Intelence (Etravirine)

(℞) Prescription Required

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Intelence 200mg

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Manufactured by: Janssen Pharmaceuticals
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Intelence 200mg
Product of Australia
Manufactured by Janssen Pharmaceuticals
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Intelence 100mg

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Intelence 100mg
Product of Canada
Manufactured by Janssen Pharmaceuticals
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Intelence 200mg

Product of Canada
Manufactured by: Janssen Pharmaceuticals
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Intelence 200mg
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Intelence 100mg

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Manufactured by: Janssen-Cilag
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Intelence 100mg
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Intelence (Etravirine) Dosage and Side Effects

INTELENCE is used for the treatment of HIV (Human Immunodeficiency Virus) infection in adults, children and adolescents (6 years to less than 18 years of age).

Proper Use of this medication

Always use INTELENCE exactly as your doctor has told you. You must check with your doctor if you are not sure.

Usual adult dose:

Take INTELENCE tablets every day exactly as prescribed by your doctor. The usual dose is 200 mg (one 200 mg tablet or two 100 mg tablets) of INTELENCE, twice daily every day. It may be easier to remember to take INTELENCE if you take them at the same time every day. If you have questions about when to take INTELENCE, your doctor can help you decide which schedule works for you.

You should always take INTELENCE following a meal. You should not take INTELENCE on an empty stomach. Taking INTELENCE on an empty stomach may lessen the effect of INTELENCE. Follow your doctor's advice on the type of meal you should be taking with INTELENCE.

Swallow the tablets whole with a liquid such as water. Do not use warm (>40°C) or carbonated beverages when taking INTELENCE tablet(s). Do not chew the tablets.

If you are unable to swallow the INTELENCE tablets whole, you may do the following:

  • place the tablets in 5 mL (1 teaspoon) of water, or at least enough liquid to cover the medication,
  • stir well until the water looks milky,
  • if desired, add more water or alternatively orange juice or milk (do not place the tablets in orange juice or milk without first adding water),
  • drink it immediately,
  • rinse the glass several times with water, orange juice, or milk and completely swallow the rinse each time to make sure you take the entire dose.

Continue taking INTELENCE unless your doctor tells you to stop. Take the exact amount of INTELENCE that your doctor tells you to take, right from the very start. To help make sure you will benefit from INTELENCE, you must not skip doses or interrupt therapy. If you do not take INTELENCE as prescribed, the beneficial effects of INTELENCE may be reduced or even lost.

Instructions for proper use for children and adolescents (6 years to less than 18 years of age) and weighing at least 16 kg:

The doctor will work out the right dose based on the weight of the child. The doctor will inform you exactly how much INTELENCE the child should take.

Do not stop administering INTELENCE without talking to the child's doctor. The other HIV medicines used in combination with INTELENCE should be taken by the child as recommended by the child's doctor.

Overdose:

In case of drug overdose, contact a health care practitioner (doctor), hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed dose:

If you miss a dose of INTELENCE by more than 6 hours, wait and then take the next dose of INTELENCE at the regularly scheduled time. If you miss a dose of INTELENCE by less than 6 hours, take your missed dose of INTELENCE immediately, following a meal. Then take your next dose of INTELENCE at the regularly scheduled time.

If a dose of INTELENCE is skipped, do not double the next dose. Do not take more or less than your prescribed dose of INTELENCE at any one time.

Do not stop using INTELENCE without talking to your doctor first.

Warnings and Precautions

BEFORE you use INTELENCE talk to your doctor or pharmacist if you:

  • have had or currently have liver problems, including hepatitis B and/or C.
  • are pregnant or planning to become pregnant. It is not known if INTELENCE can harm your unborn baby. You and your doctor will need to decide if taking INTELENCE is right for you. If you take INTELENCE while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.
  • are breast-feeding or planning to breast-feed. Do not breast-feed if you are taking INTELENCE. You should not breast-feed if you have HIV because of the chance of passing HIV to your baby. Talk with your doctor about the best way to feed your baby.

Side Effects

Like all prescription drugs, INTELENCE can cause side effects. The following is not a complete list of side effects reported with INTELENCE when taken either alone or with other anti-HIV medicines. Do not rely on this leaflet alone for information about side effects. Your doctor can discuss with you a more complete list of side effects.

The most common side effects include the following:

  • Skin rash: The rash is usually mild to moderate. In rare instances, rash can be potentially life-threatening. Children and, in particular, adolescents taking INTELENCE have a higher chance of developing serious skin rashes. It is therefore important to contact your doctor immediately if you develop a rash. Your doctor will advise you how to deal with your symptoms and decide whether INTELENCE must be stopped.

  • Diarrhea, nausea, abdominal pain, vomiting, heartburn, gas, and inflammation of the stomach.

  • Fatigue, tingling or pain in hands or feet, numbness, headache, sleeplessness, and anxiety.

  • Kidney failure, high blood pressure, heart attack, and diabetes.

  • Night sweats.

  • Changes in some values of your blood cells or chemistry; these can be seen in the results from blood tests. Your doctor will explain these to you. Examples are low red blood cell count, low blood platelet count, high or abnormal blood fat levels, high cholesterol levels, and high sugar levels.

Other side effects of INTELENCE which can be serious, include muscle pain, tenderness or weakness.

As with other anti-HIV medicines, INTELENCE may cause side effects, including:

  • Changes in body shape or body fat. These changes can happen in patients taking anti-HIV medicines. The changes may include an increased amount of fat in the upper back and neck, breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.

  • Changes in your immune system (Immune Reconstitution Inflammatory 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, or you could develop an autoimmune disease in which your immune system reacts against your own body (e.g. Graves' disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system) or polymyositis (which affects the muscles) and it may develop at any time, sometimes months later after the start of HIV therapy). Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling, or fatigue or any new symptoms contact your doctor straight away.

Interactions with this medication

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements, including St. John's wort (Hypericum perforatum). INTELENCE and many other medicines can interact. Sometimes serious side effects will happen if INTELENCE is taken with certain other medicines.

Tell your doctor if you take other anti-HIV medicines, particularly atazanavir, didanosine, fosamprenavir, maraviroc, nelfinavir, ritonavir, indinavir, saquinavir, tipranavir, nevirapine, efavirenz, rilpivirine, dolutegravir and delavirdine or any combinations of these medications. INTELENCE can be combined with some other anti-HIV medicines while other combinations are not recommended.

Do not take the following medications while taking INTELENCE as these medications will reduce the levels of INTELENCE and may make this medication ineffective:

  • Do not take anticonvulsants (to treat epilepsy and prevent seizures) such as carbamazepine (Tegretol), phenobarbital and phenytoin (Dilantin) while on an INTELENCE treatment regimen.

  • Do not take rifampin (Rifadin, Rifater) (to treat bacterial infections) while on an INTELENCE treatment regimen.

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The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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