Skyrizi 150 mg

/ AbbVie

This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which risankizumab is indicated.
The recommended dose is 150 mg administered as a subcutaneous injection at week 0, week 4, and every 12 weeks thereafter (150 mg pre-filled pen or pre-filled syringe injection).
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.
Missed dose: If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.
Elderly (aged 65 years and over): No dose adjustment is required. There is limited information in subjects aged ≥65 years.
Renal or hepatic impairment: No specific studies were conducted to assess the effect of hepatic or renal impairment on the pharmacokinetics of risankizumab. These conditions are generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered necessary.
Paediatric population: The safety and efficacy of risankizumab in children and adolescents aged 5 to 18 years have not been established. No data are available.
There is no relevant use of risankizumab in children aged below 6 years for the indication of moderate to severe plaque psoriasis or in children aged below 5 years for the indication of psoriatic arthritis.
Overweight patients: No dose adjustment is required.
See prescribing information for full details.

Plaque Psoriasis: Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Psoriatic Arthritis: Risankizumab, 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).

Hypersensitivity to the active substance or to any of the excipients.
Clinically important active infections (e.g. active tuberculosis). See prescribing information for full details.

Traceability:
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
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.
Patients treated with risankizumab should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and risankizumab should not be administered until the infection resolves.
Tuberculosis:
Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Immunisations:
Prior to initiating therapy with risankizumab, 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:
If a serious hypersensitivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated.
Excipients with known effect:
150 mg solution for injection in pre-filled pen or pre-filled syringe:
Polysorbate: This medicinal product contains 0.2 mg of polysorbate 20 in each 150 mg dose. Polysorbates may cause allergic reactions.
Sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per pre-filled pen or pre-filled syringe, that is to say, essentially ‘sodium free’.

Very common: Upper respiratory infections.
Common: Tinea infections, headache, pruritus, fatigue, injection site reactions.
See prescribing information for full details.

Risankizumab is not expected to undergo metabolism by hepatic enzymes or renal elimination. Interactions between risankizumab and inhibitors, inducers, or substrates of medicinal product metabolising enzymes are not expected, and no dose adjustment is needed. See prescribing information for full details.
Concomitant immunosuppressive therapy or phototherapy:
The safety and efficacy of risankizumab in combination with immunosuppressants, including biologics or phototherapy, have not been evaluated.

Women of childbearing potential:
Women of childbearing potential should use an effective method of contraception during treatment and for at least 21 weeks after treatment.
Pregnancy:
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of risankizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of risankizumab during pregnancy.
Breast-feeding:
It is unknown whether risankizumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. A decision should be made whether to discontinue/abstain from risankizumab therapy, taking into account the benefit of breast-feeding to the child and the benefit of risankizumab therapy to the woman.
Fertility:
The effect of risankizumab on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.

In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.

Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled pen or the pre-filled syringe(s) in the outer carton in order to protect from light.
The 150 mg pre-filled pen or pre-filled syringe may be stored out of the refrigerator (up to a maximum of 25°C) for up to 24 hours in the original carton to protect from light.