Product image of Imuldosa (Ustekinumab) supplied by GNH India

Imuldosa

Active Ingredient:
Ustekinumab
Origin:
EU

Imuldosa (Ustekinumab)

Ustekinumab, the active ingredient in Imuldosa, is a monoclonal antibody presented as a subcutaneous formulation for injection use. It modulates immune activity and is indicated for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn's disease in adult patients.

GNH India supplies Imuldosa as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality assurance, regulatory compliance, and reliable cold‑chain logistics for biologic products across multiple continents and therapeutic areas, with dedicated technical support for healthcare providers.

Manufacturer / TM Owner

Accord Healthcare S.L.U.

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Indications & Clinical Uses

Ustekinumab is a monoclonal antibody that targets interleukin‑12 and interleukin‑23 pathways, used in several immune‑mediated inflammatory conditions.

  • Plaque psoriasis: decreases erythema, scaling and plaque thickness, leading to clearer skin and improved quality of life.
  • Psoriatic arthritis: alleviates joint pain and swelling, improves physical function, and may slow radiographic progression.
  • Crohn's disease: promotes mucosal healing, reduces abdominal pain and diarrhea, and helps maintain long‑term remission.

How It Works

  • Ustekinumab binds with high affinity to the p40 subunit shared by interleukin‑12 and interleukin‑23, preventing these cytokines from engaging their cell‑surface receptors on T‑cells and natural killer cells. This blockade suppresses Th1 and Th17 signaling pathways, reducing downstream inflammatory mediators and immune‑driven tissue damage.

Side Effects

Ustekinumab may be associated with a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Injection site reactions: redness, swelling, or pain at the injection site.
  • Upper respiratory infections: nasopharyngitis, sinusitis, or mild cough.
  • Headache: mild to moderate intensity.
  • Fatigue: general feeling of tiredness.

Serious or Rare Side Effects

  • Serious infections: tuberculosis, opportunistic fungal or bacterial infections.
  • Hypersensitivity reactions: anaphylaxis, angioedema, or severe rash.
  • Malignancies: rare reports of lymphoma or skin cancer.
  • Cardiovascular events: rare cases of myocardial infarction or stroke.

Precautions & Warnings

Before initiating therapy with Ustekinumab, clinicians should consider several precautionary measures.

  • Screening: Assess for active infections, including tuberculosis, before starting treatment.
  • Vaccination: Administer necessary vaccines prior to therapy; avoid live vaccines during treatment.
  • Monitoring: Regularly monitor for signs of infection, malignancy, and laboratory abnormalities.
  • Pregnancy: Use only if potential benefit justifies potential risk; data are limited.
  • Concomitant immunosuppression: Evaluate need for additional immunosuppressants to minimize infection risk.
  • Storage: Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Ustekinumab can interact with other medicines, influencing efficacy or safety.

Major Interactions (Avoid)

  • Live vaccines: concurrent use may cause severe infection; avoid administration while on therapy.
  • Immunosuppressants: combined use with potent agents (e.g., azathioprine, methotrexate) may increase infection risk; requires close clinical judgment.

Moderate Interactions (Monitor Closely)

  • Cytochrome P450 substrates: Ustekinumab does not significantly affect CYP enzymes, but monitor drugs with narrow therapeutic windows.
  • Antifungal agents: co‑administration may require monitoring for additive immunosuppression.
  • Anticoagulants: watch for bleeding risk if severe infection occurs.

Frequently Asked Questions

Imuldosa contains ustekinumab and is approved for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and moderate to severe Crohn's disease in adult patients. It is prescribed when conventional systemic therapies are insufficient or not tolerated.

Ustekinumab is a monoclonal antibody that binds the p40 subunit shared by interleukin‑12 and interleukin‑23. By blocking these cytokines from interacting with their receptors, it suppresses the Th1 and Th17 immune pathways that drive inflammation in psoriasis, arthritis, and Crohn's disease.

The dosing regimen for Imuldosa is individualized by the prescribing clinician based on the specific indication, patient weight, and prior treatment response. Healthcare providers determine the initial loading dose and any subsequent maintenance doses according to approved labeling and clinical guidelines.

Safety data for ustekinumab in pregnancy and lactation are limited. The drug should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss risks with their healthcare professional.

To order 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, cold‑chain shipping details, and necessary import documentation.

Imuldosa (ustekinumab) targets the IL‑12/23 pathway, whereas alternatives such as secukinumab inhibit IL‑17, and TNF‑α inhibitors like adalimumab block tumor necrosis factor. Ustekinumab has a longer dosing interval and a distinct safety profile, which may be advantageous for patients who prefer less frequent injections.

Imuldosa must be stored in a refrigerator at 2‑8 °C (36‑46 °F). Keep the product in its original carton, protect it from light, and do not freeze or shake the vial. Once removed from refrigeration, use according to the manufacturer’s stability guidelines.

Imuldosa is given by subcutaneous injection, typically performed by a healthcare professional in a clinical setting. The injection is administered into the abdomen, thigh, or upper arm, following the dosing schedule prescribed by the treating physician.

The most serious risks include severe infections such as tuberculosis or opportunistic fungal infections, potential development of malignancies (e.g., lymphoma or skin cancer), and hypersensitivity reactions that can be life‑threatening. Patients should be monitored closely for any signs of infection or unusual symptoms.

Imuldosa is contraindicated in individuals with known hypersensitivity to ustekinumab or any of its excipients, and it should be avoided in patients with active, uncontrolled infections. Caution is also advised for those with a history of malignancy or severe cardiac disease, and the decision to treat should be made by a qualified clinician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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