AXS25 DigitalGuide V2 04.18 pages - Flipbook - Page 41
BRIEF SUMMARY OF PRESCRIBING INFORMATION
SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION
INDICATIONS AND USAGE
HYMPAVZI is 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)
without factor VIII inhibitors, or
• hemophilia B (congenital factor IX deficiency)
without factor IX inhibitors.
WARNINGS AND PRECAUTIONS
Thromboembolic Events HYMPAVZI is a tissue factor
pathway inhibitor (TFPI) antagonist, and may increase the
risk of thromboembolic complications. HYMPAVZI has not
been studied in patients with a history of previous
thromboembolic events. Interrupt HYMPAVZI prophylaxis
if diagnostic findings consistent with thromboembolism
occur and manage as clinically indicated. If factor VIII or
factor IX products are indicated in a patient receiving
HYMPAVZI prophylaxis, the minimum effective dose
of factor VIII or factor IX according to the product label
is recommended.
Hypersensitivity HYMPAVZI may cause hypersensitivity
reactions (including, but not limited to urticaria and pruritus).
If HYMPAVZI-treated patients develop a severe
hypersensitivity reaction, advise patients to discontinue
HYMPAVZI and seek immediate emergency treatment.
Embryofetal Toxicity Based on its mechanism of action,
HYMPAVZI may cause fetal harm when administered to a
pregnant woman. Advise pregnant women of the potential
risk to the fetus. Advise females of reproductive potential
to use effective contraception during treatment with
HYMPAVZI and for 2 months after the last dose.
ADVERSE REACTIONS
The following clinically significant adverse reactions are
described elsewhere in the labeling:
• Thromboembolic Events [see Warnings
and Precautions]
• Hypersensitivity [see Warnings and Precautions]
The safety of HYMPAVZI was evaluated in 116 adolescent
and adult patients with severe hemophilia A or B without
inhibitors (coagulation factor activity
