Camptosar Injection

DRUG DESCRIPTION

CAMPTOSAR Injection (irinotecan hydrochloride injection) is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride was clinically investigated as CPT-11.

CAMPTOSAR is supplied as a sterile, pale yellow, clear, aqueous solution. It is available in two single-dose sizes: 2 mL-fill vials contain 40 mg irinotecan hydrochloride and 5 mL-fill vials contain 100 mg irinotecan hydrochloride. Each milliliter of solution contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of sorbitol NF powder, and 0.9 mg of lactic acid, USP. The pH of the solution has been adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. CAMPTOSAR is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP.

Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata or is chemically synthesized.

The chemical name is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1Hpyrano[3',4':6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4'bipiperidine]-1'-carboxylate, monohydrochloride, trihydrate. Its structural formula is as follows:

Camptosar®
(irinotecan hydrochloride)  Structural Formula Illustration

Irinotecan hydrochloride is a pale yellow to yellow crystalline powder, with the empirical formula C33H38N4O6•HCl•3H2O and a molecular weight of 677.19. It is slightly soluble in water and organic solvents.

What are the possible side effects of irinotecan (Camptosar)?

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

Call your doctor at once if you have any of these serious side effects:

  • pale skin, easy bruising or bleeding, unusual weakness;
  • loose stools, watery diarrhea;
  • bloody or black stools;
  • runny nose, watery eyes, increased sweating, stomach cramps, and warmth, tingling, or redness under your skin;
  • fever, chills, body aches,...

Read All Potential Side Effects and See Pictures of Camptosar Injection »

What are the precautions when taking irinotecan hydrochloride (Camptosar Injection)?

Before using irinotecan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: bowel blockage (e.g., paralytic ileus), certain genetic metabolism disorder (fructose intolerance).

Before using this drug, tell your doctor your medical history, including: radiation treatments, blood/bone marrow disorders (e.g., low platelet/neutrophil/red blood cell levels), diabetes, liver disease, kidney disease, lung disease.

Before having surgery, tell...

Read All Potential Precautions of Camptosar Injection »


Camptosar Injection Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, loss of appetite, constipation, cough, drowsiness, mouth sores, weakness, or trouble sleeping may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, or if you are unable to drink/eat because of nausea/vomiting, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: pain/redness/swelling at the injection site or arms/legs, numbness/tingling/burning of arms/legs, black/bloody stools, change in the amount of urine, lung problems (such as shortness of breath, cough).

Get medical help right away if any of these unlikely but serious side effects occur: chest pain, weakness on one side of the body, slurred speech, confusion, trouble breathing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Irinotecan can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using irinotecan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: bowel blockage (e.g., paralytic ileus), certain genetic metabolism disorder (fructose intolerance).

Before using this drug, tell your doctor your medical history, including: radiation treatments, blood/bone marrow disorders (e.g., low platelet/neutrophil/red blood cell levels), diabetes, liver disease, kidney disease, lung disease.

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

To avoid dizziness and lightheadedness when rising from a sitting or lying position, get up slowly.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Wash your hands well to prevent the spread of infections.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially diarrhea.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while using this medication. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (e.g., condoms, birth control pills) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Camptosar Injection Patient Information Including Side Effects

Brand Names: Camptosar

Generic Name: irinotecan (Pronunciation: EYE ri noe TEE kan)

  • What is irinotecan (Camptosar Injection)?
  • What are the possible side effects of irinotecan (Camptosar Injection)?
  • What is the most important information I should know about irinotecan (Camptosar Injection)?
  • What should I discuss with my healthcare provider before receiving irinotecan (Camptosar Injection)?
  • How is irinotecan given (Camptosar Injection)?
  • What happens if I miss a dose (Camptosar Injection)?
  • What happens if I overdose (Camptosar Injection)?
  • What should I avoid while using irinotecan (Camptosar Injection)?
  • What other drugs will affect irinotecan (Camptosar Injection)?
  • Where can I get more information?

What is irinotecan (Camptosar Injection)?

Irinotecan is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

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

Irinotecan may also be used for other purposes not listed in this medication guide.

What are the possible side effects of irinotecan (Camptosar Injection)?

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

Call your doctor at once if you have any of these serious side effects:

  • pale skin, easy bruising or bleeding, unusual weakness;
  • loose stools, watery diarrhea;
  • bloody or black stools;
  • runny nose, watery eyes, increased sweating, stomach cramps, and warmth, tingling, or redness under your skin;
  • fever, chills, body aches, flu symptoms;
  • white patches or sores inside your mouth or on your lips;
  • sudden numbness or weakness, headache, confusion, problems with vision, speech, or balance;
  • chest pain, pain or swelling in one or both legs;
  • swelling or irritation where the IV needle is placed;
  • nausea or vomiting that keeps you from drinking enough fluids; or
  • signs of dehydration, such as dry mouth, increased thirst, drowsiness, feeling light-headed, or fainting.

Less serious side effects may include:

  • loss of appetite, constipation;
  • dizziness;
  • redness or peeling of the skin on your hands and feet;
  • cough,
  • temporary 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.

What is the most important information I should know about irinotecan (Camptosar Injection)?

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Irinotecan can cause severe diarrhea, which can be life-threatening if it leads to dehydration. Diarrhea can occur soon after your injection or more than 24 hours later.

Your doctor may recommend you have an anti-diarrhea medicine such as loperamide (Imodium) available at all times while you are receiving irinotecan. Take the anti-diarrhea medication at the first sign of loose or frequent bowel movements.

Call your doctor if you still have diarrhea after 24 hours of taking anti-diarrhea medicine.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with irinotecan, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

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