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Caprelsa

"The U.S. Food and Drug Administration today approved Cometriq (cabozantinib) to treat medullary thyroid cancer that has spread to other parts of the body (metastasized).

Medullary thyroid cancer develops in cells in the thyroid gland that m"...

Caprelsa

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
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the label:

Clinical Studies 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.

Patients with unresectable locally advanced or metastatic medullary thyroid cancer were treated with CAPRELSA 300 mg (n=231) or Placebo (n=99). The population exposed to CAPRELSA was 58% male, 94% white, and had a median age of 50 years. The data described below reflect a median exposure to CAPRELSA for 607 days.

The most commonly reported adverse drug reactions which occurred in > 20% of CAPRELSA-treated patients and with a between-arm difference of ≥ 5% included, in order of decreasing frequency: diarrhea/colitis, rash, acneiform dermatitis, hypertension, nausea, headache, upper respiratory tract infection, decreased appetite, and abdominal pain.

Among CAPRELSA-treated patients, dose interruption occurred in 109 (47%) and dose reduction occurred in 83 (36%). Adverse reactions led to study treatment discontinuation in 28 of 231 patients (12%) receiving CAPRELSA and in 3 of 99 patients (3.0%) receiving placebo. Adverse reactions leading to permanent discontinuation in 2 or more ( ≥ 0.9%) patients treated with CAPRELSA were: asthenia (1.7%), rash (1.7%), diarrhea (0.9%), fatigue (0.9%), pyrexia (0.9%), elevated creatinine (0.9%), QT prolongation (0.9%), and hypertension (0.9%).

Table 1 : Per-Patient Incidence of Selected Adverse Reactions Occurring at a Higher Incidence in CAPRELSA-Treated Patients During Randomized Treatment [Between-Arm Difference of ≥ 5% (All Grades)1]

System Organ Class Preferred Term  CAPRELSA 300 mg
N=231 
Placebo
N=99 
All Grades (%)  Grade 3-4 (%)  All Grades (%)  Grade 3-4 (%) 
Gastrointestinal Disorders 
  Diarrhea/Colitis  57 11 27 2
  Nausea  33 1 16 0
  Abdominal Pain 21 3 11 0
  Vomiting  15 1 7 0
  Dyspepsia  11 0 4 0
  Dry Mouth  9 0 3 0
Skin and Cutaneous Disorders 
  Rash 53 5 12 0
  Dermatitis Acneiform/Acne  35 1 7 0
  Dry Skin  15 0 5 0
  Photosensitivity Reaction  13 2 0 0
  Pruritus  11 1 4 0
  Nail abnormalities 9 0 0 0
  Alopecia  8 N/A  0 N/A 
Vascular Disorders 
  Hypertension/Hypertensive Crisis/Accelerated Hypertension  33 9 5 1
Nervous System Disorders 
  Headache  26 1 9 0
  Dysgeusia  8 0 3 0
General Disorders 
  Fatigue 24 6 23 1
Infections 
  Upper Respiratory Tract Infections6  23 0 16 0
Metabolic and Nutritional Disorders 
  Decreased Appetite  21 4 12 0
  Hypocalcemia  11 2 3 0
Investigations 
  ECG QT Prolonged 14 8 1 1
Eye Disorders 
  Corneal Abnormalities 13 0 1 0
  Blurred Vision  9 0 1 0
Renal Disorders 
  Proteinuria  10 0 2 0
Psychiatric Disorders 
  Depression  10 2 3 0
Endocrine Disorders 
  Hypothyroidism  6 0 0 0
Musculoskeletal Disorders 
  Muscle Spasms  6 0 1 0
1CTCAE version 3 was used to grade adverse events.
2Includes abdominal pain, abdominal pain upper, lower abdominal pain and abdominal discomfort.
3Includes rash, rash (erythematous, generalized, macular, maculo-papular, papular, pruritic, and exfoliative), dermatitis, dermatitis bullous, generalized erythema, and eczema.
4Includes nail disorder, nail bed inflammation, nail bed tenderness, paronychia, nail bed infection, and nail infection.
5Included in Table 1 due to the increased incidence of severe fatigue in the CAPRELSA group compared to the placebo group.
6Includes laryngitis, nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection, acute sinusitis, rhinitis, and tracheitis.
769% had QT prolongation > 450ms and 7% had QT prolongation > 500ms by ECG using Fridericia correction.
8Includes corneal edema, corneal opacity, corneal dystrophy, corneal pigmentation, keratopathy, arcus lipoides, corneal deposits, acquired corneal dystrophy.

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%).

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 revealed corneal opacities (vortex keratopathies) in treated patients, which can lead to halos and decreased visual acuity. Perform ophthalmologic examination, including slit lamp examination, in patients who report visual changes.

Class effects

CAPRELSA is an inhibitor of vascular endothelial growth factor receptor (VEGFR) signaling. Inhibition of VEGFR signaling can result in intestinal perforation. Intestinal perforation occurred in 0.4% of CAPRELSA treated patients versus 0% of placebo treated patients. 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.2

Table 2 : Per-Patient Incidence of Selected Laboratory Abnormalities in Patients with MTC Occurring at a Higher Incidence in CAPRELSA-Treated Patients [Between-Arm Difference of ≥ 5% (All Grades)1]

Laboratory Abnormalities  CAPRELSA 300 mg
N=231 
Placebo
N=99 
All Grades (%)  Grade 3–4 (%)  All Grades (%)  Grade 3–4 (%) 
Chemistries 
  Hypocalcemia  57 6 25 3
  ALT Increased  51 2 19 0
  Hypoglycemia  24 0 7 1
  Creatinine Increased  16 0 1 0
  Hypomagnesemia  7 < 1  2 0
Hematologic 
  Neutropenia  10 < 1  5 2
  Thrombocytopenia  9 0 3 0
1CTCAE version 3 was used to grade laboratory abnormalities.

No patient with a Grade 3-4 ALT elevation had a concomitant increase in bilirubin in the MTC study.

Read the entire FDA prescribing information for Caprelsa (Vandetanib) »

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Additional Caprelsa Information

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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