Pronunciation:

eye-ri-noe-TEE-kan

Brand Names:

• Camptosar

Dosage Forms:

• Solution

Warnings:

Irinotecan hydrochloride should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Irinotecan hydrochloride can induce both early and late forms of diarrhea that appear to be mediated by different mechanisms. Both forms of diarrhea may be severe. Early diarrhea (occurring during or shortly after infusion of irinotecan hydrochloride) may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping. Early diarrhea and other cholinergic symptoms may be prevented or ameliorated by atropine. Late diarrhea (generally occurring more than 24 hours after administration of irinotecan hydrochloride) can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis. Late diarrhea should be treated promptly with loperamide. Patients with diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated or antibiotic therapy if they develop ileus, fever, or severe neutropenia. Administration of irinotecan hydrochloride should be interrupted and subsequent doses reduced if severe diarrhea occurs.

Severe myelosuppression may occur .

Can induce both early and late forms of diarrhea that appear to be mediated by different mechanisms and both forms of diarrhea may be severe. Early diarrhea may be accompanied by cholinergic symptoms that may be prevented or ameliorated by atropine. Late diarrhea (generally occurring more than 24 hours after administration of irinotecan) can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis. Late diarrhea should be treated promptly with loperamide and administration of irinotecan should be interrupted and subsequent doses reduced if severe diarrhea occurs. Severe myelosuppression may occur with irinotecan administration .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Topoisomerase I Inhibitor

Uses of This Medicine:

Irinotecan belongs to the group of medicines called antineoplastics (cancer drugs). 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 non–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) .

Before Using This Medicine:

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.

Children—

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.

Older adults—

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

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

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.

Other medicines—

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.

• Rotavirus Vaccine, Live
• St John's Wort

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 obstruction—This medicine should NOT be used until this condition is treated .

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Irinotecan may cause these conditions to get worse and spread to other parts of your body.

• Hereditary fructose intolerance—The risk of having severe diarrhea as a side effect of this medicine may be increased .

• Infection—Irinotecan may decrease your body's ability to fight an infection.

• Kidney disease—Irinotecan may worsen condition, usually due to dehydration from severe vomiting or diarrhea .

• Liver disease or
• Severe bone marrow disease—The risk of dangerously low white blood cell counts may be increased .

• Lung disease—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 of This Medicine:

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 While Using This Medicine:

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 (Nizoral®) 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 of This Medicine:

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.