Vyloy (Zolbetuximab) is a new cancer medicine used for gastric cancer and gastroesophageal junction cancer (GEJ), it targets a protein called Claudin 18.2 on cancer cells, kills the cancer cells, and slows tumor growth. Most Importantly, Vyloy Zolbetuximab 100 mg price /cost get best at Yourmedikart. Vyloy Zolbetuximab Specifically designed to target advanced gastric cancer

Also, Vyloy may help increase the length of time before your cancer progresses and increase your life expectancy, which is sometimes called progression-free survival (PFS) and Overall survival (OS). In Addition, Vyloy is given as an infusion into a vein usually every 2 or 3 weeks

Pronunciation: vye-LOY
Generic name: zolbetuximab-clzb
Dosage form: Injection (100 mg lyophilized powder in a single-dose vial.)
Drug class: Miscellaneous antineoplastics

🔬 What is Vyloy?

Vyloy (zolbetuximab-clzb) is a monoclonal antibody-based cancer therapy specifically designed to target advanced gastric (stomach) cancer and gastroesophageal junction (GEJ) adenocarcinoma that test positive for Claudin 18.2 (CLDN18.2) and are HER2-negative.

It is intended for first-line treatment when the cancer is unresectable (cannot be removed by surgery) or has metastasized (spread). Vyloy is not used as a standalone therapy but in combination with fluoropyrimidine- and platinum-based chemotherapy such as mFOLFOX6 or CAPOX.

💉 How is Vyloy Given?

• Route: Intravenous (IV) infusion

• Schedule: Administered once every 2 or 3 weeks, depending on the chemotherapy regimen

• Duration: Continued until disease progression or unacceptable side effects

Before each infusion:

• Premedications (e.g., anti-nausea drugs and antihistamines) are required to reduce risk of nausea/vomiting and infusion-related reactions

• Patients are monitored during and after the infusion for any serious reactions

FDA Approval and Clinical Trials

FDA Approval Date: October 18, 2024
Approved Use: First-line treatment of CLDN18.2-positive, HER2-negative unresectable or metastatic gastric or GEJ adenocarcinoma.

Key Clinical Trials:

• SPOTLIGHT Trial (NCT03504397)
  • Design: Phase III, double-blind, placebo-controlled
  • Population: 565 patients with HER2-negative, CLDN18.2-positive gastric or GEJ adenocarcinoma
  • Median Progression-Free Survival (PFS):

  • • • Vyloy + chemo: 10.6 months

      • Placebo + chemo: 8.7 months

  • Median Overall Survival (OS):

    • • Vyloy + chemo: 18.2 months

      • Placebo + chemo: 15.5 months

• GLOW Trial (NCT03653507)

  • Supported similar findings in progression-free and overall survival, with Vyloy demonstrating benefit over standard treatment.

These trials confirmed that Vyloy significantly slows tumor progression and extends survival compared to standard chemotherapy alone.

How Does Vyloy Work? (Mechanism of Action)

Vyloy is a monoclonal antibody that specifically targets Claudin 18.2 (CLDN18.2) — a protein found on the surface of some stomach and GEJ cancer cells.

Once Vyloy binds to CLDN18.2, it triggers:

• Antibody-Dependent Cellular Cytotoxicity (ADCC) – recruitment of immune cells to destroy the tumor

• Complement-Dependent Cytotoxicity (CDC) – activation of the immune complement system to break down cancer cells

This dual action kills cancer cells and slows or stops tumor growth.

Serious Side Effects

1. Severe Allergic or Infusion Reactions

These may be life-threatening and require immediate medical attention. Symptoms include:

• Hives, rash

• Difficulty breathing, wheezing

• Throat tightness

• Fever or chills

• Chest discomfort or back pain

• Nausea, vomiting, or increased saliva

You will be monitored during and after infusion. Vyloy Zolbetuximab 100 mg price /cost get best at Yourmedikart. Vyloy Zolbetuximab Specifically designed to target advanced gastric cancer Your healthcare provider may adjust or stop treatment if a severe reaction occurs.

2. Severe Nausea and Vomiting

• Especially common in the first treatment cycle

• Anti-nausea medicines are given before each dose

• Tell your provider if symptoms do not improve

Common Side Effects of Vyloy

These side effects occurred in 15% or more of patients in clinical studies:

• Nausea and vomiting

• Fatigue (tiredness)

• Fever (pyrexia)

• Decreased appetite

• Peripheral sensory neuropathy (tingling or numbness in hands/feet)

• Stomach pain or cramps

• Diarrhea or constipation

• Weight loss

• Hypersensitivity reactions

Lab-related Changes:

• Decreased white/red blood cells and platelets

• Low albumin (protein levels)

• Abnormal liver and kidney function tests

• Increased blood glucose

• Imbalances in electrolytes

👩‍⚕️ Precautions and Monitoring

• Monitor vital signs during and after infusions (minimum 2 hours post-infusion)

• Check blood counts, electrolytes, kidney and liver functions regularly

• Premedicate to minimize infusion reactions and gastrointestinal side effects

• Fourthly Inform your provider if you have a history of severe allergic reactions

• Use effective contraception during treatment and for at least 9 months after the last dose

• Do not breastfeed during treatment and for 9 months after the last dose

Precautions and Warnings

• Infusion Reactions: Monitor for signs of hypersensitivity; emergency protocols must be in place.

• Pregnancy & Breastfeeding: Not recommend. Women of childbearing age should use contraception during treatment and for several months afterward.

• Kidney or Liver Impairment: Requires close monitoring and possible dose adjustments.

• No live vaccines should administer during Vyloy therapy.

Before receiving this medicine

Tell your healthcare provider if you have nausea or vomiting.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Vyloy will harm your unborn baby.

Females and Males of Reproductive Potential Vyloy is used in combination with fluoropyrimidine- or platinum-containing chemotherapy. in Addition, Refer to the Full Prescribing Information of fluoropyrimidine- and platinum-containing chemotherapy products for pregnancy testing, contraception, and infertility information.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Because it is not know if VYLOY passes into your breast milk, the effects on the breastfed child, thus the effects on milk production. Because antibodies may excret in human milk and because of the potential for adverse reactions in a breastfed child. Also do NOT breastfeed during treatment with Vyloy and for 8 months after the last dose.

Who Can Take Vyloy?

Vyloy is only for patients whose tumors test positive for CLDN18.2 using an FDA-approved diagnostic test.

Eligibility criteria:

• Diagnosis of unresectable or metastatic gastric or GEJ adenocarcinoma

• HER2-negative status

• CLDN18.2-positive tumor profile

• No prior systemic treatment for advance disease

• Adequate organ function

Patients must undergo genetic and protein expression testing to confirm eligibility before starting treatment.

Important Safety Information

Before Starting Vyloy

Tell your doctor if you:

• Have had an allergic reaction to monoclonal antibodies or IV treatments

• Are pregnant or plan to become pregnant (Vyloy may harm an unborn baby)

• Are breastfeeding or planning to breastfeed (avoid breastfeeding during treatment and for at least 4 months after the last dose)

• Have existing liver, kidney, or GI conditions

• Have immune disorders or a history of severe infusion reactions

Contraception:

• Use effective birth control during treatment and for at least 4 months after your last dose.

What to Avoid During Vyloy Treatment

• Firstly Avoid driving or operating machinery if you feel dizzy, fatigued, or unwell after infusion.

• Secondly Avoid alcohol if you experience nausea or liver abnormalities.

• Avoid exposure to people with infections, as your immune system may weak.

Storage

Vyloy vials

Store refrigerate at 2ºC to 8ºC (36ºF to 46ºF) in the original carton.

Do not freeze.

Do not shake.

Reconstituted vial(s)

Store at room temperature 15°C to 30°C (59°F to 86°F) for up to 5 hours if not use immediately. This product does not contain a preservative.

Diluted infusion

Store the prepare infusion bag:

• At room temperature 15°C to 30°C (59°F to 86°F) for no longer than 6 hours from the end of the preparation of the infusion bag to the completion of the infusion.
• Under refrigeration at 2°C to 8°C (36°F to 46°F) for no longer than 16 hours from the end of the preparation of the infusion bag to the completion of the infusion. Do not freeze.

Ingredients

Active ingredient: zolbetuximab-clzb

Inactive ingredients: arginine, polysorbate 80, sucrose, and phosphoric acid to adjust pH.

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