Furoscix
Pronunciation: fur-roh-skix
Generic name: furosemide
Dosage form: subcutaneous injection (80 mg/10 mL)
Drug class: Loop diuretics
What is Furoscix?
Furoscix is a loop diuretic that may be used to treat edema in adults with chronic heart failure or chronic kidney disease, including the nephrotic syndrome.
- Furoscix is administered by subcutaneous infusion at home by you or your caregiver with the use of the Furoscix On-Body Infusor.
- The single-use on-body infuser is designed to deliver furosemide 30 mg over the first hour, then furosemide 12.5 mg per hour for the next 4 hours.
- Furoscix can be used regardless of the New York Heart Association (NYHA) functional class for heart failure.
- Includes patients with the most severe type of heart failure (NYHA Class IV) who represent the most symptomatic patients and those with the greatest limitation on physical activity.
Furoscix first gained FDA approval on October 7, 2022, for patients with Class II and III chronic HF. This approval was expanded on August 9, 2024, to include all patients with chronic HF, regardless of the NYHA class. Furosemide was first approved on July 1, 1966.
Furoscix side effects
The most common side effects reported with Furoscix are:
- Injection site reactions, such as redness, bruising, swelling, and pain.
Serious side effects and warnings
Furoscix may cause the following serious side effects:
- fluid, electrolyte, and metabolic abnormalities. You should have regular blood tests during furosemide therapy
- dehydration, particularly in elderly patients
- tinnitus (ringing in the ears), hearing impairment, or hearing loss. Avoid higher than recommended doses
- worsening kidney function and an inability to break down waste products in the blood
- an inability to urinate.
Furoscix is not for use in emergencies or in patients with acute pulmonary edema (fluid around the lungs that happens suddenly).
The Furoscix infusion will last about 5 hours. During this time, you should limit your activity so that your bending movements are limited. Wearing the Infusor while riding in a car or flying in an airplane is not recommended.
- Do not use the On-Body Infusor within 12 inches of mobile phones, tablets, computers or wireless accessories (for example: TV remote control, Bluetooth computer keyboard or mouse).
- You may get an incomplete dose if you have contact with fluid or do certain movements, which cause the on-body infuser to prematurely terminate the infusion.
- Your healthcare provider will teach you what to do if the machine sounds an alarm.
You should notice an increase in urine production about an hour after the infusion starts and you may need to go to the bathroom more frequently. Be sure you have access to a bathroom for up to 8 hours after starting the infusion.
- If you find yourself not needing to urinate at all, call your healthcare provider, because this may indicate something more serious.
To report suspected side effects, contact scPharmaceuticals, Inc. at 1-855-727-4276 or FDA at 1-800-FDA1088 or www.fda.gov/medwatch.
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Before receiving Furoscix
Furoscix should not be given to people who have anuria (an absence of urine production), with severe scarring of the liver (hepatic cirrhosis), or who are allergic to furosemide, Furoscix, or any of the inactive ingredients in the Furoscix injection.
Before you receive Furoscix, tell your healthcare provider about all of your medical conditions, including if you have:
- anuria (lack of urine production)
- an allergy to furosemide or medical adhesives
- hepatic cirrhosis (scarring of the liver caused by liver disease)
- ascites (buildup of fluid in your abdomen).
How should I use Furoscix?
Before Starting
Read the Instructions for Use leaflet that comes with your prescription before using the Furoscix On-Body Infusor for the first time.
- You or a caregiver should receive training before using the Furoscix On-Body Infusor.
- Always wash your hands before starting.
- The Furoscix On-Body Infusor will deliver a fixed dose of 80 mg of furosemide over about 5 hours.
- The Furoscix On-Body Infusor delivers the medicine just under the skin (subcutaneously).
- When the Furoscix On-Body Infusor is started, a small needle sticks into the skin to deliver the medicine. The On-Body Infusor signals when all the medicine has been delivered. When the On-Body Infusor is removed from the skin, a needle cover will extend over the needle to protect from an accidental needle stick.
Prepare for the Infusion
STEP 1
Wash your hands, check the expiration date, and remove supplies from the carton.
STEP 2
Check the On-Body Infusor and prefilled cartridge. Do not touch the blue start button until the On-Body Infusor is on the skin and you are ready to begin the infusion.
STEP 3
Load the prefilled cartridge into the On-Body Infusor.
Apply the On-Body Infusor
STEP 4
Select and prepare the application site on the stomach on either side of the belly button (navel). The site should be a flat area below the rib cage and above the belt line.
Do not select a site where the skin is irritated or broken.
Do not apply lotions, oils, or ointments to the adhesion area of the abdomen.
Do not select a site where belts, waistbands, or other types of clothing may rub against, disturb, or dislodge the On-Body Infusor.
The site should be hairless or nearly hairless. If needed, remove excess hair by clipping or shaving the hair before applying the On-Body Infusor.
Wipe the skin where the On-Body Infusor will be applied with an alcohol wipe and allow the area to dry.
STEP 5
Pick up the On-Body Infusor. Peel away the adhesive liner by grasping the white tab and pulling it away from the blue tab/adhesive backing.
Do not touch the sticky (adhesive) part of the On-Body Infusor with your fingers or let it touch any objects or surfaces before the Infusor is placed on the skin.
Apply the On-Body Infusor to the chosen skin site while standing or sitting up straight.
Position the On-Body Infusor so that the cartridge window and the indicator light can be seen during the infusion.
Do not bend over when applying the On-Body Infusor.
Press the On-Body Infusor firmly onto the skin and hold it for several seconds, then rub your finger over the edges of the adhesive to get it to stick well.
Do not touch the blue start button until you are ready to start the infusion.
Do not remove and reapply the On-Body Infusor. The On-Body Infusor adhesive might not work as well.
Start the Infusion
STEP 6
Firmly press and release the blue start button to begin the infusion.
The On-Body Infusor will stick a very small needle just under the skin and begin delivering the medicine. The indicator light will start blinking green and the On-Body Infusor "beeps", signifying that the infusion has begun.
Note: At the start of the infusion, you may also hear the On-Body Infusor motor running for several seconds.
STEP 7
Allow the medicine to deliver for 5 hours.
Relax during the delivery period. The On-Body Infusor should remain on the skin until the delivery is complete.
Do not exercise or take part in activities that might result in the On-Body Infusor falling off. Take care not to bump the onbody Infusor while wearing it. It takes about 5 hours for the On-Body Infusor to deliver all of the medicine. During the infusion, the indicator light will continue to blink green periodically, signifying that the infusion is running.
Note: If the On-Body Infusor falls off or if the indicator light begins blinking red, call your healthcare provider right away (see On-Body Infusor Alarm section). Do not reapply or reuse the On-Body Infusor. Do not apply a new On-Body Infusor unless instructed to do so by your healthcare provider.
If you have to stop the infusion due to an emergency, do the following:
- Remove the On-Body Infusor from the skin. It will immediately stop infusing and the On-Body Infusor will deactivate. Do not reuse the On-Body Infusor.
After the On-Body Infusor is removed, it can no longer be used. - Call your healthcare provider for further instructions.
Remove and Dispose of the On-Body Infusor
STEP 8
When the infusion is complete, remove the On-Body Infusor from the skin.
The infusion is complete and the On-Body Infusor is ready to be removed when:
- The indicator light turns solid green.
- The On-Body Infusor "beeps".
- The white plunger rod fills the cartridge window all the way.
Note: If the indicator light begins blinking red instead of green and the On-Body Infusor “beeps”, call your healthcare provider.
Peel the On-Body Infusor off the skin by holding the skin down and pulling on the blue tab. When the On-Body Infusor is removed, the indicator light will turn off, the needle cover will extend over the needle to protect against accidental needle stick injuries, and the On-Body Infusor will turn off.
When the On-Body Infusor is removed, the indicator light will turn off, the needle cover will extend over the needle to protect against accidental needle sticks, and the On-Body Infusor will turn off.
Note: You might have some discomfort after you remove the adhesive. This discomfort should quickly go away. However, some redness of the skin may remain.
Check the infusion site. If there is any bleeding use a cotton ball or apply a small adhesive bandage.
STEP 9
Throw away (dispose) of the used On-Body Infusor and prefilled cartridge together into an FDA-cleared sharps container.
Do not attempt to remove the cartridge from the On-Body Infusor; it cannot be removed.
Do not throw away the used On-Body Infusor into household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used Needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
Do not recycle the On-Body Infusor or sharps disposal container or throw them into household trash.
Important: Always keep the sharps disposal container out of the reach of children.
For more information refer to: http://www.safeneedledisposal.org
Furoscix dosing information
Usual Furoscix Adult Dose for Chronic Heart Failure and Chronic Kidney Disease
Furoscix 30 mg over the first hour, then 12.5 mg per hour for the subsequent 4 hours.
- This dose is automatically delivered by the Furoscix On-Body Infusor
- Furoscix is not for chronic use and should be replaced with oral diuretics as soon as practical.
What other drugs will affect Furoscix?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Tell your doctor about all your other medicines, especially:
- aminoglycoside antibiotics;
- ethacrynic acid;
- lithium;
- chloral hydrate;
- phenytoin;
- cisplatin;
- salicylates; or
- heart or blood pressure medicines.
This list is not complete. Other drugs may interact with furosemide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Furoscix ingredients
Active ingredients: furosemide injection 80 mg/10 mL
Inactive ingredients (per 1 mL): hydrochloric acid for pH adjustment if needed, sodium chloride (5.84 mg), sodium hydroxide for pH adjustment if needed, tris HCl (7.88 mg), and water for injection (q.s.).
Furoscix is administered via a wearable, single-use, electromechanical (battery-powered, micro-processor
controlled), On-body delivery system that is pre-programmed to deliver 80 mg of Furoscix over 5 hours
using a bi-phasic delivery profile.
Furoscix storage
Store the Furoscix On-Body Infusor and prefilled cartridge at controlled room temperature between 68°F to 77°F (20°C to 25°C). Do not refrigerate or freeze.
Keep the Furoscix prefilled cartridge in the original carton to protect it from light or physical damage until you are ready to use it.
Keep out of the reach of children.
Who makes Furoscix?
Furoscix is made by scPharmaceuticals, Inc., a pharmaceutical company based in Burlington, Massachusetts. The company specializes in developing and commercializing innovative subcutaneous delivery technologies for administering medications that have traditionally been given intravenously.
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