Edurant

Pregnancy Category: B; Antiretroviral Pregnancy Registry 1-800-258-4263

Lactation: Unknown whether distributed in human breast milk; The CDC recommends that mothers should not breastfeed their infants because of risk of postnatal HIV transmission

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Tell your doctor if you are pregnant or planning to become pregnant. It is not known if Edurant will harm your unborn baby.

There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• mood changes, anxiety, severe depression, feeling hopeless, thoughts about suicide or hurting yourself;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of inflammation in your body--swollen glands, flu symptoms, easy bruising or bleeding, severe tingling or numbness, muscle weakness; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Rilpivirine may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with rilpivirine. Tell your doctor if you have:

• signs of a new infection such as fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

• cold sores, sores on your genital or anal area;

• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

• trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

• sleep problems (insomnia);

• depression;

• skin rash;

• headache; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Administration

Oral Administration

Rilpivirine (Edurant): Administer orally once daily with a meal.1 Use in conjunction with other antiretrovirals.1

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey): Administer orally once daily with a meal.244 Use alone as a complete treatment regimen.244

Emtricitabine/rilpivirine/tenofovir DF (Complera): Administer orally once daily with a meal.233 Use alone as a complete treatment regimen.233

Systemic exposure substantially decreased if rilpivirine given on empty stomach or with only a protein-rich nutritional drink.1

Because antiretrovirals in the fixed combinations also may be available in single-entity or other fixed-combination preparations, take care to ensure that therapy is not duplicated if a fixed combination is used in conjunction with other antiretrovirals.233 244 (See Precautions Related to Use of Fixed Combinations under Cautions.)

Do not use single-entity rilpivirine (Edurant) and emtricitabine/rilpivirine/tenofovir alafenamide concomitantly.1 244

Do not use single-entity rilpivirine (Edurant) and emtricitabine/rilpivirine/tenofovir DF (Complera) concomitantly, unless needed for adjustment of rilpivirine dosage (e.g., when fixed combination used concomitantly with rifabutin).1 233

Because of the tenofovir component, determine estimated CLcr, urine glucose, and urine protein prior to and monitor during treatment with emtricitabine/rilpivirine/tenofovir alafenamide or emtricitabine/rilpivirine/tenofovir DF in all patients.233 244 In addition, monitor serum phosphorous in those with chronic kidney disease or at risk for renal impairment.233 244 (See Renal Impairment under Cautions.)

Dosage

Available as rilpivirine hydrochloride;1 dosage expressed in terms of rilpivirine.1

Pediatric Patients

Rilpivirine (Edurant) in adolescents ≥12 years of age weighing ≥35 kg: 25 mg once daily.1

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey) in adolescents ≥12 years of age weighing ≥35 kg: 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide 25 mg) once daily.244

Emtricitabine/rilpivirine/tenofovir DF (Complera) in adolescents ≥12 years of age weighing ≥35 kg: 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily.233

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey) in adolescents ≥12 years of age weighing ≥35 kg: 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide 25 mg) once daily.244

Emtricitabine/rilpivirine/tenofovir DF (Complera) in adolescents ≥12 years of age weighing ≥35 kg: 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily.233

Rilpivirine (Edurant) in adolescents ≥12 years of age weighing ≥35 kg: 50 mg once daily.1 (See Specific Drugs under Interactions.)

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey) in adolescents ≥12 years of age weighing ≥35 kg: Concomitant use with rifabutin not recommended.244

Emtricitabine/rilpivirine/tenofovir DF (Complera) in adolescents ≥12 years of age weighing ≥35 kg: 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily and 25 mg of single-entity rilpivirine (Edurant) once daily to provide total rilpivirine dosage of 50 mg daily.233 (See Specific Drugs under Interactions.)

Adults

Rilpivirine (Edurant): 25 mg once daily.1

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide 25 mg) once daily.244

Emtricitabine/rilpivirine/tenofovir DF (Complera): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily.233

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide 25 mg) once daily.244

Emtricitabine/rilpivirine/tenofovir DF (Complera): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily.233

Rilpivirine (Edurant): 50 mg once daily.1 (See Specific Drugs under Interactions.)

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey): Concomitant use with rifabutin not recommended.244

Emtricitabine/rilpivirine/tenofovir DF (Complera): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily and 25 mg of single-entity rilpivirine (Edurant) once daily to provide total rilpivirine dosage of 50 mg daily.233 (See Specific Drugs under Interactions.)

Rilpivirine (Edurant): 25 mg once daily.199 Use in conjunction with 2 NRTIs (see Postexposure Prophylaxis following Occupational Exposure to HIV [PEP] under Uses).199

Emtricitabine/rilpivirine/tenofovir DF (Complera): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily.199 Use as a complete regimen for PEP.199

Initiate PEP as soon as possible following occupational exposure to HIV (preferably within hours);199 continue for 4 weeks, if tolerated.199

Emtricitabine/rilpivirine/tenofovir DF (Complera): 1 tablet (200 mg of emtricitabine, 25 mg of rilpivirine, and 300 mg of tenofovir DF) once daily.198 Use as a complete regimen for nPEP.198

Initiate nPEP as soon as possible (within 72 hours) following nonoccupational exposure that represents a substantial risk for HIV transmission and continue for 28 days.198

nPep not recommended if exposed individual seeks care >72 hours after exposure.198

Special Populations

Hepatic Impairment

Rilpivirine (Edurant): Use usual dosage in patients with mild or moderate hepatic impairment (Child-Pugh class A or B);1 not studied in those with severe hepatic impairment (Child-Pugh class C).1

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey): Use usual dosage in patients with mild or moderate hepatic impairment (Child-Pugh class A or B);244 not studied in those with severe hepatic impairment (Child-Pugh class C).244

Emtricitabine/rilpivirine/tenofovir DF (Complera): Use usual dosage in patients with mild or moderate hepatic impairment (Child-Pugh class A or B);233 not studied in those with severe hepatic impairment (Child-Pugh class C).233

Renal Impairment

Rilpivirine (Edurant): Use usual dosage in patients with mild or moderate renal impairment.1 Manufacturer makes no specific dosage recommendations for those with severe renal impairment or end-stage renal disease (ESRD);1 use with caution.1 (See Renal Impairment under Cautions.)

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey): Use usual dosage in patients with estimated Clcr ≥30 mL/minute;244 not recommended in those with severe renal impairment (estimated Clcr <30 mL/minute).244

Emtricitabine/rilpivirine/tenofovir DF (Complera): Do not use in those with moderate, severe, or end-stage renal impairment (estimated Clcr <50 mL/minute) or if dialysis required.233

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1 233

Contraindications

• Rilpivirine, emtricitabine/rilpivirine/tenofovir alafenamide, emtricitabine/rilpivirine/tenofovir DF: Concomitant use with drugs that induce CYP3A or elevate gastric pH contraindicated since substantially decreased plasma rilpivirine concentrations may occur and may result in loss of virologic response and development of resistance to rilpivirine and/or class resistance to other NNRTIs.1 233 244 This includes certain anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin), certain antimycobacterials (rifampin, rifapentine), systemic dexamethasone (given in multiple doses), proton-pump inhibitors (dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole), and certain herbal supplements (St. John’s wort [Hypericum perforatum]).1 233 244 (See Interactions.)

• Emtricitabine/rilpivirine/tenofovir alafenamide, emtricitabine/rilpivirine/tenofovir DF: Consider contraindications associated with each drug in the fixed combination.233 244

Warnings/Precautions

Sensitivity Reactions

Severe skin and hypersensitivity reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), reported during postmarketing experience.1 233 244 Some skin reactions were accompanied by constitutional symptoms such as fever;1 233 244 others were associated with organ dysfunction, including elevated hepatic enzyme serum concentrations.1 233 244 Rash generally was grade 1 or 2 and occurred in the first 4–6 weeks of therapy.1 233 244

Immediately discontinue rilpivirine, emtricitabine/rilpivirine/tenofovir alafenamide, or emtricitabine/rilpivirine/tenofovir DF if signs or symptoms of severe skin or hypersensitivity reactions develop (e.g., severe rash or rash accompanied by fever, blisters, mucosal involvement, conjunctivitis, facial edema, angioedema, hepatitis, or eosinophilia).1 233 244 Monitor clinical status, including laboratory parameters, and initiate appropriate therapy.1 233 244

Interactions

Concomitant use with certain drugs (e.g., drugs that may reduce rilpivirine concentrations, drugs known to increase risk of torsades de pointes) is contraindicated or requires particular caution.1 233 244 (See Contraindications and see Interactions.)

Depressive Disorders

Depressive disorders (e.g., depressed mood, depression, dysphoria, major depression, altered mood, negative thoughts, suicide attempt, suicidal ideation) reported.1 233 244

Depressive disorders reported in 9% of adults receiving rilpivirine in phase 3 clinical trials and in 19% of pediatric patients 12 to <18 years of age receiving rilpivirine in phase 2 clinical trials.1 233 244

Advise patients experiencing severe depressive symptoms to seek immediate medical evaluation to determine the likelihood that symptoms are related to rilpivirine and to determine if benefits of continued rilpivirine outweigh risks.1 233 244

Hepatotoxicity

Adverse hepatic effects reported;1 233 244 hepatotoxicity reported in some patients without preexisting hepatic disease or other risk factors.1 233 244

HIV-infected patients with HBV or HCV coinfection or marked elevations in aminotransferase concentrations prior to rilpivirine treatment may be at increased risk for development or worsening of aminotransferase concentration elevations.1 233 244

In patients with underlying hepatic disease (e.g., HBV or HCV infection, elevated aminotransferase concentrations), perform laboratory tests to evaluate hepatic function prior to and during rilpivirine treatment (single entity or fixed combinations).1 233 244

Consider liver enzyme monitoring in patients without preexisting hepatic disease or other risk factors.1 233 244

Precautions Related to Use of Fixed Combinations

Emtricitabine/rilpivirine/tenofovir alafenamide, emtricitabine/rilpivirine/tenofovir DF: Consider cautions, precautions, contraindications, and interactions associated with each drug in the fixed combination.233 244 Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) for each drug.233 244

Because the antiretrovirals contained in the fixed combinations also may be available in single-entity or other fixed-combination preparations, take care to ensure that therapy is not duplicated if a fixed combination is used in conjunction with other antiretrovirals.233 244

Do not use emtricitabine/rilpivirine/tenofovir DF concomitantly with single-entity rilpivirine, unless needed for adjustment of rilpivirine dosage (e.g., when fixed combination used concomitantly with rifabutin).1 233 (See Specific Drugs under Interactions.)

Because of similarities between emtricitabine and lamivudine, do not use fixed combinations containing emtricitabine concomitantly with any preparation containing lamivudine.200 233 In addition, do not use fixed combinations containing tenofovir DF concomitantly with adefovir.200 233

Adipogenic Effects

Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, facial wasting, breast enlargement, and general cushingoid appearance.1 233 244

Mechanisms and long-term consequences of adipogenic effects unknown; causal relationship not established.1 233 244

Immune Reconstitution Syndrome

During initial treatment, HIV-infected patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium, M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jirovecii [formerly P. carinii]);1 233 244 this may necessitate further evaluation and treatment.1 233 244

Autoimmune disorders (e.g., Graves' disease, polymyositis, Guillain-Barré syndrome) also reported to occur in the setting of immune reconstitution;1 233 244 time to onset is more variable and can occur many months after initiation of antiretroviral therapy.1 233 244

Specific Populations

Rilpivirine (Edurant): Category B.1

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey): Insufficient human data to assess risk of birth defects and miscarriage if used in pregnant women.244

Emtricitabine/rilpivirine/tenofovir DF (Complera): Category B.233

Antiretroviral Pregnancy Registry at 800-258-4263 or .1 202 233 244

Experts state rilpivirine in conjunction with tenofovir DF and emtricitabine (or rilpivirine in conjunction with a preferred 2-NRTI backbone) is an alternative NNRTI-based regimen for initial treatment of HIV-1 infection in pregnant women, but use only in patients with baseline plasma HIV-1 RNA levels <100,000 copies/mL and baseline CD4+ T-cell count >200 cells/mm3.202

Not known whether rilpivirine distributed into human milk;1 distributed into milk in rats.1

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.1 202 233 244

Rilpivirine (Edurant): Safety, efficacy, and pharmacokinetics not established in pediatric patients <12 years of age.1 201

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey): Safety and efficacy not established in pediatric patients <12 years of age or weighing <35 kg.244

Emtricitabine/rilpivirine/tenofovir DF (Complera): Safety and efficacy not established in pediatric patients <12 years of age or weighing <35 kg.233

Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults.1 233 244

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1 233

Rilpivirine (Edurant), emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey), emtricitabine/rilpivirine/tenofovir DF (Complera): Not studied in patients with severe hepatic impairment (Child-Pugh class C).1 233 244 (See Hepatic Impairment under Dosage and Administration.)

Higher incidence of increased serum aminotransferase concentrations reported in HIV-infected patients coinfected with HBV and/or HCV compared with those without coinfection.1

Rilpivirine (Edurant): Use with caution and increased monitoring for adverse effects in patients with severe renal impairment or ESRD;1 increased rilpivirine concentrations possible due to alterations in absorption, distribution, or metabolism.1 (See Renal Impairment under Dosage and Administration.)

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey): Not recommended in those with severe renal impairment (estimated Clcr <30 mL/minute).244

Emtricitabine/rilpivirine/tenofovir DF (Complera): Do not use in those with moderate, severe, or end-stage renal impairment (estimated Clcr <50 mL/minute) or if dialysis required.233

Common Adverse Effects

Depressive disorders (see Depressive Disorders under Cautions), insomnia, headache, rash, increased serum AST and/or ALT concentrations (>2.5 times ULN).1

• Critical nature of compliance with HIV therapy and importance of remaining under the care of a clinician.1 233 244 Importance of taking as prescribed; do not alter or discontinue antiretroviral regimen without consulting clinician.1 233 244

• Importance of using single-entity rilpivirine in conjunction with other antiretroviralsnot for monotherapy.1

• Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey) and emtricitabine/rilpivirine/tenofovir DF (Complera) are used alone as a complete treatment regimen.233 244

• Antiretroviral therapy is not a cure for HIV infection; opportunistic infections and other complications associated with HIV disease may still occur.1 233 244

• Advise patients that sustained decreases in plasma HIV RNA have been associated with reduced risk of progression to acquired immunodeficiency disease (AIDS) and death.1 233 244

• Advise patients that effective antiretroviral regimens can decrease HIV concentrations in blood and genital secretions and strict adherence to such regimens in conjunction with risk-reduction measures may decrease, but cannot absolutely eliminate, the risk of secondary transmission of HIV to others.200 Importance of continuing to practice safer sex (e.g., using latex or polyurethane condoms to minimize sexual contact with body fluids), never sharing personal items that can have blood or body fluids on them (e.g., toothbrushes, razor blades), and never reusing or sharing needles.1 200 233 244

• Importance of reading patient information provided by the manufacturer.1 233 244

• Importance of taking once daily with a meal;1 233 244 a protein drink alone does not constitute a meal.1 233 Food enhances absorption of rilpivirine.1

• If a missed dose of single-entity rilpivirine or emtricitabine/rilpivirine/tenofovir DF is remembered within 12 hours, take the dose with a meal as soon as possible and take next dose at regularly scheduled time.1 233 If the missed dose is remembered more than 12 hours after the scheduled time, omit the missed dose and take next dose at regularly scheduled time.1 233 Advise patients that doses that are larger or smaller than the prescribed dosage should not be taken at any time.1 233

• Advise patients that skin reactions ranging from mild to severe, including DRESS, reported with rilpivirine-containing antiretroviral regimens.1 233 244 Instruct patients to immediately stop taking rilpivirine (single entity or fixed combinations) and contact a clinician if a rash develops and is also associated with fever, blisters, mucosal involvement, eye inflammation (conjunctivitis), swelling of the face, eyes, lips, mouth, tongue, or throat which may lead to difficulty swallowing or breathing, or any signs and symptoms of liver problems.1 233 244

• Advise patients that depressive disorders (depressed mood, depression, dysphoria, major depression, altered mood, negative thoughts, suicide attempt, suicidal ideation) have been reported.1 233 244 Importance of immediately contacting clinician if depressive symptoms (e.g., feeling sad, hopeless, anxious, or restless; hurting oneself; having thoughts of hurting oneself) occur.1 233 244

• Advise patients that hepatotoxicity has been reported in patients receiving rilpivirine.1 233 244

• Redistribution/accumulation of body fat may occur; cause and long-term health effects unknown.1 233 244

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products (e.g., St. John’s wort), and any concomitant illnesses.1 233 244 (See Contraindications.)

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 233 244 Advise HIV-infected women not to breast-feed.1 233 244

• Importance of advising patients of other important precautionary information.1 233 244 (See Cautions.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Rilpivirine 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. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor.

This medicine will not cure HIV infection or AIDS. It works by lowering the amount of HIV in the blood and helps the immune system. This may help delay problems that 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.

• Tell all of your health care providers that you take Edurant. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine is not a cure for HIV. Stay under the care of your doctor.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

Use Edurant as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take this medicine at the same time of day.
• Take with a meal.
• Do not use a protein drink in place of a meal.
• Keep taking Edurant as you have been told by your doctor or other health care provider, even if you feel well.
• It is important that you do not miss or skip a dose of this medicine during treatment.
• Do not take antacids within 2 hours before Edurant or 4 hours after this medicine.
• Do not take cimetidine, famotidine, nizatidine, or ranitidine within 12 hours before or 4 hours after Edurant (rilpivirine).

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it, with a meal.
• If it has been 12 hours or more since the missed dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• A heartbeat that does not feel normal.
• Very bad belly pain.
• Change in body fat.
• This medicine may help the immune system work. If you have an infection that you did not know you had, it may show up when you take this medicine. Tell your doctor right away if you notice any signs of infection like fever, sore throat, weakness, cough, or shortness of breath after you start Edurant.
• Very bad skin and allergic reactions have happened with this medicine. Skin reactions have happened along with fever or problems in body organs like the liver. Call your doctor right away if you have red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; sores in your mouth, throat, nose, or eyes; trouble swallowing; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

Edurant (rilpivirine) is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Edurant is used to treat HIV, the virus that can cause the acquired immunodeficiency syndrome (AIDS). Edurant is not a cure for HIV or AIDS. Rilpivirine is for use in adults and children who are at least 12 years old.

Do not take Edurant as your only HIV medication. This medicine must be used in combination with other HIV medicines that your doctor has prescribed.

Before you take Edurant, tell your doctor if you have liver disease (including hepatitis B or C), kidney disease, a history of depression or mental illness, or if you have ever taken any HIV medication in the past.

Some medicines can interact with rilpivirine and should not be used at the same time. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Do not take Edurant as your only HIV medication. Edurant must be used in combination with other HIV medicines that your doctor has prescribed.

Call your doctor at once if you have mood changes, anxiety, severe depression, feeling hopeless, or thoughts about suicide or hurting yourself.

Taking this medication will not prevent you from passing HIV to other people.

You should not use Edurant if you are allergic to rilpivirine.

Some medicines can cause unwanted or dangerous effects when used with rilpivirine. Your doctor may need to change your treatment plan if you use any of the following drugs:

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin;

• rifabutin, rifampin, rifapentine;

• esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole;

• more than one dose of dexamethasone;

• St John's wort; or

• delavirdine, efavirenz, etravirine, nevirapine.

Using any of these medicines while you are taking Edurant can cause serious medical problems or death.

To make sure Edurant is safe for you, tell your doctor if you have:

• liver disease (including hepatitis B or C);

• kidney disease;

• a history of depression or mental illness; or

• if you have ever taken any HIV medication in the past.

Edurant is not expected to harm an unborn baby, but HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Edurant on the baby.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Rilpivirine is not approved for use by anyone younger than 12 years old.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Animal studies have failed to reveal evidence of embryofetotoxicity, an effect on reproductive function, or clinically significant teratogenicity; placental transfer was observed. There are no controlled data in human pregnancy. To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: apregistry.com AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B1 US FDA pregnancy category: B

Breastfeeding is not recommended during use of this drug; if replacement feeding is not an option, a different drug may be preferred. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: -The effects in the nursing infant are unknown. -The US CDC, American Academy of Pediatrics, and manufacturer advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected. -Local guidelines should be consulted if replacement feeding is not an option.