CINQAERO 10 mg/mL concentrate for infusion solution

2. What you need to know before you receive 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 starting treatment with CINQAERO:

• if you have a parasitic infection or if you live in an area where parasitic infections are common or if you are traveling 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 while you are receiving CINQAERO:

• if your asthma remains uncontrolled or worsens during treatment with this medicine;
• if you experience any symptoms of an allergic reaction (e.g., itching, breathing problems, 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 using, have recently used, or might use any other medicines.

This is especially important:

• if you are taking 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 plan 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 using machines

CINQAERO is unlikely to affect your ability to drive and use machines.

CINQAERO contains sodium

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

3. How CINQAERO is administered

Follow the instructions given by your doctor exactly. If you are unsure, 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 administer CINQAERO as an infusion (drip) into a vein. The infusion will take about 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 treatment with CINQAERO is interrupted

DO NOT interrupt treatment with CINQAERO unless your doctor tells you to, even if you feel better. Stopping or suspending 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 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 may occur rarely (may affect up to 1 in 100 people) during administration of CINQAERO or after. Your doctor or nurse will closely monitor you for signs of a reaction. Consult your doctor or nurse immediatelyif you have any symptoms of an allergic reaction (e.g., itching, breathing problems, wheezing [a whistling sound when breathing], fever, chills, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness, or swelling).

Other side effects

Common (may affect up to 1 in 10 people)

• Increased 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 effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side 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 which is stated on the outer carton and on the label of the vial after EXP. The expiry date refers to the last day of the month shown.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of CINQAERO

• The active substance is reslizumab.

Each milliliter 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.

Appearance and pack of the product

CINQAERO is a concentrate for solution for infusion (sterile concentrate) that is between transparent and slightly turbid opalescent, and between colorless and slightly yellowish. It may contain proteinaceous particles that appear as translucent to white amorphous particles, some of which may have a fibrous appearance. This is not uncommon for proteinaceous solutions. The concentrate should not be used if it has a color (except slightly yellowish) or if it contains foreign particles.

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

Not all pack sizes may be marketed.

Marketing authorization holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer

UAB Teva Baltics

Moletu pl. 5

LT-08409 Vilnius

Lithuania

Merckle GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

You can request more information about this medicine from the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

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

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This information is intended only for healthcare professionals:

CINQAERO is supplied as a concentrate for solution for infusion in a single-use vial. The infusion solution is intended for intravenous use only after dilution and should be prepared using an 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 infusion solution

1. Remove CINQAERO from the refrigerator. Do not shake the vial.
2. The medicine should be inspected visually before use. The concentrate is between transparent and slightly turbid opalescent, and between colorless and yellowish. The concentrate may contain proteinaceous particles that appear as translucent to white amorphous particles, some of which may have a fibrous appearance. This is not uncommon for proteinaceous solutions. The concentrate should not be used if it has a color (except slightly yellowish) or if it contains foreign particles.
3. A suitable 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 Package Leaflet).
4. Slowly transfer the contents of the syringe(s) to an infusion bag containing 50 ml of infusion solution (9 mg/ml (0.9%) sodium chloride). Gently invert the bag to mix the solution. This medicine should not be mixed with other medicines except for a 9 mg/ml (0.9%) sodium chloride infusion solution.
5. Discard any remaining concentrate in the vial.
6. The infusion solution should be administered immediately after preparation. CINQAERO solutions diluted in 9 mg/ml (0.9%) sodium chloride infusion solution can be stored refrigerated at 2°C to 8°C (or not above 25°C if the dilution has taken place in controlled and validated aseptic conditions) and protected from light for up to 16 hours.
7. CINQAERO is compatible with infusion bags made of polyvinyl chloride (PVC) or polyolefin (PO).

Administration instructions

1. CINQAERO should be administered by a healthcare professional prepared to treat hypersensitivity reactions, including anaphylaxis (see section 4.4 of the Summary of Product Characteristics or Package Leaflet). The patient should be monitored during the entire infusion and for an appropriate period after the infusion. Patients should be instructed on how to recognize the symptoms of severe allergic reactions.
2. If the infusion solution has been stored in a refrigerator, allow it to reach room temperature (15°C to 25°C).
3. The infusion solution should be administered intravenously over 20-50 minutes. The infusion time may vary depending on the total volume to be administered.
4. The infusion solution should not be administered concomitantly in the same intravenous line with other medicines. No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of reslizumab with other medicines.
5. An in-line filter with a pore size of 0.2 µm should be used for the infusion. CINQAERO is compatible with low protein-binding in-line filters made of polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, and cellulose acetate.
6. After the infusion is complete, flush the infusion set with a sterile 9 mg/ml (0.9%) sodium chloride infusion solution to ensure that all of the CINQAERO infusion solution has been administered.

See section 4.2 of the Summary of Product Characteristics or Package Leaflet for instructions related to dosage.