Registered South Africa · SAHPRA

ILUMYA

TILDRAKIZUMAB

59/30.5/0391 INN generic

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Registration & product details

Registration no.
59/30.5/0391
Registration date
2026/07/21
Expiry date
-
Status
Registered
Active ingredient
TILDRAKIZUMAB
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-08-27 10:17:28 · updated 2026-10-28 04:13:08

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

Clinical monograph: Tildrakizumab

BNF-referenced

Tildrakizumab is a recombinant human monoclonal antibody that targets interleukin-23 (IL-23), a cytokine involved in inflammatory processes. By inhibiting IL-23, Tildrakizumab reduces the release of pro-inflammatory cytokines and chemokines, thereby modulating the immune response. It is primarily used for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Indications

  • Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy

Dosage

Adults: Initially 100 mg subcutaneously, followed by 100 mg after 4 weeks, and then 100 mg every 12 weeks. Consider discontinuation if there is no response after 28 weeks, especially in patients with a high disease burden, or consider a dose of 200 mg if the patient's weight is greater than 90 kg.

Mechanism of action

Tildrakizumab specifically binds to the p19 subunit of interleukin-23 (IL-23), inhibiting its interaction with the IL-23 receptor. This blockade prevents the downstream signaling that leads to the production of inflammatory cytokines and chemokines, thus reducing inflammation and the symptoms associated with psoriasis.

Pharmacodynamics

The pharmacodynamic effects of Tildrakizumab include a reduction in inflammatory markers and improvement in skin lesions associated with plaque psoriasis. Clinical studies have shown significant improvements in the Psoriasis Area and Severity Index (PASI) scores, indicating its efficacy in managing the condition.

Pharmacokinetics

Tildrakizumab has a half-life of approximately 23 days, allowing for less frequent dosing. It is administered via subcutaneous injection, with initial dosing followed by maintenance doses. The pharmacokinetics may vary based on patient-specific factors such as body weight and the extent of psoriasis.

Contra-indications

  • Clinically significant active infection
  • History of recurrent infections
  • Recent serious infection

Adverse effects

  • Injection site reactions
  • Headache
  • Fatigue
  • Nausea
  • Upper respiratory tract infections

Precautions

  • Evaluate patients for tuberculosis infection before treatment
  • Monitor for signs and symptoms of active tuberculosis during and after treatment

Pregnancy

Limited information on the use of Tildrakizumab during pregnancy. Manufacturer advises caution.

Breast-feeding

Manufacturer advises avoiding use during breastfeeding due to limited information available.

Storage

Store in a refrigerator (2°C to 8°C). Do not freeze. Allow the syringe to reach room temperature for at least 30 minutes before administration.

Formulations

  • Ilumetri 100 mg/1 ml solution for injection in pre-filled syringes
BNF 85 (British National Formulary) p.1399 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.