Loading…
YESINTEK I.V. 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 YESINTEK/YESINTEK I.V. (ustekinumab) and the reference biologic drug STELARA®. YESINTEK/ YESINTEK I.V. (ustekinumab) should be used only by healthcare professionals who have sufficient knowledge of plaque psoriasis, psoriatic arthritis, Crohn’s disease,…
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. 2 Recommended Dose and Dosage Adjustment Plaque Psoriasis For the treatment of plaque psoriasis, YESINTEK is administered by subcutaneous injection.
Adults The recommended dose of YESINTEK 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.
4 Clinical Trials -Reference Biologic Drug, Plaque Psoriasis – Adults, Efficacy of retreatment). YESINTEK® (ustekinumab) Page 6 of 87 Pediatrics (6 to 17 years of age) The recommended dose of YESINTEK based on body weight is shown below (Table 1).
YESINTEK 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. 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, YESINTEK is administered by subcutaneous injection. The recommended dose of YESINTEK 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. V. (130 mg vial) Crohn’s disease and ulcerative colitis). V. V. vials ≤55 kg a 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 YESINTEK is 90 mg administered subcutaneously.
). 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). 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).
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 YESINTEK® (ustekinumab) Page 12 of 87 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. is contraindicated in patients with severe infections such as sepsis, tuberculosis and opportunistic infections (see 7 WARNINGS AND PRECAUTIONS, Infections). V. (ustekinumab) is intended for use under the guidance and supervision of a physician.
2 Recommended Dose and Dosage Adjustment Plaque Psoriasis For the treatment of plaque psoriasis, YESINTEK is administered by subcutaneous injection. Adults The recommended dose of YESINTEK 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.
4 Clinical Trials -Reference Biologic Drug, Plaque Psoriasis – Adults, Efficacy of retreatment). YESINTEK® (ustekinumab) Page 6 of 87 Pediatrics (6 to 17 years of age) The recommended dose of YESINTEK based on body weight is shown below (Table 1).
YESINTEK 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. 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.
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 and 7 WARNINGS AND PRECAUTIONS, Infections .
V. 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.
Other brands of Ustekinumab in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The first subcutaneous dose should be given at week 8 following the intravenous induction dose. Subsequent YESINTEK® (ustekinumab) Page 8 of 87 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. 4 Clinical Trials -Reference Biologic Drug). 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 hepatic renal insufficiency. Hepatic Insufficiency Specific studies have not been conducted in patients with hepatic insufficiency. 4 Administration Subcutaneous Administration YESINTEK is supplied as 45 mg and 90 mg prefilled syringes and 45 mg single-use vials.
In pediatric patients, it is recommended that YESINTEK be administered by a healthcare professional. A patient may self-inject with YESINTEK if a healthcare professional determines that it is appropriate after proper training in subcutaneous injection technique and disposal (see PATIENT MEDICATION INFORMATION, INSTRUCTIONS FOR INJECTING YESINTEK).
Prior to subcutaneous administration, […]
Table 2. 49 Psoriatic Arthritis - Adults For the treatment of psoriatic arthritis, YESINTEK is administered by subcutaneous injection. The recommended dose of YESINTEK 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. V. (130 mg vial) Crohn’s disease and ulcerative colitis). V. V. vials ≤55 kg a 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 YESINTEK is 90 mg administered subcutaneously.
The first subcutaneous dose should be given at week 8 following the intravenous induction dose. Subsequent YESINTEK® (ustekinumab) Page 8 of 87 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. 4 Clinical Trials -Reference Biologic Drug). 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 hepatic renal insufficiency. Hepatic Insufficiency Specific studies have not been conducted in patients with hepatic insufficiency. 4 Administration Subcutaneous Administration YESINTEK is supplied as 45 mg and 90 mg prefilled syringes and 45 mg single-use vials.
In pediatric patients, it is recommended that YESINTEK be administered by a healthcare professional. A patient may self-inject with YESINTEK if a healthcare […]