Irinotecan hydrochloride

What is Irinotecan hydrochloride?

• Irinotecan hydrochloride (Camptosar) is a topoisomerase inhibitor used alone or with other drugs to treat colon cancer or rectal cancer that has spread to other parts of the body or has come back after treatment with fluorouracil.

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Irinotecan

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What are the uses of this medicine?

Irinotecan hydrochloride (Camptosar) used for:

• First-line therapy in combination with 5-fluorouracil and leucovorin 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.

How does this medicine work?

• Irinotecan is a derivative of camptothecin.
• Camptothecins interact specifically with the enzyme topoisomerase I, which relieves torsional strain in DNA by inducing reversible single-strand breaks.
• Irinotecan hydrochloride blocks certain enzymes needed for cell division and DNA repair, and it may kill cancer cells.
• It is a type of topoisomerase inhibitor and a type of camptothecin analog.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a known hypersensitivity to the drug or its excipients.

What drug interactions can this medicine cause?

• Do not administer strong CYP3A4 inducers with Camptosar.
• Do not administer strong CYP3A4 inhibitors with Camptosar.

Is this medicine FDA approved?

• Irinotecan was approved for medical use in the United States in 1996.

How should this medicine be used?

• It is recommended that patients receive premedication with antiemetic agents.

Recommended dosage and Administration: Colorectal cancer combination regimen 1:

• Camptosar 125 mg/m2 intravenous infusion over 90 minutes on days 1, 8,15, 22 with LV 20 mg/m2 intravenous bolus infusion on days 1, 8, 15, 22 followed by 5-FU intravenous bolus infusion on days 1, 8, 15, 22 every 6 weeks.

Colorectal cancer combination regimen 2:

• Camptosar 180 mg/m2 intravenous infusion over 90 minutes on days 1, 15, 29 with LV 200 mg/m2 intravenous infusion over 2 hours on days 1, 2, 15, 16, 29, 30 followed by 5-FU 400 mg/m2 intravenous bolus infusion on days 1, 2, 15, 16, 29, 30 and 5-FU 600 mg/m2 intravenous infusion over 22 hours on days 1, 2, 15, 16, 29, 30.

Colorectal cancer single agent regimen 1:

• Camptosar 125 mg/m2 intravenous infusion over 90 minutes on days 1, 8, 15, 22 then 2-week rest.

Colorectal cancer single agent regimen 2:

• Camptosar 350 mg/m2 intravenous infusion over 90 minutes on day 1 every 3 weeks.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 40 mg/2 mL (20 mg/mL), 100 mg/5 mL (20 mg/mL), and 300 mg/15 mL (20 mg/mL) solution in a single-dose vial.

This medicine is available in fallowing brand namesː

• Camptosar

What side effects can this medication cause?

The most common side effects of this medicine include: In combination therapy:

• nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, mucositis, neutropenia, leukopenia (including lymphocytopenia), anemia, thrombocytopenia, asthenia, pain, fever, infection, abnormal bilirubin, alopecia

In single agent therapy:

• nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, neutropenia, leukopenia (including lymphocytopenia), anemia, asthenia, fever, body weight decreasing, alopecia

What special precautions should I follow?

• Early diarrhea (occurring during or shortly after infusion of Camptosar) is usually transient and may be accompanied by cholinergic symptoms. Consider prophylactic or therapeutic administration of 0.25 mg to 1 mg of intravenous or subcutaneous atropine (unless clinically contraindicated). Late diarrhea (generally occurring more than 24 hours after administration of Camptosar) can occur. Monitor and replace fluid and electrolytes. Treat with loperamide. Use antibiotic support for ileus and fever. Interrupt Camptosar and reduce subsequent doses if severe diarrhea occurs.
• Camptosar can cause severe myelosuppression. Manage promptly with antibiotic support. Interrupt Camptosar and reduce subsequent doses if necessary.
• Individuals with UGT1A1*28/*28, or *6/*6, or *6/*28 genotypes are at increased risk for severe neutropenia during Camptosar treatment.
• Hypersensitivity reactions including severe anaphylactic or anaphylactoid reactions have been observed. Discontinue Camptosar if this occurs.
• Rare cases of renal impairment and acute renal failure have been identified, usually in patients who became volume depleted from severe vomiting and/or diarrhea.
• Interstitial Pulmonary Disease (IPD)-like events, including fatalities, have occurred. Interrupt for new or progressive dyspnea, cough, and fever pending evaluation. If IPD diagnosed, discontinue and institute appropriate treatment as needed.
• Camptosar should not be used in combination with a regimen of 5-FU/LV administered for 4–5 consecutive days every 4 weeks outside of a clinical study.
• Camptosar can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. Advise male patients with female partners of reproductive potential to use condoms.
• In clinical trials, Camptosar has not been administered to patients with serum bilirubin > 2.0 mg/dL, or transaminases > 3 times ULN if no liver metastases, or transaminases > 5 times ULN if liver metastases. With the weekly dosage schedule, patients with total bilirubin levels 1.0–2.0 mg/dL had greater likelihood of grade 3–4 neutropenia.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• severe neutropenia
• severe diarrhea

Management of overdosage:

• There is no known antidote for overdosage of Camptosar.
• Maximum supportive care should be instituted to prevent dehydration due to diarrhea and to treat any infectious complications.

Can this medicine be used in pregnancy?

• Based on findings from animal studies and its mechanism of action, Camptosar can cause fetal harm when administered to a pregnant woman.
• Advise pregnant women of the potential risk to a fetus.

Can this medicine be used in children?

• The effectiveness of irinotecan in pediatric patients has not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• IRINOTECAN HYDROCHLORIDE

Inactive ingredients:

• LACTIC ACID, UNSPECIFIED FORM
• SODIUM HYDROXIDE
• HYDROCHLORIC ACID

Who manufactures and distributes this medicine?

• Packager: Pharmacia & Upjohn Company LLC

What should I know about storage and disposal of this medication?

• Store at controlled room temperature 15°C to 30°C (59° to 86°F).
• Protect from light.
• Keep the vial in the carton until the time of use.
• Inspect the vial for damage and visible signs of leaks before removing from the carton.
• If damaged, incinerate the unopened package.
• Camptosar is a hazardous drug.
• Follow special handling and disposal procedures.

• Dailymed label info on Irinotecan hydrochloride
• FDA Irinotecan hydrochloride

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