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:It is not known if CABOMETYX is safe and effective in children.
- advanced kidney cancer (renal cell carcinoma)
- liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.
Before you take CABOMETYX,tell your healthcare provider about all of your medical conditions, including if you: 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.
- 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.
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
Keep CABOMETYX and all medicines out of the reach of children.
- Store CABOMETYX at room temperature 68 F to 77 F (20 C to 25 C).
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: ⮝
cabozantinibInactive 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 CABOMETYXPRINCIPAL 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
Package Label - Bottle - 30 Tablets - 40mg CABOMETYXPRINCIPAL 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
Package Label - Bottle - 30 Tablets - 20mg CABOMETYXPRINCIPAL 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
Package Label - Professional Sample - Bottle - 15 Tablets - 60mg CABOMETYXPRINCIPAL 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
Package Label - Professional Sample - Bottle - 15 Tablets - 40mg CABOMETYXPRINCIPAL 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
Package Label - Professional Sample - Bottle - 15 Tablets - 20mg CABOMETYXPRINCIPAL 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
CABOMETYX
cabozantinib tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42388-023 Route of Administration ORAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength cabozantinib s-malate(UNII: DR7ST46X58) (CABOZANTINIB - UNII:1C39JW444G) CABOZANTINIB 60 mg
Inactive Ingredients Ingredient Name Strength 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 Color yellow Score no score Shape OVAL Size 11mm Flavor Imprint Code XL;60 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42388-023-26 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/25/2016 2 NDC:42388-023-36 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/16/2017 3 NDC:42388-023-37 15 in 1 BOTTLE; Type 0: Not a Combination Product 10/03/2018
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208692 04/25/2016
CABOMETYX
cabozantinib tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42388-025 Route of Administration ORAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength cabozantinib s-malate(UNII: DR7ST46X58) (CABOZANTINIB - UNII:1C39JW444G) CABOZANTINIB 40 mg
Inactive Ingredients Ingredient Name Strength 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 Color yellow Score no score Shape TRIANGLE Size 8mm Flavor Imprint Code XL;40 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42388-025-26 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/25/2016 2 NDC:42388-025-37 15 in 1 BOTTLE; Type 0: Not a Combination Product 02/27/2019
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208692 04/25/2016
CABOMETYX
cabozantinib tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42388-024 Route of Administration ORAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength cabozantinib s-malate(UNII: DR7ST46X58) (CABOZANTINIB - UNII:1C39JW444G) CABOZANTINIB 20 mg
Inactive Ingredients Ingredient Name Strength 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 Color yellow Score no score Shape ROUND Size 6mm Flavor Imprint Code XL;20 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42388-024-26 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/25/2016 2 NDC:42388-024-37 15 in 1 BOTTLE; Type 0: Not a Combination Product 02/27/2019
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208692 04/25/2016
Labeler -Exelixis, Inc. (785991949)
Registrant -Exelixis, Inc. (785991949)
Establishment Name Address ID/FEI Business Operations Patheon Inc. 240769596 manufacture(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.