KAVIGALE Solution for injection/infusion Ref.[114761] Active ingredients: Sipavibart

KAVIGALE must be administered by a healthcare professional.

Administration should be under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. Individuals should be monitored after administration according to local medical practice.

Posology

The recommended dose in adults and adolescents 12 years of age and older weighing at least 40 kg is 300 mg of sipavibart administered as an intramuscular injection or intravenous infusion.

Special populations

Elderly

No dose adjustment is required (see section 5.2).

Renal impairment

No dose adjustment is required (see section 5.2).

Hepatic impairment

No dose adjustment is required (see section 5.2).

Paediatric population

No dose adjustment is required in adolescents 12 years of age and older weighing at least 40 kg (see section 5.2).

The safety and efficacy of sipavibart in children less than 12 years of age and children 12 years of age and older but less than 40 kg have not been established. No data are available.

Method of administration

For intramuscular injection or intravenous infusion.

Intramuscular injection

This medicinal product should be administered as a single intramuscular injection in the anterolateral aspect of the thigh.

Intravenous infusion

Other medicinal products should not be administered through the same infusion line.

After infusion, the administration set should be flushed with sufficient sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection to ensure delivery of the required dose.

Infusion using an infusion bag

Following dilution with sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection, this medicinal product should be administered as an infusion by gravity or with an infusion pump over approximately 20 minutes using an administration set with a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.

For instructions on dilution of the medicinal product before administration, see section 6.6.

Undiluted infusion using a syringe pump

This medicinal product should be administered with a syringe pump as a 2 ml (300 mg) undiluted intravenous infusion over at least 6 minutes.

If signs and symptoms of an infusion-related reaction (IRR) occur, the infusion should be interrupted, slowed, or stopped and appropriate medicinal products and/or supportive therapy should be administered (see section 4.4).

There is no specific treatment for overdose with sipavibart.

In clinical trials, sipavibart doses up to 1 200 mg have been administered intravenously without dose-limiting toxicity.

Unopened vial:

18 months.

In-use stability of prepared syringes and prepared infusion bags:

Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C and 4 hours up to 25°C.

From a microbiological point of view, unless the method of preparation precludes the risk of microbial contamination, the product should be used immediately.

If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C and 4 hours up to 25°C, unless preparation has taken place in controlled and validated aseptic conditions.

Store in a refrigerator (2°C–8°C).

Do not freeze. Do not shake.

Keep the vial in the outer carton in order to protect from light.

For storage conditions of prepared syringes and prepared infusion bags, see section 6.3.

2 ml of solution for injection/infusion in a clear glass vial closed by a chlorobutyl elastomeric stopper sealed with a light green aluminium flip-off top.

Pack size of 1 vial.

KAVIGALE is supplied as a single-dose vial. KAVIGALE may be administered via an intramuscular injection or via an intravenous infusion using an infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection or a syringe pump. The solution for injection/infusion should be prepared and administered by a healthcare professional, using aseptic technique as follows:

Preparation of the solution before administration:

1. Remove the vial from refrigerated storage.

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

For storage conditions of the prepared syringe or prepared infusion bag, see section 6.3.

Intramuscular injection:

1. Withdraw 2 ml from the vial into a syringe.

2. Administer the intramuscular injection in the anterolateral aspect of the thigh.

Intravenous infusion – infusion bag or syringe pump:

Preparation of solution

1. Withdraw 2 ml from the vial and prepare an admixture for infusion by transferring into a 50 ml or 100 ml infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection, or administer using a syringe pump (see below).

2. Do not freeze or shake the solution.

Administration – infusion bag

1. Do not co-administer other medicinal products through the same infusion line.

2. Administer the infusion solution intravenously via infusion pump or gravity over approximately 20 minutes through an intravenous line containing a sterile, low protein-binding 0.2 or 0.22 micron in-line filter.

3. Once the infusion is complete, flush the tubing with sufficient sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection to ensure delivery of the required dose.

Administration – syringe pump

1. Administer 2 ml (300 mg) as an undiluted intravenous infusion using a syringe pump over at least 6 minutes.

2. After the entire contents of the syringe have been administered, flush the administration set with a sufficient volume of sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection to ensure that the full dose has been administered.

Disposal:

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