Extraneal (icodextrin 7.5%) solution for peritoneal dialysis

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

EXTRANEAL, 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 pharmacist.
• If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Extraneal is and what it is used for

EXTRANEAL 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 or liver. EXTRANEAL 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.

EXTRANEAL may be prescribed to you if:

• you are an adult patient with permanent kidney failure requiring peritoneal dialysis.
• sufficient fluid removal cannot be achieved using conventional glucose-based peritoneal dialysis solutions.

2. Before using Extraneal

Your doctor must supervise the administration of this product if it is the first time you are using it.

Do not use EXTRANEAL

• if you are allergic to icodextrin or to starch derivatives (e.g., corn starch) or to any of the other components of this medicine (listed in section 6).
• if you cannot tolerate maltose or isomaltose (sugars derived from starch)
• if you have a glycogen storage disease
• if you have acute lactic acidosis (excessive acid in the blood)
• if you have an uncorrectable surgical abnormality affecting your abdominal wall or cavity, 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 to use Extraneal:

• if you are an elderly patient. There is a risk of dehydration
• if you have diabetes 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 levels (e.g., if you are diabetic). Your doctor will advise you which testing method to use (see “Other interactions”)
• if you are at high risk of severe lactic acidosis (excessive 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 sudden severe kidney failure
  • you have a congenital 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. Note down the batch number and take 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 suitable 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 called 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 prevent normal nutrition
• if you have low levels of potassium.

You should also be aware that:

• a condition called encapsulating peritoneal sclerosis (EPS) is a known, rare complication of peritoneal dialysis therapy. You and your doctor should remain vigilant for this possible complication. EPS may cause:
  • inflammation of the abdomen (belly)
  • growth of fibrous tissue layers covering and binding organs, affecting their normal movement. In rare cases, this has been fatal
• you and your doctor will likely 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 given potassium chloride to compensate.

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

• you have acute kidney disease

Children

The safety and efficacy of Extraneal in children under 18 years of age has not been established.

Use of Extraneal with other medicines

• Inform your doctor or pharmacist 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 adjust your dose. This is because peritone combustible dialysis may increase the removal of certain medicines.

• Be cautious if you are taking heart medications called cardiac glycosides (e.g., digoxin). Your heart medications may become less effective or their toxicity may increase. You may:

  • need potassium and calcium supplements
  • develop heart rhythm disturbances (arrhythmia)

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

Other interactions

Pregnancy and breastfeeding

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

The use of EXTRANEAL during pregnancy or breastfeeding is not recommended unless your doctor advises otherwise.

Driving and use of machines

This treatment may cause fatigue, weakness, blurred vision, or dizziness. Do not drive or operate machinery if affected.

3. How to use Extraneal

EXTRANEAL 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 the internal organs, such as the intestines or liver.

Always follow exactly the administration instructions for this medicine as given by your physician specialized in peritoneal dialysis. If in doubt, consult your doctor.

Recommended dose

• One bag per day during the longest dwell period, for example:
  • At 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 to 20 minutes.
• The dwell time with EXTRANEAL is 6 to 12 hours in CAPD and 14 to 16 hours in APD.

Method of administration

Before using:

• Warm the bag to 37°C using 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 you have been instructed.
• Before performing an exchange, make sure to wash your hands and the area where you will carry out the exchange.
• Before opening the overpouch, check that it is the correct solution, the expiration date, and the quantity (volume). Lift the bag to check for leaks (excess fluid in the overpouch). Do not use the bag if you detect any leaks.
• After removing the overpouch, check for signs of leakage by firmly pressing the bag. Do not use the bag if you detect any leak.
• 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 that all connections are secure.
• Consult your doctor if you have any questions or doubts about this product or its use.

Use each bag only once. Discard any unused solution.

After use, check that the drained fluid is not cloudy.

Compatibility with other medicines

Your doctor may prescribe other injectable medicines to be added directly to the EXTRANEAL bag. In such cases, 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 EXTRANEAL in 24 hours

If you receive an excessive dose of EXTRANEAL, you may experience:

• Abdominal distension
• Stomach heaviness and/or
• Difficulty breathing.

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

If you interrupt treatment with EXTRANEAL

Do not interrupt peritoneal dialysis without your doctor's approval. Stopping treatment may have life-threatening consequences.

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, even if they are adverse effects not listed in this leaflet.

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

• high blood pressure (blood pressure above normal values),
• 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 (flu-like symptoms).

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

Adverse effects frequently observed (may affect up to 1 in 10 patients) in patients using EXTRANEAL:

• red, flaky skin, rash, itching (pruritus)
• dizziness, thirst (dehydration)
• decreased blood volume (hypovolemia)
• abnormal laboratory test results
• weakness, headache, fatigue
• swollen feet and ankles
• low blood pressure (hypotension)
• ringing in the ears

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, traumatic injury or interaction with the catheter

• low blood sugar concentration (hypoglycemia)

• shock or coma caused by low blood sugar concentration

• high blood sugar concentration (hyperglycemia)

• nausea, vomiting, loss of appetite, dry mouth, constipation, diarrhea, flatulence (gas), gastrointestinal disorders such as intestinal obstruction, gastric ulcer, gastritis (inflammation of the stomach), or indigestion

• abdominal swelling, abdominal hernia (this causes a bulge in the groin)

• changes in blood parameters

• abnormal liver function tests

• weight gain or 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 pale skin and lead to weakness or difficulty breathing); increase or decrease in the number of white blood cells; reduction in the number of platelets which increases the risk of bleeding or bruising

• numbness, tingling, burning sensation

• hyperkinesia (increased movement and inability to remain still)

• blurred vision

• loss of taste sensation

• fluid in the lungs (pulmonary edema), shortness of breath, difficulty breathing or wheezing, cough, hiccups

• kidney pain

• nail abnormalities

• skin disorders such as hives (urticaria), psoriasis, skin ulcers, eczema, dry skin, skin discoloration, blisters, allergic or contact dermatitis, 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 (TEN). This causes:
    • a red rash over most of the body
    • peeling of the outer layers of the skin
  • erythema multiforme. A skin allergic reaction causing spots, red rashes or areas with blisters or purplish discoloration. 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 part of the body affected, but in the skin may present as red or purple spots or rashes or symptoms similar to an allergic reaction, including skin rash, joint pain and fever.

• muscle cramps, bone, joint, muscle, back and neck pain

• drop in blood pressure upon standing (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 adverse effect, talk to your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly via 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 Extraneal

• Keep out of the sight and reach of children.
• Store in the original packaging.
• Do not store at temperatures below 4°C.
• Do not use this medicine after the expiry date stated on the label of the outer packaging and on the bag label after the abbreviation CAD. and the symbol. The expiry date refers to the last day of the month indicated.

Dispose of Extraneal as instructed.

6. Additional information

This leaflet does not contain all the information about this medicine. If you have any doubts, ask your doctor.

Composition of EXTRANEAL

The active substances are:

The other components are:

• water for injections
• sodium hydroxide or hydrochloric acid

Presentation of the product and contents of the container

• EXTRANEAL is packaged in flexible plastic bags with a capacity of 1.5, 2.0, or 2.5 liters.
• The solution in the bag is clear and colorless.
• Each bag is enclosed in an overpouch and supplied in cardboard boxes.

Only certain pack sizes may be marketed.

Further information about this medicinal product can be requested from the local representative of the marketing authorization holder:

Marketing Authorization Holder

Vantive Health, S.L.

Polígono Industrial Sector 14

C/Pouet de Camilo 2

46394 Ribarroja del Turia (Valencia) Spain

Manufacturer

Vantive Manufacturing Limited

Moneen Road

Castlebar, County Mayo

Ireland

Date of the most recent review of this leaflet: December 2021

Vantive and EXTRANEAL are registered trademarks of Vantive Health LLC or its affiliates