Fibrinogen (Intravenous route)
- Powder for Solution
Uses of This Medicine:
Fibrinogen injection is used to treat acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
This medicine is to be given only by or under the supervision of your doctor or other health care professional.
Before Using This Medicine:
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 fibrinogen injection in children.
Appropriate studies on the relationship of age to the effects of fibrinogen injection have not been performed in the geriatric population. However, 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.
Proper Use of This Medicine:
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.
Precautions While Using This Medicine:
It is very important that your doctor check you closely while you are receiving this medicine to make sure it is working properly. Blood 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 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 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.
This medicine is made from donated 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 of This Medicine:
- Less common
- Incidence not known
- chest pain or discomfort
- difficult or labored breathing
- difficulty with swallowing
- dizziness or lightheadedness
- fast heartbeat
- pain or discomfort in the arms, jaw, back, or neck
- pain, redness, or swelling in the arm or leg
- pains in the chest, groin, or legs, especially in the calves of the legs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- severe headaches of sudden onset
- skin rash, hives, or itching
- sudden loss of coordination
- sudden onset of shortness of breath for no apparent reason
- sudden onset of slurred speech
- sudden vision changes
- tightness in the chest
- unusual tiredness or weakness
- Less common
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:
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:
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.
Last Updated: 9/15/2016