Product image of Issoferrol Max (Deferasirox) supplied by GNH India

Issoferrol Max

Active Ingredient:
Deferasirox
Origin:
EU

Issoferrol Max (Deferasirox)

Deferasirox, the active ingredient in Issoferrol Max, is an iron‑chelating agent presented as an oral formulation for oral use. It reduces excess systemic iron in patients who develop chronic iron overload due to repeated blood transfusions, such as those with beta‑thalassemia major, sickle cell disease, or myelodysplastic syndromes.

GNH India supplies Issoferrol Max as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide, with a focus on quality assurance and regulatory compliance, through reliable logistics where required.

Manufacturer / TM Owner

Elpen Pharmaceutical Co. Inc.

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Indications & Clinical Uses

Issoferrol Max (deferasirox) is used to manage iron overload conditions that arise from chronic transfusion therapy.

  • Chronic iron overload due to repeated blood transfusions: Reduces total body iron stores and prevents organ damage.
  • Beta‑thalassemia major: Maintains safe iron levels to support regular transfusion regimens.
  • Sickle cell disease: Controls transfusional iron accumulation to reduce complications.

How It Works

  • Deferasirox binds free iron with high affinity in the plasma and intracellularly, forming a stable 1:1 complex that is not readily re‑absorbed. The chelate is excreted predominantly via the feces, lowering circulating ferric iron and gradually depleting tissue iron deposits, thereby mitigating iron‑induced oxidative injury. Because the complex is highly lipophilic, it is absorbed into the gastrointestinal tract and eliminated without significant renal involvement, which helps preserve kidney function during long‑term therapy.

Side Effects

Deferasirox may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Diarrhea: loose stools, often transient.
  • Abdominal pain: cramp‑like discomfort.
  • Rash: skin redness or itching.
  • Elevated liver enzymes: mild increase in ALT/AST.
  • Fatigue: general tiredness.

Serious or Rare Side Effects

  • Acute kidney injury: sudden decline in renal function.
  • Severe hepatic failure: marked elevation of liver enzymes and jaundice.
  • Blood dyscrasias: neutropenia or thrombocytopenia.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Precautions & Warnings

Before initiating therapy with Issoferrol Max, several safety considerations should be reviewed.

  • Baseline assessment: Obtain liver function tests, renal function, and serum ferritin levels prior to treatment.
  • Monitoring: Perform periodic liver and kidney labs to detect early toxicity.
  • Pregnancy: Contraindicated in pregnancy (Category D); avoid use unless benefits outweigh risks.
  • Pediatric use: Dose adjustments may be required for children; follow specialist guidance.
  • Drug interactions: Review concomitant medications for potential major interactions.
  • Store at ambient temperature: Keep below 25 °C in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Deferasirox can affect the pharmacokinetics of several co‑administered drugs; interactions are classified by clinical significance.

Major Interactions (Avoid)

  • Cyclosporine: Increases deferasirox exposure, raising risk of renal toxicity.
  • Rifampicin: Reduces deferasirox plasma levels, potentially decreasing efficacy.
  • Antacids containing aluminum or magnesium: Decrease oral absorption of deferasirox.

Moderate Interactions (Monitor Closely)

  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): May enhance renal adverse effects.
  • Vitamin C (high doses): Can increase iron‑chelator complex formation, altering iron balance.
  • Statins: Potential for increased myopathy risk; monitor muscle symptoms.

Frequently Asked Questions

Issoferrol Max contains deferasirox, an oral iron‑chelating agent prescribed to treat chronic iron overload that results from repeated blood transfusions. It is indicated for conditions such as beta‑thalassemia major, sickle cell disease and myelodysplastic syndromes, helping to lower excess iron and protect vital organs.

Deferasirox binds free iron with high affinity, forming a stable 1:1 complex that is not readily re‑absorbed. The complex is eliminated mainly through the feces, reducing circulating and tissue iron levels and preventing iron‑catalyzed oxidative damage.

The dose of deferasirox is individualized by the prescribing clinician based on factors such as the patient’s body weight, baseline serum ferritin, rate of iron accumulation, and overall clinical condition. No standard regimen is provided here; the prescriber sets the appropriate dose.

Deferasirox is classified as Pregnancy Category D, indicating evidence of risk to the fetus. It is generally avoided during pregnancy unless the potential benefit justifies the risk. Limited data are available for breastfeeding, and caution is advised; consultation with a healthcare professional is essential.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity of Issoferrol Max. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

The primary alternative to deferasirox is deferoxamine, which is administered by subcutaneous or intravenous infusion and requires a lengthy dosing schedule. Deferasirox offers the convenience of oral administration, improving adherence, but both agents share similar goals of reducing iron burden; safety profiles differ, with deferoxamine associated more with auditory and ocular toxicity.

Issoferrol Max should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed to maintain stability.

Issoferrol Max is taken orally, usually once daily, with a full glass of water. It can be taken with or without food, but consistent administration with respect to meals helps maintain stable absorption. Tablets or capsules should be swallowed whole and not crushed or chewed.

Serious adverse events include acute kidney injury, severe hepatic dysfunction, and rare but life‑threatening skin reactions such as Stevens‑Johnson syndrome. Patients should be monitored regularly for changes in renal and liver function tests, and any signs of rash or systemic illness should be reported promptly.

Contraindications include pregnancy, known hypersensitivity to deferasirox or any excipients, and patients with severe renal impairment where alternative chelation strategies are preferred. Clinicians should also exercise caution in individuals with pre‑existing liver disease or those taking interacting medications.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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