Obizur

Obizur is a prescription medication used to treat bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVIII] deficiency).

Obizur is an antihemophilic factor that temporarily replaced substances naturally produced by the body to control bleeding.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

The most common side effect of Obizur is the development of inhibitors to Obizur’s active ingredient.

Obizur is a prescription medication used to treat bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVIII] deficiency).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Baxter Healthcare Corporation

Serious side effects have been reported with Obizur. See the “Obizur Precautions” section.

The most common side effects of Obizur is the development of inhibitors to Obizur’s active ingredient. If inhibitors develop, there will be a lack of clinical response to Obizur and other therapeutic options will need to be considered.

This is not a complete list of Obizur side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No Obizur drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Obizur including the following:

• Hypersensitivity reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of hypersensitivity reactions.
  • swelling of the face, lips, or tongue
  • feeling of tightness in the chest
  • shortness of breath
  • decreased blood pressure
  • wheezing
  • rashes or hives
  • itching

Do not take Obizur if you:

• are allergic to Obizur or to any of its ingredients, including hamster protein

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Obizur, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Obizur, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Obizuror to any of its ingredients, including hamster protein
• have congenital hemophilia A or von Willebrand disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Obizur falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Obizur should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Obizur crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Obizur.

Take Obizur exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional. Dose and frequency will be adjusted on the basis of the severity and location of acute bleeding episodes and patient’s clinical condition.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight

The dose and frequency of Obizur will be adjusted on the basis of the severity and location of acute bleeding episodes and patient’s clinical condition.

If you take too much Obizur, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Obizur is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Obizur at refrigeration temperature of 2° to 8°C [36° to 46°F]. Do not freeze.
• Store vials in the original package to protect from light.
• Do not use beyond the expiration date printed on the carton or vial.
• Use Obizur within 3 hours after reconstitution. Discard any unused reconstituted product if not used within 3 hours after reconstitution.
• Do not use Obizur if the reconstituted solution is cloudy or has particulate matter.