2 ML anifrolumab-fnia 150 MG/ML Injection [Saphnelo]
NO BLACK BOX WARNING
Dosage & administration
The recommended dosage is 300 mg as an intravenous infusion over a 30‑minute period every 4 weeks. For complete dilution and intravenous administration instructions see Full Prescribing Information.
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drug label
Saphnelo prescribing information
Need to report a Saphnelo issue?
ONLINE FORMReport adverse event
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You can report a Saphnelo adverse event on MedWatch, the FDA's medical product safety reporting program for health professionals, patients and consumers.
prior authorization
Saphnelo Prior authorization resources
NOT PROVIDED BY BRANDComplete Letter of Medical Necessity
Coverage Authorization Request
Coverage Authorization Appeals
Patient Authorization Form
Coding Resource
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If available, these templates are provided by the brand to help you navigate insurance, especially with newer drugs.
Benefits investigation
NOT PROVIDED BY BRANDBenefits investigation resources
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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.
Reimbursement help (FRM)
FRM Contact
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Some brands offer a field reimbursement manager who will work with your clinical staff and preferred pharmacy to help make sure patients don't fall through the cracks.
financial assistance
Saphnelo Financial assistance options
Co-pay savings program
commercial only
Enroll in patient savings program
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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+
Denied Patient Savings Program Cover Sheet
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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
Saphnelo Patient education
Getting started on Saphnelo
NOT PROVIDED BY BRANDInstruction for Use
Patient toolkit
Patient Brochure - English
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
Patient Brochure - Spanish
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
Discussion Guide - English
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
Discussion Guide - Spanish
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
Copay Savings Brochure
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
Support Resources Brochure - English
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
Support Resources Brochure - Spanish
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
Treatment Roadmap - English
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
Treatment Roadmap - Spanish
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
Infusion Preparation Tips - English
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
Infusion Preparation Tips - Spanish
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
Living with Lupus
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
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Other resources brands publish to help support patients and caregivers.
people also ask
Saphnelo FAQs
Is SAPHNELO safe to use during pregnancy?The limited human data with SAPHNELO use in pregnant women are insufficient to inform on drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcome. Monoclonal IgG antibodies are known to be actively transported across the placenta as pregnancy progresses; therefore, anifrolumabfnia exposure to the fetus may be greater during the third trimester of pregnancy. A pregnancy exposure registry monitors pregnancy outcomes in women exposed to SAPHNELO during pregnancy. Pregnant women with SLE are at increased risk of adverse pregnancy outcomes. If you are pregnant and taking SAPHNELO, contact AstraZeneca at 1-877-693-9268.
What is the risk of birth defects and miscarriage with SAPHNELO use during pregnancy?The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Can SAPHNELO be used during lactation?No data are available regarding the presence of SAPHNELO in human milk, the effects on the breastfed child, or the effects on milk production. Anifrolumab-fnia was detected in the milk of female cynomolgus monkeys administered anifrolumab-fnia. If you are breastfeeding while taking SAPHNELO, consult with your healthcare provider to assess the potential risks and benefits.
Is SAPHNELO safe for use in pediatric patients?The safety and efficacy of SAPHNELO in pediatric patients less than 18 years of age have not been established.
Is SAPHNELO safe for use in geriatric patients?Of the 664 patients with SLE exposed to anifrolumab-fnia in clinical trials, 3% (n=20) were 65 and over. The number of patients aged 65 years of age and older was not sufficient to determine whether they respond differently from younger adult patients.
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