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CABOMETYX- cabozantinib tablet


  1. Patient Information
  2. How Should I Take Cabometyx?
  3. What Should I Avoid While Taking Cabometyx?
  4. Cabometyx May Cause Serious Side Effects, Including:
  5. Active Ingredient:
  6. Inactive Ingredients:
  7. Revised: 2/2019document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

  • Hemorrhage: Instruct patients to contact their healthcare provider to
    CABOMETYX is a prescription medicine used to treat people with:
    • advanced kidney cancer (renal cell carcinoma)
    • liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.
    It is not known if CABOMETYX is safe and effective in children.Before you take CABOMETYX,tell your healthcare provider about all of your medical conditions, including if you:
    • have a recent history of bleeding, including coughing up or vomiting blood, or black tarry stools.
    • have an open or healing wound
    • have high blood pressure
    • plan to have any surgery, including dental surgery. You should stop treatment with CABOMETYX at least 28 days before any scheduled surgery.
    • are pregnant, or plan to become pregnant. CABOMETYX can harm your unborn baby.
      • If you are able to become pregnant, your healthcare provider will check your pregnancy status before you start treatment with CABOMETYX.
      • Females who are able to become pregnant should use effective birth control (contraception) during treatment and for 4 months after your final dose of CABOMETYX.
      • Talk to your healthcare provider about birth control methods that may be right for you.
      • If you become pregnant or think you are pregnant, tell your healthcare provider right away.
    • are breastfeeding or plan to breastfeed. It is not known if CABOMETYX passes into your breast milk. Do not breastfeed during treatment and for 4 months after your final dose of CABOMETYX.
    Tell your healthcare provider about all the medicines you take,including prescription or over-the- counter medicines, vitamins, and herbal supplements. CABOMETYX and certain other medicines may affect each other causing side effects.

How Should I Take Cabometyx? 

  • Take CABOMETYX exactly as your healthcare provider tells you to take it.
  • Do nottake CABOMETYX with food. Take CABOMETYX at least 1 hour before or at least 2 hours after eating.
  • Swallow CABOMETYX tablets whole with a full glass (at least 8 ounces) of water.
  • Do notcrush CABOMETYX tablets.
  • 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 the missed dose.
    • 12 hours or more, take the missed dose as soon as you remember. Take your next dose at the normal time.

What Should I Avoid While Taking Cabometyx? 


Do notdrink grapefruit juice, eat grapefruit or take supplements that contain grapefruit or St. John s wort during treatment with CABOMETYX.

Cabometyx May Cause Serious Side Effects, Including: 

  • bleeding (hemorrhage).CABOMETYX can cause severe bleeding that may lead to death. Tell your healthcare provider right away if you get any signs of bleeding during treatment with CABOMETYX, including:
    • coughing up blood or blood clots
    • vomiting blood or if your vomit looks like coffee-grounds
    • red or black (looks like tar) stools
    • menstrual bleeding that is heavier than normal
    • any unusual or heavy bleeding
  • a tear in your stomach or intestinal wall (perforation) or an abnormal connection between 2 parts of your body (fistula).Tell your healthcare provider right away if you get tenderness or pain in your stomach-area (abdomen).
  • blood clots, stroke, heart attack, and chest pain.Get emergency help right away if you get:
    • swelling or pain in your arms or legs
    • shortness of breath
    • feel lightheaded or faint
    • sweating more than usual
    • numbness or weakness of your face, arm or leg, especially on one side of your body
    • sudden confusion, trouble speaking or understanding
    • sudden trouble
      • Store CABOMETYX at room temperature 68 F to 77 F (20 C to 25 C).
      Keep CABOMETYX and all medicines out of the reach of children.General information about the safe and effective use of CABOMETYX.
      Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CABOMETYX for a condition for which it was not prescribed. Do not give CABOMETYX to other people, even if they have the same symptoms you have. It may harm them.
      You can ask your healthcare provider or pharmacist for information about CABOMETYX that is written for health professionals.

Active Ingredient: 

cabozantinib

Inactive Ingredients: 

microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, triacetin, and iron oxide yellow.

Manufactured for Exelixis, Inc. Alameda, CA 94502
For more information, go to www.cabometyx.com or call 1-855-292-3935.This Patient Information has been approved by the U.S. Food and Drug Administration.Issued: 01/2019


Package Label - Bottle - 30 Tablets - 60mg CABOMETYX

PRINCIPAL DISPLAY PANEL

NDC42388-023-26

Cabometyx
(cabozantinib) tablets

60 mg*

Rx Only
30 tablets
Exelixis

*Each tablet contains 60 mg of
cabozantinib (equivalent to 76 mg of
cabozantinib (S)-malate).

Take once each day on an empty
stomach
. Cabometyx should not
be taken with food. Do not eat for
at least 2 hours before and at least
1 hour after taking Cabometyx.
Swallow Cabometyx tablets whole.
Do not crush Cabometyx tablets.

Store Cabometyx at 20 C to 25 C
(68 F to 77 F); excursions are
permitted from 15 C to 30 C
(59 F to 86 F) [see USP Controlled
Room Temperature].

Keep out of the reach of children.

Manufactured for Exelixis, Inc.
Alameda, CA 94502
Made in Canada

image of bottle label - 60 mg - 30 tablets


Package Label - Bottle - 30 Tablets - 40mg CABOMETYX

PRINCIPAL DISPLAY PANEL

NDC42388-025-26

Cabometyx
(cabozantinib) tablets

40 mg*

Rx Only
30 tablets
Exelixis

*Each tablet contains 40 mg of
cabozantinib (equivalent to 51 mg of
cabozantinib (S)-malate).

Take once each day on an empty
stomach
. Cabometyx should not
be taken with food. Do not eat for
at least 2 hours before and at least
1 hour after taking Cabometyx.
Swallow Cabometyx tablets whole.
Do not crush Cabometyx tablets.

Store Cabometyx at 20 C to 25 C
(68 F to 77 F); excursions are
permitted from 15 C to 30 C
(59 F to 86 F) [see USP Controlled
Room Temperature].

Keep out of the reach of children.

Manufactured for Exelixis, Inc.
Alameda, CA 94502
Made in Canada

image of bottle label - 40 mg - 30 tablets


Package Label - Bottle - 30 Tablets - 20mg CABOMETYX

PRINCIPAL DISPLAY PANEL

NDC42388-024-26

Cabometyx
(cabozantinib) tablets

20 mg*

Rx Only
30 tablets
Exelixis

*Each tablet contains 20 mg of
cabozantinib (equivalent to 25 mg of
cabozantinib (S)-malate).

Take once each day on an empty
stomach
. Cabometyx should not
be taken with food. Do not eat for
at least 2 hours before and at least
1 hour after taking Cabometyx.
Swallow Cabometyx tablets whole.
Do not crush Cabometyx tablets.

Store Cabometyx at 20 C to 25 C
(68 F to 77 F); excursions are
permitted from 15 C to 30 C
(59 F to 86 F) [see USP Controlled
Room Temperature].

Keep out of the reach of children.

Manufactured for Exelixis, Inc.
Alameda, CA 94502
Made in Canada

image of bottle label - 20 mg - 30 tablets


Package Label - Professional Sample - Bottle - 15 Tablets - 60mg CABOMETYX

PRINCIPAL DISPLAY PANEL

PROFESSIONAL SAMPLE - NOT FOR SALE

NDC42388-023-37

Cabometyx
(cabozantinib) tablets

60 mg*

Rx Only
15 tablets
Exelixis

*Each tablet contains 60 mg of
cabozantinib (equivalent to 76 mg of
cabozantinib (S)-malate).

Take once each day on an empty
stomach
. Cabometyx should not
be taken with food. Do not eat for
at least 2 hours before and at least
1 hour after taking Cabometyx.
Swallow Cabometyx tablets whole.
Do not crush Cabometyx tablets.

Store Cabometyx at 20 C to 25 C
(68 F to 77 F); excursions are
permitted from 15 C to 30 C
(59 F to 86 F) [see USP Controlled
Room Temperature].

Keep out of the reach of children.

Manufactured for Exelixis, Inc.
Alameda, CA 94502
Made in Canada

image of bottle label - professional sample - 60 mg - 15 tablets


Package Label - Professional Sample - Bottle - 15 Tablets - 40mg CABOMETYX

PRINCIPAL DISPLAY PANEL

PROFESSIONAL SAMPLE - NOT FOR SALE

NDC42388-025-37

Cabometyx
(cabozantinib) tablets

40 mg*

Rx Only
15 tablets
Exelixis

*Each tablet contains 40 mg of
cabozantinib (equivalent to 51 mg of
cabozantinib (S)-malate).

Take once each day on an empty
stomach
. Cabometyx should not
be taken with food. Take
Cabometyx at least 1 hour before
or at least 2 hours after eating.
Swallow Cabometyx tablets whole.
Do not crush Cabometyx tablets.

Store Cabometyx at 20 C to 25 C
(68 F to 77 F); excursions are
permitted from 15 C to 30 C
(59 F to 86 F) [see USP Controlled
Room Temperature].

Keep out of the reach of children.

Manufactured for Exelixis, Inc.
Alameda, CA 94502
Made in Canada

image of bottle label - professional sample - 40 mg - 15 tablets


Package Label - Professional Sample - Bottle - 15 Tablets - 20mg CABOMETYX

PRINCIPAL DISPLAY PANEL

PROFESSIONAL SAMPLE - NOT FOR SALE

NDC42388-024-37

Cabometyx
(cabozantinib) tablets

20 mg*

Rx Only
15 tablets
Exelixis

*Each tablet contains 20 mg of
cabozantinib (equivalent to 25 mg of
cabozantinib (S)-malate).

Take once each day on an empty
stomach
. Cabometyx should not
be taken with food. Take
Cabometyx at least 1 hour before
or at least 2 hours after eating.
Swallow Cabometyx tablets whole.
Do not crush Cabometyx tablets.

Store Cabometyx at 20 C to 25 C
(68 F to 77 F); excursions are
permitted from 15 C to 30 C
(59 F to 86 F) [see USP Controlled
Room Temperature].

Keep out of the reach of children.

Manufactured for Exelixis, Inc.
Alameda, CA 94502
Made in Canada

image of bottle label - professional sample - 20 mg - 15 tablets
CABOMETYX
cabozantinib tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42388-023
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
cabozantinib s-malate(UNII: DR7ST46X58) (CABOZANTINIB - UNII:1C39JW444G)CABOZANTINIB60 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize11mm
FlavorImprint CodeXL;60
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42388-023-2630 in 1 BOTTLE; Type 0: Not a Combination Product04/25/2016
2NDC:42388-023-3630 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2017
3NDC:42388-023-3715 in 1 BOTTLE; Type 0: Not a Combination Product10/03/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20869204/25/2016
CABOMETYX
cabozantinib tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42388-025
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
cabozantinib s-malate(UNII: DR7ST46X58) (CABOZANTINIB - UNII:1C39JW444G)CABOZANTINIB40 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
ColoryellowScoreno score
ShapeTRIANGLESize8mm
FlavorImprint CodeXL;40
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42388-025-2630 in 1 BOTTLE; Type 0: Not a Combination Product04/25/2016
2NDC:42388-025-3715 in 1 BOTTLE; Type 0: Not a Combination Product02/27/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20869204/25/2016
CABOMETYX
cabozantinib tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42388-024
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
cabozantinib s-malate(UNII: DR7ST46X58) (CABOZANTINIB - UNII:1C39JW444G)CABOZANTINIB20 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeXL;20
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42388-024-2630 in 1 BOTTLE; Type 0: Not a Combination Product04/25/2016
2NDC:42388-024-3715 in 1 BOTTLE; Type 0: Not a Combination Product02/27/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20869204/25/2016
Labeler -Exelixis, Inc. (785991949)
Registrant -Exelixis, Inc. (785991949)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Inc.240769596manufacture(42388-023, 42388-024, 42388-025)

Revised: 2/2019document Id: 

9b856539-69b2-4c94-8c27-3417e59f57efSet id: 3850cce2-6137-42e5-a792-d318c4a4b3b5Version: 6Effective Time: 20190227Exelixis, Inc.



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