Caprelsa Side Effects

Generic name: vandetanib

Medically reviewed by Drugs.com. Last updated on Dec 8, 2024.

Note: This document provides detailed information about Caprelsa Side Effects associated with vandetanib. Some dosage forms listed on this page may not apply specifically to the brand name Caprelsa.

Applies to vandetanib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may also be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 4 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Contact your doctor right away if you have any changes in your heart rhythm. You might feel dizzy, faint, or have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Avoid overexposing your skin to sunlight. Always use sunscreen or sun-blocking lotions and wear protective clothing and hats while you are using this medicine and for 4 months after the last dose.

Call your doctor right away if you have trouble breathing, cough, and fever that comes on suddenly. These may be symptoms of a serious lung condition.

Call your doctor right away if you have confusion, difficulty with speaking, slow speech, an inability to speak, an inability to move your arms, legs, or facial muscles, double vision, or a headache. These may be symptoms of a stroke.

This medicine may increase your chance of bleeding. Tell your doctor right away if you have bleeding gums, coughing up blood, difficulty in breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, prolonged bleeding from cuts, red or dark brown urine, or red or black, tarry stools. To help with this problem, stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Check with your doctor right away if you have chest pain, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, tightness in the chest, trouble breathing, or weight gain. These may be signs of a heart condition called congestive heart failure (CHF).

This medicine may cause diarrhea. This may also increase your risk of having an electrolyte imbalance (eg, low potassium, magnesium, or calcium in the blood). Tell your doctor right away if you start having muscle cramps or twitching, mood or mental changes, or unusual tiredness or weakness while using this medicine.

This medicine may cause hypothyroidism (underactive thyroid gland). Check with your doctor right away if you have constipation, a depressed mood, dry skin and hair, feeling cold, hair loss, hoarseness or husky voice, muscle cramps and stiffness, a slow heartbeat, weight gain, or unusual tiredness or weakness.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

Check with your doctor if you have a headache, seizures, confusion, blurred vision or any other changes in vision. These may be symptoms of a rare and serious condition called reversible posterior leukoencephalopathy syndrome (RPLS).

This medicine may cause slow wound healing. Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using it for at least 1 month before and at least 2 weeks after having surgery.

This medicine may cause blurred vision, tiredness, or weakness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal (St. John's wort) or vitamin supplements.

Serious side effects of Caprelsa

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:

Other side effects of Caprelsa

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:

For healthcare professionals

Applies to vandetanib: oral tablet.

General adverse events

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%.^[Ref]

Cardiovascular

• 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^[Ref]

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 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.^[Ref]

Dermatologic

• 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^[Ref]

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.^[Ref]

Gastrointestinal

• 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^[Ref]

CTCAE grade 3 to 4 diarrhea/colitis, nausea, abdominal pain, and vomiting were reported in 11%, 1%, 3%, and 1%, respectively.^[Ref]

Genitourinary

• Very common (10% or more): Proteinuria (10%)
• Common (1% to 10%): Urinary tract infection
• Uncommon (0.1% to 1%): Calculus ureteric^[Ref]

Hematologic

• Very common (10% or more): Bleeding (14%); neutropenia (10%)
• Common (1% to 10%): Thrombocytopenia (9%)^[Ref]

Less than 1% of patients experienced CTCAE grade 3 to 4 neutropenia. Bleeding events were grade 1 to 2 events.^[Ref]

Hepatic

• Very common (10% or more): ALT increased (51%)
• Uncommon (0.1% to 1%): Cholecystitis, cholelithiasis^[Ref]

An ALT increase classified as CTCAE grade 3 to 4 was experienced in 2% of patients.^[Ref]

Metabolic

• 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^[Ref]

CTCAE grade 3 to 4 hypocalcemia, decreased appetite, and hypomagnesemia occurred in 6%, 4%, and less than 1 % of patients, respectively.^[Ref]

Musculoskeletal

• Common (1% to 10%): Muscle spasms^[Ref]

Nervous system

• 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^[Ref]

Ocular

• Very common (10% or more): Corneal abnormalities (13%)
• Common (1% to 10%): Blurred vision
• Uncommon (0.1% to 1%): Glaucoma^[Ref]

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.^[Ref]

Other

• Very common (10% or more): Fatigue (24%); asthenia (15%)
• Common (1% to 10%): Pyrexia^[Ref]

CTCAE grade 3 to 4 fatigue was reported in 6% of patients.^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (13%); depression (10%)
• Common (1% to 10%): Anxiety
• Uncommon (0.1% to 1%): Bipolar disorder^[Ref]

CTCAE grade 3 to 4 depression was reported in 2% of patients.^[Ref]

Renal

• 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

Respiratory

• 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^[Ref]

Endocrine

• Very common (10% or more): Thyroid stimulating hormone (TSH) elevation (18.6%)
• Common (1% to 10%): Hypothyroidism

See also:

Further information

Caprelsa side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer