Caprelsa Side Effects

Generic name: vandetanib

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.

Some side effects of Caprelsa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to vandetanib: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking vandetanib (the active ingredient contained in Caprelsa) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using vandetanib and call your doctor at once if you have a serious side effect such as:

• slow healing of a wound or surgical incision;

• severe dizziness, fainting, fast or pounding heartbeats;

• fever, chest pain, dry cough, wheezing, trouble breathing;

• feeling short of breath (even with mild exertion), swelling, rapid weight gain;

• chest pain or heavy feeling, pain spreading to the arm or shoulder;

• severe or ongoing diarrhea;

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• confusion, vision problems, headache, seizure (convulsions), problems with thinking;

• sudden numbness or weakness (especially on one side of the body), sudden headache, confusion, problems with speech or balance;

• thyroid symptoms -- extreme tired feeling, dry skin, joint pain or stiffness, muscle pain or weakness, hoarse voice, feeling more sensitive to cold temperatures, weight gain; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of vandetanib may include:

• mild feeling tired;

• headache;

• mild nausea or stomach pain;

• diarrhea;

• mild skin rash; or

• acne.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to vandetanib: oral tablet

General

In general, the most commonly reported side effects (greater than 20%) have included diarrhea, rash, acne, nausea, hypertension, headache, fatigue, decreased appetite, abdominal pain, hypocalcemia, hypoglycemia, and increased ALT.

Cardiovascular

Cardiovascular side effects have included hypertension (33%; grade 3 to 4: 9%), QT interval prolongation (14%; grade 3 to 4: 8%), cardiac failure, and arrhythmias.

Dermatologic

The types of rash reported have included erythematous rash, generalized rash, maculopapular rash, exfoliative dermatitis, bullous dermatitis, generalized erythema, and eczema.

Nail abnormalities include nail disorder, nail bed inflammation, nail bed tenderness, paronychia, nail bed infection, and nail infection.

Dermatologic side effects have included rash (53%; grade 3 to 4: 5%), dermatitis acneiform/acne (35%; grade 3 to 4: 1%), dry skin (15%), photosensitivity reaction (13%; grade 3 to 4: 2%), pruritus (11%; grade 3 to 4: 1%), nail abnormalities (9%), alopecia (8%), folliculitis, blue-gray macules, and hand-foot skin reaction.

Gastrointestinal

Gastrointestinal side effects have included diarrhea/colitis (57%; grade 3 to 4: 11%), nausea (33%; grade 3 to 4: 1%), decreased appetite (21%; grade 3 to 4: 4%), abdominal pain (21%; grade 3 to 4: 3%), vomiting (15%; grade 3 to 4: 1%), dyspepsia (11%), dry mouth (9%), and pancreatitis.

Genitourinary

Genitourinary side effects have included proteinuria (10%).

Hematologic

Hematologic side effects have included bleeding events, decreased white blood cells (19%), decreased hemoglobin (13%), decreased neutrophils (10%), and decreased platelets (9%).

Hepatic

Hepatic side effects have included increased ALT (51%).

Immunologic

Immunologic side effects have included sepsis.

Metabolic

Metabolic side effects have included decreased calcium (57%; grade 3 to 4: 6%), hypoglycemia (24%), weight loss (10%; grade 3 to 4: 1%), decreased magnesium (7%), increased calcium (7%), decreased potassium (6%), increased potassium (6%), increased glucose (5%), and increased magnesium (3%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia.

Nervous system

Nervous system side effects have included headache (26%; grade 3 to 4: 1%) and dysgeusia (8%).

Ocular

Ocular side effects have included corneal abnormalities (13%) and blurred vision (9%).

Other

Other side effects have included fatigue (24%; grade 3 to 4: 6%), asthenia, and pyrexia.

Psychiatric

Psychiatric side effects have included depression (10%; grade 3 to 4: 2%).

Renal

Renal side effects have included increased creatinine (16%) and increased bilirubin (13%).

Respiratory

Respiratory side effects have included upper respiratory infection (23%), respiratory failure, respiratory arrest, and aspiration pneumonia.

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