Uses

This medication is used to treat certain types of tumors (gastroenteropancreatic neuroendocrine tumors - GEP-NETs). Lutetium Lu 177 dotatate is a radioactive drug. It works by attaching to certain tumor cells and causing them to die.

How To Use

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually once every 8 weeks for 4 doses. The dosage is based on your medical condition, lab tests, and response to treatment.

Follow your doctor's instructions about the other medications (such as octreotide) you may need to use with this product.

Drink plenty of fluids before, during, and after treatment with this medication and urinate as often as possible to lessen the risk of kidney damage. Ask your doctor for more details.

During and after receiving this medication, follow your doctor's instructions on how to reduce radiation exposure to others.

Side Effects

Dizziness, headache, nausea/vomiting, diarrhea/constipation, change in how food tastes, hair loss, or decreased appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• signs of kidney damage (such as change in amount of urine)
• signs of liver disease (such as nausea/vomiting that doesn't stop, stomach/abdominal pain, yellowing eyes/skin, dark urine)
• flushing
• shortness of breath
• swelling hands/ankles/feet
• muscle pain
• fast/irregular heartbeat
• mental/mood changes (such as anxiety)

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following unlikely symptoms:

• unusual tiredness
• pale skin
• signs of infection (such as sore throat that doesn't go away, fever, painful/burning urination)
• easy bruising/bleeding

Some people treated with this medication may rarely get other cancers (such as leukemia). Consult your doctor for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using lutetium Lu 177 dotatate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney problems
• liver problems (such as cancer)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using lutetium Lu 177 dotatate before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may affect the ability to have children. Talk to your doctor for details.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using lutetium Lu 177 dotatate. Lutetium Lu 177 dotatate may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 7 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 4 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 2.5 months after the last dose. Consult your doctor before breastfeeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as complete blood count, kidney/liver function, blood mineral levels, blood sugar) should be done before you start receiving this medication and while you are using it. Keep all medical and lab appointments.

Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).