Bebulin VH

Last updated on RxList: 11/13/2017
Bebulin VH Side Effects Center

Last reviewed on RxList 11/13/2017

Bebulin (factor IX complex) Nanofiltered and Vapor Heated is a combination of vitamin K-dependent clotting factors (Factor IX, II, X) and found in normal plasma indicated for the prevention and control of bleeding episodes in adult patients with hemophilia B (congenital Factor IX deficiency or Christmas disease). Common side effects of Bebulin include low blood pressure (hypotension), dizziness, hives, swelling, fever, and chills.

The dose of Bebulin is determined by the patient's bodyweight and the desired percent of Factor IX increase. Bebulin may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant before using Bebulin. Consult your doctor before breastfeeding.

Our Bebulin (factor IX complex) 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.

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Bebulin VH Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives or rash; fast heartbeats; chest tightness, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • sweating and feeling short of breath;
  • a light-headed feeling, like you might pass out;
  • easy bruising, increased bleeding episodes;
  • bleeding from a wound or where the medicine was injected;
  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • headache;
  • flushing (warmth, redness, or tingly feeling);
  • nausea, vomiting;
  • fever, chills; or
  • lack of energy.

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 Bebulin VH (Factor IX Complex Intravenous Administration)

QUESTION

What is hemophilia? See Answer
Bebulin VH Professional Information

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 2 lists the adverse reactions reported during postmarketing use of BEBULIN.

Table 2: 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.

Read the entire FDA prescribing information for Bebulin VH (Factor IX Complex Intravenous Administration)

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

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