Pronunciation:

eye-koe-DEX-trin, KAL-see-um KLOR-ide, mag-NEE-zee-um KLOR-ide, SOE-dee-um KLOR-ide, SOE-dee-um LAK-tate

Brand Names:

• Extraneal

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Dialysis Solution

Uses of This Medicine:

Icodextrin is used for a single daily exchange for the long (8 to 16 hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD). This medicine is a peritoneal dialysis solution. It is used as part of a process of clearing fluid and waste out of your body when your kidneys do not work correctly.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of icodextrin in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of icodextrin the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Baloxavir Marboxil
• Bictegravir
• Digoxin
• Erdafitinib
• Raltegravir
• Vadadustat

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to cornstarch or
• Glycogen storage disease or
• Lactic acidosis, severe or
• Maltose or isomaltose intolerance—Should not be used in patients with these conditions.

• Bowel problems (eg, diverticulitis, inflammatory bowel disease) or
• Diabetes or
• Fluid or nutrition imbalance or
• Heart surgery (aortic graft surgery), recent 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 problems or
• Stomach problems (eg, hernia, infection, peritonitis, open wounds, tumor, or surgery in the past 30 days)—Use with caution. May make these conditions worse.

• Hypotension (low blood pressure), severe or
• Sepsis (infection in the blood)—May increase risk for lactic acidosis.

Proper Use of This Medicine:

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.

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

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 shorter exchanges. You should not use this solution more than one time in 24 hours, unless your doctor tells you to.

To use:

• Check the liquid in its container before you use it. Do not use it if it is cloudy or has small specks floating in it. Do not use it if the container has a leak.
• You may warm the solution up to about 37°C (98.6°F) 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 heat it above 40°C (104°F).
• 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 provider if you see clumps or stringy material, or if the fluid is cloudy.
• Do not add anything to the solution unless your healthcare provider tells you to. Sometimes, you might need to add potassium (a mineral) or other medicines to the solution. Your provider 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.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.

If you measure your blood sugar levels, this solution may cause false high blood sugar readings for some kinds of monitors and test strips. You must use only a glucose-specific monitor and test strips. Ask your doctor or nurse to help you choose the right monitor and test strips. Your healthcare provider may suggest you carry a wallet card explaining your need for a specific kind of monitor and test strips.

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

Icodextrin may cause serious allergic and skin reactions, including anaphylaxis, angioedema, erythema multiforme, toxic epidermal necrolysis, serum sickness, and vasculitis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

It is important for you to keep track of how much fluid you have in your body at all times. Ask your healthcare provider about how to do this, and what to do if you have too much or too little fluid. One way to keep track of how much fluid is in your body is to weigh yourself often, and write the number down.

Tell your doctor about all other medicines you are using. Icodextrin might remove some medicines from your body, so your doctor might need to change your dose of other medicines. Do not change the dose of any of your other medicines unless your doctor tells you to.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

body aches or pain

chills

confusion

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

seizures

slow or fast heartbeat

sneezing

sore throat

stomach pain

sweating

tingling of the hands or feet

trouble breathing

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

chest tightness

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

Some side effects may occur 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 reduce 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 occur 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.