Lutetium Lu 177 dotatate injection

What is this medication?

LUTETIUM LU 177 DOTATATE (loo-TEE-shee-uhm DOE-ta-tate) is a medicine that targets certain cells in the body and stops cancer cells from growing. It is used to treat certain neuroendocrine tumors.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Lutathera

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• kidney disease
• liver disease
• low blood counts, like low white cell, platelet, or red cell counts
• an unusual or allergic reaction to lutetium Lu 177 dotatate, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• lanreotide depot injection
• octreotide depot injection

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Do not become pregnant while taking this medicine or for 7 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 4 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

Do not breast-feed an infant while taking this medicine or for 2.5 months after the last dose.

This medicine may interfere with the ability to have a child. Talk with your doctor or health care professional if you are concerned about your fertility.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

You may need blood work done while you are taking this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• breathing problems
• diarrhea
• facial flushing
• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems
• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
• signs of decreased red blood cells - unusually weak or tired, feeling faint or lightheaded, falls
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired
• signs and symptoms of low blood sugar such as feeling anxious; confusion; dizziness; increased hunger; unusually weak or tired; sweating; shakiness; cold; irritable; headache; blurred vision; fast heartbeat; loss of consciousness
• signs of low calcium like fast heartbeat, muscle cramps or muscle pain; pain, tingling, numbness in the hands or feet; seizures
• signs and symptoms of low magnesium like muscle cramps, pain, or weakness; tremors; seizures; or fast, irregular heartbeat
• signs and symptoms of low potassium like muscle cramps or muscle pain; chest pain; dizziness; feeling faint or lightheaded, falls; palpitations; breathing problems; or fast, irregular heartbeat

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• cough
• hair loss
• loss of appetite
• nausea, vomiting
• signs and symptoms of high blood sugar such as dizziness; dry mouth; dry skin; fruity breath; nausea; stomach pain; increased hunger or thirst; increased urination
• stomach pain
• swelling of the ankles, feet, hands
• upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.