Read the black box warning in the package insert to your patient and obtain any necessary. The clinically important adverse reactions observed in trials comparing plavix plus aspirin to placebo plus aspirin and trials comparing plavix alone to aspirin alone are discussed below. Indicated to reduce thrombotic cardiovascular events in patients with a history of mi or with peripheral arterial disease. Zontivity vorapaxar has been shown to reduce the rate of a combined endpoint of cardiovascular death, mi, stroke, and urgent coronary revascularization. Although minor upper gi symptoms, such as dyspepsia, are common and can occur anytime during therapy, physicians should remain alert for signs of ulceration and bleeding, even in the absence of previous gi symptoms.
Vorapaxar also increased the risk of moderate or severe bleeding, including intracranial hemorrhage intracranial hemorrhage occurring most frequently in patients with a history of stroke vorapaxar zontivity zontivity package insert 21 dos course 2015. Verapamil hydrochloride injection verapamil hydrochloride. If youve had a heart attack or have peripheral arterial disease pad, zontivity taken with aspirin andor clopidogrel may lower your chance of heart attack, stroke, or death. Vorapaxar is used to lower the risk of stroke or serious heart problems in people who have had a heart attack or a blood vessel disorder affecting circulation in the arms and legs. Clinical experience suggests that patients being treated with aggrenox capsules who also require pharmacological stress testing with intravenous dipyridamole or other adenosinergic agents e.
Nov 20, 2019 vorapaxar is a reversible antagonist of the proteaseactivated receptor1 par1 expressed on platelets, but its long halflife makes it effectively irreversible. The service or benefit will, or is reasonably expected to, reduce or ameliorate. Decreased serum concentrations of vorapaxar and thus decreased efficacy are possible when vorapaxar, a cyp3a4 substrate, is coadministered with felbamate, a. Vorapaxar is a once daily oral medication that would be added to current therapy rather than replacing a medication being taken with the. Vorapaxar sulfate pharmacokinetics absorption bioavailability. Fda approves vorapaxar zontivity to cut mi, stroke risk. Do not stop therapy without consulting health care professional. Highlights of prescribing information these highlights do not. Vorapaxar is sometimes used together with aspirin or clopidogrel plavix. Vorapaxar increases the risk of bleeding, which may include bleeding in the brain and other serious possibly fatal bleeding problems. Vorapaxar may also be used for purposes not listed in this medication guide. Dec 16, 2019 vorapaxar is used to lower the risk of stroke or serious heart problems in people who have had a heart attack or a blood vessel disorder affecting circulation in the arms and legs. Zontivity vorapaxar dosing, indications, interactions. Moderate use caution during concurrent use of vorapaxar and felbamate.
Highlights of prescribing information acute ischemic stroke. This mechanism works by a different pathway than other antiplatelet medications such as aspirin and p2y12 inhibitors. Vorapaxar zontivity vorapaxar is indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction mi or with peripheral arterial disease. It inhibits thrombin receptoractivating peptide trapinduced platelet.
It functions by inhibiting thrombinrelated platelet aggregation. Highlights of prescribing information these highlights do not include all the information needed to use hydrea safely and effectively. Bleeding risk see full prescribing information for complete boxed warning. New drugs for the primary care provider including drugs. Vorapaxar is a reversible antagonist of the proteaseactivated receptor1 par1 expressed on platelets, but its long halflife makes it effectively irreversible. Remove the protective cap from one end of the transfer device and keeping the vial of swfi upright, insert the piercing pin vertically into the center of the stopper of the vial of swfi. A par1 antagonist for the reduction of thrombotic cardiovascular events in patients with a history of mi or with pad 1. Appropriate studies have not been performed on the relationship of age to the effects of vorapaxar in the pediatric population. New drugs for the primary care provider including drugs for. Because of the proarrhythmic effects of norpace and norpace cr, their use with lesser arrhythmias is generally not recommended. A synthetic analog of the natural product himbacine, 5, 6, 8 vorapaxar figure 1 is a novel, orally active, nonprotein, highly selective, competitive par1 inhibitor. Decreased serum concentrations of vorapaxar and thus decreased efficacy are possible when vorapaxar, a cyp3a4. Thrombinreceptor antagonist vorapaxar in acute coronary syndromes. Remove the protective cap from the other end of the transfer.
Vorapaxar is a new antiplatelet drug that is part of the par1 antagonist family, a new class of antiplatelet drug. Gi side effects include stomach pain, heartburn, nausea, vomiting, and gross gi bleeding. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Felbamate package insert pdf united pdf comunication. Vorapaxar is eliminated by metabolism via cyp3a4 and cyp2j2. The clinically important adverse reactions observed in trials comparing plavix plus aspirin to placebo plus aspirin and trials comparing plavix alone to. Read the medication guide provided by your pharmacist before. Open the package containing the transfer device by peeling the paper label off the package. Vorapaxar monograph february 2016 updated version may be found at. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesisstimulating agents esas to target a. Do not use zontivity in patients with a history of stroke, transient ischemic attack tia. The medication can be used to decrease risk of heart attack, stroke, and cardiovascular death. See full prescribing information for complete boxed warning. Felbamate, also known as felbatol, has been approved by the food and drug about all potential risks before.
The incidence of syncopal episodes is approximately 1% in patients. Initiation of norpace or norpace cr treatment, as with other antiarrhythmic agents used to treat lifethreatening arrhythmias, should be carried out in the hospital. Highlights of prescribing information antiplatelet. Highlights of prescribing information these highlights do not include all the information needed to use zontivity safely and effectively. Norpace and norpace cr are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are lifethreatening. Advise patient to read medication guide before starting therapy and with each rx refill in case of changes caution patient to notify health care professional immediately if signs and symptoms of bleeding bleeding that is severe or cannot be controlled, pink, red, or brown urine. Dailymed aggrenox aspirin and dipyridamole capsule. Norpace cr, their use with lesser arrhythmias is generally not recommended. Vorapaxar is highly bound to human serum albumin and does not preferentially distribute into red blood cells. Vorapaxar is used together with other medications, such as aspirin and clopidogrel plavix, to reduce the risk of serious or lifethreatening heart or blood vessel problems such as heart attack and stroke in people who have already had a heart attack or have problems with the blood flow in their legs. In a large controlled trial in over 10,000 patients monitored over a 2 year period, alt elevations above 5 times the upper limit of normal occurred in 1% of vorapaxar vs 1. Vorapaxar has been shown to reduce the rate of a combined endpoint of cardiovascular death, mi, stroke, and urgent coronary revascularization. Patients and caregivers should be informed of the increased risk of suicidal thoughts. Trusopt sterile ophthalmic solution is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution of dorzolamide hydrochloride.
Zontivity vorapaxar is a novel antiplatelet medication for people who have had a heart attack or who have reduced blood flow in their legs. For nonprescription products, read the label or package ingredients carefully. To view other topics, please sign in or purchase a subscription. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesisstimulating agents esas to target a hemoglobin levelof greater than 11 gdl5. Felbatol is the brand name used in the united states for felbamate. Plavix has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for one year or more. Vorapaxar and the major circulating active metabolite, m20, are extensively bound.
115 480 555 1260 1163 595 169 1113 210 1167 1362 357 827 1201 1249 231 1106 1344 1317 950 755 666 1191 811 1268 263 1408 1559 638 945 33 631 578 1463 1047 1289 436 178 343 1386 271