Alphanate

Alphanate is a combination medication used to treat serious bleeding episodes in patients with a bleeding disorder called Von Willebrand disease (VWD). The bleeding episode may be related to an injury or surgical procedure. This medication may also be used to stop bleeding in patients with Hemophilia A.

Antihemophilic factor VIII and Von Willebrand factor are normally produced by the body. They help blood to clot when an injury occurs. Patients with VWD or hemophilia A do not make enough of these substances to prevent bleeding, so this product is given to increase these levels in the blood.

This medication is only available with your doctor’s prescription. This medication is available in the powder for solution form.

As with all medicines, the risks of using 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 in children 5-16 years of age.
• Geriatric: No appropriate studies have been performed on the relationship of age to the effects of this medication in elderly patients. Safety and efficacy have not been established.
• 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: 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
  • Deep vein thrombosis (blood clot in leg)
  • Pulmonary embolism (blood clot in lung)
  • Stroke - Use with caution. May make these conditions worse.

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

This medication 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.

Your dose may change based on where you are bleeding. Do not use more or less medication than your doctor tells you to.

It is very important that your doctor checks in with you often while you are receiving Alphanate to make sure that it is working properly.

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 cough
• Difficulty swallowing
• Dizziness
• Fast heartbeat (tachycardia)
• Wheezing
• Shortness of breath
• Difficulty breathing
• Chest tightness
• Swelling of the hands, face, tongue or throat
• Fever
• Chills
• Runny nose or sneezing
• Itching or hives
• Lightheadedness or faintness after receiving the injection

This medication may increase your chance of blood clots.

Inform your doctor immediately if you have a sudden or a severe headache, problems with speech or vision, chest pain, shortness of breath, numbness or weakness with this medication.

This medication is made from donated human blood. Some human blood products have transmitted certain viruses to people who receive them, however, the risk of this is very low and has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses and testing during the manufacturing process.

Discuss any concerns with your doctor.

Alphanate may produce unwanted effects 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:

More Common

• Difficulty with breathing or swallowing
• Dizziness
• Fast heartbeat (tachycardia)
• Fever
• Hives or welts
• Itching
• Nausea
• Reddening of the skin, especially around the ears
• Shortness of breath
• Skin rash
• Swelling of the face, throat, or tongue
• Unusual fatigue or weakness

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.