furoscix instructions for use

Furoscix is a prescription medicine used to treat fluid buildup (edema) in adults with chronic heart failure or chronic kidney disease. It delivers furosemide subcutaneously using an On-Body Infusor, offering a convenient, patient-friendly solution for managing fluid overload.

Indications for Use

Furoscix is indicated for treating edema in adults with chronic heart failure or chronic kidney disease, including nephrotic syndrome, using subcutaneous furosemide delivery.

2.1. Heart Failure

Furoscix is indicated for the treatment of congestion due to fluid overload in adults with chronic heart failure, specifically NYHA Class II/III. It delivers furosemide subcutaneously, reducing edema and improving symptoms like swelling and shortness of breath. The On-Body Infusor ensures continuous delivery over five hours, providing consistent diuretic effects. This method is particularly beneficial for patients who require outpatient or home-based therapy, offering a convenient alternative to traditional IV administration. By managing fluid buildup, Furoscix helps alleviate the discomfort and complications associated with heart failure, enhancing patient comfort and quality of life.

2.2. Kidney Disease

Furoscix is indicated for the treatment of edema in adults with chronic kidney disease, including nephrotic syndrome. It helps manage fluid overload by delivering furosemide subcutaneously, reducing swelling and discomfort. The On-Body Infusor provides a steady, five-hour infusion, which is especially beneficial for patients requiring ongoing diuretic therapy. This method eliminates the need for intravenous administration, offering a more convenient and patient-friendly option. Furoscix is particularly useful for individuals with kidney disease who experience challenges with oral diuretic absorption or require consistent fluid management. Regular monitoring of electrolytes and renal function is essential during treatment to ensure safe and effective use.

Mechanism of Action

Furoscix works as a loop diuretic, inhibiting sodium and chloride reabsorption in the ascending limb of the Loop of Henle in the kidneys. This action increases urine production, helping to reduce fluid overload in conditions like heart failure and kidney disease. The medication is delivered subcutaneously via the On-Body Infusor, ensuring a steady release of furosemide over approximately five hours. This method bypasses oral absorption, providing consistent therapeutic levels and avoiding first-pass metabolism. The continuous infusion mimics the natural diuretic effect, making it effective for managing edema in chronic conditions. By enhancing renal excretion of excess fluid and electrolytes, Furoscix helps alleviate symptoms associated with fluid retention.

Key Safety Information

Furoscix may cause electrolyte imbalances, dehydration, or hypotension. Monitor serum electrolytes and renal function. Contraindicated in anuria, hepatic coma, or severe hypersensitivity to furosemide. Avoid in patients with allergy to sulfonamides.

4.1. Important Warnings

Furoscix is contraindicated in patients with anuria, hepatic coma, or hypersensitivity to furosemide or sulfonamides. Use with caution in patients with severe renal impairment or hypotension.
Monitor for signs of dehydration, electrolyte imbalances, or hypokalemia. Avoid in patients with severe allergic reactions to sulfonamide-derived drugs. Not recommended for children or during pregnancy without medical advice. Hypotension may occur; monitor blood pressure. Use cautiously in patients with hepatic cirrhosis or ascites. Discontinue if allergic reactions or severe side effects occur. Regular monitoring of electrolytes, CO2, BUN, and creatinine is essential during therapy. Patients should be advised to report any unusual symptoms promptly to their healthcare provider.

4.2. Contraindications

Furoscix is contraindicated in patients with anuria (no urine production) and in those with a history of hypersensitivity to furosemide or sulfonamide-derived drugs.
It is also contraindicated in patients with hepatic coma or severe hypersensitivity reactions to furosemide. Furoscix should not be used in children due to lack of pediatric-specific studies or in pregnancy unless medically necessary. Contraindicated in patients with severe allergic reactions to sulfonamides. Use is also contraindicated in lactation without consulting a healthcare provider; Furoscix should not be administered to patients with known hypersensitivity to any component of the formulation. Patients with these conditions should avoid Furoscix and seek alternative treatments under medical supervision.

4.3. Drug Interactions

Furoscix may interact with other medications, altering its effectiveness or increasing the risk of side effects. Co-administration with NSAIDs can reduce diuretic and antihypertensive effects.
Concomitant use with aminoglycosides may increase the risk of nephrotoxicity and ototoxicity. Furoscix can potentiate the effects of ACE inhibitors, leading to hypotension or acute kidney injury.
Electrolyte imbalances caused by furosemide can affect the efficacy of digoxin and other cardiac glycosides. Patients on lithium may experience increased lithium levels and toxicity.
Monitor for potential interactions with antihypertensives, as furosemide can enhance hypotensive effects.
Always consult a healthcare provider before starting Furoscix, especially if taking other medications, to ensure safe and effective therapy.

Instructions for Use

Prepare the On-Body Infusor, load the prefilled cartridge, and apply the device to the skin. Start the infusion as directed and follow the provided instructions carefully.

5.1. Preparing the On-Body Infusor

Remove the On-Body Infusor from its packaging and inspect for damage. Ensure the device is at room temperature before use. Do not expose it to extreme heat or cold. The infusor is pre-assembled, but always verify the needle cover is in place to prevent accidental needle sticks. Before loading the cartridge, ensure the infusor is clean and dry. Follow the manufacturer’s instructions for priming if required. Read the full instructions provided with the device carefully before proceeding. Proper preparation ensures safe and effective administration of FUROSCIX.

5.2. Loading the Cartridge

Remove the prefilled FUROSCIX cartridge from its packaging and ensure it is at room temperature. Align the cartridge with the On-Body Infusor’s cartridge holder, ensuring the arrow on the cartridge matches the arrow on the infusor. Gently push the cartridge into the holder until it clicks securely into place. Close the cartridge holder firmly to confirm the cartridge is loaded properly. Avoid exposing the cartridge to direct sunlight or extreme temperatures before use. Once loaded, check that the cartridge is fully seated and the holder is closed to prevent any leakage or malfunction. Proper loading is essential for accurate medication delivery. Always follow the instructions provided with the device for correct cartridge installation.

5.3. Applying the Device

Choose a clean, dry, and flat area on the body for the On-Body Infusor, such as the abdomen, upper thigh, or back of the arm. Peel off the backing from the adhesive and press the device firmly against the skin, ensuring good adhesion. Avoid areas with scars, tattoos, or irritation. Once applied, the small needle will insert automatically under the skin. Gently press the edges of the device to ensure proper contact with the skin. Do not touch the needle or attempt to reposition the device after application. The device is designed to stay in place during the infusion. If the device does not adhere well, consult the troubleshooting section or contact a healthcare provider. Proper application is crucial for effective medication delivery.

5.4. Starting the Infusion

After applying the device, press and hold the start button until you hear a confirmation tone and the LED indicator turns green. The needle will retract automatically once the infusion begins. Confirm the infusion has started by checking the green LED light and the audible ticks. Do not reposition or remove the device during the infusion. The On-Body Infusor is designed to deliver the medication continuously over the preset time. Keep the remote control nearby in case adjustments are needed, but avoid pressing buttons unnecessarily. The device will alarm if there are issues, but under normal operation, it will run quietly. Always follow the instructions provided by your healthcare provider for specific dosing instructions.

Dosing and Administration

Furoscix administers a fixed dose of 80 mg of furosemide over approximately 5 hours via subcutaneous infusion. The On-Body Infusor is preloaded with the precise dose, eliminating the need for manual measurement. Patients should not adjust the dose independently, as the device is designed for a single, continuous administration. Once activated, the infusion cannot be paused or modified. Furoscix is intended to replace oral furosemide during the infusion period but does not affect other prescribed medications. Always follow the healthcare provider’s instructions for dosing, as they may vary based on individual patient needs. The device’s simplicity ensures consistent delivery, but proper training is essential for safe and effective use.

Storage and Handling

Furoscix should be stored at controlled room temperature between 68°F to 77°F (20°C to 25°C). The prefilled cartridge and On-Body Infusor must not be frozen or exposed to extreme temperatures. Avoid direct sunlight and moisture. Store the device in its original packaging until use to protect it from light. Do not use the cartridge if it has been damaged or dropped, as this may affect functionality. Handle the prefilled cartridge carefully to prevent leakage or contamination. Always check the expiration date before use and discard any expired product. Proper storage ensures the medication remains effective and the device operates correctly. Follow all handling instructions provided by the manufacturer to maintain safety and efficacy.

Monitoring Requirements

Patients using Furoscix require regular monitoring to ensure safe and effective treatment. Serum electrolytes, such as potassium, sodium, and chloride, should be frequently assessed to prevent imbalances. Monitoring of CO2, BUN, creatinine, glucose, and uric acid levels is also recommended, especially in those with chronic kidney disease. Blood pressure and fluid status should be checked regularly to avoid hypotension or dehydration. Signs of electrolyte imbalances, such as muscle cramps or dizziness, should be reported promptly. Renal function tests may need to be repeated based on the patient’s condition and response to therapy. Monitoring frequency may vary depending on the severity of heart failure or kidney disease. Close supervision by healthcare providers is essential to manage potential complications and adjust treatment as needed. Regular follow-ups ensure optimal outcomes and minimize risks associated with furosemide therapy. Monitoring should continue throughout the treatment duration to maintain patient safety and therapeutic efficacy. Electrolyte and renal function monitoring are critical components of Furoscix therapy, enabling timely interventions to prevent adverse effects. By adhering to these monitoring requirements, healthcare providers can effectively manage patients receiving Furoscix and address any emerging issues promptly. This approach ensures the safe and effective use of Furoscix in treating edema associated with chronic heart failure or kidney disease. Regular assessments help balance the benefits and risks of therapy, optimizing patient outcomes. Monitoring is a cornerstone of Furoscix treatment, enabling personalized care and minimizing complications.

Side Effects and Management

Furoscix may cause side effects, including electrolyte imbalances, dehydration, and hypotension. Common adverse reactions include dizziness, headache, and injection site reactions such as redness or swelling. In severe cases, patients may experience muscle cramps, fatigue, or irregular heartbeat due to low potassium or magnesium levels. If these symptoms occur, healthcare providers should assess electrolyte levels and adjust treatment as needed. Managing side effects may involve correcting electrolyte imbalances with supplements or adjusting the dosage or frequency of Furoscix. Patients should be advised to report any severe or persistent side effects promptly. Monitoring and timely intervention are essential to mitigate risks and ensure safe therapy. Proper management strategies can help minimize adverse effects and optimize treatment outcomes. Regular monitoring of electrolytes and fluid status is crucial for early detection and correction of potential issues. Patients should also be educated on signs of dehydration and electrolyte imbalances to seek medical attention if necessary.

Patient Education

Patient education is critical for safe and effective use of Furoscix. Patients should be instructed on proper use of the On-Body Infusor, including loading the cartridge, applying the device, and starting the infusion. Emphasize the importance of following the Instructions for Use and adhering to the prescribed dosing regimen. Patients should be aware of potential side effects, such as dizziness or dehydration, and know when to seek medical help. They should also be educated on monitoring for signs of electrolyte imbalances, such as muscle cramps or irregular heartbeat. Provide resources, including the patient information leaflet, to ensure understanding. Encourage patients to ask questions and seek clarification if needed to ensure proper use and safety. Regular follow-up with healthcare providers is essential for monitoring and adjusting treatment as needed. Clear communication and education empower patients to manage their therapy effectively and safely.

Reporting Adverse Effects

Patients and healthcare providers should report any adverse effects associated with Furoscix to the FDA. Adverse reactions can be reported by calling 1-800-FDA-1088 or visiting the FDA’s MedWatch website. When reporting, provide detailed information about the reaction, including the patient’s symptoms, treatment duration, and any contributing factors. This helps ensure patient safety and continuous improvement of the medication. Patients should also discuss any side effects with their healthcare provider promptly. For more information, refer to the full Prescribing Information and Instructions for Use. Reporting adverse effects is crucial for maintaining drug safety and efficacy. Always encourage open communication between patients and healthcare providers regarding any concerns or unusual symptoms. Copyright 2025. All rights reserved. scPharmaceuticals. US-FUR-25-00046 03/2025.

Troubleshooting Common Issues

Common issues with the Furoscix On-Body Infusor may include the device not starting, cartridge not loading, or alarms sounding. If the device fails to start, ensure the cartridge is properly loaded and the infusor is activated correctly. For cartridge issues, check if it is securely locked in place. Alarms may indicate low battery, blockage, or improper placement. Refer to the error messages on the device for specific guidance. If issues persist, replace the cartridge or consult the Instructions for Use. Always ensure the device is applied correctly to avoid needle stick injuries. For unresolved problems, contact customer support or your healthcare provider for assistance. Regularly reviewing the troubleshooting steps can help minimize disruptions in therapy.

Furoscix offers a convenient and effective solution for managing fluid overload in adults with chronic heart failure or chronic kidney disease. Its innovative On-Body Infusor delivers furosemide subcutaneously, providing patient-friendly treatment. By adhering to the instructions for use, patients can ensure safe and proper administration. Always consult healthcare providers for personalized guidance and to address any concerns. Furoscix is a valuable tool in managing edema, improving quality of life for those requiring diuretic therapy. Proper use and care of the device are essential for optimal outcomes. For more information, refer to the full prescribing details and patient resources available online.