Faslodex

DRUG DESCRIPTION

FASLODEX® (fulvestrant) Injection for intramuscular administration is an estrogen receptor antagonist. The chemical name is 7-alpha-[9-(4,4,5,5,5-penta fluoropentylsulphinyl) nonyl]estra-1,3,5-(10)- triene-3,17beta-diol. The molecular formula is C32H47F5O3S and its structural formula is:

FASLODEX® (fulvestrant) Structural Formula Illustration

Fulvestrant is a white powder with a molecular weight of 606.77. The solution for injection is a clear, colorless to yellow, viscous liquid.

Each injection contains as inactive ingredients: 10% w/v Alcohol, USP, 10% w/v Benzyl Alcohol, NF, and 15% w/v Benzyl Benzoate, USP, as co-solvents, and made up to 100% w/v with Castor Oil, USP as a co-solvent and release rate modifier

What are the possible side effects of fulvestrant (Faslodex)?

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

Less serious side effects may include:

  • headache, back pain;
  • nausea, vomiting, stomach pain;
  • constipation, diarrhea;
  • sore throat, cough;
  • weakness;
  • warmth, redness, or tingly feeling under your skin;
  • loss of appetite;
  • swelling in your hands or feet;
  • unusual vaginal...

Read All Potential Side Effects and See Pictures of Faslodex »

What are the precautions when taking fulvestrant (Faslodex)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: bleeding problems, low platelet counts (thrombocytopenia), current treatment with "blood thinners" (e.g., warfarin).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness...

Read All Potential Precautions of Faslodex »


Faslodex Consumer (continued)

SIDE EFFECTS: Pain/swelling/redness at the injection site, nausea, vomiting, loss of appetite, constipation, diarrhea, upset stomach, dizziness, tiredness, weakness, headache, body aches/pains, flushing and sweating (hot flushes/hot flashes), or trouble sleeping may occur. Changes in diet such as eating several small meals or limiting physical activity may help lessen the chance of nausea and vomiting. If any of these effects continue or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: burning/painful/frequent urination, numbness/tingling/swelling of the hands or feet, pain/redness/swelling of the arms or legs, bone/pelvis/hip pain, signs of infection (e.g., fever, persistent sore throat), persistent cough, persistent vaginal bleeding, mental/mood changes (e.g., anxiety, depression), chest pain, trouble breathing.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: bleeding problems, low platelet counts (thrombocytopenia), current treatment with "blood thinners" (e.g., warfarin).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Fulvestrant is used mainly in women after menopause. If you have not gone through menopause and your doctor has prescribed this for you, this medication should not be used during pregnancy. It may cause harm to an unborn baby or miscarriage. If you become pregnant or think you may be pregnant, tell your doctor immediately. Women of childbearing age should use reliable form(s) of contraception (such as latex condoms) during treatment. Products containing estrogen (such as birth control pills) should not be used. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Faslodex Patient Information Including Side Effects

Brand Names: Faslodex

Generic Name: fulvestrant (Pronunciation: ful VES trant)

  • What is fulvestrant (Faslodex)?
  • What are the possible side effects of fulvestrant (Faslodex)?
  • What is the most important information I should know about fulvestrant (Faslodex)?
  • What should I discuss with my healthcare provider before I receive fulvestrant (Faslodex)?
  • How is fulvestrant given (Faslodex)?
  • What happens if I miss a dose (Faslodex)?
  • What happens if I overdose (Faslodex)?
  • What should I avoid while receiving fulvestrant (Faslodex)?
  • What other drugs will affect fulvestrant (Faslodex)?
  • Where can I get more information?

What is fulvestrant (Faslodex)?

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 some hormone-related breast cancer. Fulvestrant is also used in postmenopausal women whose breast cancer has progressed after treatment with other anti-estrogen medication.

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

What are the possible side effects of fulvestrant (Faslodex)?

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

Less serious side effects may include:

  • headache, back pain;
  • nausea, vomiting, stomach pain;
  • constipation, diarrhea;
  • sore throat, cough;
  • weakness;
  • warmth, redness, or tingly feeling under your skin;
  • loss of appetite;
  • swelling in your hands or feet;
  • unusual vaginal bleeding;
  • hot flashes; or
  • mild pain or swelling 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.

What is the most important information I should know about fulvestrant (Faslodex)?

Do not receive fulvestrant without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you receive fulvestrant, tell your doctor if you have liver disease, a bleeding or blood clotting disorder, thrombocytopenia (a low level of platelets in your blood), or if you are taking a blood thinner such as Coumadin.

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

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