Comprehensive Product Description Guide: Camptosar Injection (Irinotecan Hydrochloride)
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What is Camptosar Injection used for
Camptosar Injection contains irinotecan hydrochloride, a chemotherapy medication used in the treatment of metastatic colorectal cancer. It works by inhibiting DNA replication in cancer cells, leading to cell death and tumor reduction. It is often used alone or in combination with other anticancer agents.
Camptosar Injection (Irinotecan Hydrochloride) – 100 mg/5 mL Vial

Irinotecan Hydrochloride Trihydrate (equivalent to Irinotecan base 100 mg per 5 mL)

Irinotecan Injection

CPT-11

Irinotecan Hydrochloride

Camptothecin analog

Camptosar Chemotherapy Injection
Therapeutic Class: Antineoplastic agent

Drug Class: Topoisomerase I inhibitor

Schedule: Prescription-only (S4 – Australia)
Camptosar (irinotecan) is a semi-synthetic derivative of camptothecin, which inhibits the enzyme topoisomerase I. This enzyme is essential for DNA replication and transcription. By stabilizing the DNA-topoisomerase I complex, irinotecan prevents the re-ligation of single-strand breaks in DNA, ultimately leading to double-stranded DNA damage and apoptosis of rapidly dividing cancer cells.

Indications / Uses:
Camptosar is indicated for the treatment of:

Metastatic colorectal cancer

As monotherapy for patients who have failed prior 5-fluorouracil-based therapy

As combination therapy (e.g., with 5-FU/leucovorin) in first-line treatment

Emerging indications in clinical trials (off-label or under investigation):

Small cell lung cancer

Gastric (stomach) cancer

Pancreatic cancer

Cervical cancer
Monotherapy Regimen (for previously treated colorectal cancer):

125 mg/m² IV over 90 minutes once weekly for 4 weeks, followed by 2-week rest, OR

350 mg/m² IV once every 3 weeks

Combination Therapy (e.g., with 5-FU/LV):

Irinotecan 180 mg/m² IV every 2 weeks in combination with bolus/infusional 5-FU and leucovorin
Administered by slow intravenous infusion over 90 minutes

Should only be given by trained healthcare professionals in a hospital or oncology clinic

Premedication with atropine or antiemetics may be necessary
TGA Schedule: S4 – Prescription-only

TGA Approved Indication: Metastatic colorectal carcinoma

Dosage must be adjusted based on hematologic status, hepatic function, and toxicity profile

Patients with UGT1A1*28 polymorphism may experience higher toxicity (genetic testing recommended)
Diarrhoea (early-onset and late-onset)

Nausea and vomiting

Neutropenia (low white blood cell count)

Fatigue

Alopecia (hair loss)

Anorexia

Fever without infection

Serious Side Effects:

Severe neutropenic sepsis

Grade 3–4 diarrhoea and dehydration

Interstitial lung disease

Liver enzyme elevations

Hypotension or anaphylactoid reactions
Monitor complete blood counts frequently during therapy

Avoid in patients with severe hepatic impairment

Early-onset diarrhoea (within 24 hours) may be cholinergic and requires atropine

Late-onset diarrhoea (after 24 hours) can be life-threatening – requires loperamide and possible hospitalization

Avoid pregnancy and breastfeeding during and for several months after therapy

Ensure adequate hydration during treatment cycles
Strong CYP3A4 inhibitors/inducers (e.g., ketoconazole, rifampin) may affect irinotecan metabolism

St. John’s Wort may reduce plasma levels of irinotecan

Increased risk of toxicity when combined with other myelosuppressive agents

Use caution with laxatives or diuretics due to risk of dehydration from diarrhoea
Store at 2°C to 8°C (refrigerated)

Protect from light

Do not freeze

Use reconstituted product within 24 hours if stored properly

Clinical Evidence & Trials:
Cunningham et al. (2000) NEJM: Irinotecan + 5-FU/LV vs. 5-FU/LV alone showed significantly improved progression-free and overall survival

Douillard et al. (2000): FOLFIRI regimen (irinotecan, 5-FU, LV) is superior first-line therapy for metastatic colorectal cancer

UGT1A1 polymorphism testing shown to predict irinotecan-induced neutropenia risk

Frequently Asked Questions (FAQs):
Q: What is Camptosar used to treat?
A: Camptosar is primarily used to treat metastatic colorectal cancer, especially when other treatments have failed. It may also be part of combination chemotherapy regimens.

Q: How is Camptosar given?
A: It is administered as a 90-minute IV infusion by a healthcare professional, often in a hospital setting.

Q: What are the major side effects of Camptosar?
A: The most serious side effects include diarrhoea, neutropenia, vomiting, and fatigue. Monitoring and supportive care are critical.

Q: Can Camptosar be used in children?
A: It is not approved for pediatric use in most regions and should be used only under clinical trial settings for children.

Q: Can Camptosar be self-administered at home?
A: No. It must be administered under the supervision of trained oncology professionals in a healthcare facility.
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