Patient Medication Information: uses, side effects, how to take - Fulvestrant Injection (Formative Pharma)
What the medication is used for:
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, 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 what the nonmedicinal ingredients are).
If you are pregnant or breast-feeding.
What the medicinal ingredient is:
Fulvestrant
What the nonmedicinal ingredients are:
Benzyl alcohol, benzyl benzoate, castor oil and ethanol 96%.
What dosage forms it comes in:
Sterile injection solution in pre-filled syringes. Each pre-filled syringe has 250 mg of fulvestrant. Components in contact with the drug product solution are not made with natural rubber latex.
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. FULVESTRANT INJECTION should not be given to children or men.
BEFORE you use 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 FULVESTRANT INJECTION and for 2 years after your last dose.
DURING treatment with 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 other drugs and FULVESTRANT INJECTION have not been established. Before using 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.
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:
Missed Dose:
If you miss your scheduled dose, call your doctor immediately.
Like all medicines, 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 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)
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
INTERACTIONS WITH THIS MEDICATION
PROPER USE OF THIS MEDICATION
If you think you, or a person you are caring for, have taken too much FULVESTRANT INJECTION, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
- increased level of bilirubin (common)
- increased level of an enzyme called Gamma-glutamyl transferase produced in the liver (uncommon)
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| 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 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 FULVESTRANT INJECTION, contact your doctor or pharmacist.
Keep out of the reach and sight of children.
Store FULVESTRANT INJECTION as directed on the original packaging. 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 FULVESTRANT INJECTION.
Keep the FULVESTRANT INJECTION syringe in its original pack and do not break the seal, in order to protect it from light. The 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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
HOW TO STORE IT
If you want more information about FULVESTRANT
INJECTION:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Consumer Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website www.formativepharma.com, or by calling 1-855-808-9528.
Formative Pharma Inc.
Burlington, Ontario, L7L 6A3