Riastap Generic Name & Formulations
Legal Class
Rx
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