Erdafitinib, ERDADX, Erdafitinib 4mg

Manufacturer: Laos Daxiong Pharmaceutical

Introduction: In March 2018, the U.S. Food and Drug Administration (FDA) granted Erdafitinib Breakthrough Therapy designation for the treatment of urothelial carcinoma. On April 12, 2019, the FDA announced the accelerated approval of Erdafitinib for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed after platinum-based chemotherapy.

【Drug name】

Name: Erdafitinib Tablets

Product Name: ERDADX

 

【Specification】

4 mg

 【Indications】

ERDADX is a prescription medicine used to treat adults with bladder cancer (urothelial carcinoma) that has spread or cannot be removed by surgery:

• Have a certain type of abnormal “FGFR” gene.

• Have tried at least one other chemotherapy drug containing platinum and it had little or no longer work.

Your healthcare provider will test your cancer for certain types of abnormal FGFR genes and make sure ERDADX is right for you.

It is not known if ERDADX is safe and effective in children.

 

【Recommended dosage】

• Take ERDADX exactly as your healthcare provider tells you to.

• Take ERDADX once daily.

• Swallow ERDADX tablets whole. You can take it with or without a meal.

• If you get certain side effects, your healthcare provider may change your ERDADX dose, temporarily stop treatment, or stop treatment completely.

• If you miss a dose of ERDADX, take the missed dose as soon as possible that day. Take ERDADX at your regular dose the next day. Do not take more ERDADX than prescribed to make up for a missed dose.

• If you vomit after taking ERDADX, do not take another ERDADX tablet. Take your regular dose of ERDADX the next day.

 

【side effect】

• Eye problems. Eye problems are common with ERDADX but can be serious. Eye problems include dry or irritated eyes, inflammation of the cornea (front part of the eye), and disease of the retina (inner part of the eye). Tell your healthcare provider right away if you have blurred vision, loss of vision, or other vision changes. You should use artificial tear substitutes, moisturizing or lubricating eye gels, or ointments at least every 2 hours while you are awake to help prevent dry eyes. Your healthcare provider will refer you to an eye specialist during treatment with ERDADX.

• High levels of phosphate in your blood (hyperphosphatemia). Hyperphosphatemia is common with ERDADX, but it can be serious. Your healthcare provider will check your blood phosphate levels 14 to 21 days after starting treatment with ERDADX, then monthly thereafter, and may change your dose as needed.

The most common side effects of ERDADX include:

• Mouth ulcers • Fatigue • Changes in kidney function • Diarrhea

• Dry mouth • Changes in liver function • Low salt (sodium) levels • Hair loss

• Loss of appetite • Changes in taste • Low red blood cells (anemia) • Constipation

• Dry skin • Stomach (abdominal) pain • Muscle pain • Nausea

• Dry eyes • Nails separating from their beds or having poorly shaped nails • Redness, swelling, peeling, or tenderness, mainly in the hands or feet ("hand-foot syndrome")

Tell your healthcare provider right away if you develop any nail or skin problems, including nail separation from the nail bed, nail pain, bleeding nails, broken nails, changes in nail color or texture, infection of the skin around the nail, itchy skin rash, dry skin, or cracked skin.

ERDADX may affect fertility in females who are able to become pregnant. Talk with your healthcare provider if you are concerned about this.

These are not all the possible side effects of ERDADX. For more information, talk with your healthcare provider or pharmacist.

 

【Storage】

• Store at temperatures not exceeding 86°F (30°C).

Keep all medicines out of the reach of children.