Disclaimer: This information is provided for illustrative purposes only. This information is not to be used as a manual or definitive guide when administering a product manufactured by AOP Orphan Pharmaceuticals GmbH, AOP Health US LLC, its affiliates, or parent company (collectively “AOP Health”). AOP Health is not responsible for any variations or differences between the equipment shown and the equipment utilized by the healthcare professional (HCP) administering the product. AOP Health encourages all HCPs to rely on their training, independent clinical decision making, and the FDA approved prescribing information (PI).
Instructions for Use
Reconstitution
The following images illustrate the step-by-step reconstitution process of RapiblykTM, demonstrating the correct handling and preparation procedures. By following these Instructions for Use, it is assumed the Healthcare Professional is using the proper equipment and is properly trained to handle, prepare, and administer the product.
Initial set-up steps
Some of these steps apply to all options listed below. Please follow instructions carefully.
Step 1
Attach the needle to the syringe.
Step 2
Swipe a resealable medication port of diluent* with alcohol prep.
* 50 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP
Step 3
Puncture resealable medication port with the syringe (as pictured) and withdraw 50 mL of diluent to the syringe.
Reconstitute each 280 mg vial of RAPIBLYKTM with 50 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP
Step 4
Remove the flip cap from RAPIBLYKTM vial, avoid touching the top of the vial where the syringe is inserted.
If you do, swipe it with alcohol prep.
Step 5
Inject 50 ml diluent into the product vial that contains the RAPIBLYKTM powder.
Step 6
Gently swirl the vial in order to dissolve powder in the diluent solution and medication thoroughly.
When the RAPIBLYKTM powder is completely dissolved, inspect it for particulate matter and discoloration prior to administration.
The reconstituted solution should be a clear and colorless solution.
Step 7
Once reconstituted solution is clear and colorless, withdraw entire diluted content (50 ml) from RAPIBLYKTM vial to the syringe.
3 options to administer Rapiblyk™:
Administer as an intravenous infusion in a monitored setting.
- Titrate according to ventricular rate.
- 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.
- 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.
Option 1 – Infusion from a hanging bag
Follow Steps 1-7 (see above). Please follow instructions carefully.
Step 8A
Use syringe containing reconstituted solution to inject it into the medication port of the 50 ml diluent bag.
Step 9A
Hang the bag on an infusion stand and connect it to the infusion pump and the tube.
Use immediately.
The reconstituted RAPIBLYKTM solution storage conditions are described in Table 2.
Discard unused portion.
Diluent used to Prepare Solution | Reconstituted RAPIBLYKTM |
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) |
Table 2: Reconstituted RAPIBLYK Solution Storage and Use Conditions
Option 2 - Syringe pump
Follow Steps 1-7 (see above). Please follow instructions carefully.
Step 8B
Attach the syringe to a syringe pump.
Step 9B
Use immediately.
The reconstituted RAPIBLYKTM solution storage conditions are described in Table 2.
Discard unused portion.
Diluent used to Prepare Solution | Reconstituted RAPIBLYKTM Solution Storage |
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) |
Table 2: Reconstituted RAPIBLYK Solution Storage and Use Conditions
Option 3 - Infusion from vial
Follow steps 1-6 (see above). Please follow instructions carefully.
Step 7C
Hang the vial on an infusion stand, using an appropriate hanging device.
Step 8C
Connect the infusion pump and the tube to the vial.
Step 9C
Use immediately.
The reconstituted RAPIBLYKTM solution storage conditions are described in Table 2.
Discard unused portion.
Diluent used to Prepare Solution | Reconstituted RAPIBLYKTM 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) |
Table 2: Reconstituted RAPIBLYK Solution Storage and Use Conditions
This information is provided for illustrative purposes only. See full disclaimer
IMPORTANT SAFETY INFORMATION
Contraindications
RAPIBLYK® is contraindicated in patients with:
- Severe sinus bradycardia
- Sick sinus syndrome
- Heart block greater than first degree
- Decompensated heart failure
- Cardiogenic shock
- Pulmonary hypertension
- Hypersensitivity to landiolol or any of the inactive ingredients
Warning and Precautions
Patients with hemodynamic compromise, hypovolemia, or receiving interacting medications are at increased risk of hypotension. Monitor blood pressure closely. Reduce or discontinue RAPIBLYK if hypotension occurs.
Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest, may occur. Monitor heart rate and rhythm. Reduce or discontinue RAPIBLYK for bradyarrhythmia.
Beta-blockers may cause depression of myocardial contractility and may precipitate heart failure or cardiogenic shock. At the first sign of impending cardiac failure, discontinue RAPIBLYK and initiate supportive therapy.
Beta-blockers may exacerbate bronchospasm. Use caution in patients with reactive airway disease. Discontinue infusion if bronchospasm occurs.
Beta-blockers may mask symptoms of hypoglycemia (e.g., tachycardia) and may increase the risk for severe or prolonged hypoglycemia. Monitor blood glucose in patients with diabetes or those at risk.
Infusion site reactions including pain, swelling, and erythema have occurred. Avoid infusions into small veins or through butterfly catheters. Use an alternative site if reactions develop.
Abrupt discontinuation of beta-blocker therapy in patients with coronary artery disease may result in exacerbations of angina, myocardial infarction, or ventricular arrhythmias. Monitor for signs of myocardial ischemia when discontinuing RAPIBLYK.
Beta-blockers may increase serum potassium. Monitor electrolytes during therapy, especially in patients with renal impairment.
Beta-adrenergic blockade may mask clinical signs of hyperthyroidism. Abrupt withdrawal may precipitate thyroid storm.
Patients at risk of anaphylaxis may be more reactive to allergen exposure and may be unresponsive to usual doses of epinephrine.
Adverse Reactions
The most common adverse reaction was hypotension in adults and pediatric patients.
Drug Interactions
- Avoid concomitant use with negative inotropes or medications that slow heart rate or cardiac conduction.
- Beta-adrenergic agonists may antagonize the effects of RAPIBLYK.
- Use caution with catecholamine-depleting drugs due to increased risk of hypotension or bradycardia.
For more information about RAPIBLYK, see full Prescribing Information.
Indications
RAPIBLYK® (landiolol) for injection is a beta-adrenergic blocker indicated for the short-term reduction of ventricular rate in:
- Adults with supraventricular tachycardia, including atrial fibrillation and atrial flutter
- Pediatric patients with supraventricular tachycardia