Drug Interaction Report

MONITOR: Coadministration of daclizumab with other agents known to induce hepatotoxicity may increase the risk of liver injury. Serious drug-related hepatic injury, including liver failure and autoimmune hepatitis, has been reported across controlled and open-label studies in 1.7% of daclizumab-treated patients and may occur at any time during treatment and up to 5 months after treatment cessation. Fatal cases have occurred. In addition, cases of hepatic injury have occurred in patients taking daclizumab concomitantly with other hepatotoxic drugs; however, the contributory role of these other medicines has not been established.

MANAGEMENT: Caution is advised if daclizumab is used with other potentially hepatotoxic agents, including non-prescription products and herbal supplements. Patients treated with daclizumab should have serum transaminase levels and total bilirubin measured prior to initiation of treatment and monthly during treatment in accordance with the manufacturer's recommendations, and the dosing adjusted or interrupted as necessary. Patients should be advised to seek medical attention if they experience potential signs and symptoms of hepatotoxicity such as fever, rash, itching, anorexia, nausea, vomiting, fatigue, malaise, right upper quadrant pain, dark urine, pale stools, and jaundice.

GENERALLY AVOID: Ethanol can exacerbate the cutaneous flushing that is a common side effect of niacin. At least one case of delirium and lactic acidosis has been reported with coadministration of these drugs, although data are limited.

MANAGEMENT: Coadministration should probably be discouraged, particularly since chronic consumption of large amounts of alcohol is associated with hyperlipidemia.

A single case has been reported in which cutaneous flushing and tremors were noted in a woman who was taking niacin while wearing a nicotine patch. The mechanism is suspected to be synergistic cutaneous vasodilatory effects. The clinical significance of this possible interaction is not known.