CAPRELSA- vandetanib tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

VANDETANIB (UNII: YO460OQ37K) (VANDETANIB - UNII:YO460OQ37K)

Disponible des:

AstraZeneca Pharmaceuticals LP

Designació comuna internacional (DCI):

VANDETANIB

Composición:

VANDETANIB 100 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. Do not use in patients with congenital long QT syndrome [see Boxed Warning ]. Pregnancy Category D [see Warnings and Precautions (5.14) ] Risk Summary Based on its mechanism of action, CAPRELSA can cause fetal harm when administered to a pregnant woman. Vandetanib is embryotoxic, fetotoxic, and teratogenic in rats, at exposures less than or equal to those expected at the recommended human dose of 300 mg/day. If CAPRELSA is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Animal data When vandetanib was administered to female rats prior to mating and through the first week of pregnancy at a do

Resumen del producto:

100 mg Tablets Available in bottles containing 30 tablets (NDC 0310–7820–30). 300 mg Tablets Available in bottles containing 30 tablets (NDC 0310–7840–30). CAPRELSA tablets should be stored at 25°C (77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) [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.1 Do not crush CAPRELSA tablets.

Estat d'Autorització:

New Drug Application

Informació per a l'usuari

CAPRELSA- VANDETANIB TABLET
AstraZeneca Pharmaceuticals LP
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MEDICATION GUIDE
CAPRELSA® (kap-rel-sah)
(vandetanib)
Tablets
Read this Medication Guide before you start taking CAPRELSA and each
time you get a refill. There
may be new information. This Medication Guide does not take the place
of talking to your healthcare
provider about your medical condition or treatment.
What is the most important information I should know about CAPRELSA?
CAPRELSA can cause a change in the electrical activity of your heart
called QT prolongation, which can
cause irregular heartbeats and that may lead to death. You should not
take CAPRELSA if you have had a
condition called long QT syndrome since birth.
Your healthcare provider should perform tests to check the levels of
your blood potassium, calcium,
magnesium, and thyroid-stimulating hormone (TSH) as well as the
electrical activity of your heart with a
test called an electrocardiogram (ECG). You should have these tests:
•
Before starting CAPRELSA
•
Regularly during CAPRELSA treatment:
o
2 to 4 weeks after starting CAPRELSA
o
8 to 12 weeks after starting CAPRELSA
o
Every 3 months thereafter
o
If your healthcare provider changes your dose of CAPRELSA
o
If you start taking medicine that causes QT prolongation
o
As instructed by your healthcare provider
Your healthcare provider may stop your CAPRELSA treatment for a while
and restart you at a lower dose
if you have QT prolongation.
Call your healthcare provider right away if you feel faint,
light-headed, or feel your heart beating
irregularly while taking CAPRELSA. These may be symptoms related to QT
prolongation.
What is CAPRELSA?
CAPRELSA is a prescription medicine used to treat medullary thyroid
cancer that cannot be removed by
surgery or that has spread to other parts of the body. It takes a long
time to get rid of CAPRELSA from
your body and you may be at risk for side effects related to CAPRELSA
after you have stopped your
treatment.
It is not known if CAPRELSA is safe and effective in children.
Who should not tak

Fitxa tècnica

CAPRELSA- VANDETANIB TABLET
ASTRAZENECA PHARMACEUTICALS LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CAPRELSA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CAPRELSA.
CAPRELSA (VANDETANIB) TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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 (5.1, 5.15).
RECENT MAJOR CHANGES
Warnings and Precautions (5.2) 3/2016
INDICATIONS AND USAGE
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. (1)
Use of CAPRELSA in patients with indolent, asymptomatic or slowly
progressing disease only after careful consideration of
the treatment related risks of CAPRELSA. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
100 mg and 300 mg tablets (3)
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse drug reactions (>20%) seen with CAPRELSA and
with a between-arm difference of ≥5 % have
been diarrhea/colitis, rash, acneiform dermatitis, hypertension,
nausea, headache, upper respiratory tract infections,
decreased appetite and abdominal pain.
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTRAZENECA AT
1–800–236–9933 OR FDA AT 1-800-FDA-
®
300 mg once daily. (2)
CAPRELSA may be taken with or without foo