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

Natriumlevofolinat Medac

Active Ingredient:
Levoleucovorin Disodium
Origin:
EU

Natriumlevofolinat Medac (Levoleucovorin Disodium)

Levoleucovorin Disodium, the active ingredient in Natriumlevofolinat Medac, is a folate analog presented as a sterile injectable solution for intravenous use. It is employed to rescue patients from methotrexate toxicity and to enhance the efficacy of fluoropyrimidine chemotherapy in oncology settings.

GNH India supplies Natriumlevofolinat 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 to modulate folate pathways in cancer therapy and to mitigate methotrexate‑induced toxicity.

  • Methotrexate toxicity rescue: reduces cellular damage caused by high‑dose methotrexate by supplying reduced folate.
  • 5‑Fluorouracil chemotherapy enhancement: stabilises the 5‑FU‑TS complex, increasing antitumour activity.
  • Folate deficiency support: provides active folate to patients with functional deficiency during intensive chemotherapy.

How It Works

  • Levoleucovorin Disodium is a reduced folate that bypasses dihydrofolate reductase inhibition, directly replenishing intracellular tetrahydrofolate pools. This restores DNA synthesis in normal cells, rescues them from methotrexate‑induced blockade, and enhances the binding of fluoropyrimidines to thymidylate synthase, thereby increasing cytotoxic efficacy against tumour cells.

Side Effects

Levoleucovorin Disodium may cause adverse reactions, most of which are mild and transient.

Common Side Effects

  • Nausea
  • Mild rash or erythema
  • Transient hypotension
  • Headache
  • Flushing
  • Mild fatigue

Serious or Rare Side Effects

  • Anaphylactic or severe hypersensitivity reactions
  • Acute renal impairment
  • Significant hepatic dysfunction
  • Severe electrolyte disturbances (e.g., hyperkalemia)
  • Thromboembolic events
  • Life‑threatening infusion reactions

Precautions & Warnings

Before administering Levoleucovorin Disodium, clinicians should consider several safety measures.

  • Renal function: evaluate creatinine clearance and adjust if impaired.
  • Hepatic function: monitor liver enzymes, especially in patients with pre‑existing liver disease.
  • Pregnancy: use only when the potential benefit justifies the potential risk to the fetus.
  • Concomitant methotrexate: coordinate timing to ensure effective rescue.
  • Known hypersensitivity: discontinue immediately if an allergic reaction occurs.
  • Store at 2‑8°C: keep refrigerated, protect from light, do not freeze or shake the vial.

Avoid Interactions

Levoleucovorin Disodium can interact with several agents; awareness of these interactions helps optimise therapy.

Major Interactions (Avoid)

  • High‑dose methotrexate administered without appropriate timing may diminish rescue efficacy.
  • Other antifolates (e.g., pemetrexed) may antagonise its action.

Moderate Interactions (Monitor Closely)

  • Nephrotoxic drugs such as cisplatin can increase renal burden; monitor renal parameters.
  • Hepatotoxic agents (e.g., high‑dose acetaminophen) may exacerbate liver injury; observe liver function.
  • Drugs affecting renal clearance (e.g., NSAIDs) may require dose adjustment or closer monitoring.

Frequently Asked Questions

Natriumlevofolinat Medac, containing levoleucovorin disodium, is used as an antidote to high‑dose methotrexate toxicity and as an adjuvant to enhance the antitumour activity of fluoropyrimidine chemotherapy such as 5‑fluorouracil. It helps protect normal cells while supporting the effectiveness of cancer treatment.

Levoleucovorin Disodium is a reduced form of folic acid that bypasses the dihydrofolate reductase block caused by methotrexate. By directly replenishing tetrahydrofolate pools, it restores DNA synthesis in healthy cells and stabilises the ternary complex of 5‑fluorouracil with thymidylate synthase, thereby increasing the drug’s cytotoxic effect on tumour cells.

The dose of Natriumlevofolinat Medac is determined by the prescribing clinician based on the specific indication, patient weight, renal function and the timing of concurrent chemotherapy. Healthcare professionals should follow institutional protocols and product labeling when calculating the appropriate regimen.

Safety data for levoleucovorin in pregnancy and lactation are limited. It should only be used when the potential therapeutic benefit outweighs any possible risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss the risks and benefits with their 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 any required import documentation.

The primary alternative is calcium leucovorin (folinic acid). Both provide reduced folate, but levoleucovorin is the levo‑isomer, offering higher affinity for cellular transporters and potentially more efficient intracellular conversion. Clinical choice depends on formulation preferences, stability, and specific institutional protocols.

The product must be stored refrigerated at 2‑8 °C. Keep the vial in its original packaging, protect it from light, and avoid freezing or shaking. If the solution reaches room temperature for a short period during preparation, it should be used promptly and not re‑refrigerated.

Natriumlevofolinat Medac is given by intravenous infusion. The exact infusion rate and duration are defined by the treating physician, often based on the timing relative to methotrexate or fluoropyrimidine administration. Administration should be performed by qualified healthcare personnel in a setting equipped for IV therapy.

Serious adverse events, although rare, include anaphylactic or severe hypersensitivity reactions, acute renal impairment, significant hepatic dysfunction, severe electrolyte disturbances, and thromboembolic events. Prompt recognition and discontinuation of the drug are essential if any of these reactions occur.

Patients with known hypersensitivity to levoleucovorin, its excipients, or other folate analogues should avoid the product. Those with severe renal impairment where adequate clearance cannot be ensured, or with uncontrolled hepatic disease, may also be contraindicated. Clinical judgment is required for each individual case.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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