Alphanine SD

Factor IX is a protein that is naturally produced by the body. It helps the blood to form clots to stop bleeding. Injections of Alphanine SD are used to treat Haemophilia B (Christmas disease).

This is a condition where the body does not make enough Factor IX. If you do not have enough of this protein and you become injured, your blood will not form clots like it should and you may bleed into, and damage, your muscles and joints.

Injections of one form of this medication, called Factor IX complex, is also used to treat certain people with Haemophilia A (classical haemophilia), in which the body does not make enough factor VIII and keeps the blood from clotting.

Injections of Ffactor IX complex may be used in patients where the medication used to treat classical haemophilia is no longer effective. Injections of Factor IX complex may also be used for other conditions as determined by your doctor.

The medication your doctor will give you is obtained naturally from human blood or artificially by a man-made process.

Factor IX obtained from human blood has been treated and is not likely to contain harmful viruses such as Hepatitis B virus, Hepatitis C (non-A, non-B) virus or Human Immunodeficiency Virus (HIV), the virus that causes Acquired Immunodeficiency Syndrome (AIDS).

The man-made Factor IX product does not contain these viruses. This medication is available only with your doctor’s prescription.

This product is available in the powder for solution form.

As with all medicines, the risks must be compared to how much a 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: Blood clots may be especially likely to occur in premature and newborn babies, who are normally more sensitive than adults to the effects of injections of Factor IX.
• Geriatric: Up-to-date studies have not shown any problems specific to the elderly that would limit the use of this medication in the elderly population.
• 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: Coagulation Factor IX Recombinant and Factor IX Fc Fusion Protein Recombinant. 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.Factor IX: Studies in women suggest that this medication poses minimal risk to the infant when used 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 or history of medical problems caused by blood clots
  • Liver disease - Risk of bleeding or developing blood clots may be increased.

Alphanine SD may be given at home to patients who do not need to be in a hospital or clinic.

If you are using this medication at home, your doctor will teach you how to prepare and inject the medication. Be sure you understand all the instructions before giving yourself an injection.

To prepare this medication:

• Take the dry medication and the liquid (diluent) out of the refrigerator and bring them to room temperature as directed by your doctor.
• When injecting the diluent into the dry medication, aim the stream of liquid against the wall of the container of dry medication to prevent foaming.
• Swirl the container gently to dissolve the medication. Do not shake the container.

Use this medication immediately. It should not be kept longer than 3 hours after it has been prepared.

A plastic disposable syringe and filter needle must be used with this medication. The medication may stick to the inside of the syringe and you may not receive a full dose.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container or dispose of them as directed by your health care professional.

Dosing

Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication.

The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children. Do not keep outdated medication or medication you no longer need.

Some Factor IX products must be stored in the refrigerator and some may be kept at room temperature for short periods of time. Store this medication as directed by your doctor or the manufacturer.

Before using Alphanine SD, there are some precautions you must take.

If you were recently diagnosed with Haemophilia B, you should receive Hepatitis A and B vaccines to further reduce your risk of getting Hepatitis A or B from Factor IX products.

Your body may eventually build up a defense against this medication. Inform your doctor if this medication seems to be less effective than normal.

It is recommended that you carry an ID stating that you have Haemophilia A or B. If you have any questions about what kind of ID to carry, ask your doctor.

Some side effects that may occur when using Alphanine SD 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.

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