Fibrinogen, Human

Fibrinogen, a human is used for acute bleeding episodes due to congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Fibrinogen, human is available under the following different brand names: RiaSTAP and Fibryna.

Dosages of Fibrinogen, Human:

Dosage Forms and Strengths

Powder for Injection

• 900-1300mg/vial (RiaSTAP)
• Approximately 1000mg/vial (Fibryna)

Dosage Considerations – Should be Given as Follows:

Fibrinogen Deficiency

Indicated for acute bleeding episodes due to congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia

Adults and children 12 years and older:

RiaSTAP

• Dose (mg/kg body weight) = [Target level (mg/dL) - measured level (mg/dL)]/1.7 (mg/dL per mg/kg body weight) given intravenously (IV)
• If fibrinogen baseline level unknown: 70 mg/kg IV
• Target fibrinogen: 100 mg/dL until hemostasis

Fibryna

• Dose (mg/kg body weight) = [Target level (mg/dL) - measured level (mg/dL)]/1.8 (mg/dL per mg/kg body weight) given IV
• If fibrinogen baseline level unknown: 70 mg/kg IV
• Target fibrinogen level (minor bleeding): 100 mg/dL
• Target fibrinogen level (major bleeding): 150 mg/dL
• Administered additional doses if the plasma fibrinogen level is below the accepted lower limit (80 mg/dL for minor bleeding, 130 mg/dL for major bleeding) of the target level until hemostasis is achieved

Children under 12 years: Safety and efficacy not established

Side effects of fibrinogen, human include:

• Allergic reactions
• Fever
• Headache
• Arterial thrombosis
• Chills
• Deep vein thrombosis (DVT)
• Shortness of breath
• Heart attack
• Nausea
• Rash
• Vomiting
• Blood clots
• Pulmonary embolism (PE)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Fibrinogen, human has no listed severe interactions with other drugs.
• Fibrinogen, human has no listed serious interactions with other drugs.
• Fibrinogen, human has no listed moderate interactions with other drugs.
• Fibrinogen, human has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains fibrinogen, human. Do not take RiaSTAP or Fibryna if you are allergic to fibrinogen, human or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using Fibrinogen, Human?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Fibrinogen, Human?”

Cautions

• Risk of anaphylactic reactions
• Not indicated for dysfibrinogenemia
• Risk of thrombosis in patients with congenital fibrinogen deficiency with or without fibrinogen replacement therapy
• Theoretical risk of bloodborne infectious disease

Pregnancy and Lactation

• Use fibrinogen, human with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• Fibrinogen, human has not been studied in lactating women. Consult your doctor before breastfeeding.