Approvals/HSA/ONIVYDE PEGYLATED LIPOSOMAL (IRINOTECAN) CONCENTRATE FOR DISPERSION FOR INFUSION 4.3 MG/ML

Approved

THERAPEUTIC

ONIVYDE PEGYLATED LIPOSOMAL (IRINOTECAN) CONCENTRATE FOR DISPERSION FOR INFUSION 4.3 MG/ML

IPSEN BIOSCIENCES, INC. - UNITED STATESAJINOMOTO ALTHEA, INC. - UNITED STATESIPSEN PHARMA BIOTECH (FRANCE)🇸🇬 Health Sciences Authority

Approval Date: Dec 28, 2017
Approval ID: fa2a68c0d66b7d94
Company: IPSEN BIOSCIENCES, INC. - UNITED STATESAJINOMOTO ALTHEA, INC. - UNITED STATESIPSEN PHARMA BIOTECH (FRANCE)
Type: Therapeutic

Approval Details

Approval Id: fa2a68c0d66b7d94
Drug Name: ONIVYDE PEGYLATED LIPOSOMAL (IRINOTECAN) CONCENTRATE FOR DISPERSION FOR INFUSION 4.3 MG/ML
Product Name: ONIVYDE PEGYLATED LIPOSOMAL (IRINOTECAN) CONCENTRATE FOR DISPERSION FOR INFUSION 4.3 MG/ML
Approval Number: SIN15397P
Approval Date: 2017-12-28
Registrant: SERVIER (S) PTE LTD
Licence Holder: SERVIER (S) PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INFUSION, SOLUTION CONCENTRATE
Dosage: 13 DOSAGE AND ADMINISTRATION 13.1 Important Use Information DO NOT SUBSTITUTE ONIVYDE pegylated liposomal for other drugs containing irinotecan HCl. 13.2 Recommended Use ONIVYDE pegylated liposomal should not be administered as a single agent and should be continued until disease progression or no longer tolerated by the patient. There is no recommended dose of ONIVYDE pegylated liposomal for patients with serum bilirubin above the upper limit of normal [see Adverse Reactions (9.1) and Clinical Studies (5) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. ONIVYDE pegylated liposomal in combination with oxaliplatin, 5-fluorouracil and leucovorin: ONIVYDE pegylated liposomal, oxaliplatin, LV and 5-FU should be administered sequentially. <ul> <li>The recommended dose of ONIVYDE pegylated liposomal is 50 mg/m2 intravenously over 90 minutes, followed by oxaliplatin 60 mg/m2 intravenously over 120 minutes, followed by LV 400 mg/m2 intravenously over 30 minutes, followed by 5-FU 2,400 mg/m2 intravenously over 46 hours. This regimen should be administered every 2 weeks.</li> <li>Oxaliplatin may be discontinued if not well tolerated and treatment with ONIVYDE pegylated liposomal + 5-FU/LV can continue.</li> <li>The recommended starting dose of ONIVYDE pegylated liposomal in patients known to be homozygous for UGT1A1*28 allele is unchanged and remains 50 mg/m2 administered intravenously over 90 minutes.</li> </ul> ONIVYDE pegylated liposomal in combination with 5-fluorouracil and leucovorin: Administer ONIVYDE pegylated liposomal prior to leucovorin and fluorouracil [see Clinical Studies (5) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. <ul> <li>The recommended dose of ONIVYDE pegylated liposomal is 70 mg/m2 administered by intravenous infusion over 90 minutes every 2 weeks.</li> <li>A reduced starting dose of ONIVYDE pegylated liposomal of 50 mg/m2 should be considered in patients known to be homozygous for the UGT1A1*28 allele. A dose increase of ONIVYDE pegylated liposomal to 70 mg/m2 should be considered if tolerated in subsequent cycles.</li> </ul> Premedication Administer a corticosteroid and an anti-emetic 30 minutes prior to ONIVYDE pegylated liposomal infusion. 13.3 Dose Modifications for Adverse Reactions All dose modifications should be based on the worst preceding toxicity. LV dose does not require adjustment. ONIVYDE pegylated liposomal in combination with oxaliplatin, 5-fluorouracil and leucovorin: <img src="/TGIF/OnivydePegylatedLiposomal-Table8.png" alt="Onivyde Pegylated Liposomal Dosage Table 8" /> Patients homozygous for the UGT1A1*28 allele should initiate ONIVYDE pegylated liposomal at the same dose and the same dose reduction requirements should apply. ONIVYDE pegylated liposomal in combination with 5-fluorouracil and leucovorin: For patients who start treatment with 50 mg/m2 ONIVYDE pegylated liposomal and do not dose escalate to 70 mg/m2, the recommended first dose reduction is to 43 mg/m2 and the second dose reduction is to 35 mg/m2. Patients who require further dose reduction should discontinue treatment. Patients who are known to be homozygous for UGT1A1*28 and without drug related toxicities during the first cycle of therapy (reduced dose of 50 mg/m2) may have the dose of ONIVYDE pegylated liposomal increased to a total dose of 70 mg/m2 in subsequent cycles based on individual patient tolerance. <img src="/TGIF/OnivydePegylatedLiposomal-Table9.png" alt="Onivyde Pegylated Liposomal Dosage Table 9" /> <img src="/TGIF/OnivydePegylatedLiposomal-Table10.png" alt="Onivyde Pegylated Liposomal Dosage Table 10" /> For recommended dose modifications of fluorouracil (5-FU) or leucovorin (LV), refer to the Full Prescribing Information; refer to Clinical Studies (5) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. 13.4 Preparation and Administration ONIVYDE pegylated liposomal is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 Preparation <ul> <li>Withdraw the calculated volume of ONIVYDE pegylated liposomal from the vial using a needle not larger than 21 gauge. Dilute ONIVYDE pegylated liposomal in 500 mL 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP and mix diluted dispersion by gentle inversion.</li> <li>Protect diluted dispersion from light.</li> <li>Chemical and physical stability for the diluted dispersion for infusion has been demonstrated at 15°C to 25°C for up to 4 hours or in the refrigerator (2°C to 8°C) for not more than 24 hours. Allow diluted dispersion to come to room temperature prior to administration. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.</li> <li>Do NOT freeze.</li> </ul> Administration <ul> <li>Infuse diluted dispersion intravenously over 90 minutes. Do not use in-line filters. Discard unused portion.</li> </ul> <hr> 16 REFERENCES <ol> <li>OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html</li> </ol>
Route Of Administration: INTRAVENOUS
Indication Info: 6 INDICATION AND USAGE ONIVYDE pegylated liposomal is indicated: <ul class="dash"> <li>in combination with oxaliplatin, 5-fluorouracil (5-FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas,</li> <li>in combination with 5-FU and LV for the treatment of metastatic adenocarcinoma of the pancreas in adult patients who have progressed following gemcitabine-based therapy.</li> </ul> Limitation of Use: ONIVYDE pegylated liposomal is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas [see Clinical Studies (5) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].
Contraindications: 7 CONTRAINDICATIONS ONIVYDE pegylated liposomal is contraindicated in patients who have experienced a severe hypersensitivity reaction to ONIVYDE pegylated liposomal or irinotecan HCl.
Atc Code: L01XX19
Atc Item Name: xl 01 xx 19
Pharma Manufacturer Name: SERVIER (S) PTE LTD
Company Detail Path: /organization/servier-s-pte-ltd

Active Ingredients

Irinotecan (anhydrous free base)

4.33 mg/mL

Irinotecan (anhydrous free base)

4.33 mg/mL

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Dec 28, 2017

Approval ID

fa2a68c0d66b7d94

Type

Therapeutic

Back to HSA Approvals