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 lutetium Lu 177 dotatate 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.

Lutetium Lu 177 dotatate 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.

lutetium Lu 177 dotatate 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 lutetium Lu 177 dotatate, 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.

Usual Adult Dose for Neuroendocrine Carcinoma:

Intravenous infusion: 7.4 GBq (200 mCi) every 8 weeks for a total of 4 doses.

Premedication and Concomitant Medications:
Somatostatin Analogs:
-Discontinue long-acting somatostatin analogs (e.g., long-acting octreotide) for at least 4 weeks prior to initiating this drug. Administer short-acting octreotide as needed; discontinue at least 24 hours prior to initiating this drug.
-During treatment: Administer long-acting octreotide 30 mg intramuscularly 4 to 24 hours after each dose of this drug. Do not administer long-acting octreotide within 4 weeks of each subsequent dose. Short-acting octreotide may be given for symptomatic management during treatment with this drug, but must be withheld for at least 24 hours before each dose of this drug.
-Following treatment: Continue long-acting octreotide 30 mg intramuscularly every 4 weeks after completing this drug until disease progression or for up to 18 months following treatment initiation.

Antiemetic
-Administer antiemetics 30 minutes before the recommended amino acid solution.

Amino Acid Solution:
-Initiate an intravenous amino acid solution containing L-lysine and L-arginine 30 minutes before administering this drug.
-Use a three-way valve to administer amino acids using the same venous access as this drug or administer amino acids through a separate venous access in the patient's other arm.
-Continue the infusion during, and for at least 3 hours after infusion of this drug.
-Do not decrease the dose of the amino acid solution if the dose of this drug is reduced.

Comments:
-Dose modifications due to adverse reactions are provided in the dose adjustment section.
-Radiation Dosimetry: The maximum penetration in tissue is 2.2 mm and the mean penetration is 0.67 mm.

Use: Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

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.

Call your doctor for instructions if you miss an appointment for your lutetium Lu 177 dotatate injection.

Since lutetium Lu 177 dotatate 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.

Lutetium Lu 177 dotatate 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 lutetium Lu 177 dotatate 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 lutetium Lu 177 dotatate, 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.