Commonly Used Brand Name(s)Benefix, Ixinity, Rixubis
Therapeutic ClassificationsAntihemophilic Agent
Factor IX is a protein that is produced naturally in the body. This medicine is a man-made protein produced to replicate the naturally occurring factor IX in the body. It is used to stop bleeding by helping the blood to clot in patients with hemophilia B.
This medicine is to be given only by or under the supervision of your doctor or other health care professional.
A doctor or other trained health professional will give you or your child this medicine. You may also be trained to administer this medicine yourself. This medicine is given through a needle placed in one of your veins.
This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Rixubis™ in children.
Appropriate studies have not been performed on the relationship of age to the effects of Ixinity® in the pediatric population. Safety and efficacy have not been established in children younger than 12 years of age.
Although appropriate studies on the relationship of age to the effects of coagulation factor IX, recombinant injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
|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.|
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.
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.
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 ProblemsTOP
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 protein—Should not be used in patients with these conditions.
- Blood clots or a history of medical problems caused by blood clots or
- Liver disease—Use with caution. These conditions may increase the risk of developing blood clots.
- Disseminated intravascular coagulation (DIC) (blood clotting problem) or
- Fibrinolysis, signs of—Rixubis™ should not be used in patients with these conditions.
- Nephrotic syndrome (kidney disorder)—Use with caution. May make this condition worse.
- Patients with factor IX inhibitors—May increased risk of having an allergic reaction.
It is very important that your doctor check you closely while you or your child are receiving this medicine to make sure it is working properly. Blood and urine tests will be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you or your child have a rash, itching skin, difficulty with swallowing, dizziness, a fast heartbeat, lightheadedness or fainting, restlessness, trouble breathing, swelling in your face, hands, tongue, or throat, or chest pain after you receive the medicine.
This medicine may increase your chance of having blood clotting problems. Tell your doctor right away if you or your child have a sudden or severe headache, problems with vision or speech, chest pain, shortness of breath, or numbness or weakness while you are receiving this medicine.
Call your doctor right away if you or your child start to have bleeding problems, especially if this medicine has worked well for you before.