Camptosar

It is used to treat cancer of the colon or rectum .

Irinotecan interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects may also occur. Some of these may be serious and must be reported to your doctor . Other effects, like hair loss, may not be serious but may cause concern. Some effects may occur after treatment with irinotecan has been stopped. Be sure that you have discussed with your doctor the possible side effects of this medicine as well as the good it can do .

This medicine is available only with your doctor`s prescription .

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems . Although these uses are not included in product labeling, irinotecan is used in certain patients with the following medical conditions:

• Carcinoma, lung, non-small cell (treatment of nona€“small cell cancer of the lung)


• Extensive-stage small-cell lung cancer, first-line treatment, in combination with cisplatin (treatment of lung cancer; used together with cisplatin [e.g., Platinol])


• Ovarian cancer, platinum-refractory or platinum-resistant (treatment of ovarian cancer which does not respond to platinum) .


• Malignant glioma, recurrent or progressive (treatment of brain cancer that has returned or is advancing) .

This product is available in the following dosage forms:

• Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing use of irinotecan in children with use in other age groups. However, one study had to be discontinued due to serious unwanted effects in children.

Geriatric

Patients greater than 65 years of age may be at an increased risk for severe diarrhea.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended . Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Atazanavir


• Rotavirus Vaccine, Live


• St John`s Wort

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aprepitant


• Bacillus of Calmette and Guerin Vaccine, Live


• Carbamazepine


• Fosaprepitant


• Influenza Virus Vaccine, Live


• Ketoconazole


• Lopinavir


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Phenobarbital


• Phenytoin


• Poliovirus Vaccine, Live


• Rifabutin


• Rifampin


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Citalopram


• Sorafenib

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Tobacco

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bowel obstructiona€”This medicine should NOT be used until this condition is treated .

• Chickenpox (including recent exposure) or


• Herpes zoster (shingles)a€”Irinotecan may cause these conditions to get worse and spread to other parts of your body .

• Hereditary fructose intolerancea€”The risk of having severe diarrhea as a side effect of this medicine may be increased .

• Infectiona€”Irinotecan may decrease your body`s ability to fight an infection.

• Kidney diseasea€”Irinotecan may worsen condition, usually due to dehydration from severe vomiting or diarrhea .

• Liver disease or


• Severe bone marrow diseasea€”The risk of dangerously low white blood cell counts may be increased .

• Lung diseasea€”An unusual side effect consisting of fever and of shortness of breath and other problems with the lungs has occurred, very rarely, in some people with lung disease who received irinotecan.

Proper Use

Irinotecan often causes nausea and vomiting . It is very important that you continue to receive the medicine even if it makes you feel ill. Ask your health care professional about ways to lessen these effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects. Some of the side effects of this medicine do not have any symptoms and must be found with a blood test .

While you are being treated with irinotecan, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor`s approval. Irinotecan may lower your body`s resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not get live vaccines (e.g., oral poliovirus vaccine, nasal influenza [flu] virus vaccine). Try to avoid persons who have taken live vaccines. Do not get close to them and do not stay in the same room with them for very long . If you cannot take these precautions, you should wear a protective face mask that covers the nose and mouth .

Irinotecan may cause diarrhea, which can last long enough and be severe enough to cause serious medical problems . If diarrhea occurs while you are being treated with irinotecan:

• Check with your doctor immediately. Be sure to let your doctor know if the diarrhea started during an irinotecan injection or less than 24 hours afterwards. Also, be sure to tell your doctor if you had any other symptoms, such as stomach cramps or sweating, before the diarrhea started. This means that you are having a certain kind of diarrhea that may need to be treated by your doctor .


• If diarrhea first occurs more than 24 hours after a dose of irinotecan, start taking loperamide (e.g., Imodium A-D) as soon as you notice that your bowel movements are occurring more often, or are more loose than usual. Loperamide is available without a prescription. Buy some of it ahead of time, so that you will have it on hand in case it is needed. Unless otherwise directed by your doctor, take 4 milligrams (mg) of loperamide (2 capsules or tablets, or 4 teaspoonfuls of the oral solution dosage form) for the first dose, then 2 mg (1 capsule or tablet, or 2 teaspoonfuls of the oral solution dosage form) every two hours. To interrupt your sleep less often, you may take 4 mg of loperamide every four hours during the night . Continue taking loperamide, day and night, until you have not had any diarrhea for twelve hours. It is very important that you follow these (or your doctor`s) directions, even though they are different from the directions on the nonprescription (over-the-counter [OTC]) loperamide package label. The largest amount of loperamide recommended on the package label for use in a twenty-four-hour period (8 mg) is not enough for treating diarrhea caused by irinotecan. Notify your doctor if the diarrhea is not controlled within 24 hours.


• Diarrhea causes loss of body fluid, which can lead to dehydration, a serious medical problem . To prevent this, it is very important that you replace the lost fluid . While you have diarrhea, and for a day or two after the diarrhea has stopped, drink plenty of clear liquids, such as ginger ale, caffeine-free cola, decaffeinated tea, and broth. Ask your doctor about the amount of liquid you should be drinking every day. Also, ask your doctor whether you should use a sports drink (e.g., Gatorade), which contains other substances, such as sodium and potassium, that may be lost along with body fluid . Follow your doctor`s directions very carefully.


• Because alcohol and caffeine can increase fluid loss, you should not drink beverages or take any medicines that contain them while you have diarrhea. Also, avoid eating foods that may make diarrhea worse, such as bran, raw fruits or vegetables, or fatty, fried, or spicy foods.


• Vomiting can also increase the amount of fluid lost by the body and increase the risk of dehydration. If vomiting occurs at the same time as diarrhea, check with your doctor right away.


• Signs of too much fluid loss (dehydration) include decreased urination, dizziness or light-headedness, dryness of the mouth, fainting, increased thirst, and wrinkled skin . If any of these occur, check with your doctor immediately.

Irinotecan can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are needed for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination .


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin .


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Also, check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. This medicine may also cause blurred vision or other vision problems . If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert or not able to see well . If these reactions are especially bothersome, check with your doctor .

Irinotecan may also cause a temporary loss of hair in some people . After treatment has ended, normal hair growth should return.

This medicine sometimes causes flushing of the face. This effect is harmless and does not need medical treatment .

Using this medicine while you are pregnant can harm your unborn baby . If you think you have become pregnant while using the medicine, tell your doctor right away .

St. John`s Wort should not be used during irinotecan therapy. If you are using St. John`s Wort, it should be discontinued at least 2 weeks before the first cycle of irinotecan .

Ketoconazole (NizoralA®) should not be used during irinotecan treatment . If you are using ketoconazole, it should be discontinued at least 1 week prior to starting irinotecan therapy .

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

More common

• Anxiety


• Black, tarry stools


• Blood in urine or stools


• Blurred vision


• Changes in skin color


• Chest pain or discomfort


• Chest tightness or heaviness


• Chills


• Clay colored stools


• Cold hands and feet


• Confusion


• Constricted pupils


• Convulsions (seizures)


• Cough or hoarseness


• Dark urine


• Diarrhea with or without stomach cramps or sweating


• Dizziness


• Fainting


• Fast, slow, or irregular heartbeat


• Fever


• Full or bloated feeling or pressure in the stomach


• Headache


• Increased production of saliva


• Increased tear production


• Itching


• Lightheadedness when getting up from a lying or sitting position suddenly


• Loss of appetite


• Low blood pressure or pulse


• Lower back or side pain


• Nausea or vomiting


• Numbness or tingling in face, arms, or legs


• Pain


• Pain in chest, groin, or legs, especially calves of legs


• Pain in the shoulders, arms, jaw, or neck


• Painful or difficult urination


• Pale skin


• Pinpoint red spots on skin


• Redness or swelling of leg


• Runny nose


• Severe headache of sudden onset


• Shortness of breath or troubled breathing


• Skin rash


• Slow breathing


• Slurred speech


• Sore throat


• Stomach pain


• Stopping of heart


• Sudden and severe weakness in arm and/or leg on one side of the body


• Sudden loss of coordination


• Sudden vision changes


• Sweating


• Swelling


• Swelling of abdomen or stomach area


• Temporary blindness


• Tenderness, pain, or swelling of arm, foot, or leg


• Trouble speaking or walking


• Ulcers, sores, or white spots on lips or in mouth


• Unconsciousness


• Unpleasant breath odor


• Unusual bleeding or bruising


• Unusual tiredness or weakness


• Vomiting of blood


• Warm, red feeling over body


• Yellow eyes or skin

Less common

• Bleeding gums


• Coughing up blood


• Decreased urination


• Difficulty with swallowing


• Dryness of mouth


• Increased menstrual flow or vaginal bleeding


• Increased thirst


• Nosebleeds


• Paralysis


• Prolonged bleeding from cuts


• Sneezing


• Wheezing


• Wrinkled skin

Rare

• Decreased amount of urine


• Decreased frequency of urination


• Fast, irregular, or troubled breathing


• Hives


• Increased blood pressure


• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• Rapid weight gain

Incidence not known

• Abdominal pain and tenderness


• Agitation


• Bloating, full feeling


• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Coma


• Constipation


• Convulsions


• Depression


• Heartburn or indigestion


• Hostility


• Increased thirst


• Irritability


• Lethargy


• Muscle pain and cramps


• Muscle twitching


• Pain in stomach, side, or abdomen, possibly radiating to the back


• Rectal bleeding


• Severe abdominal cramping or burning


• Severe and continuing nausea


• Stupor


• Swelling of face, lower legs, ankles, fingers, or hands


• Tightness in chest


• Unusual tiredness or weakness


• Vomiting of material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Accidental injury


• Acid or sour stomach


• Belching


• Blistering, peeling, redness, and/or swelling of palms of hands or bottoms of feet


• Cracked lips


• Excess air or gas in stomach or intestines


• Feeling of constant movement of self or surroundings


• Numbness, pain, tingling, or unusual sensations in palms of hands or bottoms of feet


• Passing gas


• Right upper abdominal pain and fullness


• Sensation of spinning


• Sleepiness or unusual drowsiness


• Sleeplessness


• Stomach discomfort, upset, or pain


• Trouble sleeping


• Unable to sleep


• Weight loss

The side effects listed above may occur, or continue to occur, after treatment with irinotecan has ended. Check with your doctor if you notice any of them after you stop receiving the medicine.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.