Note: This document contains side effect information about vandetanib. Some of the dosage forms listed on this page may not apply to the brand name Caprelsa.
Common side effects of Caprelsa include: exfoliative dermatitis, hypertensive crisis, upper respiratory tract infection, abdominal distress, abdominal pain, acne vulgaris, bullous dermatitis, colitis, decreased serum calcium, decreased serum glucose, depression, dermatitis, diarrhea, dyspepsia, eczema, erythematous rash, headache, hypertension, hypocalcemia, increased serum alanine aminotransferase, increased serum creatinine, lower abdominal pain, macular eruption, maculopapular rash, nausea, papular rash, prolonged qt interval on ecg, proteinuria, pruritic rash, pruritus, skin rash, upper abdominal pain, skin photosensitivity, vomiting, erythema of skin, and xeroderma. Other side effects include: hypothyroidism, and xerostomia. See below for a comprehensive list of adverse effects.
Applies to vandetanib: oral tablet
Oral route (Tablet)
Vandetanib can prolong the QT interval, and torsades de pointes and sudden death have been reported with its use. Do not use in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome; electrolyte depletion must be corrected prior to starting vandetanib and should be periodically monitored. Avoid drugs that are known to prolong the QT interval. Vandetanib is only available through a restricted distribution program (Vandetanib REMS).
Along with its needed effects, vandetanib (the active ingredient contained in Caprelsa) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking vandetanib:
Some side effects of vandetanib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to vandetanib: oral tablet
The most commonly reported adverse effects in decreasing order of frequency included diarrhea/colitis, rash, acneiform dermatitis, hypertension, nausea, headache, upper respiratory tract infections, decreased appetite, and abdominal pain.
During clinical trials, treatment discontinuation due to adverse reactions occurred in 21% of patients. Events leading to discontinuation included asthenia, rash, diarrhea, fatigue, pyrexia, elevated creatinine, QT prolongation, and hypertension. Dose interruption occurred in 47% of patients and dose reduction in 36%.
Common terminology criteria for adverse events (CTCAE) grade 3 to 4 hypertension/hypertensive crisis/accelerated hypertension was reported in 9% of patients.
CTCAE grade 3 to 4 QT prolongation was reported in 8% of patients. Among patients who experienced QT prolongation, 69% experienced a QT interval Fridericia (QTcF) greater than 450 milliseconds (msec) with 7% having reported a QTcF greater than 500 msec. In a pharmacodynamics study in patients with medullary thyroid cancer receiving vandetanib (the active ingredient contained in Caprelsa) 300 mg orally once daily, mean change in QTcF was 35 msec and mean change in QTcF remained above 30 msec for the duration of the trial (up to 2 years). A change in QTcF greater than 60 msec was reported in 36% of patients experience and 4.3% of patients had a QTcF greater than 500 msec.
Very common (10% or more): Hypertension/hypertensive crisis/accelerated hypertension (33%); ECG QT prolonged (14%)
Uncommon (0.1% to 1%): Heart failure, arrhythmia, atrial fibrillation, bradycardia, pericarditis, chest pain, cardiac arrest
Frequency not reported: Torsades de pointes; ventricular tachycardia
Very common (10% or more): Rash (53%); dermatitis acneiform/acne (35%); dry skin (15%); photosensitivity reaction (13%); pruritus (11%)
Common (1% to 10%): Nail abnormalities; alopecia
Uncommon (0.1% to 1%): Skin ulcer
Frequency not reported: Stevens-Johnson syndrome, erythema multiforme
Types of rash reported included rash, rash (erythematous, generalized, macular, maculopapular, popular, pruritic, and exfoliative), dermatitis, bullous dermatitis, generalized erythema, and eczema. CTCAE grade 3 to 4 rash, dermatitis/acneiform/acne, photosensitivity reaction, and pruritus were reported in 5%, 1%, 2%, and 1% of patients, respectively.
Nail abnormalities reported included nail disorder, nail bed inflammation, nail bed tenderness, paronychia, nail bed infection, and nail infection.
CTCAE grade 3 to 4 diarrhea/colitis, nausea, abdominal pain, and vomiting were reported in 11%, 1%, 3%, and 1%, respectively.
Very common (10% or more): Diarrhea/colitis (57%); nausea (33%); abdominal pain (21%); vomiting (15%); dyspepsia (11%);
Common (1% to 10%): Dry mouth
Uncommon (0.1% to 1%): Pancreatitis, intestinal perforation, dysphagia, gastrointestinal hemorrhage, colitis, gastritis, ileus, peritonitis
Very common (10% or more): Proteinuria (10%)
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Calculus ureteric
Very common (10% or more): Bleeding (14%); neutropenia (10%)
Common (1% to 10%): Thrombocytopenia (9%)
Less than 1% of patients experienced CTCAE grade 3 to 4 neutropenia. Bleeding events were grade 1 to 2 events.
Very common (10% or more): ALT increased (51%)
Uncommon (0.1% to 1%): Cholecystitis, cholelithiasis
An ALT increase classified as CTCAE grade 3 to 4 was experienced in 2% of patients.
Very common (10% or more): Hypocalcemia (57%); hypoglycemia (24%); decreased appetite (21%)
Common (1% to 10%): Hypomagnesemia, hypokalemia, hypercalcemia, hyperglycemia, dehydration, hyponatremia, weight loss
Uncommon (0.1% to 1%): Hypokalemia
CTCAE grade 3 to 4 hypocalcemia, decreased appetite, and hypomagnesemia occurred in 6%, 4%, and less than 1 % of patients, respectively.
Common (1% to 10%): Muscle spasms
Very common (10% or more): Headache (26%); paresthesia, dizziness
Common (1% to 10%): Dysgeusia, tremor, lethargy, loss of consciousness, balance disorder
Uncommon (0.1% to 1%): Convulsion, clonus, brain edema
Frequency not reported: Reversible posterior leukoencephalopathy syndrome
Ocular abnormalities included corneal edema, corneal opacity, corneal dystrophy, corneal pigmentation, keratopathy, arcus lipoides, corneal deposits, acquired corneal dystrophy. Slit lamp examination of vandetanib-treated patients revealed vortex keratopathy.
Very common (10% or more): Corneal abnormalities (13%)
Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Glaucoma
CTCAE grade 3 to 4 fatigue was reported in 6% of patients.
Very common (10% or more): Fatigue (24%); asthenia (15%)
Common (1% to 10%): Pyrexia
CTCAE grade 3 to 4 depression was reported in 2% of patients.
Very common (10% or more): Insomnia (13%); depression (10%)
Common (1% to 10%): Anxiety
Uncommon (0.1% to 1%): Bipolar disorder
Very common (10% or more): Increased creatinine (16%)
Common (1% to 10%): Pyelonephritis
Uncommon (0.1% to 1%): Nephrolithiasis, anuria, renal colic, renal failure, tubulointerstitial nephritis
Very common (10% or more): Upper respiratory tract infections (23%); cough (11%)
Common (1% to 10%): Pneumonia, epistaxis
Uncommon (0.1% to 1%): Pneumonitis, hemoptysis, bronchospasm, chylothorax, dyspnea, respiratory arrest, respiratory failure
Very common (10% or more): Thyroid stimulating hormone (TSH) elevation (18.6%)
Common (1% to 10%): Hypothyroidism
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Caprelsa