Patient Medication Information: uses, side effects, how to take - Act Fulvestrant
ABOUT THIS MEDICATION
What the medication is used for:
ACT FULVESTRANT 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, ACT FULVESTRANT 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 important nonmedicinal ingredients are:
ethanol, benzyl alcohol, benzyl benzoate and castor oil.
What dosage forms it comes in:
Sterile injection solution in pre-filled syringes.
Each pre-filled syringe has 250 mg of fulvestrant.
WARNINGS AND PRECAUTIONS
ACT FULVESTRANT 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. ACT FULVESTRANT should not be given to children or men.
BEFORE you use ACT FULVESTRANT 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 ACT FULVESTRANT have not been established. Before using ACT FULVESTRANT 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
ACT FULVESTRANT 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:
| For management of suspected drug overdose, contact your regional Poison Control Centre. |
Missed Dose:
If you miss your scheduled dose, call your doctor immediately.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, ACT FULVESTRANT 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 / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
| Only if severe | In all cases | ||
| Very Common | |||
| Injection site reactions, such as pain and/or inflammation | √ | ||
| Joint, muscle and back pain | √ | ||
| Weakness | √ | ||
| Nausea | √ | ||
ACT FULVESTRANT (Fulvestrant Injection)
IMPORTANT: PLEASE READ
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Changes in the level of liver enzymes (when blood test is taken) | √ | ||
| Common | |||
| Hot flushes | √ | ||
| Headache | √ | ||
| Symptoms from the stomach or the bowels, such as vomiting, diarrhea or loss of appetite | √ | ||
| Skin rash | √ | ||
| Bladder infections | √ | ||
| 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. | √ | ||
| Lower level of platelets (when a blood test is taken). Symptoms may include bruising, reddish-purple spots and unusual bleeding. | √ | ||
Contact your doctor promptly if the following happens to you, as you may 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 ACT FULVESTRAN, contact your doctor or pharmacist.
HOW TO STORE IT
Keep out of the reach and sight of children.
ACT FULVESTRANT 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 ACT FULVESTRANT.
Keep the ACT FULVESTRANT syringe in its original pack and do not break the seal, in order to protect it from light. The ACT FULVESTRANT 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:
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 the sponsor, Actavis pharma Company, at 1-866-254-6111.
This leaflet was prepared:
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, ON
Canada, L5N 6J5
Date prepared: April 11, 2017