What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU1/16/1125/001 .


Cinqaero (reslizumab) 10 mg/mL concentrate for solution for infusion

Package leaflet: Information for the patient

CINQAERO 10 mg/mL concentrate for solution for infusion

reslizumab

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 further questions, ask your doctor, pharmacist or nurse.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in 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 given
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 is a medicine containing the active substance reslizumab, a monoclonal antibody, a type of protein that recognises and binds to a specific target substance in the body.

How CINQAERO works

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

What CINQAERO is used for

CINQAERO is used to treat severe eosinophilic asthma in adult patients (18 years of age and over) when the condition is not well controlled despite treatment with high-dose inhaled corticosteroids together with another asthma medicine. Eosinophilic asthma is a type of asthma where patients have too many eosinophils in the blood or lungs. CINQAERO is used together with other medicines to treat asthma (inhaled corticosteroids plus other asthma medicines).

What are the benefits of using CINQAERO

CINQAERO reduces how often you have flare-ups of your asthma, helps you breathe better and decreases your asthma symptoms.

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

You must not receive CINQAERO:

  • if you are allergic to reslizumab or 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 or if you live in an area where parasitic infections are common or if you are travelling to such a region, 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 your asthma remains uncontrolled or worsens during treatment with this medicine;
  • if you have any of the symptoms of an allergic reaction (e.g. itching, trouble breathing, wheezing, fever, shivering, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness or swelling). Serious allergic reactions have occurred in patients receiving this medicine (see section “4. Possible side effects”).

Children and adolescents

This medicine is NOT intended for use in children and adolescents below the age of 18 years.

Other medicines and CINQAERO

Tell your doctor if you are using, have recently used or might use any other medicines.

This is particularly important:

  • if you are receiving other medicines which affect your immune system;
  • if you have recently received a vaccination or if you are likely to need a vaccination.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

The active substance in 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 affect your ability to drive and use machines.

CINQAERO contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3. How CINQAERO is given

Always follow the instructions exactly as your doctor has told you. Check with your doctor if you are not sure.

The dose depends on your body weight. Your doctor will work out the right dose for you. The maximum dose is 3 mg per kg of body weight. CINQAERO will be given every 4 weeks. You will be given CINQAERO by a doctor or nurse as an infusion (drip) into a vein. The infusion will take about 20 to 50 minutes.

It may take more than one dose before your asthma symptoms improve.

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

If you miss your scheduled dose of CINQAERO

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

If you stop using CINQAERO

Do NOT stop treatment with CINQAERO unless your doctor tells you to, even if you feel better.

Interrupting or stopping treatment with this medicine may cause your asthma symptoms to come back.

If you have any further questions on the use of this medicine, ask 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

  • Serious allergic reactions
    Serious allergic reactions can happen uncommonly (may affect up to 1 in 100 people) while receiving CINQAERO or afterwards. Your doctor or nurse will watch you closely for signs of a reaction. Tell your doctor or nurse straight away if you have any of the symptoms of an allergic reaction (e.g. itching, trouble breathing, wheezing, fever, shivering, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness or swelling).

Other side effects

Common (may affect up to 1 in 10 people)

  • Increase of an enzyme in your blood (blood creatine phosphokinase).

Uncommon (may affect up to 1 in 100 people)

  • Muscle pain (myalgia).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below).

United Kingdom

The Yellow Card Scheme
Website:www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland

HPRA Pharmacovigilance
Website: www.hpra.ie

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 outer carton and label after EXP.

The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C-8 ºC). Do not freeze.

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

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What CINQAERO contains

  • The active substance is reslizumab.
    Each mL of concentrate contains 10 mg of reslizumab (10 mg/mL). Each vial of 2.5 mL contains 25 mg of reslizumab and each vial of 10 mL contains 100 mg of reslizumab.
  • The other excipients are sodium acetate, acetic acid glacial, sucrose and water for injections.

What CINQAERO looks like and contents of the pack

CINQAERO is a clear to slightly hazy opalescent, colourless to slightly yellow concentrate for solution for infusion (sterile concentrate). Particles might 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 with 2.5 mL and in packs containing 1 or 2 vials with 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Teva UK Limited
Tel: +44 1977 628500

This leaflet was last revised in September 2019.

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

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