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ABOUT THE ON-BODY INFUSOR

FUROSCIX is a prescription medicine used to treat fluid buildup, which can cause congestion or swelling (also known as edema), in pediatric patients who weigh at least 95 lbs. (43 kg) and adult patients with chronic heart failure or chronic kidney disease.

This page can provide you with the information you need about using and storing the FUROSCIX On-Body Infusor.

USING THE ON-BODY INFUSOR

The FUROSCIX Instructions for Use will show you how to get ready for your treatment and load your medication into the device.

Adhere the device to your stomach as shown in the Instructions.

A single button press starts your 5-hour treatment.

While you have the FUROSCIX device in place, you can perform many normal, at-home activities that do not move or bump the device.

The device will tell you when it is done working and can be removed. It can only be used once, so please dispose of it when finished.

In pediatric patients weighing at least 43 kg, FUROSCIX must be administered by a healthcare provider or adult caregiver. Adult patients or caregivers should receive proper instruction in preparing and administering FUROSCIX before using the FUROSCIX On-Body Infusor.

IMPORTANT INFORMATION ABOUT USING FUROSCIX

Try to not bend over while wearing the FUROSCIX device.

Your care team will determine:

When you need FUROSCIX to treat fluid buildup
How many doses to use—FUROSCIX is not for daily use
If and when follow-up visits may be needed after treatment

NOTE: It’s important to stay at home and near your bathroom while using FUROSCIX.

You might complete the treatment for fluid buildup without using all of the FUROSCIX doses your care team gives you. Any unopened boxes can be stored in a safe place at room temperature for the next time a dose may be needed.

FUROSCIX doses can be stored for at least 9 months and up to 2 years. Please check the expiration date on the package before using FUROSCIX.

FUROSCIX^®(furosemide injection) with the On-Body Infusor is indicated for the treatment of edema (i.e., congestion, fluid overload, or hypervolemia) in pediatric patients who weigh at least 43 kg and adult patients with chronic heart failure or chronic kidney disease (CKD), including the nephrotic syndrome.

The On-Body Infusor is provided in a complete, ready-to-use kit. The Infusor itself is preprogrammed for treatment with a prefilled cartridge.

In an open-label, crossover study,

FUROSCIX AND IV FUROSEMIDE DEMONSTRATED EQUIVALENT BIOAVAILABILITY and diuresis¹*

FUROSCIX Achieved 99.6% Absolute Bioavailability¹

a chart showing that FUROSCIX achieves 99.6% absolute bioavailability

FUROSCIX DEMONSTRATED EQUIVALENT DIURESIS to IV^1†

Total Urine Output of FUROSCIX vs IV furosemide:
0–8h 2663 mL vs 2718 mL; 0–24h 3614 mL vs 3672 mL

Phase 1, randomized, open-label, single-center crossover study in representative FUROSCIX patients characterizing the bioavailability, PK, and PD of FUROSCIX 80 mg/10 mL via the On-Body Infusor compared to the equivalent IV dose of furosemide. FUROSCIX demonstrated equivalent bioavailability.¹

Urine output between FUROSCIX and IV furosemide remained consistent regardless of eGFR²
In patients with reduced eGFR, furosemide plasma levels increased as renal function declined²
Mean C_max values from FUROSCIX were lower than IV²

90% confidence interval of 94.8-104.8. The design of the device used in this study was different from the current FUROSCIX On-Body Infusor, but it used the same administration profile.

†

Urine output over the periods of 0 to 8 hours and 0 to 24 hours following administration of 80-mg furosemide by 5-hour subcutaneous infusion with FUROSCIX, or IV administration of 2 doses of 40 mg 2 hours apart. Time 0 indicates the start of diuresis therapy.

C_max=peak concentration.

Administration and dosing

FUROSCIX delivers a fixed 80 mg of medication over 5 hours³:

30 mg in the first hour
12.5 mg per hour for the next 4 hours

The number of doses of FUROSCIX should be individualized based on the patient’s therapeutic response. FUROSCIX is not for chronic use and should be replaced with oral diuretics as soon as practical.

Any unused doses of FUROSCIX can be stored at room temperature. FUROSCIX for the On-Body Infusor has up to a 2-year shelf life.

tolerability and safety

The safety of subcutaneous FUROSCIX was established based on similar systemic exposure when compared to IV furosemide¹
FUROSCIX for the On-Body Infusor is formulated with a pH of 7.4 to minimize tissue irritation^1,3
Adverse reactions were consistent with those reported with IV furosemide^3,4
The most common adverse reactions were erythema, bruising, edema, and infusion site pain³

monitoring

Monitoring is consistent with diuretic guidance and should be at the HCP’s discretion similarly to when oral diuretic regimens are augmented.⁵

How do I take FUROSCIX with the On-Body Infusor?

FUROSCIX is delivered into your body through a preprogrammed, one-time-use device that you wear on your stomach. Once you have it in place and press the start button, the FUROSCIX device does everything needed to give you the right dose of medication over a 5-hour period.

It is important to read and understand the FUROSCIX Instructions for Use. That document is included in the FUROSCIX kit that will be delivered to your home. You can also use the FUROSCIX Quick Reference Guide.

Is FUROSCIX difficult for patients to apply and use themselves?

The FUROSCIX device was designed for simple, at-home use. The team at FUROSCIX met with real patients to make sure the Instructions for Use were easy to understand. Almost every person understood the instructions and were able to correctly use the FUROSCIX device.

Where on my body should FUROSCIX be placed?

The FUROSCIX device should be placed on the stomach on either side of the belly button. The site should be a flat area below the rib cage and above the belt line. The site should be hairless or nearly hairless. Do not select a site where the skin is irritated or broken. Do not apply lotions, oils, or ointments to the area of the stomach where the device will be placed. Do not select a site where belts, waistbands, or other types of clothing may rub against, disturb, or dislodge the device. Put the device on different sides of the stomach each time your care team tells you to use another dose of FUROSCIX.

What can I do during the 5 hours that I am wearing FUROSCIX?

During the 5 hours of treatment, you should limit your activity so that you do not bend enough to disturb or dislodge the device. Wearing the FUROSCIX device while riding in a car or flying in an airplane is not recommended. You should notice an increase in urine production about an hour after the infusion is started and may need to make frequent bathroom visits. Be sure you have easy access to a bathroom for up to 8 hours after starting the infusion. Do not let the FUROSCIX device get wet. Do not shower, bathe, swim, or do activities that may make you sweat while wearing the FUROSCIX device. It contains parts that should not get wet.