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About Product
Product Description:
- SKYRIZI®(risankizumab-rzaa) injection, for subcutaneousor intravenoususe
Initial U.S. Approval: 2019Indications and Usage for Skyrizi Injection
SKYRIZI is an interleukin-23 antagonist indicated for the treatment of:
- moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
- active psoriatic arthritis in adults.
- moderately to severely active Crohn's disease in adults.
- moderately to severely active ulcerative colitis in adults.
Skyrizi Injection Dosage and Administration
- For the treatment of Crohn’s disease and ulcerative colitis: Obtain liver enzymes and bilirubin levels prior to initiating treatment with SKYRIZI.
- Complete all age-appropriate vaccinations as recommended by current immunization guidelines
Recommended Dosage
Plaque Psoriasis and Psoriatic Arthritis:
- 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. (
- In patients with psoriatic arthritis SKYRIZI can be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs).
Crohn’s Disease:
- The recommended induction dosage is 600 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage to maintain therapeutic response.
Ulcerative Colitis:
- The recommended induction dosage is 1,200 mg administered by intravenous infusion over at least two hours at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage to maintain therapeutic response.
Dosage Forms and Strengths Intravenous infusion
- Injection: 600 mg/10 mL (60 mg/mL) in each single-dose vial.
Contraindications
- SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients (4)
Warnings and Precautions
- Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur.
- Infections: SKYRIZI may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, do not administer SKYRIZI until the infection resolves.
- Tuberculosis (TB): Evaluate for TB prior to initiating treatment with SKYRIZI.
- Hepatotoxicity in Treatment of Inflammatory Bowel Disease: Drug-induced liver injury during induction has been reported. Monitor liver enzymes and bilirubin levels at baseline and, during induction, up to at least 12 weeks of treatment. Monitor thereafter according to routine patient management.
- Administration of Vaccines: Avoid use of live vaccines.
Adverse Reactions/Side Effects
Most common adverse reactions are:
- Plaque Psoriasisand Psoriatic Arthritis(≥ 1%): upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
- Crohn’s Disease(>3%):
◦Induction: upper respiratory infections, headache, and arthralgia.
◦Maintenance: arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection. - Ulcerative Colitis(≥3%):
◦Induction:arthralgia.
◦Maintenance:arthralgia, pyrexia, injection site reactions, and rash.
Product Details:
