Onivyde 4.3 mg/mL

IRINOTECAN HYDROCHLORIDE · INJECTION, POWDER, FOR SOLUTION · Ipsen Biopharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Onivyde is a injection, powder, for solution containing irinotecan hydrochloride at 4.3 mg/mL, taken intravenous. Manufactured by Ipsen Biopharmaceuticals, Inc..

Key Facts

Brand Name: Onivyde
Generic Name: IRINOTECAN HYDROCHLORIDE
NDC Code (Product): 15054-0043
Manufacturer: Ipsen Biopharmaceuticals, Inc.
Strength: 4.3 mg/mL
Dosage Form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA207793
Marketing Start: 10/22/2015

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea1,119 reports

off label use889 reports

myelosuppression650 reports

nausea597 reports

vomiting530 reports

febrile neutropenia502 reports

malignant neoplasm progression454 reports

neutropenia452 reports

death451 reports

disease progression420 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ONIVYDE is indicated, in combination with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma. ONIVYDE is indicated, in combination with fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy. Limitations of Use: ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic pancreatic adenocarcinoma. [see Clinical Studies (14) ] . ONIVYDE is a topoisomerase inhibitor indicated: in combination with oxaliplatin, fluorouracil and leucovorin, for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma, ( 1 ) in combination with fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma 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 pancreatic adenocarcinoma. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Do not substitute ONIVYDE for other drugs containing irinotecan HCl. ( 2.1 ) ONIVYDE in combination with oxaliplatin, fluorouracil and leucovorin: Recommended dose of ONIVYDE is 50 mg/m 2 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 2 every two weeks. ( 2.2 ) There is no recommended dose of ONIVYDE for patients with serum bilirubin above the upper limit of normal. ( 2.2 ) ONIVYDE in combination with fluorouracil and leucovorin: Recommended dose of ONIVYDE is 70 mg/m 2 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 2 every two weeks. ( 2.2 ) There is no recommended dose of ONIVYDE for patients with serum bilirubin above the upper limit of normal. ( 2.2 ) Premedicate with a corticosteroid and an anti-emetic 30 minutes prior to ONIVYDE. ( 2.2 ) 2.1 Important Use Information DO NOT SUBSTITUTE ONIVYDE for other drugs containing irinotecan HCl. 2.2 Recommended Dosage In combination with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of pat…

Contraindications

4 CONTRAINDICATIONS ONIVYDE is contraindicated in patients who have experienced a severe hypersensitivity reaction or anaphylaxis to ONIVYDE or irinotecan HCl. [see Warnings and Precautions (5.4) , Adverse Reactions (6.2) ]. Severe hypersensitivity reaction to ONIVYDE or irinotecan HCl. ( 4 , 5.4 )

Drug Interactions

7 DRUG INTERACTIONS Strong CYP3A4 Inducers: Avoid the use of strong CYP3A4 inducers if possible. Substitute non-enzyme inducing therapies at least 2 weeks prior to initiation of ONIVYDE. ( 7.1 ) Strong CYP3A4 Inhibitors: Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if possible; discontinue strong CYP3A4 inhibitors at least 1 week prior to starting therapy. ( 7.2 ) 7.1 Strong CYP3A4 Inducers Following administration of non-liposomal irinotecan (i.e., irinotecan HCl), exposure to irinotecan or its active metabolite, SN-38, is substantially reduced in adult and pediatric patients concomitantly receiving the CYP3A4 enzyme-inducing anticonvulsants phenytoin and strong CYP3A4 inducers. Avoid the use of strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, St. John's wort) if possible. Substitute non-enzyme inducing therapies at least 2 weeks prior to initiation of ONIVYDE therapy [see Clinical Pharmacology (12.3) ] . 7.2 Strong CYP3A4 or UGT1A1 Inhibitors Following administration of non-liposomal irinotecan (i.e., irinotecan HCl), patients receiving concomitant ketoconazole, a CYP3A4 and UGT1A1 inhibitor, have increased exposure …

Adverse Reactions

6 ADVERSE REACTIONS The following adverse drug reactions are discussed in greater detail in other sections of the label: Severe Neutropenia [see Warnings and Precautions (5.1) ] Severe Diarrhea [see Warnings and Precautions (5.2) ] Interstitial Lung Disease [see Warnings and Precautions (5.3) ] Severe Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] The most common adverse reactions (reported in ≥ 20% of patients) were for: ONIVYDE in combination with oxaliplatin, fluorouracil and leucovorin: diarrhea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, mucosal inflammation, constipation, and decreased weight. The most common laboratory abnormalities (≥ 10% Grade 3 or 4) were decreased neutrophils, decreased potassium, decreased lymphocytes, and decreased hemoglobin. ( 6.1 ) ONIVYDE in combination with fluorouracil and leucovorin: diarrhea, fatigue/asthenia, vomiting, nausea, decreased appetite, stomatitis, and pyrexia. The most common laboratory abnormalities (≥ 10% Grade 3 or 4) were lymphopenia and neutropenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc.at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/…

Frequently Asked Questions

What is Onivyde used for?

Onivyde contains IRINOTECAN HYDROCHLORIDE. It is a injection, powder, for solution taken intravenous. Consult your doctor for specific uses.

Is Onivyde a controlled substance?

Onivyde is not classified as a controlled substance by the DEA.

What is the generic name for Onivyde?

The generic name for Onivyde is IRINOTECAN HYDROCHLORIDE. There are 11 other brand versions of IRINOTECAN HYDROCHLORIDE.

What is the NDC code for Onivyde 4.3 mg/mL?

The NDC (National Drug Code) for Onivyde 4.3 mg/mL is 15054-0043, listed by Ipsen Biopharmaceuticals, Inc..

Product NDC

15054-0043

Package NDC

15054-0043-1

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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