120 mg / ml + 120 mg / ml solution for injection / infusion
casirivimab and imdevimab
What Ronapreve is and what it is used for
What Ronapreve is
Ronapreve consists of the active substances basiliximab and imdevimab. Kasirivimab and imdevimab are a type of protein called monoclonal antibodies.
What Ronapreve is used for
Ronapreve is used to treat adults and adolescents from 12 years of age who weigh at least 40 kg with covid-19 as:
- do not need oxygen therapy to treat covid-19, and
- have an increased risk of the disease becoming severe, according to the doctor’s assessment.
Ronapreve is used to prevent covid-19 in adults and adolescents from the age of 12 weighing at least 40 kg.
How Ronapreve works
Ronapreve attaches to a protein on the surface of the coronavirus called nail protein. In this way, the virus is prevented from entering your cells and from spreading between cells.
What you need to know before you get Ronapreve
You should not receive 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 cautions
- This medicine may cause allergic reactions or reactions after infusion one or injection one. Signs of such reactions are listed in section 4. Tell your doctor immediately if you get any of these signs or symptoms.
Children and young people
Do not give this medicine to children under 12 years of age or adolescents weighing less than 40 kg.
Other medicines and Ronapreve
Before you are given Ronapreve, you must tell your doctor or nurse who is giving you the medicine if you are taking any other medicines, or have recently taken any other medicines.
After receiving Ronapreve:
- Tell your doctor, nurse, or pharmacist that you have been given this medicine to treat or prevent covid-19.
- Tell your doctor, nurse, or pharmacist that you have been given this medicine if you are to receive a covid-19 vaccine.
Pregnancy and breastfeeding
Tell your doctor or nurse if you are pregnant or could be pregnant.
- The reason for this is that there is not enough information on whether this medicine is safe to use during pregnancy.
- This medicine is given only if the potential benefit of the treatment outweighs the potential risks to the mother and the unborn child.
Tell your doctor or nurse if you are breastfeeding.
- The reason for this is that it is not yet known whether this drug passes into breast milk or whether it may affect the baby or milk production.
- Your doctor will help you decide whether to continue breastfeeding or start treatment with this medicine.
Driving and using machines
This medicine is not expected to have any effect on your ability to drive.
How to get Ronapreve
How much medicine do you give?
The recommended dose for the treatment and prevention of covid-19 in adults and adolescents from 12 years of age weighing at least 40 kg is 600 mg casirivimab and 600 mg imdevimab.
The recommended dose for the continued prevention of covid-19 in adults and adolescents from 12 years of age weighing at least 40 kg is 600 mg basiliximab and 600 mg imdevimab as the first dose and subsequent dose er is 300 mg basiliximab and 300 mg imdevimab once each fourth week.
How is this medicine given?
Kasirivimab and imdevimab can be given together as a single infusion (drip) into a vein for 20 to 30 minutes or as injections given directly one after the other under the skin in different parts of the body, should an infusion delay treatment. Your doctor or nurse will decide how long you need to be monitored after receiving the medicine for any side effects.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
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 after infusion one
Tell your doctor immediately if you get any of the signs of an allergic reaction or reaction listed below or after an infusion. Infusion one may need to be given more slowly, discontinued, or stopped, and you may need other medicines to treat these symptoms. Signs and symptoms of an allergic reaction or infusion-related reactions may be:
Uncommon: may affect up to 1 in 100 people
- nausea
- overindulge
- dizziness
- rash
Rare: may affect up to 1 in 1,000 people
- severe allergic reaction ( anaphylaxis )
- itchy rash
- redness
Reactions after injection subcutaneously (under the skin)
Tell your doctor immediately if you get any of these signs of a reaction after 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 near the injection site
How to store Ronapreve
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 bottle label after EXP. The expiration date is the last day of the specified month.
Ronapreve is stored by healthcare professionals at the hospital or clinic under the following conditions:
- Before use, store unopened Ronapreve concentrate in the refrigerator until the day it is to be used. Before dilution, the concentrated solution should have reached room temperature.
- After dilution, Ronapreve should be used immediately. If necessary, the diluted solution bags can be stored at 2 ° C to 8 ° C for up to 72 hours and at room temperature up to 25 ° C for up to 20 hours. If the solution has been stored in a refrigerator, allow it to reach room temperature for about 30 minutes before administration.
- Filled syringes should be used immediately. If necessary, pre-filled syringes can be stored at 2 ° C to 8 ° C for up to 72 hours, and at room temperature up to 25 ° C for up to 24 hours. If they have been stored in a refrigerator, the syringes should be allowed to warm to room temperature for about 10-15 minutes before administration.
Do not use this medicine if it contains particles or is discolored.
Contents of the packaging and other information
Table of Contents
- The active substances are casirivimab and imdevimab. Each 20 ml multidose vial contains 1332 mg of casirivimab or 1332 mg of imdevimab.
- The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for injections.
What the medicine looks like and the contents of the pack
Ronapreve is a solution for injection/infusion. It is a clear to slightly opalescent and colorless to pale yellow solution and is available in cartons with 2 vials in each pack, one vial for each active substance.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Finland / Finland | Sweden |
| Roche OyPuh / Tel: +358 (0) 10 554 500 | Roche ABTel: +46 (0) 8 726 1200 |