What Zoladex LA is used for and how to use it
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Zoladex LA - Consumer Medicine Information

Manufacture: AstraZeneca
Country: Canada
Condition: Carcinoma of Prostate (Prostate Cancer), Prostate Cancer
Class: Gonadotropin releasing hormones, Hormones/antineoplastics
Form: Liquid solution, Subcutaneous (SC)
Ingredients: goserelin acetate, lactide-glycolide copolymer

goserelin depot

About this medication

What ZOLADEX LA is used for

Prostate Cancer

ZOLADEX LA 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).

Benign Conditions

ZOLADEX LA 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.

What ZOLADEX LA does

ZOLADEX LA treatment, given as recommended, results in suppression of your sex hormones (testosterone in men and estradiol in women). Any complaints you experience may be related to this hormone-suppressing action of ZOLADEX LA. These complaints may include hot flushes, swollen or tender breasts and reduction in sex drive.

When ZOLADEX LA should not be used

You should not use ZOLADEX LA if:

  • You are allergic to goserelin acetate or any nonmedicinal ingredients in ZOLADEX LA.
  • 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 important nonmedicinal ingredients are

Lactide-glycolide copolymer

What dosage forms ZOLADEX LA comes in

ZOLADEX LA comes in a hard, cream-coloured, rod-shaped depot which contains 10.8mg of goserelin as goserelin acetate.

Warnings and precautions

Serious Warnings and Precautions

ZOLADEX LA should be prescribed and managed by a doctor experienced with using this type of drug.

ZOLADEX LA should be administered by a healthcare professional experienced in administering deep subcutaneous injections and under the supervision of a physician.

ZOLADEX LA 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 LA. 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 LA.

In women, there are no clinical data on the effect of treating endometriosis with ZOLADEX LA for periods in excess of six months.

ZOLADEX LA is not recommended for use in children.

ZOLADEX LA is not recommended for use in very thin patients and/or those on blood thinners.

ZOLADEX LA is unlikely to affect your ability to drive a car or to operate machinery.

Before you use ZOLADEX LA, 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 disease, or have a heart condition called ‘long QT syndrome’, or a family history of this heart condition. ZOLADEX LA may increase the risk of having an abnormal heart rhythm (QT prolongation).
  • Have diabetes.
  • Are pregnant or planning to become pregnant. ZOLADEX LA 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 LA. After stopping ZOLADEX LA 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 LA 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.) especially if you are taking any medicines for abnormal heart rhythm (antiarrhythmics) or medicines that may increase the risk of having an abnormal heart rhythm.

Proper use of this medication

Usual Dose

  • ZOLADEX LA 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

In case of 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 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 LA.

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 LA. 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 LA In Men

  • When you first start receiving ZOLADEX LA 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 LA in Women

  • For pre-menopausal women: menstruation stops with the 12 week depot of ZOLADEX LA. If regular menstruation persists, notify your doctor. Occasionally some women may enter menopause early, so when ZOLADEX LA treatment is stopped menstruation will not start again.
  • 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.
  • ZOLADEX has been associated with the formation of ovarian cysts, which may cause pain for some women.

Serious side effects, how often they happen and what to do about them

Symptom / effectTalk with your doctor or pharmacistStop taking drug and call your doctor or pharmacist
Only if severeIn all cases
USE OF ZOLADEX LA 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 LA IN WOMEN
Very Common (more than 10 in every 100 patients are likely to have them)
Reduced sex drive  
Hot flushes and sweating  
Acne  
Vaginal dryness  
Change in breast size  
Injection site reaction  
Common (1 to 10 in every 100 patients are likely to have them)
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.  

* Often, acne is reported within one month after starting ZOLADEX LA.

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 it

  • ZOLADEX LA should not be used after the expiry date on the pack. Store ZOLADEX LA in its original pack between 2°C and 25°C.
  • If your doctor decides to stop your treatment, return ZOLADEX LA to the pharmacy for proper disposal
  • Keep your ZOLADEX LA in a safe place where children cannot reach it. It could harm them.

Reporting suspected 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 www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
                     Health Canada
                     Postal Locator 0701D
                     Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Forms and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. 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.astrazeneca.ca,

or by contacting the sponsor, AstraZeneca Canada Inc. at:
Customer Inquiries – 1 (800) 668-6000,
Renseignements – 1 (800) 461-3787.