Is STELARA available in India?

Ustekinumab: A Biologic for Plaque Psoriasis & Psoriatic
Arthritis Treatment
Ustekinumab is a medication that has been specifically designed to mimic normal human molecules,
and for this reason it is classed as a ‘biological’ drug. It helps reduce the skin inflammation by
inhibiting the activity of chemical molecules known as cytokines (interleukin 12 and 23) in the body
that trigger inflammation in psoriasis.
Role of an IL-12 & IL-23 inhibitor
• The cytokines IL-12 & IL-23 have a central role in the formation and maintenance of the
inflammatory cascade in psoriatic diseases and have been demonstrated to be crucial
targets for therapeutic interventions.
• Usteknumab 90 mg / 45 mg is a fully human monoclonal antibody which typically inhibits the
activity of the cytokines IL-12 & IL-23.
• Rates of adverse events observed in the paediatric study were identical to those observed in
the adult psoriasis population treated with Ustekinumab.
Indication
Stelara is a biologic medicine which specifically blocks interleukin IL-12/23. It is used for the
treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who
have a contraindication to, or are not tolerant to other systemic therapies including PUVA,
ciclosporin, and methotrexate (MTX).
It is used for the treatment of moderate to severe plaque psoriasis in adolescents (aged 12 years or
older) who are inadequately controlled by, or are not tolerant to, other systemic therapies or photo
therapies.
Usteknumab 45 mg / 90 mg is also used for treatment of active psoriatic arthritis in adult patients,
alone or along with MTX, when the response to prior non-biological
disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
Dosing, Storage and Handling
The proposed dosage of Ustekinumab is administered by a subcutaneous injection. To treat
psoriasis, the recommended posology of Ustekinumab is an initial dose of 45 mg administered
subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter. To
treat patients with a body weight >100 kg the initial dose is 90 mg which should be administered
subcutaneously, followed by a 90 mg dose 4 weeks later, and then every 12 weeks thereafter.
To treat psoriasis in adolescents (aged 12 years or older), the recommended dose is 0.75mg/kg for
patients < 60kg, 45mg for patients ≥ 60kg–≤ 100kg, and 90mg for patients > 100kg.
To treat psoriatic arthritis the recommended posology of Ustekinumab injection is an initial dose of
45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks
later, and then every 12 weeks thereafter. Alternatively, 90 mg may be prescribed in patients with a
body weight > 100 kg.
Ustekinumab should be administered at weeks 0 and 4, then every 12 weeks thereafter.
Ustekinumab comes in a pre-filled syringe or vial and needs to be stored in a refrigerator between
2°C and 8°C and not frozen. Keep this medicine in its original outer packaging for protection from
light and do not shake Ustekinumab. It should be allowed to reach room temperature (around half

an hour out of the fridge) before administration. Ustekinumab is clear to slightly opalescent,
colourless to light yellow and may contain a few small translucent or white particles of protein. Do
not use Ustekinumab 45 mg injection or any other dosage strength in case the solution is
discoloured or cloudy, or in case the foreign particulate matter exists.
Ustekinumab Efficacy & Safety
• Ustekinumab has demonstrated in clinical trials that it can provide patients with significant
enhancements in their psoriasis and psoriatic arthritis, as measured by PASI and ACR scores.
• Psoriasis patients receiving Ustekinumab showed significant enhancement in skin symptoms
(PASI 75 response) 12 weeks after initiating therapy. The maintenance of PASI 75 response
has been shown in long term follow-up of up to 5 years in patients following the every-12-
week dosing schedule.
• Psoriatic arthritis treatment with Ustekinumab 90 mg injection resulted in significant
enhancements in the ACR20 score compared to placebo at Week 24. Efficacy was
maintained through 12 months of continuous treatment with Ustekinumab. In addition,
Ustekinumab-treated patients showed significant enhancement in physical function as
assessed by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Week
24. The proportion of patients achieving a clinically meaningful ≥ 0.3 enhancement in HAQ-
DI score from baseline was also significantly higher in the Ustekinumab groups when
compared with placebo. Enhancements in physical function were maintained at 52'nd Week.
• Adverse events noted in trials of Ustekinumab include: nausea, fatigue, diarrhoea, dizziness,
pruritus, headache, myalgia, back pain, arthralgia, oropharyngeal pain, upper respiratory
tract infections, dental infections, nasopharyngitis, injection site erythema and injection site
pain, antibodies to ustekinumab.
• The safety of ustekinumab has been evaluated in a phase-3 study of 110 patients from 12-17
years of age for up to 60 weeks. In this study, the adverse events reported were identical to
those noted in previous studies in adults with plaque psoriasis.
Where can I get more information about ustekinumab?

This information sheet does not list all the details of ustekinumab. In case you want to know more
about medicine ustekinumab, or in case you are a little bit worried about your treatment, you should
speak to your health specialist. For fuller deets, look at the medication information sheet which
comes as an insert with the pack of ustekinumab. Alternatively,
Visit the: - USTEKINUMAB INFORMATION FOR PATIENTS AND CAREGIVERS
Source - https://indianpharmanetwork.mystrikingly.com/blog/a-biologic-for-plaque-psoriasispsoriatic-arthritis-treatment