Wilate

Last updated on RxList: 4/20/2018
Wilate Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/20/2018

Wilate, von Willebrand Factor/Coagulation Factor VIII Complex (Human) is indicated in children and adults with von Willebrand disease for on-demand treatment and control of bleeding episodes and perioperative management of bleeding. Wilate is not indicated for treatment of hemophilia A. Common side effects of Wilate include:

  • hypersensitivity reactions
  • hives, and
  • dizziness

The dose of Wilate is based on the patient's body weight combined with the desired VWF:RCo rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL). The dosage and duration of the substitution therapy is adjusted depending on the severity of the VWD, on the location and extent of the bleeding, and on the patient's clinical condition. Wilate may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant before receiving Wilate. It is unknown if Wilate passes into breast milk. Consult your doctor before breastfeeding.

Our Wilate, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

What is hemophilia? See Answer
Wilate Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; chest tightness, wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • hot flashes when the injection is given;
  • sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance;
  • sudden cough, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • bleeding from a wound or where the medicine was injected; or
  • bleeding that is not controlled.

Common side effects may include:

  • nosebleeds;
  • rash or itching;
  • numbness or tingling;
  • headache, dizziness; or
  • back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human))

SLIDESHOW

Anemia Symptoms and Signs, Types, Treatment and Causes See Slideshow
Wilate Professional Information

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 [see WARNINGS AND PRECAUTIONS].

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.

Read the entire FDA prescribing information for Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human))

© Wilate Patient Information is supplied by Cerner Multum, Inc. and Wilate Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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