STELARA 130MG CONCENTRATE FOR SOLUTION FOR INFUSION

Indications

• Plaque psoriasis
• Psoriatic arthritis
• Crohn's disease
• Ulcerative colitis

Dosage

Adults: For adults, the initial dose of ustekinumab is determined by body weight: 45 mg for those up to 56 kg, 90 mg for those between 56 kg and 85 kg, and 520 mg for those above 86 kg. After 4 weeks, a subsequent dose of 45 mg, 90 mg, or 90 mg is given depending on body weight. Maintenance doses are administered every 12 weeks, and higher doses may be considered in specific cases. If no response is observed within 16 weeks

Mechanism of action

Ustekinumab binds to the p40 subunit common to interleukin-12 (IL-12) and interleukin-23 (IL-23), inhibiting the interaction between these cytokines and their receptors. This action disrupts the signaling pathways that lead to inflammation and the activation of T cells, thus reducing the inflammatory response associated with autoimmune diseases.

Pharmacodynamics

The pharmacodynamics of ustekinumab involve the modulation of the immune system, particularly through the inhibition of T cell activation and differentiation. This leads to decreased production of pro-inflammatory cytokines, resulting in reduced inflammation and the alleviation of symptoms in autoimmune conditions. The therapeutic effects may take several weeks to manifest, as changes in immune cell populations and cytokine levels occur.

Pharmacokinetics

Ustekinumab is administered subcutaneously or intravenously. It has a half-life of approximately 15 to 50 days, allowing for dosing every 12 weeks after the initial doses. The pharmacokinetics can be influenced by body weight, necessitating weight-based dosing. It is primarily eliminated via the reticuloendothelial system, and its clearance may be affected by the presence of antibodies against the drug.

Contra-indications

• Active infection

Adverse effects

• Increased risk of infection
• Malignancy development
• Widespread erythema and skin exfoliation
• Dizziness

Precautions

• Elderly patients should be monitored closely due to increased risk of adverse effects.
• Patients with a history of malignancy should be cautious.
• Patients should avoid excessive exposure to UV light, including sunlight.
• Monitor for signs of tuberculosis in patients with previous treatment.

Pregnancy

Limited data available, use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Unknown if excreted in human milk, use caution.

Storage

Store in a refrigerator (2–8 degrees Celsius), do not freeze. Allow to reach room temperature before use.

Formulations

• Solution for injection: 162 mg/0.9 mL
• Solution for infusion