Risankizumab-rzaa

What is Risankizumab-rzaa?

Risankizumab-rzaa, an interleukin-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.

What are the uses of this medicine?

It is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

How does this medicine work?

• Risankizumab-rzaa is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds to the p19 subunit of human interleukin 23 (IL-23) cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses.
• Risankizumab-rzaa inhibits the release of pro-inflammatory cytokines and chemokines.

Who Should Not Use this medicine?

None.

What are the brand names and dosage forms of this medicine?

• Brand name: Skyrizi; NDC codes: 0074-1050-01, 0074-1050-70, 0074-2042-02, 0074-2042-71, 0074-2100-01, 0074-2100-70.
• SKYRIZI Pen

1. Injection: 150 mg/mL as a colorless to yellow and clear to slightly opalescent solution in each single-dose prefilled pen.

• SKYRIZI Prefilled Syringe

1. Injection: 150 mg/mL as a colorless to yellow and clear to slightly opalescent solution in each single-dose prefilled syringe.
2. Injection: 75 mg/0.83 mL as a colorless to slightly yellow and clear to slightly opalescent solution in each single-dose prefilled syringe.

Is this medicine FDA approved?

It is approved by US FDA on April 23, 2019.

What are the active and inactive ingredients in Risankizumab-rzaa?

• Active ingredient:

1. Risankizumab - 75mg  in 0.83mL

• Inactive ingredients:

1. Succinic Acid - 0.049mg in 0.83mL
2. Sorbitol - 34mg  in 0.83mL
3. Polysorbate 20 - 0.17mg  in 0.83mL
4. Water
5. Sodium Succinate Hexahydrate - 0.88mg  in 0.83mL

How should this medicine be used?

• Use SKYRIZI exactly as your healthcare provider tells you to use it.
• If you miss your SKYRIZI dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. Call your healthcare provider if you are not sure what to do.
• If you inject more SKYRIZI than prescribed, call your healthcare provider right away.

What side effects can this medication cause?

• Upper respiratory infections
• Headache
• Feeling tired
• Injection site reactions
• Fungal skin infections

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

Limited available data with SKYRIZI use in pregnant women are insufficient to evaluate a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome.

Can this medicine be used in children?

The safety and efficacy of SKYRIZI in pediatric patients less than 18 years of age have not yet been established.

What should I know about storage and disposal of this medication?

• Store in a refrigerator at 2°C to 8°C (36°F to 46° F).
• Do not freeze.
• Do not shake.
• Keep prefilled pens and prefilled syringes in the original cartons to protect from light.
• Not made with natural rubber latex.

• Dailymed label info on Risankizumab-rzaa
• FDA Risankizumab-rzaa

Risankizumab-rzaa Resources
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