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ORENCIA is a brand name for Abatacept, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 07/2022 1 INDICATIONS, 1.1 Pediatrics 07/2022 4 DOSAGE AND ADMINISTATION, • 4.2 Recommended Dose and Dosage Adjustment • 4.5 Missed Dose 07/2022 7 WARNINGS AND PRECAUTIONS • 7.1.1 Pregnant Women • 7.1.3 Pediatrics 07/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization…
Verbatim from this product's HC label. Tap a section to expand.
). It is expected, based on Pharmacokinetic information, that the SC route of administration for ORENCIA will be beneficial in the long-term (See 10 CLINICAL PHARMACOLOGY). ORENCIA may be used as monotherapy or in combination with DMARD therapy.
When used as first-line treatment in recently diagnosed patients who have not been previously treated with methotrexate (MTX), ORENCIA should be given in combination with MTX. Juvenile Idiopathic Arthritis (JIA)/Juvenile Rheumatoid Arthritis (JRA) ORENCIA administered by intravenous (IV) infusion is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis/juvenile rheumatoid arthritis in pediatric patients 6 years of age and older who have had an inadequate response to one or more DMARDs, such as MTX.
ORENCIA administered by intravenous (IV) infusion has not been studied in children less than 6 years of age. No data for the SC injection in children are available to Health Canada; therefore, Health Canada has not authorized an indication for SC pediatric use.
Adult Psoriatic Arthritis (PsA) ORENCIA is indicated for the treatment of adult patients with active psoriatic arthritis (PsA) when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
ORENCIA can be used with or without non-biologic DMARDs. Prophylaxis for Acute Graft versus Host Disease ORENCIA is indicated for the prophylaxis of moderate to severe acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 6 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele- mismatched unrelated donor.
1 Pediatrics (6 years of age and older) Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ORENCIA in pediatric patients has been established. Therefore, Health Canada has authorized an indication for pediatric use (see 1 INDICATIONS).
2 Geriatrics Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety. 2 CONTRAINDICATIONS ORENCIA (abatacept) should not be administered to • Patients with known hypersensitivity to ORENCIA or any of its components.
). Non-melanoma skin cancers have been reported in patients receiving abatacept. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer. Hematologic Blood Glucose Testing The glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems may react with the maltose present in ORENCIA for intravenous infusion, resulting in falsely elevated blood glucose readings on the day of infusion.
7 Drug-Laboratory Test Interactions). ORENCIA for subcutaneous administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring. Hepatic /Biliary/Pancreatic ORENCIA has not been studied in these patient populations.
3 Pharmacokinetics). Immune Combination with Biologic Rheumatoid Arthritis Therapy Concurrent therapy with ORENCIA (abatacept) and a biologic RA agent is not recommended. While transitioning from biologic RA therapy to ORENCIA therapy, patients should be monitored for signs of infection.
, adalimumab, anakinra, etanercept, infliximab). 5%). These studies did not provide sufficient data to complete a benefit and risk assessment of combination of ORENCIA with biologic rheumatoid arthritis agents. There is insufficient experience to assess the safety and efficacy of ORENCIA administered concurrently with anakinra, and therefore such use is not recommended.
Hypersensitivity As with any other biologic RA therapy, patients should be monitored for allergic reactions. Such reactions have been observed with ORENCIA. In clinical trials with ORENCIA, patients were not pretreated to prevent hypersensitivity reactions.
In patients treated with ORENCIA in the controlled double blind and cumulative periods, the events of hypersensitivity, anaphylaxis, and drug hypersensitivity were rarely reported. Other events potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, that occurred within 24 hours of ORENCIA infusion, were uncommon.
3 Pediatrics 07/2022 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 ......................................................................
5 1 INDICATIONS ............................................................................................................... 6 2 CONTRAINDICATIONS .................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 10 5 OVERDOSAGE............................................................................................................
10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 10 7 WARNINGS AND PRECAUTIONS ................................................................................ 15 8 ADVERSE REACTIONS ................................................................................................
37 9 DRUG INTERACTIONS ................................................................................................ 38 10 CLINICAL PHARMACOLOGY .......................................................................................
39 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 42 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 42 PART II: SCIENTIFIC INFORMATION .......................................................................................
ORENCIA (abatacept) should not be administered to • Patients with known hypersensitivity to ORENCIA or any of its components. • Patients with, or at risk of, sepsis syndrome, such as immunocompromised and HIV+ patients (see 7 WARNINGS AND PRECAUTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• Patients with, or at risk of, sepsis syndrome, such as immunocompromised and HIV+ patients (see 7 WARNINGS AND PRECAUTIONS). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Hypersensitivity • In post-marketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA has been reported (see 7 WARNINGS AND PRECAUTIONS).
Infections • Treatment with ORENCIA should not be initiated in patients with active infections including chronic or localized infections. • Treatment with ORENCIA also should not be initiated in patients with chronic or latent infections.
• Administration of ORENCIA should be discontinued if a patient develops a serious infection. • Physicians should exercise caution when considering the use of ORENCIA in patients with a history of recurrent infection or underlying conditions which may predispose them to infections, such as immunodeficiency disorders, or who have resided in regions where tuberculosis and histoplasmosis are endemic.
• If active tuberculosis is diagnosed, ORENCIA therapy should not be initiated. If inactive (‘latent’) tuberculosis is diagnosed, treatment for latent tuberculosis should be started with anti- tuberculosis therapy before the initiation of ORENCIA.
• Physicians should monitor patients receiving ORENCIA for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection. 1 Dosing Considerations General Considerations for Subcutaneous Administration • ORENCIA Injection, 125 mg pre-filled syringe is not intended for IV infusion.
• ORENCIA Injection is intended for use under the guidance of a healthcare professional. After proper training in subcutaneous injection technique, a patient may self inject with ORENCIA if a healthcare professional determines that it is appropriate.
Patients should be instructed to follow the directions provided in the “Patient/Caregivers Instructions for Use” for additional details on medication administration. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not use ORENCIA prefilled syringes exhibiting particulate matter or discoloration. ORENCIA should be clear and colorless to pale yellow. Any leftover product remaining in the prefilled syringe should not be used. 0 mL), which provides 125 mg of ORENCIA, according to the directions provided in the Patient Information leaflet and the “Patient/Caregivers Instructions for Use”.
• Injection sites should be rotated and injections should never be given into areas where the skin is tender, bruised, red, or hard. 2 Recommended Dose and Dosage Adjustment Adult Psoriatic Arthritis Intravenous Dosing Regimen ORENCIA IV should be administered as a 30-minute intravenous infusion utilizing the weight range-based dosing specified in Table 2.
Following the initial intravenous administration, an intravenous infusion should be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter. Subcutaneous Dosing Regimen ORENCIA SC 125 mg should be administered by subcutaneous injection once weekly without […]
, acetaminophen, antihistamines, corticosteroids, and/or ORENCIA (abatacept) Page 13 of 77 epinephrine) should be available for immediate use in the event of a reaction (see 8 ADVERSE REACTIONS ). Anaphylaxis or anaphylactoid reactions can occur after the first infusion and can be life-threatening.
In post-marketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA has been reported. If an anaphylactic or other serious allergic reaction occurs, administration of IV or SC ORENCIA should be stopped immediately with appropriate therapy instituted, and the use of ORENCIA should be permanently discontinued.
Infections Serious infections, including sepsis and pneumonia, have been reported in patients receiving ORENCIA. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which in addition to their underlying disease, could further predispose them to infections.
Treatment with ORENCIA should not be initiated in patients with active systemic or localized infections. Treatment with ORENCIA also should not be initiated in patients with chronic or latent infections. Patients who develop a new infection while undergoing treatment with ORENCIA should be monitored closely.
Administration of ORENCIA should be discontinued if a patient develops a serious infection. Physicians should exercise caution when considering the use of ORENCIA in patients with a history of recurrent infection or underlying conditions which may predispose them to infections, such as immunodeficiency disorders, or who have resided in regions where tuberculosis and histoplasmosis are endemic (see 8 ADVERSE REACTIONS ).
Prior to treating patients with therapies that modulate the immune system, including ORENCIA, it is appropriate to screen patients for tuberculosis. Should a patient test positive for tuberculosis screening, the patient should be treated in accordance with standard medical practice prior to therapy with ORENCIA.
Anti-rheumatic therapies have been associated with hepatitis B reactivation. Therefore, screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy with ORENCIA. In clinical studies with ORENCIA, patients who screened positive for hepatitis were excluded from study.
In clinical trials in adult RA patients, the incidence of infections did not appear to increase in the open- label period compared to the double-blind period (see 8 ADVERSE REACTIONS). During the pediatric clinical trial, there were two cases of varicella and three cases of herpes simplex.
All cases resolved appropriately without sequelae. Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) Reactivation in aGVHD Prophylaxis after Hematopoietic Stem Cell Transplant (HSCT) Post-Transplant Lymphoproliferative Disorder (PTLD) occurred in patients who received ORENCIA for aGVHD prophylaxis during unrelated HSCT.
4%) experienced PTLD. All the PTLD events were associated with Epstein-Barr virus (EBV) infection. Three of the four patients were EBV serology positive at baseline; one patient had negative baseline EBV serology with donor EBV serology unknown.
Three of the 4 patients discontinued acyclovir prophylaxis at day 30 […]
43 13 PHARMACEUTICAL INFORMATION ............................................................................ 43 14 CLINICAL TRIALS ........................................................................................................
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