Balversa

Last updated on RxList: 9/8/2020
Balversa Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Balversa?

Balversa (erdafitinib) is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has susceptible FGFR3 or FGFR2 genetic alterations, and progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

What Are Side Effects of Balversa?

Common side effects of Balversa include:

  • inflammation of the mouth and lips,
  • fatigue,
  • diarrhea,
  • dry mouth,
  • separation nails from the nail bed,
  • infection around the fingernails or toenails,
  • decreased sodium,
  • decreased appetite,
  • changes in taste,
  • dry skin, decreased magnesium,
  • dry eye,
  • hair loss,
  • hand-foot syndrome redness,
  • swelling,
  • pain on the palms of the hands and/or the soles of the feet),
  • constipation,
  • abdominal pain,
  • increased calcium,
  • nausea,
  • musculoskeletal pain,
  • vomiting,
  • fever,
  • nail discoloration,
  • blurred vision,
  • increased tearing,
  • urinary tract infection (UTI),
  • conjunctivitis,
  • mouth or throat pain,
  • shortness of breath,
  • blood in the urine,
  • joint pain, and
  • weight loss

Dosage for Balversa

The recommended initial dosage of Balversa is 8 mg orally once daily with a dose increase to 9 mg daily if criteria are met.

What Drugs, Substances, or Supplements Interact with Balversa?

Balversa may interact with strong or moderate inhibitors or inducers of CYP2C9 or CYP3A4, serum phosphate level-altering agents, CYP3A4 substrates, OCT2 substrates, or P-gp substrates. Tell your doctor all medications and supplements you use.

Balversa During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Balversa; it may harm a fetus. Because of the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended while using Balversa and for one moth following the last dose

Additional Information

TOur Balversa (erdafitinib) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Balversa Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may have high phosphate levels, and your blood will need to be tested often. Tell your doctor if you have symptoms such as numbness or tingling around your mouth, muscle stiffness, body aches, itching or rash, tiredness, trouble sleeping, nausea, vomiting, loss of appetite, or feeling short of breath.

Call your doctor at once if you have:

  • vision problems, vision loss;
  • eye pain or redness;
  • painful or irritated eyelids;
  • feeling like something is in your eye;
  • watery eyes, your eyes may be more sensitive to light; or
  • problems with your fingernails or toenails--pain, bleeding, separation of the nails from the skin (nail bed), unusual breakage, changes in nail color or texture, cracks or infection in your cuticles.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • dry eyes;
  • puffy eyelids;
  • dry mouth, mouth sores;
  • hair loss;
  • dry skin, problems with your fingernails or toenails;
  • pain, redness, numbness, and peeling skin on your hands or feet;
  • muscle pain;
  • feeling tired;
  • abnormal liver or kidney function tests;
  • low sodium levels, low red blood cell count;
  • nausea, stomach pain, loss of appetite;
  • diarrhea, constipation; or
  • changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Balversa (Erdafitinib Tablets)

Balversa Professional Information

SIDE EFFECTS

The following serious adverse reactions are also described elsewhere in the labeling:

  • Ocular Disorders [see WARNING AND PRECAUTIONS].
  • Hyperphosphatemia [see WARNING AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of BALVERSA was evaluated in the BLC2001 study that included 87 patients with locally advanced or metastatic urothelial carcinoma which had susceptible FGFR3 or FGFR2 genetic alterations, and which progressed during or following at least one line of prior chemotherapy including within 12 months of neoadjuvant or adjuvant chemotherapy [see Clinical Studies]. Patients were treated with BALVERSA at 8 mg orally once daily; with a dose increase to 9 mg in patients with phosphate levels <5.5 mg/dL on Day 14 of Cycle 1. Median duration of treatment was 5.3 months (range: 0 to 17 months).

The most common adverse reactions (ARs) including laboratory abnormalities (≥20%) were phosphate increased, stomatitis, fatigue, creatinine increased, diarrhea, dry mouth, onycholysis, alanine aminotransferase increased, alkaline phosphatase increased, sodium decreased, decreased appetite, albumin decreased, dysgeusia, hemoglobin decreased, dry skin, aspartate aminotransferase increased, magnesium decreased, dry eye, alopecia, palmar-plantar erythrodysesthesia syndrome, constipation, phosphate decreased, abdominal pain, calcium increased, nausea, and musculoskeletal pain. The most common Grade 3 or greater ARs (>1%) were stomatitis, nail dystrophy, palmar-plantar erythrodysesthesia syndrome, paronychia, nail disorder, keratitis, onycholysis, and hyperphosphatemia.

An adverse reaction with a fatal outcome in 1% of patients was acute myocardial infarction.

Serious adverse reactions occurred in 41% of patients including eye disorders (10%).

Permanent discontinuation due to an adverse reaction occurred in 13% of patients. The most frequent reasons for permanent discontinuation included eye disorders (6%).

Dosage interruptions occurred in 68% of patients. The most frequent adverse reactions requiring dosage interruption included hyperphosphatemia (24%), stomatitis (17%), eye disorders (17%), and palmar-plantar erythro-dysaesthesia syndrome (8%).

Dose reductions occurred in 53% of patients. The most frequent adverse reactions for dose reductions included eye disorders (23%), stomatitis (15%), hyperphosphatemia (7%), palmar-plantar erythro-dysaesthesia syndrome (7%), paronychia (7%), and nail dystrophy (6%).

Table 3 presents ARs reported in ≥10% of patients treated with BALVERSA at 8 mg once daily.

Table 3: Adverse Reactions Reported in ≥ 10% (Any Grade) or ≥5% (Grade 3-4) of Patients

Adverse ReactionBALVERSA 8 mg daily
(N=87)
All Grades (%)Grade 3-4 (%)
Any10067
Gastrointestinal disorders9224
Stomatitis569
Diarrhea472
Dry mouth450
Constipation281
Abdominal pain*232
Nausea211
Vomiting132
Metabolism and nutrition disorders9016
Decreased appetite380
General disorders and admin. site conditions6913
Fatigue†5410
Pyrexia141
Skin and subcutaneous disorders7516
Onycholysis‡4110
Dry skin§340
Palmar-plantar erythrodysaesthesia266
Alopecia260
Nail discoloration110
Eye disorders6211
Dry eye¶286
Vision blurred170
Lacrimation increased100
Nervous system disorders575
Dysgeusia371
Infections and infestations5620
Paronychia173
Urinary tract infection176
Conjunctivitis110
Respiratory, thoracic and mediastinal disorders407
Oropharyngeal pain111
Dyspnea#102
Renal and urinary tract disorders3810
Hematuria112
Musculoskeletal and connective tissue disorders310
Musculoskeletal painÞ200
Arthralgia110
Investigations445
Weight decreasedβ160
*Includes abdominal pain, abdominal discomfort, abdominal pain upper, and abdominal pain lower
†Includes asthenia, fatigue, lethargy, and malaise
‡Includes onycholysis, onychoclasis, nail disorder, nail dystrophy, and nail ridging
§Includes dry skin and xerostomia
¶Includes dry eye, xerophthalmia, keratitis, foreign body sensation, and corneal erosion
#Includes dyspnea and dyspnea exertional
ÞIncludes back pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal chest pain, neck pain, pain in extremity
&bate; Includes weight decreased and cachexia

Table 4: Laboratory Abnormalities Reported in ≥ 10% (All Grade) or ≥ 5% (Grade 3-4) of Patients

Laboratory AbnormalityBALVERSA 8 mg daily
(N=86*)
All Grades (%)Grade 3-4 (%)
Hematology
Hemoglobin decreased353
Platelets decreased191
Leukocytes decreased170
Neutrophils decreased102
Chemistry
Phosphate increased761
Creatinine increased525
Sodium decreased4016
Alanine aminotransferase increased411
Alkaline phosphatase increased411
Albumin decreased370
Aspartate aminotransferase increased300
Magnesium decreased301
Phosphate decreased249
Calcium increased223
Potassium increased160
Fasting glucose increased100
* One of the 87 patients had no laboratory tests.

Read the entire FDA prescribing information for Balversa (Erdafitinib Tablets)

© Balversa Patient Information is supplied by Cerner Multum, Inc. and Balversa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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