skyrizi
Pharmaranks rates Skyrizi 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Skyrizi (Risankizumab-Rzaa) is a medication used to treat Psoriasis.
Risankizumab-Rzaa · by Abbvie
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Risankizumab-Rzaa
- Form
- Injectable, Solution, Kit
- Strength
- RISANKIZUMAB-RZAA 600MG/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- psoriasis
- Manufacturer
- Abbvie
- FDA application
- BLA761262
What is Skyrizi?
From the FDA label:Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/ 0.37 mL prefilled syringe for subcutaneous use Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly…
How to use
Skyrizi is sold in more than one form (Injectable, Solution and Kit), and each is dosed differently. The instructions below come from the FDA label for application BLA761262 — follow the label that came with the product you were actually prescribed.
For the treatment of moderately to severely active Crohn’s disease and ulcerative colitis: Obtain liver enzymes and bilirubin levels prior to initiating treatment with SKYRIZI. ( 2.1 , 5.4 ) Complete all age-appropriate vaccinations as recommended by current immunization guidelines ( 2.1 , 5.5 ) Recommended Dosage Moderate-to-Severe Plaque Psoriasis: Adults : 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. ( 2.3 ) Pediatric P atients 6 Years of Age and Older : Patients weighing less than 40 kg: 55 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. ( 2.3 ) Patients weighing 40 kg or greater: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. ( 2.3 ) Active Psoriatic Arthritis: Adults: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. ( 2.4 ) Pediatric Patients 6 Y ears of Age and Older: Patients weighing less than 40 kg: 55 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. ( 2.4 ) Patients weighing 40 kg or greater: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. ( 2.4 ) SKYRIZI may be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs). ( 2.4 ) Moderately to…
Side effects
The following adverse reactions are discussed in other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Tuberculosis [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Most common adverse reactions are: Plaque Psoriasis and Psoriatic Arthritis (≥ 1%): upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. ( 6.1 ) Crohn’s Disease (>3%): ◦ Induction : upper respiratory infections, headache, and arthralgia. ( 6.1 ) ◦ Maintenance : arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection. ( 6.1 ) Ulcerative Colitis (≥3%): ◦ Induction : arthralgia. ( 6.1 ) ◦ Maintenance : arthralgia, pyrexia, injection site reactions, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults with Plaque Psoriasis A total of 2234 subjects were treated with…
Warnings
Important safety information
Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur. ( 5.1 ) 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. ( 5.2 ) Tuberculosis (TB): Evaluate for TB prior to initiating treatment with SKYRIZI. ( 5.3 ) Hepatotoxicity: Drug-induced liver injury during induction treatment of inflammatory bowel disease 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. ( 5.4 ) Immunizations: Avoid use of live vaccines. ( 5.5 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately [see Adverse Reactions ( 6.1 )]. 5. 2 Infections SKYRIZI may increase the risk of infections [see Adverse Reactions ( 6.1 )] . Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer SKYRIZI until the infection resolves. 5. 3 Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI. Across the Phase 3 psoriasis clinical studies, of the 72 subjects with latent TB who were concurrently treated with SKYRIZI and appropriate TB prophylaxis during the studies, none developed active TB during the mean follow-up of 61 weeks on SKYRIZI. Two subjects taking isoniazid for treatment of latent TB discontinued treatment due to liver injury. Of the 31 subjects from the PsO-3 study with latent TB who did not receive prophylaxis during the study, none developed active TB during the mean follow-up of 55 weeks on SKYRIZI. Consider anti-TB therapy prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB. 5. 4 Hepatotoxicity A serious adverse reaction of drug-induced liver injury in conjunction with a rash that required hospitalization was reported in a patient with Crohn’s disease (ALT 54x ULN, AST 30x ULN, and total bilirubin 2.2x ULN) following two 600 mg intravenous doses of SKYRIZI. The liver test abnormalities resolved following administration of steroids. SKYRIZI was subsequently discontinued. For the treatment of Crohn’s disease and ulcerative colitis, evaluate liver enzymes and bilirubin at baseline, and during induction at least up to 12 weeks of treatment. Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction. 5.5 Immunizations Avoid use of live vaccines in patients treated with SKYRIZI. Drugs that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy with SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or inactive vaccines.
Who should not take Skyrizi
SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients [see Warnings and Precautions ( 5.1 )] . SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients ( 4 )
Storing Skyrizi, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “If not used immediately, store the diluted SKYRIZI solution refrigerated and protected from light for up to 20 hours between 36°F to 46°F (2°C to 8°C).”
May treat (source: NIH RxClass)
Dosage forms
Injectable, Solution and Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Skyrizi treat?
- Skyrizi (Risankizumab-Rzaa) may be used to treat psoriasis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Skyrizi rated?
- pharmaranks gives Skyrizi a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Skyrizi?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Skyrizi. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Skyrizi?
- Skyrizi is marketed by Abbvie. You can see Abbvie's full profile, rating, and other products on pharmaranks.
- Is Skyrizi a brand-name or generic drug?
- Skyrizi is a brand-name product with the active ingredient Risankizumab-Rzaa.
- Is Skyrizi available over the counter?
- No. Skyrizi is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Skyrizi come in?
- Skyrizi is currently marketed as injectable, solution and kit, per the FDA's National Drug Code Directory.
- Is Skyrizi FDA-registered?
- Skyrizi is on record with the U.S. FDA under application number BLA761262. You can verify this on its official FDA label.
- Has Skyrizi been recalled by the FDA?
- Skyrizi has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Skyrizi safe?
- There's no single safe-or-not verdict. pharmaranks gives Skyrizi a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Skyrizi?
- Skyrizi's side effects are taken directly from its FDA label. From the label: The following adverse reactions are discussed in other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Tuberculosis [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] M… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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skyrizi
72/100