fibrinogen, human (Rx)

Brand and Other Names:RiaSTAP, Fibryga
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 900-1300mg/vial (RiaSTAP)
  • ~1000mg/vial (Fibryga)

Fibrinogen Deficiency

Indicated for on-demand treatment of acute bleeding episodes due to congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia

RiaSTAP

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

Fibryga

  • 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

Dosage Forms & Strengths

powder for injection

  • 900-1300mg/vial (RiaSTAP)
  • ~1000mg/vial (Fibryga)

Fibrinogen Deficiency

Indicated for on-demand treatment of acute bleeding episodes due to congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia, in adults and children

Faster clearance and shorter half-life observed in children aged 1 to <12 years compared with adults and adolescents; higher may be required in this age group

RiaSTAP

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

Fibryga

  • ≥12 years: Dose (mg/kg body weight) = [Target level (mg/dL) - measured level (mg/dL)]/1.8 (mg/dL per mg/kg body weight) given IV
  • <12 years: Dose (mg/kg body weight) = [Target level (mg/dL) - measured level (mg/dL)]/1.4 (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
Next:

Adverse Effects

Frequency Not Defined

Allergic reactions

Fever

Headache

Arterial thrombosis

Chills

DVT

Dyspnea

MI

Nausea

Rash

Vomiting

Thromboembolism

Thrombocytosis

Pulmonary embolism

Previous
Next:

Warnings

Contraindications

Hypersensitivity

Cautions

Risk of anaphylactic reactions

Not indicated for dysfibrinogenemia

Risk of thrombosis in patients with congenital fibrinogen deficiency with or without fibrinogen replacement therapy

Although risk is rare, products from human plasma may contain infectious agents

Previous
Next:

Pregnancy & Lactation

Pregnancy

Data are not available regard use in pregnant females

Animal reproduction studies have not been conducted

Unknown if it can cause fetal harm

Lactation

Data are not available regarding the presence in human milk, effect on breastfed infants, or effects on milk production

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Previous
Next:

Pharmacology

Mechanism of Action

Fibrinogen concentrate pooled from human plasma replaces this protein in patients with congenital fibrinogen deficiency

Absorption

Peak plasma concentration

  • RiaSTAP: 140 mg/dL (70 mg/kg x 1)
  • Fibryga
    • Adults and adolescents: 139 mg/dL
    • Children aged 6 to <12 years: 112.4 mg/dL
    • Children aged <6 years: 99 mg/dL

AUC (Fibryga)

  • Adults and adolescents: 124.8 mg·hr/mL; 113.7 mg·hr/mL (70 mg/kg x1)
  • Children aged 6 to <12 years: 102.1 mg·hr/mL; 97.2 mg·hr/mL (70 mg/kg x1)
  • Children aged <6 years: 83.8 mg·hr/mL; 79.8 mg·hr/mL (70 mg/kg x1)

Distribution

Vd

  • RiaSTAT: 45-60 mL/kg
  • Fibryga
    • Adults and adolescents: 70.2 mL/kg
    • Children aged 6 to <12 years: 67.2 mL/kg
    • Children aged <6 years: 68.6 mL/kg

Elimination

Half-life

  • RiaSTAP: 61-97 hr; may be decreased in children aged <16 yr
  • Fibryga
    • Adults and adolescents: 75.9 hr
    • Children aged 6 to <12 years: 66.1 hr
    • Children aged <6 years: 56.9 hr

Clearance (Fibryga)

  • Adults and adolescents: 0.7 mL/hr kg
  • Children aged 6 to <12 years: 0.7 mL/hr kg
  • Children aged <6 years: 0.9 mL/hr kg
Previous
Next:

Administration

IV Preparation

Warm both the powder and sterile water for injection (SWI) in their closed bottles to room temperature; this temperature should be maintained during reconstitution

If a water bath is used for warming, prevent water from coming into contact with the rubber stoppers or the caps of the bottles; water bath should not exceed 37°C (98°F)

Reconstitute lyophilized powder with 50 mL SWI (see prescribing information for technique)

Gently swirl vial to dissolve (do not shake); should result in a colorless solution

RiaSTAP: Filter reconstituted solution with 17-mcron filter into an appropriate syringe before administering

IV Administration

Administer through dedicated IV line

Administer by slow IV injection; not to exceed 5 mL/min

Storage

Single-use vials; these products do not contain preservatives

Unopened vial

  • Store at 2-25°C (36-77°F)
  • Do not freeze
  • Store in original container to protect from light

Reconstituted vial

  • Do not refrigerate or freeze
  • RiaSTAP: Up to 8 hr at 20-25°C
  • Fibryga: Up to 4 hr at 20-25°C
Previous
Next:

Images

Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.