Selective immunosuppressants
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Saphnelo Dosage

Drug Detail:Saphnelo (Anifrolumab-fnia [ an-i-frol-ue-mab ])

Generic Name: ANIFROLUMAB 300mg in 2.0mL

Dosage Form: injection, solution

Drug Class: Selective immunosuppressants

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Dosage Recommendations

SAPHNELO must be diluted prior to intravenous administration [see Dosage and Administration (2.2)].

The recommended dosage of SAPHNELO is 300 mg, administered as an intravenous infusion over a 30-minute period, every 4 weeks.

Missed dose

If a planned infusion is missed, administer SAPHNELO as soon as possible. Maintain a minimum interval of 14 days between infusions.

Instructions for Preparation and Administration

​SAPHNELO is supplied as a single-dose vial. Prepare the diluted infusion solution using aseptic technique, by the following procedure:

1.
​Visually inspect the vial for particulate matter and discoloration. SAPHNELO is a clear to opalescent, colorless to slightly yellow, solution. Discard the vial if the solution is cloudy, discolored or visible particles are observed. Do not shake the vial.
2.
​Withdraw and discard 2 mL of solution from a 50 mL or 100 mL 0.9% Sodium Chloride Injection, USP infusion bag.
3.
​Withdraw 2 mL of solution from the vial of SAPHNELO and add it to the infusion bag. Mix the solution by gentle inversion. Do not shake.
4.
​Each vial is intended for one time use only. Discard any unused portion remaining in the vial.
5.
​Administer the infusion solution immediately after preparation.
6.
​If the infusion solution is not administered immediately, store the diluted solution of SAPHNELO at room temperature (59°F to 77°F, 15°C to 25°C) for up to 4 hours, or refrigerated (36°F to 46°F, 2°C to 8°C) for up to 24 hours. Do not freeze. Protect from light. If refrigerated, allow the diluted SAPHNELO solution to reach room temperature prior to administration.
7.
​Administer the infusion solution intravenously over a 30-minute period through an infusion line containing a sterile, low-protein binding 0.2 to 15 micron in-line or add-on filter.
8.
​To ensure the complete dose of SAPHNELO has been administered, flush the entire infusion line with 25 mL of 0.9% Sodium Chloride Injection, USP at the end of the infusion.
9.
​Do not co-administer other medicinal products through the same infusion line.
10.
​Dispose of any unused medicinal product or waste material in accordance with local requirements.
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