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Obizur (Intravenous)

Generic Name: antihemophilic factor (RECOMBINANT) PORCINE SEQUENCE (Intravenous route)

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Commonly used brand name(s)

In the U.S.

  • Obizur

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Antihemophilic Agent

Uses For Obizur

Antihemophilic factor (AHF) recombinant porcine sequence injection is used to treat serious bleeding episodes in patients with acquired hemophilia A. The bleeding episode may be due to an injury or surgery. Antihemophilic factor recombinant porcine sequence is a manmade protein to replace the AHF produced naturally in the body to help form blood clots to stop bleeding.

Acquired Hemophilia A, also called classic hemophilia, is a condition that develops where the body does not make enough AHF. If you do not have enough AHF and you become injured, your blood will not form clots properly. You might bleed into and damage your muscles and joints. AHF injection is given to increase the levels of AHF in the blood.

This medicine is available only with your doctor's prescription.

Before Using Obizur

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of antihemophilic factor recombinant porcine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of antihemophilic factor recombinant porcine injection in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to hamster proteins, history of or
  • Congenital (from birth) Hemophilia A or
  • von Willebrand disease (a different blood clotting disorder)—Should not be used in patients with these conditions.

Proper Use of Obizur

A doctor or other trained health professional will give you this medicine in a hospital or clinic setting. This medicine is given through a needle placed in one of your veins.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form (injection):
    • For bleeding episodes in patients with hemophilia A:
      • Adults—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your doctor.
      • Children—Use and dose must be determined by your doctor.

Precautions While Using Obizur

It is very important that your doctor check you closely while you are receiving this medicine to make sure it is working properly. Blood tests will be needed.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, lightheadedness or dizziness, or any swelling of your hands, face, or mouth after you receive this medicine.

Obizur Side Effects

Along with its needed effects, a medicine may cause some unwanted 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 any of the following side effects occur:

Incidence not known
  • Confusion
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast heartbeat
  • hives or welts, itching, or skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • sweating
  • tightness in the chest
  • unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Side effects (in more detail)

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