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STELARA is a brand name for Ustekinumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: STELARA®/STELARA® I.V. (ustekinumab) should be used only by physicians who have sufficient knowledge of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and/or ulcerative colitis and who have fully familiarized themselves with the efficacy/safety profile of the drug. Plaque Psoriasis Stelara (ustekinumab) is…
Verbatim from this product's HC label. Tap a section to expand.
V. (ustekinumab) is intended for use under the guidance and supervision of a physician. V. V. and care of patients with Crohn’s disease and ulcerative colitis. BioAdvance® clinics are available across Canada. Information about the BioAdvance® Network and location of the nearest BioAdvance® Network clinic can be obtained by calling Janssen Inc.
Medical Information at: 1-800-567-3331. 2 Recommended Dose and Dosage Adjustment Plaque Psoriasis For the treatment of plaque psoriasis, Stelara is administered by subcutaneous injection. 0 Page 6 of 91 Adults The recommended dose of Stelara is 45 mg administered at Weeks 0 and 4, then every 12 weeks thereafter.
Alternatively, 90 mg may be used in patients with a body weight greater than 100 kg. In patients weighing >100 kg, both 45 mg and 90 mg were shown to be efficacious. However, 90 mg was efficacious in a higher percentage of these patients than the 45 mg dose.
For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks. Consideration should be given to discontinuing treatment in patients who have shown no response up to 12 weeks of treatment.
1 Clinical Trials by Indication, Plaque Psoriasis – Adults, Efficacy of retreatment). Pediatrics (6 to 17 years of age) The recommended dose of Stelara based on body weight is shown below (Table 1). Stelara should be administered at Weeks 0 and 4, then every 12 weeks thereafter.
Consideration should be given to discontinuing treatment in patients who have shown no response up to 12 weeks of treatment. 0083 (mL/kg). 01 mL and administered using a 1 mL graduated syringe. A 45 mg vial is available for pediatric patients who need to receive less than the full 45 mg dose.
0 Page 8 of 91 Psoriatic Arthritis – Adults For the treatment of psoriatic arthritis, Stelara is administered by subcutaneous injection. The recommended dose of Stelara is 45 mg administered at Weeks 0 and 4, then every 12 weeks thereafter.
Alternatively, 90 mg may be used in patients with a body weight greater than 100 kg. V. 4 Administration, Intravenous Infusion (Crohn’s Disease and Ulcerative Colitis)). V. V. vials ≤ 55 kg 260 mg 2 > 55 kg to ≤ 85 kg 390 mg 3 > 85 kg 520 mg 4 a Recommended dose (approximately 6 mg/kg) Subcutaneous maintenance dosing The recommended maintenance dose of Stelara is 90 mg administered subcutaneously.
). 0 Page 13 of 91 Carcinogenesis and Mutagenesis Malignancies Ustekinumab is a selective immunomodulator. Immunomodulating agents have the potential to increase the risk of malignancy. 2 Clinical Trial Adverse Reactions, Malignancies).
V. has not been studied in patients with a history of malignancy. V. in patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy. All patients, in particular those greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of skin cancer (see 8 ADVERSE REACTIONS).
Hepatic/Biliary/Pancreatic Specific studies have not been conducted in patients with hepatic insufficiency. V. (ustekinumab). V. V. because of the potential risk for shedding from the household contact and transmission to the patient. V.
4 Drug-Drug Interactions, Live Vaccines). , patients should receive all immunizations appropriate for age as recommended by current immunization guidelines. Long term treatment with Stelara does not appear to suppress the immune response to pneumococcal polysaccharide or tetanus vaccines polysaccharide or tetanus vaccines.
5 years mounted similar antibody responses to both pneumococcal polysaccharide and tetanus vaccines as a non-systemically treated psoriasis control group. Similar proportions of patients developed protective levels of anti-pneumococcal and anti-tetanus antibodies and antibody titers were similar among Stelara-treated and control patients.
V. may not elicit an immune response sufficient to prevent disease. Infant exposure in utero For infants exposed in utero to ustekinumab, a six month waiting period following birth is recommended before the administration of live vaccines.
2 Breast-feeding 01/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................
2 TABLE OF CONTENTS.................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 4 1 INDICATIONS ......................................................................................................
1 Pediatrics ............................................................................................................. 2 Geriatrics ..............................................................................................................
5 2 CONTRAINDICATIONS ....................................................................................... 5 4 DOSAGE AND ADMINISTRATION ..................................................................... 1 Dosing Considerations .......................................................................................
2 Recommended Dose and Dosage Adjustment ................................................. 4 Administration ..................................................................................................... 5 Missed Dose ......................................................................................................
10 5 OVERDOSAGE .................................................................................................. 10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........... 10 7 WARNINGS AND PRECAUTIONS ....................................................................
1 Special Populations .......................................................................................... 1 Pregnant Women ............................................................................................. 2 Breast-feeding ..................................................................................................
V. is contraindicated in patients who are hypersensitive to ustekinumab or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container (see 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance, Hypersensitivity Reactions and 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
V. is contraindicated in patients with severe infections such as sepsis, tuberculosis and opportunistic infections (see 7 WARNINGS AND PRECAUTIONS, General, Infections).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ustekinumab in Canada.
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The first subcutaneous dose should be given at week 8 following the intravenous induction dose. Subsequent doses should be given every 8 weeks thereafter. V. followed by 90 mg subcutaneous dosing 8 weeks later, then every 12 weeks thereafter may be considered at the discretion of the treating physician.
Patients should have their dose frequency adjusted to every 8 weeks if inadequate response occurs. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose (see 14 CLINICAL TRIALS).
V. V. corticosteroids may be reduced or discontinued in accordance with standard of care. If therapy is interrupted, resumption of treatment with subcutaneous dosing every 8 weeks is safe and effective. Special Populations Renal Insufficiency Specific studies have not been conducted in patients with renal insufficiency.
0 Page 9 of 91 Hepatic Insufficiency Specific studies have not been conducted in patients with […]
0 Page 14 of 91 or the benefit of the vaccination clearly outweighs the risk of administration of live vaccines to the infant (see 7 WARNINGS AND PRECAUTIONS, Immune, Immunization). Concomitant immunosuppressive therapy In the Phase 3 psoriasis studies, the safety and efficacy of Stelara (ustekinumab) in combination with immunosuppressive agents or phototherapy have not been evaluated.
In the Phase 3 psoriatic arthritis studies, concomitant methotrexate did not appear to influence the safety of Stelara. V. V. or when transitioning from other biologic agents (see
3 Pediatrics .......................................................................................................... 4 Geriatrics ..........................................................................................................
16 8 ADVERSE REACTIONS .................................................................................... 1 Adverse Reaction Overview ............................................................................. 2 Clinical Trial Adverse Reactions ......................................................................
1 Clinical Trial Adverse Reactions - Pediatrics ................................................ 3 Less Common Clinical Trial Adverse Reactions ............................................ 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...........................................................................................................
5 Post-Market Adverse Reactions....................................................................... 25 9 DRUG INTERACTIONS ..................................................................................... 2 Drug Interactions Overview ..............................................................................
3 Drug-Behavioural Interactions ......................................................................... 4 Drug-Drug Interactions ..................................................................................... 5 Drug-Food Interactions .....................................................................................
6 Drug-Herb Interactions ..................................................................................... 7 Drug-Laboratory Test Interactions .................................................................. 26 10 CLINICAL PHARMACOLOGY...........................................................................
1 Mechanism of Action ........................................................................................ 2 Pharmacodynamics .......................................................................................... 3 Pharmacokinetics ..............................................................................................
28 11 STORAGE, STABILITY AND DISPOSAL ......................................................... 31 12 SPECIAL HANDLING INSTRUCTIONS ............................................................ 31 PART II: SCIENTIFIC INFORMATION .........................................................................
32 13 PHARMACEUTICAL INFORMATION ............................................................... 32 14 CLINICAL TRIALS ............................................................................................. 1 Clinical Trials by Indication ..............................................................................
33 Plaque Psoriasis - Adults ............................................................................................. 33 Pediatric Plaque Psoriasis (6 to 17 years of age) ...................................................... 44 Plaque Psoriasis – Pediatrics (12 to 17 years of age): CADMUS..............................
44 Plaque Psoriasis – Pediatrics (6 to 11 years of age): CADMUS Jr ........................... 46 Psoriatic Arthritis .......................................................................................................... 47 Crohn’s […]