Furoscix

Furoscix is a loop diuretic used to treat edema (fluid buildup) in adults with chronic heart failure or chronic kidney disease, including the nephrotic syndrome, and in children weighing 43 kg (94.7 lb) or more.

Furoscix is given as an injection under the skin (subcutaneously) into the abdomen at home, by you or your caregiver. There are now two ways to receive it.

• Furoscix ReadyFlow is a prefilled autoinjector that delivers the full 80 mg dose in about 10 seconds. It is approved for adults only.
• The Furoscix On-Body Infusor is a wearable, single-use device that delivers 30 mg of furosemide over the first hour, then 12.5 mg per hour for the next 4 hours, giving 80 mg in total over about 5 hours. It is approved for adults and for children weighing 43 kg or more.

Both options deliver the same 80 mg dose of furosemide, and both provide furosemide exposure comparable to the same dose given intravenously. The difference is how long administration takes and how long the diuretic effect lasts.

Furoscix can be used in adults regardless of the New York Heart Association (NYHA) functional class for heart failure. This includes patients with the most severe type of heart failure (NYHA Class IV), who are the most symptomatic and have the greatest limitation on physical activity.

Furoscix is not for chronic use and should be replaced with oral diuretics as soon as practical.

Furoscix approval history

Furoscix was approved on October 7, 2022, for NYHA Class II and III heart failure, then expanded to all NYHA classes (August 2024), chronic kidney disease (March 2025), and children 43 kg or more (December 2025). The ReadyFlow autoinjector followed on July 24, 2026.

Read the Instructions for Use leaflet that comes with your prescription before using either device for the first time. You or your caregiver should receive training before your first dose, and you should always wash your hands before starting.

Furoscix is injected into the abdomen only. Change the site on your abdomen each time you use it. Check the medicine through the viewing window or cartridge first. It should be clear and colorless to slightly yellow. Do not use it if you see particles or if the liquid is cloudy or discolored.

Using the Furoscix ReadyFlow autoinjector

• Wash your hands, check the expiration date, and take the autoinjector out of the carton.
• Choose a site on your abdomen at least two inches away from your belly button, avoiding skin that is irritated or broken and any areas with scars or stretch marks. Clean the site and let it dry.
• Pull the blue cap straight off the ReadyFlow.
• Push the device firmly against your skin and hold it there until the yellow plunger rod stops moving and fills the viewing window. This takes about 10 seconds.
• Lift the device away and dispose of it in a sharps container.

Do not lift the device off your skin before the window has turned completely yellow, or you may not receive the full dose.

Using the Furoscix On-Body Infusor

The On-Body Infusor delivers a fixed dose of 80 mg of furosemide over about 5 hours. When it starts, a small needle goes just under the skin to deliver the medicine. The device signals when all the medicine has been delivered, and when it is removed, a needle cover extends over the needle to protect against accidental needle stick.

Prepare for the infusion

Step 1. Wash your hands, check the expiration date, and remove the supplies from the carton.

Step 2. Check the On-Body Infusor and prefilled cartridge. Do not touch the blue start button until the Infusor is on your skin and you are ready to begin.

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 your stomach, on either side of your belly button. The site should be a flat area below the rib cage and above the belt line, with at least 2.5 inches between the two.

• 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 before applying the device.
• Wipe the skin 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 and adhesive backing.

• Do not touch the sticky part with your fingers or let it touch any objects or surfaces before it is placed on the skin.
• Apply the device while standing or sitting up straight. Do not bend over when applying it.
• Position it so that the cartridge window and the indicator light can be seen during the infusion.
• Press it firmly onto the skin, hold for several seconds, then rub your finger over the edges of the adhesive so it sticks well.
• Do not remove and reapply the device, because the adhesive might not work as well.

Start the infusion

Step 6. Firmly press and release the blue start button. A very small needle goes just under the skin and delivery begins. The indicator light starts blinking green and the device beeps. You may also hear the motor running for several seconds.

Step 7. Allow the medicine to deliver for 5 hours. Relax during this time and leave the device on the skin until delivery is complete. Do not exercise or take part in activities that might knock the device off. The indicator light will keep blinking green while the infusion runs.

If the device falls off, or if the indicator light begins blinking red, call your healthcare provider right away. Do not reapply or reuse it, and do not apply a new one unless your healthcare provider tells you to.

If you have to stop the infusion because of an emergency, remove the device from your skin. It will stop infusing immediately and deactivate, and it cannot be used again. Call your healthcare provider for further instructions.

Remove and dispose of the On-Body Infusor

Step 8. The infusion is complete, and the device is ready to be removed when the indicator light turns solid green, the device beeps, and the white plunger rod fills the cartridge window all the way. If the light blinks red instead of green and the device beeps, call your healthcare provider.

Peel the device off by holding the skin down and pulling on the blue tab. The indicator light will turn off, the needle cover will extend over the needle, and the device will turn off.

You might have some discomfort after removing the adhesive. This should quickly go away, although some redness of the skin may remain. Check the site, and if there is any bleeding, use a cotton ball or a small adhesive bandage.

Step 9. Throw away the used On-Body Infusor and prefilled cartridge together into an FDA-cleared sharps container. Do not try to remove the cartridge from the device, as it cannot be removed. Do not put it in household trash.

Getting a complete dose

Both devices can deliver less than the full dose if they are not used as directed.

With the ReadyFlow, you may not get the full dose if the viewing window does not turn completely yellow, or if you lift the device off your skin too early. With the On-Body Infusor, contact with fluid or certain movements can make the device stop the infusion early.

If either happens, call your healthcare provider for instructions. Do not use a second device unless your healthcare provider tells you to.

What to expect with the On-Body Infusor

The On-Body Infusor infusion lasts about 5 hours. During this time, you should limit your activity so that bending movements are limited. Wearing the Infusor while riding in a car or flying in an airplane is not recommended, and it cannot be used in an MRI setting.

Do not use the On-Body Infusor within 12 inches of mobile phones, tablets, computers or wireless accessories (for example a TV remote control, or a Bluetooth keyboard or mouse). Your healthcare provider will teach you what to do if the device sounds an alarm.

Passing urine after your dose

You should notice an increase in urine production about an hour after your dose, and you may need to go to the bathroom more often. Be sure you have access to a bathroom for up to 8 hours after your dose.

If you find yourself not needing to urinate at all, call your healthcare provider, because this may indicate something more serious.

Disposing of used devices

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• made of heavy-duty plastic
• able to be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
• upright and stable during use
• leak-resistant
• properly labeled to warn of hazardous waste inside.

When your sharps container is almost full, follow your community guidelines for disposing of it. There may be state or local laws about how to throw away used needles and syringes. For more information, and for rules in your state, see the FDA website at http://www.fda.gov/safesharpsdisposal or http://www.safeneedledisposal.org.

Do not dispose of your used sharps container in household trash unless your community guidelines permit this, and do not recycle it. Always keep the sharps container out of the reach of children.

Furoscix should not be given to people who have anuria (an absence of urine production), or who are allergic to furosemide or to any of the inactive ingredients in Furoscix. The On-Body Infusor should not be used by anyone allergic to medical adhesives.

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, for the On-Body Infusor, to medical adhesives
• liver problems, including hepatic cirrhosis (scarring of the liver caused by liver disease)
• ascites (buildup of fluid in your abdomen)
• kidney problems, or trouble passing urine
• diabetes.

Pregnancy and breastfeeding

Decades of use have not shown that furosemide increases the risk of birth defects or miscarriage. Untreated heart failure and untreated cirrhosis can themselves harm both mother and baby, so treatment decisions need to weigh both sides. Tell your healthcare provider if you are pregnant, planning a pregnancy, or breastfeeding.

Furosemide passes into breast milk. There is no information on its effects on a breastfed baby, and doses that cause a large increase in urine output may reduce milk supply.

The ReadyFlow autoinjector contains benzyl alcohol as a preservative. Benzyl alcohol is broken down quickly, so exposure to a fetus or a breastfed baby is thought to be unlikely.

Common side effects

The most common side effects reported with Furoscix are reactions where the medicine is given, such as redness, bruising, swelling, and pain.

Your skin may also be more sensitive to sunlight while you are using furosemide.

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. Signs include dry mouth, increased thirst, muscle pain or cramps, passing less urine or darker urine than normal, headache, dry skin, and nausea or vomiting
• a temporary drop in blood pressure. You may feel lightheaded or dizzy, especially when standing up. Getting up slowly can help
• higher blood sugar levels if you have diabetes
• 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).

To report suspected side effects, contact MannKind Corporation at 1-877-323-8505 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usual adult dose, Furoscix ReadyFlow:

• 80 mg of furosemide delivered subcutaneously in about 10 seconds.

Usual adult and pediatric (43 kg and above) dose, Furoscix On-Body Infusor:

• 30 mg of furosemide over the first hour, then 12.5 mg per hour for the next 4 hours, delivered automatically by the device.

In children weighing at least 43 kg, the On-Body Infusor must be applied by a healthcare provider or adult caregiver. The ReadyFlow has not been established as safe or effective in children.

People with significantly reduced kidney function may need additional diuretic therapy, because both devices deliver a fixed 80 mg dose.

Furoscix is not for chronic use and should be replaced with oral diuretics as soon as practical.

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 and other medicines that can affect the kidneys
• cephalosporin antibiotics
• cyclosporine
• methotrexate
• indomethacin
• thyroid hormones
• salicylates
• heart or blood pressure medicines, including ACE inhibitors and angiotensin receptor blockers.

If you have high blood pressure, avoid over-the-counter products that can raise it, including appetite suppressants and some cold remedies.

This list is not complete. Other drugs may interact with furosemide, including prescription and over-the-counter medicines, vitamins, and herbal products.

Store Furoscix at controlled room temperature between 68°F and 77°F (20°C and 25°C). Brief excursions between 59°F and 86°F (15°C and 30°C) are permitted. Do not refrigerate or freeze.

Keep the autoinjector or prefilled cartridge in the original carton to protect it from light and physical damage until you are ready to use it. Keep the On-Body Infusor away from water.

Keep out of reach of children.

Active ingredient: furosemide.

Furoscix ReadyFlow, per 1 mL: furosemide 80 mg, with benzyl alcohol (35 mg) as a preservative, tromethamine (9.7 mg), hydrochloric acid and sodium hydroxide for pH adjustment if needed, and water for injection. The pH is 7.7.

Furoscix prefilled cartridge for the On-Body Infusor, per 1 mL: furosemide 8 mg (80 mg per 10 mL), with sodium chloride (5.84 mg), tris HCl (7.88 mg), hydrochloric acid and sodium hydroxide for pH adjustment if needed, and water for injection. The pH is 7.4.

The ReadyFlow is a disposable, single-dose, spring-driven autoinjector. The On-Body Infusor is a wearable, single-use, battery-powered and microprocessor-controlled delivery system pre-programmed to deliver 80 mg of furosemide over 5 hours in two phases.