Ziagen (Abacavir Sulfate) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 16, 2012

Ziagen

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The only drug in this class is T-20, which is administered as a twice daily subcutaneous injection. The most common side effect is redness and pain at the site of injection. Rarely, infection can occur at the injection site. There also are reports of generalized allergic reactions.

CCR5 antagonist
Although there were some early concerns of liver inflammation for drugs in this class, MVC appeared to be well tolerated in clinical trials without any specific toxicities attributable to the drug. However, it is a new drug in a new class and the first to actually target the cell. For these reasons, longer follow-up from clinical trials and those followed in the clinic will be very important for assessing the overall safety of the...

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ZIAGEN
(abacavir sulfate)

WARNING

RISK OF HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS, ANDSEVERE HEPATOMEGALYHypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions havebeen associated with ZIAGEN® (abacavir sulfate).

Hypersensitivity to abacavir is a multi-organ clinical syndrome usuallycharacterized by a sign or symptom in 2 or more of the following groups: (1) fever, (2)rash, (3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain), (4)constitutional (including generalized malaise, fatigue, or achiness), and (5) respiratory(including dyspnea, cough, or pharyngitis). Discontinue ZIAGEN as soon as ahypersensitivity reaction is suspected.

Patients who carry the HLA-B*5701 allele are at high risk for experiencing ahypersensitivity reaction to abacavir. Prior to initiating therapy with abacavir, screeningfor the HLA-B*5701 allele is recommended; this approach has been found to decrease therisk of hypersensitivity reaction. Screening is also recommended prior to reinitiation ofabacavir in patients of unknown HLA-B*5701 status who have previously toleratedabacavir. HLA-B*5701-negative patients may develop a suspected hypersensitivity reactionto abacavir; however, this occurs significantly less frequently than in HLA-B*5701-positivepatients.

Regardless of HLA-B*5701 status, permanently discontinue ZIAGEN if hypersensitivity cannot be ruled out, even when other diagnoses are possible.

Following a hypersensitivity reaction to abacavir, NEVER restart ZIAGEN or anyother abacavir-containing product because more severe symptoms can occur within hoursand may include life-threatening hypotension and death.

Reintroduction of ZIAGEN or any other abacavir-containing product, even in patients who have no identified history or unrecognized symptoms of hypersensitivity toabacavir therapy, can result in serious or fatal hypersensitivity reactions. Such reactionscan occur within hours [see WARNINGS AND PRECAUTIONS].

Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and severe hepatomegalywith steatosis, including fatal cases, have been reported with the use of nucleosideanalogues alone or in combination, including ZIAGEN and other antiretrovirals [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

ZIAGEN is the brand name for abacavir sulfate, a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9#-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C₁₄H₁₈N₆O)_2.H₂SO₄ and a molecular weight of 670.76 daltons. It has the following structural formula

ZIAGEN (abacavir sulfate) Structural Formula Illustration

Abacavir sulfate is a white to off-white solid with a solubility of approximately 77 mg/mL in distilled water at 25°C. It has an octanol/water (pH 7.1 to 7.3) partition coefficient (log P) of approximately 1.20 at 25°C.

ZIAGEN Tablets are for oral administration. Each tablet contains abacavir sulfate equivalent to 300 mg of abacavir as active ingredient and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film that is made of hypromellose, polysorbate 80, synthetic yellow iron oxide, titanium dioxide, and triacetin.

ZIAGEN Oral Solution is for oral administration. Each milliliter (1 mL) of ZIAGEN Oral Solution contains abacavir sulfate equivalent to 20 mg of abacavir (i.e., 20 mg/mL) as active ingredient and the following inactive ingredients: artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben and propylparaben (added as preservatives), propylene glycol, saccharin sodium, sodium citrate (dihydrate), sorbitol solution, and water.

In vivo, abacavir sulfate dissociates to its free base, abacavir. All dosages for ZIAGEN are expressed in terms of abacavir.12

What are the possible side effects of abacavir (Ziagen)?

Stop using abacavir and call your doctor at once if you have symptoms of an allergic reaction from two or more of these specific side effect groups:

Group 1 - fever;
Group 2 - rash;
Group 3 - nausea, vomiting, diarrhea, stomach pain;
Group 4 - general tiredness, body aches;
Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to abacavir, you must never use it again. If you stop taking abacavir for any reason, talk to your doctor before...

Read All Potential Side Effects and See Pictures of Ziagen »

What are the precautions when taking abacavir sulfate (Ziagen)?

See also Warning and How to Use sections.

Before taking abacavir, 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 problems (such as hepatitis B or C, or cirrhosis), kidney problems, alcohol use.

Abacavir may increase your risk of a heart attack. Discuss the risks and benefits of treatment with your doctor and ways to lower your risk of heart disease. Tell your doctor if you have heart problems, if you smoke, or if you have other conditions that increase your risk of heart...

Read All Potential Precautions of Ziagen »

Last reviewed on RxList: 3/26/2012
This monograph has been modified to include the generic and brand name in many instances.