Balversa

Generic name: erdafitinib
Drug class: Multikinase inhibitors

Medically reviewed by  A Ras MD.

What is Balversa?

Balversa is a prescription medicine that is used to treat bladder cancer.

Description

Erdafitinib, the active ingredient in BALVERSA, is a kinase inhibitor. The chemical name is N-(3,5-dimethoxyphenyl)-N’-(1-methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine. Erdafitinib is a yellow powder. It is practically insoluble, or insoluble to freely soluble in organic solvents, and slightly soluble to practically insoluble, or insoluble in aqueous media over a wide range of pH values. The molecular formula is C25H30N6O2 and molecular weight is 446.56.

Chemical structure of erdafitinib is as follows:

Chemical Structure

BALVERSA® (erdafitinib) tablets are supplied as 3 mg, 4 mg or 5 mg film-coated tablets for oral administration and contains the following 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).

Mechanism of Action

Erdafitinib is a kinase inhibitor that binds to and inhibits enzymatic activity of FGFR1, FGFR2, FGFR3 and FGFR4 based on in vitro data. Erdafitinib also binds to RET, CSF1R, PDGFRA, PDGFRB, FLT4, KIT, and VEGFR2. Erdafitinib inhibited FGFR phosphorylation and signaling and decreased cell viability in cell lines expressing FGFR genetic alterations, including point mutations, amplifications, and fusions. Erdafitinib demonstrated antitumor activity in FGFR-expressing cell lines and xenograft models derived from tumor types, including bladder cancer.

Before taking Balversa, tell your doctor:

  • If you are allergic to Balversa; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Balversa, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with Balversa.
  • If you are breast-feeding. Do not breast-feed while you take Balversa or for 1 month after you stop Balversa.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Balversa with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Balversa?

  • Tell all of your health care providers that you take Balversa. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have an eye exam as you have been told by your doctor.
  • If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during treatment and for 1 month after your last dose.
  • If you are a man and your sex partner gets pregnant while you take Balversa or within 1 month after your last dose, call your doctor right away.
  • This medicine may cause you to not be able to get pregnant. Talk with the doctor.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting Balversa. Talk with your doctor.
  • Use birth control that you can trust to prevent pregnancy while taking Balversa and for 1 month after stopping Balversa.
  • If you get pregnant while taking Balversa or within 1 month after your last dose, call your doctor right away.

How is Balversa best taken?

Use Balversa as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Swallow whole. Do not chew, break, or crush.
  • If you throw up after taking a dose, do not repeat the dose. Take your next dose at your normal time.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it on the same day you missed the dose.
  • If you do not think about the missed dose until the next day, skip the missed dose and go back to your normal time.
  • Do not take 2 doses on the same day.

What are the side effects of Balversa that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
  • Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Change in nails.
  • Any skin change.
  • Redness or irritation of the palms of hands or soles of feet.
  • Chest pain or pressure.
  • Shortness of breath.
  • Not able to pass urine or change in how much urine is passed.
  • Dark urine or yellow skin or eyes.
  • Low blood cell counts have happened with Balversa. If blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. Call your doctor right away if you have signs of infection like fever, chills, or sore throat; any unexplained bruising or bleeding; or if you feel very tired or weak.

What are some other side effects of Balversa?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dry eyes. Using artificial tears may help.
  • Hair loss.
  • Upset stomach or throwing up.
  • Stomach pain or diarrhea.
  • Constipation.
  • Mouth irritation or mouth sores.
  • Not hungry.
  • Weight loss.
  • Feeling tired or weak.
  • Dry skin.
  • Dry mouth.
  • Change in taste.
  • Muscle or joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Balversa?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

 

Label

PRINCIPAL DISPLAY PANEL – 3 MG TABLET BOTTLE CARTON

  • NDC 59676-030-56
  • Balversa®
    (erdafitinib) tablets
  • 3 mg
  • Each film-coated tablet
    contains 3 mg of erdafitinib.
  • Rx only
  • 56 film-coated tablets
PRINCIPAL DISPLAY PANEL - 3 mg Tablet Bottle Carton

PRINCIPAL DISPLAY PANEL – 4 MG TABLET BOTTLE CARTON

  • NDC 59676-040-56
  • Balversa®
    (erdafitinib) tablets
  • 4 mg
  • Each film-coated tablet
    contains 4 mg of erdafitinib.
  • Rx only
  • 56 film-coated tablets
PRINCIPAL DISPLAY PANEL - 4 mg Tablet Bottle Carton

SRC: NLM .

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