Intelence

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Read the Patient Information Leaflet if available from your pharmacist before you start using etravirine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

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 first dissolve the tablet. Then add about 1 tablespoonful (15 milliliters) 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. You should not mix the drug 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).

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same times every day.

Nausea may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes), signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).

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

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain.

Changes in body fat may occur while you are taking this medication (such as 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. 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.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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 (such as 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.

Tell your doctor if you are pregnant before using this medication. Treatment can lower the risk of passing HIV infection to your baby. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Because breast milk may transmit HIV, consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: orlistat.

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 macrolide antibiotics (such as erythromycin, clarithromycin), rifamycins (such as rifabutin, rifampin, rifapentine), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin, primidone), among others.

This medication can speed up or slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include clopidogrel, cobicistat, medications for heart rhythm (such as amiodarone, disopyramide, quinidine), "blood thinners" (such as warfarin), certain "statin" cholesterol medications (atorvastatin, fluvastatin, lovastatin, simvastatin), drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as viral load, T-cell counts) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose and it is within 6 hours of the time you usually take the dose, take it after a meal as soon as you remember. If it is more than 6 hours from the time you usually take the dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Store this drug in its original bottle, and keep the bottle tightly closed. Each bottle should contain small pouches of a substance (desiccant) that help keep moisture in the air from damaging the drug. Do not remove desiccant pouches from bottle. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.