icodextrin (LVP solution)

What is the most important information I should know about icodextrin (LVP solution)?

If you have diabetes and you test your blood sugar using a glucose monitor and test strips, ask a doctor or pharmacist about the best type to use. Certain glucose monitors and test strips must not be used while you are being treated with icodextrin. Tell any doctor who treats you that you are using icodextrin.

You should not use this medication if you are allergic to icodextrin or cornstarch, or if you have maltose or isomaltose intolerance, severe lactic acidosis, or a glycogen storage disease (an inherited metabolic disorder).

Before using icodextrin, tell your doctor if any of the following conditions have recently affected your stomach area: surgery, tumors, hernia, infection, or open wounds.

Also tell your doctor about all of your medical conditions and about all other medicines you use.

Drink plenty of liquids while you are using icodextrin. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

What is icodextrin (LVP solution)?

Icodextrin is a dialysis solution that draws fluid and wastes from your bloodstream into your peritoneal cavity (the space around the organs in your abdomen). These fluids and wastes are removed when the dialysis solution is drained.

Icodextrin is used in peritoneal dialysis that lasts 8 hours or longer (also called the long dwell exchange).

Icodextrin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using icodextrin (LVP solution)?

You should not use this medication if you are allergic to icodextrin or cornstarch, or if you have:

• maltose or isomaltose intolerance;
• severe lactic acidosis; or
• a glycogen storage disease (an inherited metabolic disorder).

If you have diabetes and you test your blood sugar using a glucose monitor and test strips, ask a doctor or pharmacist about the best type to use. Certain glucose monitors and test strips must not be used while you are being treated with icodextrin. Tell any doctor who treats you that you are using icodextrin.

Before using icodextrin, tell your doctor if any of the following conditions have recently affected your stomach area: surgery, tumors, hernia, infection, or open wounds.

To make sure you can safely use icodextrin, tell your doctor if you have any of these other conditions:

• a breathing disorder;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood;)
• high levels of calcium in your blood;
• high blood pressure, congestive heart failure;
• a stomach or intestinal condition such as inflammatory bowel disease, diverticulitis, or if you have a colostomy or ileostomy;
• if you are malnourished or cannot eat; or
• if you have recently had aortic graft surgery.

FDA pregnancy category C. It is not known whether icodextrin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether icodextrin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is icodextrin (LVP solution) given?

Icodextrin is used in peritoneal dialysis during the long dwell exchange (8 to 16 hours). Icodextrin is given during the night-time exchange if you are on continuous peritoneal dialysis. Icodextrin is given during the daytime exchange if you are using automated peritoneal dialysis (a cycler).

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Prepare your dose only when you are ready to give the medicine.

You may warm the medication with a heating pad to make it more comfortable to use during dialysis. Do not heat icodextrin with hot water or in a microwave. High heat can ruin the medicine.

Do not use the medication if it looks cloudy or has particles in it. Call your doctor for a new prescription.

Drink plenty of liquids while you are using icodextrin. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

You will need regular medical tests to be sure this medication is not causing harmful effects. Visit your doctor regularly.

Store at room temperature away from moisture and heat. Do not freeze. Keep the medicine in its moisture-proof pouch until you are ready to prepare your dose.

Throw away any unused icodextrin after the expiration date on the label has passed.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use icodextrin more than once in a 24 hour period.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Using too much icodextrin can cause swelling or puffiness in your stomach, feeling of fullness, feeling short of breath. Drain the solution from your peritoneal cavity if you have any of these symptoms.

What should I avoid while using icodextrin (LVP solution)?

Avoid becoming dehydrated (heavy sweating, hot and dry skin, feeling very thirsty or hot, being unable to urinate). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

What are the possible side effects of icodextrin (LVP solution)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using icodextrin and call your doctor at once if you have a serious side effect such as:

• fever, stomach pain, redness, or cloudy drained fluid;
• flu symptoms;
• chest pain;
• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or
• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

• mild stomach pain, nausea;
• headache; or
• new or worsening cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect icodextrin (LVP solution)?

Tell your doctor about all other medicines you use, especially:

• adefovir (Hepsera);
• blood pressure medication;
• digoxin (Lanoxin, Lanoxicaps);
• entecavir (Baraclude);
• insulin;
• metformin (Glucophage, Actoplus Met, Avandamet, Glucovance, Janumet, Kombiglyze, Metaglip, PrandiMet); or
• HIV or AIDS medications such as abacavir (Ziagen), didanosine (Videx), emtricitabine (Atripla, Emtriva), lamivudine (Combivir, Epzicom), stavudine (Zerit), tenofovir (Truvada, Viread), or zidovudine (Retrovir, Trizivir).

There may be other drugs that can interact with icodextrin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about icodextrin (LVP solution).