fibrinogen, human (Rx)

Brand and Other Names:RiaSTAP
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 900-1300mg
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Fibrinogen Deficiency

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

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 basline level unknown: 70 mg/kg IV 

Target fibrinogen: 100 mg/dL until hemostasis

Dosage Forms & Strengths

powder for injection

  • 900-1300mg
more...

Fibrinogen Deficiency

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

<16 years: Safety & efficacy not established

>16 years

  • As adults; 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 level unknown: 70 mg/kg IV 
  • Target fibrinogen: 100 mg/dL until hemostasis
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Adverse Effects

Frequency Not Defined

Alllergic reactions

Fever

Headache

Arterial thrombosis

Chills

DVT

Dyspnea

MI

Nausea

Rash

Vomiting

Thromboembolism

Pulmonary embolism

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Warnings

Contraindications

Hypersensitivity

Cautions

Risk of anaphylactic reactions

Not indicated for dysfibrinogenemia

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

Theoretical risk of bloodborne infectious disease

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Not studied

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.

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Pharmacology

Mechanism of Action

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

Pharmacokinetics

Half-Life: 61-97 hr; may be decreased in children < 16 years of age

Peak Plasma (70 mg/kg x1): 140 mg/dL

Vd: 45-60 mL/kg

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Administration

IV Preparation

Aseptically transfer 50 mL SWI (supplied diluent) into product vial; swirl to dissolve (do not shake), should be a colorless solution

Stable for 24 hours after reconstitution when stored at room temp

IV Administration

Administer through a separate injection site

Aseptically administer at room temperature by slow injection at NMT 5 mL/min

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Images

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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.

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  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
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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.
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