Skyrizi 75mg/0.83ml Injection

Risankizumab

75mg/0.83ml

ABBVIE DEUTSCHLAND GmbH & CO. KG

Pack size	2 Pre-filled Syringes + 2 Alcohol Pads
Dispensing mode	CITY MEDICAL STORE
Source
Agent	GERMANY
Retail Price	22295.00 AED

Indications

Skyrizi 75mg/0.83ml Injection is used for: Plaque Psoriasis

Adult Dose

Plaque Psoriasis Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy 150 mg (two 75-mg injections) SC at Week 0, Week 4, and q12Weeks thereafter

Child Dose

<18 years: Safety and efficacy not established

Renal Dose

Administration

SC Preparation Remove carton from refrigerator and allow to reach room temperature out of direct sunlight (15-30 minutes) without removing prefilled syringes from the carton Visually inspect for particulate matter and discoloration prior to administration Injectable solution is colorless to slightly yellow and clear to slightly opalescent; may contain a few translucent-to-white particles Do not use if solution contains large particles or is cloudy or discolored SC Administration SC administration only Inject 2 separate 75-mg single-dose prefilled syringes (150-mg dose) Discard prefilled syringes after use; do not reuse Self-injections: Administer injections at different anatomic locations (eg, thighs, abdomen), and avoid areas where skin is tender, bruised, erythematous, indurated, or affected by psoriasis Administration in the upper, outer arm may only be performed by a healthcare professional or caregiver Drug is intended for use under the guidance and supervision of a healthcare professional, who may train patient and caregivers to self-inject using the subcutaneous injection technique

Contra Indications

Precautions

In Phase 3 clinical studies, patients with latent TB were concurrently treated with risankizumab and appropriate TB prophylaxis during the studies, none developed active TB; consider antitubercular therapy before initiating treatment in patients with history of latent or active TB in whom course of treatment cannot be confirmed; monitor for signs and symptoms of active TB during and after treatment; do not administer to patients with active TB Before initiating therapy, consider completion of all age-appropriate immunizations according to current immunization guidelines; avoid use of live vaccines in treated patients; no data available on response to live or inactive vaccines Infections In clinical studies, infections occurred more frequently in the risankizumab-treated patients compared with placebo Consider risks and benefits of risankizumab in patients with chronic infection or history of recurrent infection If infection develops or is not responding to standard therapy, closely monitor and withhold risankizumab until the infection resolves

Pregnancy-Lactation

Pregnancy Limited available data with use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome Human IgG is known to cross the placental barrier; therefore, risankizumab is transmitted from mother to developing fetus Animal data In an enhanced prenatal and postnatal developmental toxicity study, pregnant cynomolgus monkeys were administered SC doses of 5 and 50 mg/kg risankizumab-rzaa qWeek during organogenesis up to parturition At 50 mg/kg dose (20x the maximum recommended human dose [MRHD]; 2.5 mg/kg based on administration of a 150-mg dose to a 60-kg individual), increased fetal/infant loss was noted in pregnant monkeys Clinical significance of these findings for humans is unknown Lactation There are no data on the presence of risankizumab-rzaa in human milk, the effects on the breastfed infant, or the effects on milk production Maternal IgG is known to be present in human milk Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Interactions

Adverse Effects

Side effects of Risankizumab : >10% Upper respiratory tract infections (13%) 1-10% Headache (3.5%) Fatigue (2.5%) Injection site reactions (1.5%) Tinea infections (1.1%) <1% Serious infections (eg, cellulitis, osteomyelitis, sepsis, herpes zoster)

Mechanism of Action

Humanized 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 proinflammatory cytokines and chemokines

Note

Skyrizi 75mg/0.83ml 75mg/0.83ml Injection manufactured by ABBVIE DEUTSCHLAND GmbH & CO. KG. Its generic name is Risankizumab. Skyrizi 75mg/0.83ml is availble in United Arab Emirates. Farmaco UAE drug index information on Skyrizi 75mg/0.83ml Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.