Fibrinogen

Get emergency medical help if you have any of these signs of an allergic reaction: hives, rash; tightness in your chest; wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Stop using fibrinogen and call your doctor at once if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs; or
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Common side effects may include:

• fever; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You should not use fibrinogen if you are allergic to it, or if you have ever had a severe allergic reaction.

You should not use fibrinogen if you are allergic to it, or if you have ever had a severe allergic reaction.

To make sure fibrinogen is safe for you, tell your doctor if you have:

• a history of stroke or blood clot.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether fibrinogen passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Fibrinogen 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.

Get emergency medical help if you have signs of an allergic reaction: hives, rash; tightness in your chest; wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Stop using fibrinogen and call your doctor at once if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs; or

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Common side effects may include:

• fever; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Congenital Fibrinogen Deficiency:

Dose when fibrinogen level is unknown:
Dose (mg/kg body weight) = [Target level (mg/dL) - measured level (mg/dL)]/1.7 (mg/dL per mg/kg body weight)

Dose when fibrinogen level is unknown:
Dose = 70 mg/kg body weight.

The injection rate should not exceed 5 mL per minute.

Dose when fibrinogen level is unknown:
Dose (mg/kg body weight) = [Target level (mg/dL) - measured level (mg/dL)]/1.7 (mg/dL per mg/kg body weight)

Dose when fibrinogen level is unknown:
Dose = 70 mg/kg body weight.

The injection rate should not exceed 5 mL per minute.

Fibrinogen has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Fibrinogen is only recommended for use during pregnancy when benefit outweighs risk.