Label: information for the user

EXTRANEAL, peritoneal dialysis solution

Read the entire label carefully before starting to use the medication, because it contains important information for you.

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

EXTRANEAL is a peritoneal dialysis solution. The peritoneal cavity is the cavity located in the abdomen (stomach) between the skin and the peritoneum. The peritoneum is the membrane that surrounds internal organs, such as the intestines or liver. The EXTRANEAL solution is introduced into the peritoneal cavity, where it removes water and waste products from the blood. Additionally, it corrects abnormal levels of different blood components.

EXTRANEAL may be prescribed if:

• you are an adult with permanent kidney failure requiring peritoneal dialysis.
• conventional glucose-based peritoneal dialysis solutions cannot remove sufficient amounts of water.

Your doctor should supervise the administration of this product if it is the first time it is used.

Do not use EXTRANEAL

• if you are allergic to icodextrin or to starch derivatives (e.g. cornstarch) or to any of the other components of this medicine (listed in section 6).
• if you cannot tolerate maltose or isomaltose (sugar derived from starch)
• if you have any glycogen storage disease
• if you have acute lactic acidosis (too much acid in the blood)
• if you have any irreversible surgical alteration that affects your abdominal wall or cavity or any irreversible alteration that increases the risk of abdominal infections
• if you have documented loss of peritoneal function due to severe peritoneal scarring.

Warnings and precautions

Consult your doctor before starting to use Extraneal:

• if you are an elderly patient. There is a risk of dehydration
• if you are diabetic and using this solution for the first time. You may need to adjust your insulin dose
• if you need to control your blood glucose levels (e.g. if you are diabetic). Your doctor will tell you which testing method to use (see "Other forms of interaction")
• if you have a high risk of severe lactic acidosis (too much acid in the blood). You have a high risk of lactic acidosis if:
• • you have very 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 to treat HIV, especially certain medicines called NRTIs
• if you experience abdominal pain or notice that the drainage liquid is cloudy, lumpy or contains particles. This may be a sign of peritonitis (inflamed peritoneum) or infection. You must contact your medical team urgently. Note the batch number and take the bag of drained liquid with you to the medical team. The medical team will decide whether to stop treatment or start corrective treatment. 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 that is effective against a wide range of bacteria until they know what infection you have. 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 if you need to replace these losses.
• if you have problems that affect the integrity of your abdominal wall or cavity. For example, in the case of hernia or chronic infection or inflammatory disease affecting the intestines
• if you have had an aortic graft
• if you have severe lung disease, for example emphysema
• if you have breathing difficulties
• if you have disorders that prevent normal nutrition
• if you have low potassium levels.

You should also be aware that:

• a condition called encapsulating peritoneal sclerosis (EPS) is a known and rare complication of peritoneal dialysis therapy. You, probably in conjunction with your doctor, should be aware of this possible complication. EPS causes:
• • inflammation of the abdomen (stomach)
  • growth of fibrous tissue layers that cover and connect the organs, affecting your normal movement. In rare cases, it has been fatal
• you, probably in conjunction with your doctor, will keep a record of your fluid balance and body weight. Your doctor will check your blood parameters at regular intervals
• your doctor will regularly check your potassium levels. If they drop too low, your doctor may administer potassium chloride to compensate.

In some cases, 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 have not been demonstrated.

Use of Extraneal with other medicines

• Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine. If you are using other medicines, your doctor may need to increase your dose. This is because peritoneal dialysis treatment increases the elimination of certain medicines.

• Be careful if you are using heart medicines called cardiac glycosides (e.g. digoxin). Your heart medicines may not be as effective or their toxicity may be increased. You may need:
• • potassium and calcium supplements
  • develop arrhythmias (abnormal heart rhythms)

Your doctor will perform a thorough check-up during treatment, especially of your potassium levels.

Other forms of interaction

Pregnancy and breastfeeding

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

Extraneal is not recommended for use during pregnancy or breastfeeding unless your doctor tells you otherwise.

Driving and operating machinery

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

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

Follow exactly the administration instructions of this medication indicated by your specialized doctor in peritoneal dialysis. In case of doubt, consult your doctor.

The recommended dose is

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

Administration form

Before using it:

• Warm the bag to 37 °C. Use the warming plate specifically designed for this purpose. Never submerge the bag in water to warm it.
• You must use aseptic technique during the entire administration of the solution, as you have been taught.
• Before performing an exchange, make sure to wash your hands and the area where you will perform the exchange.
• Before opening the overbag, check that it is the correct solution, the expiration date, and the amount (volume). Lift the bag to check for leaks (excess liquid in the overbag). Do not use the bag if you find that it has leaks.
• After removing the overbag, check for signs of leaks in the container by pressing firmly on the bag. Do not use the bag if you detect any leaks.
• Check that the solution is transparent. Do not use the bag if the solution is cloudy or contains particles.
• Before starting the exchange, check 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. Dispose of the remaining solution that you do not use.

After using, check that the drainage liquid is not cloudy.

Compatibility with other medications

Your doctor may prescribe other injectable medications to add directly to the EXTRANEAL bag. In such a case, add the medication through the medication addition site located at the bottom of the bag. Use the product immediately after adding the medication. Consult your doctor if you are unsure.

If you use more than one EXTRANEAL bag in 24 hours

If you are administered an excessive dose of EXTRANEAL, you may experience:

• Abdominal distension
• Fullness and/or
• Difficulty breathing.

Immediately contact your doctor. They will inform you of what to do.

If you interrupt treatment with EXTRANEAL

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

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

If you experience side effects, consult your doctor, even if they are side effects not listed in this leaflet.

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

• high blood pressure (above normal blood pressure values),
• inflammation of the ankles or legs, swollen eyes, difficulty breathing or chest pain (hypervolemia),
• allergic reaction (hypersensitivity) that may include swelling of the face, throat, or around the eyes (angioedema),
• abdominal pain,
• chills (symptoms similar to the flu).

These may be signs of serious side effects. You may need urgent medical attention.

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

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

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

• cloudy solution extracted from the peritoneum, stomach pain
• peritoneal hemorrhage, pus, swelling, pain, or infection around the catheter exit site, catheter blockage, traumatic injury, or interaction with the catheter
• low blood sugar (hypoglycemia)
• shock or coma caused by low blood sugar
• high blood sugar (hyperglycemia)
• nausea, vomiting, loss of appetite, dry mouth, constipation, diarrhea, flatulence (gas), gastrointestinal disorders such as intestinal obstruction, gastric ulcer, gastritis (stomach inflammation), or indigestion
• abdominal inflammation, abdominal cavity hernia (this causes a bulge in the groin)
• modification of your blood parameters
• abnormal liver function test results
• weight gain or loss
• pain, fever, general discomfort
• cardiac alteration, rapid heartbeat, difficulty breathing, or chest pain
• anemia (reduction in the number of red blood cells, which may cause pale skin and 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 hematomas
• numbness, tingling, burning sensation
• hyperkinesia (increase in movements and inability to remain still)
• blurred vision
• loss of taste
• fluid in the lungs (pulmonary edema), shortness of breath, difficulty breathing, or wheezing, cough, hiccups
• kidney pain
• changes in nails
• skin disorders such as hives (urticaria), psoriasis, skin ulcers, eczema, dry skin, skin discoloration, blisters, allergic contact dermatitis, or eruptions and itching
• skin eruptions may be red spots with itching covered by swelling or eruptions or peeling. The following three types of severe skin reactions may occur:
• • toxic epidermal necrolysis (TEN). This causes:
  • • a red skin rash over most of the body
    • peeling of the outer layers of the skin
  • erythema multiforme. A skin allergic reaction that causes spots, red rashes, or areas with blisters or purple color. 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 body part, but on the skin, they may manifest 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
• low blood pressure when standing up (orthostatic hypotension)
• peritonitis (inflamed peritoneum) including fungal or bacterial peritonitis
• infections, including the flu-like syndrome and furuncle
• abnormal thinking, anxiety, nervousness

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es*. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep out of sight and reach of children.
• Store in the original packaging.
• Do not store at a temperature below 4°C.
• Do not use this medication after the expiration date that appears on the outer packaging label and the bag label after the abbreviation CAD and the symbol. The expiration date is the last day of the month indicated.

Dispose of Extraneal as instructed.

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

Composition of EXTRANEAL

The active ingredients are:

The other components are:

• Water for injection.
• Sodium hydroxide or hydrochloric acid.

Appearance of the product and contents of the pack

• EXTRANEAL is packed in flexible plastic bags of 1.5, 2.0 or 2.5 liters capacity.
• The solution in the bag is transparent and colourless.
• Each bag is wrapped in a pouch and supplied in cartons.

Only some sizes of pack may be marketed.

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Marketing authorisation holder

Vantive Health, S.L.

Industrial Sector 14

Pouet de Camilo 2

46394 Ribarroja del Turia (Valencia) Spain

Manufacturer responsible

Vantive Manufacturing Limited

Moneen Road

Castlebar, County Mayo

Republic of Ireland

Last update of the leaflet: December 2021

Vantive and EXTRANEAL are trademarks of Vantive Health Inc. or its affiliates