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 (S1P) receptor modulator presented as an oral formulation for oral use. It functions as a disease‑modifying therapy for multiple sclerosis, specifically targeting relapsing‑remitting and active disease forms in adult patients.

GNH India supplies Inzolfi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality‑controlled manufacturing, regulatory compliance, and reliable distribution across EU and other global markets. The company adheres to stringent Good Distribution Practice (GDP) standards and provides full traceability from production to end‑user.

Manufacturer / TM Owner

Sandoz N.V.

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Indications & Clinical Uses

Inzolfi is a sphingosine‑1‑phosphate receptor modulator used in the management of multiple sclerosis and related disease activity.

  • Relapsing‑remitting multiple sclerosis: reduces relapse frequency and slows disability progression.
  • Active secondary progressive multiple sclerosis: delays disability progression.
  • Overall disease activity in multiple sclerosis: provides disease‑modifying effects to limit new lesion formation.

How It Works

  • Fingolimod selectively binds to sphingosine‑1‑phosphate receptors (S1P1, S1P3, S1P4, and S1P5) on lymphocytes, causing internalization of the receptor and preventing egress of lymphocytes from lymph nodes. This sequestration reduces circulating autoreactive lymphocytes, limiting their migration into the central nervous system and thereby decreasing inflammatory demyelination in multiple sclerosis.

Side Effects

Fingolimod may cause a range of adverse reactions, from mild to serious.

Common Side Effects

  • Headache: mild to moderate intensity, often transient.
  • Nasopharyngitis: upper respiratory symptoms such as sore throat and congestion.
  • Diarrhea: loose stools that may be self‑limiting.
  • Elevated liver enzymes: mild transaminase increases detectable on lab testing.
  • Hypertension: new‑onset or worsening blood pressure.
  • Cough: non‑productive cough without infection.

Serious or Rare Side Effects

  • Infections: opportunistic infections including herpes virus reactivation.
  • Cardiac arrhythmias: bradycardia or atrioventricular block, especially after first dose.
  • Macular edema: visual disturbances requiring ophthalmologic evaluation.
  • Severe liver injury: marked transaminase elevation or hepatitis.
  • Progressive multifocal leukoencephalopathy (PML): rare but potentially fatal demyelinating disease.

Precautions & Warnings

Before initiating therapy, clinicians should assess patient suitability and monitor for potential risks.

  • Monitor lymphocyte count: check baseline and periodic levels to detect lymphopenia.
  • Assess liver function: perform baseline and regular liver enzyme tests.
  • Screen for infections: evaluate for active infections and vaccinate appropriately before treatment.
  • Evaluate cardiac status: obtain ECG and monitor heart rate during first dose.
  • Avoid use in patients with active infection: defer treatment until infection resolves.
  • Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Fingolimod can interact with other medicines, requiring careful management. Major Interactions (Avoid):\n- Concomitant use with other immunosuppressants: may increase risk of severe infections.

  • Live vaccines: can cause vaccine‑derived infection due to immune suppression.
  • Drugs that prolong QT interval: may exacerbate cardiac conduction abnormalities.

Moderate Interactions (Monitor Closely)

  • Antihypertensive agents: may enhance blood pressure‑lowering effects.
  • Antidiabetic medications: monitor glucose control as fingolimod can affect glycemia.
  • CYP3A4 inhibitors or inducers: may alter fingolimod plasma concentrations, requiring dose adjustment or close observation.

Frequently Asked Questions

Inzolfi contains fingolimod, which is prescribed as a disease‑modifying therapy for relapsing forms of multiple sclerosis. It helps reduce the frequency of clinical relapses and slows the progression of disability by limiting immune cell infiltration into the central nervous system.

Fingolimod selectively modulates sphingosine‑1‑phosphate receptors on lymphocytes, causing these cells to be retained in lymph nodes. This reduces the number of circulating autoreactive lymphocytes that can enter the brain and spinal cord, thereby decreasing inflammatory damage associated with multiple sclerosis.

The dosage of Inzolfi is determined by the prescribing physician based on the patient’s clinical condition, laboratory values, and regulatory guidelines. The prescriber will select the appropriate strength and dosing schedule, which should be followed exactly as instructed.

The safety of fingolimod during pregnancy or lactation has not been fully established. Women of childbearing potential should use effective contraception while on therapy, and the drug should only be used during pregnancy or breastfeeding if the potential benefit justifies the potential risk, as assessed by a healthcare professional.

To request Inzolfi, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.

Inzolfi (fingolimod) is an oral sphingosine‑1‑phosphate receptor modulator, offering a convenient once‑daily tablet compared with injectable or infusion therapies. It provides a distinct mechanism of action by sequestering lymphocytes, whereas other disease‑modifying drugs may target different immune pathways such as cytokine inhibition or B‑cell depletion.

Inzolfi should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and do not store in bathrooms or other humid environments.

Inzolfi is taken orally, typically as a tablet swallowed with water. The exact dosing schedule, including any titration or monitoring steps, is prescribed by the treating physician and should be followed precisely.

Serious risks include opportunistic infections, cardiac conduction abnormalities such as bradycardia or atrioventricular block, macular edema affecting vision, severe liver injury, and rare cases of progressive multifocal leukoencephalopathy (PML). Patients should be monitored regularly for these potential complications.

Inzolfi is contraindicated in patients with known hypersensitivity to fingolimod, those with active infections, recent myocardial infarction, uncontrolled cardiac disease, or severe liver impairment. It should also be avoided in individuals receiving live vaccines or other immunosuppressive agents without careful medical supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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