Cangrelor Intravenous

Applies to cangrelor: intravenous powder for solution

Along with its needed effects, cangrelor may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking cangrelor:

• Abdominal or stomach pain or swelling
• back pain
• black, tarry stools
• blood in the eyes
• blood in the urine
• bruising or purple areas on the skin
• coughing up blood
• decreased alertness
• dizziness
• headache
• joint pain or swelling
• nosebleeds

• Difficult or labored breathing
• tightness in the chest

• Cough
• difficulty with swallowing
• fast heartbeat
• hives, itching, or rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• unusual tiredness or weakness

Applies to cangrelor: intravenous powder for injection

General

The most common adverse reaction was bleeding.[Ref]

Cardiovascular

Very common (10% or more): Any Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) bleeding (15.5%), mild GUSTO bleeding (14.9%)
Uncommon (0.1% to 1%): Severe/life-threatening GUSTO bleeding, moderate GUSTO bleeding, any Thrombolysis in Myocardial Infarction (TIMI) bleeding, major TIMI bleeding, minor TIMI bleeding
Frequency not reported: Coronary artery dissection, coronary artery perforation[Ref]

Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) bleeding definitions:
-Severe/life-threatening GUSTO bleeding: Intracranial hemorrhage or bleeding resulting in substantial hemodynamic compromise requiring treatment.
-Moderate GUSTO bleeding: Bleeding requiring blood transfusion but not resulting in hemodynamic compromise.
-Mild GUSTO bleeding: All other bleeding not included in severe or moderate.

Thrombolysis in Myocardial Infarction (TIMI) bleeding definitions:
-Major TIMI bleeding: Any intracranial hemorrhage or any overt bleeding associated with a reduction in hemoglobin of at least 5 g/dL (if hemoglobin is not available, an absolute reduction in hematocrit of 15% or more).
-Minor TIMI bleeding: Any overt sign of bleeding (including observation by imaging techniques) associated with a reduction in hemoglobin of 3 to less than 5 g/dL (if hemoglobin is not available, an absolute reduction in hematocrit of 9% to less than 15%).[Ref]

Respiratory

Common (1% to 10%): Dyspnea
Frequency not reported: Bronchospasm, stridor[Ref]

Renal

Common (1% to 10%): Worsening renal function in patients with CrCl less than 30 mL/min[Ref]

Immunologic

Rare (less than 0.1%): Hypersensitivity
Frequency not reported: Anaphylactic reactions, anaphylactic shock[Ref]

Dermatologic

Frequency not reported: Angioedema[Ref]

Some side effects of cangrelor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Safety has not been established during pregnancy. US FDA pregnancy category: C

Animal studies have revealed evidence of fetal growth retardation and increased incidences of abortion and intrauterine losses. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.