Alhemo® (concizumab-mtci) injection, for subcutaneous use

Novo Nordisk

Alhemo is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:

– hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors
– hemophilia B (congenital factor IX deficiency) with FIX inhibitors (1)

Before first use:

• Store unused Alhemo pens in the refrigerator between 36°F to 46°F (2°C to 8°C).

After first use:

• Store the Alhemo pen in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature no warmer than 86°F (30°C) for up to 28 days.

• Write the date of first use in the space provided on the carton.

• Throw away (discard) the Alhemo pen 28 days after first opening even if some medicine is left in the pen.

Store Alhemo with the cap on and keep it in the original carton to protect from light.

• Do not store Alhemo in direct sunlight and keep away from direct heat.

• When stored in the refrigerator, do not store the pen directly next to the cooling element (the part that cools the refrigerator).

Do not freeze Alhemo. Do not use Alhemo if it has been frozen or if it has been stored above 86°F (30°C).