Product image of Levofolic (Levoleucovorin Disodium) supplied by GNH India

Levofolic

Active Ingredient:
Levoleucovorin Disodium
Origin:
EU

Levofolic (Levoleucovorin Disodium)

Levoleucovorin Disodium, the active ingredient in Levofolic, is a folate analog (leucovorin) presented as a solution for injection for intravenous use. It is employed as an antineoplastic adjuvant to rescue normal cells from high‑dose methotrexate toxicity and to reduce side effects of antifolate chemotherapy in cancer patients.

GNH India supplies Levofolic 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

Levofolic is a folate analog used in oncology supportive care to mitigate toxicity from antifolate agents and high‑dose methotrexate.

  • Rescue therapy after high‑dose methotrexate: restores intracellular reduced folates, allowing normal cell recovery.
  • Reduction of toxicity from antifolate chemotherapy: lessens myelosuppression and mucosal damage caused by agents such as pemetrexed.
  • Supportive care in cancer treatment: improves tolerance of chemotherapy regimens by protecting healthy tissue.

How It Works

  • Levoleucovorin Disodium is a reduced folate that bypasses dihydrofolate reductase inhibition, entering cells via the reduced folate carrier. Inside the cell it is converted to active tetrahydrofolate forms that replenish the folate pool required for thymidylate and purine synthesis, thereby rescuing normal cells from the cytotoxic effects of antifolate drugs.

Side Effects

Levofolic may cause a range of adverse reactions, most of which are mild and reversible.

Common Side Effects

  • Nausea
  • Vomiting
  • Flushing or warmth sensation
  • Mild hypotension
  • Headache
  • Transient fever

Serious or Rare Side Effects

  • Anaphylactic or severe allergic reaction
  • Severe hypotension requiring intervention
  • Acute renal toxicity
  • Cardiac arrhythmias
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis
  • Pulmonary edema or severe respiratory distress

Precautions & Warnings

Before initiating Levofolic therapy, clinicians should consider several safety measures.

  • Renal function: assess creatinine clearance and adjust dose if necessary.
  • Hepatic impairment: monitor liver enzymes during treatment.
  • Concurrent antifolate therapy: avoid overlapping dosing schedules.
  • Pregnancy: use only when clearly needed, after risk‑benefit evaluation.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Levofolic can interact with several drugs; awareness of the interaction level guides management.

Major Interactions (Avoid)

  • Methotrexate: concurrent use may diminish rescue effectiveness.
  • High‑dose folic acid supplements: may interfere with intended folate rescue.

Moderate Interactions (Monitor Closely)

  • Nephrotoxic agents (e.g., cisplatin): monitor renal function closely.
  • Hepatotoxic drugs (e.g., azathioprine): observe liver parameters.
  • Other folate pathway inhibitors (e.g., pemetrexed): consider dose adjustments.

Frequently Asked Questions

Levofolic is used in oncology as a rescue agent after high‑dose methotrexate and to reduce the toxicity of antifolate chemotherapy. It helps protect normal cells by replenishing reduced folate pools, thereby improving patient tolerance to intensive cancer treatment protocols.

Levoleucovorin Disodium provides a reduced form of folate that bypasses the block created by antifolate drugs on dihydrofolate reductase. By entering cells directly, it restores the folate cycle needed for DNA synthesis, allowing healthy cells to recover while cancer cells remain targeted by the chemotherapy.

The dose of Levofolic is individualized and set by the prescribing physician based on the specific chemotherapy regimen, patient weight, renal function, and clinical response. Healthcare professionals determine the appropriate amount and infusion rate for each patient.

Safety data for Levofolic in pregnancy and lactation are limited. It should be used only if the potential benefit justifies any possible risk to the fetus or infant, and the decision must be made by the treating physician in consultation with the patient.

To order Levofolic, 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 where required) and necessary import documentation.

The primary alternative is folinic acid (leucovorin calcium). Both are reduced folates used for rescue, but Levofolic (levoleucovorin disodium) is more soluble and formulated for intravenous injection, offering rapid plasma concentrations. Clinical efficacy is comparable, while formulation differences may influence handling and stability.

Levofolic must be stored refrigerated between 2 °C and 8 °C. Keep the vials in their original packaging, protect from light, and avoid freezing or shaking the solution. If a temporary temperature excursion occurs, discard the product according to local regulations.

Levofolic is supplied as a sterile solution for injection and is administered intravenously. The infusion is typically given over a short period (e.g., 5–30 minutes) following high‑dose methotrexate or concurrently with antifolate chemotherapy, as directed by the treating oncologist.

Serious risks include anaphylactic reactions, severe hypotension, acute renal toxicity, cardiac arrhythmias, and rare severe skin reactions such as Stevens‑Johnson syndrome. Patients should be monitored closely during and after infusion for any signs of these events, and immediate medical intervention should be initiated if they occur.

Levofolic is contraindicated in individuals with known hypersensitivity to levoleucovorin or any component of the formulation. Caution is advised for patients with severe renal impairment, uncontrolled hypertension, or a history of severe allergic reactions to folate products.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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