Bleeding disorders:

Indications for PROFILNINE:

Prevention and control of bleeding in Hemophilia B.

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.

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).

Pharmacologic Class:

Coagulation factor complex.

Adverse Reactions:

Headache, fever, chills, flushing, nausea, vomiting, tingling, lethargy, urticaria; hypersensitivity reactions, thrombosis, DIC.

Note:

To report suspected adverse reactions, contact Grifols at (888) 474-3657.

How Supplied:

Single-dose vials—1 (w. diluent, supplies)