Cinqaero 10 mg/ml concentrate for infusion solution

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

CINQAERO 10mg/ml concentrate for solution for infusion

reslizumab

Read the entire leaflet carefully before starting to receive this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor, pharmacist or nurse.

• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What CINQAERO is and what it is used for
2. What you need to know before receiving CINQAERO
3. How CINQAERO is administered
4. Possible side effects
5. How to store CINQAERO
6. Contents of the pack and other information

1. What CINQAERO is and what it is used for

What CINQAERO is

CINQAERO contains the active substance reslizumab, a monoclonal antibody, a type of protein that recognizes and binds to a specific target substance in the body.

What CINQAERO is used for

CINQAERO is used to treat severe eosinophilic asthma in adult patients (18 years of age or older) when the disease is not well controlled despite treatment with high-dose inhaled corticosteroids plus another asthma medication. Eosinophilic asthma is a type of asthma in which patients have too many eosinophils in the blood or lungs. CINQAERO is used in combination with other asthma medications (inhaled corticosteroids plus other asthma medications).

How CINQAERO works

CINQAERO blocks the activity of interleukin-5 and reduces the number of eosinophils present in the blood and lungs. Eosinophils are white blood cells (leukocytes) involved in asthma-related inflammation. Interleukin-5 is a protein produced by the body that plays a key role in asthma inflammation caused by eosinophil activation.

Benefits of using CINQAERO

CINQAERO reduces the frequency of asthma exacerbations you may experience, helps you breathe better, and reduces asthma symptoms.

2. What you need to know before starting CINQAERO

Do not receive CINQAERO:

• if you are allergic to reslizumab or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or nurse before starting CINQAERO:

• if you have a parasitic infection, or live in an area where parasitic infections are common, or if you are travelling to such an area, as this medicine may weaken your body's ability to fight certain types of parasitic infections.

Also, consult your doctor or nurse while receiving CINQAERO:

• if your asthma remains uncontrolled or worsens during treatment with this medicine;
• if you experience any symptoms of an allergic reaction (for example, itching, difficulty breathing, wheezing [a whistling sound when breathing], fever, chills, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness, or swelling). Serious allergic reactions have occurred in patients treated with this medicine (see section “4. Possible side effects”).

Children and adolescents

This medicine is NOT indicated for use in children and adolescents under 18 years of age.

Other medicines and CINQAERO

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

This is especially important:

• if you are receiving other medicines that affect the immune system;
• if you have recently received a vaccine or if you are likely to need a vaccine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before receiving this medicine.

The active substance of this medicine may pass into breast milk, but only during the first few days after delivery.

Driving and use of machines

It is unlikely that CINQAERO will affect your ability to drive or operate machinery.

CINQAERO contains sodium

This medicine contains 4.6 mg of sodium (the main component of table/cooking salt) in each 10 ml vial and 1.15 mg of sodium in each 2.5 ml vial. This corresponds to 0.23% and 0.06%, respectively, of the maximum daily recommended sodium intake for an adult.

3. How CINQAERO is administered

Follow exactly the instructions given by your doctor. If you have any doubts, consult your doctor again.

The dose depends on your body weight. Your doctor will calculate the correct dose for you. The maximum dose is 3 mg per kilogram of body weight. CINQAERO will be administered every 4 weeks. A doctor or nurse will give you CINQAERO as an intravenous infusion (drip) into a vein. The infusion will last approximately 20 to 50 minutes.

Your doctor or nurse will closely monitor you during and after the infusion for signs of an allergic reaction.

If a scheduled dose of CINQAERO is missed

If a scheduled dose of CINQAERO is missed, ask your doctor when to schedule your next treatment.

If you interrupt treatment with CINQAERO

DO NOT interrupt treatment with CINQAERO unless instructed by your doctor, even if you feel better. Interrupting or stopping treatment with this medicine may cause asthma symptoms to return.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

• Severe allergic reactions

Severe allergic reactions may occur infrequently (may affect up to 1 in 100 people) during or after administration of CINQAERO. Your doctor or nurse will closely monitor you for signs of a reaction. Contact your doctor or nurse immediately if you experience any symptoms of an allergic reaction (for example, itching, difficulty breathing, wheezing [a whistling sound when breathing], fever, chills, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness or swelling).

Other adverse effects

Common (may affect up to 1 in 10 people)

• Increase in a blood enzyme (blood creatine phosphokinase).

Uncommon (may affect up to 1 in 100 people)

• Muscle pain (myalgia).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of CINQAERO

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer carton and on the label of the vial following EXP. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.

Keep the vial in the outer packaging to protect it from light.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of any unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of CINQAERO

• The active substance is reslizumab.

Each millilitre of concentrate contains 10 mg of reslizumab (10 mg/mL). Each 2.5 mL vial contains 25 mg of reslizumab and each 10 mL vial contains 100 mg of reslizumab.

• The other excipients are sodium acetate trihydrate, glacial acetic acid, sucrose and water for injections.

Nature and contents of the container

CINQAERO is a sterile concentrate for solution for infusion, ranging from transparent to slightly opalescent and turbid, colourless to slightly yellowish. It may contain particles. CINQAERO is supplied in glass vials containing 2.5 mL or 10 mL.

CINQAERO is available in packs containing 1 or 2 vials of 2.5 mL and in packs containing 1 or 2 vials of 10 mL.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer

UAB Teva Baltics

Moletu pl. 5

LT‑08409 Vilnius

Lithuania

Merckle GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

For more information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this summary of product characteristics:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended for healthcare professionals only:

CINQAERO is supplied as a concentrate for solution for infusion in a single-use vial. The solution for infusion is intended for intravenous use only after dilution and must be prepared using aseptic technique as described below:

Traceability

In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Preparation of the 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 transparent to slightly opalescent and turbid, and colourless to slightly yellow. The concentrate may contain proteinaceous particles appearing as amorphous, translucent to white particles, some of which may have a fibrous appearance. This is not uncommon for protein solutions. The concentrate must not be used if it is discoloured (except for slightly yellowish) or contains foreign particulate matter.
3. An appropriate injection syringe should be used to withdraw the required amount of concentrate from the vial(s) (see section 4.2 of the Summary of Product Characteristics or SmPC).
4. Slowly transfer the content of the syringe(s) into an infusion bag containing 50 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion. Gently invert the bag to mix the solution. This medicinal product must not be mixed with other medicinal products except with 9 mg/ml (0.9%) sodium chloride solution for infusion.
5. Any residual concentrate remaining in the vial must be discarded.
6. The solution for infusion should be administered immediately after preparation. Diluted CINQAERO solutions in 9 mg/ml (0.9%) sodium chloride solution for infusion may be stored refrigerated at 2 °C to 8 °C (or not above 25 °C if dilution has been performed under controlled and validated aseptic conditions), protected from light, for up to 16 hours.
7. CINQAERO is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags.

Instructions for administration

1. CINQAERO must be administered by a healthcare professional prepared to manage hypersensitivity reactions, including anaphylaxis (see section 4.4 of the Summary of Product Characteristics or SmPC). The patient must be monitored throughout the infusion and for an appropriate period afterwards. Patients should be advised on how to recognize symptoms of serious allergic reactions.
2. If the solution for infusion has been stored in a refrigerator, allow it to reach room temperature (between 15 °C and 25 °C).
3. The solution for infusion should be administered intravenously over 20 to 50 minutes. The infusion time may vary depending on the total volume to be administered.
4. The solution for infusion must not be co-administered simultaneously through the same intravenous line with other medicinal products. Physical or biochemical compatibility studies evaluating concomitant administration of reslizumab with other medicinal products have not been conducted.
5. An infusion set with an in-line, sterile, non-pyrogenic, low protein-binding single-use filter (pore size 0.2 µm) should be used for the infusion. CINQAERO is compatible with low protein-binding in-line infusion filters made of polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, and cellulose acetate.
6. After completion of the infusion, flush the infusion set with a sterile 9 mg/ml (0.9%) sodium chloride solution for infusion to ensure that the entire CINQAERO solution for infusion has been administered.

Refer to section 4.2 of the Summary of Product Characteristics or SmPC for instructions regarding dosage.