Introducing
LUTATHERA® (lutetium Lu 177 dotatate)

NOW FDA-APPROVED1

Speak with your health care provider to learn more about LUTATHERA® and to see if it is a treatment option for you


APPROVED USE:

LUTATHERA® (lutetium Lu 177 dotatate) is a prescription medicine used to treat adults with a type of cancer known as gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that are positive for the hormone receptor somatostatin, including GEP-NETs in the foregut, midgut, and hindgut.

IMPORTANT SAFETY INFORMATION1

LUTATHERA® can cause serious side effects. If you experience these side effects, your health care provider may need to adjust or stop your treatment. You should always follow your health care provider’s instructions. Serious side effects may include:

Radiation exposure: Treatment with LUTATHERA® will expose you to radiation which can contribute to your long-term radiation exposure. Overall radiation exposure is associated with an increased risk for cancer. The radiation in LUTATHERA® will be detectable in your urine for up to 30 days. You should stay well hydrated before, during, and after your treatment and urinate frequently.

Bone marrow problems: Treatment with LUTATHERA® may cause a drop in the number of your blood cells. You may experience blood-related side effects such as low red blood cells (anemia), low numbers of cells that are responsible for blood clotting (thrombocytopenia), and low numbers of a type of white blood cells (neutropenia). People with low blood counts can develop serious infections. Other conditions that you may develop as a direct result of treatment with LUTATHERA® is a bone marrow disorder called myelosuppression, as well as blood and bone marrow cancers known as secondary myelodysplastic syndrome and leukemia. Your health care provider will routinely check your blood counts and tell you if they are too low. Speak with your health care provider if you experience any signs or symptoms of myelosuppression or infection, such as fever, chills, dizziness, shortness of breath or increased bleeding or bruising. Your health care provider may need to adjust or stop your treatment accordingly.

Kidney problems: Treatment with LUTATHERA® will expose your kidneys to radiation and may impair their ability to work as normal. You may be at an increased risk for kidney problems after LUTATHERA® treatment if you already have kidney impairment before treatment. In some cases, patients have experienced kidney failure after treatment with LUTATHERA®. Your health care provider will monitor changes and provide you with a medication to help protect your kidneys.

Liver problems: In the clinical studies of LUTATHERA®, less than 1% of patients were reported to have tumor bleeding (hemorrhage), swelling (edema) or tissue injury (necrosis) to the liver. If you have tumors in your liver, you may be more likely to experience these side-effects. Signs that you may be experiencing liver damage include increases in blood markers called ALT, AST and GGT. Your health care provider will monitor your liver using blood tests and may need to adjust or stop your LUTATHERA® treatment accordingly.

Hormonal gland problems (carcinoid crisis): During your treatment you may experience certain symptoms that are related to hormones released from your cancer. These symptoms may include flushing, diarrhea, difficulty breathing (bronchospasm), and low blood pressure (hypotension), and may occur 24 hours after your first LUTATHERA® treatment. Your health care provider will monitor you closely. Speak with your health care provider if you experience any of these signs or symptoms.

Pregnancy warning: Tell your health care provider if you are pregnant or you or your partner plan to become pregnant. LUTATHERA® can harm your unborn baby. Use an effective method of birth control during treatment and for 7 months (for females) and 4 months (for males) after the final treatment with LUTATHERA®. You should not breastfeed during treatment with LUTATHERA® and for 2.5 months after your final LUTATHERA® infusion.

Fertility problems: Treatment with LUTATHERA® may cause infertility. This is because radiation absorbed by your testis and ovaries over the treatment period falls in the range of exposure where temporary or permanent infertility may be expected.

Tell your health care provider if you are taking any other medications, including somatostatin analogs. Somatostatin analogs may affect how your LUTATHERA® treatment works. Your health care provider may ask you to stop taking your long-acting somatostatin analogs 4 weeks before LUTATHERA® treatment. You may continue taking short-acting somatostatin analogs up to 24 hours before your LUTATHERA® treatment.

The most common and most serious side effects of LUTATHERA® include: vomiting, nausea, decreased blood cell counts and increased liver enzymes. These are not all the possible side effects of LUTATHERA®. For more information, ask your health care provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for LUTATHERA®

Distributed by: Advanced Accelerator Applications USA, Inc., NY 07041

REFERENCE

1. LUTATHERA® [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; January 2018.