Icothera

PACKAGE LEAFLET: INFORMATION FOR THE USER

Icothera peritoneal dialysis solution

Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Icothera is and what it is used for

Icothera is a solution for peritoneal dialysis. The peritoneal cavity is the empty space within the abdomen,
located between the skin and the peritoneum. The peritoneum is the membrane that surrounds internal organs, such as
the intestine and liver. Icothera solution is infused into the peritoneal cavity, where it removes
fluids and waste products from the blood. It may also correct abnormal levels of various blood components.
Icothera may be prescribed:

• to adult patients with permanent renal failure who require peritoneal dialysis,
• when standard glucose-based peritoneal dialysis solutions alone are not able to remove sufficient fluid.

2. What you need to know before using Icothera

The patient must be supervised by a physician at the time of first use of the product.
Do not use Icothera

• if you are allergic to icodextrin, starch derivatives (e.g. corn starch), or any of the other ingredients of this medicine;
• if you are intolerant to maltose or isomaltose (a sugar derived from starch);
• if you suffer from glycogenosis;
• if you have previously experienced severe lactic acidosis (excessive acid in the blood);
• if you have an abdominal wall or cavity problem that cannot be resolved surgically, or a condition that increases the risk of abdominal infections;
• if you have documented loss of peritoneal function due to extensive peritoneal scarring.

Warnings and precautions
Talk to your doctor before using Icothera

• if you are an elderly patient. There is a risk of dehydration;
• if you are diabetic and are using the solution for the first time. It may be necessary to adjust your insulin dose;
• if you need to measure your blood glucose levels (e.g. if you are diabetic). Your doctor will advise you which test kit to use (see “Other forms of interaction”);
• if you are at high risk of developing severe lactic acidosis (excessive acid in the blood). A high risk of lactic acidosis exists in the following cases:
• very low blood pressure;
• blood infection (septicaemia);
• severe acute renal failure;
• inherited metabolic disease;
• taking metformin (a medicine used to treat diabetes);
• taking medicines for HIV treatment, particularly those known as NRTIs;
• if you experience abdominal pain or notice cloudiness, opacity, or particles in the drained fluid.

This could indicate peritonitis (inflammation of the peritoneum) or infection. In such cases,
contact your healthcare providers immediately. Note down the batch number and provide it to healthcare
professionals along with the bag containing the drained fluid. The doctor will decide whether to stop
treatment or initiate corrective measures. For example, in case of infection, the doctor may perform tests
to determine the most appropriate antibiotic for your condition. Until the specific infection is identified,
you may receive an antibiotic effective against a wide range of different bacteria (broad-spectrum antibiotic).
During dialysis, your body may lose proteins, amino acids, and vitamins. Your doctor will inform you if
replacement is necessary;

• if you have conditions affecting the abdominal wall or cavity, such as hernia, infection, or chronic inflammatory bowel disease;
• if you have undergone aortic grafting;
• if you suffer from severe lung disease, such as emphysema;
• if you have breathing difficulties;
• if you have disorders that impair normal nutrition;
• if you have potassium deficiency.

You should also consider the following:

• a condition called encapsulating peritoneal sclerosis (EPS) is a known rare complication of peritoneal dialysis therapy. You and your doctor should be aware of this possible complication. EPS causes:
• abdominal inflammation;
• formation of layers of fibrous tissue that coat and block organs, preventing their normal movement. Rarely, this condition has been fatal;
• you, possibly together with your doctor, should keep a record of your fluid balance and body weight; your doctor will monitor your blood parameters at regular intervals;
• your doctor will periodically check your potassium levels. If they become very low, your doctor may prescribe potassium chloride supplementation to correct them.

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

• you suffer from acute kidney disease.

Children and adolescents
The safety and efficacy of Icothera in children under 18 years of age have not been established.
Other medicines and Icothera
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

• If you are taking other medicines, your doctor may need to increase their dosage, because peritoneal dialysis treatment increases the elimination of certain drugs.
• Use caution if you are taking heart medications called cardiac glycosides (e.g. digoxin). Your heart treatment may become less effective or toxicity may increase. You may:
• require potassium and calcium supplements;
• develop an irregular heartbeat (arrhythmia).

Your doctor will monitor you closely during treatment, particularly regarding potassium levels.
Other forms of interaction
Icothera interferes with blood glucose measurement when certain test kits are used. If you need to measure blood glucose, ensure you use a glucose-specific test kit. Your doctor will advise you which test kit to use.
Using the wrong test kit may result in falsely high blood glucose readings, leading to administration of more insulin than needed. This may cause low blood glucose levels (hypoglycaemia), with loss of consciousness, coma, neurological damage, and death. Falsely high glucose readings may also mask true hypoglycaemia and prevent its correction, leading to similar consequences.
Falsely high glucose readings may occur up to two weeks after discontinuation of Icothera therapy. If hospitalised, inform physicians about this potential interaction, who must carefully review the product information of the test kit used to ensure it is glucose-specific.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning pregnancy, or are breastfeeding, consult your doctor before starting treatment with this medicine.
During pregnancy, you will receive this medicine only if your doctor considers it absolutely necessary for recovery. Icothera should be administered to pregnant women only after careful evaluation.
At therapeutic doses of Icothera, effects on newborns/infants are not expected. However, breastfeeding is not recommended while undergoing peritoneal dialysis.
Driving and using machines
This treatment may cause fatigue, weakness, blurred vision, or dizziness. Do not drive or operate machinery in such cases.

3. How to use Icothera

Use this medicine exactly as directed by your doctor. Check with your doctor if you are unsure.
Icothera is indicated for one exchange per day during the long dwell time (from 6 to 16 hours) in continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of end-stage renal disease.
Icothera is administered into the peritoneal cavity. The peritoneal cavity is the empty space in the abdomen, located between the skin and the peritoneum. The peritoneum is the membrane surrounding internal organs such as the intestine and liver.
Always use the medicine exactly as instructed by healthcare professionals specialized in peritoneal dialysis.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is

• one bag per day during the longest dwell time, that is:
• during the night in continuous ambulatory peritoneal dialysis (CAPD);
• during the day in automated peritoneal dialysis (APD).
• The infusion of the solution lasts 10–20 minutes.
• The dwell time with Icothera is 6–12 hours in CAPD and 14–16 hours in APD.

Method of administration
Before use:

• Warm the bag to 37 °C using the appropriate heating plate. Never immerse the bag in water to warm it.
• Use an aseptic technique during administration of the solution, as instructed.
• Before starting the exchange, ensure that your hands and the area where the procedure will be performed are clean.
• Before opening the outer wrapper, check the correct solution type, volume, and expiration date. Lift the dialysis bag to check for leaks (presence of excess fluid inside the outer wrapper). Do not use the bag if there are leaks.
• After removing the outer wrapper, inspect the container for leaks by firmly compressing the bag. Do not use the bag if there are leaks.
• Ensure the solution is clear. Do not use the solution if it is cloudy or contains particles.
• Check that all connections are properly secured before starting the exchange.
• Contact your doctor or nurse if you have any questions or doubts about the product and its use.
• Use each bag only once. Dispose of any unused portion of the 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 Icothera bag. In such cases, add the medicine using the dedicated access port located at the bottom of the bag. Use the product immediately after adding the medicine. If you have any doubts, consult your doctor.
In case of using more than one Icothera bag in 24 hours
If you use an excessive amount of Icothera, you may experience abdominal distension, feeling of fullness, and/or shortness of breath.
Contact your doctor immediately. Your doctor will advise you on how to proceed.
If you stop treatment with Icothera
Do not stop or interrupt treatment without your doctor's approval. Stopping treatment may lead to potentially life-threatening consequences.
If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effect, consult your doctor or dialysis centre, even if it is not listed in this leaflet.
Contact your doctor or dialysis centre immediately if you experience any of the following side effects:

• Hypertension.
• Swollen ankles or legs, bulging eyes, shortness of breath or chest pain (hypervolemia).
• Hypersensitivity (allergic reaction), possibly with swelling of the face, throat or around the eyes (angioedema).
• Abdominal pain.
• Chills (tremors/influenza-like symptoms). The above may indicate serious side effects, requiring urgent medical attention.

Common - may affect up to 1 in 10 people using Icothera:

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

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

• Cloudy fluid drained from the peritoneal cavity, stomach ache.
• Peritoneal bleeding, pus, swelling, pain or infection at the catheter exit site, catheter blockage, injury, interaction with the catheter.
• Weakness, cold sweats, intense hunger, confusion, possible loss of consciousness and seizures due to low blood sugar levels (hypoglycaemia). In some people, this may become a serious side effect. Consult your doctor.
• Shock or coma caused by low blood sugar concentration.
• Frequent urination, thirst, fatigue due to high blood sugar levels (hyperglycaemia). In some people, this may become a serious side effect. Consult your doctor.
• Nausea, vomiting, loss of appetite, dry mouth, constipation, diarrhoea, flatulence, gastrointestinal or intestinal disorders including intestinal obstruction, gastric ulcer, abdominal pain, indigestion.
• Abdominal swelling, abdominal hernia (causing a bulge in the groin).
• Changes in blood test results.
• Abnormal liver function test results.
• Weight gain or weight loss.
• Pain, fever, malaise.
• Heart disease, rapid heartbeat, shortness of breath or chest pain.
• Anaemia (reduction in red blood cells, resulting in paleness, weakness or breathlessness), increase or decrease in white blood cell count, and reduced platelets, increasing the risk of bleeding or bruising.
• Muscle aches, tingling, burning sensation.
• Involuntary movements (hyperkinesia).
• Blurred vision.
• Loss of taste sensation.
• Fluid in the lungs (pulmonary oedema), shortness of breath, difficulty breathing or wheezing, cough, hiccups.
• Kidney pain.
• Nail disorders.
• Skin disorders, including hives, psoriasis, skin ulcers, eczema, dry skin, skin discolouration, blistering of the skin, allergic or contact dermatitis, rash and itching.
• Skin rashes may be itchy, with raised red spots or skin peeling. The following three types of serious skin reactions may occur:
• Toxic epidermal necrolysis (TEN). Causes:
  • a red rash in various parts of the body;
  • shedding of the outer layers of the skin.
• Erythema multiforme. A skin allergic reaction causing spots, red wheals or purple or blistered areas. It may also affect the mouth, eyes and other mucous membranes.
• Vasculitis. Inflammation of certain blood vessels within the body. Clinical symptoms depend on the affected area, but may manifest on the skin as:
  • red or purple spots or wheals, or symptoms similar to an allergic reaction, including rash, joint pain and fever.
• Muscle cramps, bone, joint, muscle, back and neck pain.
• Dizziness, possible fainting when moving from lying down to sitting or standing up due to low blood pressure (orthostatic hypotension).
• Peritonitis (inflammation of the peritoneum), including that caused by fungal or bacterial infection.
• Infections, including influenza-like syndrome and boils.
• Abnormal thinking, anxiety, nervousness.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Icothera

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after the word EXP. The expiry date refers to the last day of that month.
Store in the original packaging.
Do not refrigerate or freeze.
The product should be used immediately after removal from the outer wrapper.
Dispose of Icothera according to the instructions provided. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

This leaflet does not contain all the information relating to this medicinal product. If you have any questions or doubts, please consult your doctor.

What Icothera contains
The active substances are:
Icodextrin 75 mg/mL (75 g/L)
Sodium chloride 5.4 mg/mL (5.4 g/L)
Sodium S-lactate 4.5 mg/mL (4.5 g/L)
Calcium chloride dihydrate 0.257 mg/mL (0.257 g/L)
Magnesium chloride hexahydrate 0.051 mg/mL (0.051 g/L)
Theoretical osmolarity: 284 (milliosmoles per litre)
Theoretical osmolarity: 301 (milliosmoles per kg)

Composition of the electrolyte solution per 1000 mL (1 L):
Sodium 133 mmol/L
Calcium 1.75 mmol/L
Magnesium 0.25 mmol/L
Chloride 96 mmol/L
Lactate 40 mmol/L
pH = between 5 and 6

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

Description of the appearance of Icothera and package contents
Icothera is a sterile, colourless or slightly yellowish solution.
Icothera is supplied in the following two pack configurations:
A 2.0-litre plastic polypropylene bag containing the solution and an empty 3.0-litre plastic polypropylene drainage bag with connecting tube.
Both bags and their connection are enclosed in a double-layer polypropylene protective film and an overpouch made of polyamide, and supplied in cardboard boxes containing 4 bags.
A 2.0-litre plastic polypropylene bag containing the solution, enclosed in a double-layer polypropylene protective film and an overpouch made of polyamide, 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 Bucharest-Sector 3
Romania

This medicinal product has been granted marketing authorization in the Member States of the European Economic Area under the following names:

Other sources of information
The package leaflet may be provided in an alternative format (large print) upon specific
request by the patient. The patient may request the package leaflet in electronic format (PDF),
indicating an e-mail address for receipt, or in paper format, indicating name, surname and
postal address for delivery, via the following website:
https://www.vivisol.com/ , section "Contacts".