Irinotecan hydrochloride liposome

What is Irinotecan hydrochloride liposome?

• Irinotecan hydrochloride liposome (Onivyde) is a topoisomerase inhibitor used together with fluorouracil and leucovorin to treat a certain type of pancreatic cancer that has spread to other parts of the body and has gotten worse after treatment with gemcitabine anticancer therapy.
• Irinotecan hydrochloride liposome may have fewer side effects and work better than irinotecan hydrochloride.

Irinotecan structure

Irinotecan2DACSV

What are the uses of this medicine?

• Irinotecan hydrochloride liposome (Onivyde) is used 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 used as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.

How does this medicine work?

• Irinotecan liposome injection is a topoisomerase 1 inhibitor encapsulated in a lipid bilayer vesicle or liposome.
• Topoisomerase 1 relieves torsional strain in DNA by inducing single-strand breaks.
• Irinotecan and its active metabolite SN-38 bind reversibly to the topoisomerase 1-DNA complex and prevent re-ligation of the single-strand breaks, leading to exposure time-dependent double-strand DNA damage and cell death.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have experienced a severe hypersensitivity reaction to Onivyde or irinotecan HCl.

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed above and any of the following:

• atazanavir (Reyataz, in Evotaz) and gemfibrozil (Lopid).

• Tell your doctor if you are taking carbamazepine (Carbatrol, Equetro, Tegretol, Teril, Epitol), phenobarbital, phenytoin (Dilantin, Phenytek), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, in Rifamate, Rifater), and rifapentine (Priftin). Your doctor will probably tell you not to take these medications for at least 2 weeks before, and during your treatment with irinotecan lipid complex.
• Tell your doctor if you are taking clarithromycin (Biaxin, in Prevpac), indinavir (Crixivan), itraconazole (Onmel, Sporanox), ketoconazole, lopinavir (in Kaletra), nefazodone, nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, Viekira Pak), saquinavir (Invirase), telaprevir (Incivek), and voriconazole (Vfend).

Is this medicine FDA approved?

• Irinotecan and topotecan were both approved for use in the United States in 1996 and continue to be used in oncology practice.

How should this medicine be used?

• Premedicate with a corticosteroid and an anti-emetic 30 minutes prior to Onivyde.

Recommended dosage:

• Recommended dose of Onivyde is 70 mg/m2 intravenous infusion over 90 minutes every two weeks.
• Recommended starting dose of Onivyde in patients homozygous for UGT1A1*28 is 50 mg/m2 every two weeks.

Administration:

• Infuse diluted solution intravenously over 90 minutes.
• Do not use in-line filters.
• Discard unused portion.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 43 mg/10 mL single dose vial

This medicine is available in fallowing brand namesː

• Onivyde

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• fatigue/asthenia
• vomiting
• nausea
• decreased appetite
• stomatitis
• pyrexia
• lymphopenia
• neutropenia

What special precautions should I follow?

• Onivyde can cause severe or life-threatening neutropenia and fatal neutropenic sepsis. Monitor complete blood cell counts on Days 1 and 8 of every cycle and more frequently if clinically indicated.
• Onivyde can cause severe and life-threatening diarrhea. Do not administer Onivyde to patients with bowel obstruction. Administer intravenous or subcutaneous atropine 0.25 to 1 mg (unless clinically contraindicated) for early onset diarrhea of any severity. Following recovery to Grade 1 diarrhea, resume Onivyde at a reduced dose.
• Fatal ILD has occurred in patients receiving irinotecan HCl. Discontinue Onivyde if ILD is diagnosed.
• Irinotecan HCl can cause severe hypersensitivity reactions, including anaphylactic reactions. Permanently discontinue Onivyde in patients who experience a severe hypersensitivity reaction.
• 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. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• 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.
• There are no available data in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness of Onivyde have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• IRINOTECAN HYDROCHLORIDE

Inactive Ingredients:

• 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE
• CHOLESTEROL
• SODIUM N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE
• HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID
• SODIUM CHLORIDE

Who manufactures and distributes this medicine?

Manufactured for:

• Ipsen Biopharmaceuticals, Inc. Cambridge, MA
• Onivyde is a registered trademark of Ipsen Biopharm Ltd.

What should I know about storage and disposal of this medication?

• Store Onivyde at 2°C to 8°C (36°F to 46°F).
• Do NOT freeze.
• Protect from light.
• Onivyde is a cytotoxic drug.
• Follow applicable special handling and disposal procedures.

• Dailymed label info on Irinotecan hydrochloride liposome
• FDA Irinotecan hydrochloride liposome

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