Use of Raltegravir in Pediatric HIV-1 Infection

Marcia L. Buck, Pharm.D., FCCP, FPPAG; Kristi N. Hofer, Pharm.D; Michelle W. McCarthy, Pharm.D.; FASHP Susan B. Cogut, Pharm.D

Disclosures

Pediatr Pharm. 2012;18(1) 

In This Article

Adverse Effects

In clinical trials conducted in adults, the most commonly reported adverse effects with raltegravir have included insomnia in 4% of patients, and headache, neutropenia, anemia, or thrombocytopenia in 1–2%. Other adverse effects included dizziness, fatigue, pruritus, nausea, and diarrhea. Less common adverse effects included anxiety, depression, asthenia, abdominal pain, and vomiting (all occurring in < 2% of patients). Elevated serum aminotransferases, bilirubin, glucose, and lipid values occurred in 1–6% of patients. Rates of discontinuation in clinical trials have been no different in the raltegravir and placebo groups. Post-marketing reports include rare cases of elevated creatine kinase, myopathy, and rhabdomyolysis, as well as nephrolithiasis, renal and liver failure, and hypersensitivity or severe dermatologic reactions.[2–5]

The manufacturer reports that the adverse effects documented in children participating in the IMPAACT P1066 trial were similar to those seen in adults.[3] One child experienced hyperactivity and insomnia and another experienced a serious allergic rash. One patient experienced elevated serum aminotransferases.

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