What are the precautions for irinotecan hydrochloride liposome injection (Onivyde)?

In the clinical study of irinotecan hydrochloride liposome injection (Onivyde) in the treatment of pancreatic cancer, warnings and precautions such as severe neutropenia, severe diarrhea, interstitial lung disease, severe allergic reactions, and embryo-fetal toxicity occurred. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Severe neutropenia: Irinotecan Hydrochloride Liposomal InjectionE can cause severe or life-threatening neutropenia and fatal neutropenic sepsis. Monitor complete blood counts on days 1 and 8 of each cycle or more frequently if clinically indicated. This drug should be discontinued if the absolute neutrophil count (ANC) is less than 1500/mm3 or if neutropenic fever occurs. WhenANC is 1500/mm3 or above, resume use . After recovery in subsequent cycles, reduce dose in grade 3-4 neutropenia or neutropenic fever.

2. Severe diarrhea: Do not give irinotecan hydrochloride liposome injection to patients with intestinal obstruction. Severe or life-threatening diarrhea can follow one of two patterns: late-onset diarrhea (onset more than 24 hours after chemotherapy) and early-onset diarrhea (onset within 24 hours of chemotherapy, sometimes with other symptoms of a cholinergic response). An individual patient may experience both early-onset and late-onset diarrhea.

To reduce the risk of severe diarrhea, patients should discontinue use of lactose-containing products, eat a low-fat diet, and maintain hydration during treatment with irinotecan hydrochloride liposome injection. For early-onset diarrhea of u200bu200bany severity, give atropine 0.25 to 1 mg intravenously or subcutaneously (unless clinically contraindicated). Initiate loperamide to treat delayed-onset diarrhea of u200bu200bany severity. Treatment of diarrhea that does not improve within 48 hours should follow local institutional guidelines and may include the addition of other medications.

3. Interstitial lung disease (ILD):This drug can cause serious and fatalILD, including pneumonia. There have been postmarketing case reports of severe and fatal ILD with irinotecan hydrochloride liposome injection. Risk factors include preexisting lung disease, use of pulmonary toxic drugs, colony-stimulating factors, or prior radiation therapy. Patients with risk factors should be closely monitored for respiratory symptoms before and during treatment. Discontinue this medication in patients who develop new or progressive dyspnea, cough, and fever pending diagnostic evaluation. Patients diagnosed withILD should discontinue use of irinotecan hydrochloride liposome injection.

4. Severe allergic reactions: Irinotecan, including irinotecan hydrochloride liposome injection, can cause severe allergic reactions, including anaphylaxis. Patients who experience severe allergic reactions should permanently discontinue irinotecan hydrochloride liposome injection.

5. Embryonic-Fetal Toxicity: Based on the animal data of irinotecan hydrochloride and its mechanism of action, irinotecan hydrochloride liposome injection can cause fetal damage when used in pregnant women. Embryotoxicity and teratogenicity were observed in pregnant rats and rabbits treated with irinotecan hydrochloride during organogenesis at doses that would result in human exposure to irinotecan below 70 mg/m2. Inform pregnant women of potential risks to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for seven months after the last dose.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8b58efa-1820-48a4-b70d-62918fc4abfc##