Saphnelo Dosage/Direction for Use

Treatment should be initiated and supervised by a physician experienced in the treatment of SLE.
Posology: The recommended dose is 300 mg, administered as an intravenous infusion over a 30-minute period, every 4 weeks.
In patients with a history of infusion-related reactions, premedication (e.g., an antihistamine) may be administered before the infusion of anifrolumab (see Precautions).
Missed dose: If a planned infusion is missed, treatment should be administered as soon as possible. A minimum interval of 14 days should be maintained between doses.
Special populations: Elderly (≥65 years old): No dose adjustment is required. There is limited information in subjects aged ≥65 years (n=20); no data are available in patients over 75 years of age (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is required. There is no experience in patients with severe renal impairment or end-stage renal disease (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is required (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Saphnelo in children and adolescents (aged <18 years old) have not yet been established. No data are available.
Method of administration: For intravenous use.
Saphnelo must not be administered as an intravenous push or bolus injection.
Following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, Saphnelo is administered as an infusion over 30 minutes through an intravenous infusion line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
The infusion rate may be slowed or interrupted if the patient develops an infusion reaction.
Upon completion of the infusion, the infusion set should be flushed with 25 mL sodium chloride 9 mg/mL (0.9%) solution for injection to ensure that all of the solution for infusion has been administered.
Do not co-administer any other medicinal products through the same infusion line.
For instructions on dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.