500 mg concentrate for infusion solution, solution
sotrovimab
What Xevudy is and what it is used for
Judy contains the active substance sotrovimab. Sotrovimab is a so-called monoclonal antibody, a type of protein designed to recognize a specific target of the SARS-CoV-2 virus et that causes covid-19.
Judy is used to treat covid‑19 in adults and adolescents (from the age of 12 and weighing at least 40 kg). Xevudy targets the spike protein that the virus uses to bind to cells, blocking the virus from entering the cell and multiplying. By preventing the virus from multiplying in the body, Xevudy can help your body overcome infection and prevent you from becoming seriously ill.
What you need to know before you are given Xevudy
Do not receive treatment with Xevudy
- if you are allergic to sotrovimab or any of the other ingredients of this medicine (listed in section 6).
- Talk to your doctor if you think this applies to you.
Warnings and precautions
Allergic reactions
Xevudy can cause allergic reactions.
- See “Allergic reactions” in section 4.
Infusion-related reactions
Xevudy can cause infusion-related reactions
- See “Infusion-related reactions” in section 4.
Children and young people
Xevudy should not be given to children and adolescents under 12 years of age or who weigh less than 40 kg.
Other medicines and Xevudy
Tell your doctor or pharmacist if you are taking, have recently taken, or might be taking other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before being treated with Xevudy. Your doctor will advise you whether the benefits of treatment with Xevudy outweigh any likely risks to you and your baby.
It is not known whether the ingredients of Xevudy can pass into breast milk. If you are breastfeeding, you must consult your doctor before being treated with Xevudy.
Driving ability and use of machinery
Xevudy is not expected to affect the ability to drive or use machines.
How Xevudy is given
The recommended dose for adults and adolescents (from the age of 12 and weighing at least 40 kg) is:
- 500 mg (a vial ).
This medicine is prepared into a solution and given as a drip ( infusion ) into a vein ( intravenously ) by a doctor or nurse. It takes 30 minutes to give the full dose of a medicine. You will be monitored during and at least 1 hour after you are given the treatment.
“Information for healthcare professionals” below provides instructions for your doctor, pharmacist, or nurse on preparing and administering an infusion with Xevudy.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
Allergic reactions to Xevudy are common and may affect up to 1 in 10 people:
In rare cases, these reactions can be serious ( anaphylaxis ) and may affect up to 1 in 1,000 people ( rare ). If you experience any of the following symptoms after treatment with Xevudy, you may have had an allergic reaction and should seek medical attention immediately :
- skin rash, similar to hives ( hives ) or redness
- itching
- swelling, sometimes of the face or mouth ( angioedema )
- wheezing/wheezing, coughing, or difficulty breathing
- sudden dizziness or feeling weak (may lead to unconsciousness or fall)
Infusion-related reactions
Allergy-like reactions when you receive an infusion are common and may affect up to 1 in 10 people. These usually develop within minutes or hours but may develop up to 24 hours after treatment or later. Possible symptoms are presented below. If you experience any of the following symptoms after treatment with Xevudy, you may have had an infusion-related reaction and should seek medical attention immediately:
- redness
- overindulge
- fever
- breathing difficulties
- rapid heartbeat
- blood pressure drop
Other side effects are
Rare (may affect up to 1 in 100 people)
- shortness of breath ( dyspnea )
How to store Xevudy
Healthcare professionals caring for you are responsible for storing this medicine and disposing of the unused product properly.
Keep this medicine out of the sight and reach of children.
Do not use this medicine if the expiry date has passed. The expiry date is indicated on the label and carton after EXP.
Do not freeze.
Before dilution:
- store in a refrigerator (2 °C– 8 °C).
- stored in the original packaging. Light sensitive.
After dilution, this medicine is intended for immediate use. If immediate administration is not possible after dilution, the diluted solution can be stored at room temperature (up to 25 °C) for up to 6 hours or in a refrigerator (2 °C – 8 °C) for up to 24 hours from the time of dilution until the end of administration one.
Contents of the packaging and other information
Contents declaration
- The active substance is sotrovimab. One vial contains 500 mg sotrovimab in 8 ml concentrate.
- Other ingredients: histidine, histidine monohydrochloride, sucrose, polysorbate 80, methionine, and water for injections.
The appearance of the medicine and the contents of the package
Xevudy is a clear, colorless, or yellow to brown liquid supplied in a single-use vial with a rubber stopper and sealed with a flip-off aluminum cap. Each carton contains one vial.
Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer
GlaxoSmithKline Manufacturing SpA
Strada Provinciale Atlanta, 90,
43056 San Polo di Torrile, Parma
Italy
For further information about this medicinal product, contact the representative of the marketing authorization holder:
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