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OTULFI 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.
Verbatim from this product's HC label. Tap a section to expand.
V. 5%) ¥≥ 1% and more frequently with either ustekinumab 90 mg q12w or ustekinumab 90 mg q8w than placebo. Ulcerative Colitis The safety of ustekinumab was evaluated in two randomized, double-blind, placebo-controlled studies (UNIFI-I and UNIFI-M) in 960 adult patients with moderately to severely active ulcerative colitis.
The overall safety profile was similar for patients with psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The safety profile remained generally consistent throughout the Week 96 safety analysis. V. V. 5%) # ≥ 1% and more frequently with ustekinumab than placebo.
V. 6%) ¥ ≥ 1% and more frequently with either ustekinumab 90 mg q12w or ustekinumab 90 mg q8w than placebo.
Infections:
In placebo-controlled studies of patients with psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis, the rates of infection or serious infection were similar between ustekinumab-treated patients and those treated with placebo.
34 per patient- year of follow-up in placebo-treated patients. 03 per patient-year of follow-up in placebo-treated patients (15 serious infections in 434 patient-years of follow-up) (see 7 WARNINGS AND PRECAUTIONS). 0 years for ulcerative colitis studies.
91 per patient-year of follow-up in ustekinumab-treated patients. 02 per patient-year of follow-up in ustekinumab-treated patients (199 serious infections in 11581 patient-years of follow-up) and included pneumonia, anal abscess, sepsis, cellulitis, diverticulitis, gastroenteritis and viral infections.
46 per 100 patient-years of follow-up for placebo-treated patients (2 patient in 433 […]
). Carcinogenesis and Genotoxicity 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.
Caution should be exercised when considering the use of ustekinumab 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 Immunization It is recommended that live viral or bacterial vaccines not be given concurrently with ustekinumab. No data are available on the secondary transmission of infection by live vaccines in patients receiving ustekinumab.
Caution is advised when administering some live vaccines to household contacts of patients receiving ustekinumab because of the potential risk for shedding from the household contact and transmission to the patient. 4 Drug-Drug Interactions, Live Vaccines).
Prior to initiating therapy with ustekinumab, 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.
, 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).
4. V. (ustekinumab) is intended for use under the guidance and supervision of a physician. The KabiCare Clinic Network has been established to facilitate the administration of OTULFI. This network consists of clinics located across Canada that are staffed by qualified healthcare professionals specially trained in the administration of OTULFI.
Contact your doctor if you have any questions. ca. V. (Ustekinumab) Page 6 of 84 For the treatment of plaque psoriasis, OTULFI is administered by subcutaneous injection. Adults The recommended dose of OTULFI 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 Reference Biologic Drug, Plaque Psoriasis – Adults, Efficacy of retreatment). Pediatrics (6 to 17 years of age) The recommended dose of OTULFI based on body weight is shown below (Table 1). OTULFI 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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However, non-live vaccinations received during a course of ustekinumab 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).
V. (Ustekinumab) Page 13 of 84 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. Caution should be exercised when considering concomitant use of immunosuppressive agents and ustekinumab or when transitioning from other biologic agents (see 9 DRUG-DRUG INTERACTIONS, Immunosuppressants).
Immunotherapy Ustekinumab has not been evaluated in patients who have undergone allergy immunotherapy. Ustekinumab may affect allergy immunotherapy. Caution should be exercised in patients receiving or who have received allergy immunotherapy particularly for anaphylaxis.
Neurologic Reversible Posterior Leukoencephalopathy Syndrome One case of reversible posterior leukoencephalopathy syndrome (RPLS) was observed during the clinical development programs which included 6709 ustekinumab-treated subjects.
The subject, who had received 12 doses of ustekinumab over approximately two and a half years, presented with headache, seizures and confusion in the setting of alcohol abuse. No additional ustekinumab injections were administered and the subject fully recovered with appropriate treatment.
RPLS is a neurological disorder, which is not caused by demyelination or a known infectious agent. RPLS can present with headache, seizures, confusion and visual disturbances. Conditions with which it has been associated include preeclampsia, acute hypertension, cytotoxic agents, immunosuppressive therapy and alcohol abuse.
Fatal outcomes have been reported. V. Renal Specific studies have not been conducted in patients with renal insufficiency.
Reproductive Health:
Female and Male Potential • Fertility Women of Childbearing Potential: It is not known whether ustekinumab can affect reproductive potential. Women of childbearing potential initiating treatment with ustekinumab should use effective methods of contraception and should receive preconception counselling before planning a pregnancy in accordance with disease specific clinical guidelines.
Ustekinumab remains in the circulation for approximately 15 weeks after treatment. 1 Pregnant Women). V. (Ustekinumab) Page 14 of 84 Sensitivity/Resistance Hypersensitivity Reactions Systemic In post-marketing experience, serious allergic reactions, including anaphylaxis and angioedema, have been reported.
If an anaphylactic or […]
V. 49 Psoriatic Arthritis – Adults For the treatment of psoriatic arthritis, OTULFI is administered by subcutaneous injection. The recommended dose of OTULFI 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. 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 OTULFI 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. 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.
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