Intelence

DRUG DESCRIPTION

INTELENCE® (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1).

The chemical name for etravirine is 4-[[6-amino-5-bromo-2-[(4-cyanophenyl)amino]-4-pyrimidinyl]oxy]-3,5dimethylbenzonitrile. Its molecular formula is C20H15BrN6O and its molecular weight is 435.28. Etravirine has the following structural formula:

INTELENCE® (etravirine) Structural Formula Illustration

Etravirine is a white to slightly yellowish brown powder. Etravirine is practically insoluble in water over a wide pH range. It is very slightly soluble in propylene glycol and slightly soluble in ethanol. Etravirine is soluble in polyethylene glycol (PEG)400 and freely soluble in some organic solvents (e.g., N,N-dimethylformamide and tetrahydrofuran).

INTELENCE® 100 mg tablets are available as white to off-white, oval tablets for oral administration. Each 100 mg tablet contains 100 mg of etravirine and the inactive ingredients hypromellose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and lactose monohydrate.

INTELENCE® 200 mg tablets are available as white to off-white, biconvex, oblong tablets for oral administration. Each 200 mg tablet contains 200 mg of etravirine and the inactive ingredients hypromellose, silicified microcrystalline cellulose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium and magnesium stearate.

What are the possible side effects of etravirine (Intelence)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • chest pain;
  • confusion, anxiety, nightmares, seizure (convulsions);
  • loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • ...

Read All Potential Side Effects and See Pictures of Intelence »

What are the precautions when taking entravirine tablets (Intelence)?

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).

During pregnancy, this medication should be used only when clearly needed. 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...

Read All Potential Precautions of Intelence »


Intelence Consumer (continued)

SIDE EFFECTS: Nausea may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.

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, seek immediate medical attention if you develop any rash.

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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: numbness/tingling of arms/legs, irregular heartbeat, unusual tiredness/weakness, increased thirst/urination, change in the amount of urine, mental/mood changes (e.g., nervousness, confusion), seizures.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest/jaw/left arm pain, persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

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.

When you first start this medication (or other HIV medications), you may experience symptoms of an old infection. This may happen as your immune system begins to work better. Contact your doctor immediately if you notice any of the following symptoms: new cough, trouble breathing, signs of infection (e.g., fever), new vision problems, new headaches, new skin problems.

A very serious allergic reaction to this drug is rare. However, stop taking this medication and seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, muscle/joint pain, trouble breathing.

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.

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

PRECAUTIONS: 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).

During pregnancy, this medication should be used only when clearly needed. 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.


Intelence Patient Information Including Side Effects

Brand Names: Intelence

Generic Name: etravirine (Pronunciation: E tra VIR een)

  • What is etravirine (Intelence)?
  • What are the possible side effects of etravirine (Intelence)?
  • What is the most important information I should know about etravirine (Intelence)?
  • What should I discuss with my healthcare provider before taking etravirine (Intelence)?
  • How should I take etravirine (Intelence)?
  • What happens if I miss a dose (Intelence)?
  • What happens if I overdose (Intelence)?
  • What should I avoid while taking etravirine (Intelence)?
  • What other drugs will affect etravirine (Intelence)?
  • Where can I get more information?

What is etravirine (Intelence)?

Etravirine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Etravirine is used with other medications to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Etravirine is not a cure for HIV or AIDS.

Etravirine is usually given after other antiviral drugs have been tried without successful treatment of HIV.

Etravirine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of etravirine (Intelence)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • chest pain;
  • confusion, anxiety, nightmares, seizure (convulsions);
  • loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • urinating less than usual;
  • fever, chills, body aches, flu symptoms; or
  • any other signs of new infection.

Less serious side effects may include:

  • mild nausea, vomiting, stomach pain, constipation;
  • dry mouth, heartburn;
  • mild skin rash;
  • headache, dizziness, tired feeling;
  • numbness or tingly feeling in your hands or feet;
  • sleep problems (insomnia), unusual dreams;
  • blurred vision;
  • increased sweating; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about etravirine (Intelence)?

There are many other medicines that can interact with etravirine, or make it less effective. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Taking etravirine will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

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