Details for: ZOLADEX
Company: TERSERA THERAPEUTICS LLC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02049325 | ZOLADEX | GOSERELIN (GOSERELIN ACETATE) | 3.6 MG | IMPLANT | SUBCUTANEOUS |
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
Prostate Cancer
ZOLADEX is used:
- For the palliative treatment of patients with hormone-dependent advanced carcinoma of the prostate (Stage D2).
- In combination with a non-steroidal antiandrogen and radiation therapy for the management of locally advanced (T3, T4) or bulky Stage T2b, T2c carcinoma of the prostate.
- As adjuvant hormone therapy to external beam irradiation for patients with locally advanced prostate cancer (Stage T3-T4).
Breast Cancer
ZOLADEX is used:
- As an alternative to standard adjuvant chemotherapy in pre- and perimenopausal women with early breast cancer who are unsuitable for, intolerant to, or decline chemotherapy, and whose tumour contains estrogen and/or progesterone receptors.
- ZOLADEX is indicated for the palliative treatment of advanced breast cancer in pre- and perimenopausal women whose tumour contains estrogen and/or progesterone receptors.
Benign Conditions
ZOLADEX is indicated for the hormonal management of
endometriosis, including pain relief and reduction of
endometriotic lesions. Experience with ZOLADEX for the
management of endometriosis has been limited to women 18
years of age and older, treated for 6 months.
ZOLADEX is indicated for use as an endometrial thinning
agent prior to endometrial ablation.
What it does
ZOLADEX treatment, given once every 28 days, results in suppression of your sex hormones (testosterone in men and estradiol in women).
When it should not be used
You should not use ZOLADEX if:
- You are allergic to goserelin acetate or any nonmedicinal ingredients in ZOLADEX.
- You are a woman who has abnormal vaginal bleeding for an unknown reason.
- You are a woman who is pregnant.
- You are a woman who is breastfeeding.
What the medicinal ingredient is
goserelin acetate
What the non-medicinal ingredients are
Lactide-glycolide copolymer
What dosage form it comes in
ZOLADEX comes in a hard, cream-coloured, rod-shaped depot which contains 3.6mg goserelin as goserelin acetate.
Warnings and precautions
Serious Warnings and Precautions
ZOLADEX should be prescribed and managed by a
doctor experienced with using this type of drug.
ZOLADEX should be administered by a healthcare
professional experienced in administering deep
subcutaneous injections and under the supervision of a
physician.
ZOLADEX may cause:
- Worsening of symptoms of prostate cancer at the beginning of the treatment (risk of spinal cord compression, or increased difficulty in urinating)
- Bone thinning (osteoporosis)
- Injection site injury (including damage to blood vessels in the abdomen) has been reported following injection of ZOLADEX. In rare cases this has caused severe bleeding (with some cases requiring surgical treatment).
If you go into hospital, let the medical staff know you are
receiving ZOLADEX.
In women, there are no clinical data on the effect of treating
endometriosis with ZOLADEX for periods in excess of six
months.
ZOLADEX is not recommended for use in children.
ZOLADEX is not recommended for use in very thin patients
and/or those on blood thinners.
ZOLADEX is unlikely to affect your ability to drive a car or
to operate machinery.
Before you use ZOLADEX, talk to your doctor or
pharmacist if any of the following applies to you:
- Have or have had any problem passing urine.
- Family history of severe osteoporosis (thinning of the bones with fractures).
- Have low bone mineral density (BMD).
- Taking other medicines that cause thinning of the bones.
- Have a low red blood cell count (anemia)
- Have heart or blood vessel disease, have had an abnormal heart rhythm (QT prolongation), have a heart condition called ‘long QT syndrome’, a family history of this heart condition, or are being treated with medicines for these conditions. ZOLADEX may increase the risk of having an abnormal heart rhythm (QT prolongation).
- Have diabetes.
- Are pregnant or planning to become pregnant. ZOLADEX should not be used during pregnancy, therefore, effective non-hormonal contraceptive methods should be used to prevent pregnancy during the treatment and until the return of menses after the last injection with ZOLADEX. After stopping ZOLADEX it may take longer for some women to experience menses. Rarely, some women may enter menopause. If 12 weeks have passed after the last ZOLADEX injection and you do not experience menses, talk to your doctor.
- Taking blood thinners.
Interactions with this medication
Check with your doctor or pharmacist before taking any other drugs, including non-prescription drugs (for colds, nausea, etc.). ZOLADEX might interfere with some medicines used to treat heart rhythm problems or might increase the risk of heart rhythm problems when used with some other drugs that can cause heart rhythm abnormalities.
Proper use of this medication
Usual Dose
- ZOLADEX is given as an injection under the skin of the abdomen by a trained health care professional, such as a doctor or nurse.
- Prostate cancer: one injection every 3 months
- Endometriosis: one injection every 12 weeks
- It is very important your doctor checks your progress at regular medical visits. Consult your doctor before you decide to change your treatment.
- If you need more information, ask your doctor.
Overdose
Missed Dose
If you missed your scheduled dose, contact your doctor for advice.
Side effects and what to do about them
As with all medicines, side effects are sometimes experienced
with ZOLADEX.
Contact your doctor or pharmacist if you experience any of
these problems:
- Tingling in your fingers or toes.
- Psychiatric problems such as hallucinations, disordered thoughts or personality change. These have occasionally been reported.
- Injection site injury (including damage to blood vessels in the abdomen) has been reported following injection of ZOLADEX. This can cause severe bleeding. Contact your doctor immediately if you experience any of the following symptoms: bleeding underneath the skin or bruising, abdominal pain, abdominal distension, swelling at the injection site, shortness of breath, dizziness, low blood pressure and/or any altered levels of consciousness.
- There have been occasional reports of side effects with pituitary tumours. You may develop a tumour of the pituitary gland in your head or, if you have an existing tumour of the pituitary gland, ZOLADEX may cause it to bleed or collapse. Pituitary tumours may cause headaches, vomiting, loss of eyesight and unconsciousness.
- A local skin reaction may occur at the injection site such as pain, bruising, bleeding, itching, redness, burning and swelling. These reactions generally are mild and disappear after a few days. If they get worse or do not go away, tell your doctor.
- Cancer patients: Contact your doctor immediately if you develop: severe increased pain, numbness or weakness of the limbs, or persistent difficulty in urinating.
Use of ZOLADEX In Men
- When you first start receiving ZOLADEX you may feel some pain in your bones. If this happens tell your doctor and you may be given something for this.
- Very occasionally you may have trouble passing urine or experience lower back pain. If this happens, tell your doctor and you may be given something for this.
- You may experience hair loss, particularly the loss of body hair.
Use of ZOLADEX in Women
- For pre-menopausal women: menstruation stops with the monthly depot of ZOLADEX. If regular menstruation persists, notify your doctor. If a monthly ZOLADEX depot is missed, breakthrough menstrual bleeding may occur.
- Vaginal bleeding may occur. At the beginning of treatment, if you have fibroids a slight increase in symptoms, such as pain, may occur. These effects are usually short-lived and discontinue on continuation of treatment. If symptoms persist or you are uncomfortable, contact your doctor.
- Occasionally some women may enter menopause early, so when ZOLADEX treatment is stopped, menstruation will not start again.
- ZOLADEX has been associated with the formation of ovarian cysts, which may cause pain for some women.
- If you experience excessive nausea, vomiting or thirst, you should tell your doctor. This may indicate possible changes in the amount of calcium in your blood and your doctor may have to do certain blood tests.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| USE OF ZOLADEX IN MEN | |||
| Very Common (more than 10 in every 100 patients are likely to have them) | |||
| Reduced sex drive/impotence | ✔ | ||
| Hot flushes and sweating | ✔ | ||
| Common (1 to 10 in every 100 patients are likely to have them) | |||
| Change in breast size | ✔ | ||
| Injection site reaction | ✔ | ||
| Depression | ✔ | ||
| Bone pain | ✔ | ||
| Rises in blood sugar levels | ✔ | ||
| Tingling in fingers or toes | ✔ | ||
| Changes in blood pressure | ✔ | ||
| Skin rashes | ✔ | ||
| Thinning of bones | ✔ | ||
| Heart failure (reduced heart function) or heart attack | ✔ | ||
| Weight gain | ✔ | ||
| Uncommon (1 to 10 in every 1000 patients are likely to have them) | |||
| Tender breasts | ✔ | ||
| Joint pain | ✔ | ||
| Allergic reactions | ✔ | ||
| Rare (1 to 10 in every 10 000 patients are likely to have them) | |||
| Severe bleeding due to injection site injury, including damage to blood vessels in the abdomen. Symptoms such as bleeding underneath the skin or bruising, abdominal pain, abdominal distension, swelling at the injection site, shortness of breath, dizziness, low blood pressure and/or altered levels of consciousness. | ✔ | ||
| USE OF ZOLADEX IN WOMEN | |||
| Very Common (more than 10 in every 100 patients are likely to have them) | |||
| Reduced sex drive | ✔ | ||
| Hot flushes and sweating | ✔ | ||
| Vaginal dryness | ✔ | ||
| Change in breast size | ✔ | ||
| Injection site reaction | ✔ | ||
| Acne* | ✔ | ||
| Common (1 to 10 in every 100 patients are likely to have them) | |||
| Increased signs and symptoms of breast cancer | ✔ | ||
| Mood changes including depression | ✔ | ||
| Tingling in fingers and toes | ✔ | ||
| Headache | ✔ | ||
| Changes in blood pressure | ✔ | ||
| Skin rashes | ✔ | ||
| Thinning of bones | ✔ | ||
| Joint pain | ✔ | ||
| Hair loss (usually mild but occasionally severe) | ✔ | ||
| Weight gain | ✔ | ||
| Uncommon (1 to 10 in every 1000 patients are likely to have them) | |||
| Allergic reactions | ✔ | ||
| Rare (1 to 10 in every 10 000 patients are likely to have them) | |||
| Severe bleeding due to injection site injury, including damage to blood vessels in the abdomen. Symptoms such as bleeding underneath the skin or bruising, abdominal pain, abdominal distension, swelling at the injection site, shortness of breath, dizziness, low blood pressure and/or altered levels of consciousness. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking ZOLADEX® LA, contact your doctor or pharmacist.
How to store
- ZOLADEX should not be used after the expiry date on the pack. Store ZOLADEX in its original pack between 2°C and 25°C.
- If your doctor decides to stop your treatment, return ZOLADEX to the pharmacy for proper disposal
- Keep your ZOLADEX in a safe place where children cannot reach it. It could harm them.
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 (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/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
NOTE: This CONSUMER INFORMATION 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.tersera.ca, or by contacting the sponsor at:
Questions or concerns - 1-855-820-2141
This leaflet was prepared by:
TerSera Therapeutics LLC Lake Forest, IL 60045
ZOLADEX® and SAFESYSTEM® are registered
trademarks of AstraZeneca or its affiliates and are used
herein under license.
©2017 TerSera Therapeutics LLC
Last revised: December 21, 2017