Decision

Patient Information Leaflet for Ronapreve

Updated 19 November 2021

Package leaflet: Information for the user

Ronapreve 120 mg/mL solution for injection or infusion casirivimab and imdevimab

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 the vaccine is given 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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Ronapreve is and what it is used for

What Ronapreve is

Ronapreve contains the active substances ‘casirivimab’ and ‘imdevimab’. Casirivimab and imdevimab are a type of protein called ‘monoclonal antibodies’.

What Ronapreve is used for

Ronapreve is used to treat patients with confirmed acute covid-19 infection.

Ronapreve is used to prevent acute covid-19 infection.

Clinical trial experience of use is limited to individuals aged 12 years and older and weighing at least 35.5 kg.

Ronapreve is not a vaccine, it treats or prevents acute covid-19 infection.

What is acute COVID-19 infection?

Acute covid-19 infection is caused by a virus called a coronavirus. People can get COVID-19 through contact with another person who has the virus.

Acute covid-19 infection illnesses can be very mild (sometimes with no symptoms). However, the symptoms can also be severe - including illness resulting in going to the hospital or illness causing death.

• Although most acute covid-19 infection illness is mild, it can be serious - and may make some of your other illnesses worse.

• People of all ages with severe, long-lasting illness like heart disease, lung disease, and diabetes, seem to be more likely to have to go into the hospital for management of acute covid-19 infection.

The symptoms of acute covid-19 infection include fever, cough, and shortness of breath. These may appear 2 to 14 days after exposure. Serious illness can include breathing problems.

How Ronapreve works

Ronapreve attaches to a protein on the surface of the coronavirus called the ‘spike protein’. This stops the virus from getting into your cells and causing an infection. This can help your body to overcome the virus infection and may help you get better faster.

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

You must not be given Ronapreve:

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

Talk to your doctor or nurse as soon as possible, if this applies to you..

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Ronapreve:

Reactions following the infusion or injection

This medicine can cause allergic reactions or reactions following the infusion or injection. The signs of these reactions are listed in Section 4. Tell your doctor straight away if you get any of these signs or symptoms.

Children and adolescents

Clinical trial experience has been limited thus far to individuals aged 12 years and older and weighing at least 35.5 kg.

Other medicines and Ronapreve

Before you have Ronapreve, tell the doctor or nurse who is giving it to you about any other medicines you are taking, or have recently taken – this includes if you have been vaccinated against covid.

After you have had Ronapreve:

• tell any other doctors you see that you have had this medicine to treat or prevent acute covid-19 infection
• tell other doctors or nurses you have had this medicine, if you are getting a vaccine for acute covid-19 infection

Pregnancy and breastfeeding

Tell your doctor or nurse if you are pregnant, or if you might be pregnant.

• This is because there is not enough information to be sure that this medicine is safe for use in pregnancy.
• This medicine will only be given if the potential benefits of treatment outweigh the potential risks to the mother and the unborn child.

Tell your doctor or nurse if you are breast-feeding.

• This is because it is not yet known whether this medicine passes into human breast milk - or what the effects might be on the baby or milk production.
• Your doctor will help you decide whether to keep breast-feeding or to start treatment with this medicine.
• You will need to consider the potential benefits of treatment for you - compared with the health benefits and risks of breast-feeding for your baby.

Driving and machines

This medicine is not expected to have any effect on your ability to drive.

3. How Ronapreve is given

Ronapreve will be given to you by a doctor or nurse who is experienced in the use of this type of treatment. They will watch you closely while you are being given this medicine. This is in case you get any side effects.

How is this medicine given?

The recommended dose for treatment and prevention of acute covid-19 infection is 600 mg of casirivimab and 600 mg of imdevimab given as an infusion or injections.

The recommended dose for continuous prevention of acute covid-19 infection is 300 mg of casirivimab and 300 mg of imdevimab given every four weeks given as an infusion or injections.

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. The following side effects have been reported with Ronapreve.

Reactions following the infusion

Tell your doctor straight away if you get any of these signs of an allergic reaction or reaction listed below during or following the infusion. The infusion may need to be slowed down, interrupted or stopped and you may need other medicines to treat the symptoms. The signs or symptoms of allergic reaction or infusion-related reactions may include:

Uncommon: may affect up to 1 in 100 people

• Feeling sick (nausea)
• Chills
• Dizziness (fainting)
• Rash
• Itchy rash
• Hot flushes

Very rare: may affect up to 1 in 10 000 people

• Severe allergic reaction (anaphylaxis)

Reactions following the subcutaneous (under the skin) injection

Tell your doctor straight away if you get any of these signs of a reaction following the injections.

Common: may affect up to 1 in 10 people

• Redness, itching, bruising, swelling, pain or itchy rash at the injection site

Uncommon: may affect up to 1 in 100 people

• Dizziness
• Swollen lymph nodes close to injection site

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). This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

5. How to store Ronapreve

Ronapreve will be stored by the healthcare professionals at the hospital or clinic under the following conditions:

Before use

Store unopened Ronapreve concentrated solution in a refrigerator until the day it is needed. Before diluting it, allow the concentrated solution to come up to room temperature.

Once diluted

Ronapreve should be used immediately. If necessary, bags of diluted solution can be stored at 2°C to 8°C for no more than 24 hours and at room temperature up to 25ºC for no more than 6 hours. Allow the infusion solution to equilibrate to room temperature for approximately 30 minutes prior to administration.

Prepared syringes should be used immediately. If necessary, store the prepared syringes at 2ºC to 8ºC for no more than 24 hours and at room temperature up to 25ºC for no more than 4 hours. Allow the syringes to equilibrate to room temperature for approximately 10-15 minutes prior to administration.

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 vial label after EXP. The expiry date refers to the last day of that month.

Do not use this medicine if you notice particulate matter or discolouration.

Do not throw away any medicines via wastewater or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures will help protect the environment.

6. Contents of the pack and other information

What Ronapreve contains

• The active substances are casirivimab or imdevimab. Each 20 mL multidose vial contains 1 332 mg of casirivimab or imdevimab, i.e. two doses of 5 mL of casirivimab or imdevimab. Each single-use 6 mL vial contains 300 mg of casirivimab or imdevimab.
• The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for injection.

What Ronapreve looks like and contents of the pack

Ronapreve is available in cartons that contain 2 vials per package, one vial for each molecule.

Marketing Authorisation Holder

Roche Products Limited
6 Falcon Way, Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Manufacturer

Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Roche Products Ltd.
Tel: +44 (0) 1707 366000

This leaflet was last revised on 20/08/2021