

Leucovorin Calcium 50mg Injection (Calcium Leucovorin)
Manufactured By
Fresenius Kabi India Pvt Ltd
Pack Of
1
Salt Composition
Calcium Leucovorin
Storage
Controlled room temperature
ALL SUBSTITUTES
Overview
Leucovorin Calcium 50mg Injection includes calcium leucovorin (also known as folinic acid), which is an active form of folate. It is not a traditional chemotherapy medicine. Calcium leucovorin can be applied in the protection of normal cells after high-dose methotrexate administration, in managing toxicity or overdose associated with some anti-folate agents, and as a drug that increases the efficacy of 5-fluorouracil (5-FU) in some cases of colorectal and gastrointestinal tumors. The dose and frequency of administration differ depending on the indicated use; the delayed administration of calcium leucovorin in the case of methotrexate rescue may be dangerous.
Quick Product Facts
| Field | Publication wording |
|---|---|
| Brand | Leucovorin Calcium 50mg Injection |
| Active molecule | Calcium Leucovorin |
| Strength | 50 mg/5 mL |
| Dosage form | IV/IM injection |
| Manufacturer / Marketer | Fresenius Kabi India Pvt Ltd |
| Pack / Presentation | 1 vial (5 mL) |
| Storage | Controlled room temperature |
| Prescription | Required |
| Clinical supervision | Specialist supervision required |
Uses and Indications
Uses of Leucovorin Calcium 50mg Injection include:
- High-dose methotrexate therapy rescue
- Overdose of methotrexate or delayed clearance of methotrexate
- Cancers of the colon and other gastrointestinal regions when administered alongside 5-FU
- Specific side effects of folate antagonists
- Folate-deficient megaloblastic anemia where oral administration is unsuitable
In the case of methotrexate rescue, the dosage and schedule depend on the levels of methotrexate in the blood and the duration since the drug was administered. For use alongside 5-FU, calcium leucovorin assists in increasing the effectiveness of the drug against cancer. However, Leucovorin Calcium 50mg Injection is not to be used in treating vitamin B12 deficiency.
How Leucovorin Calcium 50mg Injection Works
There are two primary mechanisms of action for leucovorin calcium 50mg. The first one is with methotrexate, where calcium leucovorin supplies the active form of folate that the normal cells require, hence protecting the cells from the effects of methotrexate. The second one is with 5-FU, where medicine enhances the binding affinity of 5-FU to an enzyme.
Clinical Evidence for Leucovorin Calcium 50mg Injection
High-dose methotrexate rescue: Calcium leucovorin rescue protects normal cells from being harmed by methotrexate, thus making the use of high-dose methotrexate possible.
5-FU/leucovorin evidence: Research has proven that the combination of leucovorin calcium 50mg and 5-FU enhances the impact of 5-FU treatment. This method is applied in FOLFOX and FOLFIRI protocols.
Side Effects of Leucovorin Calcium 50mg Injection
The medicine has good tolerance among most people, but some may develop adverse reactions due to capsule treatment. Side effects will depend on its application, either in methotrexate rescue, 5-FU, or for some other condition.
Common / expected side effects
- Injection-site discomfort
- Nausea/GI upset
- Mild rash/itching (uncommon)
Serious side effects requiring prompt medical attention
- Severe hypersensitivity
- Increased 5-FU diarrhea/mucositis
- Seizure worsening via antiepileptic interactions
- Fatal toxicity with intrathecal administration
Critical Safety Warning
DO NOT ADMINISTER INTRATHECALL. Never give leucovorin calcium 50mg injection intrathecally, which means that the medicine cannot be administered to spinal fluid. Timing of calcium leucovorin is critical when used with methotrexate due to its ability to protect normal cells following therapy; this timing depends on methotrexate levels and renal function. It also improves the therapeutic effect when used in combination with 5-FU but increases the chances of side effects of 5-FU therapy.
Leucovorin Calcium 50mg Injection Dosage and How To Take It
Important: These are only general references to be used when giving treatments. The physician will prescribe the proper dosage, frequency, interaction with other drugs, adjustment of dosage because of renal or hepatic dysfunction, and management of adverse effects depending on the patient's status.
| Clinical situation | Dose |
|---|---|
| Methotrexate rescue | The dose and timing follow a specific treatment plan and may be adjusted based on repeated methotrexate blood levels. |
| Delayed clearance/overdose | In case of slow excretion of methotrexate from the body or its overdose, larger dosages or extended duration of therapy is required. |
| With 5-FU | The dose can vary depending on the treatment plan, such as FOLFOX or FOLFIRI. |
| Route | It may be given by IV or IM injection, as appropriate. Never give it intrathecally. |
Leucovorin Calcium 50mg Injection Missed Dose
For methotrexate rescue, a delayed or missed dose is potentially urgent. Contact the oncology team immediately rather than waiting for the next scheduled dose.
Safety Advice for Leucovorin Calcium 50mg Injection
| Category | Status | Guidance |
|---|---|---|
| Intrathecal use | Contraindicated | Leucovorin calcium 50mg must never be injected into the spinal canal because this route is unsafe. |
| Vitamin B12 deficiency | Do not mask | Calcium Leucovorin is not recommended for correcting or concealing a deficiency of vitamin B12 since neurological damage might still persist despite improvement in anaemia. |
| Kidney | Critical in MTX rescue | The role of the kidney is critical during methotrexate rescue as decreased functioning of the kidneys can hamper the elimination of methotrexate from the body. |
| Seizure disorder | Caution | Patients on drugs to control seizures must be watched because leucovorin calcium 50mg Injection can influence some antiepileptic drugs. |
Monitoring During Leucovorin Calcium 50mg Injection Treatment
- Serum methotrexate concentrations will be measured to ensure that the drug is being properly excreted from the body and to determine the leucovorin calcium 50mg dose.
- The function of the kidneys and the amount of urine produced will be observed because the kidneys play a role in excreting methotrexate from the body.
- Blood work, mouth ulcers, and diarrhea could be measured when the drugs Calcium leucovorin and 5-FU are used together.
- Hydration and electrolyte measurements are performed to maintain fluid and electrolyte balance.
Leucovorin Calcium 50mg Injection Fact Box
| Parameter | Verified / publication wording |
|---|---|
| Brand | Leucovorin Calcium 50mg Injection |
| Generic | Calcium Leucovorin |
| Strength | 50 mg/5 mL |
| Form | IV/IM injection |
| Manufacturer / Marketer | Fresenius Kabi India Pvt Ltd (confirm Magicine stock) |
| Pack | 1 vial (5 mL) |
| Storage | Controlled room temperature |
| Prescription | Required |
| Self-treatment | Not appropriate; follow specialist prescription |
| Major safety theme | DO NOT ADMINISTER INTRATHECALLY. In methotrexate rescue, timing is critical and guided by methotrexate levels/renal function. With 5-FU, leucovorin increases both therapeutic effect and fluoropyrimidine toxicity. |
Leucovorin Calcium 50mg Injection Drug Interactions
| Drug / Class | Risk | What To Do |
|---|---|---|
| 5-FU | Increases efficacy and toxicity | Use only as part of the prescribed treatment regimen and monitor for toxicity. |
| Methotrexate | Intentional rescue | Timing and dose are guided by methotrexate levels and kidney function. |
| Phenytoin/phenobarbital/primidone | May reduce seizure control | Monitor seizure control and medicine levels when needed. |
| Other folate antagonists | May alter effect | Use only according to the specific treatment plan. |
FAQs About Leucovorin Calcium 50mg Injection
Is Leucovorin Calcium 50mg Injection a Chemotherapy drug?
It is a form of reduced-folate agent that acts to protect normal cells from methotrexate or to enhance the action of 5-FU.
How does Leucovorin Calcium 50mg Injection do both protect and enhance the chemotherapy drugs?
For methotrexate, calcium leucovorin is involved in restoring the folate in normal cells. For 5-FU, it enhances the action of the drug on cancer cells.
Why should there be monitoring of methotrexate levels?
They provide a guide on how to give the leucovorin calcium 50mg dosage and for how long.
What if a dose of Calcium Leucovorin is missed?
Contact the oncology department for immediate advice on what to do next.
Is it possible to administer Leucovorin Calcium 50mg Injection intrathecally?
No. It is strictly forbidden to give calcium leucovorin intrathecally, as it may lead to dangerous complications and even death.
Why is the B12 deficiency significant?
It is because leucovorin calcium 50mg injection can help overcome anemia due to the B12 deficiency, but nerve damage will continue developing. For that reason, calcium leucovorin is not supposed to mask the B12 deficiency.
Does 50 mg mean a standard dose?
No. This 50 mg is the strength of calcium leucovorin. The actual dose varies according to the reason for which the medicine is administered.
References
- Current leucovorin calcium injection prescribing information https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf
- Current high-dose methotrexate rescue protocols https://pmc.ncbi.nlm.nih.gov/articles/PMC11903593/
- Evidence supporting 5-FU/leucovorin colorectal regimens https://www.sciencedirect.com/science/article/pii/S0923753419478290
- Current NCCN colorectal-cancer guidelines https://www.nccn.org/patients/guidelines/content/PDF/colon-patient.pdf
Marketer Details
Fresenius Kabi India Pvt Ltd
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