facebook
Subscribe50$/product give away!


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

FULVESTRANT injection, solution


  1. Patient Information
  2. Who Should Not Receive Fulvestrant?
  3. Before Receiving Fulvestrant, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  4. How Will I Receive Fulvestrant?
  5. Fulvestrant May Cause Serious Side Effects, Including:
  6. The Most Common Side Effects Of Fulvestrant Include:
  7. Inactive Ingredients:
  8. Revised: 10/2019document Id:
  9. What Is Fulvestrant Injection?
  10. Fulvestrant Injection May Be Used Alone, If You Have Gone Through Menopause, And Your Advanced Breast Cancer Is:
  11. Who Should Not Receive Fulvestrant Injection?
  12. Before Receiving Fulvestrant Injection, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  13. Females Who Are Able To Become Pregnant:
  14. Fulvestrant Injection?
  15. Fulvestrant Injection May Cause Serious Side Effects, Including:
  16. The Most Common Side Effects Of Fulvestrant Injection Include:
  17. Active Ingredient:

Patient Information 

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

Monotherapy

Risk of Bleeding

  • Because fulvestrant is administered intramuscularly, it should be used with caution in patients with bleeding disorders, decreased platelet count, or in patients receiving anticoagulants (for example, warfarin)[
    Fulvestrant is a prescription medicine used to treat advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic).

    Fulvestrant may be used alone, if you have gone through menopause, and your advanced breast cancer is:
    • hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative and has not been previously treated with endocrine therapy
      or
    • HR-positive and has progressed after endocrine therapy.
    Fulvestrant may be used in combination with ribociclib, if you have gone through menopause, and your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has not been previously treated with endocrine therapy or has progressed after endocrine therapy.

    Fulvestrant may be used in combination with palbociclib or abemaciclib if your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has progressed after endocrine therapy.

    When fulvestrant is used in combination with palbociclib, abemaciclib, or ribociclib, also read the Patient Information for the prescribed product.

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

    It is not known if fulvestrant is safe and effective in people with severe liver problems.

Who Should Not Receive Fulvestrant? 


Do not receive fulvestrant if youhave had an allergic reaction to fulvestrant or any of the ingredients in fulvestrant.

Before Receiving Fulvestrant, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 


  • have a low level of platelets in your blood or bleed easily.
  • have liver problems.
  • are pregnant or plan to become pregnant. Fulvestrant can harm your unborn baby.

How Will I Receive Fulvestrant? 


  • Your healthcare provider will give you fulvestrant by injection into the muscle of each buttock.
  • Your healthcare provider may change your dose of fulvestrant if needed.

Fulvestrant May Cause Serious Side Effects, Including: 


  • Injection site related nerve damage.Call your healthcare provider if you develop any of the following symptoms in your legs following a fulvestrant injection:
    • numbness
    • tingling
    • weakness

The Most Common Side Effects Of Fulvestrant Include: 

  • injection site pain
  • nausea
  • muscle, joint, and bone pain
  • headache
  • back pain
  • tiredness
  • pain in arms, hands, legs, or feet
  • hot flashes
  • vomiting
  • loss of appetite
  • weakness
  • cough
  • shortness of breath
  • constipation
  • increased liver enzymes
  • diarrhea

Fulvestrant may cause fertility problems in males and females. Talk to your healthcare provider if you plan to become pregnant.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects with fulvestrant. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.General information about the safe and effective use of fulvestrant
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about fulvestrant that is written for health professionals.

Inactive Ingredients: 

alcohol, benzyl alcohol, benzyl benzoate, and castor oil.

SafetyGlideTMis a trademark of Becton Dickinson and Company.

SAGENT
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195
Made in USA
2019 Sagent Pharmaceuticals, Inc.

Revised: October 2019

SAGENT Pharmaceuticals

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Syringe Label

NDC 25021-462-74

Fulvestrant Injection

250 mg per 5 mL

(50 mg per mL)

For Intramuscular Use Only

Rx only

5 mL Single-Dose Prefilled Syringe

Protect from light

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Syringe Label
FULVESTRANT
fulvestrant injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25021-462
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
fulvestrant(UNII: 22X328QOC4) (fulvestrant - UNII:22X328QOC4)fulvestrant50 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
alcohol(UNII: 3K9958V90M)
benzyl alcohol(UNII: LKG8494WBH)
benzyl benzoate(UNII: N863NB338G)
castor oil(UNII: D5340Y2I9G)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25021-462-742 in 1 CARTON08/01/2019
15 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20587108/01/2019
Labeler -Sagent Pharmaceuticals (796852890)

Revised: 10/2019document Id: 

8eb58962-0f18-48ab-96a5-fa9eef00e8d8Set id: 2955e481-2315-47c7-b229-3649974d6216Version: 12Effective Time: 20191021Sagent Pharmaceuticals

What Is Fulvestrant Injection? 

Fulvestrant injection is a prescription medicine used to treat advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic).

Fulvestrant Injection May Be Used Alone, If You Have Gone Through Menopause, And Your Advanced Breast Cancer Is: 

  • hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative and has not been previously treated with endocrine therapy

    or

  • HR-positive has progressed after endocrine therapy.

Fulvestrant injection may be used in combination with ribociclib, if you have gone through menopause, and your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has not been previously treated with endocrine therapy or has progressed after endocrine therapy.

Fulvestrant injection may be used in combination with palbociclib or abemaciclib if your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has progressed after endocrine therapy.

When fulvestrant injection is used in combination with palbociclib, abemaciclib, or ribociclib, also read the Patient Information for the prescribed product.

It is not known if fulvestrant injection is safe and effective in children.
It is not known if fulvestrant injection is safe and effective in people with severe liver problems.

Who Should Not Receive Fulvestrant Injection? 

Do not receive fulvestrant injection if youhave had an allergic reaction to fulvestrant or any of the ingredients in fulvestrant injection.

Before Receiving Fulvestrant Injection, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

  • have a low level of platelets in your blood or bleed easily.
  • have liver problems.
  • are pregnant or plan to become pregnant. Fulvestrant injection can harm your unborn baby.

Females Who Are Able To Become Pregnant: 

  • Your healthcare provider may perform a pregnancy test within 7 days before you start fulvestrant injection.
  • You should use effective birth control during treatment with fulvestrant injection and for one year after the last dose of fulvestrant injection.
  • Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with fulvestrant injection.
  • are breastfeeding or plan to breastfeed. It is not known if fulvestrant passes into your breast milk. Do not breastfeed during your treatment with fulvestrant injection and for one year after the final dose of fulvestrant injection. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, includingprescription and over-the-counter medicines, vitamins, and herbal supplements. Fulvestrant injection may affect the way other medicines work, and other medicines may affect how fulvestrant injection works.

Especially tell your healthcare providerif you take a blood thinner medicine.

How will I receive

Fulvestrant Injection? 

  • Your healthcare provider will give you fulvestrant by injection into the muscle of each buttock.
  • Your healthcare provider may change your dose of fulvestrant injection if needed.

Fulvestrant Injection May Cause Serious Side Effects, Including: 

  • Injection site related nerve damage.Call your healthcare provider if you develop any of the following symptoms in your legs following a fulvestrant injection:
  • numbness
  • tingling
  • weakness

The Most Common Side Effects Of Fulvestrant Injection Include: 

  • injection site pain
  • nausea
  • muscle, joint, and bone pain
  • headache
  • back pain
  • tiredness
  • pain in arms, hands, legs or feet
  • hot flashes
  • vomiting
  • loss of appetite
  • weakness
  • cough
  • shortness of breath
  • constipation
  • increased liver enzymes
  • diarrhea

Fulvestrant injection may cause fertility problems in males and females. Talk to your healthcare provider if you plan to become pregnant.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects with fulvestrant injection. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of fulvestrant injection

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about fulvestrant injection that is written for health professionals.

Active Ingredient: 

Fulvestrant, USP.


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