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Risankizumab-rzaa

Brand name: Skyrizi
Drug class: Skin and Mucous Membrane Agents, Miscellaneous
Molecular formula: C6476H9992N1720O2016S44
CAS number: 1612838-76-2

Medically reviewed by Drugs.com on Apr 27, 2022. Written by ASHP.

Introduction

Inhibitor of interleukin-23 (IL-23); a recombinant humanized IgG1 monoclonal antibody that binds specifically to the p19 subunit of IL-23.

Uses for Risankizumab-rzaa

Plaque Psoriasis

Management of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Guidelines generally support use of IL-23 inhibitors as monotherapy for moderate to severe psoriasis.

Recommendations for use and selection of psoriasis therapies vary based on patient age, disease characteristics (e.g., severity, location, presence of psoriatic arthritis), and comorbidities (e.g., inflammatory bowel disease).

Psoriatic Arthritis

Used for the management of active psoriatic arthritis in adults. May be used alone or in combination with nonbiologic disease-modifying antirheumatic drugs (DMARDs).

The American College of Rheumatology and the National Psoriasis Foundation issued a joint guideline for the treatment of psoriatic arthritis in 2018. Risankizumab is not included in these guidelines; however, current evidence suggests that the drug may provide an additional therapeutic option for patients in whom standard therapies are inadequate.

Recommendations for use and selection of disease-modifying therapies in psoriatic arthritis vary based on the presence of certain disease characteristics (e.g., psoriatic spondylitis/axial disease, enthesitis) and comorbidities (e.g., inflammatory bowel disease, diabetes).

Risankizumab-rzaa Dosage and Administration

General

Pretreatment Screening

  • Evaluate patients for tuberculosis prior to initiation of risankizumab therapy.

  • Administer all age-appropriate vaccines recommended by current immunization guidelines prior to initiation of risankizumab therapy.

Administration

Sub-Q Administration

Available as single-use prefilled syringes (containing 75 mg/0.83 mL or 150 mg/mL) and injection pens (containing 150 mg/mL). Should appear as a clear to slightly opalescent, colorless to yellow or slightly yellow (depending on concentration) solution; may contain a few translucent to white particles but should not contain large particulates.

Allow prefilled syringe or injection pen to sit at room temperature inside the carton out of direct sunlight for 15–30 minutes (prefilled syringe) or 30–90 minutes (injection pen) prior to administration.

Do not shake the injection.

Administer by sub-Q injection into the upper outer arm, anterior thigh, or abdomen; do not make abdominal injections within 2 inches of the navel. Use thigh or abdomen for self-administration; may use upper arm if administered by a caregiver or clinician. Do not make injections into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis.

When using syringes containing 75 mg of the drug, sequentially inject the full contents of 2 syringes at different anatomic sites to administer a 150-mg dose.

Intended for use under the supervision of a clinician, but may be self-administered if the clinician determines that the patient and/or their caregiver is competent to prepare and safely administer the drug after appropriate training.

Dosage

Adults

Plaque Psoriasis
Sub-Q

150 mg at 0 and 4 weeks, then every 12 weeks.

If a dose is missed, administer the missed dose as soon as possible and resume dosing at the regularly scheduled interval.

Psoriatic Arthritis
Sub-Q

150 mg at 0 and 4 weeks, then every 12 weeks.

If a dose is missed, administer the missed dose as soon as possible and resume dosing at the regularly scheduled interval.

Special Populations

Dosage adjustment based on body weight is not necessary.

Hepatic Impairment

Manufacturer makes no specific dosage recommendations.

Renal Impairment

Manufacturer makes no specific dosage recommendations.

Geriatric Patients

Manufacturer makes no specific dosage recommendations.

Cautions for Risankizumab-rzaa

Contraindications

  • History of serious hypersensitivity reactions to risankizumab or any excipients in the formulation.

Warnings/Precautions

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, reported. (See Contraindications under Cautions.)

If a serious hypersensitivity reaction occurs, immediately discontinue the drug and initiate appropriate therapy.

Infections

May increase the risk of infection. In clinical trials in patients with psoriasis, upper respiratory tract infections and tinea infections occurred more frequently with risankizumab-rzaa than with placebo.

Do not initiate risankizumab in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider risks and benefits before initiating therapy in patients with chronic infection or history of recurrent infection.

If a clinically important infection develops or does not respond to standard therapy, monitor the patient closely and discontinue risankizumab until the infection resolves.

Evaluate patients for tuberculosis prior to initiation of risankizumab. Do not administer to patients with active tuberculosis. Consider antimycobacterial therapy prior to initiating risankizumab therapy in individuals with a history of latent or active tuberculosis in whom an adequate course of antimycobacterial treatment cannot be confirmed. Closely monitor patients for active tuberculosis during and after risankizumab treatment.

Immunization

Administer all age-appropriate vaccines recommended by current immunization guidelines prior to initiating risankizumab.

Avoid live vaccines during therapy.

Immunogenicity

Antibodies to risankizumab-rzaa, including neutralizing antibodies, reported. High antidrug antibody titers (detected in approximately 1% of patients receiving risankizumab-rzaa) associated with decreased drug concentrations and decreased efficacy.

Specific Populations

Pregnancy

Data regarding use in pregnant women are inadequate to establish risk of major birth defects, spontaneous abortion, or adverse maternal or fetal outcomes. Potential for fetal exposure since human IgG crosses the placenta.

Dose-dependent increase in fetal/infant loss observed in pre- and post-natal developmental study in cynomolgus monkeys; no malformations and no adverse effects on growth and development, immunologic development, or neurobehavioral development observed. Clinical relevance unknown.

Pregnancy registry at 877-302-2161.

Lactation

Not known whether risankizumab distributes into human milk, affects milk production, or affects breast-fed infants. Maternal IgG is present in breast milk.

Because risankizumab is a large protein molecule, absorption by a breast-fed infant is unlikely since the drug will probably be destroyed in the infant's GI tract.

Consider benefits of breast-feeding and importance of the drug to the woman; also consider any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.

Pediatric Use

Safety and efficacy not established in pediatric patients <18 years of age.

Geriatric Use

No overall differences in safety, efficacy, or drug exposure relative to younger adults; however, insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults.

Hepatic Impairment

Pharmacokinetic data in patients with hepatic impairment not available.

Renal Impairment

Pharmacokinetic data in patients with renal impairment not available.

Common Adverse Effects

Common adverse effects (≥1%): Upper respiratory infection, headache, fatigue, injection site reaction, tinea infection.

Interactions for Risankizumab-rzaa

Vaccines

Avoid live vaccines. No data available regarding response to live or inactivated vaccines in patients receiving risankizumab.

Specific Drugs

Drug

Interaction

Caffeine

No clinically important effect on AUC of caffeine (CYP1A2 substrate)

Metoprolol

No clinically important effect on AUC of metoprolol (CYP2D6 substrate)

Midazolam

No clinically important effect on AUC of midazolam (CYP3A4 substrate)

Omeprazole

No clinically important effect on AUC of omeprazole (CYP2C19 substrate)

Warfarin

No clinically important effect on AUC of warfarin (CYP2C9 substrate)

Risankizumab-rzaa Pharmacokinetics

Absorption

Bioavailability

Absolute bioavailability is approximately 89% following sub-Q administration.

Peak concentration achieved within 3–14 days following a single sub-Q dose; steady-state concentrations attained by week 16 when administered at weeks 0 and 4 and every 12 weeks thereafter.

Concentrations are dose proportional over sub-Q dose range of 90–180 mg in patients with plaque psoriasis and 18–300 mg in healthy individuals.

Special Populations

Plasma concentrations are lower in patients with higher body weight.

Distribution

Extent

Not known whether distributed into human milk.

Elimination

Metabolism

Metabolic pathway not characterized. Expected to be degraded into small peptides and amino acids via catabolic pathways in similar manner as endogenous IgG.

Half-life

28 days.

Special Populations

Age does not substantially alter clearance.

Pharmacokinetics not formally studied in renal or hepatic impairment.

Stability

Storage

Parenteral

Injection

2–8°C; do not freeze. Store in original carton to protect from light until use.

Actions

  • Binds with specificity to the p19 subunit of IL-23, a naturally occurring cytokine that stimulates production of proinflammatory cytokines, including interleukin-17 (IL-17) and interleukin-22 (IL-22). IL-17 and IL-22 contribute to chronic inflammation in patients with psoriasis.

  • Disrupts IL-23-mediated signaling and inhibits release of proinflammatory cytokines and chemokines.

Advice to Patients

  • Provide all patients with a copy of the manufacturer's patient information (medication guide and instructions for use) with each prescription of the drug.

  • Importance of instructing patient and/or caregiver regarding proper storage, dosage, and administration of risankizumab, including the use of aseptic technique, and proper disposal of needles and syringes or injection pens if it is determined that the patient and/or caregiver is competent to safely administer the drug.

  • If using syringes containing 75 mg of the drug, importance of injecting the full contents of 2 syringes at separate injection sites to achieve a 150-mg dose.

  • Possible increased susceptibility to infections. Importance of promptly informing clinician if any signs or symptoms of infection (e.g., fever, sweats, or chills; muscle aches; cough, shortness of breath, or blood in the phlegm; weight loss; warm, red, or painful sores on the body; diarrhea or stomach pain; burning upon urination or increased urination) occur.

  • Importance of reviewing vaccination status with clinician and receiving all appropriate vaccinations prior to initiation of risankizumab. Advise patients that they should not receive live vaccines during or immediately before or after risankizumab therapy. Instruct patients to inform clinicians that they are receiving risankizumab prior to receiving any vaccine.

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., active infection) or any history of tuberculosis or other infections.

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. Encourage pregnant women to enroll in pregnancy registry (877-302-2161) if exposed to risankizumab.

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Risankizumab-rzaa

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for subcutaneous use

75 mg/0.83 mL

Skyrizi (available as single-dose prefilled syringes)

AbbVie

150 mg/mL

Skyrizi (available as single-dose prefilled syringes and injection pens)

AbbVie

AHFS DI Essentials™. © Copyright 2022, Selected Revisions April 27, 2022. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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