Lutathera (lutetium Lu 177 dotatate)

Lutathera generic

Lutathera is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics usually cost less than brand-name drugs.

Lutathera dosage

The following information describes dosages that are commonly used or recommended. However, your doctor will determine the best dosage to fit your needs.

Drug form and strength

Lutathera is a type of radiopharmaceutical, meaning it contains an active drug that releases small amounts of radiation. It comes as a liquid solution in single-use vials.

When prepared, each vial of Lutathera contains 370 megabecquerels of radioactivity per milliliter (MBq/mL) of solution. MBq is a unit that measures the amount of radiation in Lutathera.

The radioactivity of Lutathera decreases over time. To ensure that you receive the correct dose, a trained healthcare professional will measure the radiation of Lutathera right before giving the drug.

Each dose of Lutathera is measured in gigabecquerels (GBq). For reference, 1 GBq is equal to 1,000 MBq.

Dosage for certain neuroendocrine tumors

Lutathera is prescribed to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in certain situations. These are rare tumors that affect the pancreas, stomach, intestines, and bowel. To learn more, see the “Lutathera uses” section.

The usual dose of Lutathera for GEP-NETs is 7.4 GBq. You’ll receive one dose every 8 weeks for a total of four doses.

Your doctor may give you a different dosage depending on the side effects you have during treatment. If you have questions about the Lutathera dosage that’s right for you, talk with your doctor.

Children’s dosage

Lutathera is prescribed to treat GEP-NETs in certain children ages 12 years and older.

The dosage of Lutathera for children is the same as for adults. For details, see “Dosage for certain neuroendocrine tumors.”

How Lutathera is given

You’ll receive Lutathera in a treatment facility that has been trained to handle radiopharmaceuticals. A healthcare professional will give Lutathera as an intravenous (IV) infusion over 30 to 40 minutes.

Your doctor will provide specific details about your Lutathera treatment protocol. This may include starting or stopping other medications before, during, and after your infusion.

You may also need to stay in the facility where you received the drug for several hours. This allows your doctor to watch closely for serious side effects. They’ll recommend how long you should stay in the facility.

If you have other questions about receiving Lutathera, talk with your doctor. You can also visit the drug manufacturer’s website.

About receiving Lutathera

Below you’ll find information about key dosage issues.

• When to receive: You’ll receive Lutathera once every 8 weeks.
• If you miss a dose: If you miss an appointment to receive Lutathera, call the facility where you receive it. They’ll help you reschedule the appointment.
• Length of use: Lutathera is not meant for use as a long-term treatment. You’ll receive up to four doses of the drug.
• Length of time to work: Lutathera starts working after your first dose. Your doctor will monitor your condition during treatment to check whether the drug is working.

Lutathera side effects

Lutathera can cause mild or serious side effects. The following lists contain some of the key side effects that may occur during Lutathera treatment. These lists do not include all possible side effects.

For more information about the possible side effects of Lutathera, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect during Lutathera treatment and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

Mild side effects

Below is a partial list of mild side effects of Lutathera. To learn about other mild side effects, talk with your doctor or pharmacist or view Lutathera’s prescribing information.

Mild side effects of Lutathera can include:

• abdominal pain
• altered sense of taste
• cough
• diarrhea or constipation
• dizziness
• fatigue
• fluid buildup in your arms or legs
• nausea and vomiting
• loss of appetite
• headache
• hair loss
• flushing
• pain in your neck, back, arms, or legs
• mild increases in blood sugar or blood pressure
• low potassium level

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Lutathera aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• kidney damage, which may include symptoms such as:
  • nausea and vomiting
  • loss of appetite
  • difficulty urinating
• high levels of liver enzymes, which may be a sign of liver damage and can include symptoms such as:
  • nausea and vomiting
  • jaundice
  • upper right abdominal pain
• low levels of blood cells (including platelets, red blood cells, and white blood cells), which may include symptoms such as:
  • bruising or bleeding more easily than usual
  • pale-looking skin
  • shortness of breath
  • fever or chills
• increased risk of myelodysplastic syndrome (a group of blood cancers) or leukemia, which may include symptoms such as:
  • fatigue
  • bruising more often or more easily than usual
  • bleeding gums or nosebleeds
• neuroendocrine hormonal crisis (a condition that occurs when a tumor suddenly releases a large amount of hormones into your bloodstream), which may include symptoms such as:
  • flushing
  • diarrhea
  • low blood pressure
  • bronchospasm (sudden tightening of your airways)

ALLERGIC REACTION

For some people, Lutathera can cause an allergic reaction. But this side effect wasn’t reported in the drug’s clinical trials.

In general, symptoms of allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should continue receiving the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Lutathera, your doctor may recommend a different medication instead.

Lutathera uses

The Food and Drug Administration (FDA) approves prescription drugs such as Lutathera to treat certain conditions.

Lutathera for certain neuroendocrine tumors

Lutathera is approved to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. For this use, the cancer must be somatostatin receptor-positive. This means the tumor has receptors (attachment sites) for a hormone called somatostatin.

GEP-NETs are rare tumors that affect the pancreas, stomach, intestines, and bowel. Symptoms may include diarrhea, abdominal pain, and unintended weight loss.

To learn more about Lutathera for GEP-NETs, talk with your doctor.

Lutathera and children

Lutathera is approved to treat GEP-NETs in children ages 12 years and older. For this use, the cancer must be somatostatin receptor-positive.

To learn more about this use, see “Lutathera for certain neuroendocrine tumors” above. You can also talk with your child’s doctor.

Lutathera interactions

Lutathera can interact with several other medications. It’s not known to interact with supplements or foods.

Before receiving Lutathera, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

Interactions with medications

Below is a list of medications that can interact with Lutathera. This list does not contain all drugs that may interact with Lutathera. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Alcohol interaction

Alcohol is not known to interact with Lutathera. However, drinking alcohol may worsen certain side effects of the drug, including dizziness, headache, and diarrhea.

If you drink alcohol, talk with your doctor about how much is safe for you to drink during Lutathera treatment.

Lutathera cost and coupons

As with all medications, the cost of Lutathera can vary. The actual price you’ll pay depends on your insurance plan and your location.

Financial and insurance assistance: If you need financial support to pay for Lutathera or need help understanding your insurance coverage, help is available.

A program called Novartis Patient Support is available for Lutathera. For more information and to find out if you’re eligible for support, call 844-638-7222 or visit the program website.

Generic version: Lutathera is not available in a generic form. A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics tend to cost less than brand-name drugs.

Learn more about saving money on prescriptions.

Lutathera alternatives

Other drugs are available that can treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Some may be a better fit for you than others. If you’re interested in finding an alternative to Lutathera, talk with your doctor. They can tell you about other medications that may work well for you.

Examples of drugs that are alternatives to Lutathera include:

• capecitabine (Xeloda) with temozolomide (Temodar)
• lanreotide (Somatuline Depot)
• octreotide (Sandostatin, others)

Things to consider when receiving Lutathera

If you can become pregnant, consider the following information about pregnancy, fertility, birth control, and breastfeeding.

Note: Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.

Lutathera and pregnancy

It’s not known whether Lutathera is safe to receive during pregnancy. Because of the way the drug works, Lutathera may cause harm to a fetus. To be safe, your doctor may advise you not to receive the drug while pregnant.

If you’re planning a pregnancy or can become pregnant, talk with your doctor before receiving Lutathera. Your doctor may have you take a pregnancy test before starting treatment.

Lutathera and fertility

Lutathera may cause infertility (an inability to conceive) in males and females. This effect may be temporary or permanent.

If you have questions about Lutathera and fertility, talk with your doctor.

Lutathera and birth control

It’s not known whether Lutathera is safe to receive during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs during Lutathera treatment.

For females receiving Lutathera

If you’re a female who can become pregnant and you engage in sexual activity that could lead to pregnancy, you should use effective birth control during Lutathera treatment. You should continue using birth control for at least 7 months after your final dose of the drug.

For males receiving Lutathera

If you’re a male with a sexual partner who can become pregnant, you should use effective birth control (such as condoms) during Lutathera treatment. You should continue to use birth control for at least 4 months after your final dose of the drug.

Lutathera and breastfeeding

It’s not known whether Lutathera should be used while breastfeeding. To be safe, your doctor may advise you to avoid breastfeeding during treatment and for at least 2.5 months after your final dose.

If you’re currently breastfeeding or planning to do so, talk with your doctor before receiving this medication. They may recommend other ways to feed a child who is breastfed.

How Lutathera works

Lutathera is used to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. These are rare tumors that affect the pancreas, stomach, intestines, and bowel.

For this use, the cancer must be somatostatin receptor-positive. This means the tumor has receptors (attachment sites) for a hormone called somatostatin.

Lutathera is a type of radiopharmaceutical, meaning it contains an active drug that releases small amounts of radiation. Its mechanism of action (how it works) is to attach to somatostatin receptors on cancer cells. Lutathera then enters the cancer cells and releases radiation to kill them.

If you have other questions about how Lutathera works, talk with your doctor. You can also visit the drug manufacturer’s website.

Common questions about Lutathera

Here are answers to some frequently asked questions about Lutathera.

How does Lutathera compare with Pluvicto?

Both Lutathera and Pluvicto are radiopharmaceuticals. Each contains a form of lutetium-177 as the active drug.

However, Lutathera and Pluvicto have different uses. Lutathera is used to treat certain gastroenteropancreatic neuroendocrine tumors. Pluvicto is used to treat metastatic prostate cancer in certain situations.

To learn more about how Lutathera and Pluvicto compare, talk with your doctor.

Is Lutathera a type of chemotherapy or another cancer treatment?

No, Lutathera is not a type of chemotherapy. Instead, it’s a radiopharmaceutical that delivers targeted radiation therapy to cancer cells.

Chemotherapy works by attacking rapidly dividing cells, including cancer cells and some healthy cells. Lutathera works differently. It attaches to cancer cells and releases radiation to kill them.

If you have questions about Lutathera and chemotherapy, talk with your doctor.

Should I follow any guidance on radiation safety with Lutathera?

Yes, you should follow radiation safety practices after Lutathera treatment. This is because small amounts of radiation leave your body through urine, sweat, and other fluids for a short time. While the risk to others is low, taking precautions helps reduce exposure to those around you.

Below are the precautions you might follow with Lutathera:

• Drink plenty of fluids the day before, the day of, and the day after treatment to help flush out extra radiation.
• Stay seated while using the toilet and flush twice after each use for at least 3 days.
• Keep at least 3 feet of distance from others for at least 3 days.
• Avoid close physical contact, including sexual activity, for at least 3 days.
• Sleep in a separate bedroom from others for at least 3 days.
• Shower daily and use separate towels and washcloths from others for at least 7 days.

The treatment facility where you’ll receive Lutathera may have other safety instructions. If you have questions, talk with your doctor.