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Abacavir Sulfate / Lamivudine

Trade Names:
Epzicom
- Tablets 600 mg abacavir (as sulfate) and 300 mg lamivudine

Mechanism of Action

Pharmacology

Inhibits replication of HIV by incorporation into HIV DNA and producing incomplete, nonfunctional DNA.

Indications and Usage

Treatment of HIV-1 infection in combination with other antiretroviral agents.

Contraindications

Abacavir has been associated with fatal hypersensitivity reactions and should not be restarted following a hypersensitivity reaction to abacavir; hypersensitivity to any component of product; hepatic function impairment.

Dosage and Administration

PO 1 tablet daily (abacavir sulfate 600 mg and lamivudine 300 mg), in combination with other antiretroviral agents.

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F).

Drug Interactions

Lamivudine serum levels may be elevated, increasing the pharmacologic and adverse effects.

Lamivudine and zidovudine may inhibit the intracellular phosphorylation of each other.

Laboratory Test Interactions

None well documented.

Adverse Reactions

The following adverse reactions were reported during postapproval use of abacavir and lamivudine. Adverse reactions occurring with administration of either abacavir or lamivudine can be found listed in their respective monographs.

CNS

Paresthesia; peripheral neuropathy; seizures.

Dermatologic

Alopecia; erythema multiforme; Stevens-Johnson syndrome.

GI

Stomatitis.

Hematologic-Lymphatic

Aplastic anemia; anemia (including pure red cell aplasia and severe anemia progressing with therapy); lymphadenopathy; splenomegaly.

Hepatic

Hepatic steatosis; posttreatment exacerbation of hepatitis B.

Metabolic

Hyperglycemia; lactic acidosis.

Musculoskeletal

Muscle weakness; CPK elevation; rhabdomyolysis.

Respiratory

Abnormal breath sounds/wheezing.

Miscellaneous

Sensitivity reactions (including anaphylaxis); redistribution/accumulation of body fat; weakness.

Precautions

Pregnancy

Category C .

Lactation

Undetermined. HIV-infected mothers should not breast-feed their infants.

Children

Safety and efficacy not established.

Renal Function

Because this is a fixed-dose tablet, do not use for patients requiring dosage adjustment (eg, Ccr less than 50 mL/min).

Hepatic Function

Because this is a fixed-dose tablet and the dosage of the individual components cannot be altered, it is contraindicated in patients with hepatic function impairment.

Abacavir

Do not administer to patient who has previous suspected or documented hypersensitivity reaction to abacavir.

Antiretroviral agents

Must be used in combination with other antiretroviral agents from different pharmacologic classes (not with other nucleoside/nucleotide reverse transcriptase inhibitors).

Fat redistribution

Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance have been observed in patients receiving antiretroviral therapy.

Patient Information

• Advise patient to review Medication Guide before starting therapy and with each refill of the medication.
• Advise patient to review, and carry with them at all times, the Warning Card summarizing the symptoms of abacavir hypersensitivity reaction.
• Instruct patient to take exactly as prescribed and not to change the dose or discontinue therapy unless advised by health care provider.
• Instruct patient to take 1 tablet once daily without regard to meals but to take with food if stomach upset occurs.
• Instruct patient that if a dose is missed to take as soon as remembered and to take the next dose at the usual scheduled time.
• Warn patient that this drug is not to be used by itself but is combined with other antiviral agents and to continue to take other HIV medications as prescribed by health care provider.
• Instruct patient to discontinue use and notify health care provider immediately if a symptom from 2 or more of the following groups occurs: 1) fever; 2) rash; 3) nausea, vomiting, diarrhea, stomach pain; 4) generalized body discomfort, extreme tiredness, achiness; 5) sore throat, shortness of breath, cough.
• Caution patient not to restart this medication, or any other abacavir-containing medication, if a hypersensitivity reaction to this medication has occurred. Explain to patient that restarting abacavir or an abacavir-containing product could cause a more serious, and possibly fatal, reaction.
• Caution patient that if therapy is interrupted for a few days for reasons other than a hypersensitivity reaction (eg, interruption in drug supply) and is then restarted that there is a risk of experiencing a serious or fatal hypersensitivity reaction. Advise patient to talk with health care provider before restarting the medication. Advise patient that if health care provider tells them to take the medication again to start taking it when they are around medical help or people who could call a doctor if necessary.
• Caution patient that medication can cause a rare but serious condition called lactic acidosis with liver enlargement and that persistent nausea and tiredness may be symptoms of this condition. Instruct patient to inform health care provider if these symptoms develop.
• Caution patient who has concurrent infection with HBV that hepatitis may worsen if abacavir/lamivudine is stopped and that liver function should be closely followed for several months after stopping abacavir/lamivudine. Advise patient anti-hepatitis B virus medications may be needed.
• Advise patient that medication may cause changes in body fat distribution (eg, increased amount of fat in upper back and neck, breasts, and around the back, chest, and stomach area; or loss of fat from arms, legs, and face) and that the cause and long-term health effects of these changes is not known at this time. Advise patient to report changes in body fat distribution to health care provider.
• Inform patient that drug does not completely eliminate HIV virus and therefore does not reduce the risk of transmitting HIV to others through sexual contact or blood contamination. Instruct patient that appropriate precautions must still be followed.
• Advise patient that drug is not a cure for HIV infection and illnesses associated with HIV infection, including opportunistic infections, may continue to be acquired. Patients should remain under a health care provider"s care.
• Instruct mother not to breast-feed her infant because of risk of transmitting HIV virus to the infant and the potential for serious adverse effects from medication transmitted to her infant through breast milk.