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 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 S.P.A.

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Indications & Clinical Uses

Inzolfi belongs to the sphingosine‑1‑phosphate receptor modulator class and is used in the management of multiple sclerosis.

  • Relapsing‑remitting multiple sclerosis: reduces the frequency of clinical relapses and slows accumulation of disability.
  • Active secondary progressive multiple sclerosis: delays disability progression in patients with active disease.
  • Clinically isolated syndrome at high risk of conversion: may postpone the onset of definite multiple sclerosis.

How It Works

  • Fingolimod is a selective modulator of sphingosine‑1‑phosphate (S1P) receptors, primarily S1P1, on lymphocytes. By binding to these receptors it prevents lymphocyte egress from lymph nodes, thereby reducing the number of circulating autoreactive lymphocytes that can infiltrate the central nervous system and cause inflammatory demyelination.

Side Effects

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

Common Side Effects

  • Headache: mild to moderate intensity.
  • Diarrhoea: occasional loose stools.
  • Nausea: transient feeling of queasiness.
  • Fatigue: persistent tiredness.
  • Upper respiratory tract infection: mild cold‑like symptoms.
  • Hypertension: modest increase in blood pressure.

Serious or Rare Side Effects

  • Infections: opportunistic or severe bacterial, viral, or fungal infections.
  • Cardiac arrhythmia: bradycardia or atrioventricular block, especially after first dose.
  • Macular edema: vision‑affecting swelling of the retina.
  • Hepatic injury: elevated liver enzymes or hepatitis.
  • Progressive multifocal leukoencephalopathy (PML): rare, potentially fatal brain infection.

Precautions & Warnings

Before initiating therapy, clinicians should evaluate several safety parameters.

  • Lymphocyte monitoring: check baseline and periodic counts to detect lymphopenia.
  • Cardiac assessment: perform ECG and monitor heart rate during first dose.
  • Liver function: obtain baseline transaminases and repeat as needed.
  • Infection risk: screen for active infections and postpone treatment if present.
  • Vaccination: avoid live vaccines while on therapy.
  • Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Fingolimod can interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase fingolimod exposure.
  • Live attenuated vaccines: risk of vaccine‑derived infection.
  • Drugs that prolong QT interval: additive risk of cardiac arrhythmia.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly raise drug levels.
  • Antihypertensive agents: potential additive blood‑pressure effects.
  • Immunosuppressants (e.g., azathioprine): heightened infection risk.

Frequently Asked Questions

Inzolfi contains fingolimod, a disease‑modifying therapy indicated for relapsing forms of multiple sclerosis. It helps reduce the frequency of clinical relapses and slows the accumulation of disability by limiting immune cell migration into the central nervous system.

Fingolimod selectively binds to sphingosine‑1‑phosphate receptors on lymphocytes, especially the S1P1 subtype. This binding traps lymphocytes in lymph nodes, decreasing their circulation and preventing them from entering the brain and spinal cord where they could cause inflammatory damage.

The dose of Inzolfi is determined by the prescribing clinician based on the patient’s medical condition, weight, and laboratory parameters. The prescriber will set the appropriate dosing regimen and any necessary titration schedule.

Safety data for fingolimod in pregnancy and lactation are limited. It is generally advised to avoid use during pregnancy unless the potential benefit justifies the risk, and breastfeeding decisions should be made in consultation with a healthcare professional.

To request Inzolfi, 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 required import documentation.

Inzolfi (fingolimod) is an oral sphingosine‑1‑phosphate receptor modulator, offering a convenient once‑daily tablet compared with injectable or infusion therapies such as interferons or natalizumab. Its efficacy in reducing relapse rates is comparable, but safety profiles differ, especially regarding infection and cardiac monitoring.

Inzolfi should be stored at or below 25 °C in its original container, protected from moisture and direct sunlight. Do not refrigerate or freeze the product, and keep it out of reach of children.

Inzolfi is taken orally as a tablet, usually once daily with or without food. The tablet should be swallowed whole with water and not chewed or crushed.

The most serious risks include severe infections (including opportunistic infections), cardiac events such as bradycardia or AV block, macular edema affecting vision, liver injury, and the rare but potentially fatal progressive multifocal leukoencephalopathy (PML). Patients should be monitored regularly for these conditions.

Inzolfi is contraindicated in patients with known hypersensitivity to fingolimod, those with recent cardiac events (e.g., myocardial infarction, stroke), uncontrolled infections, severe liver disease, or active macular edema. It should also be avoided in patients receiving live vaccines.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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