Lutetium Lu 177 Vipivotide Tetraxetan: The Prostate Cancer Warrior's Secret Weapon

Overview:

An injection of Lutetium Lu 177 vipivotide tetraxetan is used to treat a particular kind of advanced prostate cancer. It is applied when the cancer has progressed to other bodily sites and has not responded to previous treatments. This injection is intended to target prostate cancer cells and contains a radioactive material. It is a member of the class of medications known as radiopharmaceuticals, which are compounds with a radioactive element. These drugs can be used to investigate the operation of the body's organs and identify and cure certain illnesses. It is crucial to remember that this treatment should only be administered or supervised by medical professionals who have received specific training in nuclear medicine. The United States Food and Drug Administration (US FDA) approved Lutetium Lu 177 vipivotide tetraxetan on March 23, 2022.

Indications

Adult patients with a particular kind of advanced prostate cancer are treated with a medication called Lutetium Lu 177 vipivotide tetraxetan. It is intended for patients whose cancer cells exhibit the prostate-specific membrane antigen (PSMA) marker and who did not improve with prior androgen receptor pathway inhibition and taxane-based chemotherapy therapies (including Paclitaxel, Docetaxel, and albumin Paclitaxel).

Dosage Forms and Available Strengths: Luteinium Lu 177 vipivotide tetraxetan is available in liquid form. It is clear to slightly yellow and comes in a single-use bottle. Given as 1,000 mega becquerels per milliliter (MBq/mL) or 27 millicuries per milliliter (mCi/mL), the medicine's strength measures its potency or activity per liquid unit.

For Patients:

What Is Prostate Cancer?

The prostate is a gland in men that produces seminal fluid, and prostate cancer is a prevalent type of cancer that arises there. Although the precise etiology is unknown, age, race, heredity, and family history are risk factors. In its early stages, prostate cancer may not show any signs at all, but as it progresses, it can cause symptoms, including difficulty in urinating, blood in the urine or semen, bone pain, and pelvic stiffness. Tests like as the PSA (prostate-specific antigen) and DRE (digital rectal examination) are used in screening, and a biopsy verifies the diagnosis. Treatment options include radiation therapy, hormone therapy, surgery, and watchful waiting, depending on the stage of the tumor. To effectively manage prostate cancer, routine screenings and early detection are essential.

What Are the Clinical Uses of Lutetium Lu 177 Vipivotide Tetraxetan?

A particular sort of prostate cancer that has progressed to other parts of the body and has not responded to earlier treatment is treated with the Lutetium Lu 177 vipivotide tetraxetan injection. This injection is a member of the class of drugs known as radiopharmaceuticals. Its mission is to locate cancer cells and target them with radiation, inflicting damage and ultimately eliminating them. In other words, it is a focused treatment that uses radiation to target specific areas of the cancer directly.

How Should Lutetium Lu 177 Vipivotide Tetraxetan Be Used?

Liquid Lutetium Lu 177 vipivotide tetraxetan is injected intravenously (IV) by medical experts at a clinic or hospital. The injection process can comprise a progressive infusion over a maximum of 30 minutes or happen slowly throughout one to 10 minutes. The body's response and any adverse effects will dictate how often to take it. There can be up to six-week intervals, with a maximum of six doses. Drinking enough water before the injection and urinating frequently afterward are encouraged. The effectiveness and side effects of the medicine may need dose modifications or the temporary or permanent cessation of treatment. It is crucial to discuss the experience with the Lutetium Lu 177 vipivotide tetraxetan treatment with the healthcare practitioner.

What Is the Prescribed Dosage and Method of Administration for Lutetium Lu 177 Vipivotide Tetraxetan?

• Important Safety Instructions: As Lutetium Lu 177 vipivotide tetraxetan is a radiation-using medication, it must be handled carefully to lower the chance of radiation exposure. The only people authorized to use Lutetium Lu 177 vipivotide tetraxetan are healthcare providers with the necessary training and authorization.

• Patient Selection: Patients with a specific kind of prostate cancer (mCRPC - metastatic castration-resistant prostate cancer) who have undergone prior treatment are treated with Lutetium Lu 177 vipivotide tetraxetan. Imaging studies demonstrating the presence of a protein called PSMA (prostate-specific membrane antigen) in tumors serve as the basis for selection.

• Recommended Dosage: Lutetium Lu 177 vipivotide tetraxetan should be administered intravenously every six weeks for a maximum of six doses or until the condition worsens or there are intolerable side effects. The recommended amount is 7.4 Gigabecquerel (GBq) (200 mCi - millicurie).

• Adjusting Doses for Unfavorable Reactions: Depending on how severe the adverse reaction is, the dosage of Lutetium Lu 177 vipivotide tetraxetan may need to be changed, lowered, or stopped.

• Administration and Preparation: To reduce radiation exposure, Lutetium Lu 177 vipivotide tetraxetan should be handled with an aseptic procedure and radiation shielding. There are several ways to provide the medication intravenously, and care should be taken to guarantee accurate administration.

What Are the Side Effects of Lutetium Lu 177 Vipivotide Tetraxetan?

Radiation exposure from Lutetium Lu 177 vipivotide tetraxetan therapy may raise a person's risk of cancer. The dangers associated with using this drug should be discussed with the patient's physician.

Lutetium Lu 177 vipivotide tetraxetan can cause adverse effects. If the patient notices a considerable increase in these symptoms or if they continue, they should let their doctor know:

• Loss of appetite.

• Vomiting.

• Dry mouth, and throat.

• Weight loss.

• Changes in taste perception.

• Diarrhea

• Eye dryness.

• Headache.

• Nausea.

• Pain in the stomach.

• Constipation.

Some adverse effects may be dangerous. If patients notice the following, they should call their doctor immediately.

• Unusual bleeding or bruising.

• Unusual weakness or fatigue.

• Pale complexion.

• Lightheadedness.

• Dyspnea.

• Mouth ulcers.

• Fever, chills, sore throat, or infection-related symptoms.

• Swelling in the hands, feet, ankles, arms, or lower limbs.

• A rise or fall in urination.

This medicine may also result in other negative effects. During this treatment, patients should contact their physician if they experience any odd difficulties.

What Are the Things to Inform the Doctor Before Taking Lutetium Lu 177 Vipivotide Tetraxetan?

• Ingredients and Allergies: If a person has an allergy to any of the injection's contents, other drugs, or Lutetium Lu 177 vipivotide tetraxetan, they should let their doctor and pharmacist know before receiving the prescribed injection. One should request an ingredient list from the pharmacist.

• Supplements and Medication: One should inform the pharmacist and doctor about all the vitamins, supplements, herbal remedies, and prescription and over-the-counter drugs they take. The physician might need to change the dose or keep an eye out for any negative effects.

• Health History and Infections: One should inform the doctor if one suspects or frequently has infections and notify them of any previous radiation therapy, cancer history, bleeding disorders, anemia, tachycardia, or problems with the kidneys or liver.

• Use Only in Men: This injection is for male use only. If the female partner of the patient has the potential to become pregnant, utilize birth control both during and for 14 weeks following the last dosage of their medication. The injection may harm the fetus, so call the doctor if they become pregnant while receiving treatment.

• Warning About Infertility: Men who use the medicine may become infertile either permanently or temporarily. However, it should not be assumed that the female spouse cannot become pregnant while undergoing therapy.

• Surgical Safety Measures: Patients should inform their physician or dentist that they are getting this injection as part of their treatment if they have surgery, even dental surgery, planned.

• Precautions Against Radiation Exposure: For a predetermined amount of time which is two days for household contacts and seven days for youngsters and pregnant women, should limit close contact with the person who has received the injection. To reduce radiation exposure to others, one should sleep apart for a specific amount of time and refrain from sexual activity for seven days following the injection.

Dietary Considerations: As the patient receives the Lutetium Lu 177 vipivotide tetraxetan injection, ensure they drink lots of water or other fluids. Until their doctor instructs them otherwise, the patient should continue on their usual diet.

Overdose: Call the poison control hotline if someone takes too much of this medication. Make an immediate call to emergency services if the person has passed out, experienced a seizure, is having difficulty breathing, or is unable to wake up.

Storage: A sterile, preservative-free solution containing 1,000 MBq/mL of Lutetium Lu 177 is called Lutetium Lu 177 vipivotide tetraxetan. It comes packaged safely and is kept in a lead-shielded vial. 120 hours are allowed for storage at or below 30°C (degree Celsius). Respect local rules, avoid using expired products, and dispose of old goods appropriately.

For Doctors:

Pharmacodynamics: The exposure-efficacy correlations of Lutetium Lu 177 vipivotide tetraxetan and the pharmacodynamic response's time course remain unclear. When used at the indicated dosage, PLUVICTO does not result in significant mean increases (less than 20 milliseconds) in the QTc interval.

Mechanism of Action: A form of radiation therapy called Lutetium Lu 177 vipivotide tetraxetan contains a unique kind of radioactive element called lutetium-177. This lutetium-177 has an attachment site that binds to PSMA, a protein in prostate cancer, especially in advanced forms. The radiation released by Lutetium Lu 177 vipivotide tetraxetan when it connects to PSMA-containing cells might damage neighboring cells' DNA (deoxyribonucleic acid) and ultimately lead to the death of those cells. Prostate cancer cells are the target and therapy of this treatment.

Pharmacokinetics:

• Blood Levels: The blood levels of Lutetium Lu 177 vipivotide tetraxetan at the indicated dosage had a maximum concentration of 6.58 ng/mL (nanograms per milliliter) and an area under the curve (AUC) of 52.3 ng/h/mL (nanograms per hour per milliliter).

• Distribution Across the Body: For Lutetium Lu 177 vipivotide tetraxetan, the dispersion volume is 123 L (liters). The drug travels to the liver, lungs, kidneys, heart, bone marrow, salivary glands, and gastrointestinal tract within 2.5 hours of consumption.

• Protein Binding: In human blood, between 60 and 70 percent of vipivotide tetraxetan and non-radioactive lutetium vipivotide tetraxetan bind to proteins.

• Elimination Process: The drug's terminal elimination half-life is 41.6 hours. The clearance, or the rate at which the body eliminates it, is 2.04 L/h (liters per hour).

• Excretion Pathway: The kidneys are the principal method of eliminating Lutetium Lu 177 vipivotide tetraxetan from the body.

Clinical Studies: The combination of Lutetium Lu 177 vipivotide tetraxetan and standard treatment (BSoC - Best Supportive Care) significantly enhanced overall survival (15.3 months vs. 11.3 months) and overall response rates compared to BSoC alone in the VISION clinical trial, which evaluated Lutetium Lu 177 vipivotide tetraxetan in males with advanced prostate cancer. The experiment proved that Lutetium Lu 177 vipivotide tetraxetan is an effective supplement to standard treatment for advanced prostate cancer, with a significant advantage indicated by the hazard ratio. Its beneficial effects on treatment response and survival were also highlighted.

Warnings and Precautions:

• Radiation Exposure Risk: Long-term radiation exposure from Lutetium Lu 177 vipivotide tetraxetan treatment can raise cancer risk. It is critical to adhere to treatment protocols, safety precautions, and medical professionals' advice to reduce this danger. Patients should drink more water, urinate more often, and take safety measures to shield others from radiation.

• Induce Myelosuppression: Lutetium Lu 177 vipivotide tetraxetan can result in myelosuppression, a severe and potentially fatal decrease in blood cell counts that can cause anemia, thrombocytopenia, leukopenia, and neutropenia. Routine blood tests are required throughout treatment, and the degree of myelosuppression may influence how the medication is administered.

• Renal Toxicity: Lutetium Lu 177 vipivotide tetraxetan has the potential to harm the kidneys seriously. Patients are advised to urinate frequently and to drink a lot of water. The degree of renal toxicity must be taken into consideration when making therapy modifications and requiring regular testing of kidney function.

• Embryo-Fetal Toxicity: There is no proof that Lutetium Lu 177 vipivotide tetraxetan is safe or effective in females, and it can be harmful to a growing baby. Male patients who have sexually active female partners should take effective contraception during their therapy and for 14 weeks after the last dosage.

• Infertility: When the cumulative dosage reaches a certain threshold, Lutetium Lu 177 vipivotide tetraxetan may result in infertility in males. Patients should be aware of this possible consequence, and family planning should be discussed.

Use in Specific Populations:

• Pregnancy: In females, Lutetium Lu 177 vipivotide tetraxetan’s safety and effectiveness have not been determined in females. The mode of action of Lutetium Lu 177 vipivotide tetraxetan may harm the fetus. No information about its use in pregnant women is currently known, and no research on animals has assessed its effects on the development of the embryo and fetus. Nevertheless, there is a chance that Lutetium Lu 177 vipivotide tetraxetan, like all radiopharmaceuticals, could harm a fetus.

• Nursing: In females, Lutetium Lu 177 vipivotide tetraxetan’s safety and effectiveness have not been determined in females. Lutetium Lu 177 vipivotide tetraxetan exists in human milk, its effects on the nursing infant or its impact on milk supply are not well-documented.

• Males and Females of Reproductive Potential: Male patients who have female partners who are capable of reproduction are recommended, depending on how Lutetium Lu 177 vipivotide tetraxetan works, to take effective contraception during treatment and for 14 weeks following the last dosage. A radiation-absorbed dose to the testes within the range where it could result in either temporary or permanent infertility could be caused by the recommended cumulative dose of 44.4 GBq (gigabecquerel) of Lutetium Lu 177 vipivotide tetraxetan.

• Use in Children: It is unknown if Lutetium Lu 177 vipivotide tetraxetan is safe or effective in treating children.

• Geriatric Use: In the VISION trial, 387 patients (73 percent) and 143 patients (27 percent) who were 65 years of age or older were among the 529 patients who got at least one dosage of Lutetium Lu 177 vipivotide tetraxetan plus BSoC. There were no discernible general differences in effectiveness between patients 75 or younger. 11 percent of people 75 or younger experienced severe adverse effects. In 40 percent of patients 75 years or older and 31 percent of younger patients, grade ≥ 3 adverse events happened.

• Renal Impairment: It is anticipated that the degree of renal impairment will increase exposure to Lutetium Lu 177 vipivotide tetraxetan. Patients with mild (baseline CLcr 60 to 89 mL/min (milliliters per minute) by Cockcroft-Gault) to moderate (CLcr 30 to 59 mL/min) renal impairment are advised not to change their dose. On the other hand, individuals with mild to severe renal impairment can be more vulnerable to poisoning. In these patients, renal function and adverse events must be regularly evaluated. Patients with end-stage renal disease or severe (CLcr 15 to 29 mL/min) renal impairment have not had the pharmacokinetics and safety of Lutetium Lu 177 vipivotide tetraxetan investigated.