Polithera (icodextrin 7.5%) solution for peritoneal dialysis

Patient Leaflet: Information for the user

Introduction

Patient Leaflet: Information for the user

Polithera (Icodextrin 7.5%) solution for peritoneal dialysis

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are possible adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Polithera is and what it is used for
2. What you need to know before using Polithera
3. How to use Polithera
4. Possible side effects
5. How to store Polithera
6. Contents of the pack and other information

1. What Polithera is and what it is used for

Polithera is a solution for peritoneal dialysis. The peritoneal cavity is the space located in the abdomen (belly), between the skin and the peritoneum. The peritoneum is the membrane that surrounds internal organs such as the intestines and liver. Polithera solution is introduced into the peritoneal cavity, where it removes excess water and waste products from the blood. In addition, it corrects abnormal levels of various blood components.

Polithera may be prescribed to you if:

• you are an adult with permanent kidney failure requiring peritoneal dialysis
• conventional glucose-based peritoneal dialysis solutions are unable to remove sufficient fluid.

2. What you need to know before using Polithera

Your doctor should supervise you the first time you use this medicine.

Do not use Polithera

• if you are allergic to icodextrin, to starch derivatives (e.g. corn starch), or to any of the other ingredients of this medicine (listed in section 6)
• if you do not tolerate maltose or isomaltose (a sugar derived from starch)
• if you have a glycogen storage disease
• if you have severe lactic acidosis (excess acid in the blood)
• if you have an abdominal wall or cavity problem that cannot be corrected by surgery, or an uncorrectable condition that increases the risk of abdominal infections
• if you have documented loss of peritoneal function due to severe peritoneal scarring.

Warnings and precautions

Talk to your doctor before starting Polithera

• if you are an elderly patient. There is a risk of dehydration
• if you are diabetic and are using this solution for the first time. You may need to adjust your insulin dose
• if you need to monitor your blood glucose level (e.g. if you are diabetic). Your doctor will advise you which testing method to use (see “Other types of interactions”).
• if you are at high risk of severe lactic acidosis (excess acid in the blood). You are at increased risk of lactic acidosis if:
  • you have severely low blood pressure
  • you have a blood infection
  • you have acute severe kidney failure
  • you have an inherited metabolic disorder
  • you are taking metformin (a medicine used to treat diabetes)
  • you are taking medicines for HIV, especially a class of medicines called NRTIs
• if you experience abdominal pain or notice that the dialysis fluid is cloudy, contains clumps, or particles.

This may be a sign of peritonitis (inflamed peritoneum) or infection. You must contact your healthcare team urgently. Record the batch number and bring it along with the drained fluid bag to your healthcare team. The healthcare team will decide whether treatment should be stopped or corrective treatment started. For example, if you have an infection, your doctor may perform several tests to determine which antibiotic is most appropriate for you. Your doctor may give you an antibiotic effective against a wide range of different bacteria until the specific infection is identified. This type of antibiotic is known as a broad-spectrum antibiotic.

• during peritoneal dialysis, your body may lose proteins, amino acids, and vitamins. Your doctor will determine whether you need to replace these losses
• if you have conditions affecting the integrity of the abdominal wall or cavity. For example, in case of hernia, chronic infection, or inflammatory bowel disease
• if you have had an aortic graft
• if you have severe lung disease, such as emphysema
• if you have breathing difficulties
• if you have disorders that impair normal nutrition
• if you have low potassium levels

You should also be aware that:

• a condition called encapsulating peritoneal sclerosis (EPS) is a known, rare complication of peritoneal dialysis therapy. You, likely together with your doctor, should be aware of this possible complication. EPS may cause:
  • inflammation of the abdomen
  • growth of fibrous tissue layers that cover and bind organs, affecting their normal movement. In rare cases, this has been fatal
• you—likely together with your doctor—will keep a record of your fluid balance and body weight. Your doctor will monitor your blood parameters at regular intervals
• your doctor will regularly check your potassium levels. If levels become very low, you may be prescribed potassium chloride to correct this.

Sometimes, treatment with this medicine is not recommended, for example, if:

• you have acute kidney failure.

Children and adolescents

The safety and efficacy of Polithera have not been established in individuals under 18 years of age.

Other medicines and Polithera

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

• if you are taking other medicines, your doctor may need to increase your dose. This is because peritoneal dialysis treatment increases the removal of certain medicines.
• be cautious if you are using heart medications called cardiac glycosides (e.g. digoxin). Your heart medication may become less effective or its toxicity may increase. You may:
  • require potassium and calcium supplements
  • develop disturbances in heart rhythm (arrhythmia)

Your doctor will closely monitor you during treatment, especially your potassium levels.

Other types of interactions

Polithera interferes with the measurement of blood glucose using certain test kits. If you need to perform blood glucose tests, make sure to use a method specific for glucose. Your doctor will advise you on which test kit to use.

Using an inappropriate test kit may result in falsely high glucose readings, which could lead to administration of more insulin than needed. This may cause low blood glucose (hypoglycemia), potentially resulting in loss of consciousness, coma, neurological damage, or death. In addition, falsely high glucose readings may mask a true hypoglycemia and prevent appropriate treatment, with similar consequences.

Falsely high glucose readings may occur up to two weeks after discontinuation of Polithera treatment. If you are admitted to hospital, you must inform doctors about this potential interaction. They must carefully review the product information of the test kit to ensure a glucose-specific kit is used.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

If you are pregnant, you will receive this medicine only if your doctor considers it absolutely necessary for your recovery. Polithera should be administered to pregnant women only after careful evaluation.

At therapeutic doses, no effects of Polithera on newborns/breastfed infants are expected. However, breastfeeding is not recommended while the patient requires peritoneal dialysis.

Driving and using machines

This treatment may cause fatigue, weakness, blurred vision, or dizziness. Do not drive or operate machinery if you experience any of these effects.

3. How to use Polithera

Follow exactly the administration instructions for this medicine as given by your doctor. Consult your doctor if you are unsure.

Polithera is indicated as an exchange performed once daily during the long dwell period (6 to 16 hours) in continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the treatment of end-stage renal failure.

Polithera must be administered into your peritoneal cavity. This cavity is located in the abdomen (belly), between the skin and the peritoneum. The peritoneum is the membrane that surrounds internal organs such as the intestines and liver.

Follow exactly the administration instructions for this medicine as provided by your peritoneal dialysis specialist. If in doubt, consult your doctor.

Recommended dose

• One bag per day during the longest dwell period, for example:
  • during the night in continuous ambulatory peritoneal dialysis (CAPD)
  • during the day in automated peritoneal dialysis (APD).
• The solution should be infused over a period of 10–20 minutes.
• The dwell time with Polithera is 6 to 12 hours in CAPD and 14 to 16 hours in APD.

Method of administration

Before use,

• Warm the bag to 37°C. Use the heating plate specifically designed for this purpose. Never immerse the bag in water to warm it.
• You must use an aseptic technique throughout the administration of the solution, as previously taught.
• Before performing an exchange, ensure you wash your hands and the area where the exchange will be performed.
• Before opening the overpouch, verify that the solution type, quantity (volume), and expiration date are correct. Lift the dialysis bag to check for leaks (excess fluid in the overpouch). Do not use the bag if it shows signs of leakage.
• After removing the overpouch, inspect the container by firmly pressing the bag to ensure there are no signs of leakage. Do not use the bag if it leaks.
• Check that the solution is clear and transparent. Do not use the bag if the solution is cloudy or contains particles.
• Before starting the exchange, ensure all connections are secure.
• Consult your doctor if you have any questions or doubts about this product or its use.
• Each bag must be used only once. Discard any unused solution.
• After use, check that the drained fluid is not cloudy.
• This solution must not be used for intravenous infusion.

Compatibility with other medicines

Your doctor may prescribe injectable medicines to be added directly to the Polithera bag. In this case, add the medicine through the medication addition site located at the bottom of the bag. Use the product immediately after adding the medicine. Consult your doctor if you are unsure.

If you use more than one bag of Polithera in 24 hours

If you use too much Polithera, you may experience abdominal distension, a sensation of fullness, and/or difficulty breathing.

Contact your doctor immediately. Your doctor will advise you on what to do.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you interrupt treatment with Polithera

Do not interrupt or discontinue treatment without your doctor's consent. Stopping treatment may have potentially life-threatening consequences.

Consult your doctor or nurse if you have any questions about using this medicine.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any adverse effects, consult your doctor or dialysis center, even if they are adverse effects not listed in this leaflet.

If you experience any of the following adverse effects, contact your doctor or dialysis center immediately:

• Hypertension.
• Swelling of the ankles or legs, puffy eyes, difficulty breathing, or chest pain (hypervolemia).
• Hypersensitivity (allergic reaction), which may include swelling of the face, throat, or around the eyes (angioedema).
• Abdominal pain.
• Chills (feeling cold/flu-like symptoms).

These may be signs of serious adverse effects. You may require urgent medical attention.

Common: may affect up to 1 in 10 patients treated with Polithera:

• Skin redness and peeling, rash, itching.
• Dizziness or thirst (dehydration).
• Decreased blood volume (hypovolemia).
• Abnormal laboratory test results.
• Weakness, headache, fatigue.
• Swollen ankles or legs.
• Low blood pressure (hypotension).
• Ringing in the ears (tinnitus).

Other adverse effects related to the peritoneal dialysis procedure or common to all peritoneal dialysis solutions:

• Cloudy fluid drained from the peritoneum, stomach pain.
• Peritoneal bleeding, pus, swelling, pain or infection around the catheter exit site, catheter blockage, injury, interaction with the catheter.
• Fainting, cold sweat, hunger, confusion, possibly loss of consciousness and seizures due to low blood sugar levels (hypoglycemia). In some cases, this may progress to serious adverse effects. Consult your doctor.
• Shock or coma caused by low blood sugar concentration.
• Frequent urination, thirst, fatigue due to high blood sugar levels (glycemia). In some cases, this may progress to serious adverse effects. Consult your doctor.
• Nausea, vomiting, loss of appetite, dry mouth, constipation, diarrhea, flatulence, stomach or intestinal disorders such as intestinal obstruction, gastric ulcer, abdominal pain or indigestion.
• Abdominal swelling, hernia of the abdominal cavity (causing a bulge in the groin area).
• Changes in blood parameters.
• Abnormal liver function tests.
• Weight gain or weight loss.
• Pain, fever, general malaise.
• Cardiac disturbances, rapid heartbeat, difficulty breathing or chest pain.
• Anemia (reduction in the number of red blood cells, which may cause paleness of the skin and lead to weakness or difficulty breathing); increase or decrease in the number of white blood cells; reduction in the number of platelets, increasing the risk of bleeding or bruising.
• Numbness, tingling, or burning sensation.
• Involuntary movements (hyperkinesia).
• Blurred vision.
• Loss of taste sensation.
• Fluid in the lungs (pulmonary edema), shortness of breath, difficulty breathing or wheezing, cough, hiccups.
• Kidney pain.
• Nail disorders.
• Skin disorders such as hives (urticaria), psoriasis, skin ulcer, eczema, dry skin, skin discoloration, blisters, allergic or contact dermatitis, skin rashes and itching.
• Skin rashes may appear as itchy red spots covered with bumps or with eruptions or peeling. The following three types of serious skin reactions may occur:
• Toxic epidermal necrolysis. This causes:
  • a red rash affecting most of the body
  • peeling of the outer layer of the skin.
• Erythema multiforme. An allergic reaction of the skin causing spots, red hives, or purple blistered areas. It may also affect the mouth, eyes, and other mucous membranes.
• Vasculitis. Inflammation of certain blood vessels in the body. Clinical symptoms depend on the affected part of the body, but in the skin may appear as red or purple spots or hives, or symptoms similar to an allergic reaction, including skin rash, joint pain, and fever.
• Muscle cramps, pain in the bones, joints, muscles, back, and neck.
• Dizziness, possible fainting when moving from lying down to sitting, or from sitting to standing, due to a drop in blood pressure (orthostatic hypotension).
• Peritonitis (inflamed peritoneum), including peritonitis caused by fungal or bacterial infection.
• Infections, including flu-like syndrome and boils.
• Abnormal thinking, anxiety, nervousness.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Polithera

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after «EXP». The expiry date refers to the last day of the month indicated.

Do not refrigerate or freeze.

The medicine should be used immediately after removing the outer pouch.

Dispose of Polithera as instructed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

This leaflet does not contain all the information about this medicine. If you have any questions or are unsure about anything, consult your doctor.

Composition of Polithera

The active substances are:

Theoretical osmolarity: 284 (milliosmoles per liter)

Theoretical osmolality: 301 (milliosmoles per kg)

Electrolyte solution containing per 1.000 ml (1 L):

pH = 5 to 6

The other components are: water for injections, sodium hydroxide, or hydrochloric acid.

Appearance of the medicinal product and content of the container

Polithera is a sterile, colorless or slightly yellowish solution.

Polithera is available in the following two presentations:

A 2.0-liter polypropylene plastic bag containing the solution and a 3.0-liter empty polypropylene plastic drainage bag with connecting tube.

Both bags and their connection are enclosed in a two-layer protective film made of polypropylene and an outer polyamide bag, supplied in cardboard boxes containing 4 bags.

A 2.0-liter polypropylene plastic bag containing the solution, enclosed in a double-layer protective film composed of polypropylene and an outer polyamide bag, supplied in cardboard boxes containing 4 bags.

Marketing Authorization Holder

Vivisol S.r.l.

Via Gerolamo Borgazzi, 27 - 20900 Monza (MB)

Italy

Manufacturer

Infomed Fluids S.r.l. Bd. Pallady Theodor, 50

032266 Bucuresti - Sector 3, Romania

Further information on this medicinal product can be requested from the local representative of the Marketing Authorization Holder:

FRESENIUS MEDICAL CARE ESPAÑA S.A.U.

Ronda de Poniente 8, Ground Floor (Euronova Business Park)

28760 Tres Cantos – MADRID - Spain

This medicinal product has been authorized in the EEA Member States under the following names:

Date of the most recent review of this leaflet: August 2024

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).