What is Etravirine?

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• Overview
• Proper Use
• Dosing
• Missed Dose
• Use & Storage
• Before Using
• Allergies
• Pediatric
• Geriatric
• Pregnancy
• Breast Feeding
• Drug Interactions
• Other Interactions
• Other Medical Problems
• Precautions

OverviewTOP

Etravirine is used together with other medicines to treat an infection caused by human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients who have received HIV treatment in the past.

Etravirine will not cure or prevent HIV infection or AIDS; however, it helps keep the HIV virus from reproducing and appears to slow the destruction of the immune system. This may help delay some of the problems related to AIDS or HIV disease. Etravirine will not keep you from spreading HIV to other people. People who take this medicine may continue to have other problems related to AIDS or HIV disease.

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

Proper UseTOP

It is important to take this medicine together with other medicines for HIV. Be sure to take all of the medicines your doctor ordered, and to take them at the right times. If you need help in planning the best times to take your medicine, check with your doctor.

It is best to take etravirine following a meal.

Swallow the tablet whole with a liquid such as water. Do not chew it. If you or your child cannot swallow the tablet whole, you may dissolve it in a glass with a small amount of water. You may also add more water, orange juice, or milk to make it easier to take. Do not use grapefruit juice, or warm or carbonated drinks. Be sure to drink or swallow the entire mixture right away. Then refill your glass with water, orange juice, or milk and drink it so that none of the medicine is left in the glass. .

Keep taking etravirine for the full time of treatment, even if you or your child begin to feel better. Do not change the amount or stop taking this medicine without checking first with your doctor. .

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. .

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

DosingTOP

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 HIV infection:
    • Adults—200 milligrams (mg) two times a day.
    • Children 6 years of age and older weighing at least 16 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 100 to 200 mg two times a day.
    • Children younger than 6 years of age—Use is not recommended.

Missed DoseTOP

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.

Do not take this medicine if it has been more than 6 hours since you missed your last dose.

Use & StorageTOP

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.

Before UsingTOP

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:

AllergiesTOP

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.

PediatricTOP

Use of etravirine is not recommended in children younger than 6 years of age. Safety and efficacy have not been established.

GeriatricTOP

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

PregnancyTOP

Breast FeedingTOP

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.

Drug InteractionsTOP

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.

• Dasabuvir

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.

• Alfentanil
• Amiodarone
• Amprenavir
• Artemether
• Atazanavir
• Avanafil
• Axitinib
• Benzhydrocodone
• Bepridil
• Buprenorphine
• Carbamazepine
• Cilostazol
• Clarithromycin
• Clopidogrel
• Cobicistat
• Codeine
• Cyclosporine
• Daclatasvir
• Deflazacort
• Delavirdine
• Dexamethasone
• Diazepam
• Dihydrocodeine
• Disopyramide
• Dolutegravir
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Efavirenz
• Elbasvir
• Enzalutamide
• Etonogestrel
• Fentanyl
• Flecainide
• Fosamprenavir
• Fosphenytoin
• Grazoprevir
• Hemin
• Hydrocodone
• Ifosfamide
• Indinavir
• Ketoconazole
• Lidocaine
• Lumefantrine
• Maraviroc
• Meperidine
• Mexiletine
• Naloxegol
• Nelfinavir
• Neratinib
• Nevirapine
• Nifedipine
• Olaparib
• Orlistat
• Oxycodone
• Pentazocine
• Perampanel
• Phenobarbital
• Phenytoin
• Piperaquine
• Posaconazole
• Propafenone
• Quinidine
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Simeprevir
• Sirolimus
• St John's Wort
• Sufentanil
• Tacrolimus
• Tipranavir
• Tramadol
• Velpatasvir
• Voxilaprevir
• Warfarin

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.

• Atorvastatin
• Boceprevir
• Clobazam
• Digoxin
• Fluconazole
• Methadone
• Ospemifene
• Raltegravir
• Sildenafil
• Voriconazole

Other InteractionsTOP

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 ProblemsTOP

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:

• Liver disease (including hepatitis B or C)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

PrecautionsTOP

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly and to check for unwanted effects.

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

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child have more than one of the following symptoms: blistering, peeling, or loosening of the skin, itching, joint or muscle pain, rash, red skin lesions, sore throat, or sores, ulcers, or white spots in the mouth or on the lips.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child 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; or a loss of fat from the legs, arms, and face.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.

Do not take any other medicines without checking first with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements. To do so may increase the chance of side effects from etravirine.