Product image of BALVERSA 5mg (Erdafitinib) 5 mg Tablet supplied by GNH India

BALVERSA 5mg

Active Ingredient:
Erdafitinib
Form:
Tablet
Brand:
BALVERSA 5mg
Origin:
USA

BALVERSA 5mg (Erdafitinib Tablet) 5 mg

Erdafitinib, the active ingredient in BALVERSA 5mg, is a fibroblast growth factor receptor (FGFR) inhibitor presented as a 5mg tablet for oral use. It is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.

GNH India supplies BALVERSA 5mg as a licensed, GDP-compliant international pharmaceutical supplier serving oncology centres worldwide.

Strength

5 mg

Pack Size

28s

Storage

Below 25°C

Manufacturer / TM Owner

Janssen Products

1
Pack/s
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Indications & Clinical Uses

BALVERSA 5mg is a targeted therapy used in the treatment of specific types of cancer. It is primarily indicated for the following conditions:

  • Metastatic urothelial carcinoma: Treats advanced bladder cancer with FGFR3 genetic alterations that has progressed after prior therapies.
  • Locally advanced urothelial carcinoma: Used in cases where the cancer has spread to nearby tissues and has specific genetic markers.
  • FGFR3-altered tumors: Targets tumors with specific genetic alterations in the FGFR3 gene, which are involved in cancer cell growth and survival.

How It Works

  • Erdafitinib works by selectively inhibiting the fibroblast growth factor receptors (FGFR) tyrosine kinases. This blockade disrupts downstream signaling pathways that are crucial for tumor cell proliferation and survival, thereby slowing or stopping the growth of cancer cells that have specific FGFR genetic alterations.

Side Effects

BALVERSA 5mg may cause various side effects, ranging from common to serious. Common Side Effects:

  • Nausea, vomiting, mouth sores/pain, change in taste, abdominal pain, diarrhea, constipation, loss of appetite, weight loss, tiredness, dry mouth/skin, or muscle/joint pain.
  • Dry eye, fluid buildup behind the retina, and visual changes.

Serious or Rare Side Effects

  • High blood phosphate levels, which may require dietary changes or additional medication.
  • Skin problems, including hand-foot syndrome, characterized by pain, swelling, redness, blisters, or numbness of the hands/feet.
  • Eye problems, such as central serous retinopathy, which may require ophthalmic evaluation and monitoring.
  • Severe allergic reactions, including rash, itching, or swelling.

Precautions & Warnings

BALVERSA 5mg should be used with caution and under medical supervision. Important precautions include:

  • Pregnancy: Avoid pregnancy while using erdafitinib, as it may harm an unborn baby. Use reliable birth control during treatment and for 1 month after the last dose.
  • Handling: Since this drug can be absorbed through the skin and lungs, pregnant women or those who may become pregnant should avoid handling the medication or breathing the dust from the tablets.
  • Eye care: Use lubricating eye drops or ointments every 2 hours while awake and seek medical help if blurred or decreased vision occurs.
  • Diet: Limit phosphate intake and follow dietary recommendations to manage blood phosphate levels.
  • Store at room temperature: Keep away from light and moisture, and store at 20-25°C (68-77°F).

Avoid Interactions

BALVERSA 5mg may interact with other medications, which can affect its efficacy or increase the risk of side effects. Major Interactions (Avoid):

  • Avoid using BALVERSA with strong CYP3A4 inducers, as they can decrease the effectiveness of erdafitinib.
  • Avoid using BALVERSA with strong CYP3A4 inhibitors, as they can increase the risk of side effects.

Moderate Interactions (Monitor Closely)

  • Monitor closely when using BALVERSA with moderate CYP3A4 inducers or inhibitors, as they may require dose adjustments.
  • Monitor closely when using BALVERSA with medications that affect phosphate levels, as they may require additional monitoring and management.

Frequently Asked Questions

BALVERSA 5mg is used to treat adult patients with locally advanced or metastatic urothelial carcinoma that has specific FGFR3 genetic alterations and has progressed after prior therapies. It is a targeted therapy that works by inhibiting the fibroblast growth factor receptors involved in cancer cell growth and survival.

Erdafitinib, the active ingredient in BALVERSA 5mg, works by selectively inhibiting the fibroblast growth factor receptors (FGFR) tyrosine kinases. This inhibition blocks downstream signaling pathways that are crucial for tumor cell proliferation and survival, thereby slowing or stopping the growth of cancer cells with specific FGFR genetic alterations.

The usual dose of BALVERSA 5mg is determined by a healthcare professional based on the patient's condition, response to treatment, and other factors. It is important to follow the prescribed dosage and consult with a doctor for any adjustments.

BALVERSA 5mg should not be used during pregnancy as it may harm an unborn baby. Women should use reliable birth control during treatment and for 1 month after the last dose. It is also important to consult with a healthcare professional regarding the use of BALVERSA 5mg while breastfeeding.

To order BALVERSA 5mg from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets and will ask the buyer to confirm trade or institutional credentials. The team will then reply with pricing, availability, shipping, and the import paperwork.

BALVERSA 5mg is a targeted therapy specifically designed for patients with metastatic urothelial carcinoma that has specific FGFR3 genetic alterations. It offers a different mechanism of action compared to traditional chemotherapy or immunotherapy, making it a valuable option for patients who have progressed after prior therapies.

BALVERSA 5mg should be stored at room temperature, away from light and moisture. It is important to keep the medication in its original packaging and out of reach of children and pets. Additionally, pregnant women or those who may become pregnant should avoid handling the medication or breathing the dust from the tablets.

BALVERSA 5mg is administered orally in the form of tablets. The dosage and administration schedule are determined by a healthcare professional based on the patient's condition and response to treatment. It is important to follow the prescribed dosage and consult with a doctor for any adjustments.

The most serious risks associated with BALVERSA 5mg include high blood phosphate levels, skin problems such as hand-foot syndrome, and eye problems such as central serous retinopathy. Patients should be monitored closely for these side effects and seek medical help if they experience any severe symptoms.

BALVERSA 5mg should not be used by patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. It is also not recommended for pregnant women or those who may become pregnant without proper contraception. Patients with a history of severe allergic reactions to erdafitinib or any of its components should also avoid using BALVERSA 5mg.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

References

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