Obizur (Antihemophilic factor (recombinant) porcine sequence Intravenous)

Generic name: Antihemophilic Factor (recombinant) Porcine Sequence (an-tye-hee-moe-FIL-ik FAK-tor (ree-KOM-bi-nant) POR-sine SEE-kwen-se)
Drug class: Miscellaneous coagulation modifiers

Usage of Obizur (Antihemophilic factor (recombinant) porcine sequence Intravenous)

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.

Obizur (Antihemophilic factor (recombinant) porcine sequence Intravenous) 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

Chest tightness

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

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.

Before taking Obizur (Antihemophilic factor (recombinant) porcine sequence Intravenous)

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.

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.

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How to use Obizur (Antihemophilic factor (recombinant) porcine sequence Intravenous)

A doctor or other trained health professional will give you this medicine in a hospital or clinic setting. It is given through a needle placed into one of your veins. You may also be taught how to give this medicine at home.

To prepare the medicine using 1 vial and 1 prefilled syringe:

Take the vial and prefilled syringe out of the refrigerator and warm them to room temperature.

Wipe the rubber stopper with an alcohol swab and allow them to dry.

Peel the lid of the vial adapter. Keep the vial on a flat surface. Hold the vial with one hand and using the other hand, connect the syringe into the vial by pushing the tip onto the luer lock (tip) in the center of the vial, turn it clockwise until secured.

On a flat surface, place the vial adapter over the vial and push the filter spike of the adapter into the center of the vial's rubber until the clear plastic cap snaps into the vial.

Slowly push down on the plunger to inject all liquid from the syringe into the vial. Swirl the bottle gently to dissolve the medicine.

Check the mixture to make sure it is clear and colorless. Do not use the medicine if you can see particles in it.

Gently unscrew the syringe from the vial by turning it counter clockwise.

Give the injection as directed by your doctor.

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.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Use the mixture within 3 hours after it is prepared. Throw away unused mixture within 3 hours after mixing.

Warnings

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 are needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you get the injection.

Disclaimer

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