Faslodex

Dosage Forms & Strengths

injectable solution

• 50mg/mL

Breast Cancer

Also see Administration

Monotherapy

• Monotherapy indications
  • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, OR
  • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy
• 500 mg IM on days 1, 15, 29, then once monthly thereafter

Combination with palbociclib

• Indicated for HR-positive, (HER2)-negative advanced or metastatic breast cancer in combination with palbociclib in women (regardless of menopausal status) with disease progression following endocrine therapy
• Fulvestrant 500 mg IM on days 1, 15, 29, and once monthly thereafter
• Palbociclib starting dose: 125 mg PO qDay with food x21 days followed by 7 days off therapy to comprise a complete cycle of 28 days
• Pre/perimenopausal women treated with the palbociclib combination should be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards

Dosage Modifications

Hepatic impairment

• Mild (Child-Pugh A): No dosage adjustment required
• Moderate (Child-Pugh B): 250 mg IM on days 1, 15, 29, then once monthly thereafter
• Severe (Child-Pugh C): Not studied

Renal impairment

• Negligible amounts of fulvestrant are eliminated in urin
• In clinical trials, fulvestrant concentrations in women with eCrCl as low as 30 mL/min were similar to women with normal creatinine

Dosage Forms & Strengths

injectable solution

• 50mg/mL

Precocious Puberty (Off-label)

Indicated in females for progressive precocious puberty associated with McCune-Albright syndrome

4 mg/kg IM qMonth 

Hepatic Impairment

• Dose adjustment may be required, although no specific recommendations defined for children with hepatic impairment (in adults with Child-Pugh class B, the dose is decreased by 50%)

IM Administration

Administer IM in buttocks slowly (over 1-2 minutes per injection) as two 5-mL (250 mg/5 mL) injections, one injection in each buttock (or one 5-mL [250 mg] IM injection for moderate hepatic impairment)

Dosage Forms And Strengths

FASLODEX, an injection for intramuscular administration, is supplied as 5-mL prefilled syringes containing 50 mg/mL fulvestrant.

Storage And Handling

FASLODEX is supplied as two 5 mL clear neutral glass (Type 1) barrels, each containing 250 mg/5 mL of FASLODEX solution for intramuscular injection and fitted with a tamper evident closure.

NDC 0310–0720–10

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

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

Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Manufactured for: AstraZeneca UK Limited Macclesfield, Cheshire, England. By: Vetter Pharma-Fertigung GMBH & Co. KG Ravensburg, Germany. Revised: March 2016

It is not known if Faslodex crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Faslodex.

Take Faslodex exactly as prescribed.

Faslodex comes in an injectable form and is usually given every 15 days at the beginning of treatment and once per month later in treatment. Your healthcare provider will give you the appropriate amount of Faslodex by injection into the muscle of your buttock. It is usually administered in a medical facility (doctor's office or hospital).

Keep all appointments with your doctor. If you miss an appointment to receive a dose of Faslodex, reschedule as soon as possible.

Breast Cancer

Treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen (e.g., tamoxifen) therapy.1 2 4 7

Efficacy in premenopausal women (e.g., those with functioning ovaries, as evidenced by menstruation and/or premenopausal LH, FSH, and estradiol concentrations) with advanced breast cancer not established.1

Storage

Parenteral

Refrigerate at 2–8°C.1 Protect from light; store in original carton until time of use.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

• If you have an allergy to fulvestrant or any other part of Faslodex (fulvestrant).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are breast-feeding. Do not breast-feed while you take this medicine and for 12 months after your last dose.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Faslodex with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Be sure to have regular breast exams and gynecology check-ups. Your doctor will tell you how often to have these. You will also need to do breast self-exams as your doctor has told you. Talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Faslodex.
• This medicine may be used with another drug called palbociclib. If you are also taking palbociclib, talk with the doctor about the risks and side effects that may happen.
• This medicine may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child. Talk with the doctor.
• If you are able to get pregnant, a pregnancy test will be done within 1 week before you start this medicine. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy while taking Faslodex and for up to 12 months after this medicine.
• If you get pregnant while taking Faslodex or within 12 months after your last dose, call your doctor right away.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

Call your doctor for instructions if you miss an appointment for your Faslodex injection.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Fulvestrant is an anti-estrogen medication. It works by blocking the actions of estrogen in the body. Certain types of breast cancer use estrogen to grow and multiply in the body.

Fulvestrant is used to treat advanced hormone-related breast cancer in women. Fulvestrant is used for this condition only if your tumor tests negative for a protein called human epidermal growth factor receptor 2 (HER2). HER2 protein can speed the growth of cancer cells.

Fulvestrant may also be used when the cancer has progressed or has spread to other parts of the body after treatment with anti-estrogen medication.

For women who have not gone through menopause, fulvestrant is given together with another medicine called palbociclib to treat advanced HER2-negative breast cancer that has progressed or spread.

Fulvestrant may also be used for purposes not listed in this medication guide.

You should not receive this medicine if you are allergic to fulvestrant, or if you are pregnant.

To make sure fulvestrant is safe for you, tell your doctor if you have:

• liver disease;

• a bleeding or blood clotting disorder; or

• thrombocytopenia (a low level of platelets in the blood).

Using fulvestrant during pregnancy could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 year after your treatment ends. Tell your doctor right away if you become pregnant during this time.

It is not known whether fulvestrant passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• signs of nerve damage--numbness, tingling, weakness, or burning pain.

Common side effects may include:

• headache;

• bone pain, joint pain, muscle pain;

• nausea, vomiting, loss of appetite, constipation;

• weakness, feeling tired;

• cough, trouble breathing;

• abnormal liver function tests;

• hot flashes; or

• pain where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.