Irinotecan liposomal Disease Interactions

Irinotecan liposomal can cause severe and life-threatening diarrhea. Do not administer Irinotecan liposomal to patients with bowel obstruction. It is recommended to withhold treatment with irinotecan liposomal for Grade 2-4 diarrhea and to initiate appropriate clinical measures for diarrhea of any severity. The dose of irinotecan liposomal should be reduced according to manufacturer indications following recovery to Grade 1 diarrhea. Care should be exercised when using this agent in patients at risk of diarrhea episodes.

Irinotecan liposomal can cause severe or life-threatening neutropenia and fatal neutropenic sepsis. In patients receiving irinotecan liposomal in combination with 5-FU and LV, the incidence of Grade 3 or 4 neutropenia and neutropenic fever/neutropenic sepsis was higher among Asian patients compared to White patients. Individuals who are homozygous for the UGT1A1*28 allele are at increased risk for neutropenia. It is recommended to monitor complete blood cell counts on Days 1 and 8 of every cycle and more frequently if clinically indicated and to withhold treatment if the absolute neutrophil count is below 1500/mm ^3 or if neutropenic fever occurs. Therapy could be resumed when the ANC is 1500/mm^ 3 or above. The dose of irinotecan liposomal should be reduced according to manufacturer indications for Grade 3-4 neutropenia or neutropenic fever following a recovery in subsequent cycles. Care is recommended when using this agent in neutropenic patients and in those patients homozygous for the UGT1A1*28 allele.

Irinotecan can cause severe and fatal interstitial pulmonary disease (IPD). Risk factors include preexisting-existing lung disease. It is recommended to withhold treatment with irinotecan in patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation and to discontinue treatment in patients with a confirmed diagnosis of IPD. Exercise caution when using this agent in patients presenting symptoms of dyspnea and patients with pulmonary impairment.

The metabolism of irinotecan liposomal has not been evaluated. Irinotecan is primary metabolized by the liver to a biologically active metabolite. The pharmacokinetic disposition of irinotecan liposomal in patients with hepatic impairment has not been formally assessed. Therapy with irinotecan liposomal should be administered cautiously to patients with or predisposed to compromised hepatic function. Clinical monitoring of hepatic function is recommended.

Population pharmacokinetic analyses suggest that no dose adjustment of irinotecan liposomal is required for patients with mild-to-moderate renal impairment. Caution is recommended when using this agent in patients with severe renal impairment as there is insufficient data to assess its effect.