CAPRELSA*
Manufacturer DetailsGENERIC*
USA AND CANADA
Compositions:
Vandetanib- mg,
Vandetanib- mg,
| Strength | Rate | Packing Style |
|---|---|---|
| mg | 0.00 | unit |
List of Related Indications:
- Treat adult patients with late-stage(metastatic) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms
List Of Drugs:
- Vandetanib- Caprelsa - @- Anti-cancer (Apr 2011)
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
The concomitant use of known strong CYP 3A4 inducers may reduce
drug levels of vandetanib and should be avoided
No clinically significant drug interaction was shown with vandetanib
and the potent CYP 3A4 inhibitor, itraconazole
The administration of vandetanib with agents that may prolong the
QT interval should be avoided
Indication:
Vandetanib (vandetanib) Tablets for Oral use
Initial U.S. Approval:
WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH
See full prescribing information for complete boxed warning.
Vandetanib can prolong the QT interval. Torsades de pointes and sudden death
have been reported in patients receiving vandetanib
Vandetanib should not be used in patients with hypocalcemia, hypokalemia
hypomagnesemia, or long QT syndrome.
Hypocalcemia, hypokalemia and/or hypomagnesemia must be corrected
prior to vandetanib administration and should be periodically monitored.
Drugs known to prolong the QT interval should be avoided.
If a drug known to prolong the QT interval must be administered,
more frequent ECG monitoring
Given the half-life of 19 days, ECGs should be obtained to monitor
the QT at baseline, at 2-4 weeks and 8-12 weeks after starting treatment
with vandetanib and every 3 months thereafter.
Following any dose reduction for QT prolongation, or any dose interruptions
greater than 2 weeks,
QT assessment should be conducted as described above
.
Because of the 19-day half-life, adverse reactions including a prolonged QT interval
may not resolve quickly. Monitor appropriately.
Only prescribers and pharmacies certified with the restricted distribution
program are able to prescribe and dispense vandetanib
Drug Name- Caprelsa
Active Ingredient - Vandetanib
To treat adult patients with late-stage(metastatic) medulallary thyroid cancer
who are ineligible for surgery and who have disease that is growing and causing
symptoms
Indication-
To treat adult patients with late-stage(metastatic) medulallary thyroid cancer
who are ineligible for surgery and who have disease that is growing and causing
symptoms
Approved by FDA on 06-4-2011 (Ref- FDA approved List- 2011)
Adverse Reaction:
The most common adverse drug reactions (>20%) seen with vandetanib
have been diarrhea, rash, acne, nausea, hypertension, headache, fatigue,
decreased appetite and abdominal pain. The most common laboratory
abnormalities (>20%) were decreased calcium, increased ALT,
and decreased glucose
Contra-Indications:
CONTRAINDICATIONS
Do not use in patients with congenital long QT syndrome.
WARNINGS AND PRECAUTIONS
Prolonged QT Interval, Torsades de pointes, and sudden death have been reported.
Monitor electrocardiograms and levels of serum potassium, calcium,
magnesium and TSH at baseline, 2-4 weeks and 8-12 weeks after starting
treatment with vandetanib, and every 3 months thereafter and following dose
adjustments. Dose reduce as appropriate
Stevens-Johnson syndrome resulting in death has been observed.
Severe skin reactions may prompt permanent discontinuation of vandetanib
Interstitial lung disease, resulting in death has been reported. Interrupt
vandetanib and investigate unexplained dyspnea, cough, and fever.
Appropriate measures should be taken for ILD
Ischemic cerebrovascular events, hemorrhage, heart failure, diarrhea,
hypothyroidism, hypertension, and reversible posterior leukoencephalopathy
syndrome, have been observed
Vandetanib can cause fetal harm when administered to a pregnant woman.
Women should be advised to avoid pregnancy while receiving vandetanib
and for four months following treatment
Dosages/ Overdosage Etc:
Drug Name- Caprelsa
Active Ingredient - Vandetanib
To treat adult patients with late-stage(metastatic) medulallary thyroid cancer
who are ineligible for surgery and who have disease that is growing and causing
symptoms
Indication-
To treat adult patients with late-stage(metastatic) medulallary thyroid cancer
who are ineligible for surgery and who have disease that is growing and causing
symptoms
Approved by FDA on 06-4-2011 (Ref- FDA approved List- 2011)
INDICATIONS AND USAGE
Vandetanib 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 of vandetanib in patients with indolent, asymptomatic or slowly progressing
disease should be carefully considered because of the treatment
related risks of vandetanib
DOSAGE AND ADMINISTRATION
300 mg once daily
Vandetanib may be taken with or without food.
Dosage reduction may be necessary in the event of severe toxicities
or QTc interval prolongation.
The starting dose should be reduced to 200 mg in patients with moderate
to severe renal impairment.
DOSAGE FORMS AND STRENGTHS
100 mg and 300 mg tablets
Patient Information:
PATIENT COUNSELING INFORMATION
1. QT Interval
Vandetanib can prolong the QT interval in a concentration-dependent manner.
Torsades de pointes, ventricular tachycardia and sudden death have been
reported in patients administered vandetanib.
Patients should be advised that their electrolytes and the electrical activity
of their heartbeat (via an ECG) should be monitored regularly during treatment with vandetanib.
2. Rash
Patients taking vandetanib should be told they may be more susceptible to sunburn
and to use appropriate sun protection (e.g., sunscreen and/or clothing)
while taking vandetanib and for at least 4 months after drug discontinuation.
Patients should consult their physician promptly if they develop a skin rash.
3. Interstitial Lung Disease
Patients should be told to contact their physician promptly if they develop
sudden onset or worsening of breathlessness, persistent cough or fever.
4. Diarrhea
Patients should be informed that they may experience diarrhea while taking
vandetanib. Patients should also be advised to use standard anti-diarrheal
medications and to seek medical attention if their diarrhea becomes
persistent or severe.
Patients with diarrhea should contact their physician to have their electrolytes monitored.
5. Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
Patients should be told to contact their physician promptly if they experience
seizures, headaches, visual disturbances, confusion or difficulty thinking.
Pharmacology/ Pharmacokinetics:
1. Mechanism of Action
Vandetanib is a kinase inhibitor. In vitro studies have shown that vandetanib inhibits
the activity of tyrosine kinases including members of the epidermal growth
factor receptor (EGFR) family, vascular endothelial cell growth factor (VEGF)
receptors, rearranged during transfection (RET), protein tyrosine kinase 6 (BRK),
TIE2, members of the EPH receptors kinase family, and members of the Src family
of tyrosine kinases.
2. Pharmacokinetics
A population pharmacokinetic analysis of vandetanib was conducted in 231 patients
with MTC following oral administration of 300 mg daily doses.
The pharmacokinetics of vandetanib at the 300 mg dose in MTC patients are
characterized by a mean clearance of approximately 13.2 L/h, a mean volume
of distribution of approximately 7450 L, and a median plasma half-life of 19 days.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
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
pregnancy while taking vandetanib and for at least four months following
the last dose of vandetanib
2. Nursing Mothers
Because many drugs are excreted in human milk and because of the potential
for serious adverse reactions in nursing infants from vandetanib,
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
3. Pediatric Use
Safety and efficacy of vandetanib in pediatric patients have not been established.
4. Geriatric Use
In total, 18% of medullary thyroid cancer patients treated with vandetanib
were age 65 years or older, and 3% were 75 years and older.
No overall differences in safety and efficacy were observed between
elderly and younger patients. No adjustment in starting dose is required
for patients over 65 years of age. There are limited data for patients over the age of 75 years
