Risankizumab-Rzaa (Skyrizi)

Trade Name : Skyrizi

AbbVie Inc.

KIT

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Risankizumab-Rzaa (Skyrizi) which is also known as Skyrizi and Manufactured by AbbVie Inc.. It is available in strength of per ml. Read more

Risankizumab-Rzaa (Skyrizi) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

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

No data

150 mg (two 75 mg injections) administered by subcutaneous injection at Week 0, Week 4 and every 12 weeks thereafter. ()

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

Injection: 75 mg/0.83 mL in each single-dose prefilled syringe. ()

None.

None ()

No data

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. ()

The following adverse reactions are discussed in greater detail in other sections of labeling:
Most common adverse reactions (u2265 1%) are upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. ()n n
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.

Avoid use of live vaccines in patients treated with SKYRIZI .
Avoid use of live vaccines in patients treated with SKYRIZI. ()

No data

In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions and administer appropriate symptomatic treatment immediately.

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.
SKYRIZI (risankizumab-rzaa) injection is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution for subcutaneous use.
Each prefilled syringe delivers 0.83 mL containing 75 mg risankizumab-rzaa, disodium succinate hexahydrate (0.88 mg), polysorbate 20 (0.17 mg), sorbitol (34 mg), succinic acid (0.049 mg), and Water for Injection, USP.

No data

Carcinogenicity and mutagenicity studies have not been conducted with SKYRIZI.
No effects on male fertility parameters were observed in sexually mature male cynomolgus monkeys subcutaneously treated with 50 mg/kg risankizumab-rzaa (at 20 times the clinical exposure at the MRHD, based on mg/kg comparison) once weekly for 26 weeks.

Four multicenter, randomized, double-blind studies [ULTIMMA-1 (NCT02684370), ULTIMMA-2 (NCT02684357), IMMHANCE (NCT02672852), and IMMVENT (NCT02694523)] enrolled 2109 subjects 18 years of age and older with moderate to severe plaque psoriasis who had a body surface area (BSA) involvement of u226510%, a static Physicianu2019s Global Assessment (sPGA) score of u22653 (u201cmoderateu201d) in the overall assessment (plaque thickness/induration, erythema, and scaling) of psoriasis on a severity scale of 0 to 4, and a Psoriasis Area and Severity Index (PASI) score u226512.
Overall, subjects had a median baseline PASI score of 17.8 and a median BSA of 20.0%. Baseline sPGA score was 4 (u201csevereu201d) in 19% of subjects. A total of 10% of study subjects had a history of diagnosed psoriatic arthritis.
Across all studies, 38% of subjects had received prior phototherapy, 48% had received prior non-biologic systemic therapy, and 42% had received prior biologic therapy for the treatment of psoriasis.
ULTIMMA-1 and ULTIMMA-2
In ULTIMMA-1 and ULTIMMA-2, 997 subjects were enrolled (including 598 subjects randomized to the SKYRIZI 150 mg group, 200 subjects randomized to the placebo group, and 199 to the biologic active control group). Subjects received treatment at Weeks 0, 4, and every 12 weeks thereafter.
Both studies assessed the responses at Week 16 compared to placebo for the two co-primary endpoints:
Secondary endpoints included the proportion of subjects who achieved PASI 100, sPGA 0, and PSS 0 at Week 16.
The results are presented in Table 2.
Examination of age, gender, race, body weight, baseline PASI score and previous treatment with systemic or biologic agents did not identify differences in response to SKYRIZI among these subgroups at Week 16.
In ULTIMMA-1 and ULTIMMA-2 at Week 52, subjects receiving SKYRIZI achieved sPGA 0 (58% and 60%, respectively), PASI 90 (82% and 81%, respectively), and PASI 100 (56% and 60%, respectively).
Arrayn- Patient Reported Outcomes
Improvements in signs and symptoms related to pain, redness, itching and burning at Week 16 compared to placebo were observed in both studies as assessed by the Psoriasis Symptom Scale (PSS). In ULTIMMA-1 and ULTIMMA-2, about 30% of the subjects who received SKYRIZI achieved PSS 0 (u201cnoneu201d) at Week 16 compared to 1% of the subjects who received placebo.
IMMHANCE
IMMHANCE enrolled 507 subjects (407 randomized to SKYRIZI 150 mg and 100 to placebo). Subjects received treatment at Weeks 0, 4, and every 12 weeks thereafter.
At Week 16, SKYRIZI was superior to placebo on the co-primary endpoints of sPGA 0 or 1 (84% SKYRIZI and 7% placebo) and PASI 90 (73% SKYRIZI and 2% placebo). The respective response rates for SKYRIZI and placebo at Week 16 were: sPGA 0 (46% SKYRIZI and 1% placebo); PASI 100 (47% SKYRIZI and 1% placebo); and PASI 75 (89% SKYRIZI and 8% placebo).
Maintenance and Durability of Response
In ULTIMMA-1 and ULTIMMA-2, among the subjects who received SKYRIZI and had PASI 100 at Week 16, 80% (206/258) of the subjects who continued on SKYRIZI had PASI 100 at Week 52. For PASI 90 responders at Week 16, 88% (398/450) of the subjects had PASI 90 at Week 52.
In IMMHANCE, subjects who were originally on SKYRIZI and had sPGA 0 or 1 at Week 28 were re-randomized to continue SKYRIZI every 12 weeks or withdrawal of therapy. At Week 52, 87% (97/111) of the subjects re-randomized to continue treatment with SKYRIZI had sPGA 0 or 1 compared to 61% (138/225) who were re-randomized to withdrawal of SKYRIZI.

No data

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) before starting SKYRIZI therapy and to reread the Medication Guide each time the prescription is renewed. Advise patients of the potential benefits and risks of SKYRIZI.
Infections
Inform patients that SKYRIZI may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection .
Administration Instruction
Instruct patients or caregivers to perform the first self-injected dose under the supervision and guidance of a qualified healthcare professional for training in preparation and administration of SKYRIZI, including choosing anatomical sites for administration, and proper subcutaneous injection technique .
Instruct patients or caregivers to administer two 75 mg single-dose syringes to achieve the 150 mg dose of SKYRIZI .
Instruct patients or caregivers in the technique of needle and syringe disposal .
Manufactured by:AbbVie Inc.North Chicago, IL 60064, USA
US License Number 1889SKYRIZI is a trademark of AbbVie Biotechnology Ltd.u00a9 2019 AbbVie Inc.20059638 08/2019

No data

Instructions for Usen n n
Read Before First Use
Refer to the for product information.
SKYRIZI Single-Dose Prefilled Syringe
IMPORTANT INFORMATION:
Keep SKYRIZI and all medicines out of the reach of children.
Please Read Complete Instructions For Use Before Using SKYRIZI Syringe
BEFORE INJECTING:
IMPORTANT INFORMATION:
STORAGE INFORMATION:
Keep SKYRIZI and all medicines out of the reach of children.
Call your healthcare provider or if you need help or do not know how to proceed. u00a0
Questions About Using the SKYRIZI Syringe
USED SKYRIZI PREFILLED SYRINGE DISPOSAL
If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDAu2019s website at: www.fda.gov/safesharpsdisposal.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by: AbbVie Inc., North Chicago, IL 60064, U.S.A. US License Number 1889SKYRIZI is a trademark of AbbVie Biotechnology Ltd.u00a9 2019 AbbVie Inc.20059637Revised: 08/2019

NDC 0074-2042-02
2 x 0.83 mL prefilled syringes
Skyriziu2122
risankizumab-rzaa Injection
75 mg/0.83 mL per Syringe
FOR SUBCUTANEOUS USE ONLY
FOR A 150 MG DOSE,TWO 75 MG SYRINGES ARE REQUIRED,INJECT ONE SYRINGE AFTER THE OTHER
ATTENTION PHARMACIST:Dispense the enclosed Medication Guide to each patient.
The entire carton is to be dispensed as a unit.
Return to pharmacy if carton perforations are broken.
www.SKYRIZI.com
Rx only
abbvie
NDC 0074-2042-71
NOT FOR SALE
2 x 0.83 mL prefilled syringes
Skyriziu2122
risankizumab-rzaa Injection
75 mg/0.83 mL per Syringe
FOR SUBCUTANEOUS USE ONLY
FOR A 150 MG DOSE,TWO 75 MG SYRINGES ARE REQUIRED,INJECT ONE SYRINGE AFTER THE OTHER
ATTENTION PHYSICIAN:Dispense the enclosed Medication Guide to each patient.
The entire carton is to be dispensed as a unit.
Return to physician if carton perforations are broken.
www.SKYRIZI.com
Rx only
abbvie

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Risankizumab-Rzaa (Skyrizi)

Trade Name : Skyrizi

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Risankizumab-Rzaa (Skyrizi)

Trade Name : Skyrizi

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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