LUTATHERA 370 MBq/mL SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Lutathera 370 MBq/ml Solution for Infusion

lutetium (177Lu) oxodotreotide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or other healthcare professional who will be supervising the procedure.

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

Contents of the Package Leaflet

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

1. What is Lutathera and what is it used for

What is Lutathera

Lutathera contains lutetium (177Lu) oxodotreotide. This medicine is a radiopharmaceutical for treatment only.

What is Lutathera used for

Lutathera is used to treat adults with certain tumors (gastroenteropancreatic neuroendocrine tumors) that cannot be completely removed from the body by surgery, have spread through the body (metastatic) or have stopped responding to current treatment.

How Lutathera works

The tumor must have somatostatin receptors on the surface of its cells for the medicine to be effective. Lutathera binds to these receptors and emits radiation directly into the tumor cells, causing their death.

The use of Lutathera involves exposure to a certain amount of radiation. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will get from the procedure with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before you start using Lutathera

Do not use Lutathera

• if you are allergic to lutetium (177Lu) oxodotreotide or any of the other components of this medicine (listed in section 6).
• if you are pregnant, think you may be pregnant or it is not confirmed that you are not pregnant
• if you have severe kidney impairment

Warnings and precautions

Consult your doctor before starting treatment with Lutathera as it may cause:

• secondary blood cancer (myelodysplastic syndrome or acute leukemia), which can occur in rare cases several years after finishing treatment with Lutathera.

Tell your doctor or other healthcare professional before or during treatment with Lutathera:

• if you have or have had weakness, tiredness, difficulty breathing, lack of concentration, infections, fever, bleeding or bruising more easily than normal or difficulty stopping bleeding (signs and symptoms of myelosuppression),
• if you have had another type of cancer in the last 5 years, bone metastases, or previous cancer treatment (chemotherapy) or radiotherapy,

• if you have or have had swelling of feet and ankles, too much or too little urine, itching or difficulty breathing (signs and symptoms of chronic kidney disease),
• if you have or have had yellow skin with itching, if the whites of your eyes have turned yellow, nausea or vomiting, tiredness, loss of appetite, pain in the upper right part of your stomach (abdomen), dark or brown urine or bleeding or bruising more easily than normal (signs and symptoms of liver disease),
• if you have difficulty breathing, weakness, numbness, chest pain, palpitations or irregular heartbeat (signs and symptoms of high potassium levels in the blood, also known as hyperkalemia),
• if you have shortness of breath, difficulty breathing when lying down or swelling of feet or legs (signs and symptoms of heart failure),
• if your kidney or urinary tract has not developed properly,
• if you suffer from urinary incontinence.

Tell your doctor or other healthcare professional immediately if after starting treatment with Lutathera you experience any of the following:

• swelling of the face/throat and/or difficulty breathing (signs and symptoms of angioedema),
• redness, diarrhea, difficulty breathing with wheezing or coughing, dizziness, fainting (signs and symptoms of neuroendocrine crisis) that may occur in the first 24 hours after administration of Lutathera,
• if you feel tired, lose your appetite, notice changes in your heart rate, have problems thinking clearly (signs and symptoms of metabolic acidosis),
• if you have muscle cramps, muscle weakness, confusion or difficulty breathing (signs and symptoms of tumor lysis syndrome). Treatment with Lutathera (lutetium (177Lu) oxodotreotide) may cause tumor lysis syndrome, due to the rapid breakdown of tumor cells. This may lead to abnormal blood test results, irregular heartbeats, kidney failure or seizures within a week of treatment. Your doctor will ask for a blood test to check for this syndrome.

Unless your doctor has considered that the clinical benefit of treatment outweighs the possible risks, you will not be given this medicine:

• if you have ever received external radiotherapy to more than 25% of your bone marrow,
• if you have severe heart impairment,
• if you have severe blood test abnormalities,
• if you have severe liver impairment,
• if it seems that your tumor does not have a sufficient number of somatostatin receptors.

Before administration of Lutathera you should

• drink plenty of water to urinate as often as possible during the first hours after infusion.

Children and adolescents

The safety and efficacy of this medicine in children and adolescents under 18 years have not yet been established. Talk to your doctor or nuclear medicine doctor if you are under 18 years old.

Other medicines and Lutathera

Tell your doctor or nuclear medicine doctor if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription, as they may interfere with your treatment. This includes in particular somatostatin analogs or glucocorticoids (also known as corticoids). If you are taking somatostatin analogs, you may be asked to stop treatment for a short period.

Consult your doctor or pharmacist if you are not sure if your medicine is one of those mentioned above.

Pregnancy, breastfeeding, and fertility

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

Lutathera is contraindicated in pregnant women as ionizing radiation is hazardous to the fetus. Breastfeeding should be interrupted during treatment with this medicine. If treatment with Lutathera is necessary during breastfeeding, the mother will not continue to breastfeed the child.

You must inform your doctor and/or nuclear medicine doctor before administration of Lutathera if there is any possibility that you may be pregnant, if you have a delayed period or if you are breastfeeding.

In case of doubt, it is important that you consult your nuclear medicine doctor or other healthcare professional who will be supervising the procedure.

Female patients must use an effective contraceptive method during treatment with Lutathera and for 7 months after completion of treatment.

Male patients must use an effective contraceptive method during treatment with Lutathera and for 4 months after completion of treatment.

If you are a woman who could become pregnant, your doctor or other healthcare professional will check if you are pregnant and perform a pregnancy test if necessary before starting treatment with Lutathera.

If you become pregnant or think you are pregnant after starting treatment with Lutathera, inform your doctor and/or nuclear medicine doctor immediately.

The radiation from the medicine could reduce your fertility. If you want to have children after treatment, it is recommended that you have genetic counseling. Before treatment, you may be offered the opportunity to cryopreserve sperm or eggs.

Driving and using machines

It is considered unlikely that Lutathera will affect your ability to drive and use machines. However, you should take into account your general condition and possible side effects of treatment before driving or using machines.

Lutathera contains sodium

This medicine contains up to 81.1 mg of sodium (main component of cooking/table salt) in each vial. This is equivalent to 4% of the maximum recommended daily intake of sodium for an adult.

3. How to use Lutathera

There are strict rules about the use, handling, and disposal of radiopharmaceuticals. Lutathera will only be used in special controlled areas. This medicine will only be handled and administered by trained and qualified personnel to use it safely. These people will take special care in the safe use of this medicine and will inform you of their actions.

How much Lutathera is administered to you

The recommended dose is 7,400 MBq (Megabecquerel, unit used to express radioactivity) in a single infusion, which is administered approximately once every 8 weeks for a total of 4 times.

Administration of Lutathera and procedure

Lutathera is administered directly into a vein.

Due to the radiation emitted by this medicine, during the administration procedure, you will need to be isolated from other patients who are not receiving the same treatment. The doctor or other healthcare professional will inform you when you can leave the controlled area of the hospital.

In addition to Lutathera, you will be administered an amino acid infusion to protect your kidneys. This may cause nausea and vomiting, and therefore, before starting treatment, you will also receive an injection with an antiemetic to help reduce these symptoms.

Duration of the administration procedure

Your nuclear medicine doctor or other healthcare professional will inform you of the usual duration of the procedure.

The Lutathera infusion lasts 30 ± 10 minutes, but the complete administration procedure will take approximately 5 hours. During administration, your doctor will periodically check your condition.

Monitoring of treatment

Treatment with Lutathera may affect blood cells, liver, and kidneys (see section 4). Therefore, your doctor will ask you to undergo regular blood tests to check if it is safe for you to receive this treatment and to detect any side effects as soon as possible. If necessary, your heart's electrical activity will also be checked before discharge from the hospital (with a test called an electrocardiogram or ECG). Based on the results, the doctor may decide to postpone, modify, or suspend your treatment with this medicine if necessary.

After administration of Lutathera

You will be asked to drink enough water (e.g., 1 glass of water every hour) to allow you to urinate as often as possible on the day of infusion and the next day, and to try to defecate every day, in order to eliminate the medicine from your body.

As this is a radioactive medicine, you must follow the instructions described below to minimize radiation exposure to others unless your doctor tells you otherwise.

Based on current knowledge and experience in this field and the properties of the medicine, it is estimated that the health risks to people living with you and the general public are low.

Contact with others living with you

You should limit close contact (less than 1 meter) with people living with you for 7 days after receiving Lutathera. You should sleep in a separate room from others for 7 days after receiving Lutathera.

Contact with children and/or pregnant women

After receiving Lutathera, it is strongly recommended that you limit close contact (less than 1 meter) with children and/or pregnant women to less than 15 minutes per day for 7 days. You should sleep in a separate room from children and/or pregnant women for 15 days after receiving Lutathera.

Use of toilets

It is strongly recommended that you defecate every day and, if necessary, use a laxative. Also, drink frequently and try to urinate as often as possible during the day of treatment and the next day. Follow the advice of your doctor or other healthcare professional regarding the amount of liquids you should drink.

Be particularly careful to avoid contamination during the 7 days after treatment (applies to all patients, regardless of whether they are men or women):

• you must always sit down when using the toilet,
• it is essential that you use toilet paper every time you use the toilet,
• always wash your hands well after using the toilet,
• throw away all wipes and/or toilet paper into the toilet immediately after use,
• throw into the toilet any tissues or other materials that contain any bodily fluids, such as blood, urine, or feces. Items that cannot be thrown into the toilet, such as sanitary products and dressings, should be placed in separate plastic waste bags (as shown in the "Waste disposal recommendations" section below).

Shower and laundry

During the first 7 days, take the following special precautions:

• Shower every day,
• Wash underwear, pajamas, sheets, and clothing that contain sweat, blood, or urine separately from the rest of the household laundry, using a standard wash cycle. It is not necessary to use bleach or perform extra rinses.

People with reduced mobility

People who must stay in bed or have reduced mobility will preferably receive assistance from a caregiver. It is recommended that when assistance is provided in the bathroom, the caregiver wears disposable gloves for 7 days after administration. Any medical equipment that may be contaminated with your bodily fluids (e.g., catheters, colostomy bags, urinals, water bottles) should be emptied immediately into the toilet and cleaned afterwards. Caregivers who remove vomit, blood, urine, or feces must wear plastic gloves that should be discarded in a separate plastic waste bag (see "Waste disposal recommendations" below).

Waste disposal recommendations

All materials to be disposed of should be thrown away in a separate plastic waste bag that is used only for this purpose. Keep the separate plastic waste bags away from the rest of the trash and keep them out of the reach of children and animals.

A member of the hospital staff will tell you how and when you can dispose of these waste bags.

Hospitalization and emergency care

If for any reason you require emergency medical attention or unplanned hospitalization within 3 months after treatment, you must inform healthcare professionals about the nature, date, and dose of your radioactive treatment. To facilitate this information, always carry your discharge report with you.

Travel

For at least 3 months after treatment, when traveling, always carry your discharge report with you.

Other precautions

Your nuclear medicine doctor or other healthcare professional will inform you if it is necessary to take any special precautions after receiving this medicine. Consult your doctor or nuclear medicine doctor if you have any doubts.

If you have been administered more Lutathera than you should

An overdose is unlikely, as you will only receive a single dose of Lutathera controlled with precision by the nuclear medicine doctor or other healthcare professional supervising the procedure. However, in the case of an overdose, you will receive appropriate treatment.

If you have any further questions about the use of Lutathera, ask your nuclear medicine doctor or other healthcare professional supervising the procedure.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The adverse effects of Lutathera are mainly related to radioactivity.

The most frequently observed adverse effect in patients treated with Lutathera is its effect on the bone marrow. This can lead to a decrease in the different types of blood cells, mainly red blood cells (cells responsible for transporting oxygen from the lungs to the various organs), platelets (special cells that help blood clot), and other blood cells, such as white blood cells (which help fight infections). This occurs in many patients and is often temporary. However, in rare cases, the decrease in blood cells can be long-lasting and/or permanent.

As a consequence, a decrease in the different types of blood cells can put you at risk of bleeding, fatigue, difficulty breathing, and infection. If this happens, your doctor may decide to postpone, modify, or suspend treatment.

Some adverse effects can be serious

If you experience any serious adverse effect, inform your doctor immediately:

Very common:can affect more than 1 in 10 people

• Bleeding or bruising more easily than normal or difficulty stopping bleeding (possible signs of low platelet levels in blood) (thrombocytopenia)
• Infections with signs such as fever, sore throat, or mouth ulcers (possible signs of low white blood cell levels) (lymphopenia)
• Fatigue, weakness, pale skin, or difficulty breathing (possible signs of low red blood cell levels) (anemia)
• Fatigue, weakness, pale skin, difficulty breathing, bleeding or bruising more easily than normal, or difficulty stopping bleeding, and infections with signs such as fever, chills, sore throat, or mouth ulcers (possible signs of low blood cell levels) (pancytopenia)

Common:can affect up to 1 in 10 people

• Bone marrow cancer that produces malformed or non-functioning blood cells, with signs and symptoms of anemia, lymphopenia, neutropenia, and/or thrombocytopenia (myelodysplastic syndrome)
• Infections with signs such as fever, sore throat, or mouth ulcers (possible signs of low white blood cell levels) (leukopenia and neutropenia)
• Weight gain, fatigue, hair loss, muscle weakness, feeling of cold (possible signs of low thyroid activity) (secondary hypothyroidism)
• Excessive thirst, low urine production, weight loss, dry and reddened skin, irritability (possible signs of dehydration)
• Transient and self-limiting loss of consciousness followed by spontaneous recovery (syncope)
• Irregular heartbeat (change in heart electrical activity) (prolonged QT interval on electrocardiogram)
• Dizziness, lightheadedness (possible signs of low blood pressure) (hypotension)
• Urinating less frequently or in smaller amounts than usual (possible signs of kidney problems) (renal insufficiency and acute kidney injury)

Uncommon:can affect up to 1 in 100 people

• Sore throat, nasal discharge, difficulty or pain when breathing, and fever (possible signs of a respiratory tract infection)
• Cough, difficulty or pain when breathing, wheezing, chest pain when breathing, fever (possible symptoms of lower respiratory tract infection) (pneumonia)
• Rash of small fluid-filled blisters that appear on reddened skin, signs of viral infection that can be potentially serious (herpes zoster)
• Viral eye infection (herpes zoster ophthalmicus)
• Staphylococcal infections
• Bacteria in the blood (streptococcal bacteremia)
• Persistent fatigue, frequent or severe infections, easy bleeding, weight loss (possible symptoms of bone marrow cancer) (acute myeloid leukemia, acute leukemia, and chronic myelomonocytic leukemia)
• Bone marrow cancer that produces malformed or non-functioning blood cells with signs and symptoms of anemia (refractory cytopenia with unilineage dysplasia)
• Anemia caused by kidney problems (nephrogenic anemia)
• Bone pain or fractures, fatigue, increased infections, changes in urination frequency, confusion, thirst, nausea, or vomiting, weight loss (possible symptoms of bone marrow failure)
• Bleeding and/or bruising under the skin (possible signs of low platelet levels in blood) (thrombocytopenic purpura)
• Rash, itching, hives, shortness of breath or difficulty breathing, wheezing or cough, dizziness, lightheadedness, changes in consciousness, hypotension with or without generalized mild itching, skin redness, facial or throat swelling, bluish discoloration of the lips, tongue, or skin (signs of severe allergic reaction) (hypersensitivity)
• Excessive thirst, high urine production, increased appetite with weight loss, fatigue (signs of high blood sugar levels) (diabetes mellitus)
• Facial flushing, irritation, and rapid onset of heat in the face that is sometimes confused with menopausal hot flashes, diarrhea, rapid heartbeat, wheezing, sudden drop in blood pressure (possible signs of carcinoid syndrome)
• Nausea, sweating, weakness, dizziness, tremors, headache (signs of low blood sugar levels) (hypoglycemia)
• Rapid and shallow breathing, confusion, fatigue, headache, drowsiness, loss of appetite, jaundice, increased heart rate, possible signs of metabolic acidosis that occur when the body produces excessive amounts of acid or when the kidneys do not eliminate enough acid from the body (metabolic acidosis)
• Seeing, feeling, or hearing things that do not exist (hallucinations)
• Altered consciousness due to liver failure (possible signs of hepatic encephalopathy)
• Pressure on the nerves of the spinal cord that can be caused by a tumor or other injury (spinal cord compression)
• Irregular heartbeat (atrial fibrillation)
• Chest pain or discomfort, fatigue, irregular heartbeats (possible symptoms of a heart attack) (myocardial infarction)
• Chest pain or discomfort (possible symptom of a heart problem) (angina pectoris)
• Collapse caused by a heart problem during which you may become short of breath, pale, experience cold sweat, and dry mouth (cardiogenic shock)
• Dizziness, fainting when standing up, drop in blood pressure when standing up (orthostatic hypotension)
• Swelling and redness of a vein (sign of phlebitis)
• Chest pain, cough, hiccups, rapid breathing (signs of fluid accumulation between the layers of tissue that cover the lungs and the thoracic cavity) (pleural effusion)
• Abdominal swelling due to fluid accumulation (ascites)
• Constipation, abdominal bloating, abdominal pain (intestinal obstruction)
• Diarrhea, abdominal pain, fever (possible signs of colon inflammation) (colitis)
• Vomiting, belching, upper and lower abdominal pain with or without nausea and vomiting (possible signs of pancreas inflammation) (acute pancreatitis)
• Vomiting blood (hematemesis)
• Acute and swollen abdomen due to fluid accumulation (hemorrhagic ascites)
• Abdominal pain, general feeling of discomfort (ileus)
• Decreased levels of pancreatic enzymes in blood (decrease in pancreatic enzymes)
• Yellowish skin and eyes, nausea, loss of appetite, dark urine (signs of liver problems) (hepatocellular injury)
• Yellowish eyes or skin (signs of liver problems) (cholestasis)
• Liver congestion (hepatic congestion)
• Liver failure (hepatic failure)
• Acute pre-renal insufficiency
• Death
• Clavicle fracture

Frequency not known:cannot be estimated from the available data

• Swelling of the face/throat and/or difficulty breathing (signs and symptoms of angioedema)

Other possible adverse effects

Other adverse effects include those listed below. If these adverse effects become serious, inform your doctor or another healthcare professional.

Very common:can affect more than 1 in 10 people

• Loss of appetite
• Nausea
• Vomiting
• Fatigue

Common:can affect up to 1 in 10 people

• Excessive thirst, high urine production, increased appetite with weight loss (signs of high blood sugar levels) (hyperglycemia)
• Sleep disturbance
• Dizziness
• Altered sense of taste (dysgeusia)
• Headache
• Feeling of having little energy, fatigue (lethargy)
• Headache, dizziness (sign of high blood pressure) (hypertension)
• Flushing and hot flashes
• Shortness of breath, difficulty breathing (dyspnea)
• Swelling, feeling of having a full abdomen
• Diarrhea
• Stomach pain
• Constipation
• Pain in the upper part of the stomach
• Indigestion, pain or discomfort in the middle to upper part of the stomach (dyspepsia)
• Stomach pain, nausea (gastritis)
• Yellowish skin and eyes, possible symptoms of elevated levels of bile pigment (bilirubin) in the blood
• Hair loss (alopecia)
• Pain in muscles, bones, or joints
• Muscle spasms
• Blood in urine
• Abnormal urine test results (presence of serum proteins)
• Skin reactions such as redness, swelling, and pain at the injection site
• Swollen hands, ankles, or feet (peripheral edema)
• Pain at the injection site
• Chills
• Fatigue, chills, sore throat, joint or muscle pain (pseudoflu syndrome)

Uncommon:can affect up to 1 in 100 people

• Eye discharge with itching, redness, and swelling (signs of conjunctivitis)
• Frequent and painful urination (possible symptoms of bladder inflammation) (cystitis)
• Flu-like symptoms such as fatigue, chills, sore throat, muscle or joint pain (flu)
• Weight gain, fatigue, hair loss, muscle weakness, feeling of cold (signs of low thyroid activity) (hypothyroidism)
• Bone and joint pain, excessive urination, abdominal pain, weakness, fatigue (signs of parathyroid gland overactivity) (hyperparathyroidism)
• Nausea, difficulty breathing, irregular heartbeats, cloudy urine, fatigue, and/or joint pain associated with abnormal laboratory values - high levels of potassium, uric acid, and phosphorus, and low levels of calcium in the blood (signs of tumor cell death) (tumor lysis syndrome)
• Excessive emotional distress, problems (anxiety)
• Disorientation
• Sensation of ants crawling on the skin (formication)
• Sensation of tingling (pins and needles, burning, tingling, or numbness) (paresthesia)
• Distorted sense of smell (parosmia)
• Drowsiness (somnolence)
• Eye problems
• Dizziness, with a sensation of spinning (vertigo)
• Rapid or irregular heartbeats (palpitations)
• Facial flushing and/or warmth (due to blood vessel dilation) (vasodilation)
• Cold hands and feet
• Pale skin (pallor)
• Sore throat (oropharyngeal pain)
• Increased sputum production
• Sensation of choking
• Dry mouth
• Flatulence
• Gastrointestinal pain
• Mouth ulcers with gum inflammation (stomatitis)
• Bright red blood in stools (hematochezia)
• Abdominal discomfort (abdominal distress)
• Bleeding from the anus (rectal hemorrhage)
• Black stools (melena)
• Pain in the lower abdominal area
• Rash
• Dry skin
• Facial swelling
• Excessive sweating (hyperhidrosis)
• Generalized itching (generalized pruritus)
• Abnormal urine test results (presence of white blood cells)
• Involuntary loss of urine (urinary incontinence)
• Abnormal test results indicating kidney problems (decrease in glomerular filtration rate)
• Kidney problems
• Kidney failure
• Abnormal hardening, swelling, or lump on the skin at the injection site (injection site nodule)
• Fatigue, chest discomfort, palpitations (possible signs of heart problems) (chest discomfort)
• Chest pain
• Fever (pyrexia)
• General feeling of discomfort (malaise)
• Pain
• Feeling of abnormality
• Weight loss
• Physical disability

During treatment with Lutathera, you may also have adverse effects from abnormal blood test results that can provide your doctor with information about the functioning of certain parts of your body.

Common:can affect up to 1 in 10 people

• High levels of the following enzymes:

• Gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, blood alkaline phosphatase

• High levels of creatinine in the blood
• Low levels of magnesium and sodium in the blood

Uncommon:can affect up to 1 in 100 people

• High levels of the following enzymes:

• Creatine phosphokinase in the blood, which can indicate muscle damage such as heart damage

• Lactate dehydrogenase in the blood, which provides information about the health of certain organs

• Low levels of potassium, phosphate, calcium, and albumin in the blood
• High levels of sodium, calcium, urea, hemoglobin A1c, catecholamines, and C-reactive protein in the blood
• Low levels of red blood cells (decrease in hematocrit)
• Presence of proteins in the urine

During treatment with Lutathera, you may also undergo medical/surgical procedures

Common

• Blood transfusion

Uncommon

• Drainage of fluid from the peritoneal cavity, the space between the abdominal wall and the organs (abdominal cavity drainage)
• Filtering of your blood to remove harmful waste products, excess salt, and water from your body (dialysis)
• Implantation of a stent
• Drainage of abscesses
• Insertion of a gastrointestinal tube
• Collection of stem cells from your bone marrow (bone marrow harvest)
• Removal of polyps from the inside of the colon, also called the large intestine (polypectomy)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nuclear medicine doctor, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lutathera

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended only for the specialist:

• Keep this medicine out of the sight and reach of children.
• Do not use Lutathera after the expiration date and time shown on the label after CAD.
• Store below 25°C. Do not freeze.
• Store in the original packaging to protect from ionizing radiation (lead shielding).

6. Container contents and additional information

Composition of Lutathera

• The active substance is lutetium (177Lu) oxodotreotide. One milliliter of solution for infusion contains 370 MBq of lutetium (177Lu) oxodotreotide at the date and time of calibration.
• The other components are: acetic acid, sodium acetate, gentisic acid, ascorbic acid, pentetic acid, sodium chloride, sodium hydroxide, water for injectable preparations (see section 2 "Lutathera contains sodium").

Appearance and container contents of the product

Lutathera is a clear, colorless to slightly yellowish solution for infusion, supplied in a type I colorless glass vial, closed with a bromobutyl rubber stopper and sealed with an aluminum cap.

One vial contains a solution volume ranging from 20.5 to 25.0 ml, corresponding to an activity of 7,400 MBq at the date and time of infusion.

The vial is enclosed in a lead container for protection.

Marketing authorization holder

Advanced Accelerator Applications

8-10 Rue Henri Sainte-Claire Deville

92500 Rueil-Malmaison

France

Manufacturer

Advanced Accelerator Applications Ibérica, S.L.U.

Polígono Industrial la Cuesta – Sector 3

Parcelas 1 y 2 La Almunia de Doña Godina

50100 Zaragoza

Spain

Advanced Accelerator Applications (Italy) S.r.l

Via Ribes 5

10010

Colleretto Giacosa (TO)

Italy

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of last revision of this prospectus

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

---------------------------------------------------------------------------------------------------------------------------This information is intended for healthcare professionals only:

The complete summary of product characteristics of Lutathera is included as a separate document in the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the summary of product characteristics.