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COMETRIQ- cabozantinib kitCOMETRIQ- cabozantinib capsule


  1. Patient Information
  2. Inform Patients Of The Following:
  3. Cometriq Can Cause Serious Side Effects Which Can Lead To Death, Including:
  4. What Is Cometriq?
  5. How Should I Take Cometriq?
  6. What Should I Avoid While Taking Cometriq?
  7. Cometriq May Cause Serious Side Effects, Including:
  8. Active Ingredient:
  9. Inactive Ingredients:
  10. Revised: 1/2019document Id:

Patient Information 

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

Inform Patients Of The Following: 

  • Diarrhea: Inform patients of the need to contact their healthcare provider if severe diarrhea occurs during treatment with COMETRIQ.
  • Palmar-plantar erythrodysesthesia syndrome: Advise patients to contact their healthcare provider for progressive or intolerable rash[

Cometriq Can Cause Serious Side Effects Which Can Lead To Death, Including: 

  • 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:
    severe pain in your stomach-area (abdomen)
    coughing, gagging, and choking especially when eating or drinking
  • Severe bleeding (hemorrhage). Tell your healthcare provider right away if you get any signs of bleeding while taking or after you stop taking COMETRIQ, 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

What Is Cometriq? 

COMETRIQ is a prescription medicine used to treat people with medullary thyroid cancer that has spread to other parts of the body.

It is not known if COMETRIQ is safe and effective in children.

Before you take COMETRIQ,tell your healthcare provider about all of your medical conditions including if you:

  • have a recent history of coughing up blood or bleeding or any unusual bleeding
  • have an open wound
  • have high blood pressure
  • plan to have any surgery or a dental procedure
  • have liver problems
  • are pregnant or plan to become pregnant. COMETRIQ can harm your unborn baby. If you are able to become pregnant, you should use effective birth control during treatment and for 4 months after the final dose of COMETRIQ. 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 COMETRIQ passes into your breast milk. Do not breastfeed during treatment and for 4 months after the final dose of COMETRIQ.

Tell your healthcare provider about all the medicines you take,including prescription or over-the-counter medicines, vitamins, and herbal supplements. COMETRIQ and certain other medicines may affect each other causing side effects.

How Should I Take Cometriq? 

  • Take COMETRIQ exactly as your healthcare provider tells you to take it.
  • Do nottake COMETRIQ with food.Do noteat for at least 2 hours before and at least 1 hour after taking COMETRIQ.
  • Swallow COMETRIQ capsules whole with a full glass (at least 8 ounces) of water.
  • Do not crush or open COMETRIQ capsules.
  • 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 Cometriq? 

Do notdrink grapefruit juice, eat grapefruit or supplements that contain grapefruit during treatment with COMETRIQ.

Cometriq May Cause Serious Side Effects, Including: 

    • Store COMETRIQ at room temperature 68 F to 77 F (20 C to 25 C).

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

    General information about COMETRIQ.

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use COMETRIQ for a condition for which it was not prescribed. Do not give COMETRIQ 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 COMETRIQ that is written for health professionals.

Active Ingredient: 

cabozantinib

Inactive Ingredients: 

silicified microcrystalline cellulose, croscarmellose sodium, sodium starch glycolate, fumed silica, and stearic acid

Capsule shells: Grey gelatin capsule shells contain black iron oxide and titanium dioxide. Swedish orange gelatin capsule shells contain red iron oxide, and titanium dioxide.

The printing ink contains shellac glaze, black iron oxide, N-butyl alcohol, isopropyl alcohol, propylene glycol, and ammonium hydroxide.

Manufactured for Exelixis, Inc. South San Francisco, CA 94080

For more information, go to www.cometriq.com or call 1-855-292-3935.

This Patient Information has been approved by the U.S. Food and Drug Administration.


Package Label - CARTON - 140 mg Daily Dose of COMETRIQ

PRINCIPAL DISPLAY PANEL

Cometriq
(cabozantinib) capsules

140 mg Daily Dose
Blister Cards


Each 140 mg daily dose contains a combination of
one Swedish orange 80 mg and three grey 20 mg
capsules. Each capsule contains cabozantinib
(S)-malate equivalent to 80 mg or 20 mg of
cabozantinib.

EXELIXIS

NDC 42388-011-14

Carton containing 4 blister cards:
The blister cards in this carton are for
patients prescribed a 140 mg daily dose.

Rx Only


carton - 140 mg daily dose of COMETRIQ


Package Label - CARTON - 100 mg Daily Dose of COMETRIQ

PRINCIPAL DISPLAY PANEL

Cometriq
(cabozantinib) capsules

100 mg Daily Dose
Blister Cards


Each 100 mg daily dose contains a combination
of one Swedish orange 80 mg and one grey
20 mg capsule. Each capsule contains
cabozantinib (S)-malate equivalent to 80 mg
or 20 mg of cabozantinib.

EXELIXIS

NDC 42388-012-14

Carton containing 4 blister cards:
The blister cards in this carton are for
patients prescribed a 100 mg daily dose.

Rx Only


carton - 100 mg daily dose of COMETRIQ


Package Label - CARTON - 60 mg Daily Dose of COMETRIQ

PRINCIPAL DISPLAY PANEL

Cometriq
(cabozantinib) capsules

60 mg Daily Dose
Blister Cards


Each 60 mg daily dose contains three grey 20 mg
capsules. Each capsule contains cabozantinib
(S)-malate equivalent to 20 mg of cabozantinib.

EXELIXIS

NDC 42388-013-14

Carton containing 4 blister cards:
The blister cards in this carton are for
patients prescribed a 60 mg daily dose.

Rx Only


carton - 60 mg daily dose of COMETRIQ
COMETRIQ
cabozantinib kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42388-011
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42388-011-144 in 1 CARTON11/29/2012
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 17
Part 221
Part 1 of 2
COMETRIQ
cabozantinib capsule
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
cabozantinib s-malate(UNII: DR7ST46X58) (cabozantinib - UNII:1C39JW444G)cabozantinib80 mg
Inactive Ingredients
Ingredient NameStrength
cellulose, microcrystalline(UNII: OP1R32D61U)
croscarmellose sodium(UNII: M28OL1HH48)
sodium starch glycolate type a potato(UNII: 5856J3G2A2)
silicon dioxide(UNII: ETJ7Z6XBU4)
stearic acid(UNII: 4ELV7Z65AP)
gelatin(UNII: 2G86QN327L)
ferric oxide red(UNII: 1K09F3G675)
ferrosoferric oxide(UNII: XM0M87F357)
titanium dioxide(UNII: 15FIX9V2JP)
shellac(UNII: 46N107B71O)
butyl alcohol(UNII: 8PJ61P6TS3)
isopropyl alcohol(UNII: ND2M416302)
propylene glycol(UNII: 6DC9Q167V3)
ammonia(UNII: 5138Q19F1X)
Product Characteristics
ColorORANGE (Swedish Orange)Scoreno score
ShapeCAPSULESize19mm
FlavorImprint CodeXL184;80mg
Contains
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20375611/29/2012
Part 2 of 2
COMETRIQ
cabozantinib capsule
Product Information
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)
croscarmellose sodium(UNII: M28OL1HH48)
sodium starch glycolate type a potato(UNII: 5856J3G2A2)
silicon dioxide(UNII: ETJ7Z6XBU4)
stearic acid(UNII: 4ELV7Z65AP)
gelatin(UNII: 2G86QN327L)
ferrosoferric oxide(UNII: XM0M87F357)
titanium dioxide(UNII: 15FIX9V2JP)
shellac(UNII: 46N107B71O)
butyl alcohol(UNII: 8PJ61P6TS3)
isopropyl alcohol(UNII: ND2M416302)
propylene glycol(UNII: 6DC9Q167V3)
ammonia(UNII: 5138Q19F1X)
Product Characteristics
ColorGRAYScoreno score
ShapeCAPSULESize19mm
FlavorImprint CodeXL184;20mg
Contains
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20375611/29/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20375611/29/2012
COMETRIQ
cabozantinib kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42388-012
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42388-012-144 in 1 CARTON11/29/2012
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 17
Part 27
Part 1 of 2
COMETRIQ
cabozantinib capsule
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
cabozantinib s-malate(UNII: DR7ST46X58) (cabozantinib - UNII:1C39JW444G)cabozantinib80 mg
Inactive Ingredients
Ingredient NameStrength
cellulose, microcrystalline(UNII: OP1R32D61U)
croscarmellose sodium(UNII: M28OL1HH48)
sodium starch glycolate type a potato(UNII: 5856J3G2A2)
silicon dioxide(UNII: ETJ7Z6XBU4)
stearic acid(UNII: 4ELV7Z65AP)
gelatin(UNII: 2G86QN327L)
ferric oxide red(UNII: 1K09F3G675)
ferrosoferric oxide(UNII: XM0M87F357)
titanium dioxide(UNII: 15FIX9V2JP)
shellac(UNII: 46N107B71O)
butyl alcohol(UNII: 8PJ61P6TS3)
isopropyl alcohol(UNII: ND2M416302)
propylene glycol(UNII: 6DC9Q167V3)
ammonia(UNII: 5138Q19F1X)
Product Characteristics
ColorORANGE (Swedish Orange)Scoreno score
ShapeCAPSULESize19mm
FlavorImprint CodeXL184;80mg
Contains
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20375611/29/2012
Part 2 of 2
COMETRIQ
cabozantinib capsule
Product Information
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)
croscarmellose sodium(UNII: M28OL1HH48)
sodium starch glycolate type a potato(UNII: 5856J3G2A2)
silicon dioxide(UNII: ETJ7Z6XBU4)
stearic acid(UNII: 4ELV7Z65AP)
gelatin(UNII: 2G86QN327L)
ferrosoferric oxide(UNII: XM0M87F357)
titanium dioxide(UNII: 15FIX9V2JP)
shellac(UNII: 46N107B71O)
butyl alcohol(UNII: 8PJ61P6TS3)
isopropyl alcohol(UNII: ND2M416302)
propylene glycol(UNII: 6DC9Q167V3)
ammonia(UNII: 5138Q19F1X)
Product Characteristics
ColorGRAYScoreno score
ShapeCAPSULESize19mm
FlavorImprint CodeXL184;20mg
Contains
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20375611/29/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20375611/29/2012
COMETRIQ
cabozantinib capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42388-013
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)
croscarmellose sodium(UNII: M28OL1HH48)
sodium starch glycolate type a potato(UNII: 5856J3G2A2)
silicon dioxide(UNII: ETJ7Z6XBU4)
stearic acid(UNII: 4ELV7Z65AP)
gelatin(UNII: 2G86QN327L)
ferrosoferric oxide(UNII: XM0M87F357)
titanium dioxide(UNII: 15FIX9V2JP)
shellac(UNII: 46N107B71O)
butyl alcohol(UNII: 8PJ61P6TS3)
isopropyl alcohol(UNII: ND2M416302)
propylene glycol(UNII: 6DC9Q167V3)
ammonia(UNII: 5138Q19F1X)
Product Characteristics
ColorGRAYScoreno score
ShapeCAPSULESize19mm
FlavorImprint CodeXL184;20mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42388-013-144 in 1 CARTON11/29/2012
121 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20375611/29/2012
Labeler -Exelixis, Inc. (785991949)
Establishment
NameAddressID/FEIBusiness Operations
Catalent CTS, LLC962674474MANUFACTURE(42388-011, 42388-012, 42388-013) , LABEL(42388-011, 42388-012, 42388-013) , PACK(42388-011, 42388-012, 42388-013) , ANALYSIS(42388-011, 42388-012, 42388-013)
Establishment
NameAddressID/FEIBusiness Operations
Catalent U.K. Packaging Limited232616826LABEL(42388-011, 42388-012, 42388-013)

Revised: 1/2019document Id: 

13893f7e-edcc-400b-bd4c-56bbe283ef64Set id: 1a0c3bea-c87b-4d25-bb44-5f0174da6b34Version: 10Effective Time: 20190129Exelixis, Inc.



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