Winrevair® 60 mg powder and solvent for solution for injection (1 vial - pack)

• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to sotatercept or any of the other ingredients of this medicine (listed in section 6).
• If the number of platelets in your blood is repeatedly very low.

Winrevair can increase the levels of haemoglobin in your blood, decrease the number of platelets in your blood, or increase the risk of serious bleeding.

Talk to your doctor or pharmacist before and while using Winrevair if you have:

• high levels of haemoglobin in your blood (a protein in red blood cells that carries oxygen).

This can increase the chance of a blood clot forming that can block a blood vessel. Your doctor will check haemoglobin levels with regular blood tests before each of your first 5 doses of Winrevair, or longer before each dose if needed, and regularly while you are using this medicine.

• low number of platelets in your blood (blood cells that help blood to clot).
  This can cause easy bruising, continued bleeding from cuts and nosebleeds. Your doctor will check your number of platelets with regular blood tests before each of your first 5 doses of Winrevair, or longer before each dose if needed, and regularly while you are using this medicine. In case the number of platelets in your blood is repeatedly very low, your doctor will not start your treatment.
• signs and symptoms of serious bleeding:
  • persistent headache
  • nausea
  • weakness
  • black or tarry stool
  • blood in your stool
  • bright red blood from vomiting or coughing
  • persistent abdominal cramps
  • severe back pain
  • abnormally heavy menstrual bleeding

These are signs and symptoms of serious bleeding that can happen if you take Winrevair and are more likely to happen if you take Winrevair with certain medicines. Your doctor will inform you on how to recognize them. Talk to your doctor if you notice any of these signs or symptoms. Serious bleeding could lead to hospitalisation, need for blood transfusion or other treatments, and could be life-threatening.

Do not give this medicine to children and adolescents below the age of 18 years. It is not known if this medicine is safe and works in people under 18 years of age.

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

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

Pregnancy:

Winrevair may harm your unborn baby.

This medicine is not recommended during pregnancy. Your doctor should do a pregnancy test before you start your treatment and you should use effective birth control (contraception) during your treatment and for at least 4 months after the last dose of Winrevair. Ask your doctor or pharmacist about birth control methods that would work well for you.

Tell your doctor immediately if you become pregnant or think you may be pregnant while using this medicine.

Breast-feeding:

It is not known whether Winrevair passes into breast milk. Do not breastfeed during your treatment and for at least 4 months after the last dose of Winrevair. Talk to your doctor or pharmacist about the best way to feed your baby.

Fertility:

Winrevair may decrease female and male fertility.

It is unlikely that this medicine will affect your ability to drive and use machines.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.

This medicine contains 0.20 mg of polysorbate 80 in each mL of reconstituted solution. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

• Your dose of Winrevair depends on your body weight and blood tests. You will begin your treatment with a dose of 0.3 mg/kg, which will be increased to 0.7 mg/kg.
• Your doctor will tell you how much Winrevair to take and when to take it. It is very important that you follow the instructions from your doctor.
• Do not take Winrevair more often than your doctor tells you to. If you are not sure when to take Winrevair, talk to your doctor or pharmacist.

• Before each of your first 5 doses, or longer before each dose if needed, and regularly while taking Winrevair, your doctor will do blood tests. This is so your doctor can monitor you and find the best dose for you.
• Your doctor may change your dose, delay treatment, or stop treatment depending on how you respond to Winrevair.

You will take Winrevair, as an injection just under your skin (subcutaneous (SC)) only in these injection sites:

• stomach (abdomen), at least 5 cm away from the belly button, or
• upper thigh

Note: In case your doctor or nurse is giving you the injection, they may also use your upper arm as injection site as they have received training in how to do it properly.

• If your doctor decides that you or your caregiver can give the injections of Winrevair at home, you or your caregiver should receive training. This training will teach you the right way to prepare and inject Winrevair. Do not try to inject Winrevair until your doctor has shown you how to do it the right way.
• Your doctor will tell you how much Winrevair to take and when to take it.
• Read the separate “Instructions for Use” booklet that comes with Winrevair.

If you use less or more Winrevair than you should, talk to your doctor or pharmacist.

If you miss your prescribed dose of Winrevair and it is within 3 days of when you should have taken it, take it immediately and follow your original schedule for your next dose. If you miss your prescribed dose of Winrevair and it is more than 3 days of when you should have taken it, your injection schedule has to be changed, talk to your doctor or pharmacist for guidance.

Do not change your dose or stop taking Winrevair without talking to your doctor.

Talk to your doctor or pharmacist immediately if you notice:

• Easy bruising, prolonged bleeding from cuts and nosebleeds. These could be signs of a low number of platelets (thrombocytopenia). This will be shown in your blood tests.

In addition, your doctor will do regular blood tests to notice whether you have:

• High levels of haemoglobin.

The serious side effects above may affect more than 1 in 10 people.

Talk to your doctor or pharmacist if you notice any of the following:

Very common (may affect more than 1 in 10 people):

• Headache
• Nosebleeds (epistaxis)
• Spider veins or tiny blood vessels that look like pink or red lines on the skin (telangiectasia)
• Diarrhoea
• Dizziness
• Skin rash

Common (may affect up to 1 in 10 people):

• High blood pressure
• Redness of the skin
• Bleeding gums
• Itching at the injection site

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 via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is sotatercept. Each vial contains 45 mg or 60 mg of sotatercept. After reconstitution, each mL of solution contains 50 mg of sotatercept.
• The other ingredients are
  • In the powder: citric acid monohydrate (E330), sodium citrate (E331) (see section 2 “Winrevair contains sodium”), polysorbate 80 (E433) (see section 2 “Winrevair contains polysorbate 80”) and sucrose.
  • In the solvent: water for injections.

Winrevair is a powder and solvent for solution for injection (powder for injection). The white to off-white powder comes in a 2 mL glass vial containing 45 mg or 60 mg of sotatercept. The solvent is a clear and colourless water for injections in a prefilled syringe of 1 mL or 1.3 mL.

Winrevair 45 mg is available in:

• Pack containing 1 vial 45 mg (powder), 1 prefilled syringe 1.0 mL (solvent), 1 vial adaptor, 1 dosing syringe, 1 needle and 4 alcohol wipes.
• Pack containing 2 vials 45 mg (powder), 2 prefilled syringes 1.0 mL (solvent), 2 vial adaptors, 1 dosing syringe, 1 needle and 8 alcohol wipes.

Winrevair 60 mg is available in:

• Pack containing 1 vial 60 mg (powder), 1 prefilled syringe 1.3 mL (solvent), 1 vial adaptor, 1 dosing syringe, 1 needle and 4 alcohol wipes.
• Pack containing 2 vials 60 mg (powder), 2 prefilled syringes 1.3 mL (solvent), 2 vial adaptors, 1 dosing syringe, 1 needle and 8 alcohol wipes.

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