ENJAYMO Solution for infusion Ref.[50928] Active ingredients: Sutimlimab

Enjaymo must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological disorders.

Posology

Patients should be vaccinated according to the most current local recommendations for patients with persistent complement deficiencies (see section 4.4).

The recommended dose is based on body weight. For patients weighing 39 kg to less than 75 kg, the recommended dose is 6500 mg and for patients weighing 75 kg or more, the recommended dose is 7500 mg. Administer Enjaymo intravenously weekly for the first two weeks, with administration every two weeks thereafter. Enjaymo should be administered at the recommended dose regimen time points, or within two days of these time points (see section 4.4). Enjaymo is intended for continuous use as chronic therapy only, unless the discontinuation of Enjaymo is clinically indicated.

Missed dose

If a dose is missed, the missed dose should be administered as soon as possible. If the duration after the last dose exceeds 17 days, therapy should be reinitiated with weekly administrations for the first two weeks followed by administration every two weeks thereafter.

Special populations

Elderly

No dose adjustment is required for patients with CAD aged 65 years and over (see sections 5.1 and 5.2).

Hepatic impairment

No dose adjustment is required in patients with hepatic impairment.

Renal impairment

No dose adjustment is required in patients with renal impairment.

Paediatric population

There is no relevant use of Enjaymo in children <18 years of age in the treatment of CAD.

Method of administration

Enjaymo is for intravenous infusion only. Do not administer as an intravenous push or bolus. For instructions on preparation and administration, see section 6.6.

Following preparation, Enjaymo infusion solution should be administered intravenously at the infusion rate presented in Table 1.

Table 1. Infusion reference table:

Patients with cardiopulmonary disease may receive the infusion over 120 minutes.

If an adverse reaction occurs during the administration of Enjaymo, the infusion may be slowed or stopped at the discretion of the physician. If hypersensitivity reactions occur, discontinue Enjaymo and initiate appropriate treatment. Monitor the patient for at least two hours following completion of the initial infusion for signs or symptoms of an infusion and/or hypersensitivity reaction. Monitor the patient for one hour following completion of subsequent infusions for signs or symptoms of an infusion reaction.

Home infusion

Home infusions should be performed by a healthcare professional.

The decision to consider home infusion should be based on individual clinical characteristics of the patient and individual needs of the patient. Transitioning the infusion from a clinical facility to home administration includes ensuring that adequate infrastructure and resourcing is in place and consistent with treating physician orders. Infusion of Enjaymo at home may be considered for patients who have tolerated their infusion well in a clinical facility and have not had infusion related reactions. A patient’s underlying co-morbidities and ability to adhere to the home infusion requirements need to be considered when evaluating the patient for eligibility to receive home infusion. In addition, the following criteria should be considered:

• The patient must have no ongoing concurrent condition that, in the opinion of the physician, may place the patient at greater risk when receiving an infusion in the home setting rather than in the clinic setting. A comprehensive evaluation should be completed before the initiation of home infusion to ensure that the patient is medically stable.
• The patient must have successfully received Enjaymo infusion in a clinical setting (hospital or outpatient) for at least three months under the supervision of a physician or care provider experienced in the management of patients with CAD.
• The patient must be willing and able to comply with home infusion procedures and recommendations of the treating physician or care provider.
• The healthcare professional administering the infusion at home should be available at all times during the home infusion and for at least 1 hour after infusion.

If the patient experiences adverse reactions during the home infusion, the infusion process should be stopped immediately, appropriate medical treatment should be initiated (see section 4.4) and the treating physician should be notified. In such cases, the treating physician should decide if subsequent infusions should occur and if so, whether the infusions should be administered in a hospital or supervised outpatient care setting.

In patients who experience overdose, immediate interruption of infusion and close monitoring is recommended.

Unopened vial:

3 years

Storage of the medicinal product after opening:

Chemical and physical in-use stability has been demonstrated for 16 hours at 18°C to 25°C or for 72 hours at 2°C to 8°C. From a microbiological point of view, the product should be used immediately.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be for longer than 24 hours at 2°C to 8°C or 8 hours at room temperature, unless vial opening and pooling into the infusion bag has taken place in controlled and validated aseptic conditions.

Store in a refrigerator (2°C-8°C).

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

Do not freeze.

For storage conditions after first opening of the medicinal product vial, see section 6.3.

22 mL solution in vial (type I glass) with a stopper (butyl rubber), seal (aluminium) and a flip-off cap

Each pack contains 1 or 6 vials.

Not all pack sizes may be marketed.

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

Enjaymo is provided as a solution in a single-dose vial and should be prepared by a healthcare professional using aseptic technique.

Preparation:

1. Remove Enjaymo from the refrigerator. To minimize foaming, do not shake.

2. Inspect vials visually for particulate matter and discoloration prior to administration. The solution is an opalescent and colourless to slightly yellow liquid. Do not administer if discoloured or if other foreign particulate matter is present.

3. Withdraw the calculated volume from the appropriate number of vials based on the recommended dose (see Table 1) and add to an empty infusion bag. Discard unused portion remaining in the vial.

4. The prepared solution should be administered immediately. For storage conditions, see section 6.3.

Administration:

1. Prior to administration, allow the infusion solution to adjust to room temperature (18°C-25°C). Refer to Table 1 for infusion rate, see section 4.2. The infusion should be administered over 1-2 hours depending on the patient’s body weight. Administer the infusion only through a 0.22-micron filter with a polyethersulfone (PES) membrane. Infusion warmers may be used, do not exceed a temperature of 40°C.

2. The infusion catheter and tubing should be primed with the dosing solution immediately before infusion and flushed immediately following completion of the infusion with enough quantity (approximately 20 mL) of sodium chloride 9 mg/mL (0.9%) solution for injection.

3. No incompatibilities have been observed between Enjaymo infusion solution and infusion bags made of Di-(2-ethylhexyl)phthalate (DEHP) plasticized polyvinyl chloride (PVC), Ethyl Vinyl Acetate (EVA) and polyolefin (PO); administration sets made of DEHP-plasticized PVC, DEHP-free polypropylene (PP) and polyethylene (PE); and vial adapters made of polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS).