Generic Name and Formulations:
Coagulation Factor IX (human) 500 IU, 1000 IU; per vial; lyophilized pwd for IV infusion after reconstitution.
Company:
CSL Behring, LLC

Select therapeutic use: Bleeding disorders
Indications for MONONINE:
Prevention and control of bleeding in Hemophilia B.

Adults and Children:
Dosage Required (IU) = Body Weight (kg) × Desired Factor IX increase × 1 IU/kg. Individualize. Infuse at a rate of 2mL/min. Minor spontaneous hemorrhage, prophylaxis: increase FIX 15–25%; give up to 20–30 IU/kg once; may repeat in 24hrs if needed. Major trauma, surgery: increase FIX 25–50%; give up to 75 IU/kg every 18–30hrs for up to 10 days; adjust based on FIX levels. FIX inhibitors: may use higher doses.

Contraindications:
Mouse protein sensitivity.

Warnings/Precautions:
Not for Hemophilia A or other factor deficiencies, reversal of coumarin-induced anticoagulation or for bleeding due to low levels of liver-dependant coagulation factors. Fibrinolysis, disseminated intravascular coagulation (DIC), liver disease, neonates, or during post-op period; increased risk of thromboembolic events. Immune tolerance induction. Contains human plasma; monitor for possible infection transmission. Monitor for Factor IX inhibitors and deletion mutations of Factor IX gene; increased risk of hypersensitivity reactions. Pregnancy (Cat.C).

Pharmacological Class:
Clotting factor.

Adverse Reactions:
Headache, fever, chills, flushing, GI upset, tingling, lethargy, inj site reaction, elevated ALT, inhibitor development; hypersensitivity reactions, thrombosis.

Note:
Report all infections suspected to be transmitted by Mononine to (800) 504-5434.

How Supplied:
Single-dose vial—1 (w. diluent, supplies)