Active Ingredient: Calcium folinate
A treatment technique using calcium folinate in conjunction with methotrexate, to minimise systemic toxicity.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, between 6 milligrams calcium folinate per kilogram of body weight and 12 milligrams calcium folinate per kilogram of body weight, once every 6 hours, over the duration of 48 hours. Afterwards, intravenous, between 15 milligrams calcium folinate per kilogram of body weight and 200 milligrams calcium folinate per kilogram of body weight, once every 6 hours.
Refer to the applied intermediate- or high-dose methotrexate protocol for posology and method of administration of calcium folinate. The methotrexate protocol will dictate the dosage regimen of Calcium Folinate Rescue because it depends heavily on the posology and method of the intermediate- or high-dose methotrexate administration.
The following guidelines may serve as an illustration of regimens used in adults, elderly and children:
Calcium folinate rescue has to be performed by parenteral administration in patients with malabsorption syndromes or other gastrointestinal disorders where enteral absorption is not assured.
Dosages above 25-50 mg should be given parenterally due to saturable enteral absorption of calcium folinate.
Calcium Folinate Rescue is necessary when methotrexate is given at doses exceeding 500 mg/m² body surface and has to be considered with doses of 100 mg – 500 mg/m² body surface.
Dosage and duration of use of Calcium folinate primarily depend on the type and dosage of methotrexate therapy, the occurrence of toxicity symptoms, and the individual excretion capacity for methotrexate. As a rule, the first dose of Calcium folinate is 15 mg (6-12 mg/m²) to be given 12-24 hours (24 hours at the latest) after the beginning of the methotrexate infusion. The same dose is given every 6 hours throughout a period of 72 hours. After several parenteral doses treatment can be switched over to the oral form.
In addition to calcium folinate administration, measures to ensure the rapid excretion of methotrexate (maintenance of high urine output and alkalinisation of urine) are integral parts of the Calcium Folinate Rescue treatment. Renal function should be monitored by measuring serum creatinine levels daily.
The residual methotrexate-level, in the blood, should be measured, forty-eight hours after the start of the methotrexate-infusion. If the residual methotrexate-level is >0.5 µmol/l, then the dosage of calcium folinate dosages should be adapted according to the following table:
| Residual methotrexate level in the blood 48 hours after the start of the methotrexate administration | Additional Calcium folinate to be administered every 6 hours for 48 hours or until levels of methotrexate are lower than 0.05µmol/l |
|---|---|
| >0.5 µmol/l | 15 mg/m² |
| >1.0 µmol/l | 100 mg/m² |
| >2.0 µmol/l | 200 mg/m² |
For:
Intramuscular, between 6 milligrams calcium folinate per kilogram of body weight and 12 milligrams calcium folinate per kilogram of body weight, once every 6 hours, over the duration of 48 hours. Afterwards, intramuscular, between 15 milligrams calcium folinate per kilogram of body weight and 200 milligrams calcium folinate per kilogram of body weight, once every 6 hours.
Refer to the applied intermediate- or high-dose methotrexate protocol for posology and method of administration of calcium folinate. The methotrexate protocol will dictate the dosage regimen of Calcium Folinate Rescue because it depends heavily on the posology and method of the intermediate- or high-dose methotrexate administration.
The following guidelines may serve as an illustration of regimens used in adults, elderly and children:
Calcium folinate rescue has to be performed by parenteral administration in patients with malabsorption syndromes or other gastrointestinal disorders where enteral absorption is not assured.
Dosages above 25-50 mg should be given parenterally due to saturable enteral absorption of calcium folinate.
Calcium Folinate Rescue is necessary when methotrexate is given at doses exceeding 500 mg/m² body surface and has to be considered with doses of 100 mg – 500 mg/m² body surface.
Dosage and duration of use of Calcium folinate primarily depend on the type and dosage of methotrexate therapy, the occurrence of toxicity symptoms, and the individual excretion capacity for methotrexate. As a rule, the first dose of Calcium folinate is 15 mg (6-12 mg/m²) to be given 12-24 hours (24 hours at the latest) after the beginning of the methotrexate infusion. The same dose is given every 6 hours throughout a period of 72 hours. After several parenteral doses treatment can be switched over to the oral form.
In addition to calcium folinate administration, measures to ensure the rapid excretion of methotrexate (maintenance of high urine output and alkalinisation of urine) are integral parts of the Calcium Folinate Rescue treatment. Renal function should be monitored by measuring serum creatinine levels daily.
The residual methotrexate-level, in the blood, should be measured, forty-eight hours after the start of the methotrexate-infusion. If the residual methotrexate-level is >0.5 µmol/l, then the dosage of calcium folinate dosages should be adapted according to the following table:
| Residual methotrexate level in the blood 48 hours after the start of the methotrexate administration | Additional Calcium folinate to be administered every 6 hours for 48 hours or until levels of methotrexate are lower than 0.05µmol/l |
|---|---|
| >0.5 µmol/l | 15 mg/m² |
| >1.0 µmol/l | 100 mg/m² |
| >2.0 µmol/l | 200 mg/m² |
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