Brand Name
Caprelsa
Generic Name
Vandetanib
View Brand Information FDA approval date: July 25, 2011
Classification: Kinase Inhibitor
Form: Tablet
What is Caprelsa (Vandetanib)?
CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. CAPRELSA is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.
Approved To Treat
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Related Clinical Trials
Precision Medicine Applied to Locally Advanced Thyroid Cancer Using Tumor-derived Organoids and In-vitro Sensitivity Testing: a Phase 2a, Single-center, Open-label, and Non-comparative Study
Summary: The current study aims to explore the potential advantages of anti-cancer therapy that is implemented based on drug sensitivity testing. This pertains to individuals with locally advanced thyroid cancer who have undergone conventional therapy in the past or unresectable patients .
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Brand Information
CAPRELSA (Vandetanib)
WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH
CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Do not use CAPRELSA in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Correct hypocalcemia, hypokalemia and/or hypomagnesemia prior to CAPRELSA administration. Monitor electrolytes periodically. Avoid drugs known to prolong the QT interval. Only prescribers and pharmacies certified with the restricted distribution program are able to prescribe and dispense CAPRELSA
1INDICATIONS AND USAGE
CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.
Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.
2DOSAGE AND ADMINISTRATION
The recommended dose of CAPRELSA is 300 mg taken orally once daily until disease progression or unacceptable toxicity occurs.
CAPRELSA may be taken with or without food.
Do not take a missed dose within 12 hours of the next dose.
Do not crush CAPRELSA tablets. The tablets can be dispersed in 2 ounces of water by stirring for approximately 10 minutes (will not completely dissolve). Do not use other liquids for dispersion. Swallow immediately after dispersion. Mix any remaining residue with 4 additional ounces of water and swallow.
The dispersion can also be administered through nasogastric or gastrostomy tubes.
3DOSAGE FORMS AND STRENGTHS
CAPRELSA 100 mg tablets are white, round, biconvex, film-coated, and intagliated with 'Z 100' on one side and plain on the reverse side.
CAPRELSA 300 mg tablets are white, oval, biconvex, film-coated, and intagliated with 'Z 300' on one side and plain on the reverse side.
4CONTRAINDICATIONS
Do not use in patients with congenital long QT syndrome
5ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the label:
- QT Prolongation and Torsades de Pointes
- Severe Skin Reactions
- Interstitial Lung Disease
- Ischemic Cerebrovascular Events
- Hemorrhage
- Heart Failure
- Diarrhea
- Hypothyroidism
- Hypertension
- Reversible Posterior Leukoencephalopathy Syndrome
- Renal Failure
- Embryo-Fetal Toxicity
- Osteonecrosis
5.1Clinical Trials 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%).
5.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of CAPRELSA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Vascular disorders: Arterial (including aortic) aneurysms, dissections, and rupture
Musculoskeletal and connective tissue disorders: Osteonecrosis
General disorders: Impaired wound healing
6OVERDOSAGE
In the event of an overdose, monitor patients closely for QTc prolongation. Adverse events including QT interval prolongation should be monitored closely as they may not resolve fully until approximately three plasma half-lives of the drug.
7DESCRIPTION
Vandetanib has the chemical name N-(4-bromo-2-fluorophenyl)-6-methoxy-7-[(1-methylpiperidin-4-yl) methoxy]quinazolin-4-amine.
The structural and molecular formulas are:
C
Vandetanib has a molecular weight of 475.36 g/mol. Vandetanib exhibits pH-dependent solubility, with increased solubility at lower pH. Vandetanib is practically insoluble in water with a value of 0.008 mg/mL at 25°C (77°F).
CAPRELSA tablets for daily oral administration are available in two dosage strengths containing either 100 mg or 300 mg of vandetanib. The tablet cores contain the following inactive ingredients: calcium hydrogen phosphate dihydrate, crospovidone, magnesium stearate, microcrystalline cellulose, and povidone. The tablet film-coat contains the following inactive ingredients: hypromellose 2910, macrogol 300, and titanium dioxide E171.
8REFERENCES
- OSHA Hazardous Drugs (OSHA Technical Manual). OSHA.
9HOW SUPPLIED/STORAGE AND HANDLING
100 mg Tablets available in bottles containing 30 tablets (NDC 58468-7820-3).
300 mg Tablets available in bottles containing 30 tablets (NDC 58468-7840-3).
9.1Storage and Handling
CAPRELSA tablets should be stored at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted to 59°F–86°F (15°C-30°C) [See USP controlled room temperature].
Procedures for proper handling and disposal of anticancer drugs should be considered. A guideline on this subject has been published.
10PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
11PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Carton
NDC 58468-7820-3
Caprelsa
100 mg
Dispense enclosed medication
30 Tablets
12PRINCIPAL DISPLAY PANEL - 300 mg Tablet Bottle Carton
NDC 58468-7840-3
Caprelsa
300 mg
Dispense enclosed medication
30 Tablets
