Cinqaero

Patient Information Leaflet

CINQAERO 10 mg/mL concentrate for solution for infusion

reslizumab
Please read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What CINQAERO is and what it is used for
2. What you need to know before you are given 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, which is a protein that
recognizes and binds to a specific target substance in the body.

What CINQAERO is used for
CINQAERO is used for the treatment of severe eosinophilic asthma in adult patients (aged 18 years and older) whose disease is not well controlled despite treatment with high-dose inhaled corticosteroids in combination with another asthma medication. Eosinophilic asthma is a type of asthma characterized by the presence of too many eosinophils in the blood or lungs. CINQAERO is used in combination with other asthma medications (inhaled corticosteroids together with other asthma medicines).

How CINQAERO works
CINQAERO blocks the activity of interleukin-5 and reduces the number of eosinophils in the blood and lungs. Eosinophils are white blood cells involved in the inflammation associated with asthma. Interleukin-5 is a protein produced by the body that plays a key role in asthma-related inflammation by activating eosinophils.

What benefits of using CINQAERO can be expected
CINQAERO reduces the frequency of asthma attacks, improves breathing, and reduces asthma symptoms.

2. What you need to know before you are given CINQAERO

Do not receive CINQAERO:

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

Warnings and precautions
Talk to your doctor or nurse before you are given CINQAERO:

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

Also, talk to your doctor or nurse when you are given CINQAERO:

• if asthma control is not achieved or worsens during treatment with this medicine;
• if you experience any symptoms of an allergic reaction (e.g. itching, difficulty breathing, wheezing, fever, chills, dizziness, headache, nausea, vomiting, abdominal pain, rash, redness or swelling). Severe allergic reactions have occurred in patients receiving this medicine (see section 4 “Possible side effects”).

Children and adolescents
This medicine is NOT intended for children and adolescents under 18 years of age.
Other medicines and CINQAERO
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
This is particularly important:

• if you are receiving other medicines that affect the immune system;
• if you have recently been vaccinated or if you are likely to need vaccination.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before you are given this medicine.
The active substance of this medicine may pass into breast milk, but only during the first few days after birth.
Driving and using machines
It is unlikely that CINQAERO will impair your ability to drive or operate machinery.
CINQAERO contains sodium
This medicine contains 4.6 mg of sodium (a main component of table salt) per 10 mL vial, and 1.15 mg of sodium per 2.5 mL vial. This corresponds to 0.23% and 0.06% of the maximum recommended daily dietary intake of sodium for an adult, respectively.

3. How CINQAERO is administered

Always follow the doctor's instructions exactly. If you have any doubts, consult your doctor.
The dose depends on your body weight. Your doctor will determine the appropriate dose for you. The maximum dose is 3 mg per kg of body weight. CINQAERO will be administered every 4 weeks. CINQAERO will be given to you by a doctor or nurse through an intravenous infusion (drip) into a vein. The infusion will last approximately 20–50 minutes.
The doctor or nurse will carefully monitor you during and after the infusion for any signs of an allergic reaction.
If you miss a scheduled dose of CINQAERO
If you do not receive a scheduled dose of CINQAERO, ask your doctor when to schedule the next treatment.
If you stop treatment with CINQAERO
DO NOT stop treatment with CINQAERO unless your doctor advises you to do so, even if you feel better. Stopping or interrupting treatment with this medicine may cause asthma symptoms to return.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects

• Severe allergic reactions
  Severe allergic reactions can occur uncommonly (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. Inform your doctor or nurse immediately if you experience any symptoms of an allergic reaction (e.g. itching, difficulty breathing, wheezing, fever, chills, dizziness, headache, nausea, vomiting, abdominal discomfort, rash, redness or swelling).

Other side 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 side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CINQAERO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label of the vial after Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep the vial in the carton to protect the medicine from light.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CINQAERO contains

• The active substance is reslizumab.

Each mL 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 ingredients are sodium acetate trihydrate, glacial acetic acid, sucrose and water for injections.

Description of the appearance of CINQAERO and contents of the pack
CINQAERO is a concentrate for solution for infusion (sterile concentrate), from clear to slightly opalescent, colourless to pale yellow. Particulate matter may be present. 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.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
UAB Teva Baltics
Molėtų pl. 5
LT-08409 Vilnius
Lithuania
Merckle GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany

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

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
Specifar A.B.E.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
Specifar A.B.E.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals:

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 aseptically using the technique described below:

Traceability
To improve the traceability of biological medicinal products, the name and batch number of the administered product must be clearly documented.

Preparation of the infusion solution

1. Remove CINQAERO from the refrigerator. Do not shake the vial.
2. The medicinal product must be inspected visually before use. The concentrate ranges from clear to slightly opalescent and from colourless to pale yellow. Amorphous protein particles, translucent to white, some of which may have a fibrous appearance, may be present in the concentrate. This is not unusual for protein solutions. The concentrate must not be used if it appears discoloured (except pale yellow) or if extraneous particulate matter is present.
3. An appropriate syringe for injection must be used to withdraw the required volume of concentrate from the vial(s) (see section 4.2 of the Summary of Product Characteristics).
4. Slowly transfer 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. Any residual concentrate remaining in the vial must be discarded.
6. It is recommended that the infusion solution be administered immediately after preparation. Diluted solutions of CINQAERO in sodium chloride 9 mg/mL (0.9%) solution for infusion may be stored refrigerated at 2 °C–8 °C (or at temperatures not exceeding 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). The patient must be monitored throughout the infusion and for an appropriate period after completion of the infusion. Patients should be informed about how to recognize symptoms of severe allergic reactions.
2. If the infusion solution has been stored in the refrigerator, allow it to reach room temperature (15 °C–25 °C) before administration.
3. The infusion solution must be administered intravenously over 20–50 minutes. The infusion time may vary depending on the total volume to be administered.
4. The infusion solution must not be administered simultaneously with other medicinal products in the same intravenous line. Physical or biochemical compatibility studies to evaluate co-administration of reslizumab with other medicinal products have not been conducted.
5. An in-line sterile, single-use, non-pyrogenic, low-protein-binding infusion set with a 0.2 µm filter must be used for infusion. CINQAERO is compatible with low-protein-binding in-line filters made of polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, or cellulose acetate (CA).
6. At the end of the infusion, flush the infusion set with a sterile sodium chloride 9 mg/mL (0.9%) solution for infusion to ensure that the entire CINQAERO infusion solution has been administered.

For dosage instructions, see section 4.2 of the Summary of Product Characteristics.