abacavir

Detailed Prescribing Information

March 2007

Solution 20 mg/cc

300 mg AZT + 150 mg 3TC + 300 mg abacavir as Trizivir
300 mg 3TC + 600 mg abacavir as Epzicom

Rare lactic acidosis and hepatic steatosis

5-8% (slightly higher in Caucasians and Caucasians with HLA-B*5701) incidence of Abacavir Hypersensitivity Syndrome (usually occurs in first 6 weeks of therapy) which is characterized by the following:

          Worsens with each dose

          Fever

          Rash

          Progressive nausea, malaise

          Pulmonary symptoms
          Diarrhea

Treatment of hypersensitivity syndrome: Discontinue abacavir and supportive care.

DO NOT RECHALLENGE.

DO NOT attempt desensitization

See Ziagen administration protocol below.
There is a slightly higher incidence of abacavir hypersensitivity with single daily dosing (Epzicom).

Suggested

Administration

Protocol
including
Evaluation & Management
of
Suspected or Proven
Hypersensitivity Syndrome

1.  Educate patient about the abacavir hypersensitivity syndrome and provide a written summary of the syndrome as well as contact information for the provider [patient handout HERE]

2.  Patient should be instructed to avoid travel for the first 6 weeks of therapy with abacavir if possible

3.  Patient should be instructed to notify provider of any symptoms compatible with the syndrome promptly

4.  Patient should be instructed to NOT discontinue the abacavir until seen by the provider unless the syndrome is already severe

5.  Patient should be physically seen by the provider as soon as possible if symptoms compatible with abacavir hypersensitivity develop

a.  If a detailed evaluation reveals a high likelihood of the syndrome, the abacavir should be discontinued promptly and permanently.  The supply of the drug should be disposed of with a witness present preferably or returned to the healthcare provider

b.  If the detailed evaluation is equivocal, the patient should be monitored very frequently or at least daily.  If the symptomatology increases with each subsequent dose of abacavir, the diagnosis is then certain, and the drug should be stopped permanently.  Drug should be returned to the provider or disposed of with a witness present.

If the patient discontinues the abacavir prior to being seen by a provider experienced in abacavir hypersensitivity evaluation, it is important to regard the patient as having had definite abacavir hypersensitivity, and the drug should be permanently discontinued.  

Rechallenge with abacavir for diagnostic or therapeutic purposes is CONTRAINDICATED.

Suggested Usage

Complete prescribing information