Caprelsa Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Caprelsa (vandetanib) is indicated for the treatment of the latter stages of a rare form of thyroid cancer called medullary thyroid cancer. Caprelsa is not available as a generic. Common side effects of Caprelsa can include nausea, diarrhea, and abdominal pain, loss of appetite, rash, high blood pressure and malaise.
Caprelsa (vandetanib) is available in two strengths, 100 and 300 mg tablets. Because of the potential for sudden death and cardiac problems, Caprelsa is available only through a restricted distribution program called CAPRELSA REMS Program. Only prescribers and pharmacies certified with the program are able to prescribe and dispense Caprelsa. The recommended daily dose is 300 mg of Caprelsa taken orally, with or without food. Caprelsa should not be taken with medications prescribed for a heart rhythm defect called long QT syndrome. While taking Caprelsa, patients should avoid taking St. John's wort or drugs that may prolong the QT interval. Caprelsa tablets should not be crushed. Direct contact of crushed tablets with the skin or mucous membranes should be avoided. Serious side effects include respiratory problems, heart failure, cardiac arrhythmias, hypothyroidism, and a serious infection of the blood called sepsis. Heart rhythm disorders and sudden deaths have been reported.
Caprelsa can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during treatment with Caprelsa. Breastfeeding mothers are advised to discontinue nursing while receiving Caprelsa therapy. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Caprelsa, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Safety and efficacy of Caprelsa in pediatric patients have not been established.
Our Caprelsa Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Caprelsa tablets should not be crushed.
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.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Caprelsa FDA Prescribing Information: Side Effects
The most commonly reported adverse drug reactions ( > 20%) have been diarrhea, rash, acne, nausea, hypertension, headache, fatigue, upper respiratory tract infections, decreased appetite, and abdominal pain. The most common laboratory abnormalities ( > 20%) were decreased calcium, increased ALT, and decreased glucose [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
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.
Clinical Studies Experience
Patients with unresectable locally advanced or metastatic medullary thyroid cancer were treated with CAPRELSA 300 mg (n=231) or Placebo (n=99). Patients with investigator-determined progression or patients who continued treatment after the data cut-off could receive open label CAPRELSA. The following adverse reactions have been reported. [see Clinical Studies]
Table 1 : Adverse Reactions With a ≥ 5% Increased
Incidence in Patients on CAPRELSA Compared to Placebo During Randomized
|System Organ Class Preferred Term||CAPRELSA 300 mg
|All Grades||Grade 3-4||All Grades||Grade 3-4|
|Diarrhea/Colitis||132 (57%)||26 (11%)||27 (27%)||2 (2%)|
|Nausea||77 (33%)||2 (1%)||16 (16%)||0|
|Abdominal Pain1||48 (21%)||6 (3%)||11(11%)||0|
|Vomiting||34 (15%)||2 (1%)||7 (7%)||0|
|Dyspepsia||25 (11%)||0||4 (4%)||0|
|Dry Mouth||20 (9%)||0||3 (3%)||0|
|Skin and Cutaneous Disorders|
|Rash2||123 (53%)||11 (5%)||12 (12%)||0|
|Dermatitis Acneiform/Acne||81 (35%)||2 (1%)||7 (7%)||0|
|Dry Skin||35 (15%)||0||5 (5%)||0|
|Photosensitivity Reaction||31 (13%)||4 (2%)||0||0|
|Pruritus||25 (11%)||3 (1%)||4 (4%)||0|
|Nail abnormalities3||20 (9%)||0||0||0|
|Hypertension/Hypertensive Crisis/Accelerated hypertension||76 (33%)||20 (9%)||5 (5%)||1 (1%)|
|Nervous System Disorders|
|Headache||59 (26%)||2 (1%)||9 (9%)||0|
|Dysgeusia||19 (8%)||0||3 (3%)||0|
|Fatigue4||55 (24%)||13 (6%)||23(23%)||1 (1%)|
|Upper Respiratory Tract Infections5||54 (23%)||0||16(16%)||0|
|Metabolic and Nutritional Disorders|
|Decreased Appetite||49 (21%)||10 (4%)||12 (12%)||0|
|Hypocalcemia||25 (11%)||4 (2%)||3 (3%)||0|
|ECG QT Prolonged6||33 (14%)||18 (8%)||1 (1%)||1 (1%)|
|Corneal Abnormalities7||31 (13%)||0||1 (1%)||0|
|Blurred Vision||21 (9%)||0 (0%)||1 (1%)||0|
|Proteinuria||23 (10%)||0||2 (2%)||0|
|Depression||22 (10%)||4 (2%)||3 (3%)||0|
|Muscle Spasms||15 (6%)||0||1 (1%)||0|
|1Includes abdominal pain, abdominal pain upper, lower
abdominal pain and abdominal discomfort.
2Includes rash, rash erythematous, generalized, macular, maculo-papular, papular, pruritic, exfoliative, dermatitis, dermatitis bullous, generalized erythema and eczema.
3Includes nail disorder, nail bed inflammation, nail bed tenderness, paronychia, nail bed infection, and nail infection.
4Included in Table 1 due to the increased incidence of severe fatigue in the CAPRELSA group compared to the placebo group.
5Includes laryngitis, nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection, acute sinusitis, rhinitis, and tracheitis.
669% had QT prolongation > 450ms and 7% had QT prolongation > 500ms by ECG using Fridericia correction.
7Includes corneal edema, corneal opacity, corneal dystrophy, corneal pigmentation, keratopathy, arcus lipoides, corneal deposits, acquired corneal dystrophy.
Adverse reactions resulting in death in patients receiving CAPRELSA (N=5) were respiratory failure, respiratory arrest, aspiration pneumonia, cardiac failure with arrhythmia, and sepsis. Adverse reactions resulting in death in patients receiving placebo were gastrointestinal hemorrhage (1%) and gastroenteritis (1%). In addition there was one sudden death and one death from cardiopulmonary arrest, in patients receiving CAPRELSA after data cut-off. Causes of discontinuation in 2 or more CAPRELSA-treated patients included asthenia, fatigue, rash, arthralgia, diarrhea, hypertension, prolonged QT interval, increase in creatinine and pyrexia. Serious adverse events reported in > 2% of CAPRELSA-treated patients included diarrhea, pneumonia, and hypertension. Clinically important uncommon adverse drug reactions in patients who received CAPRELSA versus patients who received placebo included pancreatitis (0.4% vs. 0%) and heart failure (0.9% vs. 0%). In the integrated summary of safety database, the most common cause of death in patients who received CAPRELSA was pneumonia.
The incidence of Grade 1-2 bleeding events was 14% in patients receiving CAPRELSA compared with 7% on placebo in the randomized portion of the medullary thyroid cancer (MTC) study. The incidence was similar in the 300 mg monotherapy safety program with a 13% incidence.
Blurred vision was more common in patients who received CAPRELSA versus patients who received placebo for medullary thyroid cancer (9% vs. 1%, respectively). Scheduled slit lamp examinations have revealed corneal opacities (vortex keratopathies) in treated patients, which can lead to halos and decreased visual acuity. It is unknown if this will improve after discontinuation. Ophthalmologic examination, including slit lamp, is recommended in patients who report visual changes. If a patient has blurred vision, do not drive or operate machinery.
Table 2 provides the frequency and severity of laboratory abnormalities reported for patients with medullary thyroid cancer receiving randomized treatment with CAPRELSA or placebo.
Table 2 : Laboratory Abnormalities in Patients with MTC
|Laboratory Parameter||CAPRELSA 300 mg N=231||Placebo N=99|
|All Grades||Grade 3-4||All Grades||Grade 3-4|
|Calcium Decreased||132 (57%)||13 (6%)||25 (25%)||3 (3%)|
|ALT Increased||118 (51%)||4 (2%)||19 (19%)||0|
|Glucose Decreased||55 (24%)||0||7 (7%)||1 (1%)|
|Creatinine Increased||38 (16%)||0||1 (1%)||0|
|Bilirubin Increased||29 (13%)||0||17 (17%)||0|
|Magnesium Decreased||17 (7%)||1 ( < 1%)||2 (2%)||0|
|Calcium Increased||16 (7%)||2 (1%)||9 (9%)||1 (1%)|
|Potassium Decreased||15 (6%)||1 ( < 1%)||3 (3%)||0|
|Potassium Increased||13 (6%)||1 ( < 1%)||4 (4%)||2 (2%)|
|Glucose Increased||12 (5%)||4 (2%)||7 (7%)||0|
|Magnesium Increased||6 (3%)||0||4 (4%)||0|
|WBC Decreased||45 (19%)||0||25 (25%)||0|
|Hemoglobin Decreased||31 (13%)||1 ( < 1%)||19 (19%)||2 (2%)|
|Neutrophils Decreased||21 (10%)||1 ( < 1%)||5 (5%)||2 (2%)|
|Platelets Decreased||18 (9%)||0||3 (3%)||0|
Alanine aminotransferase elevations occurred in 51% of patients on CAPRELSA in the randomized medullary thyroid cancer (MTC) study. Grade 3-4 ALT elevations were seen in 2% of patients and no patients had a concomitant increase in bilirubin. Elevations in ALT have resulted in temporary discontinuation of CAPRELSA. However, 16 of 22 patients with a grade 2 elevation in ALT continued 300 mg CAPRELSA. Seven patients who continued CAPRELSA had a normal ALT within 6 months. In the protocol, ALT was monitored every 3 months and more frequently as indicated.
Read the entire FDA prescribing information for Caprelsa (Vandetanib) »
Additional Caprelsa Information
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