Saphnelo

(anifrolumab)
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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Saphnelo prescribing information

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prior authorization

Saphnelo Prior authorization resources

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Benefits investigation

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Reimbursement help (FRM)

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financial assistance

Saphnelo Financial assistance options

Co-pay savings program

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Bridge program

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Foundation programs

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patient education

Saphnelo Patient education

Getting started on Saphnelo

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Instruction for Use

Patient toolkit

Patient Brochure - English
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Patient Brochure - Spanish
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Discussion Guide - English
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Discussion Guide - Spanish
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Copay Savings Brochure
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Support Resources Brochure - English
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Treatment Roadmap - English
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Treatment Roadmap - Spanish
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Infusion Preparation Tips - English
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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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