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

Lutathera is used to treat certain cancers of the digestive tract, including the stomach, pancreas, and intestines.

Lutathera may also be used for purposes not listed in this medication guide.

Do not become pregnant or breast-feed a baby while receiving Lutathera.

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

Lutathera is given as an infusion into a vein. A healthcare provider will give you this injection once every 8 weeks for a total of 4 doses.

Lutathera must be given slowly, and the infusion can take 30 to 40 minutes to complete.

After each infusion, you will be given another medicine called octreotide, which is injected into a muscle. Octreotide injections are usually given once every 4 weeks for up to 18 months.

You may be given other medications to help prevent serious side effects or allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

Drink plenty of fluids while being treated with this medicine. You should urinate often, to help keep your kidneys working properly.

You will need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

For up to 30 days after you are treated with Lutathera, your urine will contain radiation. To prevent the spread of this radiation, use a toilet rather than a urinal, and sit on the toilet while urinating.

Always wash your hands after using the bathroom. Avoid handling any clean-up of your stools or urine without wearing latex rubber gloves. If another person is handling your urine, they should wear gloves, eye protection, and a mask to cover the nose and mouth.

When cleaning any spills of bodily fluid, use only disposable cleaning cloths that can be flushed down a toilet. Ask your doctor or health department how to dispose of any bodily fluid spills that cannot be flushed down a toilet.

Wash any soiled clothing separately from the laundry of other people in your home.

You should not use Lutathera if you are pregnant or breast-feeding.

Lutathera 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 Lutathera.

Do not breast-feed while receiving Lutathera, 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.

Lutathera 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 Lutathera may harm the baby if a pregnancy does occur.

Call your doctor for instructions if you miss an appointment for your Lutathera.

Since Lutathera is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Lutathera may cause serious side effects. 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 of Lutathera 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.

Other drugs may affect Lutathera, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.