Description
Antihemophilic factor (recombinant) pegylated-aucl injection is used to treat, control, prevent, and decrease the frequency of bleeding episodes, and prevent bleeding during surgery in patients with hemophilia A (congenital Factor VIII deficiency).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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) pegylated-aucl injection in children younger than 2 years of age. Safety and efficacy have not been established. Use is not recommended for children younger than 7 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of antihemophilic factor (recombinant) pegylated-aucl injection in the elderly.
Breastfeeding
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.
Drug Interactions
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.
Other Interactions
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 polyethylene glycol (PEG), or mouse or hamster proteins, history of or
- von Willebrand disease (blood clotting disorder)—Should not be used in patients with these conditions.
Proper Use
A doctor or other trained health professional will give you this medicine. This medicine is given through an IV catheter that is placed into one of your veins.
This medicine may also be given at home to patients who do not need to be in a hospital or clinic. If you or your child is using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Make sure you understand all of the instructions before giving yourself an injection. Your dose may change based on where you are bleeding. Do not use more medicine or use it more often than your doctor tells you to.
This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
To use:
- Allow the vial and diluent syringe to warm up to room temperature.
- Remove the cap from the vial. Clean the rubber stopper with an alcohol swab.
- Peel off the paper cover on the vial adapter plastic housing. Do not remove the adapter from the plastic housing. Place over the vial and firmly press down. The adapter will snap over the vial cap. Do not remove the adapter housing.
- Attach the prefilled syringe to the vial adapter. Hold the plunger rod by the top plate. Do not touch the sides and thread of the plunger rod. Attach the plunger rod by turning it clockwise. Inject the diluent slowly by pushing down on the plunger rod.
- Swirl the vial gently to dissolve the medicine. Do not shake. Do not use it if the mixture is cloudy or has particles in it.
- While holding the plunger down, turn the vial upside down. Tilt the vial to the side and back to make sure all mixture has been drawn toward the opening. Detach the syringe by turning it counter-clockwise.
- Give the injection as directed by your doctor. Follow instructions for the infusion set provided.
- If you are using more than one bottle of medicine for your dose, prepare the second bottle the same way. Add the mixture from the second bottle to the same syringe.
Use the mixture within 3 hours after it is prepared.
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 and children 7 years of age and older—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your doctor.
- Children younger than 7 years of age—Use is not recommended.
- For bleeding episodes in patients with hemophilia A:
Missed Dose
Call your doctor or pharmacist for instructions.
Storage
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.
Store in the refrigerator. Do not freeze.
You may store the medicine at room temperature for up to 6 months. Do not put it back in the refrigerator. Throw the medicine away after 6 months.
Precautions
It is very important that your doctor check your or your child's progress closely while receiving this medicine to make sure it is working properly. Blood tests will be needed to check for unwanted effects.
This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
Call your doctor right away if this medicine does not prevent or stop bleeding as expected.
Tell your doctor if you have plans to travel. You should bring enough medicine for your treatment during this time.
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:
Less common
- Chest tightness
- fast heartbeat
- fever
- hives, itching, skin rash
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- redness of the skin
- swelling of the eyelids, face, lips, hands, or feet
- trouble breathing or swallowing
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Cough
- headache
Less common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- change or loss of taste
- dizziness
- feeling of warmth
- nausea
- stomach pain
- trouble sleeping
- vomiting
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.
DRG-20444008
