Drug Interaction:
Live vaccines: Live vaccines should not be given with STELARA
Concomitant therapy:
The safety of concomitant use of STELARA with immunosuppressants or
phototherapy has not been evaluated.
Indication:
Proprietary Name- Sterlara
Established Name - Usterkinumab- human interlutin -12 & 2 3 antagonist
Applicant- Centocor Ortho Biotech Inc.
Indication-
Treat Adult (18 years and older) with moderate to severe psoriasis
Dosage-
Patients weight < 100kg - 45mg initially and 4 weeks later followed by 90mg
every 12weeks
Approved by FDA on 25-9-2010 (Ref- FDA approved List- 2010)
Adverse Reaction:
Most common adverse reactions (incidence >3% and greater than with placebo):
Nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
Contra-Indications:
CONTRAINDICATIONS
Clinically significant hypersensitivity to ustekinumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Infections: Serious infections have occurred. Do not start STELARA during
any clinically important active infection.
If a serious infection develops, stop STELARA until the infection resolves.
Theoretical Risk for Particular Infections: Serious infections from mycobacteria,
salmonella and Bacillus Calmette-Guerin (BCG) vaccinations have been reported
in patients genetically deficient in IL12/IL-23.
Diagnostic tests for these infections should be considered as dictated by clinical
circumstances.
Tuberculosis (TB): Evaluate patients for TB prior to initiating treatment
with STELARA
Initiate treatment of latent TB before administering STELARA
Malignancies: STELARA may increase risk of malignancy.
The safety of STELARA in patients with a history of or a known malignancy has
not been evaluated.
Anaphylaxis or other clinically significant hypersensitivity reactions may occur.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS):
One case was reported. If suspected, treat promptly and discontinue STELARA
Dosages/ Overdosage Etc:
Indication-
Treat Adult (18 years and older) with moderate to severe psoriasis
INDICATIONS AND USAGE-
STELARA is a human interleukin-12 and -23 antagonist indicated for the
treatment of adult patients (18 years or older) with moderate to severe
plaque psoriasis who are candidates for phototherapy or systemic therapy.
DOSAGE AND ADMINISTRATION
STELARA is administered by subcutaneous injection.
For patients weighing <100 kg (220 lbs), the recommended dose is 45 mg
initially and 4 weeks later, followed by 45 mg every 12 weeks.
For patients weighing >100 kg (220 lbs), the recommended dose is 90 mg initially
and 4 weeks later, followed by 90 mg every 12 weeks.
DOSAGE FORMS AND STRENGTHS
Injection: 45 mg/0.5 mL in a single-use prefilled syringe
Injection: 90 mg/1 mL in a single-use prefilled syringe
Injection: 45 mg/0.5 mL in a single-use vial
Injection: 90 mg/1 mL in a single-use vial
Patient Information:
1.Instruct patients to read the Medication Guide before starting STELARA therapy
and to reread the Medication Guide each time the prescription is renewed.
2.Infections
Inform patients that STELARA may lower the ability of their immune system
to fight infections.
3.Instruct patients of the importance of communicating any history of infections
to the doctor, and contacting their doctor if they develop any symptoms of infection.
4.Malignancies
Patients should be counseled about the risk of malignancies while receiving STELARA .
5.Allergic Reactions
Advise patients to seek immediate medical attention if they experience any symptoms
of serious allergic reactions.
Pharmacology/ Pharmacokinetics:
1 Mechanism of Action
Ustekinumab is a human IgG1. monoclonal antibody that binds with high affinity
and specificity to the p40 protein subunit used by both the interleukin (IL)-12
and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are
involved in inflammatory and immune responses, such as natural killer cell activation
and CD4+ T-cell differentiation and activation.
2. Pharmacokinetics
Absorption
In psoriasis subjects, the median time to reach the maximum serum concentration
(Tmax) was 13.5 days and 7 days, respectively, after a single subcutaneous
administration of 45 mg and 90 mg of ustekinumab.
In healthy subjects the median Tmax value (8.5 days) following a single
subcutaneous administration of 90 mg of ustekinumab was comparable to that
observed in psoriasis subjects
Elimination
The mean (± SD) systemic clearance (CL) following a single intravenous
administration of ustekinumab to psoriasis subjects ranged from
1.90 ± 0.28 to 2.22 ± 0.63 mL/day/kg.
The mean (±SD) half-life ranged from 14.9 ± 4.6 to 45.6 ± 80.2 days
across all psoriasis studies following intravenous and subcutaneous
administration.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1 Pregnancy
Pregnancy Category B
There are no studies of STELARA in pregnant women. STELARA should be used
during pregnancy only if the potential benefit justifies the potential risk to the fetus.
No teratogenic
2.Nursing Mothers
Caution should be exercised when STELARA is administered to a nursing woman.
The unknown risks to the infant from gastrointestinal or systemic exposure
to ustekinumab should be weighed against the known benefits of breast-feeding.
It is not known if ustekinumab is absorbed systemically after ingestion; however,
published data suggest that antibodies in breast milk do not enter the neonatal
and infant circulation in substantial amounts.
3.Pediatric Use
Safety and effectiveness of STELARA® in pediatric patients have not been evaluated.
4.Geriatric Use
Of the 3117 psoriasis subjects exposed to STELARA, a total of 183 were 65 years
or older, and 21 subjects were 75 years or older.
Although no differences in safety or efficacy were observed between older
and younger subjects, the number of subjects aged 65 and over is
not sufficient to determine whether they respond differently from younger
subjects.
Manufacturer Details