Chemical formula: C₂₀H₂₃N₇O₇ Molecular mass: 473.439 g/mol PubChem compound: 135398559
There are no adequate and well-controlled clinical studies conducted in pregnant women.
No formal animal reproductive toxicity studies with disodium levofolinate 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, there are no limitations as to the use of disodium levofolinate 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 levofolinate with 5-fluorouracil.
Please refer also to the summaries of product characteristics for methotrexate-, other folate antagonists and 5-fluorouracil-containing medicinal products.
There are no adequate and well-controlled clinical studies conducted in breast-feeding women.
Calcium levofolinate may be excreted in human milk and should only be administered where the benefits of the drug to the mother outweigh possible hazards to the infant. Calcium levofolinate 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.
There is no evidence that calcium levofolinate has an effect on the ability to drive or use machines.
Frequencies: 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).
| Immune system disorders | Very rare Allergic reactions including anaphylactoid/anaphylactic reactions and urticaria |
| Psychiatric disorders | Rare Insomnia, agitation and depression after high doses |
| Nervous system disorders | Rare Increase in the frequency of attacks in epileptics |
| Gastrointestinal disorders | Rare Gastrointestinal disorders after high doses |
| General disorders and administration site conditions | Uncommon Fever has been observed after administration of disodium levofolinate as solution for injection |
Generally, the safety profile depends on the applied regimen of 5-fluorouracil due to enhancement of the 5-fluorouracil induced toxicities.
| Blood and lymphatic system disorders | Very common Bone marrow failure, including fatal cases |
| Metabolism and nutrition disorders | Not known Hyperammonaemia |
| Skin and subcutaneous tissue disorders | Common Palmar-plantar erythrodysaesthesia |
| General disorders and administration site conditions | Very common Mucositis, including stomatitis and cheilitis. Fatalities have occurred as a result of mucositis. |
Monthly regimen:
| Gastrointestinal disorders | Very common Vomiting and nausea |
No enhancement of other 5-fluorouracil induced toxicities (e.g. neurotoxicity).
Weekly regimen:
| Gastrointestinal disorders | Very common Diarrhoea with higher grades of toxicity, and dehydration resulting in hospital admission for treatment and even death |
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