Balversa

Balversa is a prescription medication used to treat bladder cancer (urothelial cancer) that has spread or cannot be removed by surgery.

Balversa belongs to a group of drugs called kinase inhibitors. A kinase inhibitor is a substance that blocks a type of enzyme (a protein) called a kinase. Human cells have many different kinases, and they help control important functions. Balversa works by inhibiting the activity of FGFR, which is present in the bladder cancer tumor cell as well as healthy cells throughout the body.

This medication comes in tablet form and is taken once a day with or without food. Do not chew, divide or break Balversa. Swallow tablets whole.

Common side effects include low red blood cells, mouth sores, and tiredness.

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

• which has a certain type of abnormal fibroblast growth factor receptor (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.

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 known if Balversa is safe and effective in children.

Balversa is approved based on tumor response. Data are not yet available to show if Balversa improves survival or symptoms.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Balversa. See the "Balversa Precautions" section.

Common side effects of Balversa 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

This is not a complete list of Balversa side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or does not go away. 

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medications you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Moderate/Strong CYP2C9 or CYP3A4 inhibitors
  • clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir
  • amiodarone, Plavix, Antabuse, efavirenz, fluconazole, 5-FU, Gleevec, metronidazole
• Strong CYP2C9 or CYP3A4 inducers
  • carbamazepine, dexamethasone, (fos)phenytoin, griseofulvin, modafinil, phenobarbital, rifabutin, rifampin, St. John's wort
  • barbituates, bosenten, carbamazepine
• Serum phosphate level-altering agents
  • biphosphonates (alendronate, zoledronic acid), diuretics (HCTZ, furosemide), theophylline, antacids, erythropoietin, acyclovir, dopamine, epinephrine
• Sensitive CYP3A4 substrates with narrow therapeutic indices
  • alfentanil, astemizole(a), cisapride(a), cyclosporine, (di)ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, terfenadine(a)
• OCT2 substrates
  • norepinephrine, histamine, dopamine, cimetidine, prazosin, metformin, epinephrine, cisplatin, memantidine, reserpine
• P-gp substrates with narrow therapeutic indices
  • verapamil, quinidine, amiodarone

This is not a complete list of Balversa drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Balversa including the following:

• Eye problems. Eye problems are common with Balversa but can also be serious. Eye problems include dry or inflamed eyes, inflamed cornea (front part of the eye), and disorders of the retina, an internal part of the eye. Tell your healthcare provider right away if you develop blurred vision, loss of vision, or other visual changes. You should use artificial tear substitutes, hydrating or lubricating eye gels or ointments at least every 2 hours during waking hours to help prevent dry eyes. During treatment with Balversa, your healthcare provider will send you to see an eye specialist.
• High phosphate levels in the blood (hyperphosphatemia). Hyperphosphatemia is common with Balversa but can also be serious. Your healthcare provider will check your blood phosphate level between 14 and 21 days after starting treatment with Balversa, and then monthly, and may change your dose if needed.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Balversa, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Balversa, tell your doctor about all of your medical conditions. Expecially tell your doctor if you:

• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• are allergic to Balversa or any of its ingredients
• have vision or eye problems

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Based on the mechanism of action and findings in animal reproduction studies, Balversa can cause fetal harm. Female patients of reproductive potential and male patients with female partners of reproductive potential are advised to use effective contraception during treatment and for one month after the last dose. 

Females who can become pregnant:

•  Your healthcare provider may do a pregnancy test before you start treatment with Balversa.
•  You should use effective birth control during treatment and for 1 month after the last dose of Balversa. Talk to your healthcare provider about birth control methods that may be right for you.
•  Tell your healthcare provider right away if you become pregnant or think you may be pregnant.

Males with female partners who can become pregnant:

•  You should use effective birth control when sexually active during treatment with Balversa and for 1 month after the last dose.

Tell your doctor if you are breastfeeding or plan to breastfeed.

There is no data whether or not erdafitinib crosses into human milk. Because of the potential for serious adverse reactions from erdafitinib in a breastfed child, lactating women are advised not to breastfeed during treatment and for one month following the last dose.

Take Balversa exactly as prescribed. 

Balversa comes in tablet form and is taken once daily. 

Swallow Balversa tablets whole, with or without food.

If you miss a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of Balversa at the same time. If you vomit after taking Balversa, do not take another Balversa tablet. Take your regular dose of Balversa the next day.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

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.

If you take too much Balversa, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Balversa tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Balversa and all medicines out of the reach of children.