Albutrepenonacog Alfa (Factor IX) Injection 1 unit

Brands: IDELVION

Uses

For hemophilia (bleeding disorder).

Instructions

This medicine is given as an IV injection into a vein.

Read and make sure you understand the instructions for measuring dose and using syringe. If you have any questions, talk to your doctor, nurse, or pharmacist.

The medicine needs to be mixed before being injected.

Dilute the powder with the liquid provided. Gently swirl the vial until the medicine is completely dissolved. Do not shake the vial.

Do not dilute the medicine until ready to use.

Always inspect the medicine before using.

The liquid should be clear or light yellow.

Do not use the medicine if it contains any particles or if it has changed color.

Store at room temperature or in refrigerator. Do not freeze. Protect from light.

Do not store above 77 degrees F (25 degrees C).

Do not store in the bathroom.

If your medicine is stored in the refrigerator, take it out of the refrigerator before use to warm to room temperature.

Inject the medicine immediately after mixing.

Injecting cold drug may be uncomfortable.

Speak with your nurse or pharmacist about how long the medicine can be stored safely at room temperature or in the refrigerator before it needs to be discarded.

Never use any medicine that has expired.

Discard any unused, mixed medicine after 4 hours.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

Wash your hands before and after handling this medicine.

You or a family member can be trained to give this medicine at home.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

It is very important that you follow your doctor's instructions for all blood tests.

Cautions

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

Contact your doctor if you notice a change in the amount or darkening of your urine.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

Always carry an ID card or wear a medical alert bracelet indicating your medical condition.

Ask your pharmacist how to properly throw away used needles or syringes.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• feeling of heat or flushing
• fever or chills
• headaches
• pain, redness, swelling near injection
• nausea and vomiting

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• chest pain
• swelling of the legs, feet, and hands
• fast or irregular heart beats
• signs of kidney damage (such as change in urine color or bubbly urine)
• sudden leg pain, swelling, warmth or redness
• pale or blue skin, lips or fingernails
• rapid heartbeat
• shortness of breath

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Extra

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

IMPORTANT NOTE: This document tells you briefly how to take your medicine, but it does not tell you all there is to know about it. Your doctor or pharmacist may give you other documents about your medicine. Please talk to them if you have any questions. Always follow their advice. There is a more complete description of this medicine available in English. Scan this code on your smartphone or tablet or use the web address below. You can also ask your pharmacist for a printout. If you have any questions, please ask your pharmacist. The display and use of this drug information is subject to Terms of Use. Copyright(c) 2023 First Databank, Inc.