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WEZLANA 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: Indications have been granted on the basis of similarity between WEZLANA and the reference biologic drug STELARA®. WEZLANA / WEZLANA I.V. should be used only by healthcare professionals who have sufficient knowledge of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and/or ulcerative colitis and who have fully…
Verbatim from this product's HC label. Tap a section to expand.
4) XX / XXXX 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
). Carcinogenesis and Mutagenesis Malignancies Ustekinumab is a selective immunomodulator. Immunomodulating agents have the potential to increase the risk of malignancy. Some patients who received ustekinumab in clinical studies developed malignancies (see 8 ADVERSE REACTIONS, Malignancies).
Ustekinumab 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).
WEZLANA™ (ustekinumab) Page 13 of 116 Hepatic/Biliary/Pancreatic Specific studies have not been conducted in patients with hepatic insufficiency. Immune Concomitant Immunosuppressive Therapy In the Phase 3 psoriasis studies, the safety and efficacy of 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 ustekinumab. In Crohn’s disease and ulcerative colitis studies, concomitant use of immunomodulators (6- mercaptopurine (6-MP), azathioprine (AZA), MTX) or corticosteroids did not appear to influence the overall safety of ustekinumab.
V. or when transitioning from other biologic agents (see
, Infections). V. (ustekinumab) is intended for use under the guidance and supervision of a physician. V. V. infusions. 2735. 2 Recommended Dose and Dosage Adjustment Plaque Psoriasis For the treatment of plaque psoriasis, Wezlana is administered by subcutaneous injection.
Adults The recommended dose of Wezlana 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.
Re-treatment with a dosing regimen of Weeks 0 and 4 followed by 12-week dosing after interruption of therapy has been shown to be safe and effective (see Plaque Psoriasis – Adults, Efficacy of retreatment). Pediatrics (6 to 17 years of age) The recommended dose of Wezlana based on body weight is shown below (Table 1).
Wezlana 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. Table 1. 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. a. For patients with body weight < 60 kg, use the vial presentation only. b. There were only 3 patients aged 12 to 17 years, with a body weight > 100 kg in the study.
Table 2. 49 Psoriatic Arthritis - Adults For the treatment of psoriatic arthritis, Wezlana is administered by subcutaneous injection. The recommended dose of Wezlana is 45 mg administered at Weeks 0 and 4, then every 12 weeks thereafter.
V. is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Wezlana / Wezlana is contraindicated in patients with severe infections such as sepsis, tuberculosis and opportunistic infections (see 7 WARNINGS AND PRECAUTIONS, Infections).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Alternatively, 90 mg may be used in patients with a body weight greater than 100 kg. V. V. (130 mg vial) Crohn’s disease and ulcerative colitis). Table 3. 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 Wezlana is 90 mg administered subcutaneously.
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 healthcare professional.
Patients should have their dose frequency adjusted to every 8 weeks if inadequate response occurs. 5 Clinical Trials – Reference Biologic Drug). V. V. corticosteroids may be reduced or discontinued in accordance with standard of care. WEZLANA™ (ustekinumab) Page 9 of 116 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 hepatic renal insufficiency. Hepatic Insufficiency Specific studies have not been conducted in patients with hepatic insufficiency. 4 Administration Subcutaneous […]