SAPHNELO Concentrate for solution for infusion Ref.[50047] Active ingredients: Anifrolumab

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 an infusion of anifrolumab (see section 4.4).

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=33); no data are available in patients over 75 years of age (see section 5.2).

Renal impairment

No dose adjustment is required. There is no experience in patients with severe renal impairment or end-stage renal disease (see section 5.2).

Hepatic impairment

No dose adjustment is required (see section 5.2).

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 to 15 micron in-line or add-on 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.

Transitioning between routes of administration

If transitioning a patient from subcutaneous administration to intravenous administration, the first intravenous infusion should be administered approximately 3 to 4 weeks after the last subcutaneous dose.

If transitioning a patient from intravenous administration to subcutaneous administration, the first subcutaneous injection should be administered approximately 2 weeks after the last intravenous dose.

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.

Unopened vial:

Store in a refrigerator (2°C–8°C).

Store in the original package in order to protect from light.

Do not freeze or shake.

Diluted solution for infusion:

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:

1. Visually inspect the vial for particulate matter and discolouration. Saphnelo is a clear to opalescent, colourless to slightly yellow solution. Discard the vial if the solution is cloudy, discoloured or visible particles are observed. Do not shake the vial.

2. Dilute 2.0 ml of Saphnelo solution for infusion in an infusion bag to 50 ml or 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection.

3. Mix the solution by gentle inversion. Do not shake.

4. Any concentrate remaining in the vial must be discarded.

5. It is recommended that the solution for infusion should be administered immediately after preparation. If the solution for infusion has been stored in a refrigerator (see section 6.3), allow it to reach room temperature (15°C–25°C) prior to administration.

Disposal:

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.