Description
Table of Contents
Composition and Formulation
Active Ingredient
- Calcium Folinate: Each vial contains 200 mg of calcium folinate equivalent to 200 mg of folinic acid.
Excipients
- The solution includes excipients with known effects, such as sodium.
Indications
Methotrexate Toxicity
Calcium folinate is indicated to reduce the toxicity and counteract the action of folic acid antagonists such as methotrexate in cytotoxic therapy and overdose in both adults and children.
Combination Therapy
Calcium folinate is also employed in combination with 5-fluorouracil in cytotoxic therapy.
Dosage and Administration
Methotrexate Therapy
- Initial Dose: 15 mg (6-12 mg/m²) administered 12-24 hours after the start of the methotrexate infusion.
- Subsequent Doses: The same dose is given every 6 hours over a 72-hour period.
Administration Method
- Parenteral Administration: Recommended for patients with malabsorption syndromes or other gastrointestinal disorders where enteral absorption is not assured.
Precautions and Monitoring
Renal Function
- Monitoring: Serum creatinine levels should be measured daily to monitor renal function.
Methotrexate Levels
- Residual Methotrexate Level: Should be measured 48 hours after the initiation of the methotrexate infusion.
Contraindications
- B12 Deficiency Anemia: Not recommended for patients with B12 deficiency anemia.
- Hypersensitivity: Not recommended for patients with known hypersensitivity to calcium folinate.
Side Effects
| Type | Side Effects |
|---|---|
| Common | Gastrointestinal: Nausea, vomiting, diarrhea; Neurological: Seizures, syncope |
| Rare | Allergic Reactions: Rash, itching, swelling |
Storage and Handling
- Storage Conditions: Store in a refrigerator (2°C – 8°C). Do not freeze.
- Shelf Life: Refer to the expiry date on the packaging.
Drug Interactions
Folic Acid Antagonists
- Methotrexate: Calcium folinate is used to reduce the harmful effects and treat overdose of methotrexate.
- Co-trimoxazole and Pyrimethamine: Calcium folinate may reduce or counteract their effects.
Anticancer Medications
- 5-Fluorouracil: Enhances the effectiveness and side effects of 5-fluorouracil.
Antiepileptic Drugs
- Phenobarbital, Phenytoin, Primidone, Ethosuximide: Calcium folinate may reduce the effect of these medications. Blood levels need to be monitored, and doses adjusted to prevent increased convulsions.
Other Interactions
- Droperidol: Incompatibility reported between injectable forms of calcium folinate and droperidol, leading to immediate precipitation when mixed.
- Foscarnet: Similar incompatibilities reported.
Monitoring and Precautions
- Blood Levels: Regular monitoring of blood levels of methotrexate and antiepileptic drugs is recommended.
- Renal Function: Important to monitor renal function, especially in combination with methotrexate.
Allergic Reactions
Common Allergic Reactions
- Rash and itching are common symptoms.
Severe Allergic Reactions
- Difficulty breathing, swelling of the face, lips, throat, or tongue, and anaphylactoid reactions have been reported.
Precautions
- Calcium folinate should not be administered to individuals with known hypersensitivity to the medication or any of its ingredients.
Administration with 5-Fluorouracil
Administration Protocol
- Calcium Folinate Dosage: 200 mg/m² by intravenous infusion over two hours.
- 5-Fluorouracil Dosage: 400 mg/m² intravenous bolus immediately following the Calcium Folinate infusion, then 600 mg/m² intravenous infusion over 22 hours.
Schedule
- Typically repeated for 2 consecutive days every 2 weeks.
Supervision
- Both Calcium Folinate and 5-fluorouracil must be administered under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.
Precautions
- No more than 160 mg (16 ml) of Calcium Folinate should be injected per minute due to the calcium content.
Use in Other Types of Cancer
Other Cancer Treatments
Colorectal Cancer
- Combination Therapy: Commonly used with 5-fluorouracil to treat advanced colorectal cancer.
Head and Neck Cancer
- Enhancing Chemotherapy: Used with 5-fluorouracil for head and neck cancers.
Other Applications
- Detoxifying Agent: Reduces the toxic side effects of certain anticancer drugs like methotrexate.
Summary Table
| Category | Information |
|---|---|
| Indications | Methotrexate toxicity, Combination therapy with 5-fluorouracil |
| Dosage | Methotrexate: 15 mg (6-12 mg/m²) initially, every 6 hours for 72 hours |
| 5-Fluorouracil: 400 mg/m² bolus, 600 mg/m² infusion | |
| Administration | Parenteral, Intravenous infusion |
| Monitoring | Serum creatinine, Methotrexate levels |
| Contraindications | B12 deficiency anemia, Hypersensitivity to calcium folinate |
| Common Side Effects | Gastrointestinal: Nausea, vomiting, diarrhea; Neurological: Seizures, syncope |
| Rare Side Effects | Allergic reactions: Rash, itching, swelling |
| Storage | Refrigerate (2°C – 8°C), do not freeze |
| Drug Interactions | Methotrexate, Co-trimoxazole, Pyrimethamine, 5-Fluorouracil, Phenobarbital, Phenytoin, Droperidol |
| Other Cancer Applications | Colorectal cancer, Head and neck cancer, Detoxifying agent for certain anticancer drugs |
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