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
RAPIBLYKTM 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 reactions to RAPIBLYKTM or any of the inactive ingredients
Warning and Precautions
- Hypotension: Patients with hemodynamic compromise, hypovolemia, or on interacting medications are at increased risk of hypotension.
- Bradycardia: Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders are at increased risk of bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest.
- Cardiac Failure: Beta-blockers, like RAPIBLYKTM, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock.
- Reactive Airways Disease: Patients with reactive airways disease should, in general, not receive Beta blockers. Because of its relative beta-1 selectivity and titratability, RAPIBLYKTM injection may be titrated to the lowest possible effective dose.
- Patients with Diabetes Mellitus and Hypoglycemia: beta blockers may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus, patients who are fasting, or children.
- Infusion Site Reactions: Infusion site reactions such as pain, swelling and erythema have occurred with the use of RAPIBLYKTM.
- Patients with Prinzmetal’s Angina: beta blockers may exacerbate anginal attacks.
- Patients with Pheochromocytoma: Administration of RAPIBLYK without opposing alpha blockade in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure from the attenuation of beta receptor-mediated vasodilation in skeletal muscle.
- Patients with Peripheral Circulatory Disorders: RAPIBLYKTM may exacerbate peripheral circulatory disorders, such as Raynaud’s disease or syndrome, and peripheral occlusive vascular disease.
- Abrupt Discontinuation of RAPIBLYK Injection: Severe exacerbations of angina, myocardial infarction, and ventricular arrhythmias have been reported in patients with coronary artery disease upon abrupt discontinuation of beta-blocker therapy.
- Hyperkalemia: Beta-blockers, including RAPIBLYKTM, can cause increases in serum potassium and hyperkalemia. The risk is increased in patients with risk factors such as renal impairment.
- Patients with Metabolic Acidosis: Beta-blockers have been reported to cause hyperkalemic renal tubular acidosis.
- Patients with Hyperthyroidism: Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism.
- Patients at Risk of Severe Acute Hypersensitivity Reactions: may be more reactive to allergen exposure. Patients using beta blockers may be unresponsive to the usual doses of epinephrine used to treat anaphylactic or anaphylactoid reactions.
Adverse Reactions
The most important and common adverse reaction is hypotension, which in clinical trials occurred in 9.9% of patients receiving RAPIBLYKTM vs. 1% in those receiving placebo.
Please see the full Prescribing Information for RAPIBLYKTM at
Indications
RAPIBLYKTM is indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter.