Irinotecan Hydrochloride, Injection

________________________________________________________________________

KEY POINTS

• This medicine is given by IV to treat cancer of the colon or rectum.
• If you develop severe diarrhea or diarrhea that lasts more than 2 or 3 days while taking this medicine, or for several weeks after you stop taking this medicine, contact your healthcare provider right away.
• You may get infections more easily when you are taking this medicine.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: irinotecan hydrochloride, injection; Camptosar

What is this medicine used for?

This medicine is given by infusion (slow drip through a needle into a large vein) along with other medicines to treat cancer of the colon or rectum in people whose cancer has come back or progressed under other treatment.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetes
• Fructose intolerance
• Liver or kidney problems
• Lung disease
• Radiation therapy to your pelvis or stomach

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I use it?

This is a very strong medicine. Only healthcare providers experienced with this medicine should prescribe it. It should only be given in a clinic or hospital where you can be monitored closely.

These infusions are given by your healthcare provider, usually for several weeks. The treatment may be repeated for as long as necessary. Be sure to keep all appointments for these infusions and for blood tests to find out how this medicine affects you. Your healthcare provider may also prescribe other medicines to reduce nausea and diarrhea, which are common side effects of this medicine. Follow your healthcare provider's directions exactly.

What should I watch out for?

Diarrhea within 24 hours of the infusion may be severe but not last long. Diarrhea that starts more than 24 hours after the infusion may be severe and last longer. It can lead to dehydration and other conditions that are life-threatening. Talk to your healthcare provider about medicine to treat the late diarrhea. Contact your healthcare provider right away if you develop diarrhea that is severe and does not stop.

This medicine may lower the number of certain types of blood cells in your body. You may get infections or bleed more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Do not have any vaccines without getting your healthcare provider's approval first. If you develop a fever or other signs of infection, or have any unusual bruising or bleeding, contact your healthcare provider right away.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you have pain at the injection site during the infusion, tell your healthcare provider immediately.

This medicine may make you dizzy or cause blurred vision. Do not drive or operate machinery unless you are fully alert and can see clearly.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; tightness in your chest; swelling of your lips, mouth, or throat; trouble breathing).

Serious (Report these to your healthcare provider right away.): Severe and prolonged diarrhea; fever, new or worsening cough, or sore throat; trouble breathing; severe nausea or vomiting; decreased urination; confusion; fast or irregular heartbeat; unusual bruising or bleeding; unusual tiredness or weakness; yellowish ski or eyes; black or tarry bowel movements; coughing up blood; pain in your calf; runny nose, watery eyes, flushing, or slowed heart rate; severe dizziness or fainting.

Other: Constipation, sweating, flushing, stomach pain, headache, back pain, weakness, white patches or sores in your mouth or on your lips, loss of appetite, weight loss, trouble sleeping, dizziness, hair loss; redness, pain, or swelling at the injection site.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as azithromycin (Zithromax, Zmax), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), telithromycin (Ketek), and tetracycline
• Antidepressants such as citalopram (Celexa), desipramine (Norpramin), nefazodone, and sertraline (Zoloft)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Cancer medicines such as abiraterone (Zytiga), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), and nilotinib (Tasigna)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), gemfibrozil (Lopid), and lomitapide (Juxtapid)
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Dexamethasone
• Eliglustat (Cerdelga)
• Heart medicines such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Laxatives
• Medicines to raise white blood cell counts such as eltrombopag (Promacta), filgrastim (Neupogen), pegfilgrastim (Neulasta), and sargramostim (Leukine)
• Nausea medicines such as aprepitant (Emend) and fosaprepitant (Emend)
• Other cancer medicines
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Simeprevir (Olysio)
• St. John's wort
• Vaccines

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.