ONIVYDE 5 mg/ml concentrate for solution for infusion
Servier Laboratories Limited
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1. Name of the medicinal product
ONIVYDE 5 mg/ml concentrate for solution for infusion
2. Qualitative and quantitative composition
One 10 ml vial of concentrate contains the equivalent of 50 mg irinotecan hydrochloride trihydrate (as irinotecan sucrosofate salt in a pegylated liposomal formulation) which corresponds to 43 mg irinotecan.
One ml of concentrate contains the equivalent of 5 mg irinotecan hydrochloride trihydrate (as irinotecan sucrosofate salt in a pegylated liposomal formulation) which corresponds to 4.3 mg irinotecan.
Excipient with known effect
One ml of concentrate contains 0.144 mmol (3.31 mg) sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
White to slightly yellow opaque isotonic liposomal dispersion.
The concentrate has a pH of 7.2 and an osmolality of 295 mOsm/kg.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy.
4.2 Posology and method of administration
ONIVYDE (liposomal irinotecan) must only be prescribed and administered to patients by healthcare professionals experienced in the use of anti-cancer therapies.
ONIVYDE (liposomal irinotecan) is not equivalent to non-liposomal irinotecan formulations and should not be interchanged.
Posology
ONIVYDE, leucovorin and 5-fluorouracil should be administered sequentially. The recommended dose and regimen of ONIVYDE is 80 mg/m2 intravenously over 90 minutes, followed by LV 400 mg/m2 intravenously over 30 minutes, followed by 5-FU 2,400 mg/m2 intravenously over 46 hours, administered every 2 weeks. ONIVYDE should not be administered as a single agent.
A reduced starting dose of ONIVYDE (liposomal irinotecan) of 60 mg/ m2 should be considered for patients known to be homozygous for the UGT1A1*28 allele (see sections 4.8 and 5.1). A dose increase of ONIVYDE to 80 mg/m2 should be considered if tolerated in subsequent cycles.
Pre-medication
It is recommended that patients receive pre-medication with standard doses of dexamethasone (or an equivalent corticosteroid) together with a 5-HT3 antagonist (or other antiemetic) at least 30 minutes prior to ONIVYDE infusion.
Dosage adjustments
All dos modifications should be based on the worst preceding toxicity. LV dose does not require adjustment. For Grade 1 and 2 toxicities there are no dose modifications recommended. Dose adjustments, as summarised in Table 1 and Table 2, are recommended to manage Grade 3 or 4 toxicities related to ONIVYDE.
For patients who start treatment with 60 mg/m2 ONIVYDE and do not dose escalate to 80 mg/m2, the recommended first dose reduction is to 50 mg/m2 and the second dose reduction is to 40 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 60 mg/m2) may have the dose of ONIVYDE increased to a total dose of 80 mg/m2 in subsequent cycles based on individual patient tolerance.
Table 1: Recommended dose modifications for ONIVYDE+5-FU/LV for Grade 3-4 toxicities for patients not homozygous for UGT1A1*28
Toxicity grade (value) by NCI |
