Isentress

DRUG DESCRIPTION

ISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is N-[(4-Fluorophenyl)methyl]-1,6-dihydro5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4pyrimidinecarboxamide monopotassium salt.

The empirical formula is C20H20FKN6O5 and the molecular weight is 482.51. The structural formula is:

ISENTRESS (raltegravir) Structural Formula Illustration

Raltegravir potassium is a white to off-white powder. It is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol and acetonitrile and insoluble in isopropanol.

Each film-coated tablet of ISENTRESS for oral administration contains 434.4 mg of raltegravir potassium (as salt), equivalent to 400 mg of raltegravir (free phenol) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide and black iron oxide.

What are the possible side effects of raltegravir (Isentress)?

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 a serious side effect such as:

  • pale skin, easy bruising or bleeding;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms;
  • sore throat and headache with a severe blistering, peeling, and red skin rash;
  • drowsiness, confusion, increased thirst, lower back pain, urinating less...

Read All Potential Side Effects and See Pictures of Isentress

What are the precautions when taking raltegravir tablets (Isentress)?

Before taking raltegravir, 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 Isentress


Isentress Consumer (continued)

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

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: unusual tiredness/weakness, changes in body fat (e.g., increased fat in upper back), change in the amount of urine, persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin, muscle pain/tenderness/weakness.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest/jaw/left arm pain.

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, 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, 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 raltegravir, 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.


Isentress Patient Information Including Side Effects

Brand Names: Isentress

Generic Name: raltegravir (Pronunciation: ral TEG ra veer)

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

What is raltegravir (Isentress)?

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

Raltegravir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Raltegravir is not a cure for HIV or AIDS.

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

What are the possible side effects of raltegravir (Isentress)?

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 a serious side effect such as:

  • pale skin, easy bruising or bleeding;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms;
  • sore throat and headache with a severe blistering, peeling, and red skin rash;
  • drowsiness, confusion, increased thirst, lower back pain, urinating less than usual or not at all;
  • depressed mood, unusual thoughts about hurting yourself;
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

Less serious side effects may include:

  • nausea, vomiting, diarrhea, stomach pain;
  • headache;
  • tired feeling;
  • dizziness; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

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 raltegravir (Isentress)?

Before using raltegravir, tell your doctor if you are allergic to any drugs, or if you have a muscle disorder, kidney disease, or liver disease.

HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

You should not breast-feed while you are using raltegravir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Call your doctor at once if you have serious side effects such as easy bruising or bleeding, signs of a new infection, jaundice (yellowing of the skin or eyes), muscle weakness with fever and dark colored urine, or if you urinate less than usual or not at all.

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