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Indication and clinical use:PrXELJANZ® (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) with an inadequate response, loss of response or intolerance to either conventional UC therapy or a TNF inhibitor.
Use of XELJANZ in combination with biological UC therapies or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
SELECTED THERAPEUTIC OPTIONS FOR ULCERATIVE COLITIS (UC):Dosage, administration and storage information
Dosage, administration and storage information
tofacitinib citrate infliximab adalimumab vedolizumab golimumab ustekinumab
PrXELJANZ® 1 PrREMICADE® 2 PrINFLECTRA® 3 PrRENFLEXISTM 4 PrAVSOLATM 5 PrHUMIRA® 6 PrHADLIMATM 7 PrHYRIMOZTM 8 PrAMGEVITATM 9 PrIDACIO® 10 PrHULIO® 11 PrENTYVIO® 12 PrSIMPONI® 13PrSTELARA®/
PrSTELARA® I.V.14
Oral pillTwice daily
Intravenous infusionOnce on:
Week 0, 2 and 6Maintenance:
Once every 8 weeks
Intravenous infusionOnce on:
Week 0, 2 and 6Maintenance:
Once every 8 weeks
Intravenous infusionOnce on:
Week 0, 2 and 6Maintenance:
Once every 8 weeks
Intravenous infusionOnce on:
Week 0, 2 and 6 Maintenance:
Once every 8 weeks
Subcutaneous injectionWeek 0:
2 or 4 injections in one day or split over two
consecutive days Week 2:
1 or 2 injections in one day
Maintenance: Once every 2 weeks
Subcutaneous injectionWeek 0:
4 injections in one day or split over two
consecutive days (2 injections each day)
Week 2: 2 injections in one day
Maintenance: Once every 2 weeks
Subcutaneous injectionWeek 0:
2 or 4 injections in one day or split over two
consecutive days Week 2:
1 or 2 injections in one day
Maintenance: Once every 2 weeks
Subcutaneous injectionWeek 0:
4 injections in one day or split over two
consecutive days (2 injections each day)
Week 2: 2 injections in one day
Maintenance: Once every 2 weeks
Subcutaneous injection Week 0:
4 injections in one day or split over two
consecutive days (2 injections each day)
Week 2: 2 injections in one day
Maintenance: Once every 2 week
Subcutaneous injection Week 0:
4 injections in one day or split over two
consecutive days (2 injections each day)
Week 2: 2 injections in one day
Maintenance: Once every 2 weeks
Intravenous infusionOnce on:
Week 0, 2 and 6 Maintenance: Once every
8 weeks
Subcutaneous injectionMaintenance (following
≥2 doses of IV infusions): The first SC dose should be administered in place of the next scheduled IV dose and every 2 weeks
thereafter
Subcutaneous injectionOnce on:
Week 0 and 2 Maintenance:
Once every 4 weeks
+
Intravenous infusionOnce on: Week 0
+
Subcutaneous injectionOnce on: Week 8
Maintenance: Once every 8 weeks
15°–30°C 2°–8°C 2°–8°C 2°–8°C 2°–8°C 2°–8°C
Pen or prefilled syringe may be kept at ≤25°C
for up to 14 days.
2°–8°C
May be kept at ≤25°C for up to 28 days.
2°–8°C
Prefilled syringe or autoinjector may be
kept at ≤25°C for up to 21 days.
2°–8°C
Prefilled syringe or autoinjector may be
kept at ≤25°C for up to 14 days.
2°–8°C
Prefilled syringe or autoinjector may be
kept at ≤25°C for up to 14 days.
2°–8°C
Pen or prefilled syringe may be kept at ≤25°C
for up to 14 days.
2°–8°C
Pen or prefilled syringe may be kept at ≤25°C
for up to 7 days.
2°–8°C
May be stored at ≤25°C for a single
period of up to 30 days.
2°–8°C
Prefilled syringe may be stored at ≤30°C for a single period of up to 30 days.
Data from separate product monographs. Comparative clinical significance has not been established.
INFLECTRA® (infliximab) is indicated for reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing, and reduction or elimination of corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy (i.e., aminosalicylate and/or corticosteroid and/or an immunosuppressant).3
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IV = Intravenous; SC = Subcutaneous
XELJANZ ® PF Prism C.V., owner/Pfizer Canada ULC, Licensee© 2021 Pfizer Canada ULC, Kirkland, Quebec H9J 2M5
XELJANZConsult the Product Monograph at http://pfizer.ca/pm/en/XELJANZ.pdf for important information about:
• Contraindications during pregnancy and breastfeeding, and in patients with severe hepatic impairment.
• Most serious warnings and precautions regarding risk of serious infections, malignancies and thrombosis.
• Other relevant warnings and precautions regarding risk of infection and immunosuppression when co-administered with potent immunosuppressants, women of reproductive potential, hypersensitivity reactions, risk of viral reactivation, being up to date with all immunizations in accordance with current vaccination guidelines, live zoster vaccine, risk of malignancies, lymphoproliferative disorder, and nonmelanoma skin cancer, risk of lymphopenia, neutropenia, anemia, and lipid elevations, patients with hepatic and/or renal impairment, patients undergoing hemodialysis, liver enzyme elevations, patients with a risk or history of interstitial lung disease (ILD), pediatric patients, the elderly and patients with diabetes, patients with a history of chronic lung disease, lymphocyte counts, Asian patients, patients with risk of gastrointestinal perforation, increases in creatine kinase, decrease in heart rate and prolongation of the PR interval, patients that may be at an increased risk of thrombosis, patients with symptoms of thrombosis and dosing considerations in patients with ulcerative colitis (use XELJANZ at the lowest effective dose and shortest duration needed to achieve/maintain therapeutic response).
• Conditions of clinical use, adverse reactions, drug interactions and dosing instructions.
The Product Monograph is also available through our medical information department. Call 1-800-463-6001.
INFLECTRA
For more information:Please consult the Product Monograph at http://pfizer.ca/pm/en/INFLECTRA.pdf for contraindications, warnings, precautions, adverse reactions, interactions, dosing information and conditions of clinical use. The Product Monograph is also available by calling 1-800-463-6001.
References: 1. Pfizer Canada ULC. XELJANZ Product Monograph. October 24, 2019. 2. Janssen Inc. REMICADE Product Monograph. June 6, 2019. 3. Pfizer Canada ULC. INFLECTRA Product Monograph. July 6, 2020. 4. Merck Canada Inc. RENFLEXIS Product Monograph. February 25, 2020. 5. Amgen Canada Inc. AVSOLA Product Monograph. March 12, 2020. 6. AbbVie Corporation. HUMIRA Product Monograph. June 25, 2019. 7. Merck Canada Inc. HADLIMA Product Monograph. November 26, 2020. 8. Sandoz Canada Inc. HYRIMOZ Product Monograph. November 4, 2020. 9. Amgen Canada Inc. AMGEVITA Product Monograph. November 4, 2020. 10. Fresenius Kabi Canada Ltd. IDACIO Product Monograph. October 30, 2020. 11. BGP Pharma ULC. HULIO Product Monograph. November 24, 2020. 12. Takeda Canada Inc. ENTYVIO Product Monograph. September 10, 2020. 13. Janssen Inc. SIMPONI Product Monograph. June 20, 2019. 14. Janssen Inc. STELARA Product Monograph. October 14, 2020.
REMICADE® is a registered trademark of Janssen Inc. INFLECTRA® is a registered trademark of Pfizer Inc., used under license. RENFLEXIS™ is a trademark of Samsung Bioepis, distributed by Merck Canada Inc. AVSOLA™ is a trademark Amgen Canada Inc. HUMIRA® is a registered trademark of AbbVie Corporation. HADLIMATM is a trademark of SAMSUNG BIOEPIS, distributed by by Merck Canada Inc. HYRIMOZ® is a registered trademark of Sandoz Canada Inc. AMGEVITATM is a trademark of Amgen Canada Inc. IDACIO® is a registered trademark of Fresenius Kabi Canada Ltd. HULIO® is a registered trademark of BGP Pharma ULC. ENTYVIO® is a registered trademark of Millenium Pharmaceuticals Inc., and used under license by Takeda Canada Inc. SIMPONI® is a registered trademark of Janssen Inc. STELARA® is a registered trademark of Janssen Inc.
PP-XEL-CAN-0663-EN