WILATE SIDE EFFECTS

SIDE EFFECTS

The most common adverse reactions to treatment with WILATE ( ≥ 1%) in patients with VWD were hypersensitivity reactions, urticaria, and dizziness. Seroconversions for antibodies to parvovirus B19 not accompanied by clinical signs of disease have been observed.

The most serious adverse reactions to treatment with WILATE in patients with VWD were hypersensitivity reactions.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed during these trials cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.

A total of 157 VWD subjects (aged 1 to 83 years) received WILATE on 6769 occasions, including clinical studies that involved prophylactic use, treatment on demand, surgery, and pharmacokinetics. Of the 157 subjects, 32 (20.4%) had VWD type 1, 42 (26.8%) had VWD type 2, and 83 (52.9%) had VWD type 3; 96 (61.1%) subjects were female and 61 (38.9%) subjects were male. Overall, subjects received 11,222,241 IU of WILATE during 6355 exposure days. The most common adverse reactions were hypersensitivity reactions (3 subjects; 1.9%), urticaria and dizziness (each with 2 subjects; 1.3%). Five subjects (3.2%) showed seroconversion for antibodies to parvovirus B19 not accompanied by clinical signs of disease. Seroconversion for parvovirus B19 DNA has not been reported since implementation of minipool testing of plasma used for the manufacture of WILATE.

Immunogenicity

The immunogenicity of WILATE was specifically assessed in 97 subjects in 3 clinical studies in which subjects received 9,635,041 IU of WILATE during 5575 exposure days. No inhibitors of VWF were detected in these 3 studies. In one of 3 studies, which also assessed FVIII inhibitor development in 15 subjects, no inhibitors of FVIII were detected after administration of a total of 223,290 IU of WILATE over 419 administrations.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to WILATE with the incidence of antibodies to other products may be misleading.

Postmarketing Experience

The following adverse reactions have been identified during the post-approval use of WILATE. 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 product exposure.

Post-marketing adverse reactions reported in patients treated with WILATE include, dyspnea, nausea, vomiting, rash, headache, tachycardia, flushing, hypotension, chills, cough, chest discomfort, abdominal pain, pyrexia, factor VIII inhibition, anaphylactic reaction and paresthesia.

SRC: NLM .