Safety Frequently Asked Questions

Questions About LUTATHERA Safety

When your health care professional decides that treatment with LUTATHERA® (lutetium Lu 177 dotatate) injection for intravenous use is right for you, it’s not uncommon to have safety questions.

All prescription medications come with safety considerations. Some considerations you should be aware of before starting LUTATHERA relate to:

 

  • Radiation exposure
  • Bone marrow problems
  • Secondary bone marrow and blood cancers
  • Kidney problems
  • Liver problems
  • Hormonal gland problems (neuroendocrine hormonal crisis)
  • Infertility
  • Embryo-fetal toxicity

 

Please see more information on each of these considerations below, as well as additional warnings regarding pregnancy, breastfeeding, and use of birth control. Additional side effects may occur. If you experience any side effects with treatment, contact your health care professional.

Treatment with LUTATHERA will expose you to radiation, which can contribute to your long-term exposure. 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 safety practices as advised by your health care professional.

 

You may worry about exposing those around you to radiation during your treatment with LUTATHERA. Or you may struggle with how to explain it to your family and friends. Speak to your health care professional if you have these concerns.

Nuclear medicine involves diagnosing and treating certain diseases, such as cancer, by delivering a dose of radiation through radioactive materials called radiopharmaceuticals to a specific part of the body.


Radiopharmaceuticals are made from radioactive materials that release energy in the form of radiation. Radioactive materials occur naturally or can be man-made. Every radioactive material has its own half-life, which determines how quickly it stops being radioactive.


In the United States, the Nuclear Regulatory Commission (NRC), US Food and Drug Administration (FDA), and individual states regulate the use of radioactive materials for nuclear medicine. Radiopharmaceuticals should be used by health care professionals who are qualified by specific training and experience in their safe use and handling, and whose experience and training have been approved by the appropriate governmental agency authorized to license their use.

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

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 final dose of LUTATHERA. Males with female partners should use an effective method of birth control during treatment and for 4 months after the final dose of LUTATHERA.

Patients should not breastfeed during treatment with LUTATHERA and for 2.5 months after the final dose.

Your health care professional is always available to support you through your treatment with LUTATHERA.