Convenience

Packaging Enhancements, Mix2Vial™, and Smaller Diluent

Improved Packaging

Humate-P is more convenient than ever: Along with the Mix2Vial™ needle-free transfer device, Humate-P now has improved product packaging:

The new eco-friendly, recyclable tray protects vials during transportation, and provides a secure space for mixing factor
- Environment-friendly, and vials can be held in place to make mixing factor easier
Peel-off label stickers for 1200 IU VWF:RCo and 2400 IU VWF:RCo vials can be easily removed from the vials and placed in a log
- Makes it easier and simpler to track the amount of factor infused and the lot numbers
New box size allows for multiple boxes of Humate-P^® to be easily stacked
- Reduces the amount of space needed for storage

(Note: The product itself has not changed.)

The Mix2Vial™ Needle-Free Transfer Device is a simple way to mix Humate-P^®:

Needle-free device with no handle or glass syringes
- Results in less risk of accidental injury
Built-in filter; simple process; can be used with all Luer-Lok^® syringes
- Encourages independence and saves time with infusion process

View a step-by-step demonstration of how Mix2Vial™ works. Learning how to self-infuse at home can save you time and help you better manage your bleeding disorder. View the Home Infusion Video on the 6 simple steps to self-infuse Humate-P^® using the Mix2Vial™ device.

For more information about Humate-P, packaging updates, or the Mix2Vial™, call Consumer Affairs at 1-888-508-6978.

Reminder: When stored up to 25°C (up to 77°F), Humate-P^® is stable up to the expiration date printed on its label. Avoid freezing.

Mix2Vial™ is a trademark of Medimop Medical Projects Ltd.

Luer-Lok^® is a trademark of Becton, Dickinson and Company.

Important Safety Information

Humate-P is indicated for treatment and prevention of bleeding in adult patients with hemophilia A (classical hemophilia). Humate-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of spontaneous and trauma-induced bleeding episodes, and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD, and patients with mild and moderate VWD for whom use of desmopressin is known or suspected to be inadequate. Humate-P is not indicated for the prophylaxis of spontaneous bleeding episodes.

Humate-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations.

Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. Also monitor VWF:RCo and FVIII levels in VWD patients, especially those undergoing surgery.

Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement. Caution should be exercised and antithrombotic measures considered, particularly in patients with known risk factors for thrombosis.

Humate-P is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

In patients receiving Humate-P in clinical studies for treatment of VWD, the most commonly reported adverse reactions observed by >5% of subjects are allergic-anaphylactic reactions, including urticaria (hives), chest tightness, rash, pruritus (itching), and edema (swelling). For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding, and epistaxis (nosebleed).

Please see full prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.