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Reduction of methotrexate toxicity; adjunct to fluorouracil in colorectal cancer


Known hypersensitivity to calcium levofolinate, or to any components of the excipients. Calcium levofolinate should not be used for the treatment of pernicious anaemia or other megaloblastic anaemias due to vitamin B12 deficiency. Regarding the use of calcium levofolinate with methotrexate or 5-FU during pregnancy and lactation, see section 4.6, and the Summaries of Product Characteristics for methotrexate and 5-FU-containing medicinal products

Adverse reactions:

Withhin the organ system classes, adverse reactions are listed under the headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10,000, <1/1000); very rare (<1/10,000); not known (could not be accurately estimated through clinical studies). .Immune system disorders: Very rare: Anaphylactoid / anaphylactic reactions (including shock) Not known: Allergic reactions, urticaria .Nervous system disorders: Rare: Seizures and syncope .General disorders and administration site conditions: Not known: Fever Cases of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), some fatal, have been reported in patients receiving calcium levofolinate in combination with other agents known to be associated with these disorders. A contributory role of calcium levofolinate in these cases cannot be excluded. Calcium levofolinate may enhance 5-FU induced toxicities depending on the applied regimen. Additional undesirable effects when used in combination with 5-FU: .Gastrointestinal disorders: Very common: Nausea, vomiting, diarrhoea .Hepatobiliary disorders: Not known: Hyperammonemia .Skin and subcutaneous tissue disorders: Not known: Palmer-Plantar Erythrodysaesthesia .General disorders and administration site conditions: Not known: Mucositis, including stomatitis and chelitis Fatalities have occurred as a result of gastrointestinal toxicity (predominantly mucositis and diarrhoea) and myelosuppression.


When calcium levofolinate is given in conjunction with a folic acid antagonist (e.g. cotrimoxazole, pyrimethamine) the efficacy of the folic acid antagonist may either be reduced or completely neutralised. Calcium levofolinate may diminish the antiepileptic effect of phenobarbital, phenytoin, primidone and succinimides, and may increase the frequency of seizures in susceptible patients. Clinical monitoring is therefore recommended.


Calcium levofolinate must not be administered intrathecally. When levofolinic acid has been administered intrathecally, following intrathecal overdose of methotrexate, a death has been reported. General Calcium levofolinate treatment may mask pernicious anaemia and other megaloblastic anaemias resulting from vitamin B12 deficiency. Calcium levofolinate should only be used with 5-FU or methotrexate under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents. Many cytotoxic medicinal products – direct or indirect DNA synthesis inhibitors – lead to macrocytosis (hydroxycarbamide, cytarabine, mercaptopurine, thioguanine). Such macrocytosis should not be treated with folinic acid. Calcium levofolinate / 5-FU Calcium levofolinate may enhance the toxicity profile of 5-FU, particularly in elderly or debilitated patients. The most common manifestations are leucopenia, mucositis, stomatitis and / or diarrhoea, which may be dose limiting. Combined 5-FU / calcium levofolinate treatment should neither be initiated nor maintained in patients with symptoms of GI toxicity, regardless of the severity, until all of these symptoms have completely disappeared. Patients presenting with diarrhoea must be carefully monitored until the symptoms have disappeared completely, since a rapid clinical deterioration leading to death can occur. If diarrhoea and / or stomatitis occur, it is advisable to reduce the dose of 5-FU. The elderly and patients with a low physical performance due to their illness are especially prone to these toxicities. Therefore, particular care should be taken when treating these patients. In elderly patients and patients who have undergone preliminary radiotherapy, it is recommended to begin with a reduced dosage of 5-FU. Calcium levofolinate must not be mixed with 5-FU in the same IV injection or infusion. Calcium levofolinate / methotrexate An accidental overdose with a folate antagonist, such as methotrexate, should be treated quickly as a medical emergency. As the time interval between methotrexate administration and calcium levofolinate rescue increases, calcium levofolinate effectiveness in counteracting toxicity decreases. Calcium levofolinate has no effect on non-haematological toxicities of methotrexate such as the nephrotoxicity resulting from methotexate and / or metabolite precipitation in the kidney. Patients who experience delayed early methotrexate elimination are likely to develop reversible renal failure and all toxicities associated with methotrexate. The presence of pre-existing or methotrexate-induced renal insufficiency is potentially associated with delayed excretion of methotrexate and may increase the need for higher doses or more prolonged use of calcium levofolinate. The possibility that the patient is taking other medications that interact with methotrexate (e.g. medications which may interfere with methotrexate elimination or binding to serum albumin) should always be considered when laboratory abnormalities or clinical toxicities are observed. Excessive calcium levofolinate doses must be avoided since this might impair the anti-tumour activity of methotrexate, expecially in CNS tumours where calcium levofolinate accumulates after repeated courses. Resistance to methotrexate as a result of decreased membrane transport implies also resistance to folinic acid rescue as both medicinal products share the same transport system



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