Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common adverse reaction (9.9%) is hypotension ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact AOP Orphan Pharmaceuticals at drugsafety.us@aop-health.com 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.
5 WARNINGS AND PRECAUTIONS Risk of hypotension, bradycardia, and cardiac failure: Monitor for signs and symptoms of cardiovascular adverse effects.
Reduce or discontinue use ( 5.1 , 5.2 , 5.3 ) Risk of exacerbating reactive airway disease ( 5.5 ) Diabetes mellitus: May mask symptoms of hypoglycemia and alter glucose levels;
monitor ( 5.6 ) Monitor for signs of myocardial ischemia when abruptly discontinuing in patients with coronary artery disease ( 5.10 ) 5.1 Hypotension Patients with hemodynamic compromise, hypovolemia, or on interacting medications are at increased risk of hypotension.
Monitor blood pressure closely, especially if pretreatment blood pressure is low.
Reduce or stop RAPIBLYK injection for hypotension then expect the blood pressure effect to wane within 30 minutes.
Like all medications, Rapiblyk can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: