Riastap

— THERAPEUTIC CATEGORIES —
  • Bleeding disorders

Riastap Generic Name & Formulations

General Description

Fibrinogen concentrate (human) 900–1300mg; per vial; lyophilized pwd for IV inj after reconstitution; contains albumin; preservative-free.

Pharmacological Class

Hemostatic.

How Supplied

Single-use vial—1

Manufacturer

Generic Availability

NO

Riastap Indications

Indications

Acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Riastap Dosage and Administration

Adults and Children

See full labeling. Give by slow IV inj at rate not exceeding 5mL/min. Individualize. Calculate dose when baseline fibrinogen level is known: Dose (mg/kg body wt) = [Target level (mg/dL) – measured level (mg/dL)] / 1.7 (mg/dL per mg/kg body wt). When baseline fibrinogen level is not known: 70mg/kg. Monitor fibrinogen level during therapy. Maintain target fibrinogen level of 100mg/dL until hemostatis is obtained.

Riastap Contraindications

Not Applicable

Riastap Boxed Warnings

Not Applicable

Riastap Warnings/Precautions

Warnings/Precautions

Not for use in dysfibrinogenemia. Monitor for allergic or hypersensitivity reactions; discontinue if occur. Risk of thrombosis (monitor). Contains human plasma; monitor for possible infection transmission. Labor & delivery. Pregnancy (Cat.C). Nursing mothers.

Riastap Pharmacokinetics

See Literature

Riastap Interactions

Not Applicable

Riastap Adverse Reactions

Adverse Reactions

Fever, headache, chills, nausea, vomiting; thrombotic episodes (eg, pulmonary embolism, MI, DVT), anaphylactic reactions.

Riastap Clinical Trials

See Literature

Riastap Note

Not Applicable

Riastap Patient Counseling

See Literature