Etravirine

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Generic Name: Etravirine Brand Name(s): Generics only. No brands available.

Uses

What is Etravirine used for?

Etravirine is commonly used with other HIV medications 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. This medication is usually prescribed to people who have taken other HIV medications (e.g., efavirenz, nevirapine, delavirdine) that did not work well enough to control their HIV. Etravirine is known as a non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the virus from growing and infecting more cells.

Etravirine 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 should I take Etravirine?

Take this medication by mouth after a meal as directed by your doctor, usually 2 times daily. Swallow the medication whole. Do not crush, chew, or split the tablets.

In children, the dosage is based on weight.

If you have trouble swallowing this medication whole, you may place your dose in a glass with about 1 teaspoonful (5 milliliters) of water to dissolve the tablet. If needed, add more water to cover the tablet. Stir the mixture well until it looks milky. Use only water to dissolve the tablet before adding other liquids. You may then add a small amount of water, orange juice, or milk to the glass and drink all of it right away. Rinse the glass with more water, orange juice, or milk and drink all of it. Rinse and drink several times to make sure you have taken the whole dose. The manufacturer says you should not mix the drug with grapefruit juice, or with warm or carbonated drinks.

It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.

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).

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 times each day.

How do I store Etravirine?

Etravirine is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Etravirine in the bathroom or the freezer. There may be different brands of Etravirine that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Etravirine down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Etravirine?

Before taking etravirine, tell your doctor or pharmacist if you are allergic to it; 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: liver disease (e.g., hepatitis B, hepatitis C).

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

Children may be more sensitive to the side effects of this drug, especially rash.

During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and etravirine may be part of that treatment. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Etravirine during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Etravirine. Etravirine is pregnancy risk category B according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Etravirine?

Nausea may occur. If this effect persists or worsens, 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.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn’t go away, headaches that are severe or don’t go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, 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 trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking).

Tell your doctor right away if any of these unlikely but serious side effects occur: increased thirst/urination, signs of kidney problems (such as change in the amount of urine), mental/mood changes (e.g., nervousness, confusion), seizures.

Get medical help right away if any of these rare but very serious side effects occur: chest/jaw/left arm pain.

Changes in body fat may occur while you are taking this medication (e.g., 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 role of exercise to reduce this side effect.

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.

Etravirine can commonly cause a mild rash that is usually not serious. The rash usually occurs during the second week of treatment and goes away in 1 to 2 weeks. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash, especially with symptoms such as fever, tiredness, muscle/joint pain, blisters, mouth sores, or red/swollen eyes.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Etravirine?

Some products that may interact with this drug include: certain anti-seizure medicines (carbamazepine, phenobarbital, phenytoin, primidone), other HIV NNRTIs (e.g., efavirenz, nevirapine, delavirdine), certain HIV protease inhibitors (atazanavir, fosamprenavir, tipranavir/ritonavir), orlistat, rifampin, rifapentine, St John’s wort.

Make sure your doctor is aware of all the HIV drugs you are taking. This medication may interact with other HIV medications. Your doctor may need to change your treatment or monitor you more closely if you are taking a certain combination of HIV medications. Consult your doctor or pharmacist for more details.

Other medications can affect the removal of etravirine from your body, which may affect how etravirine works. Examples include rifabutin, azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin, clarithromycin), among others.

This drug can speed up or slow down the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include clopidogrel, cobicistat, medications for heart rhythm (e.g., amiodarone, disopyramide, quinidine), “blood thinners” (e.g., warfarin), certain “statin” cholesterol medications (atorvastatin, fluvastatin, lovastatin, simvastatin), drugs to treat erectile dysfunction-ED or pulmonary hypertension (e.g., sildenafil, tadalafil), among others.

Etravirine may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Etravirine?

Etravirine may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Etravirine?

Etravirine may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Etravirine.

What is the dose of Etravirine for an adult?

Usual Adult Dose for HIV Infection

200 mg orally twice a day after a meal

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild or moderate hepatic impairment (Child-Pugh Class A or B): No adjustment recommended.

Severe hepatic impairment (Child-Pugh Class C): Data not available

Precautions

Severe, potentially life-threatening, and fatal skin reactions have occurred. Hypersensitivity reactions (characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver failure) have also been reported. Rash most commonly occurred within 6 weeks of treatment initiation. If signs or symptoms of skin reactions or hypersensitivity reactions develop, etravirine therapy should be discontinued at once, clinical status (including liver transaminases) should be monitored, and appropriate treatment should be started. Delay in discontinuing etravirine following the onset of severe rash may result in a life-threatening reaction.

Etravirine may potentially interact with many drugs resulting in altered plasma levels of the other drugs or of etravirine. Patients should be advised to report all concurrent medications they are taking, including nonprescription medications and nutritional/herbal supplements; especially St. John’s wort.

Immune reconstitution syndrome has occurred during combination antiretroviral therapy. Patients responding to therapy may develop an inflammatory response to indolent or residual opportunistic infections and require evaluation and treatment.

The potential for HIV cross-resistance among nonnucleoside reverse transcriptase inhibitors (NNRTI) exists but has not been fully explored. Cross-resistance to other NNRTIs is expected following virologic failure with an etravirine-containing regimen for the virologic failure isolates. Selection of antiretroviral agents for a patient’s medication regimen should be done carefully.

Use in combination with other active antiretroviral agents will increase the likelihood of treatment response. Patients who have experienced virologic failure on an NNRTI-containing regimen should not use etravirine in combination with only nucleoside/nucleotide reverse transcriptase inhibitors.

Safety and efficacy have not been established in treatment-naive patients.

Special attention should be given to accurate dose selection, transcription of the medication order, dispensing information, and dosing instructions to reduce the risk of medication errors, overdosing, and underdosing.

Dialysis

No adjustment recommended.

Other Comments

Etravirine should be taken after a meal. The type of food does not affect the exposure to etravirine.

The etravirine tablet(s) should be swallowed whole with a liquid (such as water). Patients unable to swallow the etravirine tablet(s) whole may disperse the tablet(s) in a glass of water. The following instructions are recommended:

  1. Place the tablet(s) in 5 mL of water, or at least enough liquid to cover the medication.
  2. Stir well until the water looks milky.
  3. If desired, add more water or alternatively orange juice or milk; the tablet(s) should not be placed in orange juice or milk without first adding water. Grapefruit juice, warm beverages (greater than 40 degrees Celsius), and carbonated beverages should be avoided.
  4. Drink it immediately.
  5. The glass should be rinsed with water, orange juice, or milk several times and each rinse should be completely swallowed to ensure the entire dose is consumed.

Etravirine should always be used in combination with other antiretroviral agents.

What is the dose of Etravirine for a child?

Usual Pediatric Dose for HIV Infection

6 to less than 18 years:

16 kg to less than 20 kg: 100 mg orally twice a day after a meal

20 kg to less than 25 kg: 125 mg orally twice a day after a meal

25 kg to less than 30 kg: 150 mg orally twice a day after a meal

30 kg or more: 200 mg orally twice a day after a meal

Precautions

Safety and efficacy have not been established in pediatric patients less than 6 years of age.

How is Etravirine available?

Etravirine is available in the following dosage forms and strengths:

  • Oral tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Etravirine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: January 29, 2018 | Last Modified: January 29, 2018

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