FUROSCIX readyflow™ demonstrated IV-equivalent bioavailability and diuresis1†
| MEAN (SD) TOTAL URINE OUTPUT (L) | Furoscix ReadyFlow | iv furosemide |
|---|---|---|
| 0-6 H | 3.19 (0.88) |
2.92 (0.72) |
| 0-8 H | 3.52 (0.90) |
3.19 (0.79) |
| 0-12 H | 3.99 (0.96) |
3.70 (0.95) |
Pivotal PK/PD study: randomized, open-label, single-center crossover study in healthy participants characterizing the bioavailability, PK, and PD of FUROSCIX 80 mg/mL via the ReadyFlow autoinjector compared to the equivalent IV dose of furosemide. FUROSCIX ReadyFlow demonstrated equivalent bioavailability.1‡
In a study performed with the FUROSCIX On-Body Infusor,
URINE OUTPUT BETWEEN FUROSCIX AND IV FUROSEMIDE REMAINED CONSISTENT REGARDLESS OF eGFR2,3
*
Urine output over the periods of 0 to 6 hours, 0 to 8 hours, and 0 to 12 hours following administration of 80 mg/mL as a subcutaneous injection via an autoinjector compared with an equivalent dose of furosemide administered as two 40-mg IV injections over 1 to 2 minutes, 2 hours apart. Time 0 indicates the start of diuresis therapy.
†
90% confidence intervals for the geometric mean ratios were determined.
‡
Bioavailability was estimated by least squares mean ratios of AUClast and AUCinf between FUROSCIX ReadyFlow and IV.
eGFR=estimated glomerular filtration rate; PD=pharmacodynamics; PK=pharmacokinetics; SD=standard deviation.
The safety of subcutaneous FUROSCIX ReadyFlow was established based on similar systemic exposure when compared to IV furosemide1
Formulated with a pH of 7.7 to minimize tissue irritation4
Adverse reactions were consistent with those reported with IV furosemide1,4,5
The most common adverse reactions were muscle spasm and injection site pain, bruising, and erythema1
Monitoring is consistent with diuretic guidance and should be at the HCP’s discretion similarly to when oral diuretic regimens are augmented6
Delivered as a fixed 80 mg of medication4
Pharmacodynamics from ReadyFlow is similar to that of FUROSCIX delivered as a 5-hour infusion1,2