Landiolol
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Dosing in kidney impairment
Observe patients for signs of myocardial ischemia when discontinuing RAPIBLYK injection. 5.11 Hyperkalemia Beta-blockers, including RAPIBLYK injection, can cause increases in serum potassium and hyperkalemia. The risk is increased in patients with risk factors such as renal impairment. Intravenous administration of beta-blockers has been reported to cause potentially life-threatening hyperkalemia in hemodialysis patients.
Monitor serum electrolytes during therapy with RAPIBLYK injection. 5.12 Use in Patients with Metabolic Acidosis Beta-blockers have been reported to cause hyperkalemic renal tubular acidosis. Acidosis in general may be associated with reduced cardiac contractility. 5.13 Use in Patients with Hyperthyroidism Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism.
Dosing in liver impairment
Hepatic Impairment More conservative dose titration is recommended in patients with mild hepatic impairment (Child-Pugh A). The effect of moderate or severe hepatic impairment (Child-Pugh B or C) on landiolol pharmacokinetics is unknown. Avoid use of RAPIBLYK in patients with moderate or severe hepatic impairment (Child-Pugh B or C). [see Pharmacokinetics] .
Preparation and administration
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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. [See table below.] 36 mcg/kg/min 36 mcg/kg/min *There are no data to guide dosage recommendations in pediatric patients with impaired cardiac function.
Instructions for Preparation Use appropriate aseptic technique for reconstitution. Reconstitute each 280 mg vial of RAPIBLYK with 50 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Gently swirl to dissolve contents. Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.
The reconstituted solution should be a clear, colorless solution. Use immediately. The reconstituted RAPIBLYK solution storage conditions are described in Table 2. Discard unused portion. [See table below.]
Administration Following reconstitution, the product contains 280 mg landiolol/50 mL = 5.6 mg/mL. The infusion rate can be calculated as: Infusion rate (mL/hour) = target dose (mcg/kg/min) × body weight (kg) / 93
| Diluent used to Prepare Solution | Reconstituted RAPIBLYK Solution Storage and Use Conditions |
| 50 mL of 0.9% Sodium Chloride Injection, USP | Use within 4 hours at room temperature (25°C, 77°F) |
| 50 mL of 5% Dextrose Injection, USP | Use within 48 hours at room temperature (25°C, 77°F) |
Drug interactions
Check landiolol against a medication listLabel text (4 paragraphs)
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 )] .
Contraindications
4 CONTRAINDICATIONS 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 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary The available published data on RAPIBLYK use in pregnant women are insufficient to inform a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Landiolol exposure was limited to a single injection at the time of Cesarean delivery in a small clinical trial. Neonatal bradycardia, hypoglycemia, and respiratory depression have been observed with use of beta-blockers in pregnancy near the time of delivery (see Clinical Considerations) . Administration of landiolol to pregnant rats showed distribution of landiolol to the placenta and the fetus.
In animal reproduction studies, no embryo-fetal toxicity was observed in rats or rabbits during the period of organogenesis at landiolol exposure in rats approximately 2.7 times human exposure at the maximum recommended human dose (MRHD) (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Landiolol crosses the placenta in rats. Neonates born to mothers who are receiving landiolol during pregnancy, may be at risk for hypotension, hypoglycemia, bradycardia, and respiratory depression. Monitor neonates exposed to landiolol during pregnancy and labor for hypotension, hypoglycemia, bradycardia, and respiratory depression and manage accordingly. Data Animal Data Landiolol HCl was administered intravenously to pregnant rats (25, 50, or 100 mg/kg/day from gestation day 7 to 17) and rabbits (25, 50, or 100 mg/kg/day from gestation day 8 to 18).
No adverse embryo-fetal effects were observed in rats at the landiolol HCl dose of 25 mg/kg/day, resulting in systemic landiolol exposure (AUC) of approximately 2.7-times the exposure at the MRHD. In rabbits, no adverse embryo-fetal effects were detected at the landiolol HCl dose of 100 mg/kg/day; the resulting systemic landiolol exposure (AUC) at this dose level was not determined. In a prenatal and postnatal development study in rats, landiolol HCl was administered intravenously at 25, 50, or 100 mg/kg/day from gestation day 17 to postpartum/lactation day 20. A decrease in the viability index for the offspring on postpartum day 4 was observed for the high dose group.
No effect on pre/post-natal development was observed at 50 mg/kg…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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