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Adverse Effects and Toxicity
05-06-2008
- Maintain good adherence
- Reduce potential adverse impacts of drug side effects
- Identify serious adverse drug reactions and manage appropriately
- Determine seriousness of toxicity and manage according to severity
- Establish whether adverse event due to ART or to other medication or illness (e.g., viral hepatitis, malaria, IRIS)
- An individual drug may be substituted due to toxicity
- Stress adherence despite mild to moderate reactions
- If ART must be stopped because of severe life-threatening toxicity, stop all drugs together until patient stabilized
- Adverse events should be recorded and reported regularly to HIV/AIDS program manager and to National Pharmacovigilance Unit at Pharmacy Regulatory Authority
- Early complications seen most commonly when therapy started in pts with severe immunodeficiency. Mortality increased in 1st 6 months on treatment, especially in patients with Stage IV disease and severe immunosuppression
- Educate patient about possible adverse effects
- Consider other medical conditions (e.g. hepatitis) and medications when selecting regimen to decrease risk of adverse effects
- Follow recommendations for lab and clinical monitoring while on ART
- Educate about symptoms of life-threatening conditions
- Make sure patient knows how to reach provider for questions or concerns
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GRADE 1 (mild)
- Transient or mild discomfort, no limitation in activity no medical intervention needed
- Does not require change in therapy, symptomatic treatment may be given
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GRADE 2 (moderate)
- Limitation in activity, some assistance may be needed; no or minimal medical intervention/therapy required
- Continue ART if possible; if no improvement consider substitution with drug in same class but with different toxicity profile
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GRADE 3 (severe)
- Marked limitation in activity, some assistance usually required, medical intervention required, possible hospitalization
- Substitute offending agent without stopping therapy
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GRADE 4 (severe, life-threatening)
- Extreme limitation in activity, significant assistance required, significant medical intervention/therapy required, hospitalization or hospice care
- Discontinue all ARV drugs, manage medical event until patient stable and toxicity resolved
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