Product image of Isovorin (Levoleucovorin) supplied by GNH India

Isovorin

Active Ingredient:
Levoleucovorin
Origin:
EU

Isovorin (Levoleucovorin)

Levoleucovorin, the active ingredient in Isovorin, is a folate analog presented as a sterile solution for intramuscular and intravenous use. It is employed to mitigate toxicity from high‑dose methotrexate and to enhance the efficacy of fluoropyrimidine chemotherapy in cancer patients. It is commonly used in combination protocols for solid tumours and hematologic malignancies.

GNH India supplies Isovorin as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The company adheres to stringent quality standards and provides regulatory‑approved batches for clinical use.

Manufacturer / TM Owner

Pfizer Limited

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Indications & Clinical Uses

Isovorin (levoleucovorin) is used to modulate folate pathways in oncology and chemotherapy rescue protocols.

  • High‑dose methotrexate therapy: reduces methotrexate‑induced toxicity and supports normal cell recovery.
  • 5‑Fluorouracil‑based chemotherapy: enhances antitumor activity by stabilising drug‑target interaction.
  • Pemetrexed treatment: lessens hematologic toxicity associated with antifolate agents.

How It Works

  • Levoleucovorin is a reduced form of folic acid that bypasses dihydrofolate reductase, directly replenishing intracellular tetrahydrofolate pools. This restores normal DNA synthesis in healthy cells and stabilises the binding of fluoropyrimidines to thymidylate synthase, thereby reducing methotrexate toxicity and potentiating the cytotoxic effect of 5‑fluorouracil‑based regimens.

Side Effects

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

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Transient rash: mild skin erythema or itching.
  • Elevated liver enzymes: temporary increase in hepatic transaminases.
  • Fatigue: mild, short‑lasting tiredness.

Serious or Rare Side Effects

  • Severe hypersensitivity: anaphylactic reactions requiring immediate medical attention.
  • Renal failure: acute kidney injury in susceptible patients.
  • Hepatic dysfunction: significant liver injury or jaundice.
  • Hematologic abnormalities: neutropenia or thrombocytopenia.
  • Cardiovascular events: rare cases of arrhythmia or hypotension.

Precautions & Warnings

Before initiating therapy, clinicians should evaluate patient-specific risk factors.

  • Renal function: assess creatinine clearance and adjust dosing if impaired.
  • Hepatic function: monitor liver enzymes during treatment.
  • Concurrent methotrexate: ensure appropriate rescue timing to avoid excess toxicity.
  • Pregnancy: use only when benefits outweigh potential risks.
  • Allergy: discontinue immediately if hypersensitivity signs appear.
  • Store at ambient temperature: keep in original container, protect from light and moisture.

Avoid Interactions

Levoleucovorin may interact with several agents; monitoring is essential.

Major Interactions (Avoid)

  • Methotrexate: inadequate rescue can increase toxicity.
  • Antifolates (e.g., pemetrexed): may diminish the protective effect of levoleucovorin.
  • High‑dose vitamin C: could interfere with folate metabolism.

Moderate Interactions (Monitor Closely)

  • 5‑Fluorouracil: dose adjustments may be required when combined.
  • Nephrotoxic drugs (e.g., cisplatin): monitor renal parameters.
  • Hepatotoxic drugs (e.g., acetaminophen): watch liver function tests.

Frequently Asked Questions

Isovorin (levoleucovorin) is used as a folate rescue agent to reduce toxicity from high‑dose methotrexate and to enhance the efficacy of fluoropyrimidine‑based chemotherapy such as 5‑fluorouracil. It is also employed to lessen hematologic side effects when pemetrexed is administered.

Levoleucovorin is a reduced folate that bypasses the dihydrofolate reductase step, directly replenishing tetrahydrofolate pools needed for DNA synthesis. This protects normal cells from methotrexate‑induced folate depletion and stabilises the binding of fluoropyrimidines to thymidylate synthase, improving their anticancer activity.

The dosage of Isovorin is individualized and determined by the prescribing clinician based on the specific chemotherapy regimen, patient weight, renal function, and treatment context. Healthcare professionals should follow local guidelines and the product label when calculating the appropriate amount.

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

To request Isovorin, 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 if needed) and necessary import documentation.

The primary alternative is leucovorin (folinic acid), which is a racemic mixture of levoleucovorin and its inactive enantiomer. Levoleucovorin provides a more pharmacologically active form, potentially allowing lower doses and reduced variability in rescue efficacy compared with the racemic preparation.

Isovorin should be stored at ambient temperature, below 25 °C, in its original packaging. Protect the product from direct light, moisture and extreme temperature fluctuations. Inspect the vial for particulate matter or discoloration before use and discard if any abnormalities are observed.

Isovorin is supplied as a sterile solution for intramuscular or intravenous injection. The route, infusion rate and timing are determined by the treating physician, usually given shortly after high‑dose methotrexate or concurrently with fluoropyrimidine chemotherapy according to protocol.

Serious adverse events include severe hypersensitivity reactions such as anaphylaxis, acute renal failure, significant hepatic injury, and hematologic disturbances like neutropenia or thrombocytopenia. Prompt recognition and medical intervention are essential if any of these reactions occur.

Isovorin is contraindicated in patients with known hypersensitivity to levoleucovorin or any component of the formulation. Caution is also advised for individuals with severe renal or hepatic impairment, as well as for those receiving incompatible chemotherapy agents without appropriate monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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