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|Alphanate

Alphanate

Alphanate is used for:

Preventing and controlling bleeding in patients with factor VII deficiency, also known as hemophilia A, including in surgical settings.

Alphanate is a human clotting factor derived from pooled human plasma. It works by increasing the amount of clotting factor VII in the blood, helping the blood form clots and stop bleeding.

Do NOT use Alphanate if:

• you are allergic to any ingredient in Alphanate or to mouse proteins

Contact your doctor or health care provider right away if any of these apply to you.

Before using Alphanate :

Some medical conditions may interact with Alphanate . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Alphanate . However, no specific interactions with Alphanate are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Alphanate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Alphanate :

Use Alphanate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do not shake Alphanate .
• Alphanate is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Alphanate at home, carefully follow the injection procedures taught to you by your health care provider.
• If Alphanate contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• When drawing a dose into a syringe, be sure to follow the procedure demonstrated to you by your doctor to prevent contamination of the vial, syringe, or medicine. Never touch the rubber stopper of the vial or the needle of the syringe with your fingers.
• Carefully check that you have drawn the correct dose before administration.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of this medicine, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Alphanate .

Important safety information:

• Alphanate may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Alphanate . Using Alphanate alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Patients receiving clotting factors sometimes develop antibodies or inhibitors to the medicine. This makes Alphanate less effective. If Alphanate stops working or does not work as well as it has before, contact your doctor immediately for instructions.
• Contact your doctor if you develop a fever, drowsiness, chills, or a runny nose followed by a rash and joint pain 2 weeks later.
• Contact your doctor if you develop several days to weeks of poor appetite, tiredness, or low-grade fever followed by nausea, vomiting, and pain in the stomach; dark urine; or a yellowed complexion.
• LAB TESTS, including factor VIII levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Alphanate is not recommended for use in CHILDREN younger than 16 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Alphanate during pregnancy. If you are or will be breast-feeding while you are using Alphanate , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Alphanate :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Drowsiness; headache; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anemia; chills; difficulty swallowing; dizziness; fever.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Alphanate in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Alphanate may be stored at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), for 2 months. Throw away any unused portion. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Alphanate out of the reach of children and away from pets.

General information:

• If you have any questions about Alphanate , please talk with your doctor, pharmacist, or other health care provider.
• Alphanate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Alphanate . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.