Pfizer Corporation Hong Kong Limited 美國輝瑞科研製藥

campto_pdt

Indication¹

Campto® is indicated for the treatment of patients with:

Advanced colorectal cancer (ACC) – in combination with 5-fluorouracil (5-FU) and folinic acid in patients without prior chemotherapy for advanced disease, or as a single agent in patients who have failed to respond to an established 5-FU-containing treatment regimen
Epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer – in combination with cetuximab after failure of irinotecan-inducing therapy;
Small cell or non-small cell lung cancer
Gastric cancer (inoperable or recurred)

Clinical Evidence

Irinotecan combined with fluorouracil and calcium folinate was well tolerated and increased response rate, time to progression and survival, with a later deterioration in quality of life²

Response rate was significantly higher in patients in the irinotecan group than in those in the non-irinotecan group (p<0.001 for evaluable patients, p<0.005 by intention to treat)
Time to progression was significantly longer in the irinotecan group than in the non-irinotecan group (p<0.001), and overall survival was higher (p=0.031).

Survival data from the Douillard trial

5-FU/FA, 5-fluoruracil/folinic acid

Safety Profile¹

ADVERSE REACTIONS: Delayed diarrhea, nausea and vomiting, dehydration, constipation; neutropenia, anemia, thrombocytopenia; transient acute cholinergic syndrome, fever, mild infusion site reactions; dyspnea; alopecia, mild cutaneous allergic reactions; muscular contraction or cramps, paresthesia; transient speech disorders

INTERACTIONS: Drugs with anticholinesterase activity may prolong neuromuscular blocking effects of suxamethonium; neuromuscular blockade of non-depolarizing drugs may be antagonized.

Dosages¹

Monotherapy of ACC (previously treated patients): 350 mg/m² IV infusion over 30–90 minutes every 3 weeks

Combination therapy of ACC with 5-FU (previously untreated patients): 180 mg/m² IV infusion over 30–90 minutes once every 2 weeks, followed by infusion with folinic acid and 5-FU¹

Combination therapy with cetuximab for EGFR-expressing metastatic colorectal cancer: Refer to the prescribing information of cetuximab

Monotherapy of small cell or non-small cell lung cancer, and gastric cancer: 100 mg/m² IV infusion in 3 or 4 repeated cycles of weekly treatment followed by at least 2 weeks rest; alternatively for gastric cancer, once every 2 weeks dosage schedule (150 mg/m2 IV infusion given every 2 weeks followed by at least 3 weeks rest in 2 or 3 repeated cycles)

Strengths¹

40 mg/2 mL, 100 mg/5 mL.

Packing¹

Vial 40 mg/2 mL x 1's. 100 mg/5 mL x 1's.

Important Safety Information¹

CONTRAINDICATIONS: Campto® is contraindicated in chronic inflammatory bowel disease and/or bowel obstruction; severe hypersensitivity to irinotecan hydrochloride trihydrate or any of the excipients of Campto®; bilirubin levels >3 times the upper limit of normal; interstitial pneumonia or pulmonary fibrosis; severe bone marrow failure; World Health Organization (WHO) performance status >2; concomitant treatment with atazanavir sulfate, St John’s wort; pregnancy and lactation.

SPECIAL PRECAUTIONS: Patients with impaired hepatic and renal function; elderly; increased risk of diarrhea in women and patients who have previous abdominal/pelvic radiotherapy, baseline hyperleukocytosis and WHO performance status ≥2; weekly monitoring of complete blood cell counts recommended; perform liver function tests at baseline and before each cycle; patients with bowel obstruction should not be treated with Campto® until condition is resolved; contraceptive measures should be taken during and for at least 3 months after cessation of therapy; may impair ability to drive or operate machinery

ADVERSE REACTIONS: Delayed diarrhea, nausea and vomiting, dehydration, constipation; neutropenia, anemia, thrombocytopenia; transient acute cholinergic syndrome, fever, mild infusion site reactions; dyspnea; alopecia, mild cutaneous allergic reactions; muscular contraction or cramps, paresthesia; transient speech disorders

PREGNANCY and LACTATION: Campto® should not be used in pregnancy. Breastfeeding should be discontinued for the duration of Campto® therapy. Women of child-bearing potential should be advised to avoid getting pregnant; should this occur, the attending physician should be immediately informed.

Please refer to the full prescribing information for more safety information

References

1. Campto (irinotecan). Prescribing Information: Pfizer Corporation Hong Kong Ltd; 26 August 2009
2. Douillard JY, Cunningham D, Roth AD, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. The Lancet. 2000;355(9209):1041-1047.

Please review the full product information or package insert before prescribing.