Type of medicine: antihemophilic factor
Generic and brand names: factor VIII; antihemophilic factor (human or recombinant); ADVATE; Alphanate; Helixate FS; Hemofil M; Koate-DVI; Kogenate FS; Monarc-M; Monoclate-P; Humate-P; antihemophilic factor/von Willebrand Factor Complex; Recombinate; Xyntha
This medicine is a clotting factor (factor VIII). It helps people with hemophilia A prevent and control bleeding episodes. It may also be given to people with hemophilia A before surgery to prevent bleeding.
Humate-P and Alphanate may also be used to treat von Willebrand disease.
Before taking this medicine, tell your healthcare provider if you have ever had an allergic reaction to any medicine or to latex rubber.
Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.
These infusions may be given by your healthcare provider. You may be able to infuse this medicine yourself or with the help of someone at home. Your healthcare provider or a hemophilia center can teach you the proper technique for self-infusion. If you have not been taught how to use this medicine, do not attempt to self-infuse. Once you learn how to self-infuse, you can follow the instructions in the medicine package.
The number of infusions you need depends on how severe your bleeding is and how quickly it stops.
You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.
Some forms of this medicine are made from human blood. It is tested for viruses such as hepatitis. The risk of getting an infection from this medicine is very low, but it is still possible. Talk with your healthcare provider about this.
If your bleeding is not controlled after you receive this medicine, contact your healthcare provider immediately.
If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Wear some form of identification stating that you take this medicine (such as a Medic Alert bracelet).
Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.
Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).
Serious (report these to your healthcare provider right away): Sudden headache, chest or back pain, wheezing or trouble breathing, dark urine, weak pulse, feeling lightheaded or dizzy when you stand, chest or upper abdominal pain, yellowing of eyes or skin, tingling in hands or feet.
Other: Fever, headache, irritation at spot where the shot was given, swelling of your hands or feet, strange taste in the mouth, cold shivers, hot flushes, diarrhea, sweating, nausea, weakness, tiredness, blurred vision, swelling of joints.
No significant drug interactions have been reported.
If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.
Store the medicine without the diluent added to it in the refrigerator. Do not let it freeze. After you add the diluent to the medicine, use it within 3 hours. Do not refrigerate the medicine after you add the diluent. Any medicine left in the vial at the end of your infusion should be discarded, and you should properly dispose of the needle and syringe as well.
Once the medicine is kept at room temperature, it should remain so until infused. Do not put it back in the refrigerator and do not use it past the specified period of time according to the package instructions. Do not use the medicine after the expiration date printed on the vial. Protect it from heat, high humidity, and bright light.
If Alphanate or Advate, the medicine may be kept at room temperature for up to 2 months.
If Hemofil M, Humate P, Monarc-M, or Recombinate, the medicine may be kept at room temperature until the expiration date on the vial.
If Helixate FS, Kogenate FS, ReFacto, or Xyntha, the medicine may be kept at room temperature for up to 3 months.
If Koate-DVI or Monoclate P, the medicine may be kept at room temperature for up to 6 months.
This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.
Keep all medicines out of the reach of children.
Do not share medicines with other people.
