Skip to content
MedsAcross

Molecule

Risankizumab

Interleukin-23 Antagonist
Available on requestBiologicOrphanCold chainImmunology and transplantRheumatology
Presentations
6
Brands
1
Manufacturers
1
Available from stock
0

Risankizumab is an interleukin-23 antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy, among other approved uses. MedsAcross supplies Risankizumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Interleukin-23 Antagonist, Interleukin-23 Antagonists
ATC classification
L04AC18 Risankizumab · Immunosuppressive drug, subgroup L04AC
US FDA first approval
23 April 2019
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Subcutaneous, Intravenous
Dosage forms
Injection, Kit
Biologic
Yes
Identifiers
UNII 90ZX3Q3FR7RxCUI 2166040CAS 1612838-76-2DrugBank DB14762Q25112466

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. active psoriatic arthritis in adults and pediatric patients 6 years of age and older. moderately to severely active Crohn's disease in adults. moderately to severely active ulcerative colitis in adults.

Source: US FDA prescribing information

How it works

Risankizumab-rzaa is a humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of human 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.

Source: US FDA prescribing information

Dosing overview

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. Complete all age-appropriate vaccinations as recommended by current immunization guidelines. Recommended Dosage Moderate-to-Severe Plaque Psoriasis: Adults: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. 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. Patients weighing 40 kg or greater: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. Active Psoriatic Arthritis: Adults: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.

Source: US FDA prescribing information

Contraindications

SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients.

Source: US FDA prescribing information

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): Consider evaluating for TB prior to initiating treatment with SKYRIZI based on clinical judgement. 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. Immunizations: Avoid use of live vaccines.

Source: US FDA prescribing information

Side effects

The following adverse reactions are discussed in other sections of labeling: Hypersensitivity Reactions Infections Tuberculosis Hepatotoxicity Most common adverse reactions are: Plaque Psoriasis and 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.

Source: US FDA prescribing information

Storage

Store in a refrigerator at 36°F to 46° F (2°C to 8°C). Do not freeze. Do not shake. Keep in the original cartons to protect from light.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

6 presentations of Risankizumab, sorted by availability.

MedicineManufacturerRegisterAvailability
Skyrizi kitIntravenous Cold chainAbbVieUS FDAAvailable on request
Skyrizi kit Cold chainAbbVieUS FDAAvailable on request
Skyrizi 150 mg/1 mL injectionSubcutaneous Cold chainAbbVieUS FDAAvailable on request
Skyrizi 180 mg/1.2 mL injectionSubcutaneous Cold chainAbbVieUS FDAAvailable on request
Skyrizi 55 mg/0.37 mL injectionSubcutaneous Cold chainAbbVieUS FDAAvailable on request
Skyrizi 600 mg/10 mL injectionIntravenous Cold chainAbbVieUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 23 April 2019Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Risankizumab available for export from India?

Yes, on request. MedsAcross lists 6 presentations of Risankizumab and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Risankizumab have?

The catalogue lists 1 brand names for Risankizumab, including Skyrizi.

Is Risankizumab approved by the US FDA?

Yes. The US FDA first approved Risankizumab on 23 April 2019, according to Drugs@FDA.

Is Risankizumab authorised in the European Union?

Yes. Risankizumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Risankizumab need cold chain shipping?

At least one listed presentation of Risankizumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Risankizumab in?

Risankizumab is classified under ATC code L04AC18 (Risankizumab).

References

  1. Skyrizi prescribing information (AbbVie). U.S. National Library of Medicine, DailyMed. Retrieved 23 October 2026
  2. Skyrizi: European public assessment report (EPAR). European Medicines Agency. Retrieved 26 August 2026

Request Risankizumab for export supply

Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.