Erdafitinib

What is Erdafitinib?

• Erdafitinib (Balversa) is a kinase inhibitor used to treat adults with bladder cancer (urothelial cancer).

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What are the uses of this medicine?

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

• which has a certain type of abnormal "FGFR" gene, and
• who have tried at least one other chemotherapy medicine that contains platinum, and it did not work or is no longer working.

How does this medicine work?

• An orally bioavailable, pan fibroblast growth factor receptor (FGFR) inhibitor with potential antineoplastic activity.
• Upon oral administration, erdafitinib binds to and inhibits FGFR, which may result in the inhibition of FGFR-related signal transduction pathways and thus the inhibition of tumor cell proliferation and tumor cell death in FGFR-overexpressing tumor cells.
• FGFR, upregulated in many tumor cell types, is a receptor tyrosine kinase essential to tumor cell proliferation, differentiation and survival.

Who Should Not Use this medicine ?

• This mediciation have no usage limitations.

What drug interactions can this medicine cause?

Avoid Co-administration of Balversa with:

• moderate CYP2C9 or strong CYP3A4 inhibitors
• Strong CYP2C9 or CYP3A4 inducers
• Moderate CYP2C9 or CYP3A4 inducers
• Serum phosphate level-altering agents
• CYP3A4 substrates
• OCT2 substrates
• P-gp substrates

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

• Select patients for the treatment of locally advanced or metastatic urothelial carcinoma with Balversa based on the presence of susceptible FGFR genetic alterations in tumor specimens as detected by an FDA-approved companion diagnostic.

Recommended Dosage

• The recommended starting 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.

Administration

• Take Balversa exactly as your healthcare provider tells you.
• Take Balversa 1 time each day.
• Swallow Balversa tablets whole with or without food.
• Your healthcare provider may change your dose of Balversa, temporarily stop or completely stop treatment if you get certain side effects.
• If you miss a dose of Balversa, take the missed dose as soon as possible on the same day. Take your regular dose of Balversa the next day. Do not take more Balversa than prescribed to make up for the missed dose.
• If you vomit after taking Balversa, do not take another Balversa tablet. Take your regular dose of Balversa the next day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 3 mg, 4 mg, and 5 mg

This medicine is available in fallowing brand namesː

• Balversa

What side effects can this medication cause?

The most common side effects of this medicine include:

• mouth sores
• feeling tired
• change in kidney function
• diarrhea
• dry mouth
• nails separate from the bed or poor formation of the nail
• change in liver function
• low salt (sodium) levels
• decreased appetite
• change in sense of taste
• low red blood cells (anemia)
• dry skin
• dry eyes
• hair loss
• redness, swelling, peeling or tenderness, mainly on the hands or feet ('hand-foot syndrome')
• constipation
• stomach (abdominal) pain
• nausea
• muscle pain

Balversa may cause serious side effects, including:

• Eye problems
• High phosphate levels in the blood (hyperphosphatemia)

What special precautions should I follow?

• Balversa can cause central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED). Perform monthly ophthalmological examinations during the first four months of treatment, every 3 months afterwards, and at any time for visual symptoms. Withhold Balversa when CSR/RPED occurs and permanently discontinue if it does not resolve within 4 weeks or if Grade 4 in severity.
• Increases in phosphate levels are a pharmacodynamic effect of Balversa. Monitor for hyperphosphatemia and manage with dose modifications when required.
• This medicine Can cause fetal harm. Advise patients of the potential risk to the fetus and to use effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Balversa can cause fetal harm when administered to a pregnant woman .
• There are no available data on Balversa use in pregnant women to inform a drug-associated risk.

Can this medicine be used in children?

• Safety and effectiveness of Balversa in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• erdafitinib

Inactive ingredients: Tablet Core: Croscarmellose sodium, Magnesium stearate (from vegetable source), Mannitol, Meglumine, and Microcrystalline Cellulose. Film Coating (Opadry amb II): Glycerol monocaprylocaprate Type I, Polyvinyl alcohol-partially hydrolyzed, Sodium lauryl sulfate, Talc, Titanium dioxide, Iron oxide yellow, Iron oxide red (for the orange and brown tablets only), Ferrosoferric oxide/iron oxide black (for the brown tablets only)

Who manufactures and distributes this medicine?

• Manufactured by: Janssen-Cilag SpA, Latina, Italy
• Manufactured for: Janssen Products, LP, Horsham, PA 19044

What should I know about storage and disposal of this medication?

• Store Balversa tablets at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Erdafitinib
• FDA Erdafitinib

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