Frequently Asked Questions

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1. What are the possible side effects of HYMPAVZI?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Hympavzi may cause a rash (seen in up to 1 in 100 people), which may be severe. Contact your doctor immediately if you have a severe rash; some rashes may be serious. Do not use Hympavzi again until you have talked with your doctor about your rash.

Hympavzi may cause blood clots (thromboembolism) (seen in up to 1 in 100 people). Stop using Hympavzi and contact your doctor immediately if you notice any signs or symptoms of a possible blood clot. Please refer to question 2 “What you need to know before you use Hympavzi” for a list of possible symptoms of a blood clot (thromboembolic event).

Other side effects

Tell your doctor, nurse or pharmacist if you get any of these side effects.

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

• a reaction in the area where the injection is given (including itching, swelling, redness, pain, bruising, hardening)

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Common (may affect up to 1 in 10 people)

• Headache
• High blood pressure
• Itching (pruritus)

2. What should I know about blood clots (thomboembolic events) when using HYMPAVZI?

Hympavzi increases how easily your blood clots and may cause blood clots in the blood vessels (so called thromboembolic events. Blood clots may be life threatening. Tell your doctor if you have a history of blood clots or if you have a condition which increases your risk of blood clots. This includes if you:

• have a history of coronary artery disease (heart disease caused by narrowing or blockage of blood vessels supplying the heart muscle)
• have a history of ischaemic disease (reduced blood flow due to narrowed or blocked blood vessels)
• have a history of blood clots in veins or arteries
• have a genetic condition that increases your risk for blood clotting (such as Factor V Leiden)
• are bedridden, immobilised or off your feet for a long time
• are obese (overweight)
• are a smoker
• currently have serious infections
• currently have sepsis (blood poisoning)
• currently have trauma or crush injuries
• currently have cancer

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Stop using Hympavzi, and talk to a doctor immediately if you notice any symptoms of a possible blood clot including the following side effects:

3. Should I use HYMPAVZI for breakthrough bleeds?

Do not use HYMPAVZI to treat breakthrough bleeding.

HYMPAVZI is a routine prophylaxis treatment only. You may need to use other factor VIII or factor IX products to treat episodes of breakthrough bleeding while using HYMPAVZI. Carefully follow your healthcare provider’s instructions regarding when and how to use these factor VIII or factor IX products while using HYMPAVZI.

4. What should I do if I forget to use HYMPAVZI?

If you forget your scheduled dose, inject the forgotten dose as soon as possible before the day of the next scheduled dose. Then continue to inject the medicine as scheduled. Do not inject a double dose to make up for a forgotten dose. If you forget two scheduled doses in a row (that is if it has been more than 13 days since your last injection), contact your doctor as soon as possible and ask what to do.

If you are not sure what to do, ask your doctor, pharmacist or nurse.

5. What should I do if I use more HYMPAVZI than I should?

6. What happens if I stop using HYMPAVZI?

7. What are symptoms of an allergic reaction and what should I do if I get one?

Symptoms of allergic reaction have been seen in people using HYMPAVZI.

Stop using HYMPAVZI and get medical help right away if you get any symptoms of a possible severe allergic reaction including the following:

• rash, hives, generalised itching
• swelling of the face, lips, tongue or throat
• difficulty breathing or swallowing
• dizziness

8. What should I do in cases of pregnancy, contraception and breast-feeding?

If you are able to get pregnant, you should use an effective method of contraception (birth control) during treatment with HYMPAVZI and for at least 1 month after the last injection.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Your doctor will consider the benefit of you using HYMPAVZI against the risk to your unborn baby.

If you are breast-feeding, ask your doctor for advice on whether to stop breast-feeding or stop using HYMPAVZI. Your doctor will consider the benefit of you using HYMPAVZI against the benefits for your nursing infant.