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Angiomax

Last reviewed on RxList: 7/29/2019
Angiomax Side Effects Center

Last reviewed on RxList 7/29/2019

Angiomax (bivalirudin) is a reversible direct thrombin inhibitor used to prevent blood clots in people with severe chest pain or other conditions undergoing a procedure called angioplasty (to open blocked arteries). Common side effects of Angiomax include:

  • pain in the back or pelvis,
  • nausea,
  • vomiting,
  • stomach pain or upset,
  • restlessness,
  • nervousness,
  • anxiety,
  • headache,
  • fever,
  • sleep problems (insomnia), or
  • pain/bleeding/irritation where the injection was given.

The recommended dose of Angiomax is an intravenous (IV) bolus dose of 0.75 mg/kg, followed by an infusion of 1.75 mg/kg/h for the duration of the PCI/PTCA procedure. Five min. after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.3 mg/kg should be given if needed. Angiomax may interact with blood thinners, or other medications used to prevent blood clots. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant before taking Angiomax. Aspirin is usually given with this drug, and aspirin can cause bleeding when it is taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Angiomax (bivalirudin) 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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Angiomax Consumer Information

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

Tell your caregivers right away if you have:

  • a light-headed feeling, like you might pass out;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • any bleeding that will not stop;
  • slow heartbeats;
  • little or no urinating;
  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing;
  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs; or
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears.

Common side effects may include:

  • headache, anxiety;
  • nausea, vomiting;
  • pelvic pain, back pain;
  • sleep problems (insomnia); or
  • pain or irritation where the injection was given.

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 Angiomax (Bivalirudin)

QUESTION

In the U.S., 1 in every 4 deaths is caused by heart disease. See Answer
Angiomax Professional Information

SIDE EFFECTS

Clinical Trials 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 practice.

In the BAT trials, 79 of the 2161 (3.7%) patients undergoing PCI for treatment of unstable angina and randomized to Angiomax experienced major bleeding events which consisted of: intracranial bleeding, retroperitoneal bleeding, and clinically overt bleeding with a decrease in hemoglobin >3 g/dL or leading to a transfusion of >2 units of blood.

Immunogenicity

As with all peptides, there is potential for immunogenicity. 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 Angiomax in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

In in vitro studies, Angiomax exhibited no platelet aggregation response against sera from patients with a history of HIT/HITTS.

Among 494 subjects who received Angiomax in clinical trials and were tested for antibodies, 2 subjects had treatment-emergent positive bivalirudin antibody tests. Neither subject demonstrated clinical evidence of allergic or anaphylactic reactions and repeat testing was not performed. Nine additional patients who had initial positive tests were negative on repeat testing.

Postmarketing Experience

Because postmarketing adverse 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 drug exposure.

The following adverse reactions have been identified during post approval use of Angiomax: fatal bleeding; hypersensitivity and allergic reactions including reports of anaphylaxis; lack of anticoagulant effect; thrombus formation during PCI with and without intracoronary brachytherapy, including reports of fatal outcomes; pulmonary hemorrhage; cardiac tamponade; and INR increased.

Read the entire FDA prescribing information for Angiomax (Bivalirudin)

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Related Resources for Angiomax

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

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