IMAAVY Concentrate for solution for infusion Ref.[116055] Active ingredients: Nipocalimab

Treatment should be supervised by a physician experienced in the management of patients with neuromuscular disorders and must be administered by a healthcare professional.

Posology

The recommended dose regimen is shown in Table 1.

Table 1. Recommended dose regimen:

Missed dose(s)

If a scheduled infusion appointment is missed, the maintenance dose should be administered as soon as possible. Dosing should be resumed every 2 weeks thereafter.

Special populations

Elderly

No dose adjustment is required in patients aged 65 years and older (see section 5.2).

Renal impairment

No dose adjustment is required for patients with renal impairment (see section 5.2).

Hepatic impairment

No dose adjustment is required for patients with hepatic impairment (see section 5.2).

Paediatric population

The safety and efficacy of nipocalimab in children below 12 years of age have not been established. No data are available.

Method of administration

This medicinal product should only be administered via intravenous infusion with in-line or add-on filtration as described in section 6.6. Do not administer as an intravenous push or bolus injection.

The initial single dose of medicinal product should be administered over approximately 30 minutes and the maintenance dose should be administered over approximately 15 minutes.

Patients should be monitored for 30 minutes after each infusion for signs or symptoms of an infusion-related or hypersensitivity reaction. If an adverse reaction occurs during administration of treatment, the infusion may be slowed or discontinued (see section 4.4).

Prior to administration, this medicinal product requires dilution in sodium chloride 9 mg/mL (0.9%) solution for infusion. For instructions on dilution of the medicinal product before administration, see section 6.6.

Single doses up to 60 mg/kg have been administered intravenously in clinical studies without dose-limiting toxicity. There are no known specific signs and symptoms of overdose with nipocalimab. In case of overdose, it is recommended that patients are monitored closely for any adverse reactions, and appropriate symptomatic and supportive treatment should be initiated immediately.

Unopened vial:

2 years.

After dilution:

From a microbiological point of view, unless the method of dilution precludes the risks of microbial contaminations, the prepared diluted solution (see section 6.6) should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. If immediate administration is not possible, the diluted solution can be refrigerated for up to 24 hours at 2°C to 8°C, with an additional 12 hours of storage at room temperature, including infusion time, at 15°C to 30°C. Do not freeze.

Store in a refrigerator (2°C to 8°C).

Do not freeze.

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

For storage conditions after dilution of the medicinal product, see section 6.3.

1.62 mL concentrate for solution for infusion in a single-use Type 1 glass vial with an elastomeric stopper with an aluminium seal with a flip-off cap containing 300 mg of nipocalimab. Pack size of 1 vial.

6.5 mL concentrate for solution for infusion in a single-use Type 1 glass vial with elastomeric stopper with an aluminium seal with a flip-off cap containing 1200 mg of nipocalimab. Pack size of 1 vial.

Prior to administration, Imaavy single-dose vials require dilution in sodium chloride 9 mg/mL (0.9%) solution for infusion.

Preparation:

Prepare the solution for infusion using aseptic technique as follows:

• Calculate the dose (mg), total volume (mL) of concentrate required, and the number of vials needed based on the patient's current weight for the recommended initial single dose of 30 mg/kg or 15 mg/kg for subsequent doses every 2 weeks. Each vial is at a concentration of 185 mg/mL.
• Check that the solution in each vial is colourless to slightly brownish, clear to slightly opalescent, and free of visible particles. Do not use if visible particles are present or if the solution is discoloured (other than colourless to slightly brownish). Do not shake.
• Gently withdraw the calculated volume of concentrate from the vial(s). Discard any unused portion of the vials.
• Dilute the total volume of the withdrawn concentrate by adding it to an infusion bag containing 250 mL sodium chloride 9 mg/mL (0.9%) solution for infusion for patients who weigh 40 kg or more, or 100 mL sodium chloride 9 mg/mL (0.9%) solution for infusion for patients who weigh less than 40 kg. Only use infusion bags made of polyolefin, polypropylene, or polyvinylchloride.
• Gently invert the infusion bag at least ten times to mix the solution. Do not shake.
• Verify that a uniform solution has been achieved by visual inspection. Do not use if particulate matter or discolouration are present.

Administration:

• Administer the diluted solution by intravenous infusion using an infusion set with an in-line or add-on, sterile, non-pyrogenic, low protein-binding filter made of polyethersulfone or polysulfone (pore size 0.2 micrometre or less). Administration sets must be made of either polybutadiene, polyethylene, polyurethane, polypropylene, or polyvinylchloride.
• Do not infuse the diluted concentrate concomitantly in the same intravenous line with other agents.
• Administer the infusion intravenously over approximately 30 minutes for the initial dose (30 mg/kg) and approximately 15 minutes for subsequent doses (15 mg/kg).
• If an adverse reaction occurs during administration, the infusion may be slowed or stopped at the discretion of the heatlthcare professional.

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