Fulvestrant (Page 6 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Fulvestrant injection is supplied as two 5 mL clear neutral glass (Type 1) barrels, each containing 250 mg/5 mL of fulvestrant solution for intramuscular injection.

NDC 68842–301–12 Carton containing 2 single-dose pre-filled syringes

The single-dose prefilled syringes are presented in a tray with polystyrene plunger rod and safety needles (SafetyGlide™) for connection to the barrel.

Discard each syringe after use. If a patient dose requires only one syringe, unused syringe should be stored as directed below.

Storage

REFRIGERATE, 2° to 8°C (36° to 46°F). TO PROTECT FROM LIGHT, STORE IN THE ORIGINAL CARTON UNTIL TIME OF USE.

17 PATIENT COUNSELING INFORMATION

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

Monotherapy

Risk of Bleeding

Because fulvestrant injection 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) [seeWarnings and Precautions (5.1) ].

Embryo-Fetal Toxicity

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with fulvestrant injection and for one year after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy [seeWarnings and Precautions (5.4) and Use in Specific Populations (8.1), (8.3)].

Lactation

Advise women not to breastfeed during treatment with fulvestrant injection and for one year after the last dose [seeUse in Specific Populations (8.2) ].

Combination Therapy

When fulvestrant injection is used in combination with palbociclib, abemaciclib, or ribociclib, refer to the respective Full Prescribing Information for Patient Counseling Information.

PATIENT INFORMATION

Fulvestrant Injection

(full-VES-trant)

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 and 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 you have had an allergic reaction to fulvestrant or any of the ingredients in fulvestrant injection. See the end of this leaflet for a list of the ingredients in fulvestrant injection.

Symptoms of an allergic reaction to fulvestrant injection may include:

itching or hives
swelling of your face, lips, tongue or throat
trouble breathing

What should I tell my healthcare provider before receiving 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
1.
Your healthcare provider may perform a pregnancy test within 7 days before you start fulvestrant injection.
2.
You should use effective birth control during treatment with fulvestrant injection and for one year after the last dose of fulvestrant injection.
3.
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, including prescription 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 provider if you take a blood thinner medicine.

How will I receive fulvestrant injection?

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

What are the possible side effects of fulvestrant injection?

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.

What are the ingredients in fulvestrant injection?

Active ingredient: fulvestrant.

Inactive ingredients: alcohol, benzyl alcohol, benzyl benzoate, and castor oil.

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

SafetyGlide™ is a trademark of Becton Dickinson and Company.

Manufactured by

Ebewe Pharma, Austria

Rev. November 2019

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