Alprolix

Alprolix is used in patients with Hemophilia B (congenital Factor IX deficienty) to control or prevent bleeding episodes or prevent bleeding during surgery.

Factor IX is a protein that is naturally produced by the body. Alprolix is a man-made protein produced to replicate the naturally occuring factor IX in the body. It is used to stop bleeding by helping the blood to clot in patients with Hemophilia B.

This medication is only to be given by or under the supervision of your doctor.

This product is available in the following form:

• Powder for solution

As with all medicines, the risks of using Alprolix must be compared to how much this medication will help you. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

Allergies

Inform your doctor if you have ever had an allergic reaction to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.

Pediatric

Up-to-date pediatric appropriate studies have not indicated any problems that would limit the use of this medication.

Geriatric

No appropriate studies have been performed on the relationship of age to the effects of this medication in the elderly. However, no geriatric-specific problems have been documented to date.

Pregnancy

This medication is listed as Pregnancy Category C. This means that animal studies have shown an adverse effect and no studies have been performed on pregnant women OR there are no adequate studies on pregnant animals and pregnant women.

Breastfeeding

There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.

Drug Interactions

Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any prescription or over the counter medications.

Other Interactions

Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.

Other medical problems

Pre-existing medical problems may affect the use of this medication.

Be sure to tell your doctor if you have any other medical problems, especially:

• Blood clots - Use with caution. These conditions may increase the risk of developing blood clots.
• Patients with factor IX inhibitors - May increase the risk of allergic reaction.

A nurse or other trained health professional will give you Alprolix. It is placed in one of your veins through a needle (intravenously).

This medication comes with a patient information brochure. It is very important that you read this information. Ask your doctor if you have any questions.

It is very important that your doctor checks in with the you often while you are receiving Alprolix to make sure that it is working properly. Blood tests will be needed to check for unwanted effects.

This medication may cause a serious type of allergic reaction called anaphylaxis, which is life-threatening and requires immediate emergency medical help.

Inform your doctor immediately if you have:

• a rash
• itching skin
• difficulty swallowing
• dizziness
• fast heartbeat (tachycardia)
• lightheadedness or fainting (syncope)
• restlessness
• difficulty breathing
• swelling in the hands, face, tongue or throat
• chest pain after receiving this medication

This medication may increase your chance of blood clotting issues.

Inform your doctor immediately if you have:

• a sudden or severe headache
• problems with vision or speech
• chest pain
• shortness of breath
• numbness or weakness while you are receiving this medication

Inform your doctor if this medication does not prevent or stop bleeding as expected.

Alprolix may produce unwanted affects along with the intended effects. Although not all of these side-effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if you experience any of the following side-effects:

Rare

• Dizziness, faintness or lightheadedness when getting up suddenly from a lying or sitting position.
• Fast, irregular, pounding or racing heartbeat (tachycardia, arrhythmias, palpitations)
• Sweating

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

Less Common

• Headache

Rare

• Burning, itching, numbness, prickling or tingling feelings in the mouth
• Change or loss of taste
• Pain or tenderness in the injections site

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

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