Details for: FASLODEX
Company: ASTRAZENECA CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02248624 | FASLODEX | FULVESTRANT | 50 MG / ML | SOLUTION | INTRAMUSCULAR |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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 non-medicinal 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.
- If you can become pregnant, you should use effective contraception while you are being treated with FASLODEX and for 2 years after your last dose.
DURING treatment with FASLODEX, 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.
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. Your healthcare provider will administer this medicine.
Usual Dose
500 mg 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.
During FASLODEX treatment, you may also have the following side effects which are seen when a blood test is taken:
- increased level of liver enzymes (very common)
- increased level of bilirubin (common)
- increased level of an enzyme called Gamma-glutamyl transferase produced in the liver (uncommon)
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Injection site reactions, such as pain and/or inflammation | ✔ | ||
| Weakness | ✔ | ||
| Fatigue | ✔ | ||
| Nausea | ✔ | ||
| Joint, muscle and back pain | ✔ | ||
| Hot flushes | ✔ | ||
| Skin rash | ✔ | ||
| 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. | ✔ | ||
| Common | |||
| Feelings of numbness, tingling or weakness in your legs following a FASLODEX injection. | ✔ | ||
| Headache | ✔ | ||
| Pain in extremity | ✔ | ||
| Symptoms from the stomach or the bowels, such as vomiting, diarrhea or loss of appetite | ✔ | ||
| Urinary tract infections | ✔ | ||
| Lower level of platelets (symptoms may include bruising, reddish-purple spots and unusual bleeding) | ✔ | ||
| Uncommon | |||
| 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. | ✔ | ||
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
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 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 MedEffect (www.healthcanada.gc.ca/medeffect);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and
sending it by:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Ottawa, ON
K1A 0K9
NOTE: Contact your health professional if you need information about how to manage your side effects. 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, under Patients
with Prescriptions or by contacting the sponsor, AstraZeneca
Canada Inc. at:
Questions or Concerns: 1-800-668-6000
This leaflet was prepared by:
AstraZeneca Canada Inc.
Mississauga, Ontario
L4Y 1M4
FASLODEX® is a registered trademark of AstraZeneca UK Limited, used under license by AstraZeneca Canada Inc.
The AstraZeneca logo is a registered trademark of AstraZeneca AB, used under license by AstraZeneca Canada Inc.
© AstraZeneca 2004-2019
Last revised: November 15, 2019