Zoladex

The active ingredient in Zoladex is goserelin acetate, a gonadotropin releasing hormone analogue (GNRH analogue). Goserelin is a synthetic form of the natural GNRH hormone. In males, GNRH naturally increases testosterone production. In females, it increases estrogen and progesterone production.

When goserelin levels increase in the body, it stops the body from producing natural GNRH. Reducing GNRH levels means the body makes less testosterone, estrogen, and progesterone.

Prostate and breast cancers can leverage the body’s hormones to grow faster.

Zoladex works by reducing testosterone levels in males, which helps slow prostate cancer, and estrogen and progesterone levels in females, which helps treat endometriosis and breast cancer.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide for additional information before using Zoladex.

Zoladex is to be injected by deep subcutaneous injection under the abdominal skin by a trained healthcare professional. Do not administer Zoladex on your own.

The 3.6mg Zoladex implant should be administered every 28 days and the 10.8mg implant every three months.

Non-hormonal methods of contraception should be used in women receiving Zoladex.

Your doctor will require you to do regular blood work while taking Zoladex.

Some mild and most common side effects of Zoladex seen in clinical trials as compared to placebo include:

-Bruising, itching, redness, or burning at the injection site.

-Hot flashes, sweating

-Changes in blood pressure

-Fatigue, headache

-Nausea, vomiting

-Reduced sex drive or difficulty having or maintaining an erection (erectile dysfunction)

-Vaginal dryness

-Acne

-Mood changes

-Breast tenderness

-Joint pain

-Weight gain

Some individuals may experience serious side effects while using Zoladex. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

-Worsening of pain and urinary symptoms of prostate cancer. This may be a flare reaction to goserelin acetate.

-Chest pains, difficulty breathing, swelling of the ankles, or other signs that may suggest a heart attack or heart failure. Zoladex may lead to an increased risk of cardiovascular events.

-Tingling of extremities.

-Mood changes or other psychiatric changes like hallucinations or disordered thoughts.

-Significant bruising, abdominal pain or distension, shortness of breath, dizziness, loss or altered consciousness: These may be signs of bleeding.

-Hives, difficulty breathing, or swelling of the lips, mouth, or throat. These may be signs of a serious allergic reaction.

These are not all of the possible side effects of Zoladex. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

The treatment of endometriosis with Zoladex has not been studied for longer than 6 months.

Zoladex may cause a flare reaction: a short-term worsening of prostate cancer symptoms.

Before starting Zoladex, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

-A tumour of the pituitary gland.

-Diabetes: Zoladex may cause high blood sugar and worsen diabetes control.

-Heart problems, including arrhythmias (Abnormal heart rhythm): Zoladex may cause QTc prolongation and lead to arrhythmias, which can be life-threatening. Your doctor may require you to do tests for your heart before starting Zoladex.

-Anemia.

-Osteoporosis: Zoladex may lead to decreased bone mineral density and worsening of osteoporosis, including an increase in bone pain.

-A mental health condition: Zoladex may cause mood changes, including worsening of depression.

Boxed Warning

Zoladex should be administered by a healthcare professional experienced in giving deep subcutaneous injections.

Zoladex should only be prescribed by doctors who are experienced with this type of medication.

Zoladex may cause a flare of prostate cancer symptoms.

Zoladex may worsen osteoporosis.

Reports of severe injection site injury have been made.

Zoladex should not be used by:

-People who have had an allergic reaction to goserelin acetate or to the inactive ingredients of the formulation.

-Children.

-People who have undiagnosed vaginal bleeding

-Pregnant or breastfeeding people.

-Post-menopausal women.

-Zoladex is only indicated for the treatment of prostate cancer in patients who are also using a non-steroidal antiandrogen medication (such as flutamide), and who are receiving radiation therapy.

Suppression of natural hormones from Zoladex may take a couple of weeks.

When Zoladex is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

-Medications used to control heart rhythm, for example, quinidine, amiodarone, flecainide, etc. Zoladex may increase the QTc interval of the heart and increase risk the for arrhythmias, which may be fatal.

-Medications that can increase the QTc interval of the heart, including antipsychotics (ie chlorpromazine), antidepressants (ie amitriptyline), opioids (ie methadone), some antibiotics (ie clarithromycin, moxifloxacin), antifungal medications (ie ketoconazole), ondansetron, salbutamol, etc.

Zoladex is available as long-acting biodegradable implants containing 3.6mg and 10.8mg of goserelin acetate. These are injected subcutaneously through a ready-to-use syringe.

Zoladex should be stored between 2 and 25 degrees Celsius in the original packaging.

Zoladex depot injections are manufactured by Tersera Therapeutics LLC.

Zoladex is currently only available as a brand-name product.

You should continue receiving Zoladex injections as instructed by your doctor.

The use of Zoladex has not been studied in pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Breastfeeding while taking Zoladex is not recommended. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.