Product image of Levofolinate De Sodium Medac (Levoleucovorin Disodium) supplied by GNH India

Levofolinate De Sodium Medac

Active Ingredient:
Levoleucovorin Disodium
Origin:
EU

Levofolinate De Sodium Medac (Levoleucovorin Disodium)

Levoleucovorin Disodium, the active ingredient in Levofolinate De Sodium Medac, is a folate analog presented as an intravenous formulation for parenteral use. It is employed to mitigate toxicity of certain chemotherapy agents and to support folate metabolism in patients undergoing high‑dose methotrexate therapy.

GNH India supplies Levofolinate De Sodium Medac as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)

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Indications & Clinical Uses

Levoleucovorin Disodium is used in oncology and supportive care to counteract the effects of antifolate chemotherapy agents.

  • High‑dose methotrexate therapy: reduces systemic toxicity and facilitates rapid clearance of methotrexate.
  • Fluoropyrimidine‑based chemotherapy (e.g., 5‑FU, capecitabine): lessens mucosal and hematologic adverse effects.
  • Folate deficiency in patients receiving antifolate drugs: restores intracellular folate pools.

How It Works

  • Levoleucovorin Disodium is a reduced form of folic acid that bypasses dihydrofolate reductase, directly supplying 5‑methyltetrahydrofolate to cells. This restores folate‑dependent one‑carbon transfer reactions, supporting DNA synthesis and repair in normal tissues while allowing antifolate agents to continue inhibiting tumor cell proliferation.

Side Effects

Levoleucovorin Disodium is generally well tolerated, but adverse reactions can occur.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Vomiting: occasional emesis after infusion.
  • Diarrhea: transient loose stools.
  • Rash: mild skin erythema.
  • Fever: low‑grade temperature elevation.
  • Headache: transient mild headache.

Serious or Rare Side Effects

  • Anaphylaxis: severe allergic reaction requiring immediate medical attention.
  • Hypotension: sudden drop in blood pressure during infusion.
  • Renal impairment: worsening kidney function in susceptible patients.
  • Severe allergic reactions: angioedema or bronchospasm.
  • Cardiac arrhythmia: irregular heart rhythm in rare cases.

Precautions & Warnings

When using Levoleucovorin Disodium, clinicians should consider several safety measures.

  • Renal function: assess baseline creatinine and monitor during therapy.
  • Hepatic impairment: use with caution and monitor liver enzymes.
  • Concurrent antifolate therapy: adjust timing to avoid antagonism.
  • Pregnancy: administer only if potential benefits justify the risk.
  • Allergy: discontinue immediately if hypersensitivity signs appear.
  • Store at ambient temperature: keep in original container, protect from moisture and light.

Avoid Interactions

Levoleucovorin Disodium may interact with other medications, requiring monitoring.

Major Interactions (Avoid)

  • Concurrent high‑dose pemetrexed: may diminish the rescue effect of levoleucovorin.
  • Strong folate antagonists (e.g., trimethoprim at high doses): can reduce efficacy of levoleucovorin.

Moderate Interactions (Monitor Closely)

  • Nephrotoxic agents (e.g., aminoglycosides): increased risk of renal toxicity.
  • NSAIDs: may affect renal clearance of folate compounds.
  • Loop diuretics: can alter folate excretion and plasma levels.
  • Vitamin B12 deficiency: may exacerbate hematologic effects if not corrected.

Frequently Asked Questions

Levofolinate De Sodium Medac contains levoleucovorin disodium, a folate analog used primarily to reduce the toxic effects of high‑dose methotrexate and fluoropyrimidine chemotherapy, and to support normal cell folate metabolism during antifolate treatment.

Levoleucovorin provides a reduced form of folic acid that bypasses the dihydrofolate reductase step, directly supplying active folate co‑factors needed for DNA synthesis and repair in healthy cells, thereby counteracting the inhibition caused by antifolate drugs.

The specific dose and infusion schedule are determined by the prescribing clinician based on the patient’s treatment protocol, renal function, and the chemotherapy regimen being supported.

Use during pregnancy or lactation should only occur when the potential therapeutic benefit outweighs any possible risk to the fetus or infant, and it must be decided by the treating physician.

Enquiries can be submitted on the product page at gnhindia.com by providing the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then replies with pricing, availability, shipping details (including cold‑chain if needed) and import documentation.

Levofolinate (levoleucovorin) is a calcium‑free, highly soluble form of folinic acid that offers rapid plasma concentrations and convenient intravenous administration, similar in function to calcium folinate but often preferred for precise dosing in high‑dose methotrexate protocols.

Store at ambient temperature, preferably below 25 °C, in the original packaging to protect from moisture and light. Do not freeze. Inspect the solution for particulate matter before use.

The product is supplied for intravenous infusion. It is typically diluted in a compatible IV fluid and infused over a prescribed period, following the timing recommendations of the chemotherapy regimen.

Serious risks include anaphylactic reactions, severe hypotension, renal impairment, and rare cardiac arrhythmias. Immediate medical attention is required if any of these events occur.

Patients with known hypersensitivity to levoleucovorin or any component of the formulation, and those with severe uncontrolled renal or hepatic impairment, should not receive the product unless a risk‑benefit assessment justifies its use.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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