An UNYIELDINGDEDICATION to SAFETY
CSL Behring’s Integrated Safety System helps the product meet high quality and safety standards. The collecting, processing, and packaging procedures of HUMATE-P are designed to:
- Retain inherent properties of the VWF and FVIII proteins
- Help provide product purity and viral safety. The risk of virus transmission cannot be completely eliminated.
- Allergic symptoms, including allergic reaction, urticaria, chest tightness, rash, pruritus, and edema, were reported in 6 of 97 (6%) subjects in a Canadian retrospective study [see section 14.1, Clinical Studies, in full prescribing information]. Four of 97 (4%) subjects experienced seven adverse events that were considered to have a possible or probable relationship to HUMATE-P. These included chills, phlebitis, vasodilation, paresthesia, pruritus, rash, and urticaria. All were mild in intensity with the exception of a moderate case of pruritus.
- In a prospective, open-label safety and efficacy study of HUMATE-P in VWD subjects with serious life- or limb-threatening bleeding or undergoing emergency surgery, seven of 71 (10%) subjects experienced nine adverse reactions. These were one occurrence each of mild vasodilation and mild pruritis; two occurrences of mild paresthesia; and one occurrence each of moderate peripheral edema and extremity pain and severe pseudothrombocytopenia (platelet clumping with a false low reading). HUMATE-P was discontinued in the subject who experienced the peripheral edema and extremity pain.
- Among the 63 VWD subjects who received HUMATE-P for prevention of excessive bleeding during and after surgery, including one subject who underwent colonoscopy without the planned polypectomy, the most common adverse events were postoperative hemorrhage (35 events in 19 subjects with five subjects experiencing bleeding at up to three different sites), postoperative nausea (15 subjects), and postoperative pain (11 subjects).
- Pulmonary embolus considered possibly related to HUMATE-P occurred in one elderly subject who underwent bilateral knee replacement.
- 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.