Product image of Otulfi (Ustekinumab) supplied by GNH India

Otulfi

Active Ingredient:
Ustekinumab
Origin:
EU

Otulfi (Ustekinumab)

Ustekinumab, the active ingredient in Otulfi, is a biologic presented as a injection for subcutaneous use. It modulates immune responses and is indicated for several chronic inflammatory conditions in adults.
GNH India supplies Otulfi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres and specialty clinics worldwide.

Manufacturer / TM Owner

Fresenius Kabi Deutschland Gmbh

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Indications & Clinical Uses

Ustekinumab is a monoclonal antibody that targets key cytokines involved in the inflammatory cascade of immune‑mediated diseases.

  • Plaque psoriasis: reduces skin lesions and improves quality of life.
  • Crohn’s disease: induces and maintains clinical remission.
  • Ulcerative colitis: helps achieve mucosal healing and symptom control.
  • Psoriatic arthritis: alleviates joint pain and prevents structural damage.

How It Works

  • Ustekinumab binds selectively to the p40 subunit shared by interleukin‑12 and interleine‑13 (IL‑12/IL‑13), blocking their interaction with cell‑surface receptors. This inhibition dampens Th‑1 and Th‑2 mediated inflammatory pathways, reducing cytokine release and downstream immune activation associated with chronic inflammatory disorders.

Side Effects

Adverse reactions to ustekinumab vary in frequency and severity.

Common Side Effects

  • Injection site pain
  • Upper respiratory tract infection
  • Headache
  • Fatigue
  • Nausea
  • Diarrhea

Serious or Rare Side Effects

  • Severe infections (e.g., tuberculosis)
  • Malignancies such as lymphoma
  • Hypersensitivity reactions
  • Cardiovascular events
  • New onset or worsening inflammatory bowel disease
  • Neurologic disorders including demyelination

Precautions & Warnings

Ustekinumab should be used under careful medical supervision, with attention to infection risk and immune status.

  • Screen for latent TB: perform interferon‑gamma release assay before initiation.
  • Monitor for signs of infection: advise patients to report fever, cough, or unexplained malaise.
  • Assess vaccination status: avoid live vaccines during treatment.\n- Review cardiac history: use cautiously in patients with known cardiovascular disease.
  • Pregnancy and lactation: weigh benefits against potential risks; discuss with a specialist.
  • 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 or infection risk.

Major Interactions (Avoid)

  • Live vaccines: concurrent use can cause severe infection.
  • Systemic immunosuppressants (e.g., high‑dose corticosteroids): may increase infection risk.

Moderate Interactions (Monitor Closely)

  • Antifungal agents (e.g., azoles): may require infection monitoring.
  • Antiviral therapies: observe for altered immune response.
  • Cytokine‑targeting biologics: assess cumulative immunosuppression.
  • Concomitant antibiotics: monitor for opportunistic infections.

Frequently Asked Questions

Otulfi contains ustekinumab, a monoclonal antibody indicated for adult patients with moderate to severe plaque psoriasis, Crohn’s disease, ulcerative colitis and psoriatic arthritis. It is prescribed when conventional systemic therapies are insufficient or not tolerated.

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 inflammatory cascade that drives the skin and gut lesions seen in psoriasis and inflammatory bowel disease.

The dosing schedule for ustekinumab is individualized by the prescribing clinician based on the specific indication, patient weight, and prior treatment response. The prescriber determines the initial dose, maintenance interval and any necessary adjustments.

Safety data for ustekinumab in pregnancy and lactation are limited. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and the decision should be made in consultation with a specialist obstetrician and the treating physician.

To request Otulfi, submit an enquiry on the product page at gnhindia.com with 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 if needed) and import documentation.

Compared with TNF‑α inhibitors, ustekinumab targets a different cytokine pathway (IL‑12/IL‑23) and is administered less frequently, which may improve convenience. Efficacy and safety profiles differ, so the choice depends on disease characteristics, prior therapy response and patient preference.

Otulfi should be stored in a refrigerator at 2‑8 °C, protected from light and never frozen. Once removed from refrigeration, the product may be kept at room temperature for a limited period as specified in the labeling, but should be returned to the fridge if not used promptly.

Otulfi is supplied as a pre‑filled syringe for subcutaneous injection. A healthcare professional administers the dose under aseptic technique, typically in the thigh, abdomen or upper arm, following the dosing schedule prescribed by the treating physician.

Serious risks include severe infections such as tuberculosis, opportunistic fungal infections, and rare malignancies. Patients should be monitored for signs of infection, undergo regular skin examinations and report any new or worsening symptoms promptly.

Otulfi is contraindicated in individuals with known hypersensitivity to ustekinumab or any excipients, and should be used with caution in patients with active infections, uncontrolled heart disease, or a history of malignancy. A thorough medical assessment is required before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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