Product image of Levofolino Rūgštis Medac (Levoleucovorin Disodium) supplied by GNH India

Levofolino Rūgštis Medac

Active Ingredient:
Levoleucovorin Disodium
Origin:
EU

Levofolino Rūgštis Medac (Levoleucovorin Disodium)

Levoleucovorin disodium, the active ingredient in Levofolino Rūgštis Medac, is a folate analog (leucovorin) presented as an injectable solution for intravenous use. It is employed to rescue patients from methotrexate toxicity and to supplement folate in deficiency states. The product is manufactured under EU GMP standards and is intended for clinical settings that require rapid folate repletion.

GNH India supplies Levofolino Rūgštis Medac as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres and pharmacies worldwide, ensuring regulatory‑aligned sourcing and reliable logistics.

Manufacturer / TM Owner

Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)

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Indications & Clinical Uses

  • Levoleucovorin disodium is used in clinical situations that involve folate pathway disruption or high‑dose methotrexate exposure.
  • Methotrexate toxicity rescue: restores folate‑dependent DNA synthesis and reduces toxic effects in patients receiving methotrexate.
  • Folate deficiency: replenishes reduced folate stores in individuals with documented folate deficiency.
  • High‑dose methotrexate therapy: provides rescue after chemotherapy to protect normal cells while allowing antineoplastic activity.

How It Works

  • Levoleucovorin disodium supplies a reduced form of folate that bypasses the inhibition of dihydrofolate reductase caused by methotrexate. The molecule enters cells via the reduced‑folate carrier and is converted to tetrahydrofolate derivatives that act as one‑carbon donors for purine and pyrimidine synthesis, thereby restoring DNA replication and cellular function in normal tissues while methotrexate continues to affect malignant cells.

Side Effects

Levoleucovorin disodium may be associated with a range of adverse reactions, which are classified by frequency.

Common Side Effects

  • Nausea
  • Vomiting
  • Mild rash or erythema
  • Transient fever
  • Headache
  • Mild elevation of liver enzymes

Serious or Rare Side Effects

  • Anaphylactic or severe hypersensitivity reaction
  • Acute renal failure
  • Severe electrolyte disturbances (e.g., hyperkalemia, hypomagnesemia)
  • Pulmonary toxicity (interstitial pneumonitis)
  • Severe hepatic dysfunction
  • Hematologic abnormalities such as thrombocytopenia

Precautions & Warnings

  • Levoleucovorin disodium requires careful clinical monitoring to minimise risk.
  • Renal function: assess baseline renal status and adjust dose in impairment.
  • Hepatic function: monitor liver enzymes during therapy.
  • Pregnancy: safety not established; use only if benefit outweighs potential risk.
  • Concomitant methotrexate: avoid overlapping high‑dose methotrexate without appropriate rescue.
  • Electrolyte balance: monitor serum electrolytes, especially potassium and magnesium.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Levoleucovorin disodium can interact with several drug classes; awareness of the interaction level guides clinical decisions.

Major Interactions (Avoid)

  • High‑dose methotrexate administered without rescue: may increase toxicity.
  • Other folate antagonists (e.g., trimethoprim, pyrimethamine): reduce therapeutic efficacy.
  • Nephrotoxic agents (e.g., cisplatin, aminoglycosides): heighten risk of renal injury.

Moderate Interactions (Monitor Closely)

  • NSAIDs: may affect renal clearance of levoleucovorin.
  • Proton pump inhibitors: potential alteration of folate metabolism.
  • Sulfonamides: competition for renal excretion pathways.
  • Antacids containing aluminum or magnesium: may affect concurrent oral folate absorption.
  • Warfarin: possible alteration of anticoagulant effect, requiring INR monitoring.

Frequently Asked Questions

Levofolino Rūgštis Medac contains levoleucovorin disodium, which is used to rescue patients from the toxic effects of high‑dose methotrexate therapy and to treat documented folate deficiency. It provides a reduced folate form that supports normal cellular DNA synthesis while methotrexate continues to act on malignant cells.

Levoleucovorin disodium supplies a reduced folate that bypasses the dihydrofolate reductase blockade created by methotrexate. Once inside cells, it is converted to tetrahydrofolate derivatives that donate one‑carbon units for purine and pyrimidine synthesis, thereby restoring DNA replication and normal cell function.

The dose of levoleucovorin disodium is individualized by the prescribing clinician based on the indication, patient weight, renal function and the methotrexate regimen being rescued. Healthcare professionals determine the appropriate amount and infusion rate; patients should not adjust the dose on their own.

Safety data for levoleucovorin disodium in pregnancy and lactation are limited. It should be used only when the potential benefit to the mother outweighs any possible risk to the fetus or infant, and only under the guidance of a qualified healthcare provider.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain logistics if needed) and the necessary import documentation.

Levofolino Rūgštis Medac delivers levoleucovorin disodium, a reduced folate analogue similar in function to folinic acid (leucovorin). Both bypass methotrexate‑induced dihydrofolate reductase inhibition, but formulation differences (e.g., concentration, stability) may influence handling and dosing preferences in specific clinical protocols.

The product should be stored at 2‑8 °C, protected from light, and kept in its original container. Do not freeze or shake the vial. Before use, inspect for particulate matter or discoloration and follow aseptic techniques for preparation and intravenous administration.

Levofolino Rūgštis Medac is given by intravenous infusion. The solution is typically diluted with a compatible IV fluid and administered over a period defined by the treating physician, often immediately after or shortly before high‑dose methotrexate infusion, to ensure optimal rescue effect.

Serious adverse events, although rare, include anaphylactic or severe hypersensitivity reactions, acute renal failure, severe electrolyte imbalances, pulmonary toxicity, and significant hepatic dysfunction. Prompt recognition and medical intervention are essential if any of these reactions occur.

Patients with known hypersensitivity to levoleucovorin disodium or any component of the formulation should avoid the product. Caution is also advised in individuals with severe renal impairment, uncontrolled electrolyte disturbances, or those receiving concurrent high‑dose folate antagonists without appropriate monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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