What Faslodex is used for and how to use it
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Faslodex - Consumer Medicine Information

Manufacture: AstraZeneca
Country: Canada
Condition: Breast Cancer, Breast Cancer, Metastatic
Class: Estrogen receptor antagonists, Hormones/antineoplastics
Form: Liquid solution, Intramuscular (IM)
Ingredients: fulvestrant, ethanol, benzyl alcohol, benzyl benzoate, castor oil

FASLODEX

fulvestrant injection

50 mg/mL

About this Medication

What the medication is used for

FASLODEX is used to treat breast cancer in postmenopausal women.

What it does

In hormone sensitive breast cancer, estrogen (female sex hormone) promotes tumour growth. By stopping some of the actions of estrogen, FASLODEX reduces the amount that is in the body, which has an effect in reducing breast cancer tumour growth.

When it should not be used

  • If you are allergic to this drug or any of its ingredients (see important nonmedicinal ingredients).
  • If you are pregnant or breast-feeding.

What the medicinal ingredient is

fulvestrant

What the nonmedicinal ingredients are

ethanol, benzyl alcohol, benzyl benzoate and castor oil

What dosage form it comes in

Sterile injection solution in pre-filled syringes.

Each pre-filled syringe has 250 mg of fulvestrant.

Warnings and Precautions

FASLODEX is not expected to affect your ability to drive or use machines. However, some patients may occasionally feel tired and/or weak. If this happens to you, do not drive or operate machines and ask your doctor for advice. FASLODEX should not be given to children or men.

BEFORE you use FASLODEX talk to your doctor or pharmacist if:

  • If you have any problems with your liver or kidneys;
  • If you have been told you have a low blood platelet count, problems with bleeding or if you use medicine to prevent blood clots (e.g. anticoagulants);
  • If you have a personal or family history of osteoporosis (thinning of the bone), or have low bone density, or have a recent history of fracture.

Interactions with this Medication

Interactions with other drugs and FASLODEX have not been established. Before using FASLODEX talk to your doctor or pharmacist if you are taking, or have recently taken any other medicines, even those you have bought without prescription.

Proper Use of this Medication

FASLODEX is to be given as an injection into the muscle (intramuscular) of the buttock.

Usual Dose

500 mg once a day as two 250 mg/5 mL injections, one in each buttock on days 0, 14 and 28 and then every 28 days thereafter.

Overdose

In case of suspected drug overdose, contact a health care practitioner, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed dose

If you miss your scheduled dose, call your doctor immediately.

Side Effects and what to do about them

Like all medicines, FASLODEX can have side effects. Tell your doctor as soon as possible if any of the following side effects bothers you or continues.

Serious Side Effects, how often they Happen and what to do about them

Symptom / EffectTalk with your
doctor or
pharmacist
Stop taking
drug and call
your doctor or
pharmacist
Only if
severe
In all
cases
Very Common (more than 10 of every 100 patients have these events)
injection site reactions,
such as pain and/or
inflammation
weakness
nausea
changes in the level of
liver enzymes (when a
blood test is taken)
Common (1 to 10 of every 100 patients have these events)
hot flushes
headache
symptoms from the
stomach or the bowels,
such as vomiting, diarrhea
or loss of appetite
skin rash
bladder infections
Uncommon (Less than 1 in every 100 patients have these events)
Inflammation of the liver.
Symptoms may include a
general feeling of being
unwell, with or without
jaundice (yellowing of the
skin and eyes), liver pain
or liver swelling.
Contact your doctor promptly if the following happens to you, as you may need further examination or treatment
Allergic reactions,
including swelling of the
face, lips, tongue and/or
throat, hives/welts and/or
difficulty with
swallowing.
Such reactions may
happen immediately, or
several days after
injection.

If you notice any other side effects, please tell your doctor or pharmacist as soon as possible.

This is not a complete list of side effects. For any unexpected effects while taking FASLODEX, contact your doctor or pharmacist.

How to Store it

Keep out of the reach and sight of children.

FASLODEX must be kept in the refrigerator (2°C-8°C). The pre-filled syringe will normally be stored for you by your doctor or the hospital. The staff is responsible for the correct storage, use and disposal of FASLODEX.

Keep the FASLODEX syringe in its original pack and do not break the seal, in order to protect it from light. The FASLODEX pre-filled syringe should not be used after the expiry date on the pack.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, ON K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

NOTE: This INFORMATION FOR THE CONSUMER leaflet provides you with the most current information at the time of printing.

For the most current information, the Consumer Information Leaflet plus the full Product Monograph, prepared for health professionals can be found at:

www.astrazeneca.ca,

or by contacting the sponsor, AstraZeneca Canada Inc. at:

Customer Inquiries – 1 (800) 668-6000,

Renseignements – 1 (800) 461-3787.