;
Events occurring in separate subjects.
Body as a whole Pain – 11
Fever – 4
Abdominal pain – 3
Infection – 3
Surgery – 3
Back pain – 2
Facial edema – 2
Cardiovascular Chest pain – 3
Pulmonary embolus† 1 1
Thrombophlebitis† 1 1
Digestive Nausea 1 15
Constipation – 7
Vomiting 1 3
Sore throat – 2
Hemic and lymphatic system Anemia / decreased hemoglobin – 2
Metabolic/nutritional Increased SGPT 1 1
Nervous Dizziness 1 5
Headache 1 4
Increased sweating – 3
Insomnia – 2
Skin and appendages Pruritus – 3
Rash 1 1
Urogenital Urinary retention – 4
Urinary tract infection – 2
Eight subjects experienced 10 postoperative serious adverse events: one with subdural hematoma and intracerebral bleeding following intracranial surgery related to an underlying cerebrovascular abnormality; one with two occurrences of gastrointestinal bleeding following gastrojejunal bypass; and one each with sepsis, facial edema, infection, menorrhagia requiring hysterectomy following hysteroscopy and dilation and curettage, pyelonephritis, and pulmonary embolus.
6.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Humate-P. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Humate-P exposure.
Adverse reactions reported in patients receiving Humate-P for treatment of VWD or hemophilia A are allergic-anaphylactic reactions (including urticaria, chest tightness, rash, pruritus, edema, and shock), development of inhibitors to FVIII, and hemolysis. Additional adverse reactions reported for VWD are thromboembolic complications, chills and fever, and hypervolemia.
7DRUG INTERACTIONS
None reported.
8USE IN SPECIFIC POPULATIONS
8.1Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with Humate-P. It is also not known whether Humate-P can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Humate-P should be given to a pregnant woman only if clearly needed.
8.2Labor and Delivery
It is not known whether Humate-P can cause harm to the mother or the fetus when administered during labor and delivery. Humate-P should be given during labor and delivery only if clearly needed.
8.3Nursing Mothers
It is not know whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Humate-P is administered to a nursing woman.
8.4Pediatric Use
Hemophilia A
Adequate and well-controlled studies with long-term eva luation of joint damage have not been done in pediatric subjects. Joint damage may result from suboptimal treatment of hemarthroses.
VWD
The safety and effectiveness of Humate-P for the treatment of VWD was demonstrated in 26 pediatric subjects, including infants, children, and adolescents, but have not been eva luated in neonates. The safety of Humate-P for the prevention of excessive bleeding during and after surgery was demonstrated in eight pediatric subjects (ages 3 to 15) with VWD. Of the 34 pediatric subjects studied for either treatment of bleeding episodes in VWD or prevention of excessive bleeding during and after surger |
