You may have questions about PLUVICTO

PLUVICTO is a prescription medicine for adults with PSMA+ metastatic prostate cancer to treat¹:​

• Metastatic androgen pathway modulation-naïve or -sensitive prostate cancer (mAPMN/S PC)* in combination with hormone therapy​ 

OR

• Metastatic androgen pathway modulation-resistant prostate cancer (mAPMR PC)^† after a previous hormone therapy if appropriate to delay chemotherapy

*mAPMN/S PC is also known as metastatic hormone-sensitive prostate cancer (mHSPC).²

^†mAPMR PC is also known as metastatic castration-resistant prostate cancer (mCRPC).​² 

PSMA+, prostate-specific membrane antigen–positive.

Yes, PLUVICTO is only approved for metastatic prostate cancer (mPC). It is a prescription medicine for adults with PSMA+ mPC to treat¹:​

• Metastatic androgen pathway modulation-naïve or -sensitive prostate cancer (mAPMN/S PC)* in combination with hormone therapy​ 

OR​

• Metastatic androgen pathway modulation-resistant prostate cancer (mAPMR PC)^† after a previous hormone therapy if appropriate to delay chemotherapy

*mAPMN/S PC is also known as metastatic hormone-sensitive prostate cancer (mHSPC).²

^†mAPMR PC is also known as metastatic castration-resistant prostate cancer (mCRPC).^2​

PSMA+, prostate-specific membrane antigen–positive.

PLUVICTO treats different types of mPC. It is a prescription medicine for adults with PSMA+ mPC to treat¹:​

• Metastatic androgen pathway modulation-naïve or -sensitive prostate cancer (mAPMN/S PC)* in combination with hormone therapy​ ​

OR

• Metastatic androgen pathway modulation-resistant prostate cancer (mAPMR PC)^† after a previous hormone therapy if appropriate to delay chemotherapy

*mAPMN/S PC is also known as metastatic hormone-sensitive prostate cancer (mHSPC).²

^†mAPMR PC is also known as metastatic castration-resistant prostate cancer (mCRPC).​²

PSMA+, prostate-specific membrane antigen–positive.

PLUVICTO is a targeted therapy with the goal to deliver radiation directly into PSMA-positive (PSMA+) cells to destroy them from within.¹ PSMA is normally found on prostate cells, and its levels are up to 1000 times higher in prostate cancer cells.³

Once PLUVICTO finds PSMA on the surface of a cell, it goes into the cell and releases radiation, damaging or destroying the cell from within. It may also affect some nearby healthy cells.¹

PSMA, prostate-specific membrane antigen.

PSMA stands for prostate-specific membrane antigen. PSMA is normally found on prostate cells, and its levels are up to 1000 times higher in prostate cancer cells.³ If you have higher levels of PSMA compared with a standard level, your PSMA status is considered PSMA positive (PSMA+).⁴ More than 80% of men with prostate cancer have PSMA+ status.^5-7

Your PSMA status is considered PSMA positive (PSMA+) if you have higher levels of PSMA compared with a standard level as detected by a PSMA-PET scan. This scan can show if and where the cancer has spread and determine if PLUVICTO could be right for you.^1,4 More than 80% of men with prostate cancer have PSMA+ status.^5-7

PET, positron emission tomography; PSMA, prostate-specific membrane antigen.

PLUVICTO could be right for you if you have PSMA-positive (PSMA+) metastatic prostate cancer and¹:

• Are responding to hormone therapy, or

• Have stopped responding to hormone therapy and it is appropriate to delay chemotherapy, or

• Have stopped responding to hormone therapy and received chemotherapy

PSMA, prostate-specific membrane antigen.

No, PLUVICTO isn’t chemotherapy. It’s a targeted therapy with the goal to deliver radiation directly into PSMA+ cancer cells to destroy them from within. It may also affect nearby healthy cells.¹

PSMA, or prostate-specific membrane antigen, is normally found on prostate cells, and its levels are up to 1000 times higher in prostate cancer cells.³ If you have higher levels of PSMA compared with a standard level, your PSMA status is considered PSMA positive (PSMA+).⁴

The success rate of PLUVICTO has been studied in men with PSMA+ mHSPC (also known as mAPMN/S prostate cancer) and mCRPC (also known as mAPMR prostate cancer).^1,2

In a primary analysis, PLUVICTO reduced the risk of cancer worsening in men with mHSPC by an additional 28% vs hormone therapy alone.¹

In an updated analysis 14 months later, PLUVICTO reduced the risk of cancer worsening by ​an additional 33% ​vs hormone therapy alone.^8,9 50% of men on hormone therapy alone lived without cancer worsening for 48.5 months while men on PLUVICTO lived longer than that without cancer worsening (the exact length of time is continuing to be measured).⁹

86% of men on PLUVICTO had their tumors shrink or disappear (vs 81%).^9,10

Men with mCRPC who were appropriate to delay chemotherapy and on PLUVICTO had more time without cancer worsening (9.3 months with PLUVICTO vs 5.6 months with a second hormone therapy).¹

49% of men on PLUVICTO had their tumors shrink or disappear (vs 14%).^1,10

See more mCRPC results

mAPMN/S prostate cancer, metastatic androgen pathway modulation-naïve or -sensitive prostate cancer; mAPMR prostate cancer, metastatic androgen pathway modulation-resistant prostate cancer; mCRPC, metastatic castration-resistant prostate cancer; mHSPC, metastatic hormone-sensitive prostate cancer; PSMA+, prostate-specific membrane antigen–positive.

Some of the most common side effects of PLUVICTO include¹:

• Tiredness

• Dry mouth

• Nausea

• Laboratory abnormalities

These are not all of the possible side effects of PLUVICTO. Call your doctor for advice about side effects. 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.

Talk to your care team. Your health care provider may temporarily delay your next dose, decrease your dose, or completely stop your treatment with PLUVICTO if you develop certain side effects.¹

FDA, US Food and Drug Administration.

PLUVICTO may cause temporary or permanent infertility in males.¹ Talk to your doctor if you have any questions.

PLUVICTO is given as an intravenous (IV) injection or infusion.¹ Talk to your doctor about your treatment plan. 

PLUVICTO is given every 6 weeks for up to 6 doses.^1* After that, your PLUVICTO treatment is complete. If PLUVICTO is given together with other treatments, you may continue taking them. Talk to your doctor about your treatment plan.

*Dosing may change or stop based on disease progression or unmanageable side effects.¹

You will receive PLUVICTO at a treatment center near you. To find your local treatment center, visit the Treatment Center Locator.

Before PLUVICTO treatment, you'll need to have blood counts and kidney function tests.¹ Ask your doctor about the length of each infusion or treatment, potential side effects, and how to minimize radiation exposure.

While on treatment with PLUVICTO, a team of doctors will work together to make sure you are taken care of. You will also get support from nurses and other health care professionals. Doctors that may be part of your team include a medical oncologist, a urologist, a radiation oncologist, and a nuclear medicine doctor.¹¹

Throughout your treatment with PLUVICTO, you will continue to have laboratory tests, such as blood work, done.¹ Your first test will likely be performed a few days before your first dose of PLUVICTO.

It’s important to know that your sweat, blood, and urine give off radiation after each dose of PLUVICTO.^1,12 You can help eliminate this radiation through frequent urination. Your doctor may recommend drinking about 8 ounces of fluid every hour on the day of your dose to help you urinate frequently.^1,13

You can minimize radiation exposure and protect your family by following some requirements, including:

• Stay hydrated to eliminate radiation from your body by urination¹

• Stay more than 3 feet away from others (for 2 days from other adults and for 7 days from children, pregnant women, or pets)^1,14

• Sleep alone in a separate bedroom (away from adults and pets for 3 days, children for 7 days, and pregnant women for 15 days)^1,14

• No sex for 7 days, and then using effective birth control to prevent pregnancy during the entire course of treatment and for 14 weeks after your last dose¹

Yes, PLUVICTO can be taken with other treatments. If you have PSMA+ mAPMN/S prostate cancer (also known as mHSPC), PLUVICTO is taken along with hormone therapy.^1,2 Your doctor will decide on the best treatment plan for you. It is important to discuss all treatments and medications you are taking with your doctor. This will help ensure there are no interactions. 

mAPMN/S prostate cancer, metastatic androgen pathway modulation-naïve or -sensitive prostate cancer; mHSPC, metastatic hormone-sensitive prostate cancer; PSMA+, prostate-specific membrane antigen–positive.

Coverage for PLUVICTO can vary depending on the type of insurance you have. Novartis Patient Support^TM is a comprehensive program designed to assist you every step of the way. They can help you with 1-on-1 patient navigation support, navigating the insurance process, and getting financial support if eligible.

Lutetium-177 is the radioactive particle in PLUVICTO. The full name of the PLUVICTO molecule is lutetium Lu 177 vipivotide tetraxetan.¹

If you are newly diagnosed with mPC or if prostate cancer came back as metastatic while still responding to hormone therapy, then you have metastatic androgen pathway modulation-naïve or -sensitive prostate cancer (mAPMN/S PC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).​^2,15,16

If your mPC stopped responding to hormone therapy that lowers testosterone, then you have metastatic androgen pathway modulation-resistant prostate cancer (mAPMR PC), also known as metastatic castration-resistant prostate cancer (mCRPC).^2,17

There are different types of mPC because of the way each responds to treatment. 

mPC that responds to hormone therapy is called metastatic androgen pathway modulation-naïve or -sensitive prostate cancer (mAPMN/S PC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).^2,16

mPC that has stopped responding to hormone therapy that lowers testosterone is called metastatic androgen pathway modulation-resistant prostate cancer (mAPMR PC), also known as metastatic castration-resistant prostate cancer (mCRPC).^2,17

No, there is not a difference between metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-sensitive prostate cancer (mCSPC). They are different names for same type of metastatic prostate cancer that responds to hormone therapy.^16,18

No, there is not a difference between metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-resistant prostate cancer (mHRPC). They are different names for the same type of metastatic prostate cancer that has stopped responding to hormone therapy that lowers testosterone.¹⁷

Yes, there is a difference between metastatic hormone-sensitive prostate cancer (mHSPC), also known as metastatic castration-sensitive prostate cancer (mCSPC),¹⁸ and metastatic castration-resistant prostate cancer (mCRPC). They are different types of metastatic prostate cancer. 

mHSPC (or mCSPC) responds to hormone therapy, and mCRPC has stopped responding to hormone therapy that lowers testosterone.^16,17

No, as of October 26, 2023, there is no supply issue for PLUVICTO. Novartis announced the resolution of the drug shortage status by the US Food and Drug Administration (FDA).