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FDA Drug information

CAPRELSA

Read time: 1 mins
Marketing start date: 23 Nov 2024
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Summary of product characteristics


Effective Time

20220701

Version

1

Spl Product Data Elements

CAPRELSA Vandetanib VANDETANIB VANDETANIB DIBASIC CALCIUM PHOSPHATE DIHYDRATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE POLYETHYLENE GLYCOL 300 CROSPOVIDONE biconvex Z300

Brand Name

CAPRELSA

Generic Name

Vandetanib

Product Ndc

58468-7860

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL - 300 mg Tablet Blister Pack Carton Oral use Caprelsa ® 300 mg film-coated tablets vandetanib 30 film-coated tablets SANOFI GENZYME PRINCIPAL DISPLAY PANEL - 300 mg Tablet Blister Pack Carton

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THIS MEDICINAL PRODUCT IS SUBJECT TO ADDITIONAL MONITORING. THIS WILL ALLOW QUICK IDENTIFICATION OF NEW SAFETY INFORMATION. HEALTHCARE PROFESSIONALS ARE ASKED TO REPORT ANY SUSPECTED ADVERSE REACTIONS. SEE SECTION 4.8 FOR HOW TO REPORT ADVERSE REACTIONS.

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Table 1: Dosing nomogram for Paediatric Patients with MTC
BSA (m2)Start dose (mg)The starting dose is the dose at which treatment should be initiatedDose increase (mg)Higher vandetanib doses than 150 mg/m2 have not been used in clinical studies in paediatric patients when tolerated well after 8 weeks at starting doseDose reduction (mg) Patients with an adverse reaction requiring a dose reduction should stop taking vandetanib for at least a week. Dosing can be resumed at a reduced dose thereafter when fully recovered from adverse reactions
0.7 – <0.9100 every other day100 daily-
0.9 – <1.2100 daily7 day schedule: 100-200-100-200-100-200-100100 every other day
1.2 – <1.67 day schedule: 100-200-100-200-100-200-100200 daily100 daily
≥ 1.6200 daily300 daily 7 day schedule: 100-200-100-200-100-200-100

Spl Patient Package Insert Table

In addition to this leaflet you will be given the Patient Alert Card, which contains important safety information that you need to know before you are given Caprelsa and during treatment with Caprelsa.

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