Extraneal (Intraperitoneal)

Icodextrin is used for one daily exchange during the long (8 to 16 hour) dwell in continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD). This medicine is a solution for peritoneal dialysis. It helps remove fluid and waste from your body when your kidneys are not functioning properly.

This medicine is available only with your doctor's prescription.

Your doctor will monitor your progress closely while you are taking this medicine. This will help your doctor see if the medicine is working correctly. Blood tests may be necessary to check for side effects.

If you check your blood sugar levels, this solution may give false high readings on some types of monitors and test strips. You must use only a glucose-specific monitor and test strips. Ask your doctor or nurse to help you select the appropriate monitor and test strips. Your caregiver may suggest that you carry a wallet card explaining your need for a specific type of monitor and test strips.

Icodextrin may cause an infection in the peritoneal cavity called peritonitis. This is common in patients on peritoneal dialysis. Inform your doctor if you experience pain, redness, fever, or cloudy fluid when drained.

Icodextrin may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical help. Notify your doctor right away if you have blistering, peeling, or a red skin rash, itching, difficulty breathing, difficulty swallowing, or any swelling of your hands, face, or mouth while using this medicine.

It is important for you to monitor how much fluid you have in your body at all times. Ask your health caregiver about how to do this, and what to do if you have too much or too little fluid. One way to keep track of your fluid levels is to weigh yourself regularly and record the number.

Inform your doctor about all other medicines you are taking. Icodextrin might remove some medicines from your body, so your doctor may need to adjust your dose of other medicines. Do not change the dose of any of your other medicines unless your doctor instructs you to.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it will provide. The following points should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been enough studies to understand how icodextrin affects children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of icodextrin.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before taking this medicine during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction might happen. In such cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are highlighted for their significance but may not include all possible interactions.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may alter the dose or frequency for one or both medicines.

• Baloxavir Marboxil
• Bictegravir
• Digoxin
• Eltrombopag
• Erdafitinib
• Raltegravir

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed, your doctor may adjust the dose or frequency for one or both medicines.

• Chlorothiazide
• Delafloxacin
• Felodipine
• Isradipine
• Nicardipine
• Strontium Ranelate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to possible interactions. Consuming alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works. Ensure you inform your doctor if you have any other medical problems, especially:

• Allergy to cornstarch or
• Glycogen storage disease or
• Severe lactic acidosis or
• Intolerance to maltose or isomaltose—Should not be used in these patients.

• Bowel problems (e.g., diverticulitis, inflammatory bowel disease) or
• Diabetes or
• Fluid or nutrition imbalance or
• Recent heart surgery (aortic graft surgery) or
• Hypercalcemia (high calcium in the blood) or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Lung disease or breathing issues or
• Stomach problems (e.g., hernia, infection, peritonitis, open wounds, tumor, or surgery in the past 30 days)—Use with caution. May worsen these conditions.

• Severe hypotension (low blood pressure) or
• Sepsis (infection in the blood)—May increase the risk for lactic acidosis.

Along with its necessary effects, this medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Check with your doctor right away if any of the following side effects happen:

More common

• Abdominal or stomach pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• body aches or pain
• chills
• confusion
• convulsions
• cough
• decreased urine
• difficulty with breathing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• ear congestion
• fever
• headache
• increased thirst
• irregular heartbeat
• loss of appetite
• loss of voice
• muscle pain or cramps
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pale skin
• pounding in the ears
• rapid weight gain
• runny or stuffy nose
• slow or fast heartbeat
• sneezing
• sore throat
• sweating
• tingling of the hands or feet
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

Less common

• Chest pain
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased urination
• unexplained weight loss

Incidence not known

• Blistering, peeling, or loosening of the skin
• diarrhea
• difficulty with swallowing
• hives, itching, or skin rash
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• redness or swelling at the catheter site
• redness, soreness, or itching skin
• sores, ulcers, or white spots in the mouth or on the lips
• sores, welting, or blisters
• tightness in the chest

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain
• lack or loss of strength

Less common

• Acid or sour stomach
• belching
• heartburn
• indigestion
• stomach discomfort, upset, or pain

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Extraneal

Available Dosage Forms:

• Solution

Therapeutic Class: Dialysis Solution

Icodextrin should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor will decide how much of the solution you need and tell you how often it should be used. This solution is given through a special tube called a catheter. The catheter is placed in your abdomen during a minor operation.

Your doctor, nurse, or other trained health professional will teach you about peritoneal dialysis and how it works. Make sure you understand all instructions before doing the process yourself. Follow all of the steps in the process exactly as you were trained to do.

This solution is only one kind of fluid that you will use during peritoneal dialysis. This solution is for the long dwell exchange of peritoneal dialysis. The long dwell exchange lasts longer than 8 hours. You will have other fluids to use during other exchanges. You should not use this solution more than one time in 24 hours, unless your doctor tells you to.

To use:

• Look at the solution in its container before you use it. Do not use the solution if it is cloudy or has small specks floating in it. Do not use the solution if the container has a leak.
• You may warm the solution up to about 37 degrees C before you use it. Do not take the wrapping off of the container of solution until after you have warmed the solution. The best way to warm the solution is to wrap a dry heating pad around the container and wrapping. Do not warm the solution in a microwave oven or put it in water. Do not let the temperature of the solution get above 40 degrees C.
• Keep the solution in the container and the wrapping until you are ready to use it. Keep the solution container and connections clean.
• Put the solution into your catheter over about 10 to 20 minutes.
• After you drain the fluid back out of your catheter, look at the fluid. Call your caregiver if you see clumps or stringy material, or if the fluid is cloudy.
• Do not add anything to the solution unless your health caregiver tells you to. Sometimes, you might need to add potassium (a mineral) or other medicines to the solution. Your health caregiver will tell you if need to add anything to the solution.
• Throw away any unused solution. Do not use this solution for more than one time.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.