Product image of Inzolfi (Fingolimod) supplied by GNH India

Inzolfi

Active Ingredient:
Fingolimod
Origin:
EU

Inzolfi (Fingolimod)

Fingolimod, the active ingredient in Inzolfi, is a sphingosine‑1‑phosphate receptor modulator presented as an oral formulation for oral use. It is indicated for relapsing forms of multiple sclerosis and works by retaining lymphocytes in lymph nodes, thereby reducing inflammatory activity in the central nervous system.

GNH India supplies Inzolfi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Sandoz Pharmaceuticals D.D.

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Indications & Clinical Uses

Inzolfi acts on the sphingosine‑1‑phosphate pathway to modify disease activity in multiple sclerosis.

  • Relapsing‑remitting multiple sclerosis: reduces the frequency of clinical relapses and slows disability progression.
  • Active secondary progressive multiple sclerosis: decreases relapse rate and may delay worsening of disability.
  • Clinically isolated syndrome: lowers the risk of conversion to clinically definite multiple sclerosis.

How It Works

  • Fingolimod is a selective modulator of sphingosine‑1‑phosphate (S1P) receptors. After oral absorption, it is phosphorylated to an active metabolite that binds S1P1 receptors on lymphocytes, causing internalisation of the receptor and sequestration of lymphocytes within lymph nodes. This reduces circulating lymphocyte counts and limits their migration into the central nervous system, thereby diminishing autoimmune inflammation characteristic of multiple sclerosis.

Side Effects

Fingolimod is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Headache: mild to moderate intensity.
  • Diarrhoea: usually transient.
  • Nausea: may occur early in treatment.
  • Fatigue: common during the first weeks.
  • Upper respiratory tract infection: mild symptoms.
  • Elevated liver enzymes: monitored via laboratory tests.

Serious or Rare Side Effects

  • Infections: opportunistic or severe bacterial infections.
  • Cardiac arrhythmias: bradycardia or atrioventricular block, especially after first dose.
  • Macular edema: visual disturbances requiring ophthalmologic assessment.
  • Severe liver injury: marked transaminase elevation.
  • Progressive multifocal leukoencephalopathy (PML): rare but life‑threatening.
  • Malignancies: increased incidence of certain cancers reported.

Precautions & Warnings

Before initiating Fingolimod, clinicians should assess baseline parameters and educate patients about potential risks.

  • Lymphocyte monitoring: check absolute lymphocyte count before start and periodically thereafter.
  • Liver function: obtain baseline liver enzymes and repeat during therapy.
  • Cardiac evaluation: perform ECG and monitor heart rate after the first dose.
  • Infection risk: advise patients to report signs of infection promptly and avoid live vaccines.
  • Pregnancy and lactation: discuss potential risks and advise contraception during treatment.
  • Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Fingolimod can interact with several drug classes, influencing safety and efficacy.

Major Interactions (Avoid)

  • Concurrent immunosuppressants: may amplify immunosuppression and infection risk.
  • Live vaccines: can cause uncontrolled infection due to impaired immunity.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): increase Fingolimod plasma levels.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may modestly raise drug exposure.
  • Antihypertensive agents (especially beta‑blockers): additive bradycardia effect after first dose.
  • Antiplatelet or anticoagulant therapy: heightened bleeding tendency if liver enzymes rise.
  • Vaccines (non‑live): monitor immune response effectiveness.

Frequently Asked Questions

Inzolfi contains fingolimod, which is prescribed to treat relapsing forms of multiple sclerosis, including relapsing‑remitting, active secondary progressive disease, and clinically isolated syndrome. It helps reduce the frequency of relapses and may slow the accumulation of disability by modulating immune cell trafficking.

Fingolimod is a selective sphingosine‑1‑phosphate receptor modulator. After oral absorption, it is phosphorylated and binds to S1P1 receptors on lymphocytes, causing receptor internalisation. This traps lymphocytes in lymph nodes, lowering their presence in peripheral blood and limiting their migration into the central nervous system, thereby reducing inflammatory damage.

The dosage of Inzolfi is determined by the prescribing physician based on the patient’s clinical condition, laboratory values, and safety considerations. The prescriber will set the appropriate dose and schedule, and any adjustments are made under medical supervision.

The safety of fingolimod during pregnancy and lactation has not been fully established. Women of childbearing potential should use effective contraception while on therapy, and the drug should be discontinued if pregnancy is confirmed. Breastfeeding decisions should be made in consultation with a healthcare professional.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide. After verification of trade or institutional credentials, the sales team will provide pricing, availability, shipping details (including any cold‑chain requirements) and assist with import documentation.

Inzolfi (fingolimod) is an oral disease‑modifying therapy that offers the convenience of once‑daily dosing, unlike injectable agents such as interferons or natalizumab. Its mechanism of sequestering lymphocytes differs from agents that block cell adhesion or deplete B cells. Efficacy and safety profiles vary, so treatment choice depends on individual disease activity, comorbidities and patient preference.

Inzolfi should be stored at temperatures below 25 °C (77 °F). Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed when not in use.

Inzolfi is taken orally, usually as a tablet, with or without food. The patient should swallow the tablet whole with water and follow the dosing schedule prescribed by the healthcare provider.

Serious risks include severe infections, cardiac conduction abnormalities (especially after the first dose), macular edema leading to visual impairment, significant liver injury, and the rare occurrence of progressive multifocal leukoencephalopathy (PML). Patients should be monitored regularly for these events and report any concerning symptoms promptly.

Inzolfi is contraindicated in patients with known hypersensitivity to fingolimod or any of its excipients, those with recent myocardial infarction, unstable angina, stroke, or uncontrolled cardiac disease, and individuals with active infections. It should also be avoided in patients who are pregnant or planning pregnancy without appropriate contraception.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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