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, hives, chest tightness, rash, itching, and swelling, were reported in 6 of 97 (6%) subjects in a Canadian study.
- 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, blood vessel inflammation, blood vessel widening, abnormal sensation on the skin, itching, rash, and hives. All were mild in intensity with the exception of a moderate case of itching.
- In a study of HUMATE-P in VWD subjects who had serious life- or limb-threatening bleeding or who were undergoing emergency surgery, seven of 71 (10 %) subjects experienced nine adverse reactions. These were one occurrence each of mild blood vessel widening and mild itching; two occurrences of mild abnormal sensation on the skin; and one occurrence each of moderate swelling and extremity pain, and severe platelet clumping. HUMATE-P was discontinued in the subject who experienced the swelling and extremity pain.
- Among the 63 VWD subjects who received HUMATE-P for prevention of excessive bleeding during and after surgery, the most common adverse events were postoperative bleeding (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).
- A blood clot occurring in the lungs considered possibly related to HUMATE-P occurred in one elderly subject who underwent knee replacement.
- Eight subjects experienced 10 postoperative serious adverse events: one subject had bleeding outside and inside the brain following intracranial surgery, which was related to an underlying brain blood vessel abnormality; one had two occurrences of gastrointestinal bleeding following bypass; and one subject each had sepsis, swelling, infection, heavy menstrual bleeding requiring hysterectomy, kidney infection, and a blood clot in the lung.