Factor IX (Human), Factor IX Complex (Human) and Stiolto Respimat 28 ACT

• Generic Name: coagulation factor ix
• Dosage Forms: n.a.
• Other Brand Names: Alphanine SD, Alprolix, BeneFIX, Idelvion, Ixinity, Mononine, Rebinyn, Rixubis, BeneFIX 250 Int'l Units, BeneFIX

Prevention and control of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease).

Maintenance of hemostasis in patients with hemophilia B undergoing surgery.

In patients with preexisting thromboembolic risk factors, some experts state that pure (i.e., single-factor) factor IX preparations are preferred over factor IX complex for treatment of hemophilia B. (See Thromboembolic Events under Cautions.)

Also used for routine prophylaxis (i.e., administration at regular intervals on an ongoing basis) to prevent or reduce frequency of hemorrhagic events. Such prophylactic therapy currently considered the standard of care for patients with hemophilia B. Decreases frequency of spontaneous musculoskeletal hemorrhage, preserves joint function, and improves quality of life.

Several factor IX concentrates are currently available in the US, including a variety of recombinant and plasma-derived preparations; the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation recommends preferential use of recombinant factor IX preparations because of their potentially superior safety profile with respect to pathogen transmission. (See Risk of Transmissible Agents in Plasma-derived Preparations under Cautions.) Other experts (e.g., World Federation of Hemophilia) state that choice of preparation should be determined by local criteria. When selecting an appropriate factor IX preparation, consider characteristics of each clotting factor concentrate, individual patient variables, patient/provider preference, and emerging data.

Factor IX (human) is not indicated for treatment of coagulation factor II, VII, or X deficiency or for management of hemophilia A in patients with inhibitors to factor VIII.

Factor IX complex (human) is not indicated for treatment of factor VII deficiency or other coagulation factor deficiencies.

Factor IX complex (human) (i.e., 3-factor PCC) has been used for urgent reversal of warfarin anticoagulation in patients experiencing major bleeding or in those who require immediate reversal of anticoagulation for other reasons (e.g., urgent surgery).

Factor IX (human) is not indicated for treatment or reversal of coumarin-induced anticoagulation or for treatment of hemorrhagic states caused by hepatitis-induced lack of production of liver-dependent coagulation factors.

• Generic Name: olodaterol / tiotropium
• Dosage Forms: spray, metered
• Other Brand Names: Stiolto Respimat, Stiolto Respimat 28 ACT, Stiolto Respimat 60 ACT, Stiolto Respimat 10 ACT

Stiolto Respimat 28 ACT is a combination medicine used to prevent airflow obstruction and reduce flare-ups in adults with COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema.

Stiolto Respimat 28 ACT is for use only in people with COPD and should not be used to treat asthma.

Stiolto Respimat 28 ACT may also be used for purposes not listed in this medication guide.