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Important Safety Information

What are some important things to know about the safety of LUTATHERA?
LUTATHERA is associated with some serious safety considerations and, in some cases, these may require your health care provider to adjust or stop your treatment. You should always follow your health care provider's instructions. Safety considerations 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 will be detectable in your urine for up to 30 days following administration of the drug. It is important to minimize radiation exposure to household contacts consistent with good radiation safety practices as advised by your health care provider.

• Bone marrow problems: Treatment with LUTATHERA increases the risk of myelosuppression, a condition in which bone marrow activity is decreased, resulting in a drop in blood cell counts. 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 white blood cells (neutropenia). Speak with your health care provider if you experience any signs or symptoms of infection, fever, chills, dizziness, shortness of breath, or increased bleeding or bruising. Your health care provider may need to adjust or stop your treatment accordingly.

• Secondary bone marrow and blood cancers: Other serious conditions that you may develop as a direct result of treatment with LUTATHERA include blood and bone marrow disorders known as secondary myelodysplastic syndrome and cancer known as acute leukemia. Your health care provider will routinely check your blood cell counts and tell you if they are too low or too high.

• 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 provide you with an amino acid solution before, during, and after LUTATHERA to help protect your kidneys. You should stay well hydrated before, on the day of, and on the day after your treatment. You should urinate frequently before, on the day of, and on the day after administration of LUTATHERA. Your doctor will monitor your kidney function and may withhold, reduce, or stop your LUTATHERA treatment accordingly.

• Liver problems: In clinical studies of LUTATHERA, less than 1% of patients were reported to have tumor bleeding (hemorrhage), swelling (edema), or tissue damage (necrosis) to the liver. If you have tumors in your liver, you may be more likely to experience these side effects. Tell your health care provider right away if you have any of these signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, unusual tiredness, right upper stomach area (abdomen) pain, confusion, and/or swelling of the stomach area (abdomen). Your health care provider will monitor your liver using blood tests and may need to withhold, reduce, or stop your LUTATHERA treatment accordingly.

• Allergic reactions: Allergic reactions have occurred in people who were treated with LUTATHERA. Notify your health care provider if you develop symptoms of an allergic reaction. Seek emergency help right away for any serious allergic reactions. Symptoms may include trouble breathing or swallowing; raised bumps (hives); rash or itching; and swelling of the face, lips, tongue, throat, or arms.

• 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 during or within the 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. LUTATHERA can harm your unborn baby. Females should use an effective method of birth control during treatment and for 7 months after the last dose of LUTATHERA. Males with female partners should use an effective method of birth control during treatment with LUTATHERA and for 4 months after the last dose.

• Breastfeeding warning: You should not breastfeed during treatment with LUTATHERA and for 2.5 months after your last dose of LUTATHERA.

• Fertility problems: Treatment with LUTATHERA may cause infertility. This is because radiation absorbed by your testes or ovaries over the treatment period falls within the range of exposure in which temporary or permanent infertility may occur.

What are the most common side effects of LUTATHERA?

The most common and most serious side effects of LUTATHERA include decreased blood cell counts, increased liver enzymes, vomiting, nausea, increased blood glucose, and decreased blood potassium levels.

Talk to your doctor if you experience any of these side effects. There are other possible side effects of LUTATHERA. For more information and to learn more about LUTATHERA, talk to your doctor or health care provider.

Adverse reactions observed in children aged 12 years and older were similar to those observed in adults treated with LUTATHERA.

What other medicines may interact with LUTATHERA?

Tell your health care provider if you are taking any other medications. You should stop taking your long-acting somatostatin analogue at least 4 weeks before LUTATHERA treatment. You may continue taking short-acting somatostatin analogues up to 24 hours before your LUTATHERA treatment.

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.

What is LUTATHERA?

LUTATHERA^® (lutetium Lu 177 dotatate) is a prescription medicine used to treat adults and children aged 12 years and older 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.

Please see fullPrescribing Informationfor LUTATHERA.

Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936- 1080. © 2024 Novartis 5/24 422673

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It depends on the amount. For example, a large model created from Canadian health data suggests the following:

• For women, there's less risk per drink than per cigarette.

• For men who drink fewer than 5 drinks per day, there's less risk per drink than per cigarette.

• For men, the risk per drink is equal to the risk per cigarette at 5 drinks per day or more.

But these are estimates only, and they don't account for drinking patterns (binge vs. daily drinking). At the end of the day, what matters is this: Abstaining from both alcohol and cigarettes is the best way to decrease your risk of health problems.

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Perhaps. There's definitely a link between alcohol, memory loss, and dementia. But determining cause and effect is difficult in medicine. Heavy and chronic alcohol use contributes to brain damage for sure. Questions remain about moderate consumption, but it's likely that it has a negative effect on cognition.

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Different types of alcohol contain different amounts, so there isn't a "worst" type. In other words, the amount is as important as the type. It helps to understand how much alcohol is in whatever you're drinking.

Sarah Pozniak, MD

Sarah Pozniak, MD, has 9 years of experience since graduating medical school (6 since completing residency). She is a board-certified general internal medicine physician and has practiced as a primary care physician in both Utah and Washington, D.C. Currently, she cares for patients with chronic illnesses such as diabetes and high blood pressure using telemedicine as part of a virtual care program.

Sophie Vergnaud, MD

Sophie Vergnaud, MD, is an experienced and dedicated pulmonologist and hospitalist who spent a decade practicing and teaching clinical medicine at academic hospitals throughout London.

Mandy Armitage, MD

Mandy Armitage, MD, has combined her interests in clinical medicine with her passion for education and content development for many years. She served as medical director for the health technology companies HealthLoop (now Get Well) and Doximity.

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Breast Cancer Research Foundation. (2024). The alcohol and breast cancer connection.

Centers for Disease Control and Prevention. (2024). About moderate alcohol use.

Chuang, S. C., et al. (2015). Alcohol consumption and liver cancer risk: A meta-analysis. Cancer Causes and Control.

Henley, J. (2018). 3 weird things about acetaldehyde. Centers for Disease Control and Prevention.

Islami, F., et al. (2017). Proportion and number of cancer cases and deaths attributable to potentially modifiable risk factors in the United States. A Cancer Journal for Clinicians.

Jaswal, H., et al. (2024). A drink equals how many cigarettes? Equating mortality risks from alcohol and tobacco use in Canada. Frontiers in Public Health.

LoConte, N. K., et al. (2017). Alcohol and cancer: A statement of the American Society of Clinical Oncology. Journal of Clinical Oncology.

National Cancer Institute. (2015). Hormones.

National Cancer Institute. (2021). Alcohol and cancer risk.

Rehm, J., et al. (2019). Alcohol use and dementia: A systematic scoping review. Alzheimer's Research and Therapy.

Rethinking Drinking. (n.d.). What's a "standard drink"? National Institute on Alcohol Abuse and Alcoholism.

Rossi, M., et al. (2018). Colorectal cancer and alcohol consumption-populations to molecules. Cancer.

Salehi, B., et al. (2018). Resveratrol: A double-edged sword in health benefits. Biomedicines.

Seidenberg, A. B., et al. (2023). Do beliefs about alcohol and cancer risk vary by alcoholic beverage type and heart disease risk beliefs?Cancer Epidemiology, Biomarkers and Prevention.

U.S. Department of Health and Human Services. (2024). Alcoholic beverage consumption. Report on Carcinogens, Fifth Editions.

Visontay, R., et al. (2021). Alcohol use and dementia: New research directions. Current Opinion in Psychiatry.

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