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PYZCHIVA 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 PYZCHIVA and the reference biologic drug STELARA®. PYZCHIVA/PYZCHIVA 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…
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, PYZCHIVA is administered by subcutaneous injection.
Adults The recommended dose of PYZCHIVA 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. PYZCHIVA (ustekinumab) Page 6 of 100 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. 5 Clinical Trials – Reference Biologic Drug, Plaque Psoriasis – Adults, Efficacy of retreatment). Pediatrics (6 to 17 years of age) The recommended dose of PYZCHIVA based on body weight is shown below (Table 1).
PYZCHIVA 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.
49 Psoriatic Arthritis – Adults For the treatment of psoriatic arthritis, PYZCHIVA is administered by subcutaneous injection. The recommended dose of PYZCHIVA 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 PYZCHIVA (ustekinumab) Page 8 of 100 > 85 kg 520 mg 4 a Recommended dose (approximately 6 mg/kg) Subcutaneous maintenance dosing The recommended maintenance dose of PYZCHIVA 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.
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 Concomitant immunosuppressive therapy PYZCHIVA (ustekinumab) Page 13 of 100 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
1 Pregnant Women 04/2025 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 ...........................................................................................................
9 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.
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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.
Hepatic Insufficiency Specific studies have not been conducted in patients with hepatic insufficiency. 4 Administration Subcutaneous Administration PYZCHIVA is supplied as 45 mg and 90 mg pre-filled syringes and pre-filled pens, and 45 mg single-use vials.
In pediatric patients, it is recommended that PYZCHIVA be administered by a health care provider. A patient may self-inject with PYZCHIVA if a physician determines that it is appropriate after proper training in subcutaneous injection technique and disposal (see PATIENT MEDICATION INFORMATION, How to take PYZCHIVA).
Prior to subcutaneous administration, visually inspect the solution for particulate matter and discolouration. The product is clear, colourless to light yellow. This […]
3 Pediatrics ............................................................................................................. 4 Geriatrics ..............................................................................................................
15 8 ADVERSE REACTIONS ...................................................................................... 1 Adverse Reaction Overview ................................................................................ 2 Clinical Trial Adverse Reactions .........................................................................
3 Less Common Clinical Trial Adverse Reactions ................................................ 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .................................................................................................
5 Post-Market Adverse Reactions ......................................................................... 23 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...................................................................... 25 10 CLINICAL PHARMACOLOGY .............................................................................
1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics ............................................................................................. 3 Pharmacokinetics ................................................................................................
26 11 STORAGE, STABILITY AND DISPOSAL............................................................ 29 12 SPECIAL HANDLING INSTRUCTIONS .............................................................. 30 PART II: SCIENTIFIC INFORMATION ...........................................................................
31 13 PHARMACEUTICAL INFORMATION .................................................................. 31 14 CLINICAL TRIALS ............................................................................................... 5 Clinical Trials – Reference Biologic Drug ..........................................................
31 15 MICROBIOLOGY ................................................................................................. 62 16 NON-CLINICAL TOXICOLOGY ........................................................................... 62 17 SUPPORTING PRODUCT MONOGRAPHS ........................................................
65 PATIENT MEDICATION INFORMATION ....................................................................... 66 PATIENT MEDICATION INFORMATION ....................................................................... 94 PYZCHIVA (ustekinumab) Page 4 of 100 PYZCHIVATM (ustekinumab) is a biosimilar biologic drug (biosimilar) to Stelara.
A biosimilar is a biologic drug that was granted authorization based on […]