Onivyde Vial

GENERIC NAME(S): Irinotecan Liposomal

OTHER NAME(S): Onivyde Dispersion

WARNINGS:

Irinotecan liposomal has caused a serious decrease in white blood cells (neutropenia). Low white blood cells can make you more likely to get serious (sometimes fatal) infections or make any infection you have worse. Get medical help right away if you develop signs of infection such as sore throat that doesn't go away, fever, chills.

Your doctor will monitor your blood counts while you are using this medication. Keep all medical and lab appointments.

Irinotecan liposomal may cause severe diarrhea which may occur right away and/or more than 24 hours after you receive the medication. If the diarrhea starts right away, you may also have other side effects such as runny nose, increased saliva, watery eyes, sweating, slow heartbeat, stomach cramps, or flushing. You should not receive this medication if you have stomach/intestinal blockage. Tell your doctor right away if you have diarrhea. Your doctor will prescribe medications to help control the diarrhea.

Who should not take Onivyde Vial?

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Uses

Uses

Irinotecan liposomal is used to treat cancer of the pancreas.

How to use Onivyde Vial

This medication is given by a health care professional. It is injected slowly into a vein over 90 minutes as directed by your doctor, usually every 2 weeks. The dosage is based on your medical condition, body size, and response to treatment. To help prevent side effects such as nausea/vomiting, your doctor may direct you to take other medications before you receive this medication. Use these additional medications exactly as directed by your doctor.

Side Effects

Side Effects

See also Warning section.

Nausea, vomiting, loss of appetite, weight loss, mouth sores, or tiredness may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: symptoms of lung disease (such as shortness of breath, cough), signs of kidney problems (such as change in the amount of urine), easy bruising/bleeding, unusual tiredness, extreme thirst, dizziness, fainting, irregular heartbeat, mental/mood changes, muscle cramps/weakness, pain/redness/swelling at the injection site or arms/legs, black/bloody stools.

Get medical help right away if you have any very serious side effects, including: chest pain, weakness on one side of the body, confusion.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Precautions

Before using irinotecan liposomal, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal blockage, blood/bone marrow disorders (such as low platelet/white blood cell/red blood cell levels).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Irinotecan liposomal can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Women of childbearing age should use reliable forms of birth control during treatment and for 1 month after the last dose of irinotecan liposomal. Men using this medication should use condoms while on treatment and for 4 months after the last dose of irinotecan liposomal. Consult your doctor for more details. If you become pregnant or think you may be pregnant, or if your partner becomes pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 1 month after the last dose of this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of irinotecan liposomal from your body, which may affect how irinotecan liposomal works. Examples include azole antifungals (such as itraconazole, ketoconazole), clarithromycin, gemfibrozil, nefazodone, HIV protease inhibitors (such as ritonavir, atazanavir), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), telaprevir, among others.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as complete blood count, kidney/liver function, blood mineral levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised March 2019. Copyright(c) 2019 First Databank, Inc.

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Onivyde 4.3 mg/mL intravenous dispersion
Onivyde 4.3 mg/mL intravenous dispersion

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This medicine is a white, vial

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.