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Selzentry

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Selzentry

SELZENTRY
(maraviroc) Film-coated Tablets

WARNING

HEPATOTOXICITY

Hepatotoxicity has been reported with use of SELZENTRY®. Severe rash or evidence of a systemic allergic reaction (e.g., fever, eosinophilia, or elevated IgE) prior to the development of hepatotoxicity may occur. Patients with signs or symptoms of hepatitis or allergic reaction following use of SELZENTRY should be evaluated immediately [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

SELZENTRY (maraviroc) is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells.

SELZENTRY is available as film-coated tablets for oral administration containing either 150 or 300 mg of maraviroc and the following inactive ingredients: dibasic calcium phosphate (anhydrous), magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coat (Opadry® II Blue [85G20583]) contains FD&C blue #2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide.

Maraviroc is chemically described as 4,4-difluoro-N-{(1S)-3-[exo-3-(3-isopropyl-5methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1phenylpropyl}cyclohexanecarboxamide.

The molecular formula is C29H41F2N5O and the structural formula is:

SELZENTRY (maraviroc) Structural Formula Illustration

Maraviroc is a white to pale-colored powder with a molecular weight of 513.67. It is highly soluble across the physiological pH range (pH 1.0 to 7.5).

What are the possible side effects of maraviroc (Selzentry)?

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.

Maraviroc may also cause severe liver symptoms. Stop taking maraviroc and call your doctor at once if you have any of these liver symptoms:

  • low fever, itching;
  • nausea, upper stomach pain, loss of appetite;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

Call your doctor at once if you have any other serious side effect, such...

Read All Potential Side Effects and See Pictures of Selzentry »

What are the precautions when taking maraviroc (Selzentry)?

Before taking maraviroc, 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 taking this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., previous heart attack), kidney disease, liver problems (including hepatitis B or C infection), low blood pressure.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying...

Read All Potential Precautions of Selzentry »

Last reviewed on RxList: 4/11/2014
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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