

ALPROLIX®
Safety
Bleed protection with a proven safety profile
Most common side effects (≥1%):
1.3%
Previously treated adults, adolescents, and kids
- Headache
- Mouth numbness or tingling
- Urinary blockage
3%
Previously untreated kids
- Injection site redness and irritation
- Allergic reactions
- Factor IX inhibitors

Contraindications
ALPROLIX should not be used by people who have a known history of allergic reactions, including anaphylaxis, to the product or its inactive ingredients

Allergic reactions
Allergic reactions may occur with ALPROLIX. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: hives, chest tightness, wheezing, difficulty breathing, or swelling of the face

Formation of inhibitors
Your body can also make antibodies called “inhibitors” against ALPROLIX, which may stop ALPROLIX from working properly. Your healthcare provider should continue to monitor you for inhibitors with blood tests. If you have developed inhibitors with the use of another factor IX therapy, you may be at an increased risk of anaphylaxis with the use of ALPROLIX

Blood clots
ALPROLIX may increase the risk of formation of abnormal blood clots in your body, especially if you have risk factors for developing blood clots. Call your healthcare provider or seek emergency care if you have symptoms of a possible abnormal blood clot, which may include chest pain, difficulty breathing, unexpected swelling of an arm or leg with or without pain or tenderness

Tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have any allergies and all your medical conditions, including if you are pregnant or planning to become pregnant, are breastfeeding, or have been told you have inhibitors (antibodies) to Factor IX.
Common side effects of ALPROLIX include headache, abnormal sensation in the mouth, and pain in your side with blood in your urine, which may be a sign of clot formation in the urinary collecting system.
Allergic reactions may occur with ALPROLIX. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: hives, chest tightness, wheezing, difficulty breathing, or swelling of the face.
Redness to the skin at the injection site may also occur.
ALPROLIX may increase the risk of formation of abnormal blood clots in your body, especially if you have risk factors for developing blood clots. Call your healthcare provider or seek emergency care if you have symptoms of a possible abnormal blood clot, which may include: chest pain, difficulty breathing, unexpected swelling of an arm or leg with or without pain or tenderness.
Your body can also make antibodies called "inhibitors" against ALPROLIX, which may stop ALPROLIX from working properly.
These are not all of the possible side effects of ALPROLIX. Talk to your healthcare provider right away about any side effect that bothers you or does not go away, or if bleeding is not controlled using ALPROLIX.