Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
CAMPTO is indicated for the treatment of patients with advanced colorectal cancer:
CAMPTO in combination with cetuximab is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing RAS wild-type metastatic colorectal cancer, who had not received prior treatment for metastatic disease or after failure of irinotecan-including cytotoxic therapy (see section 5.1).
CAMPTO in combination with 5-fluorouracil, folinic acid and bevacizumab is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum.
CAMPTO in combination with capecitabine with or without bevacizumab is indicated for first-line treatment of patients with metastatic colorectal carcinoma.
For adults only. CAMPTO solution for infusion should be infused into a peripheral or central vein.
In monotherapy (for previously treated patient): The recommended dosage of CAMPTO is 350 mg/m² administered as an intravenous infusion over a 30- to 90- minute period every three weeks (see sections 4.4 and 6.6).
In combination therapy (for previously untreated patient): Safety and efficacy of CAMPTO in combination with 5-fluorouracil (5FU) and folinic acid (FA) have been assessed with the following schedule (see section 5.1).
The recommended dose of CAMPTO is 180 mg/m² administered once every 2 weeks as an intravenous infusion over a 30- to 90-minute period, followed by infusion with folinic acid and 5 fluorouracil.
For the posology and method of administration of concomitant cetuximab, refer to the product information for this medicinal product.
Normally, the same dose of irinotecan is used as administered in the last cycles of the prior irinotecan-containing regimen. Irinotecan must not be administered earlier than 1 hour after the end of the cetuximab infusion.
For the posology and method of administration of bevacizumab, refer to the bevacizumab summary of product characteristics.
For the posology and method of administration of capecitabine combination, please see section 5.1 and refer to the appropriate sections in the capecitabine summary of product characteristics.
CAMPTO should be administered after appropriate recovery of all adverse events to Grade 0 or 1 NCI-CTC grading (National Cancer Institute Common Toxicity Criteria) and when treatment-related diarrhoea is fully resolved.
At the start of a subsequent infusion of therapy, the dose of CAMPTO, and 5FU when applicable, should be decreased according to the worst grade of adverse events observed in the prior infusion. Treatment should be delayed by 1 to 2 weeks to allow recovery from treatment-related adverse events.
With the following adverse events a dose reduction of 15 to 20% should be applied for CAMPTO and/or 5FU when applicable:
Recommendations for dose modifications of cetuximab when administered in combination with irinotecan must be followed according to the product information for this medicinal product.
In combination with capecitabine for patients 65 years of age or more, a reduction of the starting dose of capecitabine to 800 mg/m² twice daily is recommended according to the summary of product characteristics for capecitabine. Refer also to the recommendations for dose modifications in combination regimen given in the summary of product characteristics for capecitabine.
Treatment with CAMPTO should be continued until there is an objective progression of the disease or an unacceptable toxicity.
In monotherapy: Blood bilirubin levels [up to 3 times the upper limit of the normal range (ULN)] in patients with performance status ≤ 2, should determine the starting dose of CAMPTO. In these patients with hyperbilirubinemia and prothrombin time greater than 50%, the clearance of irinotecan is decreased (see section 5.2) and therefore the risk of hepatotoxicity is increased. Thus, weekly monitoring of complete blood counts should be conducted in this patient population.
No data are available in patients with hepatic impairment treated by CAMPTO in combination.
CAMPTO is not recommended for use in patients with impaired renal function, as studies in this population have not been conducted (see sections 4.4 and 5.2).
No specific pharmacokinetic studies have been performed in elderly. However, the dose should be chosen carefully in this population due to their greater frequency of decreased biological functions. This population should require more intense surveillance (see section 4.4).
The safety and efficacy of CAMPTO in children have not yet been established. No data are available.
Precautions to be taken before handling or administering the medicinal product.
For instructions on dilution of the medicinal product before administration, see section 6.6.
There have been reports of overdosage at doses up to approximately twice the recommended therapeutic dose, which may be fatal. The most significant adverse reactions reported were severe neutropenia and severe diarrhoea.
There is no known antidote for CAMPTO. Maximum supportive care should be instituted to prevent dehydration due to diarrhoea and to treat any infectious complications.
The shelf life of unopened vials is 24 months (40 mg in 2 mL presentation) or 36 months (100 mg in 5 mL and 300 mg in 15 mL presentations).
CAMPTO solution is physically and chemically stable with infusion solutions (0.9% (w/v) sodium chloride solution and 5% (w/v) glucose solution) for up to 28 days when stored in LDPE or PVC containers at 5°C or at 30°C and protected from light. When exposed to light, physico-chemical stability has been demonstrated for up to 3 days.
It is recommended, however, that in order to reduce microbiological hazard, the infusion solutions should be prepared immediately prior to use and infusion commenced as soon as practicable after preparation. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
For storage conditions after dilution of the medicinal product, see section 6.3.
Single amber-coloured medical-grade polypropylene vial closed with halobutyl rubber stopper. Vials contain 40 mg/2 ml; 100 mg/5ml or 300 mg/15 ml of solution.
Not all pack sizes may be marketed.
As with other antineoplastic agents, CAMPTO must be prepared and handled with caution. The use of glasses, mask and gloves is required.
If CAMPTO solution or infusion solution should come into contact with the skin, wash immediately and thoroughly with soap and water. If CAMPTO solution or infusion solution should come into contact with the mucous membranes, wash immediately with water.
As with any other injectable medicinal products, the CAMPTO solution must be prepared aseptically (see section 6.3).
If any precipitate is observed in the vials or after dilution, the product should be discarded according to standard procedures for cytotoxic agents.
Aseptically withdraw the required amount of CAMPTO solution from the vial with a calibrated syringe and inject into a 250 ml infusion bag or bottle containing either 0.9% sodium chloride solution or 5% glucose solution. The infusion should then be thoroughly mixed by manual rotation.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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