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abacavir

Detailed Prescribing Information

March 2007

 

 

Ziagen = abacavir
Also a component of
Trizivir & Epzicom
Forms Available 300 mg tabs

Solution 20 mg/cc

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

Dosing 300 mg twice a day or 300 mg 2 once a day
Renal dosing1: no adjustment necessary
Hepatic dosing: in mild liver disease, reduce dose to 200 mg twice a day; in severe disease, abacavir is contraindicated
Food dependence This medication may be taken with or without food.
Adverse Effects Nausea which usually improves, headache.

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).

Interactions Unclear interaction with tenofovir: do not use without a PI or NNRTI until further information available.
Suggested lab follow-up CBC, comprehensive metabolic profile monthly x 3 months and then as indicated.
Warning Rechallenge of patient with abacavir hypersensitivity reaction is usually fatal.
Contraindications Previous abacavir hypersensitivity

Suggested

Administration

Protocol
including
Evaluation & Management
of
Suspected or Proven
Hypersensitivity Syndrome

Do not start patients on nevirapine or sulfamethoxazole/trimethoprim simultaneously if possible to avoid confusion over etiology of any hypersensitivity that develops.

 

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

Do not use in combination with Epzicom or Trizivir due to identical mechanism of action or duplication of abacavir dosing.

Complete prescribing information

Ziagen Prescribing Info

 

 

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Quick Menu / Table of Contents
Introduction Principles Management NRTI Info NNRTI Info
PI Info Fusion Inhibitors Drug Summary Investigational Adherence
Lab Evaluation Resistance Tests PEP Antiretroviral Tables OI Prevention
Vaccinations TB Therapy Hepatitis Therapy OI Diagnosis OI Therapy
Bibliography Links Palliative Therapy

 

Updated 3.30.2007

 


 

1. Renal dosing information from: Ian R. McNicholl & Rudolph A. Rodriguez, MD, Dosing of Antiretroviral Drugs in Renal Insufficiency and Hemodialysis, May 2004
http://hivinsite.ucsf.edu/InSite?page=md-rr-18