Camptosar is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Camptosar is used to treat cancers of the colon and rectum. It is usually given with other cancer medicines in a combination chemotherapy..

Camptosar injection is available in three single-dose sizes: 2 ml vial containing 40 mg irinotecan hydrochloride, 5 ml vial containing 100 mg irinotecan hydrochloride, and 15 ml vial containing 300 mg irinotecan hydrochloride.

Camptosar can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

Camptosar can cause severe diarrhea, which can be life-threatening if it leads to dehydration. You may be given medications to prevent or quickly treat diarrhea. Call your doctor whenever you have diarrhea during your treatment with Camptosar.

Before taking this medicine

You should not use Camptosar if you are allergic to irinotecan.

To make sure Camptosar is safe for you, tell your doctor if you have:

• liver or kidney disease;

• lung disease;

• an intestinal disorder or obstruction;

• Gilbert's syndrome;

• fructose intolerance (Camptosar injection contains sorbitol);

• radiation treatment to your abdomen or pelvic area; or

• if you take a diuretic or "water pill."

Irinotecan can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need to have a negative pregnancy test. Use effective birth control to prevent pregnancy while you are using Camptosar and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Camptosar.

Pregnancy may be less likely to occur while the mother or the father is using Camptosar. Both men and women should still use birth control to prevent pregnancy because irinotecan can harm an unborn baby.

Do not breastfeed while using Camptosar, and for at least 7 days after your last dose.

Camptosar is given as an infusion into a vein. A healthcare provider will give you this injection.

Your doctor may recommend a DNA test before your first dose. Some people are genetically more likely to have certain side effects from irinotecan.

Camptosar must be given slowly, and the infusion can take up to 90 minutes to complete.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle.

If any of this medicine gets on your skin, wash right away with soap and water.

Camptosar can cause severe diarrhea, which can be life-threatening if it leads to dehydration.

Your doctor may recommend keeping anti-diarrhea medicine on hand at all times (such as loperamide or Imodium). Take this medicine at the first sign of loose or frequent bowel movements. Do not take loperamide for longer than 2 full days without your doctor's advice.

Call your doctor whenever you have diarrhea during your treatment with Camptosar.

You may need frequent medical tests to be sure Camptosar is not causing harmful effects. Your cancer treatments may be delayed based on the results.

Usual Adult Dose of Camptosar for Colorectal Cancer:

COMBINATION REGIMEN 1:
125 mg/m2 IV over 90 minutes on Days 1, 8,15, and 22 with LV 20 mg/m2 IV bolus on Days 1, 8, 15, and 22 followed by 5-FU 500 mg/m2 IV bolus on Days 1, 8, 15, and 22 every 6 weeks

COMBINATION REGIMEN 2:
180 mg/m2 IV over 90 minutes on Days 1, 15, and 29 with LV 200 mg/m2 IV over 2 hours on Days 1, 2, 15, 16, 29, and 30 followed by 5-FU 400 mg/m2 IV bolus on Days 1, 2, 15, 16, 29, and 30 and 5-FU 600 mg/m2 IV over 22 hours on Days 1, 2, 15, 16, 29, 30 (NOTE: 5-FU IV follows 5-FU bolus)

SINGLE AGENT REGIMEN 1:
125 mg/m2 IV over 90 minutes on Days 1, 8, 15, and 22 then 2-week rest

SINGLE AGENT REGIMEN 2:
350 mg/m2 IV over 90 minutes on Day 1 every 3 weeks

Comments:
-It is recommended that patients receive premedication with antiemetics (e.g., 10 mg dexamethasone given in conjunction with another antiemetic agent, such as a 5-HT 3 blocker [e.g., ondansetron or granisetron]).
-Antiemetic agents should be given at least 30 minutes before this drug.
-Physicians should consider providing patients with an antiemetic regimen (e.g., prochlorperazine) for subsequent use as needed.
-A similar antiemetic regimen should be used with combination therapy.
-Prophylactic or therapeutic administration of atropine should be considered in patients experiencing cholinergic symptoms.

Uses:
-First-line therapy in combination with 5-fluorouracil (5-fu) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum
-Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy

You should not use Camptosar if you are allergic to irinotecan.

To make sure Camptosar is safe for you, tell your doctor if you have:

• liver or kidney disease;

• lung disease;

• an intestinal disorder or obstruction;

• Gilbert's syndrome;

• fructose intolerance (Camptosar injection contains sorbitol);

• radiation treatment to your abdomen or pelvic area; or

• if you take a diuretic or "water pill."

Irinotecan can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need to have a negative pregnancy test. Use effective birth control to prevent pregnancy while you are using Camptosar and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Camptosar.

Pregnancy may be less likely to occur while the mother or the father is using Camptosar. Both men and women should still use birth control to prevent pregnancy because irinotecan can harm an unborn baby.

Do not breastfeed while using Camptosar, and for at least 7 days after your last dose.

Call your doctor for instructions if you miss an appointment for your Camptosar injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid using a laxative or stool softener.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid driving or hazardous activity until you know how Camptosar will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction t0 Camptosar: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe or ongoing vomiting or diarrhea;

• black or bloody stools;

• nausea or vomiting that keeps you from drinking enough fluids;

• sores or white patches in or around your mouth;

• new or worsening cough or shortness of breath;

• dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• low blood cell counts - fever, tiredness, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed; or

• symptoms of sepsis - confusion, fever or chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill.

Severe diarrhea may be more likely in older adults.

Common Camptosar side effects may include:

• fever, pain, mouth sores, or other signs of infection;

• low blood cell counts, abnormal liver function tests;

• diarrhea, constipation;

• nausea, vomiting, stomach pain;

• loss of appetite, weight loss;

• weakness; or

• hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with irinotecan. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.