Skyrizi^® (Solution) Instructions for Use

ATC Code

L04AC18 (Risankizumab)

Active Substance

Risankizumab (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Immunosuppressant. Recombinant humanized monoclonal antibodies (IgG₁)

Pharmacotherapeutic Group

Immunosuppressants, interleukin inhibitors

Pharmacological Action

Psoriasis treatment agent, a humanized monoclonal immunoglobulin G1 antibody that selectively and with high affinity binds to the p19 subunit of the human cytokine interleukin-23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a natural cytokine involved in inflammatory and immune responses. IL-23 promotes the formation, maintenance, and activation of Th17 lymphocytes, which produce IL-17A, IL-17F, and IL-22, as well as other pro-inflammatory cytokines, and play an important role in the pathogenesis of autoimmune diseases, particularly psoriasis.

In patients with plaque psoriasis, IL-23 levels are elevated in the diseased skin. By preventing the binding of IL-23 to its receptor, Risankizumab inhibits the signaling pathway and the release of pro-inflammatory cytokines.

Risankizumab does not bind to human IL-12, which shares the p40 subunit with IL-23.

According to study data, a single administration of risankizumab to patients with psoriasis leads to a reduction in the skin expression of genes associated with the IL-23/IL-17 immune axis. A decrease in epidermal thickness, inflammatory infiltration, and expression of psoriasis markers was also observed in psoriatic lesions.

Pharmacokinetics

Risankizumab is characterized by linear pharmacokinetics with dose-dependent increases in exposure in the dose range from 18 to 300 mg and from 0.25 to 1 mg/kg upon subcutaneous administration, as well as from 200 to 1200 mg and from 0.01 to 5 mg/kg upon intravenous administration.

After subcutaneous administration of risankizumab, the C_max in plasma is reached in 3-14 days, the estimated absolute bioavailability is 89%. The mean steady-state C_max and trough plasma concentration are estimated to be 12 and 2 µg/ml, respectively, with the following dosing regimen in patients with psoriasis: 150 mg at weeks 0, 4, and every 12 weeks thereafter.

In a typical psoriasis patient with a body weight of 90 kg, the steady-state V_d is 11.2 L, indicating that the distribution of risankizumab is primarily confined to the vascular and interstitial spaces.

Therapeutic monoclonal IgG antibodies are typically degraded into small peptides and amino acids via catabolism similar to endogenous IgG.

For a typical psoriasis patient with a body weight of 90 kg, the systemic clearance of risankizumab is 0.31 L/day, and the terminal T_1/2 is 28 days.
Risankizumab is not expected to undergo glomerular filtration or be excreted unchanged in the urine.

Indications

Treatment of moderate to severe plaque psoriasis in adult patients; as monotherapy or in combination with basic anti-inflammatory drugs (BAIDs) for the treatment of active psoriatic arthritis in adult patients.

ICD codes

Dosage Regimen

Administer the recommended dose of 150 mg subcutaneously at Week 0, Week 4, and every 12 weeks thereafter.

Prepare the dose as two separate 75 mg injections.

Inject the two 75 mg doses simultaneously at different anatomical sites.

Appropriate injection areas include the thigh, abdomen, or upper arm.

Do not inject into skin that is tender, bruised, erythematous, or indurated.

Ensure a minimum interval of 12 weeks is maintained between doses after the initial loading doses.

If a dose is missed, administer the injection as soon as possible.

Thereafter, resume dosing according to the original schedule from the most recent administration.

Adverse Reactions

Infections and infestations Very common – upper respiratory tract infections; Common – dermatomycosis; Uncommon – folliculitis.

Nervous system disorders Common – headache.

General disorders and administration site conditions Common – fatigue, injection site reaction.

Contraindications

Severe hypersensitivity reactions to risankizumab;
Active tuberculosis; children under 18 years of age.

With caution

Chronic infections or a history of recurrent infection.

Vaccination with live vaccines should not be carried out during therapy with risankizumab.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

There are no specific instructions for limiting use in elderly patients.

Special Precautions

The use of risankizumab may increase the risk of developing infections.

Patients should be informed of the need to consult a doctor if signs and symptoms suggestive of an infection develop. The condition of a patient who develops an infection or who does not respond to standard therapy should be carefully monitored. Therapy with risankizumab should not be carried out until the clinical symptoms of the infectious disease have resolved.

Patients with latent tuberculosis should receive anti-tuberculosis therapy before starting treatment with risankizumab.

Age-appropriate vaccination should be completed according to current immunization guidelines prior to initiating therapy with risankizumab. Immunization with live vaccines should not be carried out during treatment with risankizumab.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.