facebook
Subscribe50$/product give away!


Submit an Article to Pharmacy HQ     
Please include the author's name, title, and citations.     

CAPRELSA- vandetanib tablet, film coated


  1. Patient Information
  2. What Is The Most Important Information I Should Know About Caprelsa?
  3. 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:
  4. What Is Caprelsa?
  5. Who Should Not Take Caprelsa?
  6. Before You Take Caprelsa, Tell Your Healthcare Provider If You:
  7. Especially Tell Your Healthcare Provider If You Take:
  8. How Should I Take Caprelsa?
  9. Caprelsa May Cause Serious Side Effects, Including:
  10. What Are The Ingredients In Caprelsa?
  11. Tablet Core:
  12. Tablet Film-coat:
  13. Distributed By:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

QT Prolongation and Torsades de Pointes

Advise patients to contact their healthcare provider in the event of syncope, pre-syncopal symptoms, and cardiac palpitations. Advise patients that their healthcare provider will monitor their electrolytes and ECGs during treatment [seeWarnings and Precautions (5.1)].

Severe Skin Reactions

Advise patients to contact their healthcare provider in the event of skin reactions or rash [seeWarnings and Precautions (5.2)].

Interstitial Lung Disease (ILD)

Advise patients to contact their health care provider in the event of sudden onset or worsening of breathlessness, persistent cough or fever [seeWarnings and Precautions (5.3)].

Diarrhea

Advise patients to contact their healthcare provider in the event of diarrhea [seeWarnings and Precautions (5.7)].

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

Advise patients to contact their healthcare provider in the event of seizures, headaches, visual disturbances, confusion or difficulty thinking [seeWarnings and Precautions (5.10)].

Embryo-Fetal Toxicity

Advise females of reproductive potential to use effective contraception during treatment with CAPRELSA and for 4 months following the last dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with CAPRELSA[seeUse in Specific Populations (8.1),(8.3)].

Lactation

Advise women not to breastfeed during treatment with CAPRELSA and for 4 months after the last dose[seeUse in Specific Populations (8.2)].

Photosensitivity

Advise patients to use appropriate sun protection due to the increased susceptibility to sunburn while taking CAPRELSA and for at least 4 months after drug discontinuation[seeWarnings and Precautions (5.2)].

Administration

Advise patients that CAPRELSA can be taken with or without food and not to crush CAPRELSA tablets[seeClinical Pharmacology (12.3)].

Distributed by:
Genzyme Corporation
Cambridge, MA 02142

CAPRELSA is a registered trademark of Genzyme Corporation
2018 Genzyme Corporation.

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:
    • 2 to 4 weeks after starting CAPRELSA
    • 8 to 12 weeks after starting CAPRELSA
    • Every 3 months thereafter
    • If your healthcare provider changes your dose of CAPRELSA
    • If you start taking medicine that causes QT prolongation
    • 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 Take Caprelsa? 

Do not take CAPRELSA if you have had QT prolongation.

Before You Take Caprelsa, Tell Your Healthcare Provider If You: 

  • have any heart problems, including a condition called congenital long QT syndrome
  • have an irregular heartbeat
  • take or have stopped taking a medicine that causes QT prolongation
  • have low blood levels of potassium, calcium, or magnesium
  • have high blood levels of thyroid-stimulating hormone
  • have high blood pressure
  • have skin problems
  • have a history of breathing problems
  • have a recent history of coughing up blood or bleeding
  • have diarrhea
  • have liver problems
  • have kidney problems
  • have seizures or are being treated for seizures
  • are pregnant or plan to become pregnant. CAPRELSA can cause harm to your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
    • If you are able to become pregnant, you should use effective birth control during your treatment with CAPRELSA and for at least 4 months after your last dose of CAPRELSA.
    • Talk to your healthcare provider about birth control methods to prevent pregnancy while you are taking CAPRELSA.
  • are breastfeeding or plan to breastfeed. It is not known if CAPRELSA passes into your breast milk. You and your healthcare provider should decide if you will take CAPRELSA or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take,including prescription and non-prescription medicines, vitamins, and herbal supplements. CAPRELSA and other medicines may affect each other causing side effects.

Especially Tell Your Healthcare Provider If You Take: 

  • St. John's Wort. You should not take St. John's Wort while taking CAPRELSA
  • certain medicines that can affect how your liver breaks down medicine
  • a medicine for your heart

Ask your healthcare provider if you are not sure if your medicine is one listed above.

Do not take other medicines while taking CAPRELSA until you have talked with your healthcare provider or pharmacist.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How Should I Take Caprelsa? 

  • Take CAPRELSA exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking CAPRELSA unless your healthcare provider tells you to.
  • CAPRELSA may be taken with or without food.
  • Swallow CAPRELSA tablets whole with water.
  • Do not crush or chew CAPRELSA tablets. If CAPRELSA tablets are accidentally crushed, contact with skin should be avoided. If contact occurs, wash affected areas well with water.
  • If you cannot swallow CAPRELSA tablets whole:
    • place your dose of CAPRELSA in a glass that contains 2 ounces of noncarbonated water (no other liquids should be used).
    • stir the CAPRELSA tablet(s) and water mixture for about 10 minutes or until the tablet(s) are in very small pieces (the tablets will not completely dissolve).
    • swallow CAPRELSA and water mixture right away.
    • if any CAPRELSA and water mixture remains in the glass, mix with an additional 4 ounces of noncarbonated water and swallow the mixture to make sure that you take your full dose of CAPRELSA.
  • If you miss a dose and your next dose is in:
    • less than 12 hours, take your next dose at the normal time. Do not make up for the missed dose.
    • 12 hours or more, take the missed dose as soon as you remember. Take the next dose at the normal time.

Call your healthcare provider right away if you take too much CAPRELSA.

  • During treatment with CAPRELSA, your healthcare provider should check your blood and heart for side effects.

    • Limit exposure to the sun. CAPRELSA can make your skin sensitive to the sun. While taking CAPRELSA and for 4 months after stopping your CAPRELSA treatment, use sun block and wear clothes that cover your skin, including your head, arms and legs when you go outdoors.
    • Use caution before driving or using machinery. Keep in mind CAPRELSA may make you feel tired, weak, or cause blurred vision.

Caprelsa May Cause Serious Side Effects, Including: 

    • Store CAPRELSA tablets at 59 F to 86 F (15 C to 30 C).
    • Safely throw away medicine that is out of date or that you no longer need. Ask your pharmacist how to safely throw away CAPRELSA tablets.

    Keep CAPRELSA and all medicines out of the reach of children.

    General information about CAPRELSA.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CAPRELSA for a condition for which it was not prescribed. Do not give CAPRELSA to other people, even if they have the same symptoms you have. It may harm them.

    This Medication Guide summarizes important information about CAPRELSA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CAPRELSA that is written for health professionals.

    For more information, go to www.caprelsa.com or call 1-800-817-2722.

What Are The Ingredients In Caprelsa? 

Active ingredient: vandetanib

Tablet Core: 

calcium hydrogen phosphate dihydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate

Tablet Film-coat: 

hypromellose 2910, macrogol 300, and titanium dioxide E171

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed By: 

Sanofi Genzyme
Cambridge, MA 02142

Issued 12/2016
CAPRELSA is a registered trademark of Genzyme Corporation
Genzyme Corporation 2016. All Rights Reserved.



Your use of this website constitutes your agreement to the terms and conditions linked below:
Terms and Conditions | Resources
2017 © Copyright PharmacyHQ.com. Questions?
Please contact: pharmacyhq.mail@gmail.com