Chemical formula: C₂₀H₂₂N₇NaO₇ Molecular mass: 495.148 g/mol
There are no adequate and well-controlled clinical studies conducted in pregnant or breast-feeding women. No formal animal reproductive toxicity studies with disodium folinate have been conducted. There are no indications that folinic acid induces harmful effects if administered during pregnancy.
During pregnancy, methotrexate should only be administered on strict indications, where the benefits of the medicinal product to the mother should be weighed against possible hazards to the foetus. Should treatment with methotrexate or other folate antagonists take place despite pregnancy or lactation, there are no limitations as to the use of disodium folinate to diminish toxicity or counteract the effects.
5-fluorouracil use is generally contraindicated during pregnancy and breast-feeding; this applies also to the combined use of disodium folinate with 5-fluorouracil. Please refer also to the summaries of product characteristics for methotrexate-, other folate antagonists and 5-fluorouracil-containing medicinal products.
It is not known whether disodium folinate is excreted into human breast milk. Disodium folinate can be used during breast feeding when considered necessary according to the therapeutic indications.
No information is available on the effects of folinic acid alone on fertility and general reproductive performance.
Disodium folinate has no or negligible influence on the ability to drive and use machines. The general condition of the patient is likely to be more significant than any effects induced by this medicinal product.
Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Very rare: Allergic reactions – sensitisation, including anaphylactoid reactions and urticaria
Rare: Insomnia, agitation and depression after high doses
Rare: Increase in the frequency of attacks in epileptics
Rare: Gastrointestinal disorders after high doses
Uncommon: Fever has been observed after administration of disodium folinate as solution for injection.
Disodium folinate enhances the toxicity of 5-fluorouracil. Generally, the safety profile depends on the applied regimen of 5-fluorouracil.
Very common: Bone marrow failure, including fatal cases
Not known: Hyperammonaemia
Common: Palmar-plantar erythrodysaesthesia
Very common: Mucositis, including stomatitis and cheilitis. Fatalities have occurred as a result of mucositis.
Very common: Vomiting and nausea
No enhancement of other 5-fluorouracil induced toxicities (e.g. neurotoxicity).
Very common: Bone marrow failure, including fatal cases
Very common: Diarrhoea with higher grades of toxicity, and dehydration resulting in hospital admission for treatment and even death
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