Balversa 4 Mg

Janssen Pharmaceuticals Inc.

Generic Name : Erdafitinib Tablets

Packing : 2 x 4 Mg Tablets

Balversa 4 Mg
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What is used for Balversa and Balversa Cost?

BALVERSA is a medicine used to treat bladder and urinary tract cancer called urothelial cancer. BALVERSA can be used in patients with urothelial cancer: their tumors have a certain type of abnormal gene (FGFR) and. The cancer has spread (locally advanced or metastatic urothelial cancer). Balversa cost is low in India at yourmedikart.store Balversa online price is low in India.

What is Balversa and Balversa Price?

BALVERSA is a prescription drug used to treat adults with bladder cancer (urothelial cancer) that has spread or cannot be removed by surgery: they have a certain type of abnormal fibroblast growth factor receptor gene (FGFR) and have tried at least one Kind of other platinum drugs containing chemotherapy drugs, which do not work or no longer work. Your healthcare provider will test your cancer for certain types of abnormal FGFR genes and make sure that BALVERSA is right for you. It is not clear whether BALVERSA is safe and effective for children. BALVERSA is approved based on tumor response. There is no data to show whether BALVERSA can improve survival or improve symptoms.

Safe and Effective Use

Sometimes prescription drugs are used for purposes other than those listed in the patient information leaflet. Do not use BALVERSA in over-the-counter situations. Do not give BALVERSA to other people, even if they have the same symptoms as you. You can damage them. For more information, please consult your healthcare provider. You can ask your healthcare provider for information about BALVERSA, which is written for healthcare professionals. Balversa cost is low in India at yourmedikart.store Balversa online price is low in India. Balversa rx is Erdafitinib Tablets.

Safety Information

Before taking, please tell your healthcare provider about all your medical conditions, including:

  • you have vision or eye problems.
  • Are pregnant or planning to become pregnant.
  • This medicine can harm the fetus. Do not become pregnant during treatment with this medication.

Women who may become pregnant:

  • Your healthcare provider may conduct a pregnancy test before you start treatment.
  • You must take effective contraception during treatment and within 1 month after the last dose of BALVERSA.
  • Talk to your healthcare provider about birth control methods that may be right for you. If you are pregnant or think you may be pregnant, tell your healthcare provider immediately.

Males with female partners who may become pregnant:

  • You must take effective contraceptive measures when you are sexually active during treatment and within 1 month after the last dose.
  • Are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 1 month after the last dose of BALVERSA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects

BALVERSA can cause serious side effects, including:

Eye problems. Eye problems with BALVERSA are common, but they can also be serious. Eye problems include dry or inflamed eyes, inflammation of the cornea (the front part of the eye), and diseases of the retina (the inner part of the eye). If you have blurred vision, loss of vision, or other visual changes, tell your healthcare provider immediately. You should use artificial tear substitutes, moisturizing or lubricating eye gels or ointments or ointments at least every 2 hours while you are awake to help prevent dry eyes. During treatment with BALVERSA, your healthcare provider will send you to see an ophthalmologist.

High levels of phosphate in the blood (hyperphosphatemia). Hyperphosphatemia is common in BALVERSA, but it can also be serious. Your healthcare provider will check your blood phosphorus levels 14 to 21 days after starting BALVERSA treatment, and then once a month, and may change your dose if necessary.

Most common side effects of :

  • Dry skin
  • diarrhea
  • low salt levels
  • feeling tired
  • change in liver function
  • low red blood cells
  • hair loss
  • nausea
  • peeling or tenderness,  swelling, redness mainly on the hands or feet
  • change in sense of taste
  • loss of appetite
  • mouth sores
  • nails separate from the bed or poor formation of the nail

If you have any nail or skin problems, including nail separation from the nail bed, nail pain, nail bleeding, broken nails, nail color or texture changes, skin infections around the nails, or itchy rash, please tell your healthcare provider immediately, Dry skin or cracks in the skin.

This medicine can affect the fertility of women who may become pregnant. If this is relevant to you, please consult your healthcare provider.

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Warnings and Precautions

Contraindications No preventive measures

According to the mechanism of action and animal studies, it may cause fetal harm if administered to pregnant women. Eye diseases may lead to eye diseases, including central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED), leading to visual field defects During the first 4 months of the treatment and every 3 months thereafter, an eye examination should be performed every month, and visual symptoms should be checked urgently at any time. Dry eye symptoms are common; all patients should use eye relievers for dry eye prevention as needed.

Hyperphosphatemia

Due to FGFR inhibition, elevated serum phosphate levels are a pharmacodynamic effect. The average onset time of any level of hyperphosphatemia is 20 days. Monitor hyperphosphatemia and adjust the dose if necessary. Patients may need to during treatment Phosphate binder

Summary of drug interactions

Co-administration of moderate CYP2C9 inhibitors or strong CYP3A4 inhibitors

Will increase the plasma concentration of erdafitinib. Consider alternative therapies. If co-administration is unavoidable, closely monitor adverse reactions and consider dose adjustments accordingly. If CYP2C9 or strong CYP3A4 is stopped for moderate inhibitors, the dose of erdafitinib can significantly increase or decrease the dose of CYP3A4. Erdafitinib plasma concentration and efficacy Avoid co-administration of CYP2C9 or CYP3A4 Moderate inducer Co-administration can significantly reduce the plasma concentration and efficacy of Erdafitinib. If the moderate inducer must be co-administered at the beginning of treatment, use a dose of 8 mg/day Initially, it is possible to increase to 9 mg/day based on the serum phosphate level and tolerance on days 14-21. If a moderate inducer must be co-administered after the initial dose escalation period based on serum phosphate level and tolerance, then Increase the dose of erdatinib to 9 mg. When the moderate inducer is discontinued, continue to use erdatinib at the same dose in the absence of drug-related toxicity.

Co-administration of drugs that change serum phosphate levels with other drugs that change serum phosphate levels may increase or decrease serum phosphate levels. Avoid co-administration of Erdafitinib before the initial dose escalation period (days 14-21) of CYP3A4 substrates. Will change the plasma concentration of CYP3A4 substrates, resulting in loss of activity or increased substrate toxicity. Avoid co-administration of OCT2 substrate Erdafitinib with sensitive CYP3A4 substrates with a narrow therapeutic index. Erdafitinib may increase the plasma substrate concentration of OCT2. Consider alternative therapy P-gp substrates Erdafitinib may increase the plasma concentration of P-gp substrates if co-administered before or at least 6 hours after dosing, separate from P-gp substrates with a narrow therapeutic index.

Indications

  • susceptible FGFR3 or FGFR2 genetic alterations, and
  • progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA.

This indication is approved under accelerated approval based on tumor response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

DOSAGE AND ADMINISTRATION

Patient Selection

Select patients for the treatment of locally advanced or metastatic urothelial carcinoma with BALVERSA dependent on the presence of helpless FGFR genetic alterations in cancer examples as distinguished by a approved companion diagnostic. Information on FDA-approved tests for the discovery of FGFR genetic alterations in urothelial cancer is available at: http://www.fda.gov/CompanionDiagnostics.

Suggested Dosage And Schedule

The suggested beginning dose of BALVERSA is 8 mg (two 4 mg tablets) orally once daily, with a dose increase to 9 mg (three 3 mg tablets) once daily based on serum phosphate (PO4) levels and tolerability at 14 to 21 days.

Swallow tablets whole with or without food. If vomiting occurs any time after taking BALVERSA, the next dose should be taken the next day. Treatment should continue until disease progression or unacceptable toxicity occurs.

If a dose of BALVERSA is missed, it can be taken as soon as possible on the same day. Resume the regular daily dose schedule for BALVERSA the next day. Extra tablets should not be taken to make up for the missed dose.

FAQ

What is Balversa used for?

BALVERSA is a medicine used to treat bladder and urinary tract cancer called urothelial cancer. BALVERSA can be used in patients with urothelial cancer: their tumors have a certain type of abnormal gene (FGFR) and. The cancer has spread (locally advanced or metastatic urothelial cancer).

What type of drug is Balversa?

Is Balversa a chemo drug?

Use of Erdafitinib. It is used to treat patients with metastatic or late-mutated fibroblast growth factor receptor (FGFR) bladder cancer. It is used to treat cancers that have progressed during or 12 months after platinum-containing chemotherapy.

Is Erdafitinib an immunotherapy?

FGFR3 (mut / fus) mutations or fusions are common in the luminal-1 UC subtype, which has a poor response to immunotherapy. Erdafitinib is a potent and selective pan-FGFR tyrosine kinase inhibitor.

How effective is Balversa?

The 5-year relative survival rate for patients with locally advanced bladder cancer is 7%, and that for patients with metastatic disease is 5%.

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