Product image of Imuldosa (Ustekinumab) supplied by GNH India

Imuldosa

Active Ingredient:
Ustekinumab
Origin:
EU

Imuldosa (Ustekinumab)

Ustekinumab, the active ingredient in Imuldosa, is an interleukin‑12/23 inhibitor presented as a subcutaneous formulation for injection use. It is indicated for the treatment of plaque psoriasis, psoriatic arthritis, and moderately to severely active Crohn’s disease in appropriate adult patients.

GNH India supplies Imuldosa as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality and regulatory compliance.

Manufacturer / TM Owner

Accord Healthcare S.L.U.

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Indications & Clinical Uses

  • Imuldosa (ustekinumab) targets the interleukin‑12/23 pathway and is used in several immune‑mediated inflammatory conditions.
  • Plaque psoriasis: reduces skin lesions and improves quality of life in adult patients.
  • Psoriatic arthritis: alleviates joint inflammation and pain, improving functional ability.
  • Moderately to severely active Crohn’s disease: induces and maintains remission of intestinal inflammation in adults.

How It Works

  • Ustekinumab binds with high affinity to the p40 subunit shared by interleukin‑12 and interleukin‑23, blocking their interaction with cell‑surface receptors on T‑cells and other immune cells. This inhibition prevents downstream activation of the Th1 and Th17 pathways, reducing the production of pro‑inflammatory cytokines and thereby dampening the inflammatory response that drives psoriasis, psoriatic arthritis, and Crohn’s disease.

Side Effects

Common Side Effects

  • Injection site reactions: redness, swelling, or pain at the injection site.
  • Upper respiratory tract infections: mild cold‑like symptoms.
  • Headache: transient and usually mild.
  • Fatigue: general feeling of tiredness.
  • Nausea: occasional upset stomach.
  • Diarrhea: loose stools that may be self‑limiting.

Serious or Rare Side Effects

  • Serious infections: including tuberculosis, bacterial, fungal, or viral infections.
  • Malignancies: rare reports of lymphoma or skin cancers.
  • Severe hypersensitivity: anaphylaxis or angioedema.
  • Inflammatory bowel disease exacerbation: worsening of Crohn’s disease symptoms.
  • Demyelinating disorders: new or worsening neurologic conditions.
  • Cardiovascular events: rare cases of myocardial infarction or stroke.

Precautions & Warnings

  • Before initiating therapy, patients should be evaluated for infection risk and immunization status.
  • Screen for active infections: assess and treat any current infection before starting.
  • Monitor for signs of infection: advise patients to report fever, cough, or unusual symptoms promptly.
  • Assess tuberculosis risk: perform TB screening (e.g., interferon‑gamma release assay) prior to treatment.
  • Vaccination considerations: avoid live vaccines during therapy and schedule inactivated vaccines appropriately.
  • Pregnancy and lactation: discuss potential risks with a healthcare professional; data are limited.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Ustekinumab may interact with other agents that affect immune function.

Major Interactions (Avoid)

  • Live vaccines: may cause severe infection when administered concurrently.
  • Concurrent biologic immunosuppressants: increased risk of serious infections.
  • High‑dose systemic immunosuppressants (e.g., methotrexate): heightened immunosuppression.

Moderate Interactions (Monitor Closely)

  • Corticosteroids: may augment infection risk; monitor patient closely.
  • Antifungal agents (e.g., azoles): additive immunosuppressive effect; observe for infections.
  • Inactivated vaccines: possible reduced efficacy; assess immune response when needed.

Frequently Asked Questions

Imuldosa, whose active ingredient is ustekinumab, is prescribed for adult patients with moderate to severe plaque psoriasis, psoriatic arthritis, and moderately to severely active Crohn’s disease. It works by targeting specific immune pathways that drive inflammation in these disorders.

Ustekinumab binds to the p40 subunit shared by interleukin‑12 and interleukin‑23, preventing these cytokines from activating their receptors on immune cells. This blocks the downstream Th1 and Th17 inflammatory pathways, reducing the production of pro‑inflammatory mediators that contribute to skin, joint, and intestinal inflammation.

The dosing regimen for Imuldosa is determined individually by a qualified prescriber based on the patient’s condition, weight, and clinical response. Healthcare professionals follow the approved prescribing information to select the appropriate dose and administration schedule.

Safety data for ustekinumab in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. Women who are pregnant, planning pregnancy, or breastfeeding should discuss potential risks and benefits with their healthcare provider before starting therapy.

To request Imuldosa, 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 (including cold‑chain handling if needed), and any required import documentation.

Imuldosa (ustekinumab) belongs to the interleukin‑12/23 inhibitor class, whereas many other biologics target tumor necrosis factor‑α or interleukin‑17 pathways. Ustekinumab typically has a longer dosing interval after the initial loading phase and a safety profile that emphasizes infection monitoring, offering an alternative for patients who may not respond to or tolerate other biologic classes.

Imuldosa should be stored at 2‑8 °C (refrigerated). Keep the product in its original packaging, protect it from light, and avoid freezing or shaking the container. Maintaining the cold‑chain ensures the medication retains its potency and safety.

Imuldosa is given by subcutaneous injection. The initial dose is usually administered in a healthcare setting, followed by subsequent injections according to the prescriber’s schedule, which may be every 8 or 12 weeks after the loading phase. Patients should be trained on proper injection technique if self‑administration is planned.

The most serious risks include the development of serious infections such as tuberculosis, opportunistic fungal or viral infections, and rare cases of malignancy. Patients should be monitored for signs of infection, and any unexplained fever, cough, or weight loss should be promptly evaluated by a healthcare professional.

Imuldosa is contraindicated in individuals with known hypersensitivity to ustekinumab or any of its excipients. It should also be avoided in patients with active, uncontrolled infections, including active tuberculosis, and in those receiving live vaccines. A thorough medical assessment is required before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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