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Profilnine Generic Name & Formulations
Legal Class
Rx
General Description
Coagulation Factor IX complex (human) 500 IU, 1000 IU, 1500 IU; per vial; lyophilized concentrate for IV infusion after reconstitution; contains Factor X, Factor II, Factor VII; preservative-free.
Pharmacological Class
Coagulation factor complex.
How Supplied
Single-dose vials—1 (w. diluent, supplies)
Manufacturer
Profilnine Indications
Indications
Prevention and control of bleeding in Hemophilia B.
Profilnine Dosage and Administration
Adult
Dosage Required (IU) = Body Weight (kg) × Desired Factor IX increase × 1 IU/kg. Individualize. Max infusion rate: 10mL/min. Minor to moderate hemorrhage: 20–30% FIX increase every 16–24hrs for 1–2 days (minor) or 2–7 days (moderate) until healing achieved. Major hemorrhage: 30–50% FIX increase every 16–24hrs for 3–10 days; then maintain FIX levels at 20% until healing achieved. Surgery (pre-op): 30–50% FIX increase every 16–24hrs for 7–10 days (increase FIX to 50% immediately prior to dental extractions); maintain FIX levels at 30–50% until healing achieved.
Children
Not established.
Profilnine Contraindications
Not Applicable
Profilnine Boxed Warnings
Not Applicable
Profilnine Warnings/Precautions
Warnings/Precautions
Not for treating Factor VII deficiency. Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Liver disease, prolonged treatment duration or if undergoing surgery: increased risk of disseminated intravascular coagulation (DIC) and thrombosis. Monitor for development of inhibitors. Latex sensitivity (diluent). Pregnancy (Cat.C).
Profilnine Pharmacokinetics
See Literature
Profilnine Interactions
Not Applicable
Profilnine Adverse Reactions
Adverse Reactions
Headache, fever, chills, flushing, nausea, vomiting, tingling, lethargy, urticaria; hypersensitivity reactions, thrombosis, DIC.
Profilnine Clinical Trials
See Literature
Profilnine Note
Notes
To report suspected adverse reactions, contact Grifols at (888) 474-3657.
Profilnine Patient Counseling
See Literature
