CINQAERO Concentrate for solution for infusion Ref.[8992] Active ingredients: Reslizumab

CINQAERO should be prescribed by physicians experienced in the diagnosis and treatment of the above-mentioned indication (see section 4.1).

Posology

CINQAERO is given as intravenous infusion once every four weeks.

Patients below 35 kg or above 199 kg

The recommended dose is 3 mg/kg body weight. The volume (in mL) required from the vial(s) should be calculated as follows: 0.3 x patient body weight (in kg).

Patients between 35 kg and 199 kg

The recommended dose is achieved using the vial-based dosing scheme in Table 1 below. The recommended dose is based on patient body weight and should only be adjusted for significant changes in body weight.

Table 1. Vial-based dosing scheme for patients with body weight between 35 kg and 199 kg:

* This dosing scheme is based on a maximum dose of 3 mg/kg.
** The nominal volume of the vials (10 mL or 2.5 mL for each vial) has to be used.
*** Patients weighing more than 188 kg were not studied.

Treatment duration

CINQAERO is intended for long-term treatment.

A decision to continue the therapy should be made at least annually based on disease severity and level of exacerbation control.

Missed dose

If a reslizumab infusion is missed on the planned date, dosing should resume as soon as possible on the indicated dose and regimen. A double dose must not be administered to make up for a missed dose.

Special populations

Elderly

There are limited data available on the use of reslizumab in patients older than 75 years of age. Based on the similar reslizumab exposure observed in patients older than 65 years of age as compared to patients 18 to <65 years of age, no dose adjustment is recommended (see section 5.2).

Renal impairment

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

Hepatic impairment

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

Paediatric population

The safety and efficacy of CINQAERO in children and adolescents aged up to 17 years have not been established for the indication of CINQAERO. No data are available for children aged up to 11 years. Currently available data in adolescents from 12 to 17 years are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.

Method of administration

Intravenous use.

CINQAERO is for intravenous infusion only. It must not be administered by the subcutaneous, oral or intramuscular route.

The appropriate volume of CINQAERO should be dispensed into an infusion bag containing 50 mL sodium chloride 9 mg/mL (0.9%) solution for infusion.

The diluted medicinal product should then be administered as a 20–50-minute intravenous infusion through a sterile, non-pyrogenic infusion, single-use, low protein binding filter (0.2 µm). CINQAERO must not be administered as a bolus injection or as undiluted concentrate.

The infusion must be discontinued immediately if the patient experiences a hypersensitivity reaction to reslizumab or to any of the excipients (see section 4.4).

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

The highest single dose administered intravenously was reported at 12.1 mg/kg and had no clinical consequences for the patient. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and given appropriate symptomatic treatment.

3 years.

Diluted medicinal product: Chemical and physical in-use stability has been demonstrated at 2°C-8°C and at 25°C in sodium chloride 9 mg/mL (0.9%) solution for infusion protected from light for up to 16 hours.

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 normally not be longer than 16 hours at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Store in a refrigerator (2°C-8°C).

Do not freeze.

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

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

2.5 mL of concentrate in a clear type I glass vial closed by a poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on aluminium ring and a white plastic flip-off cap.

10 mL of concentrate in a clear type I glass vial closed by a poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on aluminium ring and a blue plastic flip-off cap.

Pack sizes:

• 1 vial of 2.5 mL
• 2 vials of 2.5 mL
• 1 vial of 10 mL
• 2 vials of 10 mL

Not all pack sizes may be marketed.

CINQAERO is provided as a concentrate for solution for infusion in a single-use vial. The solution for infusion is intended only for intravenous use after dilution and should be prepared using aseptic technique as follows:

Preparation of solution for infusion:

1. Remove CINQAERO from the refrigerator. Do not shake the vial.
2. The medicinal product should be inspected visually before use. The concentrate is clear to slightly hazy opalescent, colourless to slightly yellow. Proteinaceous particles may be present in the concentrate that appear as translucent to white, amorphous particles, some of which may look fibrous. This is not unusual for proteinaceous solutions. The concentrate must not be used if coloured (except slightly yellow) or if foreign particles are present.
3. A suitable injection syringe should be used to withdraw the needed amount of the concentrate from the vial(s) (see section 4.2).
4. Slowly dispense the contents of the syringe(s) into an infusion bag containing 50 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion. Gently invert the bag to mix the solution. This medicinal product must not be mixed with other medicinal products except sodium chloride 9 mg/mL (0.9%) solution for infusion.
5. The concentrate does not contain any preservatives. Any concentrate remaining in the vial must be discarded.
6. It is recommended that the solution for infusion be administered immediately after preparation. Solutions of CINQAERO diluted in sodium chloride 9 mg/mL (0.9%) solution for infusion may be stored refrigerated at 2°C-8°C (or not above 25 °C if dilution has taken place in controlled and validated aseptic conditions), protected from light for up to 16 hours.
7. CINQAERO is compatible with polyvinylchloride (PVC) or polyolefin (PO) infusion bags.

Instructions for administration:

1. CINQAERO should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis (see section 4.4). The patient has to be observed over the duration of the infusion and for an appropriate period afterwards. Patients should be instructed on how to recognise symptoms of serious allergic reactions.
2. If the solution for infusion has been stored in a refrigerator, allow it to reach room temperature (15°C-25°C).
3. The solution for infusion should be infused intravenously over 20–50 minutes. Infusion time may vary depending on the total volume to be infused.
4. The solution for infusion should not be infused concomitantly in the same intravenous line with other medicinal products. No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of reslizumab with other medicinal products.
5. An infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 0.2 µm) should be used for infusion. CINQAERO is compatible with polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, cellulose acetate (CA) low protein binding in-line infusion filters.
6. Upon completion of the infusion, flush the infusion set with sterile sodium chloride 9 mg/mL (0.9%) solution for infusion to ensure that all of the CINQAERO solution for infusion has been administered.

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