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Angiomax

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Angiomax

Angiomax

Angiomax Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Angiomax (bivalirudin) is used to prevent blood clots in people with severe chest pain or other conditions undergoing a procedure called angioplasty (to open blocked arteries). It is a reversible direct thrombin inhibitor. Common side effects include pain in the back or pelvis, nausea, vomiting, stomach pain or upset, restlessness or nervousness, headache, fever, insomnia, pain, bleeding, or 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Angiomax in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • pain or swelling in one or both legs;
  • any bleeding that will not stop;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • slow heart rate;
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • decreased blood pressure (feeling light-headed or fainting); or
  • urinating less than usual or not at all.

Less serious side effects are more likely to occur, such as:

  • pain in your back or pelvis;
  • nausea, vomiting, stomach pain or upset;
  • feeling restless or nervous;
  • headache;
  • fever;
  • sleep problems (insomnia);
  • pain, bleeding, or irritation where the injection was given.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Angiomax (Bivalirudin) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Angiomax Overview - Patient Information: Side Effects

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Angiomax (Bivalirudin)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Angiomax FDA Prescribing Information: Side Effects
(Adverse Reactions)

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.

Bleeding

In 6010 patients undergoing PCI treated in the REPLACE-2 trial, Angiomax patients exhibited statistically significantly lower rates of bleeding, transfusions, and thrombocytopenia as noted in Table 2.

Table 2: Major Hematologic Outcomes REPLACE-2 Study (Safety Population)

  Angiomax with “provisional” GPI1
( n=2914)
HEPARIN + GPI
(n=2987)
p-value
Protocol defined major hemorrhage2 (%) 2.30% 4.00% < 0.001
Protocol defined minor hemorrhage3 (%) 13.60% 25.80% < 0.001
TIMI defined bleeding4
-Major 0.60% 0.90% 0.259
-Minor 1.30% 2.9 < 0.001
Non-access site bleeding
-Retroperitoneal bleeding 0.20% 0.50% 0.069
-Intracranial bleeding < 0.1% 0.10% 1
Access site bleeding
-Sheath site bleeding 0.90% 2.40% < 0.001
Thrombocytopenia5
<100,000 0.70% 1.70% < 0.001
<50,000 0.30% 0.60% 0.039
Transfusions
-RBC 1.30% 1.90% 0.08
-Platelets 0.30% 0.60% 0.095
1GPIs were administered to 7.2% of patients in the Angiomax with provisional GPI group
2Defined as the occurence of any of the following: intracranial bleeding, retroperitoneal bleeding, a transfusion of ≥ 2 units of blood/blood products, a fall in hemoglobin > 4g/dL, whether of not bleeding site is identified, spontaneous or non-spontaneous blood loss with a decrease in hemoglobin > 3g/Dl
3Defined as observed bleeding that does not meet the criteria for major hemorrhage
4TIMI major bleeding is defined as intracranial, or a fall in adjusted Hgb > 5g/dL or Hct of > 15%: TIMI minor bleeding is defined as a fall in adjusted Hgb of 3 to < 5 g/dL or a fall in adjusted Hct of 9 to < 15%, with a bleeding site such as hematuria, hematemesis, hematomas, retroperitoneal bleeding or a decrease in Hgb of > 4 g/dL with no bleeding site
5If < 100,000 and > 25% reduction from baseline, or < 50,000

In 4312 patients undergoing PTCA for treatment of unstable angina in 2 randomized, double-blind studies comparing Angiomax to heparin, Angiomax patients exhibited lower rates of major bleeding and lower requirements for blood transfusions. The incidence of major bleeding is presented in Table 3. The incidence of major bleeding was lower in the Angiomax group than in the heparin group.

Table 3: Major Bleeding and Transfusions in BAT Trial (all patients) 1

  Angiomax
N=2161
Heparin
N=2151
No. (%) Patients with Major hemorrhage2 79 (3.7) 199 (9.3)
-with ≥ 3 g/dL fall in Hgb 41 (1.9) 124 (5.8)
-with ≥ 5 g/dL fall in Hgb 14 (0.6) 47 (2.2)
-retroperitoneal bleeding 5 (0.2) 15 (0.7)
-intracranial bleeding 1 ( < 0.1) 2 (0.1)
Required transfusions 43 (2.0) 123 (5.7)
1No monitoring of ACT (or PTT) was done after a target ACT was achieved.
2Major hemorrhage was defined as the occurence of any of the following, intracranial bleeding, retroperitoneal bleeding, clinically overt bleeding with a decrease in hemoglobin > 3 g/dL or leading to a transfusion of > 2 units of blood. This table includes data from the entire hospitalization period.

In the AT-BAT study, of the 51 patients with HIT/HITTS, 1 patient who did not undergo PCI had major bleeding during CABG on the day following angiography. Nine patients had minor bleeding (mostly due to access site bleeding), and 2 patients developed thrombocytopenia.

Other Adverse Reactions

Adverse reactions, other than bleeding, observed in clinical trials were similar between the Angiomax treated patients and the control groups.

Adverse reactions (related adverse events ) seen in clinical studies in patients undergoing PCI and PTCA are shown in Tables 4 and 5.

Table 4 : Most frequent ( ≥ 0.2%) treatment-related adverse events (reactions) (through 30 days) in the REPLACE-2 Safety population

  Angiomax with “provisional” GPI1
(N = 2914)
Heparin+GPI
(N = 2987)
n (%) n (%)
Patients with at least one treatment-related AE 78 (2.7) 115 (3.9)
Thrombocytopenia 9 (0.3) 30 (1)
Nausea 15 (0.5) 7 (0.2)
Hypotension 7 (0.2) 11 (0.4)
Angina pectoris 5 (0.2) 12 (0.4)
Headache 6 (0.2) 5 (0.2)
Injection site pain 3 (0.1) 8 (0.3)
Nausea and vomiting 2 (0.1) 6 (0.2)
Vomiting 3 (0.1) 5 (0.2)
Note: A patient could have more than one event in any category. Abbreviation: AE = adverse event.

Table 5: Adverse Events Other Than Bleeding Occurring In ≥ 5% Of Patients In Either Treatment Group In BAT Trial

EVENT Treatment Group
ANGIOMAX
N=2161
HEPARIN
N=2151
Number of Patients (%)
CARDIOVASCULAR
  Hypotension 262 (12) 371 (17)
  Hypertension 135 (6) 115 (5)
  Bradycardia 118 (5) 164 (8)
GASTROINTESTINAL
  Nausea 318 (15) 347 (16)
  Vomiting 138 (6) 169 (8)
  Dyspepsia 100 (5) 111 (5)
GENITOURINARY
  Urinary retention 89 (4) 98 (5)
MISCELLANEOUS
  Back pain 916 (42) 944 (44)
  Pain 330 (15) 358 (17)
  Headache 264 (12) 225 (10)
  Injection site pain 174 (8) 274 (13)
  Insomnia 142 (7) 139 (6)
  Pelvic pain 130 (6) 169 (8)
  Anxiety 127 (6) 140 (7)
  Abdominal pain 103 (5) 104 (5)
  Fever 103 (5) 108 (5)
  Nervousness 102 (5) 87 (4)

Serious, non-bleeding adverse events were experienced in 2% of 2161 Angiomax-treated patients and 2% of 2151 heparin-treated patients. The following individual serious non-bleeding adverse events were rare ( > 0.1% to < 1%) and similar in incidence between Angiomax-and heparin-treated patients. These events are listed by body system: Body as a Whole: fever, infection, sepsis; Cardiovascular: hypotension, syncope, vascular anomaly, ventricular fibrillation; Nervous: cerebral ischemia, confusion, facial paralysis; Respiratory: lung edema; Urogenital: kidney failure, oliguria. In the BAT trial, there was no causality assessment for adverse events.

Immunogenicity/Re-Exposure

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 postapproval 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.

Read the entire FDA prescribing information for Angiomax (Bivalirudin) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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