Lutetium lu 177 dotatate (By injection)

Lutathera

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use long-acting somatostatin products for at least 4 weeks before receiving this medicine.
• Do not use short-acting octreotide for at least 24 hours before receiving this medicine.

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• You will receive other medicines (including medicines to prevent nausea and vomiting, amino acid solution) before, during, or after receiving this medicine.
• Drink extra fluids so you will urinate more often and help prevent kidney problems.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Lutetium Lu 177 Dotatate (loo-TEE-shee-um loo 177 DOE-ta-tate)

Treats cancer of the stomach, pancreas, bowels, and other parts of the body.

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Decrease in how much or how often you urinate, rapid weight gain, swelling in your hands, ankles, or feet
• Fever, chills, cough, sore throat, body aches
• Unusual bleeding, bruising, or weakness
• Warmth or redness of the skin, diarrhea, difficulty breathing, lightheadedness or fainting

If you notice these less serious side effects, talk with your doctor:

• Constipation, decreased appetite
• Hair loss
• Headache, cough
• Pain in the back, arms, or legs
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control during treatment with this medicine and for at least 7 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for 4 months after the last dose.
• Do not to breastfeed during treatment with this medicine and for 2.5 months after the last dose.
• Tell your doctor if you have kidney disease, liver disease (including cancer), diabetes, or high blood pressure.
• This medicine may cause the following problems:
  • Increased risk of cancer (including secondary myelodysplastic syndrome and leukemia)
  • Kidney problems
  • Liver problems
• You will be exposed to radiation when you receive this medicine and can be detected in your urine for up to 30 days. Talk with your doctor if you have concerns about this.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.