Furmecil

The standard and reduced Furmecil Capsule and cisplatin doses should be calculated according to the body surface area

The recommended standard dose of Furmecil when taken by mouth with water at least 60 minutes before or 60 minutes after a meal is 25 mg/m2 (expressed as tegafur content) twice a day, morning and evening, for 3 weeks or 21 consecutive days followed by one week or 7 days rest (1 treatment cycle). This cycle is repeated every 4 weeks (28 days). The capsule should not be opened, broken, crushed or chewed because it may affect the healthy cells when it comes into contact as it is a cytotoxic agent.

The recommended dose of cisplatin with this regimen is 75 mg/m2 administered by intravenous infusion once every 4 weeks. Cisplatin should be discontinued after 6 cycles without withdrawal of Furmecil. If cisplatin is discontinued prior to 6 cycles, Furmecil treatment alone can be resumed when the criteria for restarting it are met.

The most commonly reported side effects due to Furmecil in combination with cisplatin may include neutropenia (low levels of neutrophils, a type of WBC), anaemia (low RBCs count) and fatigue (tiredness).

• Furmecil 20 mg capsule should only be prescribed by a qualified health specialist in treating cancer patients with anti-neoplastic medicinal products. Patients should be provided with outpatient prescriptions for antiemetic and antidiarrheal medicinal products.
• Patients treated with Furmecil together with cisplatin should be precisely monitored and laboratory tests, including haematology, renal function, liver function, and serum electrolytes, should be done frequently. Treatment should be interrupted if progressive disease or intolerable toxicity is noticed.
• Treatment-related bone marrow suppression, including neutropenia, thrombocytopenia, leukopenia, anaemia, and pancytopenia, has been seen among patients treated with Furmecil along with cisplatin. Patients with low WBC counts should be assessed carefully for infection and risk of other complications of neutropenia and treated as medically required. Patients with reduced platelet counts are at higher risk for bleeding and need to be monitored carefully.
• Test patients for HBV infection before initiating treatment with Furmecil. Experts in liver disease and in treating hepatitis B should be consulted prior to the initiation of treatment in those with positive hepatitis B serology (including those with active disease) and for those who test positive for HBV infection during treatment.
• Patients with diarrhoea need to be carefully monitored and given fluid and electrolyte replacement in case they become dehydrated. Prophylactic treatment for diarrhoea needs to be used as required. Standard anti-diarrhoeal therapy and intravenous fluids/electrolytes should be started early when diarrhoea occurs.
• Patients with nausea, anorexia, asthenia, vomiting, stomatitis, diarrhoea, and gastrointestinal obstruction should be evaluated closely for signs/symptoms of dehydration. Dehydration needs to be managed aggressively with rehydration and other apt measures. In case higher dehydration occurs, treatment should be promptly suspended and the dehydration corrected.
• Treatment with Furmecil 20 mg -Tegafur 20 mg + Gimeracil 5.8 mg + Oteracil 15.8 mg is not for patients with severe renal impairment because of the possibly greater incidence of adverse events in the blood and lymphatic system and the probability of unexpectedly greater exposure to 5-FU as an outcome of fluctuations in renal function in these patients, unless the benefits clearly outweigh the risks.
• Fluoropyrimidines may enhance the phenytoin plasma concentration when used concomitantly with phenytoin causing phenytoin toxicity. A bit more frequent monitoring of phenytoin blood or plasma levels is needed when Furmecil and phenytoin are used concomitantly.
• Women of childbearing age should avoid becoming pregnant while receiving treatment with Furmecil. Contraceptive measures should be considered by both male and female patients during and up to six months after stopping Furmecil treatment.
• Furmecil is contraindicated during breastfeeding. It is not specified whether Furmecil or its metabolites are excreted in human milk. Available pharmacodynamic/toxicological findings in animals have demonstrated excretion of Furmecil or its metabolites in milk. A risk to infants or newborns cannot be excluded. Breast-feeding must be discontinued while on therapy with Furmecil.
• This medicinal product has moderate influence on the potential to drive and use machines as dizziness, fatigue, blurred vision, and nausea are common side effects of Furmecil in combination with medicine cisplatin.

Store the Capsules of Tegafur/Gimeracil/Oteracil at room temperature between 15°C and 25°C. Protect it from excess heat and moisture. Keep the capsules away from the access of children.

• Brivudine must not be used concomitantly with Furmecil. Fatal cases have been seen following capecitabine interaction. There must be at least a 4 week waiting time-span between end of therapy with brivudine and start of Furmecil therapy. Therapy with brivudine can be initiated 24 hours after the final dose of Furmecil.
• Co-administration of other fluoropyrimidines such as 5-FU, capecitabine, tegafur, or flucytosine may lead to additive toxicities, and is contraindicated. A minimum washout time-span of 7 days is needed between administration of Furmecil and other fluoropyrimidines.
• As CYP2A6 is a major enzyme responsible for the conversion of tegafur to 5-FU, co-administration of CYP2A6 inhibitors and Furmecil needs to be avoided as effectiveness of Furmecil could be decreased.
• Activity of a coumarin-derivative anticoagulant was increased by Furmecil 15 mg -Tegafur 15 mg + Gimeracil 4.35 mg + Oteracil 11.8 mg. Caution is needed as co-administration of this medicine and coumarin anticoagulation therapy may increase the probability of bleeding.
• Depending on non-clinical findings, allopurinol may reduce anti-tumour activity because of the suppression of phosphorylation of 5-FU. Therefore, concurrent use with Furmecil should be avoided.