Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: AstraZeneca AB, SE-151 85, Södertälje, Sweden
Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy.
Treatment should be initiated and supervised by a physician experienced in the treatment of SLE.
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 section 4.4).
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.
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 section 5.2).
No dose adjustment is required. There is no experience in patients with severe renal impairment or end-stage renal disease (see section 5.2).
No dose adjustment is required (see section 5.2).
The safety and efficacy of Saphnelo in children and adolescents (aged <18 years old) have not yet been established. No data are available.
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 section 6.6.
In clinical trials, doses of up to 1 000 mg have been administered intravenously in patients with SLE with no evidence of dose limiting toxicities.
There is no specific treatment for an overdose with anifrolumab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Unopened vial:
3 years.
Diluted solution for infusion:
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C–8°C and for 4 hours at 25°C.
From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C–8°C.
Store in a refrigerator (2°C–8°C).
Store in the original package in order to protect from light.
Do not freeze or shake.
For storage conditions after dilution of the medicinal product, see section 6.3.
2.0 mL of concentrate in a clear type I glass vial with an elastomeric stopper and a gray flip-off aluminium seal.
Pack size of 1 vial.
Saphnelo is supplied as a single-dose vial. The solution for infusion should be prepared and administered by a healthcare professional, using aseptic technique as follows:
Preparation of solution:
Disposal:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
