Description
Etravirine is used together with other medicines 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 received HIV treatment in the past.
Etravirine will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. 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.
This product is available in the following dosage forms:
- Tablet
Before Using
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
Use of etravirine is not recommended in children younger than 2 years of age. 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 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.
Breastfeeding
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 Interactions
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
- Lonafarnib
- Maraviroc
- Mavacamten
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
- Atidarsagene Autotemcel
- Atogepant
- Avacopan
- Avanafil
- Avapritinib
- Axitinib
- Bedaquiline
- Benzhydrocodone
- Bepridil
- Brigatinib
- Buprenorphine
- Cabotegravir
- Capecitabine
- Capivasertib
- Capmatinib
- Carbamazepine
- Cilostazol
- Citalopram
- Clarithromycin
- Clopidogrel
- Cobicistat
- Codeine
- Cyclosporine
- Daclatasvir
- Daridorexant
- Deflazacort
- Delavirdine
- Desogestrel
- Dexamethasone
- Diazepam
- Dienogest
- Dihydrocodeine
- Diltiazem
- Disopyramide
- Dolutegravir
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
- Methadone
- Ospemifene
- Raltegravir
- Voriconazole
Other Interactions
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:
- 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.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor or pharmacist if you have any questions.
It is important that you 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, talk with your doctor.
It is best to take etravirine following a meal.
Swallow the tablet whole with a liquid (eg, 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 (1 teaspoon). Stir until the water looks milky. 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. .
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 HIV infection:
- Adults—200 milligrams (mg) (one 200 mg tablet or two 100 mg tablets) taken 2 times a day.
- Children 2 to 17 years of age—Dose is based on body weight and must be determined by your doctor.
- Weighing 30 kilograms (kg) or more—200 mg taken 2 times a day.
- Weighing 25 kg to less than 30 kg—150 mg taken 2 times a day.
- Weighing 20 kg to less than 25 kg—125 mg taken 2 times a day.
- Weighing 10 kg to less than 20 kg—100 mg taken 2 times a day.
- Children younger than 2 years of age and weighing less than 10 kg—Use is not recommended.
- For HIV infection:
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.
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
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe skin rash, or fever or chills while using this medicine.
Check with your doctor right away if you or your child have a fever, chills, cough, sore throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine. These could be symptoms of a serious condition called drug reaction with eosinophilia and systemic symptoms (DRESS).
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.
Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.
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 (eg, St. John's wort) or vitamin supplements. To do so may increase the chance of side effects from etravirine.
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
- Rash
Less common
- Blurred vision
- burning, numbness, tingling, or painful sensations
- dizziness
- headache
- nervousness
- pounding in the ears
- slow or fast heartbeat
- unsteadiness or awkwardness
- weakness in the arms, hands, legs, or feet
Rare
- Blistering, peeling, or loosening of the skin
- chills
- cough
- diarrhea
- fever
- hives, itching
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- muscle pain
- red skin lesions, often with a purple center
- red, irritated eyes
- redness of the skin
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- trouble with breathing or swallowing
- unusual tiredness or weakness
Incidence not known
- Dark urine
- general feeling of tiredness or weakness
- headache
- light-colored stools
- stomach pain, continuing
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- 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:
Less common
- Stomach pain
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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