0.4 ML abatacept 125 MG/ML Prefilled Syringe [Orencia]0.7 ML abatacept 125 MG/ML Prefilled Syringe [Orencia]
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NO BLACK BOX WARNING
Dosage & administration
Intravenous Use for Adult RA (2.1) and Adult PsA (2.3)
Body Weight of Patient
Dose
Number of Vials
Less than 60 kg
500 mg
2
60 to 100 kg
750 mg
3
More than 100 kg
1,000 mg
4
Subcutaneous Use for Adult RA (2.1)
* Prior to the first subcutaneous dose, may administer an optional loading dose as a single intravenous infusion as per body weight categories above. * Administer 125 mg by subcutaneous injection once weekly (within a day of the intravenous infusion if infusion given). * Patients switching from intravenous use to subcutaneous use, administer first subcutaneous dose instead of next scheduled intravenous dose.
Intravenous Use for pJIA in Pediatric Patients ≥6 Years Old (2.2)
* Pediatric patients weighing <75 kg administer 10 mg/kg intravenously and those weighing ≥75 kg administer the adult intravenous dosing regimen (not to exceed a maximum dose of 1,000 mg), as a 30-minute infusion. * Subsequently administer infusions at 2 and 4 weeks and every 4 weeks thereafter.
Subcutaneous Use for pJIA in Pediatric Patients ≥2 Years Old (2.2)
* Administer subcutaneously without an intravenous loading dose
Body Weight of Pediatric Patient
Dose (once weekly)
10 kg to less than 25 kg
50 mg
25 kg to less than 50 kg
87.5 mg
50 kg or more
125 mg
Subcutaneous Use for Adult PsA
* Administer 125 mg by subcutaneous injection once weekly without an intravenous loading dose. * Patients switching from intravenous use to subcutaneous use, administer first subcutaneous dose instead of next scheduled intravenous dose.
Intravenous Use for prophylaxis of aGVHD (2.4)
* For patients 6 years and older, administer at a 10 mg/kg dose (maximum dose 1,000 mg) as a 60-minute infusion on the day before transplantation, followed by a dose on Day 5, 14, and 28 after transplant (2.4). * For patients 2 to less than 6 years old, administer a 15 mg/kg dose as a 60-minute infusion on the day before transplantation, followed by a 12 mg/kg dose as a 60-minute infusion on Day 5, 14, and 28 after transplant (2.4).
Preparation and Administration Instructions
* Administer as a 30-minute intravenous infusion for RA, pJIA, and PsA (2.5). * Administer as a 60-minute intravenous infusion for aGVHD prophylaxis (2.5). * See the Full Prescribing Information for preparation and administration instructions for intravenous infusion and recommendations for subcutaneous use (2.5, 2.6). Prepare ORENCIA using only the silicone-free disposable syringe (2.5).
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Benefits investigations are conducted to determine whether a therapy is covered under a patient's insurance, if a prior authorization is required, and which specialty pharmacies are preferred.
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financial assistance
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Co-pay savings program
commercial only
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Overview
Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)
Patient benefit
A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max
Patient eligibility
Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
May never be used with government insurance
How to sign up
Cards may be downloadable digital cards or hard copies
Some pharmacos offer debit cards with pre-loaded copay benefit
Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form
Bridge program
commercial only
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Overview
Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)
Patient benefit
100% free (outside of insurance)
Patient eligibility
HCP must enroll patient
May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries
How to sign up
Typically HCP assisted enrollment (via form)
Foundation programs
under insured
no insurance
goverment insurance
65+
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Overview
Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned
Patient benefit
Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and co-pays) until the grant is exhausted
Patient eligibility
Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.
How to sign up
Patients submit proof of out-of-pocket drug costs to charities for reimbursement
patient education
Orencia Patient education
Getting started on Orencia
Instructions for Use - Prefilled Syringe
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Instructions for Use - ClickJect Autoinjector
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Patient toolkit
Orencia pJIA Observational Registry Guide
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About RA
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Dual Seropositive RA
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Diagnosing RA
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Assess your RA
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About Psoriatic Arthritis
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About Polyarticular Juvenile Idiopathic Arthritis
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Treatment Journal
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About Orencia
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Patient Stories
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Dual Seropositive Questions
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Orencia Patient Brochure - English
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Orencia Patient Brochure - Spanish
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people also ask
Orencia FAQs
Is there a pregnancy exposure registry for ORENCIA?Yes, there is a pregnancy exposure registry for ORENCIA that monitors pregnancy outcomes in women exposed to the drug during pregnancy. Healthcare professionals are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972.
What is the risk associated with ORENCIA use during pregnancy?The data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. However, there are clinical considerations for administering live vaccines to infants who were exposed to ORENCIA while in utero (see Clinical Considerations).
What are the clinical considerations for administering live vaccines to infants who were exposed to ORENCIA while in utero?It is unknown if abatacept, the active ingredient in ORENCIA, can cross the placenta into the fetus when a woman is treated with the drug during pregnancy. It is also unknown if the immune response of an infant who was exposed in utero to abatacept and subsequently administered a live vaccine is impacted. Risks and benefits should be considered prior to vaccinating such infants.
Is ORENCIA safe to use during lactation?There is no information regarding the presence of abatacept, the active ingredient in ORENCIA, in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with the drug.
Is ORENCIA safe to use in pediatric patients?ORENCIA is safe and effective for reducing signs and symptoms in pediatric patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). Use of ORENCIA for this indication is supported by evidence from clinical studies. The safety and effectiveness of ORENCIA use in pJIA in pediatric patients less than two years of age have not been established.
Can geriatric patients use ORENCIA for Rheumatoid Arthritis?Yes, geriatric patients (patients aged 65 years of age and older) can use ORENCIA for Rheumatoid Arthritis. Clinical studies involving 323 patients aged 65 years and older, including 53 patients aged 75 years and older, showed no overall differences in safety or effectiveness between geriatric patients and younger adults. However, caution should be used when treating geriatric patients due to the higher incidence of infections and malignancies in the geriatric population in general. The frequency of serious infection and malignancy among ORENCIA-treated patients over age 65 was higher than for those under age 65.
Are there differences in response between geriatric patients and younger adult patients using ORENCIA for Rheumatoid Arthritis?Other reported clinical experience has not identified differences in responses between geriatric patients and younger adults when using ORENCIA for Rheumatoid Arthritis. However, greater sensitivity of some geriatric patients cannot be ruled out. Clinical studies of ORENCIA for acute graft versus host disease (aGVHD) did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
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