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BYSTOLIC—Effective as monotherapy in adult patients <55 years of age

In an 8-week study

BYSTOLIC monotherapy provided significant BP reductions in an adult patient population <55 years of age12

1.3_Monotherapy_Adults_55_MobileReductions From Baseline in Mean Sitting DBP and SBP at Trough at 8 Weeks12Placebo(n=211)153.4SBP99.9DBPBYSTOLIC 5, 10, or 20 mgChange From Baseline (mm Hg)-4-20-6-8-10-12-14-16(n=423)153.7 mm HgSBP99.9DBP-5.5-11.8*-13.7**P<0.001 vs placebo ITT LOCF-5.5Baseline:Start BYSTOLIC in appropriate adult patients under 55 years of age

Study Design: Results from a U.S. phase IV, 8-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled, dose-titration study of BYSTOLIC monotherapy for the treatment of stage I-II hypertension in patients 18-54 years of age. All patients receiving study medication were initiated on a starting dose of BYSTOLIC 5 mg. After 2 weeks, 4 weeks, and/or 6 weeks of double-blind treatment, patients were uptitrated, if needed, to achieve BP treatment goal defined as DBP <90 mm Hg, SBP <140 mm Hg (or DBP <80 mm Hg, SBP <130 mm Hg for patients with diabetes). Primary endpoint was change from baseline in trough seated DBP at week 8. Mean values at baseline were similar between treatment arms: sitting DBP at trough, 99.9 mm Hg, sitting SBP at trough, 153.6 mm Hg (n=634).

  • Mean age for this study was 45.3 years12

Adverse events in this study of adult patients less than 55 years of age12

  • In an 8-week study of patients <55 years of age, the most common adverse events occurring in ≥1% of patients taking BYSTOLIC and more frequently than in patients taking placebo were upper respiratory tract infection (5.4% for BYSTOLIC vs 1.9% for placebo), peripheral edema (1.9% vs 0.5%), cough (1.6% vs 1.4%), arthralgia (1.2% vs 0.5%), bradycardia (1.1% vs 0%), bronchitis (1.2% vs 0.5%), diarrhea (1.2% vs 0.9%), and joint swelling (1.2% vs 0%).12

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Important Safety Information

Contraindications

  • BYSTOLIC is contraindicated in patients with severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.

Warnings and Precautions

  • Do not abruptly discontinue BYSTOLIC therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction, and ventricular arrhythmias have been reported following the abrupt discontinuation of therapy with beta blockers. Myocardial infarction and ventricular arrhythmias may occur with or without preceding exacerbation of the angina pectoris. Caution patients without overt coronary artery disease against interruption or abrupt discontinuation of therapy. As with other beta blockers, when discontinuation of BYSTOLIC is planned, carefully observe and advise patients to minimize physical activity. Taper BYSTOLIC over 1 to 2 weeks when possible. If the angina worsens or acute coronary insufficiency develops, restart BYSTOLIC promptly, at least temporarily.
  • BYSTOLIC was not studied in patients with angina pectoris or who had a recent MI.
  • In general, patients with bronchospastic diseases should not receive beta blockers.
  • Because beta blocker withdrawal has been associated with an increased risk of MI and chest pain, patients already on beta blockers should generally continue treatment throughout the perioperative period if undergoing major surgery. If BYSTOLIC is to be continued perioperatively, monitor patients closely when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene are used. If beta-blocking therapy is withdrawn prior to major surgery, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

The beta-blocking effects of BYSTOLIC can be reversed by beta agonists, eg, dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Additionally, difficulty in restarting and maintaining the heartbeat has been reported with beta blockers.

  • Beta blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Advise patients subject to spontaneous hypoglycemia and diabetic patients receiving insulin or oral hypoglycemic agents about these possibilities.
  • Beta blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of beta blockers in these patients may be followed by an exacerbation of symptoms or may precipitate a thyroid storm.
  • Beta blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.
  • Because of significant negative inotropic and chronotropic effects in patients treated with beta blockers and calcium channel blockers of the verapamil and diltiazem type, monitor the ECG and blood pressure of patients treated concomitantly with these agents.
  • When BYSTOLIC is co-administered with an inhibitor or an inducer of CYP2D6, monitor patients closely and adjust the nebivolol dose according to blood pressure response. The dose of BYSTOLIC may need to be reduced. When BYSTOLIC is administered with fluoxetine, significant increases in d-nebivolol may be observed (ie, an 8-fold increase in AUC and a 3-fold increase in Cmax for d‑nebivolol).
  • Renal clearance of nebivolol is decreased in patients with severe renal impairment. In patients with severe renal impairment (ClCr less than 30 mL/min) the recommended initial dose is 2.5 mg once daily; titrate up slowly if needed. BYSTOLIC has not been studied in patients receiving dialysis.
  • Metabolism of nebivolol is decreased in patients with moderate hepatic impairment. In patients with moderate hepatic impairment, the recommended initial dose is 2.5 mg once daily; titrate up slowly if needed. BYSTOLIC has not been studied in patients with severe hepatic impairment and therefore it is not recommended in that population.
  • Patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenge and may be unresponsive to the usual doses of epinephrine while taking beta blockers.
  • In patients with known or suspected pheochromocytoma, initiate an alpha blocker prior to the use of any beta blocker.

Adverse Reactions

  • The most common adverse events with BYSTOLIC versus placebo (approximately ≥1% and greater than placebo) were headache, fatigue, dizziness, diarrhea, nausea, insomnia, chest pain, bradycardia, dyspnea, rash, and peripheral edema. The most common adverse events that led to discontinuation of BYSTOLIC were headache (0.4%), nausea (0.2%), and bradycardia (0.2%).

Drug Interactions

  • Use caution when BYSTOLIC is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc).
  • Do not use BYSTOLIC with other beta blockers.
  • Both digitalis glycosides and beta blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
  • BYSTOLIC can exacerbate the effects of myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide.

Use in Specific Populations

  • BYSTOLIC is not recommended during nursing.
  • In a placebo-controlled trial of 2128 patients (1067 BYSTOLIC, 1061 placebo) over 70 years of age with chronic heart failure receiving a maximum dose of 10 mg per day for a median of 20 months, no worsening of heart failure was reported with nebivolol compared to placebo. However, if heart failure worsens consider discontinuation of BYSTOLIC.

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