"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Proplex-T Patient Information including How Should I Take
In this Article
- What is factor IX complex (Proplex-T)?
- What are the possible side effects of factor IX complex (Proplex-T)?
- What is the most important information I should know about factor IX complex (Proplex-T)?
- What should I discuss with my healthcare provider before using factor IX complex (Proplex-T)?
- How should I use factor IX complex (Proplex-T)?
- What happens if I miss a dose (Proplex-T)?
- What happens if I overdose (Proplex-T)?
- What should I avoid while using factor IX complex (Proplex-T)?
- What other drugs will affect factor IX complex (Proplex-T)?
- Where can I get more information?
What should I discuss with my healthcare provider before using factor IX complex (Proplex-T)?
Before using factor IX complex, your specific blood clotting disorder must be diagnosed as factor IX deficiency.
To make sure factor IX complex is safe for you, tell your doctor if you have liver disease.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether factor IX complex passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Factor IX complex is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.
Your doctor may want you to receive a hepatitis vaccination before you start using factor IX complex.
How should I use factor IX complex (Proplex-T)?
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Factor IX is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.
Always check the strength of the medicine on the label to be sure you are using the correct potency.
Always wash your hands before preparing and giving your injection.
Factor IX must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine. Take the medicine and diluent out of the refrigerator and allow them to reach room temperature before mixing your dose. Do not heat the medicine or diluent.
Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
After mixing, gently swirl the mixture and allow the medicine to completely dissolve. The mixture should be kept at room temperature and must be used within 3 hours. Do not put mixed medicine into the refrigerator.
Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your pharmacist for new medication.
A single dose of factor IX may be enough to control minor bleeding. If you need another dose, wait at least 24 hours before using the medication again.
Check your pulse before and during your injection. If your pulse rate changes, slow or stop the injection until your pulse rate returns to normal.
Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.
If you need any type of surgery or dental work, tell the surgeon or dentist ahead of time that you have hemophilia.
You may need regular medical tests to be sure this medication is not causing harmful effects. Visit your doctor regularly.
Store the medication and the diluent in the refrigerator and do not allow them to freeze.
Throw away any unused medicine or diluent after the expiration date on the label has passed.
Additional Proplex-T Information
Report Problems to the Food and Drug Administration
Find out what women really need.