ONIVYDE- irinotecan hydrochloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IRINOTECAN HYDROCHLORIDE (UNII: 042LAQ1IIS) (IRINOTECAN - UNII:7673326042)

Available from:

Merrimack Pharmaceuticals

INN (International Name):

IRINOTECAN HYDROCHLORIDE

Composition:

IRINOTECAN HYDROCHLORIDE 4.3 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ONIVYDE™   is indicated, in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Limitation of Use: ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas [see Clinical Studies (14) ] . ONIVYDE is contraindicated in patients who have experienced a severe hypersensitivity reaction to ONIVYDE or irinotecan HCl. Risk Summary Based on animal data with irinotecan HCl and the mechanism of action of ONIVYDE, ONIVYDE can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ]. There are no available data in pregnant women. Embryotoxicity and teratogenicity were observed following treatment with irinotecan HCl, at doses resulting in irinotecan exposures lower than those achieved with ONIVYDE 70 mg/m2 in humans, administered to pregnant rats and rabbits during organogenesis [see Data ]. A

Product summary:

How Supplied ONIVYDE is available in a single-dose vial containing 43 mg irinotecan free base at a concentration of 4.3 mg/mL NDC: 69171-398-01 Storage and Handling Store ONIVYDE at 2ºC to 8ºC (36°F to 46°F). Do NOT freeze. Protect from light. ONIVYDE is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Authorization status:

New Drug Application

Summary of Product characteristics

ONIVYDE- IRINOTECAN HYDROCHLORIDE INJECTION
MERRIMACK PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO
USEONIVYDE™ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ONIVYDE™
ONIVYDE™ (IRINOTECAN LIPOSOME INJECTION), FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
WARNING: SEVERE NEUTROPENIA AND SEVERE DIARRHEA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
FATAL NEUTROPENIC SEPSIS OCCURRED IN 0.8% OF PATIENTS RECEIVING
ONIVYDE. SEVERE OR LIFE-THREATENING
NEUTROPENIC FEVER OR SEPSIS OCCURRED IN 3% AND SEVERE OR
LIFE-THREATENING NEUTROPENIA OCCURRED IN
20% OF PATIENTS RECEIVING ONIVYDE IN COMBINATION WITH FLUOROURACIL AND
LEUCOVORIN. WITHHOLD
ONIVYDE FOR ABSOLUTE NEUTROPHIL COUNT BELOW 1500/MM3 OR NEUTROPENIC
FEVER. MONITOR BLOOD CELL
COUNTS PERIODICALLY DURING TREATMENT (2.2), (5.1).
SEVERE DIARRHEA OCCURRED IN 13% OF PATIENTS RECEIVING ONIVYDE IN
COMBINATION WITH FLUOROURACIL AND
LEUCOVORIN. DO NOT ADMINISTER ONIVYDE TO PATIENTS WITH BOWEL
OBSTRUCTION. WITHHOLD ONIVYDE FOR
DIARRHEA OF GRADE 2-4 SEVERITY. ADMINISTER LOPERAMIDE FOR LATE
DIARRHEA OF ANY SEVERITY. ADMINISTER
ATROPINE, IF NOT CONTRAINDICATED, FOR EARLY DIARRHEA OF ANY SEVERITY
(2.2), (5.2).
INDICATIONS AND USAGE
ONIVYDE is a topoisomerase inhibitor indicated, in combination with
fluorouracil and leucovorin, for the treatment of
patients with metastatic adenocarcinoma of the pancreas after disease
progression following gemcitabine-based therapy.
(1)
Limitation of Use: ONIVYDE is not indicated as a single agent for the
treatment of patients with metastatic adenocarcinoma
of the pancreas. (1)
DOSAGE AND ADMINISTRATION
DO NOT SUBSTITUTE ONIVYDE FOR OTHER DRUGS CONTAINING IRINOTECAN HCL.
(2.1)
Recommended dose of ONIVYDE is 70 mg/m intravenous infusion over 90
minutes every two weeks. (2.2)
Recommended starting dose of ONIVYDE in patients homozygous for
UGT1A1*28 is 50 mg/m every two weeks.
(2.2)
There is no recommended dose of ONIVYDE for patients