BEBULIN VH SIDE EFFECTS

  • Generic Name: factor ix complex intravenous administration
  • Brand Name: Bebulin VH
Last updated on MDtodate: 10/03/2022

SIDE EFFECTS

Clinical Trial Experience

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

The following adverse reactions were reported in clinical studies with a previous formulation of BEBULIN:

Hypotension, Dizziness, Urticaria, Erythema, Pyrexia, and Chills.

The formation of inhibitor antibodies to Factor IX has been observed with the administration of BEBULIN.

Postmarketing Experience

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.

Table 1 lists the adverse reactions reported during postmarketing use of BEBULIN.

Table 1: Postmarketing Adverse Reactions

Blood and Lymphatic System Disorders Disseminated intravascular coagulation
Immune System Disorders Anaphylactic/Anaphylactoid reactions, Hypersensitivity
Nervous System Disorders Headache
Cardiac Disorders Tachycardia
Vascular Disorders Thromboembolic events (including Deep vein thrombosis, Pulmonary embolism, Thrombotic stroke), Flushing
Respiratory, Thoracic, and Mediastinal Disorders Dyspnea, Bronchospasm, Wheezing, Cough
Gastrointestinal Disorders Abdominal pain, Nausea
Skin and Subcutaneous Tissue Disorders Angioedema, Facial edema, Rash, Pruritus
Renal and Urinary Disorders Nephrotic syndrome (following attempted immune tolerance induction)
General Disorders and Administration Site Conditions Infusion site reactions, including Infusion site pain

 

In addition to reactions listed above, myocardial infarction has been identified in the published literature with other Factor IX products.

 

SRC: NLM .