Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Adverse reactions to calcium folinate are rare, but following intravenous or intramuscular administration, occasional pyrexial reactions have been reported.

The most common dose-limiting adverse reaction occurring in patients receiving combination of Calcium Folinate and 5-fluorouracil are stomatitis and diarrhoea. In addition, haematological adverse reactions, such as leukocytopenia and thrombocytopenia, may occur. These adverse reactions are dose-dependent and their occurrence can usually be decreased by reducing the dosage of cytotoxic drugs. These adverse reactions can be controlled by close monitoring of haematological values, e.g.
blood leucocyte and thrombocyte levels, serum electrolyte (e.g. Na, K, Ca) and creatinine levels.

Anaphylactoid and urticaria allergic reactions have also been reported with the use of Calcium Folinate.


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il