Consumer Information for: TEVA-FULVESTRANT INJECTION
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
TEVA-FULVESTRANT INJECTION 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, TEVA-FULVESTRANT INJECTION 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 prefilled syringe has 250 mg of fulvestrant.
Warnings and precautions
Serious Warnings and Precautions
TEVA-FULVESTRANT INJECTION 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. TEVA-FULVESTRANT INJECTION should not be given to children or men.
BEFORE you use TEVA-FULVESTRANT INJECTION 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 TEVA-FULVESTRANT INJECTION and for 2 years after your last dose.
DURING treatment with TEVA-FULVESTRANT INJECTION, 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 fulvestrant have not been established. Before using TEVA-FULVESTRANT INJECTION 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
TEVA-FULVESTRANT INJECTION 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
If you think you have taken too much TEVAFULVESTRANT INJECTION, contact your healthcare professional, 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, TEVA-FULVESTRANT INJECTION can have side effects. Tell your doctor as soon as possible if any of the following side effects bothers you or continues.
During TEVA-FULVESTRANT INJECTION 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 Gammaglutamyl 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 get immediate medical help |
|---|---|---|---|
| Very 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 TEVA-FULVESTRANT 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 TEVAFULVESTRANT INJECTION contact your doctor or pharmacist.
How to store
Keep out of the reach and sight of children
TEVA-FULVESTRANT INJECTION 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 TEVA-FULVESTRANT INJECTION.
Keep the TEVA-FULVESTRANT INJECTION syringe in its original package. The TEVA-FULVESTRANT INJECTION pre-filled syringe should not be used after the expiry date on the pack.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
This document plus the full product monograph, prepared
for health professionals can be found by contacting
Teva Canada Limited by:
Phone: 1-800-268-4127 ext. 3
Email: druginfo@tevacanada.com; or
Fax: 1-416-335-4472
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Last revised: February 18, 2020
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