Pronunciation:

eye-ri-noe-TEE-kan

Brand Names:

• Camptosar
• Novaplus Irinotecan Hydrochloride

Dosage Forms:

• Solution

Warnings:

Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine; late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt irinotecan and reduce subsequent doses if severe diarrhea occurs. Severe myelosuppression may occur .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Topoisomerase I Inhibitor

Uses of This Medicine:

Irinotecan injection is given together with other medicines (eg, 5-fluorouracil, leucovorin) to treat patients with metastatic cancer (a cancer that has already spread) of the colon or rectum. This medicine is also given to patients with metastatic cancer of the colon or rectum who have received fluorouracil but disease has progressed or recurred.

Irinotecan belongs to the group of medicines called antineoplastics (cancer medicines). It 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 benefits it can do.

This medicine is to be given only by or under the direct supervision of your doctor.

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—

Appropriate studies have not been performed on the relationship of age to the effects of irinotecan injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of irinotecan injection in the elderly. However, elderly patients are more likely to have severe diarrhea, which may require caution and an adjustment in the dose for patients receiving irinotecan.

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—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. 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 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
• Itraconazole
• Ketoconazole
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

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.

• Abametapir
• Adenovirus Vaccine, Live
• Asciminib
• Bacillus of Calmette and Guerin Vaccine, Live
• Boceprevir
• Capmatinib
• Carbamazepine
• Cholera Vaccine, Live
• Clarithromycin
• Cobicistat
• Conivaptan
• Darolutamide
• Darunavir
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Eltrombopag
• Enasidenib
• Encorafenib
• Fedratinib
• Fexinidazole
• Fosnetupitant
• Fosphenytoin
• Idelalisib
• Indinavir
• Influenza Virus Vaccine, Live
• Leflunomide
• Leniolisib
• Lopinavir
• Mavacamten
• Midostaurin
• Momelotinib
• Nefazodone
• Nelfinavir
• Netupitant
• Omaveloxolone
• Phenobarbital
• Phenytoin
• Poliovirus Vaccine, Live
• Posaconazole
• Primidone
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Saquinavir
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• St John's Wort
• Tafamidis
• Telaprevir
• Telithromycin
• Teriflunomide
• Tipranavir
• Typhoid Vaccine, Live
• Voriconazole
• 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
• Rolapitant

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.

• Grapefruit Juice
• 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:

• Bleeding problems or
• Kidney disease or
• Liver disease or
• Lung disease (eg, interstitial pulmonary disease) or
• Severe diarrhea—Use with caution. May make these conditions worse.

• Bone marrow disease, severe or
• Bowel blockage or
• Gilbert's syndrome (an inherited disorder) or
• Neutropenia (low white blood cells) or
• Reduced UGT1A1 activity (an enzyme problem)—May increase risk for more serious side effects.

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

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

Irinotecan often causes nausea and vomiting. However, it is very important that you continue to receive this medicine even if you begin to feel ill. You may receive other medicines to help with the nausea and vomiting. Ask your doctor for other ways to lessen these effects.

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. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 6 months after your last dose. Males who are using this medicine, with female partners who can become pregnant must use effective birth control during and for at least 3 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have chills, fever, hives, hoarseness, itching, rash, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.

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 (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 2 hours. To interrupt your sleep less often, you may take 4 mg of loperamide every 4 hours during the night. Continue taking loperamide, day and night, until you have not had any diarrhea for 12 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 24-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 (eg, 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 the 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.

Call your doctor right away if you have an unexplained fever, cough, or trouble breathing after receiving this medicine. These may be symptoms of a serious lung problem.

This medicine may increase your risk of having blood clots. Tell your doctor right away if you start having a sudden and severe headache, trouble breathing, or problems with vision, speech, or walking.

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.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

Ketoconazole (Nizoral®) and St. John's wort should not be used while you are receiving irinotecan. If you are using St. John's wort, it should be discontinued at least 2 weeks before the first cycle of irinotecan. If you are using ketoconazole, it should be discontinued at least 1 week before starting irinotecan treatment.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 or nurse immediately if any of the following side effects occur:

More common

Anxiety

black, tarry stools

blood in the 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

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 or skin rash

lightheadedness when getting up suddenly from a lying or sitting position

loss of appetite

low blood pressure or pulse

lower back or side pain

nausea or vomiting

numbness or tingling in the face, arms, or legs

pain

pain in the chest, groin, or legs, especially calves of the legs

pain in the shoulders, arms, jaw, or neck

painful or difficult urination

pale skin

pinpoint red spots on the skin

redness or swelling of the leg

runny nose

severe headache of sudden onset

slow breathing

slurred speech

sore throat

stomach pain

stopping of the heart

sudden and severe weakness in the arm or leg on one side of the body

sudden loss of coordination

sudden vision changes

sweating

swelling

swelling of the abdomen or stomach area

temporary blindness

tenderness, pain, or swelling of the arm, foot, or leg

troubled breathing

trouble with speaking or walking

ulcers, sores, or white spots on the lips or in the mouth

unconsciousness

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood

warm, red feeling over the body

yellow eyes or skin

Less common

Bleeding gums

coughing up blood

decreased urination

difficulty with swallowing

dryness of the mouth

increased menstrual flow or vaginal bleeding

increased thirst

nosebleeds

paralysis

prolonged bleeding from cuts

sneezing

wrinkled skin

Rare

Decreased amount of urine

decreased frequency of urination

fast, irregular, or troubled breathing

hives

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid weight gain

Incidence not known

Abdominal or stomach pain and tenderness

agitation

bloated or full feeling

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

coma

constipation

depression

heartburn or indigestion

hostility

irritability

lethargy

muscle pain and cramps

muscle twitching

pain in the stomach, side, or abdomen, possibly radiating to the back

pain or discomfort in the arms, jaw, back, or neck

rectal bleeding

severe abdominal or stomach cramping or burning

severe and continuing nausea

stupor

swelling of the face, lower legs, ankles, fingers, or hands

tightness in the 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

Acid or sour stomach

belching

blistering, peeling, redness, or swelling of the palms of hands or bottoms of the feet

cracked lips

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of feet

passing gas

right upper abdominal or stomach pain and fullness

sensation of spinning

sleepiness or unusual drowsiness

stomach discomfort, upset, or pain

trouble sleeping

weight loss

Incidence not known

Hiccups

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.