Brand Name(s):

Onivyde^®

IMPORTANT WARNING

Irinotecan lipid complex can cause a severe decrease in the number of white blood cells made by your bone marrow. A decrease in the number of white blood cells in your body may increase the risk that you will develop a serious infection. Your doctor will order laboratory tests regularly during your treatment to check the number of white blood cells in your blood. You may be at greater risk of experiencing this side effect if you are of Asian descent. If you experience any of the following symptoms of infection, call your doctor immediately: fever, chills, sore throat, ongoing cough and congestion, or other signs of infection.

Irinotecan lipid complex can cause severe and life threatening diarrhea that may lead to dehydration. Tell your doctor if you have or have ever had a bowel obstruction (blockage in your intestine). You may experience the following symptoms within 24 hours after receiving irinotecan lipid complex: diarrhea (sometimes called "early diarrhea"), runny nose, increased saliva, shrinking pupils (black circles in the middle of the eyes), watery eyes, sweating, flushing, slowed heartbeat, or stomach cramps. Tell your doctor right away if you experience any of these symptoms. You may also experience severe diarrhea more than 24 hours after receiving irinotecan lipid complex (sometimes called "late diarrhea"). If you experience any of the following symptoms of late diarrhea, call your doctor immediately: diarrhea, vomiting that stops you from drinking anything, black or bloody stools, lightheadedness, dizziness, or faintness. Your doctor will probably tell you to take loperamide (Imodium AD) to treat symptoms of late diarrhea.

Talk to your doctor about the risks of receiving irinotecan lipid complex.

WHY is this medicine prescribed?

Irinotecan lipid complex is used in combination with other medications to treat pancreatic cancer that has spread to other parts of the body that has worsened after treatment with other chemotherapy medications. Irinotecan lipid complex is in a class of antineoplastic medications called topoisomerase I inhibitors. It works by stopping the growth of cancer cells.

HOW should this medicine be used?

Irinotecan lipid complex comes as a liquid to be injected intravenously (into a vein) over 90 minutes by a doctor or nurse in a medical facility. It is usually given once every 2 weeks.

Your doctor may need to delay your treatment and adjust your dose if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with irinotecan lipid complex.

Your doctor may give you medications to prevent nausea and vomiting before you receive each dose of irinotecan lipid complex. Your doctor may also give you or tell you to take other medication(s) to prevent or treat other side effects.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking irinotecan lipid complex,

tell your doctor and pharmacist if you are allergic to irinotecan, any other medications, or any of the ingredients in the irinotecan lipid complex injection. Ask your pharmacist for a list of the ingredients.
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). Your doctor will probably tell you not to take these medications for at least one week before, and during your treatment with irinotecan lipid complex.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, 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). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with irinotecan lipid complex, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on these lists.
tell your doctor what herbal products you are taking, especially St. John's wort. Your doctor will probably tell you not to take St. John's wort for at least 2 weeks before, and during your treatment with irinotecan lipid complex.
tell your doctor if you have or have ever had liver or kidney disease.
tell your doctor if you are pregnant or plan to become pregnant, or plan to father a child. You should not become pregnant while you are receiving irinotecan lipid complex and for 1 month after you receive your final treatment. Use a reliable method of birth control during your treatment and for 1 month after your final treatment. If you are a male and your partner can become pregnant, you should use birth control while receiving this medication, and for 4 months after your final treatment. Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while receiving irinotecan lipid complex, call your doctor immediately. Irinotecan lipid complex may harm the fetus.
tell your doctor if you are breast-feeding. Your doctor may tell you not to breast-feed during your treatment and for 1 month after your last treatment.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory.

Ask your pharmacist any questions you have about irinotecan lipid complex.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: February 15, 2016.