Lutathera - patient leaflet, side effects, dosage

1. What Lutathera is and what it is used for

Lutathera is a radiopharmaceutical medicine used for the treatment of certain tumours (gastroentero­pancreatic neuroendocrine tumours), which cannot be completely removed from your body by surgery, have spread in your body (metastatic) and does not respond more to your current treatment. The tumour needs to have somatostatin receptors on the surface of its cells in order for the medicine to be effective. Lutathera binds with these receptors and emits radioactivity directly into the tumour cells, causing their death.

The use of Lutathera does involve exposure to amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

In addition to administration of Lutathera, an infusion with amino acids will be given to you in order to protect your kidneys as well as medicines (antiemetics) to avoid nausea and vomiting that may be caused by amino acid infusion.

2. What you need to know before Lutathera is used

Lutathera must not be used

• – if you are allergic to lutetium (177Lu) oxodotreotide or any of the other ingredients of this

medicine (listed in section 6)

• – if you are pregnant or think you may be pregnant or it is not confirmed if you are pregnant

• – if your kidneys are seriously impaired

Warnings and precautions

Talk to your doctor before you are given Lutathera as it may cause:

• – secondary blood cancer (myelodisplastic syndrome or acute leukaemia) which can rarely occur

several years after you have completed Lutathera treatment.

If any of these apply to you, tell your doctor or pharmacist or healthcare provider before receiving Lutathera, as well as during treatment with Lutathera:

• – If you had or have weakness, fatigue, shortness of breath, poor concentration, frequent

infections, fever, easily bleeding or difficulty to stop bleeding (signs and symptoms of myelossupression). Tell your doctor if you had other type of cancer within the last 5 years, bone metastasis, previous anti-cancer treatment (chemotherapy) or radiation therapy.

• – If you had or have swollen feet and ankle, too much urine or not enough urine, itching or

trouble catching your breath (signs and symptoms of chronic kidney disease).

• – If you had or have any itchy yellow skin or if the whites of your eye turn yellow, nausea or

vomiting, fatigue, loss of appetite, pain in the upper right side of your stomach area (abdomen), dark or brown urine, or you bleed or bruise more easily than normal (signs and symptoms of liver disease).

• – If you have breathlessness, weakness, numbness, chest pain, palpitations or abnormal heart

rhythm (signs and symptoms of high potassium levels in blood (hyperkalemia)).

• – If you have breathlessness, difficulty breathing when lying down or swelling of the feet or legs

(signs and symptoms of heart failure).

• – If your kidney or urinary tract is not correctly developed.

• – If you are suffering from urinary incontinence.

Treatment with Lutathera (lutetium (177Lu) oxodotreotide) may cause tumour lysis syndrome, due to the rapid breakdown of tumour cells. This may result in abnormal blood test results, irregular heartbeat, kidney failure or seizures within a week of treatment. Your doctor will perform blood tests to monitor you for this syndrome. Tell your doctor if you have muscle cramping, muscle weakness, confusion, or shortness of breath.

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

• – if you have received a previous external radiation therapy on more than 25% of your bone

marrow

• – if you heart is seriously impaired

• – if you have seriously affected blood cell counts

• – if your liver is seriously impaired

• – if it appears that your tumour does not have sufficient somatostatin receptors

Children and adolescents

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

Other medicines and Lutathera

Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines including somatostatin analogues, glucocorticoids (also called corticosteroids), since they may interfere with your treatment. If you are taking somatostatin analogues you might be asked to stop and/or adapt your treatment for a short period of time.

Pregnancy, breast -feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.

Lutathera is contraindicated in pregnant women, as ionizing radiation is dangerous for the foetus. Breast-feeding should be avoided during treatment with this medicinal product. If treatment with Lutathera during breast-feeding is necessary, the child must be weaned.

You must inform the nuclear medicine doctor before the administration of Lutathera if there is a possibility you might be pregnant or if you have missed your period or if you are breast-feeding. When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.

During treatment with Lutathera and for a minimum of the following 6 months after the end of the treatment, appropriate measures must be taken to avoid pregnancy; this applies to patients of both genders.

Fertility

Ionizing radiations of the medicine may potentially decrease your fertility. Genetic consultation is recommended if you wish to have children after treatment. Cryopreservation of sperm or eggs may be offered to you before the treatment.

Driving and using machines

It is considered unlikely that Lutathera will affect your ability to drive or to use machines; however, your general condition and the possible adverse reactions to treatment must be taken into account to assess this ability before driving or using machines.

Lutathera contains sodium

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

• 3. How Lutathera is used

There are strict laws on the use, handling and disposal of radiopharmaceutical products. Lutathera will only be used in special controlled areas. This medicine will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this medicine and will keep you informed of their actions.

The recommended dose is 7,400 MBq (megabecquerel, the unit used to express radioactivity) in a single infusion, which is given at 4 times once every 8 weeks.

Administration of Lutathera and conduct of the procedure

Lutathera is administered directly into a vein.

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

In addition to administration of Lutathera, an infusion with amino acids will be given to you in order to protect your kidneys. This might induce nausea and vomiting; you will also receive an injection before the start of the treatment to reduce these symptoms.

Duration of the procedure

Your nuclear medicine doctor will inform you about the usual duration of the procedure.

The medicine infusion takes 30 ±10 minutes; but the complete administration procedure will take approximately 5 hours. This treatment is given in 4 treatment cycles which are separated by 8 to 16 weeks. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.

Treatment monitoring

Treatment with Lutathera can have an impact on blood cells, liver and kidneys (see section 4). In consequence, your doctor will ask you to have regular blood tests in order to check your eligibility for this treatment and to detect any side effects as early as possible. Based on the results, your doctor may decide to delay or stop your treatment with this medicine if necessary.

After administration of Lutathera

You will be requested to drink a sufficient amount of water (1 glass every hour) necessary to urinate every hour on the day of infusion and the day after, and try to defecate every day, in order to eliminate the medicine from your body.

Because this medicine is radioactive, you will have to follow the instructions described below to minimize radiation exposure to others.

Considering current knowledge and experience in this field and the physical and pharmaceutical properties of the medicine, it is estimated that the health risks to your family members and the general public are low. However, you must adhere to the following rules to maximize the safety of other persons. These rules are the result of many years of experience in the use of radioactivity in medicine, and they include recommendations issued by international organizations.

General rule

You should limit close contact with people who live with you by keeping a distance of at least one meter for 7 days after you receive Lutathera.

Use of toilets

Toilets must be used in a seated position, even for men. It is absolutely necessary to use toilet paper each time. It is also important to wash your hands to avoid contaminating the door handles. It is strongly recommended to move your bowels every day and use a laxative if necessary. Furthermore, drink frequently and try to urinate every hour on the day you received treatment and on the day after. Follow your doctor’s advice on how much fluid to drink.

Contact with children and/or pregnant women

After your receive 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.

Contact with spouse and people in the family circle

You should sleep in a separate bedroom from other people for 7 days after you receive Lutathera. You should sleep in separate bedrooms from children and/or pregnant women for 15 days after you receive Lutathera.

Breast-feeding

Breast-feeding must be stopped. If treatment with Lutathera during breast-feeding is necessary, the child must be weaned.

Pregnancy

Ionizing radiation is dangerous for the foetus, therefore pregnancy is contraindicated. Men and women of child-bearing potential must refrain from procreation by using effective contraceptive methods during the treatment and for 6 months after.

People who need extra assistance

People who are confined to the bed or have reduced mobility will preferably receive assistance by a care provider. It is recommended that when providing assistance in the bathroom, the care provider wears disposable gloves for 7 days after administration. In the case of the use of special medical equipment such as catheters, colostomy bags bedpan, water nozzle, or anything that could be contaminated by your body fluids these must be emptied immediately in the toilet and then cleaned. If anyone helps you clean up vomit, blood, urine, or stool they should wear plastic gloves; the gloves should then be disposed of in a specific trash plastic bag (according to the recommendation stated in section „Trash recommendations“ below).

Dishes and bathroom accessories

Take special precautions during the 7 days after treatment:

• – Flush all wipes and/or toilet paper down the toilet immediately after use,

• – Always wash your hands well after using the toilet,

• – Take a shower every day,

• – Flush any tissues or any other items that contain anything from your body, such as blood, urine

and faeces down the toilet. Items that cannot be flushed down the toilet, such as menstrual pads and bandages, must be placed in specific trash plastic bags (according to the recommendation stated in section „Trash recommendations“ below).

• – Wash your underwear, pyjamas, sheets and any clothes that contain sweat, blood or urine

separately from the laundry of other members of your household, using a standard washing cycle. You do not need to use bleach and do not need extra rinses.

Trash recommendations

Keep the specific plastic trash bags separated from the other trash; keep the bags away from children and animals.

A member of the hospital staff will tell you how and when to get rid of these trash bags. You might be asked to bring the bag back to your treatment facility, or, after 70 days, the bag may be removed as the other household waste.

Hospitalisation and Emergency Care

If for any reason you require emergency medical assistance or unplanned hospitalisation occurs during the 3 months after your treatment, you should inform the medical providers about the nature, the date and the dose of your radioactive treatment. To facilitate that, carry your discharge letter with you at all times.

Travel

Keep the discharge letter with you whenever you are travelling for at least 3 months after treatment.

The Nuclear medicine doctor will inform you if you need to take any other special precautions after receiving this medicine. Contact your nuclear medicine doctor if you have any questions.

If you have been given more Lutathera than you should

An overdose is unlikely because you will only receive a single dose of Lutathera precisely controlled by the nuclear medicine doctor supervising the administration procedure. However, in the case of an overdose, you will receive the appropriate treatment.

Should you have any further question on the use of this medicine, please ask the nuclear medicine doctor who supervises the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Lutathera side effects are mainly linked to radioactivity.

The most common side effect seen in patients being treated with Lutathera is the impact on the bone marrow. This can lead to the decrease of the different types of blood cells, most importantly, red blood cells (responsible for transporting the oxygen from the lungs to the different organs), platelets (a special cell which helps the blood to clot), and other blood cells such as white blood cells (helps to fight infection). This happens in many patients and is frequently temporary. However, in rare cases the decrease in blood cells may be long standing and/or permanent.

As a consequence, a decrease in the various blood cell types may put you at risk for bleeding, fatigue, shortness of breath, and infection. If this does occur to you, your doctor may decide to delay or stop the treatment administration.

Some side effects could be serious

If you experience any serious side effects, tell your doctor immediately.

Very common: may affect more than 1 in 10 people

• Spontaneous bleeding or bruising (possible signs of low level of blood platelets)

(thrombocytopenia)

• Fever, sore throat or mouth ulcers due to infections (possible signs of low level of white blood

cells) (lymphopenia)

• Tiredness, fatigue, pale skin (possible signs of low level of red blood cells) (anaemia)
• Pale skin, weakness, spontaneous bleeding or bruising and frequent infections with signs such

as fever, chills, sore throat or mouth ulcers (possible signs of low level of blood cells) (pancytopenia)

Common: may affect up to 1 in every 10 people

• Bone marrow cancer resulting in poorly formed blood cells or ones that do not work properly,

with signs and symptoms of anaemia (myelodysplastic syndrome)

• Fever, sore throat or mouth ulcers due to infections (possible signs of low level of white blood

cells) (leukopenia and neutropenia)

• Weight gain, tiredness, hair loss, muscle weakness, feeling cold (possible signs of underactive

thyroid gland) (secondary hypothyroidism)

• Thirst, low urine output, weight loss, dry flushed skin, irritability (possible signs of dehydration)
• Transient, self-limited loss of consciousness followed by spontaneous recovery (syncope)
• Irregular heart-beat (change in the electrical activity of the heart)
• Dizziness, light-headedness (possible signs of low blood pressure)
• Severely decreased urine output (possible signs of kidney disorders) (renal failure and acute

kidney injury)

Uncommon: may affect up to 1 in every 100 people

• Sore throat, runny nose, difficult or painful breathing and fever (possible signs of a respiratory

tract infection)

• Cough, difficult or painful breathing, wheezing, pain in chest when breathing, fever (possible

symptoms of upper respiratory tract infection) (pneumonia)

• Rash of small fluid-filled blisters, appearing on reddened skin, signs of viral infection that can

be potentially severe (herpes zoster)

• Viral infection of the eyes (ophthalmic herpes zoster)
• Staphylococcal infections
• Streptococcal bacteraemia
• Persistent fatigue, frequent or severe infections, easy bleeding, weight loss (possible symptoms

of bone marrow cancer) (acute myeloid leukaemia, acute leukaemia and chronic myelomonocytic leukaemia)

• Bone marrow cancer resulting in poorly formed blood cells or ones that do not work properly,

with signs and symptoms of anaemia (refractory cytopenia with unilineage dysplasia)

• Nephrogenic anaemia
• 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 underneath the skin (possible signs of low level of blood platelets)

(thrombocytopenic purpura)

• Rash, itching, hives, breathlessness or difficult breathing, wheezing or coughing, light

headedness, dizziness, changes in levels of consciousness, hypotension, with or without mild generalized itching, skin reddening, facial/throat swelling, blue discoloration of the lips, tongue or skin (signs of severe allergic reaction) (hypersensitivity)

• Excessive thirst, high urine output, increased appetite with weight loss, tiredness (signs of high

level of sugar in blood) (diabetes mellitus)

• Facial flushing, redness, and a sudden rush of warmth in the face that is sometimes confused

with the hot flashes of menopause, diarrhoea, a fast heartbeat, wheezing, a sudden drop in blood pressure (possible signs of carcinoid crisis)

• Nausea, sweating, weakness, dizziness, trembling, headache (sign of low level of sugar in the blood)
• Rapid and shallow breathing, confusion, fatigue, headache, sleepiness, lack of appetite,

jaundice, increased heart rate, possible signs of metabolic acidosis that occurs when the body produces excessive quantities of acid or when the kidneys are not removing enough acid from the body (metabolic acidosis)

• Seeing, feeling or hearing things that are not there (hallucination)
• Altered level of consciousness as a result of liver failure (possible signs of hepatic

encephalopathy)

• Pressure on the spinal cord nerves which can be caused by a tumour or other lesion (spinal cord

compression)

• Irregular heartbeat (atrial fibrillation)
• Sudden and crushing chest pain, tiredness, irregular heart-beat (possible symptoms of heart

attack) (myocardial infarction)

• Crushing chest pain (possible symptoms of problem in the heart) (angina pectoris)
• Collapse caused by a heart problem, during which you may become breathless, pale, experience

cold sweat and dry mouth (cardiogenic shock)

• Dizziness, fainting on standing up, fall in blood pressure upon standing (orthostatic

hypotension)

• Swelling and reddening of a vein (sign of phlebitis)
• Chest pain, cough, hiccups, rapid breathing (signs of fluid collection between the layers of

tissue that line the lungs and chest cavity) (pleural effusion)

• Swelling of the abdomen due to accumulation of fluid (ascites)
• Constipation, swollen abdomen, abdominal pain (intestinal obstruction)
• Diarrhoea, abdominal pain, fever (possible signs of inflammation of the colon)
• Vomiting, belching, abdominal pain upper and lower, with or without nausea and vomiting

(possible signs of inflammation of the pancreas) (acute pancreatitis)

• Blood vomiting (haematemesis)
• Acute pain and swelling of the abdomen due to accumulation of fluid (haemorrhagic ascites)
• Abdominal pain, general feeling of being unwell (ileus)
• Decreased blood levels of pancreatic enzymes
• Yellow skin and eyes, nausea, loss of appetite, dark urine (signs of liver disorder)

(hepatocellular injury)

• Yellow eyes or skin (cholestasis) (signs of liver disorder)
• Liver injury or congestion
• Liver failure
• Acute pre-renal failure
• Death
• Clavicle fracture

Other possible side effects

Other side effects include the following listed below. If these side effects become severe, please tell your doctor, pharmacist or healthcare provider.

Very common: may affect more than 1 in 10 people

• Loss of appetite
• Nausea
• Vomiting
• Tiredness (fatigue)

Common: may affect up to 1 in every 10 people

• Excessive thirst, high urine output, increase appetite with weight loss (signs of high level of

sugar in the blood)

• Sleep disturbance
• Dizziness
• Disturbed sense of taste (dysgeusia)
• Headache
• Feeling of having little energy, fatigue, (lethargy)
• Headache, dizziness (sign of high blood pressure)
• Flushing and hot flushes
• Short of breath, labored breathing (dyspnoea)
• Swelling, feeling of fullness in the abdomen
• Diarrhoea
• Stomach pain
• Constipation
• Upper stomach pain
• Indigestion, pain or an uncomfortable feeling in the upper middle part of your stomach

(dyspepsia)

• Stomach pain, nausea (gastritis)
• Yellow skin and eyes, possible symptoms of high amounts of bile pigment (bilirubin) in the

blood

• Hair loss (alopecia)
• Pain in muscles, bones or joints
• Muscle spasm
• Blood in urine
• Abnormal results of urine test (presence of serum proteins)
• Skin reaction such as redness or swelling and pain at the site of injection
• Swollen hands, ankles or feet (oedema peripheral)
• Pain in the site of injection
• Chills
• Tiredness, chills, sore throat, joint or muscles aching

Uncommon: may affect up to 1 in every 100 people

• Discharge from the eye with itching, redness and swelling (signs of conjunctivitis)
• Painful and frequent urination (possible symptoms of bladder inflammation) (cystitis)
• Flu-like symptoms (Influenza)
• Weight gain, tiredness, hair loss, muscle weakness, feeling cold (signs of underactive thyroid

gland) (hypothyroidism)

• Bone and joint pain, excessive urination, abdominal pain, weakness, tiredness (signs of

overactive parathyroid gland) (hyperparathy­roidism)

• Nausea, shortness of breath, irregular heart-beat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory values – high potassium, uric acid, and phosphorous levels and low calcium levels in the blood (signs of dying tumour cells)
• Excessive emotional distress, troubled (anxiety)
• Disorientation
• A sensation like insects crawling over the skin (formication)
• Sensation of pins and needles (pricking, burning, tingling or numbing sensation) (paraesthesia)
• A distorted sense of smell (parosmia)
• Drowsiness (somnolence)
• Eye disorders
• Dizziness, with spinning sensation (vertigo)
• Rapid or irregular heartbeat or tremor (palpitations)
• Redness and/or facial flushing due to widening of blood vessels (vasodilation)
• Coldness of hands and feet
• Pale skin (pallor)
• Sore throat (oropharyngeal pain)
• Increased sputum
• Choking sensation
• Dry mouth
• Flatulence
• Gastrointestinal pain
• Mouth sores with gum inflammation (stomatitis)
• Passage of fresh blood through the anus usually in or with stool (haematochezia)
• Abdominal discomfort
• Bloody stools (rectal haemorrhage)
• Black stools (melaena)
• Lower abdominal pain
• Rash
• Dry skin
• Swelling face
• Excessive sweating (hyperhidrosis)
• Generalized itching (pruritus generalised)
• Abnormal results of urine test (presence of leukocytes)
• Involuntary leakage of urine (urinary incontinence)
• Test result that indicates kidney disorders (glomerular filtration rate decreased)
• Kidney disorder
• Renal impairment
• Injection site mass
• Tiredness, chest discomfort, light headedness pain, palpitations (possible signs of heart

disorder)

• Chest pain
• Fever
• Generally feeling unwell (malaise)
• Pain
• Feeling abnormal
• Loss of weight
• Physical disability

During Lutathera treatment, you may also have side effects of abnormal blood test results, which can give your doctor information on the functioning of some parts of your body

Common: may affect up to 1 in every 10 people

• High level of the following enzymes:
• Gamma glutamyl transferase, alanine amino transferase, aspartate amino transferase, blood

alkaline phosphate

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

Uncommon : may affect up to 1 in every 100 people

• High level of the following enzymes:
• High level of creatine phosphokinase in the blood that may indicate muscle damage, such as of the heart
• High level of lactate dehydrogenase in the blood that gives information about the health of

certain organs

• Low levels of potassium, phosphate, calcium and albumin in the blood
• High levels of sodium, calcium, urea, glycosylated hemoglobin, catecholamines and c-reactive

protein in the blood

• Haematocrit decreased
• Presence of protein in urine

During Lutathera treatment, you may also have surgical/medical procedures

Common

• Blood transfusion

Uncommon

• To drain fluid from the peritoneal cavity, the space between the abdominal wall and organs

(abdominal cavity drainage)

• To filter your blood to rid your body of harmful wastes, extra salt, and water (dialysis)
• To place a stent
• To drain abscess
• For gastrointestinal tube insertion
• To harvest (collect) stem cells from your bone marrow (bone marrow harvest)
• To remove polyps from the inside of the colon, also called the large intestine (polypectomy)

Reporting of side effects

If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

• 5. How Lutathera is stored

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmace­uticals will be in accordance with national regulation on radioactive materials.

The following information is intended for the specialist only.

Keep this medicine out of the sight and reach of children.

Lutathera must not be used after the expiry date which is stated on the label after EXP.

Store below 25 °C.

Store in the original package to protect from radiation.

6. Contents of the pack and other information

What Lutathera contains

• – The active substance is lutetium (177Lu) oxodotreotide. One mL of solution for infusion contains

370 MBq lutetium (177Lu) oxodotreotide at the date and time of calibration.

• – The other ingredients are: acetic acid, sodium acetate, gentisic acid, ascorbic acid, diethylene

What Lutathera looks like and contents of the pack

Lutathera is a clear and colourless solution for infusion, supplied in a colourless glass vial closed with a rubber stopper and sealed with an aluminium capsule.

Each vial contains a volume varying from 20.5 to 25.0 mL of solution corresponding to an activity of 7,400 MBq at date and time of infusion.

The vial is enclosed within a plastic sealed, lead shielded container.

Marketing Authorisation Holder

Advanced Accelerator Applications

20 rue Diesel

01630, Saint Genis Pouilly

France

Manufacturers

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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

AT, BE, BG, CZ, FR, HR, HU, IS, LU, LV, LT, MT, NL, RO, SI, SK Advanced Accelerator Applications

IE/UK Advanced Accelerator Applications UK Limited Tel: + 44 207 25 85 200

Tel/Tél/Te^/Simi: + 33 4 50 99 30 70

CY, EL BIOKOZMOZ AEBE Tql: + 30 22920 63900	IT Advanced Accelerator Applications (Italy) S.r.l Tel: + 39 0125 561211
DE Advanced Accelerator Applications Germany GmbH Tel: + 49 228 925 8830	PL Advanced Accelerator Applications Polska Sp. z o. o. Tel: + 48 22 275 56 47
DK, EE, FI, NO, SE SAM Nordic Tel/Puh/Tlf: + 46 8 720 5822	PT Advanced Accelerator Applications (Portugal), Unipessoal, Lda Tel: + 351 211 212 018

ES

Advanced Accelerator Applications Ibérica, S.L.U.

Tel: + 34 97 660 0126

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: . --------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

The complete SmPC of Lutathera is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmace­utical.

Please refer to the SmPC.

50