Lutathera
Lutathera (lutetium Lu 177 dotatate) is a radiopharmaceutical that's FDA approved to treat rare cancers known as neuroendocrine tumors (NETs) found in the digestive tract, including the stomach, intestines, and pancreas. It’s given as an injection through the vein at specific centers with trained healthcare professionals who know how to handle radiation safely. You’ll typically get one dose every 8 weeks, for a total of 4 doses. Some common side effects include nausea, vomiting, and tiredness.
What is Lutathera (lutetium Lu 177 dotatate)?
What is Lutathera (lutetium Lu 177 dotatate) used for?
- Neuroendocrine tumors (NETs) in the digestive tract that have the somatostatin hormone receptor - in adults and children 12 years and older
How Lutathera (lutetium Lu 177 dotatate) works
Lutathera (lutetium Lu 177 dotatate) is a radiopharmaceutical. It works by finding and attaching to somatostatin hormone receptors, which are proteins found on the surface of certain tumor cells.
Once Lutathera (lutetium Lu 177 dotatate) attaches to these cells, it enters the tumor and releases radiation. This radiation damages the cancer cells from the inside, helping to slow down or stop the tumor from growing or spreading.
Drug facts
Side effects of Lutathera (lutetium Lu 177 dotatate)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Low white blood cell count (up to 90%)
- Rise in creatinine (85%)
- High blood sugar (82%)
- Anemia (81%)
- Rise in liver enzymes (up to 66%)
- Nausea (65%)
- Vomiting (53%)
- Low platelets (53%)
- Tiredness (38%)
- High uric acid (34%)
- Low calcium (32%)
- Low potassium (26%)
- Stomach pain (26%)
- Diarrhea (26%)
- Reduced appetite (21%)
Less Common Side Effects
- Headache
- Dizziness
- Swelling or pain in the arms and legs
- Flushing
- Back pain
- Hair loss
- Anxiety
- Cough
- Constipation
- Fever
- Changes in taste
- Muscle pain
- Neck pain
- High potassium
- High sodium
- Low blood sugar
Lutathera (lutetium Lu 177 dotatate) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reaction: breathing problems, hives, rash, itchiness; swelling of the face, mouth, or lips
- Hormone gland problems: flushing, diarrhea, difficulty breathing, low blood pressure
- Low blood cell counts: fever, chills, feeling very tired, dizziness, unusual bleeding or bruising
- Bone marrow problems and blood cancers: feeling very weak or tired, bruising or bleeding easily, blood in the urine or stool, fevers, unexplained weight loss
- Kidney problems: making little or no urine, dark urine
- Liver problems: yellowing of the skin or eyes, dark urine, unusual tiredness, right upper stomach pain, confusion, swelling in the stomach
The following Lutathera (lutetium Lu 177 dotatate) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
- Flushing, diarrhea, dizziness, feeling faint or lightheaded, blurry vision, wheezing or trouble breathing
- High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
- Infection—fever, chills, cough, or sore throat
- Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
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Pros and cons of Lutathera (lutetium Lu 177 dotatate)
Pros
- Given only once every 8 weeks
- Targets cancer cells directly with radiation
- First radioactive medication approved for children with certain NETs in the digestive tract
Cons
- Requires special handling and administration in a hospital setting
- Long-term risks from radiation exposure
- Can cause serious blood or kidney problems
Pharmacist tips for Lutathera (lutetium Lu 177 dotatate)
- Plan to spend at least half a day at the treatment center when receiving Lutathera (lutetium Lu 177 dotatate). Even though the infusion takes about 30 to 40 minutes, you'll receive other medications before, during, and after to protect your body. These extra medications start about 30 minutes before and continue at least 3 hours after treatment.
- Lutathera (lutetium Lu 177 dotatate) is a radiation treatment, so you'll likely have your own space at the treatment center to protect others from radiation. Your oncology care team will wear protective gear and give you instructions on staying safe after you leave.
- For the first 3 days after your Lutathera (lutetium Lu 177 dotatate) dose, limit close contact with others. Sleep alone, avoid sexual activity, sit when using the toilet, and wash your hands often. It's also important to take a shower everyday for at least a week after your treatment.
- Drink plenty of water and urinate often before, on the day of, and the day after your Lutathera (lutetium Lu 177 dotatate) infusion. This helps protect your kidneys from the effects of radiation.
- It’s possible to have an allergic reaction to Lutathera (lutetium Lu 177 dotatate). Tell your treatment team right away if you feel dizzy, itchy, have trouble breathing, chills, chest pain, or swelling of the lips or mouth.
- Stop taking long-acting octreotide treatments at least 4 weeks before your Lutathera (lutetium Lu 177 dotatate) infusion. You can still use short-acting octreotide for symptoms if needed, but not within 24 hours of Lutathera (lutetium Lu 177 dotatate).
- Continue taking long-acting octreotide between 4 to 24 hours after your Lutathera (lutetium Lu 177 dotatate) infusion.
- Lutathera (lutetium Lu 177 dotatate) can lower your blood cell counts, raising your risk of infections. Let your oncology care team know right away if you notice signs of infection like fever, chills, or unusual tiredness.
- Lutathera (lutetium Lu 177 dotatate) can harm unborn babies. For women who can get pregnant, use effective birth control during treatment and for 7 months after your last dose. For men with partners who can get pregnant, use birth control during treatment and for 4 months after your last dose.
- Don’t breastfeed while taking Lutathera (lutetium Lu 177 dotatate) and for 2.5 months after your last dose, since it could harm a nursing baby.
- Lutathera (lutetium Lu 177 dotatate) can affect fertility, making it harder to have children in the future. Talk with your care team if you have concerns.
Common questions about Lutathera (lutetium Lu 177 dotatate)
Yes. Lutathera (lutetium Lu 177 dotatate) is a radiopharmaceutical. It's designed to deliver tiny amounts of radiation directly to the cancer cells. Because it uses radiation, your oncology care team will give you special instructions to follow after your treatment to keep you and others safe.
No, Lutathera (lutetium Lu 177 dotatate) is a targeted therapy that works by delivering radiation to specific cancer cells. It finds tumor cells with somatostatin receptors and targets them, helping to limit damage to healthy cells. On the other hand, traditional chemotherapy affects any rapidly dividing cells in the body, which can lead to more side effects.
It can. In studies, about 12% of people who took Lutathera (lutetium Lu 177 dotatate) experienced hair loss. Hair can become thinner, fall out in clumps, and can affect hair all over your body. If you’re concerned about hair loss, talk to your oncologist. They can help you find ways to manage it, including access to low-cost or free wigs.
In a clinical study, adults who took Lutathera (lutetium Lu 177 dotatate) were around 72% less likely to have their cancer get worse or to die compared to those who got standard treatment. Half of the people who received Lutathera (lutetium Lu 177 dotatate) lived about 23 months before their cancer worsened, compared to 8.5 months in the standard treatment group. Talk to your oncologist if you have questions about how well this medication might work for you.
Lutathera (lutetium Lu 177 dotatate) is given as an infusion through a vein over about 30 to 40 minutes at a special treatment center. You’ll also get other medications before and after the infusion to help protect your kidneys and lower the chance of side effects. Lutathera (lutetium Lu 177 dotatate) is usually given once every 8 weeks, for a total of 4 doses. Your oncology care team will watch you closely during and after each treatment to make sure you’re doing well.
Lutathera (lutetium Lu 177 dotatate) stays in your body for about 12 to 15 days after each dose. This estimate is based on its half-life, which is the time it takes the amount of medication in your body to go down by half. Most of the radiation from Lutathera (lutetium Lu 177 dotatate) leaves your body through your urine within the first few days after treatment, but small amounts remain longer. Drink plenty of water and follow your care team's instructions to help clear it from your body faster.
Lutathera (lutetium Lu 177 dotatate) was FDA approved in January 2018 to treat adults with certain neuroendocrine tumors (NETs) of the digestive tract. In April 2024, the FDA expanded the approval to treat children 12 years and older for the same condition.
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Risks and warnings for Lutathera (lutetium Lu 177 dotatate)
Lutathera (lutetium Lu 177 dotatate) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk from radiation exposure
- Risk factors: Children
Lutathera (lutetium Lu 177 dotatate) contains radiation, which can build up in your body over time. Being exposed to radiation over a long period can raise your risk of developing cancer later in life, especially in children.
Radiation from Lutathera (lutetium Lu 177 dotatate) can be found in your urine for up to 30 days after treatment. Your oncology care team will help you follow safety measures to keep you and others safe from radiation, both during treatment and when you go home.
Low blood cell counts
Lutathera (lutetium Lu 177 dotatate) affects your bone marrow, causing your body to make fewer blood cells. Having fewer blood cells raises your chance of bleeding and makes you more likely to get infections. Your care team will regularly check your blood cell levels and might pause, lower, or stop the medication if your levels get too low. Let your care team know right away if you notice signs like unusual bruising or bleeding, or symptoms of infection like fever, chills, sore throat, or feeling very tired.
Risk of bone marrow and blood cancers
In rare cases, Lutathera (lutetium Lu 177 dotatate) can cause serious blood conditions, like a bone marrow problem called myelodysplastic syndrome (MDS) or a type of blood cancer called acute leukemia. People who developed these conditions were usually diagnosed months or even years after starting Lutathera (lutetium Lu 177 dotatate). Your care team will check your blood regularly during and after treatment. Let them know immediately if you feel unusually tired, get frequent infections or fevers, or notice easy bruising or bleeding.
Kidney problems
- Risk factors: History of kidney problems | Diabetes | High blood pressure
Lutathera (lutetium Lu 177 dotatate) can harm your kidneys, including causing kidney failure. Your risk is higher if you already have kidney problems or other risk factors, like diabetes or high blood pressure. To lower this risk, you'll receive amino acid infusions before, during, and after each Lutathera (lutetium Lu 177 dotatate) treatment. It’s important to drink plenty of water and urinate frequently before, during, and after your treatment. Your care team will monitor your kidney function and might pause, lower, or stop treatment if needed.
Liver problems
- Risk factors: Cancer that's spread to the liver
Lutathera (lutetium Lu 177 dotatate) might cause damage to your liver, especially if your cancer has spread there. Tell your care team if you notice signs of liver damage, like pain on the right side of your stomach, yellowing of your eyes or skin, or dark or brown urine. Sometimes, liver damage doesn’t cause noticeable symptoms, so your care team will regularly do blood tests to check how well your liver is working during treatment.
Serious allergic reactions
Serious allergic reactions can happen with Lutathera (lutetium Lu 177 dotatate). Your care team will watch you closely during and for at least 2 hours after your infusion, and they'll be ready to treat you if you have a reaction. Tell your oncology care team if you have trouble breathing, chills, flushing, nausea, chest discomfort, or swelling in the mouth, lips, or throat during the infusion. If you have a serious allergic reaction, your care team will stop the infusion and decide if it’s safe for you to continue treatment in the future.
Hormone gland problem (carcinoid crisis)
While rare, some people developed a hormone gland problem called carcinoid crisis after Lutathera (lutetium Lu 177 dotatate) treatment. This happens when the tumor suddenly releases hormones into your body. Symptoms include flushing, diarrhea, wheezing or trouble breathing, and low blood pressure. This usually occurs during or within 24 hours after your first infusion. Your care team will closely watch for these symptoms and can quickly provide medications and fluids if needed.
Harm to unborn baby
Lutathera (lutetium Lu 177 dotatate) can harm an unborn baby if taken during pregnancy. Your oncologist might have you do a pregnancy test before starting treatment to be safe. If you're able to get pregnant, use effective birth control during treatment and for at least 7 months after your last dose. For men with partners who can get pregnant, use effective birth control during treatment and for at least 4 months after the last dose. Let your care team know right away if you or your partner becomes pregnant during this time.
Fertility problems
Lutathera (lutetium Lu 177 dotatate) might cause infertility, or trouble having children. This can happen because radiation from the medication can affect your reproductive organs, like the testes or ovaries. If you or your partner are planning to have children in the future, talk to your oncologist before starting Lutathera (lutetium Lu 177 dotatate). They can help you understand your options.
Lutathera (lutetium Lu 177 dotatate) dosage
Vial| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 30ml of 370MBq/mL | 1 vial | $0.00 | $0.00 |
Typical dosage for Lutathera (lutetium Lu 177 dotatate)
The typical dose is 7.4 GBq given as an injection through the vein about every 8 weeks for a total of 4 doses.
Between 4 to 24 hours after each Lutathera (lutetium Lu 177 dotatate) dose, you’ll need to use long-acting octreotide (Sandostatin LAR).
Note: GBq is a unit of radioactivity. Since this medication works by delivering radiation to cancer cells, the dose is measured using radioactivity units.
How much does Lutathera (lutetium Lu 177 dotatate) cost?
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