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IMULDOSA 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 Imuldosa and the reference biologic drug Stelara/Stelara I.V ®. IMULDOSA/IMULDOSA I.V. (ustekinumab) should be used only by physicians who have sufficient knowledge of plaque psoriasis, psoriatic arthritis, and Crohn’s disease, and who have fully…
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, Imuldosa is administered by subcutaneous injection.
Adults The recommended dose of Imuldosa 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, Clinical Trials by Indication, Plaque Psoriasis – Adults, Efficacy of retreatment). IMULDOSA (ustekinumab) – Product Monograph Page 6 of 71 Unclassified / Non classifié Psoriatic Arthritis – Adults For the treatment of psoriatic arthritis, Imuldosa is administered by subcutaneous injection.
The recommended dose of Imuldosa 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).
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 Imuldosa 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 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.
). 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. V. (ustekinumab). No data are available on the secondary transmission of infection by live vaccines in patients receiving ustekinumab.
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 ustekinumab 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 ustekinumab-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. Administration of a live vaccine prior to 6 months of age may be considered if ustekinumab serum levels are undetectable in the infant, 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).
, 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).
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, Imuldosa is administered by subcutaneous injection.
Adults The recommended dose of Imuldosa 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, Clinical Trials by Indication, Plaque Psoriasis – Adults, Efficacy of retreatment). IMULDOSA (ustekinumab) – Product Monograph Page 6 of 71 Unclassified / Non classifié Psoriatic Arthritis – Adults For the treatment of psoriatic arthritis, Imuldosa is administered by subcutaneous injection.
The recommended dose of Imuldosa 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).
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 Imuldosa is 90 mg administered subcutaneously. The first subcutaneous dose should be given at week 8 following the intravenous induction dose.
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.
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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. Hepatic Insufficiency Specific studies have not been conducted in patients with hepatic insufficiency.
4 Administration Subcutaneous Administration Imuldosa is supplied as 45 mg and 90 mg in pre-filled syringes. A patient may self-inject with Imuldosa if a physician determines that it is appropriate after proper training in subcutaneous injection technique and disposal (see PATIENT MEDICATION INFORMATION, How to take Imuldosa).
Prior to subcutaneous administration, visually inspect the solution for particulate matter and discoloration. The product is colorless to slightly yellow and clear to slightly opalescent solution. The product should not be used if solution is discolored or cloudy, or if other particulate matter is present.
Imuldosa does not contain preservatives; therefore, any unused product remaining in the vial or syringe should not be used. Patients should be instructed to inject the prescribed amount of Imuldosa according to the directions provided in the PATIENT MEDICATION INFORMATION Section.
V. is supplied in a 130 mg vial. 3. V. should be administered by qualified healthcare professionals. V. V. must be diluted and be prepared for IV infusion by a healthcare professional using aseptic technique. 1. V. vials needs based on patient’s body weight (see Table 1).
V. contains 130 mg of ustekinumab. 2. V. to be added. V. needed, for 2 vials – discard 52 mL, for 3 vials – discard 78 mL, for 4 vials – discard 104 mL). 45% w/v sodium chloride solution may be used. 3. V. 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. 4. Visually inspect the diluted solution before administration. Do not use if visibly opaque particles, discoloration or foreign particles are observed. 5. Infuse the diluted solution over a period of at least one hour.
Once diluted, the infusion should be completed within eight hours of the […]
IMULDOSA (ustekinumab) – Product Monograph Page 11 of 71 Unclassified / Non classifié 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 or efficacy of ustekinumab. In Crohn’s disease studies, concomitant use of immunomodulators (6-mercaptopuine (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
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. Hepatic Insufficiency Specific studies have not been conducted in patients with hepatic insufficiency.
4 Administration Subcutaneous Administration Imuldosa is supplied as 45 mg and 90 mg in pre-filled syringes. A patient may self-inject with Imuldosa if a physician determines that it is appropriate after proper training in subcutaneous injection technique and disposal (see PATIENT MEDICATION INFORMATION, How to take Imuldosa).
Prior to subcutaneous administration, visually inspect the solution for particulate matter and discoloration. The product is colorless to slightly yellow and clear to slightly opalescent solution. The product should not be used if solution is discolored or cloudy, or if other particulate matter is present.
Imuldosa does not contain preservatives; therefore, any unused product remaining in the vial or syringe should not be used. Patients should be instructed to inject the prescribed amount of Imuldosa according to the directions provided in the PATIENT MEDICATION INFORMATION Section.
V. is supplied in a 130 mg vial. 3. V. should be administered by qualified healthcare professionals. V. V. must be diluted and be prepared for IV infusion by a healthcare professional using aseptic technique. 1. V. vials needs based on patient’s body weight (see Table 1).
V. contains 130 mg of ustekinumab. 2. V. to be added. V. needed, for 2 vials – discard 52 mL, for 3 vials – discard 78 mL, for 4 vials – discard 104 mL). 45% w/v sodium chloride solution may be used. 3. V. from each vial needed and add it to the 250 ml infusion bag.
The final volume in the infusion […]