Important Safety Information for Stimate
Stimate Nasal Spray is indicated for patients with hemophilia A with Factor VIII
coagulant activity levels greater than 5%. Desmopressin acetate is not indicated
for the treatment of hemophilia A with Factor VIII coagulant activity levels equal
to or less than 5%, or for the treatment of hemophilia B, or in patients who have
Factor VIII antibodies.
Stimate® Nasal Spray is indicated for patients with mild to moderate classic type
1 von Willebrand disease (VWD) with Factor VIII levels greater than 5%. Stimate®
Nasal Spray is not indicated for the treatment of severe classic VWD (Type I) and
when there is evidence of an abnormal molecular form of Factor VIII antigen.
Stimate® Nasal Spray is contraindicated if you have a known hypersensitivity to
desmopressin or any of the components of Stimate. Stimate should not be used by
patients with type 2B VWD, since platelet aggregation may be induced. Stimate Nasal
Spray is for intranasal use only.
To reduce the potential for water intoxication or hyponatremia, especially in the
young and the elderly, patients using desmopressin may be advised to reduce fluid
intake, ingesting only enough to satisfy thirst. Your doctor will monitor for a
rare occurrence of an extreme decrease in plasma osmolality that could result in
seizures, possibly leading to coma.
Other adverse reactions reported with use of injectable and/or intranasal desmopressin
acetate include headache, nausea, somnolence (sleepiness), dizziness, chest pain,
palpitations and tachycardia (rapid heartbeat), and severe allergic reactions, including
anaphylaxis. See full prescribing information for a complete list of adverse reactions.
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.
Important Safety Information for Humate-P
Antihemophilic Factor/von Willebrand Factor Complex (Human), Humate-P® is approved to treat and prevent bleeding in adult patients with hemophilia A (classical hemophilia). Humate-P also treats spontaneous or trauma-induced bleeding episodes in adults and children with von Willebrand disease (VWD) and prevents excessive bleeding during and after surgery in patients with mild, moderate or severe VWD. Humate-P is not known to prevent spontaneous bleeding episodes.
Do not take Humate-P if you have had extreme sensitivity or an allergic response to antihemophilic or von Willebrand factor preparations. Your doctor will monitor you for events related to abnormal blood clotting.
Humate-P is made from human blood and could contain infectious agents. The risk that these agents may transmit disease cannot be completely eliminated, but has been reduced by screening plasma donors and testing donated plasma for certain viruses, and by inactivating and/or removing viruses during manufacturing.
In studies, more than 5% of patients reported the following adverse reactions to Humate-P: allergic/anaphylactic reactions, including hives, chest tightness, rash, itching, and swelling. The most common adverse reactions after surgery were bleeding at the wound or infusion site, and nosebleeds.
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.