced renal events while receiving HEPSERA®, it is recommended that estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein be assessed prior to initiation of COMPLERA, and periodically during COMPLERA therapy.
COMPLERA should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs)) [See Drug Interactions (7.3)]. Cases of acute renal failure after initiation of high dose or multiple NSAIDs have been reported in HIV-infected patients with risk factors for renal dysfunction who appeared stable on tenofovir DF. Some patients required hospitalization and renal replacement therapy. Alternatives to NSAIDs should be considered, if needed, in patients at risk for renal dysfunction.
Persistent or worsening bone pain, pain in extremities, fractures and/or muscular pain or weakness may be manifestations of proximal renal tubulopathy and should prompt an evaluation of renal function in at-risk patients.
Emtricitabine and tenofovir are principally eliminated by the kidney; however, rilpivirine is not. Since COMPLERA is a combination product and the dose of the individual components cannot be altered, patients with estimated creatinine clearance below 50 mL per minute should not receive COMPLERA.
5.7 Bone Effects of Tenofovir DF
Bone Mineral Density:
In clinical trials in HIV-1-infected adults, tenofovir DF was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism, suggesting increased bone turnover relative to comparators. Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher in subjects receiving tenofovir DF. For more information, please consult the VIREAD prescribing information.
The effects of tenofovir DF-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk are unknown. Assessment of BMD should be considered for patients who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. Although the effect of supplementation with calcium and Vitamin D was not studied, such supplementation may be beneficial for all patients. If bone abnormalities are suspected then appropriate consultation should be obtained.
Cases of osteomalacia associated with proximal renal tubulopathy, manifested as bone pain or pain in extremities and which may contribute to fractures, have been reported in association with the use of tenofovir DF [See Adverse Reactions (6.2)]. Arthralgias and muscle pain or weakness have also been reported in cases of proximal renal tubulopathy. Hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy should be considered in patients at risk of renal dysfunction who present with persistent or worsening bone or muscle symptoms while receiving products containing tenofovir DF [See Warnings and Precautions (5.3)].
5.8 Coadministration with Other Products
COMPLERA should not be administered concurrently with other medicinal products containing any of the same active components, emtricitabine, rilpivirine, or tenofovir DF (ATRIPLA®, Edurant®, EMTRIVA, STRIBILD®, TRUVADA®, VIREAD), with medicinal products containing lamivudine (Epivir®, Epivir-HBV®, Epzicom®, Combivir®, Trizivir®), or with adefovir dipivoxil (HEPSERA).
5.9 Fat Redistribution
Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are unknown. A causal relationship has not been established.
5.10 Immune Reconstitution Syndrome
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including the components of COMPLERA. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections [such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis], which may necessitate further evaluation and treatment.
Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment.
7 DRUG INTERACTIONS
COMPLERA is a complete regimen for the treatment of HIV-1 infection; therefore, COMPLERA should not be administered with other antiretroviral medications. Information regarding potential drug-drug interactions with other antiretroviral medications is not provided. Please refer to the Edurant, VIREAD and EMTRIVA prescribing information as needed.
There were no drug-drug interaction trials conducted with the fixed-dose combination tablet. Drug interaction studies were conducted with emtricitabine, rilpivirine, or tenofovir DF, the components of COMPLERA. This section describes clinically relevant drug interactions with COMPLERA [See Contraindications (4) and Clinical Pharmacology (12.3)].
7.1 Drugs Inducing or Inhibiting CYP3A Enzymes
Rilpivirine is primarily metabolized by cytochrome P450 (CYP) 3A, and drugs that induce or inhibit CYP3A may thus affect the clearance of rilpivirine [See Clinical Pharmacology (12.3), Contraindications (4)]. Coadministration of rilpivirine and drugs that induce CYP3A may result in decreased plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs. Coadministration of rilpivirine and drugs that inhibit CYP3A may result in increased plasma concentrations of rilpivirine.
Rilpivirine at a dose of 25 mg once daily is not likely to have a clinically relevant effect on the exposure of drugs metabolized by CYP enzymes.
7.2 Drugs Increasing Gastric pH
Coadministration of rilpivirine with drugs that increase gastric pH may decrease plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs [See Table 4].
7.3 Drugs Affecting Renal Function
Because emtricitabine and tenofovir are primarily eliminated by the kidneys through a combination of glomerular filtration and active tubular secretion, coadministration of COMPLERA with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of emtricitabine, tenofovir, and/or other renally eliminated drugs. Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [See Warnings and Precautions (5.3)].
7.4 QT Prolonging Drugs
There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and drugs that prolong the QTc interval of the electrocardiogram. In a study of healthy subjects, supratherapeutic doses of rilpivirine (75 mg once daily and 300 mg once daily) have been shown to prolong the QTc interval of the electrocardiogram [See Clinical Pharmacology (12.2)]. COMPLERA should be used with caution when coadministered with a drug with a known risk of Torsade de Pointes.
7.5 Established and Other Potentially Significant Drug Interactions
Important drug interaction information for COMPLERA is summarized in Table 4. The drug interactions described are based on studies conducted with emtricitabine, rilpivirine, or tenofovir DF as individual medications that may occur with COMPLERA or are potential drug interactions; no drug interaction studies have been conducted using COMPLERA [for pharmacokinetic data see Clinical Pharmacology (12.3), Tables 6–7]. The tables include potentially significant interactions, but are not all inclusive.
Table 4 Established and Other Potentially Significant* Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction
|Concomitant Drug Class: Drug Name
||Effect on Concentration†
(e.g., aluminium, magnesium hydroxide, or calcium carbonate)
(antacids taken at least 2 hours before or at least 4 hours after rilpivirine)
↓ rilpivirine (concomitant intake)
|The combination of COMPLERA and antacids should be used with caution as coadministration may cause significant decreases in rilpivirine plasma concentrations (increase in gastric pH). Antacids should only be administered either at least 2 hours before or at least 4 hours after COMPLERA.
|Azole Antifungal Agents:
|Concomitant use of COMPLERA with azole antifungal agents may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes). No dose adjustment is required when COMPLERA is coadministered with azole antifungal agents. Clinically monitor for breakthrough fungal infections when azole antifungals are coadministered with COMPLERA.
(famotidine taken 12 hours before rilpivirine or 4 hours after rilpivirine)
(famotidine taken 2 hours before rilpivirine)
|The combination of COMPLERA and H2-receptor antagonists should be used with caution as coadministration may cause significant decreases in rilpivirine plasma concentrations (increase in gastric pH). H2-receptor antagonists should only be administered at least 12 hours before or at least 4 hours after COMPLERA.
|Macrolide or Ketolide Antibiotics:
| ↑ rilpivirine
|Concomitant use of COMPLERA with clarithromycin, erythromycin or telithromycin may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes). Where possible, alternatives such as azithromycin should be considered.
|↓ R(–) methadone‡
↓ S(+) methadone‡
↔ methadone‡ (when used with tenofovir)
|No dose adjustments are required when initiating coadministration of methadone with COMPLERA. However, clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients.
7.6 Drugs with No Observed or Predicted Interactions with COMPLERA
No clinically significant drug interactions have been observed between emtricitabine and the following medications: famciclovir or tenofovir DF. Similarly, no clinically significant drug interactions have been observed between tenofovir DF and the following medications: entecavir, methadone, oral contraceptives, ribavirin, or tacrolimus in studies conducted in healthy subjects.
No clinically significant drug interactions have been observed between rilpivirine and the following medications: acetaminophen, atorvastatin, chlorzoxazone, digoxin, ethinyl estradiol, norethindrone, sildenafil, telaprevir, or tenofovir DF. No clinically relevant drug-drug interaction is expected when rilpivirine is coadministered with ribavirin.
COMPLERA is a fixed-dose combination tablet containing emtricitabine, rilpivirine hydrochloride, and tenofovir DF. EMTRIVA is the brand name for emtricitabine, a synthetic nucleoside analog of cytidine. Edurant is the brand name for rilpivirine, a non-nucleoside reverse transcriptase inhibitor. VIREAD is the brand name for tenofovir DF, which is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. VIREAD and EMTRIVA are the components of TRUVADA.
COMPLERA tablets are for oral administration. Each tablet contains 200 mg of emtricitabine, 27.5 mg of rilpivirine hydrochloride (equivalent to 25 mg of rilpivirine), and 300 mg of tenofovir DF (equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: pregelatinized starch, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, povidone, polysorbate 20. The tablets are film-coated with a coating material containing polyethylene glycol, hypromellose, lactose monohydrate, triacetin, titanium dioxide, iron oxide red, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake.
Emtricitabine: The chemical name of emtricitabine is 5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Emtricitabine is the (–) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position.
It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.24. It has the following structural formula:
Emtricitabine is a white to off-white crystalline powder with a solubility of approximately 112 mg per mL in water at 25 °C.
Rilpivirine: Rilpivirine is available as the hydrochloride salt. The chemical name for rilpivirine hydrochloride is 4-[[4-[[4-[(E)-2-cyanoethenyl]-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile monohydrochloride. Its molecular formula is C22H18N6 • HCl and its molecular weight is 402.88. Rilpivirine hydrochloride has the following structural formula:
Rilpivirine hydrochloride is a white to almost white powder. Rilpivirine hydrochloride is practically insoluble in water over a wide pH range.
Tenofovir Disoproxil Fumarate: Tenofovir DF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P • C4H4O4 and a molecular weight of 635.52. It has the following structural formula:
Tenofovir DF is a white to off-white crystalline powder with a solubility of 13.4 mg per mL in water at 25 °C. All dosages are expressed in terms of tenofovir DF except where otherwise noted.
(emtricitabine, rilpivirine, tenofovir disoproxil fumarate)
Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with COMPLERA. For more information, see the section "What should I tell my healthcare provider before taking COMPLERA?"
Read this Patient Information before you start taking COMPLERA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about COMPLERA?
COMPLERA can cause serious side effects, including:
- Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take COMPLERA or similar (nucleoside analogs) medicines. Lactic acidosis is a serious medical emergency that can lead to death.
Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis:
- feeling very weak or tired
- have unusual (not normal) muscle pain
- have trouble breathing
- have stomach pain with
- nausea (feel sick to your stomach)
- feel cold, especially in your arms and legs
- feel dizzy or lightheaded
- have a fast or irregular heartbeat
- Severe liver problems. Severe liver problems can happen in people who take COMPLERA or similar medicines. In some cases these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis) when you take COMPLERA.
Call your healthcare provider right away if you have any of the following symptoms of liver problems:
- your skin or the white part of your eyes turns yellow (jaundice)
- dark "tea-colored" urine
- light-colored bowel movements (stools)
- loss of appetite for several days or longer
- stomach pain
You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking COMPLERA or a similar medicine containing nucleoside analogs for a long time.
- Worsening of Hepatitis B infection. If you also have hepatitis B virus (HBV) infection and you stop taking COMPLERA, your HBV infection may become worse (flare-up). A "flare-up" is when your HBV infection suddenly returns in a worse way than before. COMPLERA is not approved for the treatment of HBV, so you must discuss your HBV therapy with your healthcare provider.
- Do not let your COMPLERA run out. Refill your prescription or talk to your healthcare provider before your COMPLERA is all gone.
- Do not stop taking COMPLERA without first talking to your healthcare provider.
- If you stop taking COMPLERA, your healthcare provider will need to check your health often and do blood tests regularly to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking COMPLERA.
What is COMPLERA?
COMPLERA is a prescription HIV (Human Immunodeficiency Virus) medicine. HIV is the virus that causes AIDS (Acquired Immunodeficiency Syndrome).
COMPLERA is used to treat HIV-1 infection in:
- adults who have never taken HIV medicines before, and who have an amount of HIV in their blood (this is called 'viral load') that is no more than 100,000 copies/mL before they start taking COMPLERA,
- certain adults who have a viral load that is less than 50 copies/mL when they start taking COMPLERA, to replace their current HIV medicines.
Your healthcare provider will measure your viral load.
COMPLERA contains 3 medicines, (rilpivirine, emtricitabine, tenofovir disoproxil fumarate) combined in one tablet. Emtricitabine (EMTRIVA®) and tenofovir disoproxil fumarate (VIREAD®) are HIV-1 (human immunodeficiency virus) nucleoside analog reverse transcriptase inhibitors (NRTIs). Rilpivirine (Edurant®) is an HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI).
It is not known if COMPLERA is safe and effective in children under the age of 18 years.
COMPLERA may help:
- Reduce the amount of HIV in your blood.
- Increase the number of white blood cells called CD4+ (T) cells in your blood that help fight off other infections.
Reducing the amount of HIV and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).
COMPLERA does not cure HIV infections or AIDS.
You must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.
Avoid doing things that can spread HIV-1 infection to others.
- Do not share or re-use needles or other injection equipment.
- Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
- Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.
Ask your healthcare provider if you have any questions about how to prevent passing HIV to other people.
Who should not take COMPLERA?
Do not take COMPLERA if:
- you are taking any of the following medicines:
- anti-seizure medicines:
- carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol- XR®, Teril®, Epitol®)
- oxcarbazepine (Trileptal®)
- phenobarbital (Luminal®)
- phenytoin (Dilantin®, Dilantin-125®, Phenytek®)
- anti-tuberculosis (anti-TB) medicines:
- rifabutin (Mycobutin®)
- rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®)
- rifapentine (Priftin®)
- proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems:
- dexlansoprazole (Dexilant®)
- esomeprazole (Nexium®, Vimovo®)
- lansoprazole (Prevacid®)
- omeprazole (Prilosec®, Zegerid®)
- pantoprazole sodium (Protonix®)
- rabeprazole (Aciphex®)
- more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
- St. John's wort (Hypericum perforatum)
What should I tell my healthcare provider before taking COMPLERA?
Before you take COMPLERA, tell your healthcare provider if you:
- have liver problems, including hepatitis B or C virus infection
- have kidney problems
- have ever had a mental health problem
- have bone problems
- are pregnant or plan to become pregnant. It is not known if COMPLERA can harm your unborn child.
- Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
- are breast-feeding or plan to breast-feed. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby. Do not breastfeed if you are taking COMPLERA. At least two of the medicines contained in COMPLERA can be passed to your baby in your breast milk. We do not know whether this could harm your baby. Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
COMPLERA may affect the way other medicines work, and other medicines may affect how COMPLERA works, and may cause serious side effects. If you take certain medicines with COMPLERA, the amount of COMPLERA in your body may be too low and it may not work to help control your HIV infection. The HIV virus in your body may become resistant to COMPLERA or other HIV medicines that are like it.
COMPLERA provides a complete treatment for HIV infection. Do not take other HIV medicines with COMPLERA.
If you take COMPLERA, you should not take:
- other medicines that contain tenofovir (VIREAD, TRUVADA®, STRIBILD®, ATRIPLA®)
- other medicines that contain emtricitabine or lamivudine (EMTRIVA, Combivir®, Epivir® or Epivir-HBV®, Epzicom®, Trizivir®, ATRIPLA, TRUVADA, STRIBILD)
- rilpivirine (Edurant)
- adefovir (HEPSERA®)
Especially tell your healthcare provider if you take:
- an antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. If you take an antacid during treatment with COMPLERA, take the antacid at least 2 hours before or at least 4 hours after you take COMPLERA.
- a medicine to block the acid in your stomach, including cimetidine (Tagamet®), famotidine (Pepcid®), nizatidine (Axid®), or ranitidine hydrochloride (Zantac®). If you take one of these medicines during treatment with COMPLERA, take the acid blocker at least 12 hours before or at least 4 hours after you take COMPLERA.
- any of these medicines (if taken by mouth or injection):
- clarithromycin (Biaxin®)
- erythromycin (E-Mycin®, Eryc®, Ery-Tab®, PCE®, Pediazole®, Ilosone®)
- fluconazole (Diflucan®)
- itraconazole (Sporanox®)
- ketoconazole (Nizoral®)
- methadone (Dolophine®)
- posaconazole (Noxafil®)
- telithromycin (Ketek®)
- voriconazole (Vfend®)
- certain medicines that can affect how your kidneys work, including acyclovir (Zovirax®), cidofovir (VISTIDE®), ganciclovir (Cytovene IV®, Vitrasert®), valacyclovir (Valtrex®), and valganciclovir (Valcyte®)
Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider and your pharmacist can tell you if you can take these medicines with COMPLERA. Do not start any new medicines while you are taking COMPLERA without first talking with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that can interact with COMPLERA.
How should I take COMPLERA?
- Stay under the care of your healthcare provider during treatment with COMPLERA.
- Take COMPLERA exactly as your healthcare provider tells you to take it.
- Always take COMPLERA with food. Taking COMPLERA with food is important to help get the right amount of medicine in your body. A protein drink does not replace food. If your healthcare provider decides to stop COMPLERA and you are switched to new medicines to treat HIV that includes rilpivirine tablets, the rilpivirine tablets should be taken only with a meal.
- Do not change your dose or stop taking COMPLERA without first talking with your healthcare provider. See your healthcare provider regularly while taking COMPLERA.
- If you miss a dose of COMPLERA within 12 hours of the time you usually take it, take your dose of COMPLERA with food as soon as possible. Then, take your 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 take more than your prescribed dose to make up for a missed dose.
- When your COMPLERA supply starts to run low, get more from your healthcare provider or pharmacy. It is very important not to run out of COMPLERA. The amount of virus in your blood may increase if the medicine is stopped for even a short time.
- If you take too much COMPLERA, contact your local poison control center or go to the nearest hospital emergency room right away.
What are the possible side effects of COMPLERA?
COMPLERA can cause serious side effects, including:
- See "What is the most important information I should know about COMPLERA?"
- New or worse kidney problems, including kidney failure, can happen in some people who take COMPLERA. Your healthcare provider should do blood tests to check your kidneys before starting treatment with COMPLERA. If you have had kidney problems in the past or need to take another medicine that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with COMPLERA.
- Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms:
- feeling sad or hopeless
- feeling anxious or restless
- have thoughts of hurting yourself (suicide) or have tried to hurt yourself
- Change in liver enzymes. People with a history of hepatitis B or C virus infection or who have certain liver enzyme changes may have an increased risk of developing new or worsening liver problems during treatment with COMPLERA. Liver problems can also happen during treatment with COMPLERA in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with COMPLERA.
- Bone problems can happen in some people who take COMPLERA. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones.
- Changes in body fat can happen in people taking HIV medicine. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long term health effect of these conditions are not known.
- Changes in your immune system (Immune Reconstitution 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. Tell your healthcare provider if you start having new symptoms after starting your HIV medicine.
The most common side effects of COMPLERA include:
- trouble sleeping (insomnia)
- abnormal dreams
Additional common side effects include:
- stomach pain or discomfort
- skin discoloration (small spots or freckles)
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of COMPLERA. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How do I store COMPLERA?
- Store COMPLERA at room temperature between 68 °F to 77 °F (20 °C to 25 °C).
- Keep COMPLERA in its original container and keep the container tightly closed.
- Do not use COMPLERA if the seal over the bottle opening is broken or missing.
Keep COMPLERA and all other medicines out of reach of children.
General information about COMPLERA:
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use COMPLERA for a condition for which it was not prescribed. Do not give COMPLERA to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about COMPLERA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about COMPLERA that is written for health professionals. For more information, call 1-800-445-3235 or go to www.COMPLERA.com.
What are the ingredients of COMPLERA?
Active ingredients: emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate.
Inactive ingredients: pregelatinized starch, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, povidone, polysorbate 20. The tablet film coating contains polyethylene glycol, hypromellose, lactose monohydrate, triacetin, titanium dioxide, iron oxide red, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake.
This Patient Information has been approved by the U.S. Food and Drug Administration
Manufactured and distributed by:
Gilead Sciences, Inc.
Foster City, CA 94404
Revised: December 2013
COMPLERA, EMTRIVA, HEPSERA, STRIBILD, TRUVADA, VIREAD, and VISTIDE are trademarks of Gilead Sciences, Inc., or its related companies. Edurant is a trademark of Janssen Pharmaceuticals, Inc. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks referenced herein are the property of their respective owners.