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 tablet for oral use. It is indicated for the treatment of relapsing forms of multiple sclerosis in adult patients.
GNH India supplies Inzolfi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Sandoz Ltd

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Indications & Clinical Uses

  • Inzolfi (fingolimod) is used in the management of relapsing forms of multiple sclerosis, a disease mediated by immune‑driven inflammation.
  • Relapsing‑Remitting MS: reduces the frequency of clinical relapses and slows disability progression.
  • Active Secondary Progressive MS: decreases relapse rate and disease activity.
  • Clinically Isolated Syndrome with high risk of conversion: delays conversion to definite multiple sclerosis.

How It Works

  • Fingolimod selectively modulates sphingosine‑1‑phosphate (S1P) receptors on lymphocytes, causing their retention within lymph nodes. This limits the egress of autoreactive lymphocytes into the circulation and central nervous system, thereby reducing inflammatory activity and demyelination associated with multiple sclerosis.

Side Effects

Common Side Effects

  • Headache: mild to moderate intensity, often transient.
  • Nasopharyngitis: upper respiratory symptoms such as sore throat or runny nose.
  • Diarrhoea: loose stools that may resolve with continued therapy.
  • Elevated liver enzymes: mild increases in ALT/AST detected on routine labs.
  • Hypertension: new‑onset or worsening blood pressure.
  • Fatigue: generalised tiredness without specific cause.

Serious or Rare Side Effects

  • Severe infections: opportunistic infections requiring medical attention.
  • Cardiac arrhythmia: bradycardia or atrioventricular block, especially after first dose.
  • Macular edema: visual disturbances due to retinal swelling.
  • Progressive multifocal leukoencephalopathy (PML): rare demyelinating brain infection.
  • Severe liver injury: marked transaminase elevation or hepatitis.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Precautions & Warnings

  • Before initiating therapy, clinicians should assess cardiac, hepatic and infection risk.
  • Cardiac monitoring: obtain baseline ECG and observe patients for at least six hours after the first dose due to potential bradycardia.
  • Infection risk: avoid starting treatment in patients with active infections and monitor for signs of new infections.
  • Liver function: perform baseline and periodic liver enzyme tests.
  • Vaccination: administer required live vaccines before therapy; avoid live vaccines during treatment.
  • Pregnancy and breastfeeding: contraindicated unless benefits outweigh risks; discuss with a specialist.
  • Store at ambient temperature: keep below 25 °C, retain original packaging, protect from moisture.

Avoid Interactions

Fingolimod may interact with several medicines that affect immune function or cardiac conduction.

Major Interactions (Avoid)

  • Live attenuated vaccines: increased risk of vaccine‑derived infection.
  • Concomitant immunosuppressants: heightened susceptibility to serious infections.
  • QT‑prolonging drugs: additive risk of cardiac arrhythmias.

Moderate Interactions (Monitor Closely)

  • Beta‑blockers: may mask fingolimod‑induced bradycardia.
  • CYP4F2 inhibitors: can raise fingolimod plasma concentrations.
  • Antihypertensives: monitor blood pressure for additive hypotensive effect.

Frequently Asked Questions

Inzolfi contains fingolimod, which is prescribed to treat relapsing forms of multiple sclerosis. It helps reduce the frequency of clinical relapses and slows the progression of disability by modulating immune activity in the central nervous system.

Fingolimod binds to sphingosine‑1‑phosphate receptors on lymphocytes, preventing these cells from leaving lymph nodes. By limiting their circulation, the drug reduces the number of autoreactive lymphocytes that can enter the brain and spinal cord, thereby decreasing inflammatory damage in multiple sclerosis.

The specific dose of Inzolfi is determined by the prescribing physician based on the patient’s clinical condition, weight, and other factors. Dosing regimens are individualized and should follow the prescriber’s instructions and local regulatory guidelines.

Safety of fingolimod in pregnancy and lactation has not been established. It is generally contraindicated unless the potential benefit justifies the risk. Women of child‑bearing potential should use effective contraception and discuss any pregnancy plans with their healthcare provider.

To place an order, 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 and any 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. Its efficacy in reducing relapse rates is comparable to some high‑efficacy agents, but safety profiles differ, particularly regarding cardiac and infection risks.

Inzolfi should be stored at ambient temperature, preferably below 25 °C. Keep the tablets in the original blister pack, protect them from moisture and direct sunlight, and ensure they are out of reach of children.

Inzolfi is taken orally as a tablet, usually once daily with or without food. The exact timing and any special instructions should be provided by the prescribing clinician.

Serious risks include severe infections, cardiac arrhythmias such as bradycardia or AV block, macular edema affecting vision, progressive multifocal leukoencephalopathy, and significant liver injury. Patients should be monitored regularly for these events.

Inzolfi is contraindicated in patients with known hypersensitivity to fingolimod, active severe infections, recent cardiac events, uncontrolled hypertension, significant liver disease, or those who are pregnant or breastfeeding unless the benefits outweigh the risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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