Trade Name: BalversaTM
Erdafitinib is the generic name for the trade name drug BalversaTM. In some cases, health care professionals may use the trade name BalversaTM when referring to the generic drug name erdafitinib.
Drug Type: Erdafitinib is a targeted therapy drug. This medication is classified as a tyrosine kinase inhibitor (for more detail, see "How Erdafitinib Works" below).
What Erdafitinib Is Used For
- For the treatment of patients with fibroblast growth factor receptor (FGFR) mutant advanced or metastatic bladder cancer. It is used for cancer that has progress during or within 12 months of platinum-containing chemotherapy.
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Erdafitinib Is Given
- Erdafitinib is a tablet taken by mouth once a day with or without food
- Do not chew or crush the tablets
- Take erdafitinib exactly as prescribed
- If you throw up after taking a dose or erdafitinib, do not take another dose; take the next dose at the normal time the following day
- If a dose is missed, take the missed dose as soon as possible on the same day; return to the normal dosing schedule the following day
The amount of erdafitinib that you will receive depends on many factors, including your general health or other health problems, the type of cancer or condition you have, and the levels of phosphate in your bloodwork. Your doctor will determine your exact dosage and schedule.
Important things to remember about the side effects of erdafitinib:
- Most people will not experience all of the side effects listed.
- Side effects are often predictable in terms of their onset, duration, and severity.
- Side effects will improve after therapy is complete
- There are many options to minimize or prevent the side effects.
- There is no relationship between the presence or severity of side effects and the effectiveness of the medication.
The following side effects are common (occurring in greater than 30%) for patients taking erdafitinib:
- Onycholysis (separation of nail from the nail bed)
- Hyperphosphatemia (high levels of phosphate in the blood)
- Dry mouth
These are less common side effects (occurring in 10-29%) for patients receiving erdafitinib:
Not all side effects are listed above. Side effects that are rare -- occurring in less than about 10 percent of patients -- are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.
When to Contact Your Doctor or Health Care Provider
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
- Fever of 100.4º F (38º C) or higher, chills (possible signs of infection)
- Shortness of breath, wheezing, difficulty breathing, closing up of the throat, swelling of facial features, hives (possible allergic reaction).
The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:
- Nausea (interferes with ability to eat and unrelieved with prescribed medication)
- Vomiting (vomiting more than 4-5 times in a 24-hour period)
- Diarrhea (4-6 episodes in a 24-hour period)
- Unusual bleeding or bruising
- Black or tarry stools, or blood in your stools
- Blood in the urine
- Pain or burning with urination
- Extreme fatigue (unable to carry on self-care activities)
- Mouth sores (painful redness, swelling or ulcers)
- Changes in eyesight or eye pain
- Rash, hives, or blistered and peeling skin
- Mood changes
- Muscle pain or weakness
- Signs of infection such as redness or swelling, pain or swallowing, coughing up mucous, or painful urination.
- Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decreased amount of urine, or dizziness.
- Depressed (interfering with your ability to carry on your regular activities).
- Any skin or nail changes (rash, itching, severe dryness, blisters, nail infection, inflammation of the lips, etc.).
Always inform your health care provider if you experience any unusual symptoms.
- Before starting erdafitinib treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
- Avoid taking St. John's Wart while taking this medication.
- Do not receive any kind of immunization or vaccination without your doctor's approval while taking erdafitinib.
- Get monthly eye exams during the first 4 months of treatment, and every 3 months afterwards.
- Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category X (erdafitinib may cause fetal harm when given to a pregnant woman. This drug must not be given to a pregnant woman or a woman who intends to become pregnant. If a woman becomes pregnant while taking erdafitinib, the medication must be stopped immediately and the woman given appropriate counseling).
- For both men and women: use contraceptives, and do not conceive a child (get pregnant) while taking erdafitinib. Barrier methods of contraception, such as condoms, are recommended for up to one month after last dose of erdafitinib.
- Do not breast feed while taking erdafitinib.
- Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
- You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
- Wash your hands often.
- To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.
- Use an electric razor and a soft toothbrush to minimize bleeding.
- Avoid contact sports or activities that could cause injury.
- To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
- Follow regimen or anti-diarrhea medication as prescribed by your health care professional.
- Eat foods that may help reduce diarrhea (see managing side effects - diarrhea)
- Avoid sun exposure. Wear SPF 30 (or higher) sunblock and protective clothing.
- In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
- Get plenty of rest.
- Maintain good nutrition.
- Remain active as you are able. Gentle exercise is encouraged such as a daily walk.
- Have a routine eye exam performed monthly while taking this medication, and every 3 months afterwards.
- If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
Monitoring and Testing While Taking Erdafitinib
You will be checked regularly by your doctor while you are taking erdafitinib, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as function of other organs (such as your kidneys and liver) will also be ordered by your doctor.
How Erdafitinib Works
Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.
Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.
There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.
Researchers agree that targeted therapies are not a replacement for traditional therapies. They may best be used in combination with traditional therapies. More research is needed to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.
Erdafitinib is a tyrosine kinase inhibitor that binds to and inhibits pan-fibroblast growth factor receptor (FGFR) found on the surface of the cells. Tumor cells may overexpress FGFR. By binding to these receptors, erdafitinib blocks an important pathway that promotes cell growth and division, thus inhibiting cancer cell growth.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and education, but is not a substitute for medical advice.