Hympavzi Pre-filled Pen

Hympavzi Pre-filled Pen is used in adults and children who are at least 12 years old with hemophilia A or B (without inhibitors) to help prevent bleeding episodes or reduce how often they happen.

Your doctor will confirm that you can be treated with Hympavzi Pre-filled Pen.

Hympavzi Pre-filled Pen may also be used for reasons not mentioned in this medication guide.

Hympavzi Pre-filled Pen can lead to unwanted blood clots, particularly if you are using other medicines that help your blood clot.

Tell your doctor if you also use factor or non-factor based medicines. Your healthcare provider will give you instructions on how to stop your current treatment when switching to Hympavzi Pre-filled Pen.

Tell your doctor if you have or have ever had:

• a planned surgery;
• serious infection, sepsis (a severe reaction to an infection); or
• recent injury or trauma.

May harm an unborn baby. You may need a pregnancy test to ensure you are not pregnant. Use effective birth control while using Hympavzi Pre-filled Pen and for at least 2 months after your last dose. Tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using Hympavzi Pre-filled Pen.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Hympavzi Pre-filled Pen may cause serious side effects. Call your doctor right away if you experience:

• fast or pounding heartbeats;
• chest or back pain, feeling short of breath, coughing up blood;
• swelling, pain, redness, or skin discoloration in your arms or legs;
• headache, dizziness, fainting, sweating;
• numbness in your face; or
• eye pain or swelling, vision problems.

Common side effects of Hympavzi Pre-filled Pen may include:

• pain, bruising, swelling, redness, itching, irritation, or hardening where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Hympavzi Pre-filled Pen is injected under the skin, usually once every week.

Your healthcare provider will show you where to inject Hympavzi Pre-filled Pen. Do not inject into the same place two times in a row.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Throw away a prefilled syringe after one use, even if there is still medicine left inside.

If you need surgery, tell the surgeon ahead of time that you are using Hympavzi Pre-filled Pen. You will need to stop using the medicine for a short time.

Do not use Hympavzi Pre-filled Pen to treat breakthrough bleeding. You may be given other medicines to treat breakthrough bleeding during treatment with this medicine. Follow your doctor's instructions very carefully.

Call your doctor if your symptoms do not improve, or if they get worse.

Store this medicine in the original container in the refrigerator. Protect from light and do not freeze or shake the medicine.

Do not warm the medicine with hot water, sunlight, or a microwave.

Take the medicine out of the refrigerator and let it reach room temperature before using.

You may store this medicine at room temperature for up to 7 days. Throw the medicine away if not used within 7 days. Do not put it back into the refrigerator.

Use the medicine as soon as you remember, and then return to your regular schedule. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into skin that has scars or stretch marks.

Other drugs may affect Hympavzi Pre-filled Pen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.