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SKYRIZI 150mg Pre-filled syringe/pen

IL-23/P19 INHIBITOR APPROVED FOR 2 INDICATIONS1



Dermatology
PLAQUE PSORIASIS

SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.



Reumatology
PSORIATIC ARTHRITIS

SKYRIZI alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs)


  1. AbbVie is transitioning to a new manufacturing process of the drug substance for Skyrizi for increased productivity to support long-term supply continuity.
  2. The new manufacturing process has been approved by the Israeli Ministry of Health and additional regulatory authorities including the EMA (European Medicines Agency) and the FDA (Food and Drug Administration).
  3. No changes have been identified in the overall safety profile. Kindly keep monitoring patients for adverse events routinely. 

SKYRIZI 150mg Dosing
in Dermatology and Reumatology

Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. Some plaque psoriasis patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
SC - subcutaneous; PFP - prefilled pen; PFS - prefilled syringe; 
For full information please refere to SKYRIZI prescribing information


ACCESS in Israel

Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. Some plaque psoriasis patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
SC - subcutaneous; PFP - prefilled pen; PFS - prefilled syringe; 
For full information please refere to SKYRIZI prescribing information


Abbreviated Safety Summary* (November 2025_V2)

Skyrizi 150 mg (Risankizumab 150mg/ml solution for injection in pre-filled pen or pre-filled syringe)
Skyrizi 600 mg (Risankizumab 60mg/ml concentrate for solution for infusion)
Skyrizi 180 mg (Risankizumab 150 mg/ml solution for injection in cartridge)
Skyrizi 360 mg (Risankizumab 150 mg/ml solution for injection in cartridge)

Indications: 

  • Skyrizi 150 mg is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults who are candidates for systemic therapy.  
  • Skyrizi 150 mg, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
  • Skyrizi 360mg and 600mg are indicated for the treatment of patients 16 years and older with moderately to severely active Crohn's disease (CD) who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy, or if such therapies are not advisable.   
  • Skyrizi 180mg, 360mg and 600mg are indicated for the treatment for the treatment of adult patients with moderately to severely active Ulcerative Colitis (UC) who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

Important Safety Information:
Important identified risks: Serious hypersensitivity reactions. Important potential risks: MACE, Serious infections, Malignancies.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Clinically important active infections [e.g. active tuberculosis (TB)].

Special warnings and precautions for use:

Infections: Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Tuberculosis/Immunisations: Prior to initiating treatment with risankizumab, patients should be evaluated for TB infection and completion of all appropriate immunisations should be considered according to current immunisation guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment. Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of risankizumab. If a serious hypersensitivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated. Excipients with known effect: This medicinal product contains polysorbate 20. Polysorbates may cause allergic reactions. This medicinal product contains less than 1 mmol sodium (23 mg) per pre-filled pen/pre-filled syringe/cartridge or vial, that is to say essentially ‘sodium-free’. Fertility/Pregnancy: Women of childbearing potential should use an effective method of contraception during treatment and for at least 21 weeks after treatment.

Adverse reactions:
The most common adverse reactions (Very common ≥10%) were: Upper respiratory infections (13.0% in psoriasis, 15.6% in Crohn’s disease and 26.2% in ulcerative colitis).

For full information please see Skyrizi® prescribing information. Full prescribing information can be received from Abbvie Biopharmaceuticals Ltd. Israel at 4 Hacharash Street, Hod Hasharon 4524075. Tel: 09-7909600, Fax: 09-7909606.

Updated to abbreviated Safety Summary Sky_API_Nov25_V2


References:

  1. Please refer to Skyrizi prescribing information.

Click here to Prescribing Information >

 

IL-SKZD-260041 | June 2026

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