Lutathera 370 MBq/ml solution for infusion

Package leaflet: Information for the user

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, as you may need to read it again.

• If you have any questions, ask your doctor or another healthcare professional who will supervise the procedure.

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

Contents of this leaflet

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

1. What Lutathera is and what it is used for

What Lutathera is

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

What Lutathera is used for

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

How Lutathera works

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

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

2. What you need to know before using Lutathera

Do not use Lutathera

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

Warnings and precautions

Talk to your doctor before starting treatment with Lutathera, as it may cause:

• secondary blood cancer (myelodysplastic syndrome or acute leukemia), which may rarely occur several years after completing treatment with Lutathera.

Inform your doctor or another healthcare professional before or during treatment with Lutathera:

• if you have or have had weakness, fatigue, shortness of breath, difficulty concentrating, infections, fever, bleeding, bruise easily or have difficulty stopping bleeding (signs and symptoms of myelosuppression),
• if you have had another type of cancer within the past 5 years, bone metastases, or prior 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 yellowing of the skin with itching, yellowing of the whites of your eyes, nausea or vomiting, fatigue, loss of appetite, pain in the upper right part of your stomach (abdomen), dark or brown urine, or bruise or bleed 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 did not develop properly,
• if you suffer from urinary incontinence.

Immediately inform your doctor or another healthcare professional 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),
• flushing, diarrhea, difficulty breathing with wheezing or coughing, dizziness, lightheadedness (signs and symptoms of neuroendocrine hormonal crisis), which may occur within the first 24 hours after administration of Lutathera,
• fatigue, loss of appetite, changes in your heart rate, difficulty thinking clearly (signs and symptoms of metabolic acidosis),
• 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 heartbeat, kidney failure or seizures within a week of treatment. Your doctor will request blood tests to monitor for this syndrome.

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

• if you have previously received external radiotherapy to more than 25% of your bone marrow,
• if you have severe heart impairment,
• if you have severe blood count abnormalities,
• if you have severe liver impairment,
• if your tumor appears to lack a sufficient number of somatostatin receptors.

Before administration of Lutathera you should

• drink plenty of fluids to urinate as frequently as possible during the first few hours after infusion.

Children and adolescents

The safety and efficacy of this medicine in children and adolescents under 18 years of age have not yet been established. Speak with your doctor or nuclear medicine physician if you are under 18 years of age.

Other medicines and Lutathera

Inform your doctor or nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, as they may interfere with your treatment. This includes in particular somatostatin analogues or glucocorticoids (also known as corticosteroids). If you are taking somatostatin analogues, you may be asked to temporarily discontinue treatment.

Consult your doctor or pharmacist if you are unsure whether your medicine is one of those mentioned above.

Pregnancy, breastfeeding and fertility

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

Lutathera must not be administered to pregnant women as ionizing radiation is harmful to the fetus. Breastfeeding must be discontinued during treatment with this medicine. If treatment with Lutathera is required during breastfeeding, the mother will no longer breastfeed the child.

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

In case of doubt, it is important to consult your nuclear medicine physician or another healthcare professional supervising the procedure.

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

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

If you are a woman of childbearing potential, your doctor or another healthcare professional will check whether 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 physician immediately.

Radiation from the medicine may reduce your fertility. If you wish to have children after treatment, genetic counseling is recommended. Before treatment, you may be offered the possibility of cryopreserving sperm or eggs.

Driving and using machines

Lutathera is considered unlikely to affect the ability to drive or operate machinery. However, your general condition and possible adverse effects of treatment should be taken into account before driving or using machines.

Lutathera contains sodium

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

3. How to use Lutathera

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Lutathera will only be used in specially controlled areas. This medicine will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in ensuring the safe use of this medicine and will inform you of their actions.

How much Lutathera will be administered to you

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

Administration of Lutathera and performance of the procedure

Lutathera is administered directly into a vein.

Due to the radiation emitted by this medicine, you will need to remain isolated from other patients who are not receiving the same treatment during the administration procedure. Your doctor or another healthcare professional will inform you when you may leave the hospital’s controlled area.

In addition to Lutathera, you will receive an amino acid infusion to protect your kidneys. This may cause nausea and vomiting; therefore, prior to starting treatment, you will also receive an injection of a medication to help reduce these symptoms.

Duration of the administration procedure

Your nuclear medicine physician or another healthcare professional will inform you about the usual duration of the procedure.

The Lutathera infusion lasts 30 ±10 minutes, but the total duration of the complete administration procedure will be approximately 5 hours. During administration, your doctor will periodically monitor your condition.

Monitoring during treatment

Treatment with Lutathera may affect blood cells, the liver, and the kidneys (see section 4). Therefore, your doctor will request regular blood tests to determine whether this treatment is suitable for you and to detect any adverse effects as early as possible during treatment. If necessary, your heart’s electrical activity will also be checked before hospital discharge (using a test called an electrocardiogram or ECG). Based on the results, your doctor may decide to delay, modify, or discontinue your treatment with this medicine, if needed.

After administration of Lutathera

You will be advised to drink sufficient fluids (e.g., 1 glass of water per hour) to allow you to urinate as frequently as possible on the day of the infusion and the following day, and to try to empty your bowel daily, in order to eliminate the medicine from your body.

As this is a radioactive medicine, you must follow the instructions below to minimize radiation exposure to other people, unless your doctor advises otherwise.

Based on current knowledge and experience in this field and on the properties of the medicine, the health risks to household contacts and the general public are considered low.

Contact with household members

You should limit close contact (closer than one meter) with people you live with 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 (closer than one 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

You are strongly advised to defecate every day and, if necessary, use a laxative. In addition, drink fluids frequently and try to urinate as often as possible on the day you receive treatment and the following day. Follow your doctor’s or healthcare professional’s advice regarding the amount of fluid you should drink.

Take special precautions to avoid contamination during the 7 days after treatment (applies to all patients, regardless of sex):

• Always sit down when using the toilet,
• It is essential to use toilet paper every time you use the toilet,
• Always wash your hands thoroughly after using the toilet,
• Immediately flush all tissues and toilet paper into the toilet after use,
• Flush tissues or any other materials containing bodily substances such as blood, urine, or feces into the toilet. Items that cannot be flushed, such as sanitary pads and dressings, should be placed in separate plastic garbage bags (in accordance with the recommendations in the section “Disposal recommendations” below).

Showering and laundry

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

• Shower daily,
• Wash underwear, pajamas, bed sheets, and clothing stained with sweat, blood, or urine separately from the rest of the household laundry, using a standard washing cycle. There is no need to use bleach or perform extra rinses.

Patients with limited mobility

Patients who are bedridden or have limited mobility should preferably receive assistance from a caregiver. It is recommended that caregivers wear disposable gloves when assisting in the bathroom for 7 days after administration. Any medical equipment that may become contaminated with your body fluids (e.g., catheters, colostomy bags, bedpans, water bottles) should be emptied immediately into the toilet and then cleaned. Caregivers who handle vomit, blood, urine, or feces should wear plastic gloves, which must be discarded into a separate plastic waste bag (see “Disposal recommendations” below).

Disposal recommendations

All materials intended for disposal must be placed in a separate plastic garbage bag used exclusively for this purpose. Keep the plastic waste bags separate from other household waste and store them out of reach of children and animals.

A member of the hospital staff will advise you on how and when to dispose of these waste bags.

Hospitalization and emergency care

If, for any reason, you require emergency medical care 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, always carry your discharge summary with you.

Travel

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

Other precautions

Your nuclear medicine physician or another healthcare professional will inform you if any special precautions are necessary after receiving this medicine. Consult your doctor or nuclear medicine physician if you have any questions.

If you have received more Lutathera than you should

An overdose is unlikely, as you will receive only a single precisely controlled dose of Lutathera administered by the nuclear medicine physician or other healthcare professional supervising the procedure. However, in the event of an overdose, appropriate treatment will be given.

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

4. Possible side effects

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

The side effects of Lutathera are mainly related to radioactivity.

The most commonly observed side effect in patients treated with Lutathera is its effect on the bone marrow. This may lead to a decrease in the different types of blood cells, primarily red blood cells (cells responsible for transporting oxygen from the lungs to various organs), platelets (special cells that help blood to 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 reduction in blood cells may be long-lasting and/or permanent.

As a result, a decrease in different types of blood cells may increase your risk of bleeding, fatigue, difficulty breathing, and infection. If this occurs, your doctor may decide to delay, modify, or discontinue treatment.

Some side effects may be serious

If you experience any serious side effects, inform your doctor immediately:

Very common: may 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: may affect up to 1 in 10 people

• Bone marrow cancer producing 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 cold (possible signs of low thyroid gland activity) (secondary hypothyroidism)
• Thirst, low urine output, weight loss, dry and reddened skin, irritability (possible signs of dehydration)
• Transient, self-limiting loss of consciousness followed by spontaneous recovery (syncope)
• Irregular heartbeat (change in the heart's electrical activity) (prolonged QT interval on electrocardiogram)
• Dizziness, lightheadedness (possible signs of low blood pressure) (hypotension)
• Urinating less frequently or producing much less urine than usual (possible signs of kidney problems) (renal failure and acute kidney injury)

Uncommon: may 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 with small fluid-filled blisters appearing on red skin, signs of viral infection that may be potentially severe (herpes zoster)
• Viral infection in the eyes (ophthalmic herpes zoster)
• Staphylococcal infections
• Presence of 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, chronic myelomonocytic leukemia)
• Bone marrow cancer producing 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) (purpuric thrombocytopenia)
• Rash, itching, hives, dyspnea or breathing difficulty, wheezing or cough, dizziness, changes in level of consciousness, hypotension with or without mild generalized itching, skin redness, facial/throat swelling, bluish discoloration of lips, tongue, or skin (signs of severe allergic reaction) (hypersensitivity)
• Excessive thirst, high urine output, increased appetite with weight loss, fatigue (signs of high blood sugar levels) (diabetes mellitus)
• Facial redness, irritation, and sudden, rapid heat in the face sometimes mistaken for menopausal hot flashes, diarrhea, rapid heartbeat, wheezing, sudden drop in blood pressure (possible signs of carcinoid crisis)
• 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 occurring when the body produces excessive acid or when the kidneys fail to eliminate enough acid from the body (metabolic acidosis)
• Seeing, feeling, or hearing things that are not real (hallucinations)
• Altered consciousness due to liver failure (possible signs of hepatic encephalopathy)
• Pressure on spinal cord nerves that may result from a tumor or other lesion (spinal cord compression)
• Irregular heartbeat (atrial fibrillation)
• Sudden, crushing chest pain, fatigue, irregular heartbeats (possible symptoms of a heart attack) (myocardial infarction)
• Crushing chest pain (possible symptom of a heart problem) (angina pectoris)
• Collapse due to a heart problem during which you may become breathless, pale, experience cold sweat and dry mouth (cardiogenic shock)
• Dizziness, fainting upon standing, drop in blood pressure when standing (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 lining the lungs and chest cavity) (pleural effusion)
• Swelling of the abdomen due to fluid accumulation (ascites)
• Constipation, bloated abdomen, 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 abdominal pain and swelling due to fluid accumulation (hemorrhagic ascites)
• Abdominal pain, general malaise (ileus)
• Decreased levels of pancreatic enzymes in blood (decreased pancreatic enzymes)
• Yellowing of skin and eyes, nausea, loss of appetite, dark urine (signs of liver problems) (hepatocellular injury)
• Yellow eyes or skin (signs of liver problems) (cholestasis)
• Liver congestion (hepatic congestion)
• Liver failure (hepatic failure)
• Acute pre-renal failure
• Death
• Clavicle fracture

Frequency not known: cannot be estimated from available data

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

Other possible side effects

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

Very common: may affect more than 1 in 10 people

• Loss of appetite
• Nausea
• Vomiting
• Fatigue (tiredness)

Common: may affect up to 1 in 10 people

• Excessive thirst, high urine output, increased appetite with weight loss (signs of high blood sugar levels) (hyperglycemia)
• Sleep disturbance
• Dizziness
• Altered sense of taste (dysgeusia)
• Headache
• Feeling of low energy, tiredness (lethargy)
• Headache, dizziness (sign of high blood pressure) (hypertension)
• Flushing and hot flashes
• Shortness of breath, difficulty breathing (dyspnea)
• Swelling, feeling of fullness in the abdomen
• Diarrhea
• Stomach pain
• Constipation
• Upper abdominal pain
• Indigestion, pain or discomfort in the middle to upper part of the stomach (dyspepsia)
• Stomach pain, nausea (gastritis)
• Yellow skin and eyes, possible symptoms of elevated bilirubin (a bile pigment) in the blood
• Hair loss (alopecia)
• Muscle, bone, or joint pain
• 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 (flu-like illness)

Uncommon: may 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 (influenza)
• Weight gain, fatigue, hair loss, muscle weakness, feeling cold (signs of low thyroid gland activity) (hypothyroidism)
• Bone and joint pain, excessive urination, abdominal pain, weakness, fatigue (signs of overactive parathyroid gland) (hyperparathyroidism)
• Nausea, difficulty breathing, irregular heartbeat, cloudy urine, fatigue and/or joint discomfort associated with abnormal blood test results—high levels of potassium, uric acid, and phosphorus and low calcium levels in blood (signs of tumor cell death) (tumor lysis syndrome)
• Excessive emotional distress, problems (anxiety)
• Disorientation
• Sensation like ants crawling on the skin (tingling)
• Tingling sensation (pins and needles, burning, pricking, or numbness) (paresthesia)
• Distorted sense of smell (parosmia)
• Drowsiness (somnolence)
• Eye problems
• Dizziness with spinning sensation (vertigo)
• Rapid or irregular heartbeats (palpitations)
• Facial redness and/or warmth (due to blood vessel widening) (vasodilation)
• Cold hands and feet
• Pale skin (pallor)
• Sore throat (oropharyngeal pain)
• Increased sputum
• Sensation of suffocation
• Dry mouth
• Flatulence
• Gastrointestinal pain
• Mouth sores with inflamed gums (stomatitis)
• Bright red blood in stool (hematochezia)
• Abdominal discomfort (abdominal discomfort)
• Rectal bleeding (rectal hemorrhage)
• Black stools (melena)
• Lower abdominal pain
• 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)
• Test results indicating kidney problems (decreased glomerular filtration rate)
• Kidney problems
• Kidney failure
• Abnormal hardening, swelling, or lump 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 experience side effects from abnormal blood test results that can provide your doctor with information about how certain parts of your body are functioning.

Common: may affect up to 1 in 10 people

• Elevated levels of the following enzymes:

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

• Elevated blood creatinine levels

• Low levels of magnesium and sodium in blood

Uncommon: may affect up to 1 in 100 people

• Elevated levels of the following enzymes:

• Creatine phosphokinase in blood, which may indicate muscle damage including heart muscle

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

• Low levels of potassium, phosphate, calcium, and albumin in blood

• High levels of sodium, calcium, urea, glycated hemoglobin, catecholamines, and C-reactive protein in blood

• Low levels of red blood cells (decreased hematocrit)

• Presence of proteins in 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 organs (abdominal cavity drainage)
• Filtering your blood to remove harmful waste products, excess salt, and water from your body (dialysis)
• Stent implantation
• Abscess drainage
• Insertion of a gastrointestinal tube
• Collection of stem cells from your spinal marrow (bone marrow extraction)
• Removal of polyps from inside the colon, also known as the large intestine (polypectomy)

Reporting of side effects

If you experience any side effects, consult your doctor or the nuclear medicine physician, even if they are possible side effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lutathera

You will not be required to store this medicine. This medicine will be stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations regarding radioactive materials.

The following information is intended for healthcare professionals only:

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

6. Contents of the pack and other information

Composition of Lutathera

• The active substance is lutetium (177Lu) oxodotreotide. One ml of infusion solution 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 injections (see section 2 “Lutathera contains sodium”).

Appearance of the medicinal product and contents of the pack

Lutathera is a clear, colourless to slightly yellow infusion solution supplied in a colourless type I glass vial, closed with a bromobutyl rubber stopper and sealed with an aluminium cap.

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

The vial is enclosed within a lead container for shielding.

Marketing Authorisation 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

Further information on this medicinal product is available by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

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

Please consult the summary of product characteristics.