rapiblyk

Administer as an intravenous infusion in a monitored setting. ( 2.1 ) Titrate according to ventricular rate. ( 2.1 ) If normal cardiac function, start at 9 mcg/kg/min; adjust dose in 10-minute intervals as needed in increments of 9 mcg/kg/min to a maximum of 36 mcg/kg/min. ( 2.1 ) If impaired cardiac function, start at 1 mcg/kg/min; adjust dose in 15-minute intervals as needed in increments of 1 mcg/kg/min to a maximum of 36 mcg/kg/min. ( 2.1 ). 2.1 Recommended Dosage Administer RAPIBLYK as a continuous intravenous infusion in a monitored setting, titrating as needed for heart rate control. There are limited data beyond 24 hours of use. Adults Pediatric patients Normal cardiac function Impaired cardiac function Normal cardiac function* Starting dose 9 mcg/kg/min 1 mcg/kg/min 9 mcg/kg/min Titration interval 10 min 15 min 10 min Titration step 9 mcg/kg/min 1 mcg/kg/min 9 mcg/kg/min Maximum dose 36 mcg/kg/min 36 mcg/kg/min 36 mcg/kg/min *There are no data to guide dosage recommendations in pediatric patients with impaired cardiac function. 2.2 Transitioning from RAPIBLYK Injection Therapy to Alternative Medications When transitioning to alternative medications consider the pharmacodynamics of the medication to which the patient is being transitioned and monitor clinical response. If switched to an oral beta-blocker, the dosage of RAPIBLYK can be reduced as follows: Ten minutes…

The most common adverse reaction (9.9%) is hypotension ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact AOP Orphan Pharmaceuticals at [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the 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 clinical practice. The safety of RAPIBLYK was evaluated in 19 placebo-controlled clinical trials involving 1,761 adult patients (in a variety of clinical in-patient settings) with supraventricular tachycardia or at high risk for supraventricular tachycardia. The most common adverse reaction is hypotension, which occurred in 9.9% of patients receiving RAPIBLYK vs. 1% in those receiving placebo [see Warnings and Precautions ( 5.1 )]. In a single-arm, unblinded clinical trial in 60 pediatric patients who received RAPIBLYK, the most common adverse reaction was hypotension, which occurred in 10% of patients aged birth to <18 years receiving RAPIBLYK [see Warnings and Precautions ( 5.1 )]. Hypotension was also the most common adverse reaction leading to treatment discontinuation.

RAPIBLYK is contraindicated in patients with: Severe sinus bradycardia, sick sinus syndrome, heart block greater than first degree [see Warnings and Precautions ( 5.2 )] . Decompensated heart failure [see Warnings and Precautions ( 5.3 )] . Cardiogenic shock: May precipitate further cardiovascular collapse and cause cardiac arrest. Pulmonary hypertension: May precipitate cardiorespiratory decompensation. Hypersensitivity reactions, including anaphylaxis, to landiolol or any of the inactive ingredients 5.3 Severe sinus bradycardia ( 4 ) Sick sinus syndrome ( 4 ) Heart block greater than first degree ( 4 ) Decompensated heart failure ( 4 ) Cardiogenic shock ( 4 ) Pulmonary hypertension ( 4 ) Known hypersensitivity to landiolol ( 4 )

10.1 Signs and Symptoms of Overdose Overdoses of RAPIBLYK injection can cause adverse cardiac and central nervous system effects. These adverse effects may precipitate severe signs, symptoms, sequelae, and complications such as severe cardiac and respiratory failure, including shock and coma, and may be fatal. Continuous monitoring of the patient is required. Cardiac adverse effects include bradycardia, atrioventricular block (1-, 2-, 3-degree), junctional rhythms, intraventricular conduction delays, decreased cardiac contractility, hypotension, cardiac failure (including cardiogenic shock), cardiac arrest/asystole, and pulseless electrical activity. Central nervous system adverse effects include respiratory depression, seizures, sleep and mood disturbances, fatigue, lethargy, and coma. In addition, bronchospasm, hyperkalemia, and hypoglycemia (especially in pediatric patients) may occur. 10.2 Treatment Recommendations Because of its approximately 4-minute elimination half-life, the first step in the management of toxicity should be to discontinue RAPIBLYK infusion. Then, based on the observed clinical effects, consider the following general measures: Bradycardia Consider intravenous administration of atropine or another anticholinergic drug or cardiac pacing. Cardiac Failure Consider intravenous administration of a diuretic or digitalis glycoside. In shock resulting from…

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

Negative Inotropes and Chronotropes: Avoid ( 7.1 ) Sympathomimetics, Positive Inotropes and Vasoconstrictors: Avoid ( 7.2 ) Catecholamine Depleting Drugs: Monitor blood pressure and heart rate ( 7.3 ). 7.1 Negative Inotropes and Chronotropes Avoid concomitant use of RAPIBLYK with negative inotropes and medications that slow heart rate or cardiac conduction. Beta-blockers, like RAPIBLYK, can cause depression of myocardial contractility and increase the risk of bradycardia or heart block. Concomitant use of RAPIBLYK with negative inotropes or chronotropes may augment these effects [see Warnings and Precautions ( 5.2 )( 5.3 )] . 7.2 Sympathomimetics, Positive Inotropes and Vasoconstrictors Beta adrenergic agonists will antagonize the effects of RAPIBLYK and may attenuate the heart rate lowering effects of RAPIBLYK. Positive inotropes and vasoconstrictors may attenuate the heart rate and blood pressure lowering effects of RAPIBLYK. 7.3 Catecholamine Depleting Drugs Observe patients treated with RAPIBLYK plus a catecholamine depletor (e.g., reserpine, monoamine oxidase inhibitors) for hypotension or marked bradycardia, which may cause vertigo, syncope, or postural hypotension. Catecholamine depleting drugs may have an additive effect when given with beta-blockers, which may increase the risk of hypotension or marked bradycardia related vertigo, syncope, or postural hypotension [see Warnings and Precautions ( 5.1 )] .