Isentress Disease Interactions

There were no clinically important pharmacokinetic differences between subjects with severe renal impairment and healthy subjects. No dosage adjustment is necessary for these patients. Because the extent to which raltegravir may be dialyzable is unknown, dosing before a dialysis session should be avoided.

There were no clinically important pharmacokinetic differences between subjects with moderate hepatic impairment and healthy subjects. No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. Therapy with raltegravir should be administered with caution in patients with severe hepatic impairment, as the pharmacokinetics of raltegravir have not been studied in this population. Liver transaminases and bilirubin should regularly be monitored during therapy.

The use of raltegravir has been associated with creatine kinase elevations. There have been reports of myopathy and rhabdomyolysis in patients taking raltegravir. Therapy with raltegravir should be used with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions or patients with a history of rhabdomyolysis, myopathy or increased serum creatine kinase levels.

Isentress (brand of raltegravir) chewable tablets contain phenylalanine. The 25 mg chewable tablet contains approximately 0.05 mg phenylalanine and the 100 mg contains approximately 0.10 mg phenylalanine. The phenylalanine content should be considered when this product is used in patients who must restrict their intake of phenylalanine (i.e. phenylketonuria).