Description
Factor XIII injection is used to prevent bleeding in patients with congenital Factor XIII deficiency.
Factor XIII is a protein that is produced naturally in the body. Corifact™ or Tretten® is a man-made protein produced to replicate the naturally occurring factor XIII in the body. It is used to stop bleeding by helping the blood to clot.
This medicine is to be given only by or under the supervision of your doctor or other health care professional.
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Factor XIII injection in children.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of Factor XIII injection in the geriatric population. Safety and efficacy have not been established.
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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Coagulation Factor VIIa
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:
- Blood clots, history of or
- Stroke, history of—Use with caution. May increase risk for more serious side effects.
Proper Use
A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.
This medicine is usually given about once a month, depending on your recent blood test results.
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.
Precautions
It is very important that your doctor check you or your child closely while you are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious type of 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 cough, difficulty with swallowing, dizziness, a fast heartbeat, lightheadedness or fainting, trouble breathing, chest tightness, swelling in your face, hands, tongue, or throat, a fever, chills, a runny nose or sneezing, itching or hives, or lightheadedness or faintness 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.
Corifact™ is made from human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.
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 or nurse immediately if any of the following side effects occur:
More common
- Bloody nose
- bruise
- collection of blood under the skin
- deep, dark purple bruise
- fever
- itching, pain, redness, or swelling
Incidence not known
- Chest pain
- cough
- dizziness or fainting
- hives
- pain in the chest, groin, or legs, especially the calves
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, scaly, swollen, or peeling areas of the skin
- severe, sudden headache
- shortness of breath
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
- unusual tiredness or weakness
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
- Difficulty with moving
- general feeling of discomfort or illness
- headache
- joint pain
- muscle aches and pains
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.
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