Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Prefilled Syringe Kit, Subcutaneous [preservative free]:
Skyrizi (150 MG Dose): Risankizumab-rzaa 75 mg/0.83 mL [contains 2 prefilled syringes] (1 ea)
Pharmacology
Mechanism of Action
Human IgG1 monoclonal antibody which selectively binds to the p19 subunit of interleukin (IL)-23, thereby inhibiting its interaction with the IL-23 receptor, resulting in inhibition of the release of proinflammatory cytokines and chemokines.
Pharmacokinetics/Pharmacodynamics
Distribution
Vdss: 11.2 L
Metabolism
Degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG
Time to Peak
3 to 14 days
Half-Life Elimination
~28 days
Use in Specific Populations
Special Populations Note
Body weight: Risankizumab clearance and volume of distribution increase and plasma concentrations decrease as body weight increases.
Use: Labeled Indications
Plaque psoriasis, moderate to severe: Treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Contraindications
There are no contraindications listed in the manufacturer's labeling.
Canadian labeling: Hypersensitivity to risankizumab or any component of the formulation
Dosage and Administration
Dosing: Adult
Plaque psoriasis, moderate to severe: SubQ: Two consecutive injections (75 mg each) for a total dose of 150 mg at weeks 0, 4, and then every 12 weeks thereafter.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Obesity
No dosage adjustment necessary.
Reconstitution
Allow prefilled syringe to reach room temperature (15 to 30 minutes) in original carton before injecting. Intact solution should be colorless to light yellow and clear to slightly opalescent; solution may develop a few translucent to white particles. Discard unused portion of prefilled syringe.
Administration
SubQ: Administer the two consecutive injections subcutaneously at different anatomic locations, such as thighs, abdomen, or back of upper arms. Do not inject into areas where the skin is tender, bruised, red, hard, or affected by psoriasis. Intended for use under supervision of a health care professional; self-injection may occur after proper training (except back of upper arms).
Storage
Store at 2°C to 8°C (36°F to 46° F) in the original carton; do not freeze. Protect from light. Do not shake.
Drug Interactions
Belimumab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Avoid combination
InFLIXimab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Avoid combination
Vaccines (Live): Risankizumab may enhance the adverse/toxic effect of Vaccines (Live). Avoid combination
Adverse Reactions
>10%:
Immunologic: Antibody development (24%; neutralizing: 14%)
Infection: Infection (22%)
Respiratory: Upper respiratory tract infection (13%)
1% to 10%:
Central nervous system: Headache (4%), fatigue (3%)
Dermatologic: Tinea (1%)
Local: Injection site reaction (2%)
Frequency not defined:
Neuromuscular & skeletal: Asthenia
Respiratory: Nasopharyngitis, pneumonia, rhinitis, sinusitis, tonsillitis
<1%, postmarketing, and/or case reports: Cellulitis, folliculitis, herpes zoster infection, osteomyelitis, sepsis, urticaria
Warnings/Precautions
Concerns related to adverse effects:
- Infections: Risankizumab may increase the risk of infections; upper respiratory tract and tinea infections have occurred more frequently. Consider the risks versus benefits prior to treatment initiation in patients with a history of chronic or recurrent infection; treatment should not be initiated in patients with clinically important active infections until it is resolved or treated. Monitor for infections; patients should seek medical attention for signs/symptoms of a clinically important infection (acute or chronic). If a serious infection develops or is unresponsive to appropriate therapy for the infection, monitor closely and discontinue risankizumab until the infection resolves.
- Tuberculosis: Patients should be evaluated for tuberculosis (TB) infection prior to initiating therapy. Do not administer to patients with an active TB infection. Treatment for latent TB should be administered prior to administering risankizumab. Consider anti-TB therapy prior to treatment initiation in patients with a history of latent or active TB in whom an adequate course of TB treatment cannon be confirmed. Monitor closely for signs/symptoms of active TB during and after risankizumab treatment.
Other warnings/precautions:
- Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently; there are no data available concerning secondary transmission of infection by live vaccines in patients receiving therapy.
Monitoring Parameters
Tuberculosis screening (prior to initiating and periodically during therapy); signs and symptoms of infection, including tuberculosis (during and after treatment).
Pregnancy
Pregnancy Considerations
Risankizumab is a humanized monoclonal antibody (IgG1). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Patient Education
What is this drug used for?
- It is used to treat plaque psoriasis.
Frequently reported side effects of this drug
- Common cold symptoms
- Loss of strength and energy
- Injection site irritation
- Headache
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Infection
- Flu-like symptoms
- Shortness of breath
- Weight loss
- Warm, red, or painful skin or sores
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
