Factor ix albumin fusion protein recombinant (Intravenous)

Factor IX albumin fusion protein recombinant injection is used in patients with hemophilia B (congenital Factor IX deficiency) to control or prevent bleeding episodes, or to prevent bleeding during surgery.

Factor IX is a protein that the body makes naturally. This medicine is a man-made version of the naturally occurring factor IX in the body. It helps stop bleeding by assisting the blood in clotting for patients with hemophilia B.

This medicine should only be given by or under the supervision of your doctor or another health care professional.

It is very important that your doctor check you closely while you or your child are receiving this medicine to make sure it is working properly. Blood and urine tests will be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you or your child have a rash, itching skin, difficulty swallowing, dizziness, a fast heartbeat, lightheadedness or fainting, restlessness, trouble breathing, swelling in your face, hands, tongue, or throat, or chest pain after you receive the medicine.

This medicine may increase your chance of having blood clotting problems. Tell your doctor right away if you or your child have a sudden or severe headache, problems with vision or speech, chest pain, shortness of breath, or numbness or weakness while you are receiving this medicine.

Call your doctor right away if you or your child start to have bleeding problems, especially if this medicine has worked well for you before.

In deciding to use a medicine, you and your doctor must weigh the risks against the potential benefits. The following should be considered for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies to date have not shown any specific problems in children that would limit the use of Idelvion®.

Geriatric

While studies on how age affects the effects of Idelvion® in older adults have not been done, no specific problems for older adults have been documented.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Allergy to hamster protein—Should not be used in patients with these conditions.

• Blood clots or a history of medical issues caused by blood clots or
• Fibrinolysis or
• Liver disease—Use with caution. These conditions may raise the risk of developing blood clots.

• Nephrotic syndrome (kidney disorder)—Use with caution. This may worsen the condition.

• Patients with factor IX inhibitors—May have an increased risk of an allergic reaction.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare

• Cough
• fast heartbeat
• fever
• hives, itching, or rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• redness of the skin
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Headache

Rare

• Dizziness
• skin rash, encrusted, scaly, and oozing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Idelvion

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Hemostatic

A doctor or other trained health professional will give you or your child this medicine. You may also be trained to administer this medicine yourself. This medicine is given through a needle placed in one of your veins.

This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.