Stelara Injection
Ustekinumab
90mg/ml
Janssen-Cilag AG
| Pack size | 0.5ml Pre-filled Syringe |
|---|---|
| Dispensing mode | POM |
| Source | SWITZERLAND |
| Agent | CITY MEDICAL STORE |
| Retail Price | 16561.00 AED |
Available as:
Indications
Stelara Injection is used for:
Plaque Psoriasis, Psoriatic Arthritis, Crohn Disease, Ulcerative Colitis
Adult Dose
Plaque Psoriasis
Indicated for the treatment of adults and adolescents aged ?12 years with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy
<100 kg: 45 mg SC at Weeks 0 and 4, then q12weeks thereafter
>100 kg: 90 mg SC at Weeks 0 and 4, then q12weeks thereafter
Psoriatic Arthritis
Indicated for adults with active psoriatic arthritis alone or in combination with methotrexate
45 mg SC at Weeks 0 and 4, then q12weeks thereafter
For patients >100 kg with co-existent moderate-to-severe plaque psoriasis, increase dose to 90 mg SC at Weeks 0 and 4, then q12weeks thereafter
Crohn Disease
Indicated for adults with moderately to severely active Crohn disease who have
Initial weight-based IV dose
Single IV dose infused over 1 hr
<55 kg: 260 mg IV
>55 kg to 85 kg: 390 mg IV
>85 kg: 520 mg IV
Maintenance SC dose
Begin 90 mg SC 8 weeks after the initial IV infusion, then q8wk thereafter
Ulcerative Colitis
Indicated for adults with moderately to severely active ulcerative colitis
Initial weight-based IV dose
Single IV dose infused over 1 hr (also see maintenance dose below)
<55 kg: 260 mg IV
>55 kg to 85 kg: 390 mg IV
>85 kg: 520 mg IV
Maintenance SC dose
Begin 90 mg SC 8 weeks after the initial IV infusion, then q8wk thereafter
Child Dose
Plaque Psoriasis
Indicated for treatment of adolescents aged ?12 years with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy
<12 years: Safety and efficacy not established
>12 years
<60 kg: 0.75 mg/kg SC at Weeks 0 and 4, then q12weeks thereafter
60-100 kg: 45 mg SC at at Weeks 0 and 4, then q12weeks thereafter
>100 kg: 90 mg SC at Weeks 0 and 4, then q12weeks thereafter
Renal Dose
Administration
SC Preparation
Visually inspect for particulate matter and discoloration
Solution should appear clear, colorless to light yellow and may contain a few small translucent or white particles
Do not use if it is discolored or cloudy, or if other particulate matter is present
Does not contain preservatives; therefore, discard any unused product remaining in the vial and/or syringe
SC Administration
See full prescribing information for how to use prefilled syringe injector
Each injection should be administered at a different anatomic location (eg, upper arms, gluteal regions, thighs, or any quadrant of abdomen) than the previous injection
Do not inject into areas where the skin is tender, bruised, erythematous, or indurated
When using the single-dose vial, a 27-gauge, 0.5-inch needle is recommended
IV Preparation
Must be diluted, prepared and infused by a healthcare professional using aseptic technique
Calculate dose and the number of ustekinumab vials needed based on patient weight (see Adult Dosing)
Each 26 mL vial contains 130 mg of ustekinumab
Withdraw, and then discard a volume of the 0.9% NaCl from the 250 mL infusion bag equal to the volume ustekinumab to be added (discard 26 mL NaCl for each vial of needed, for 2 vials- discard 52 mL, for 3 vials- discard 78 mL, 4 vials- discard 104 mL)
Withdraw 26 mL from each vial needed and add it to the 250 mL infusion bag
The final volume in the infusion bag should be 250 mL
Gently mix
Visually inspect the diluted solution before infusion
Do not use if visibly opaque particles, discoloration or foreign particles are observed
IV Administration
Infuse the diluted solution over a period of at least 1 hr
Once diluted, the infusion solution may be stored for up to 4 hr prior to infusion
Use only an infusion set with an in-line, sterile, nonpyrogenic, low protein-binding filter (pore size 0.2 micrometer)
Do not infuse concomitantly in the same IV line with other agents
Does not contain preservatives
Each vial is for single use only
Discard any remaining solution
Contra Indications
Hypersensitivity
Active serious infection
Concomitant live vaccines
Precautions
Use caution in patients genetically deficient in IL-12/IL-23
Reversible posterior leukoencephalopathy syndrome (RPLS) reported (1 case); if RPLS is suspected, administer appropriate therapy and discontinue treatment
Provide age-appropriate immunization prior to initiating therapy
Hypersensitivity reactions reported, including anaphylaxis and angioedema
Infections
Do not administer treatment to patients with active tuberculosis infection; initiate treatment of latent tuberculosis (TB) prior to administering ustekinumab; closely monitor for signs and symptoms of active tuberculosis during and after treatment
May increase risk of infections and reactivation of latent infections; serious bacterial, fungal, mycobacterial, and viral infections observed with treatment; evaluate for TB infection before initiating drug
Malignancies
Increased risk of malignancy
Reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients with pre-existing risk factors for developing nonmelanoma skin cancer; monitor all patients for nonmelanoma skin cancer
Pregnancy-Lactation
Pregnancy
Limited data on ustekinumab use in pregnant women to inform a drug associated risk
In animal reproductive and developmental toxicity studies, no adverse developmental effects were observed after administration of ustekinumab to pregnant monkeys at exposures greater than 100 times the human exposure at the maximum recommended human subcutaneous dose (MRHD)
Lactation
Data are not available on the presence of ustekinumab in human milk, effects on the breastfed infant, or effects on milk production
Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ustekinumab and any potential adverse effects on the breastfed child from ustekinumab or from the underlying maternal condition
Interactions
Formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation; ustekinumab (IL-12 and IL-23 antagonist) may normalize the formation of CYP450 enzyme; monitor therapeutic effects (eg, warfarin) or concentration (eg, cyclosporine) with concomitant CYP450 substrates use (especially narrow therapeutic index drugs)
Psoriasis studies the safety of ustekinumab in combination with immunosuppressive agents or phototherapy has not been evaluated; in psoriatic arthritis studies, concomitant methotrexate use did not appear to influence the safety or efficacy
May decrease the protective effect of allergen immunotherapy
Avoid use of live vaccines with ustekinumab
BCG vaccines should not be given during treatment or for one year prior to initiating treatment or one year following discontinuation of treatment; use caution when administering live vaccines to household contacts of patients receiving treatment due to the potential risk for shedding from the household contact and transmission to patient
Adverse Effects
Side effects of Ustekinumab :
>10%
Upper respiratory infection
1-10%
Nasopharyngitis
Back pain
Cellulitis
Depression
Diarrhea
Fatigue
Headache
Injection site erythema
Myalgia
Fatigue
Nasal congestion
Urticaria
Rash
Pruritus
Antibody formation
<1% (selected)
Severe infection
Malignancy
Reversible posterior leukoencephalopathy syndrome
Mechanism of Action
Human IgG1κ monoclonal antibody binds to the p40 protein subunit used by IL-12 and IL-23 cytokines; IL-12 and IL-23 are involved in inflammatory and immune responses (eg, natural killer cell activation, CD4+ T-cell differentiation, and activation)
Note
Stelara 90mg/ml Injection manufactured by Janssen-Cilag AG. Its generic name is Ustekinumab. Stelara is availble in United Arab Emirates.
Farmaco UAE drug index information on Stelara Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.