Lutetium Lu 177 Dotatate

• It is used to treat a certain type of cancer called neuroendocrine tumor from the gastrointestinal tract or the pancreas (GEP-NETs).

• Tell all of your health care providers that you take lutetium lu 177 dotatate. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine is radioactive. You will need to follow what the doctor has told you to lessen being exposed to lutetium lu 177 dotatate. Talk with the doctor.
• Pass urine often. You need to empty your bladder often. Drinking lots of liquids will help.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Rarely, a bone marrow problem called myelodysplastic syndrome (MDS) has happened in patients treated with lutetium lu 177 dotatate. A type of leukemia has also rarely happened. If you have questions, talk with your doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Tell your doctor if you have signs of high or low blood sugar like breath that smells like fruit, dizziness, fast breathing, fast heartbeat, feeling confused, feeling sleepy, feeling weak, flushing, headache, more thirsty or hungry, passing urine more often, shaking, or sweating.
• This medicine may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child. Talk with the doctor.
• If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for at least 4 months after stopping lutetium lu 177 dotatate. Use birth control that you can trust.
• If you are a man and your sex partner gets pregnant while you take lutetium lu 177 dotatate or within 4 months after your last dose, call your doctor right away.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting lutetium lu 177 dotatate. Talk with your doctor.
• Use birth control that you can trust to prevent pregnancy while taking lutetium lu 177 dotatate and for at least 7 months after stopping lutetium lu 177 dotatate.
• If you get pregnant while taking lutetium lu 177 dotatate or within 7 months after your last dose, call your doctor right away.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Feeling very tired or weak.
• Flushing.
• Very loose stools (diarrhea).
• A heartbeat that does not feel normal.
• Swelling in the arms or legs.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Lutetium Lu 177 dotatate is a radioactive medicine that binds itself to a specific part of certain tumor cells, allowing the radiation to enter and destroy those cells.

Lutetium Lu 177 dotatate is used to treat certain cancers of the digestive tract, including the stomach, pancreas, and intestines.

Lutetium Lu 177 dotatate may also be used for purposes not listed in this medication guide.

Do not become pregnant or breast-feed a baby while receiving lutetium Lu 177 dotatate.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Lutetium Lu 177 dotatate can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

You should not use lutetium Lu 177 dotatate if you are pregnant or breast-feeding.

Lutetium Lu 177 dotatate can harm an unborn baby or cause birth defects if the mother or the father is receiving this medicine.

• If you are a woman, use effective birth control to prevent pregnancy while you are receiving this medicine and for at least 7 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is receiving lutetium Lu 177 dotatate.

Do not breast-feed while receiving lutetium Lu 177 dotatate, and for at least 4 months after your last dose.

Tell your doctor if you have ever had:

• kidney disease;
• liver disease;
• diabetes;
• high blood pressure; or
• any type of radiation treatment.

Lutetium Lu 177 dotatate may cause other types of cancer, such as leukemia. Ask your doctor about this risk.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because lutetium Lu 177 dotatate may harm the baby if a pregnancy does occur.BasicDescription Back to TopLutetium Lu 177 Dotatate Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• little or no urination;
• flushing (warmth, redness, or tingly feeling);
• diarrhea;
• a light-headed feeling, like you might pass out;
• wheezing, chest tightness, trouble breathing;
• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• nausea, vomiting;
• high blood sugar;
• low potassium; or
• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.