Zoladex® (goserelin acetate implant)

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A woman with HR+ breast cancer

What to expect from Zoladex®

Your doctor is recommending Zoladex as part of your treatment plan. You may be feeling a little bit overwhelmed right now, and it helps to know what to expect when starting a new treatment.

Here is some basic information that may help you feel a little bit more comfortable before getting started with Zoladex. Always remember that your doctor or nurse will be able to help you with any questions you might have.

Zoladex can be part of the answer for people with:

Zoladex for premenopausal HR+ breast cancer

Why Zoladex?

You may be wondering why your doctor prescribed Zoladex.

If you are premenopausal, your ovaries make a lot of estrogen, which can fuel HR+ breast cancer. Zoladex is a GnRH agonist, which stands for gonadotropin-releasing hormone agonist. Zoladex blocks a hormone produced in the brain called GnRH that triggers the ovaries to make estrogen.1

Blocking the ovaries from making estrogen is called ovarian suppression. It can slow the growth of HR+ breast cancer or help prevent it from coming back.1-3

Ovarian suppression is for women who have not yet gone through menopause. When ovarian suppression is used with other breast cancer treatments, such as tamoxifen or an aromatase inhibitor, it can help keep breast cancer from coming back in women who are at higher risk.1-3

What is Zoladex?

Zoladex is an implant about the size of a grain of rice. Your doctor or nurse will use a needle to inject Zoladex under your skin.1

Zoladex implant
1 cm

Your doctor may follow treatment guidelines from the National Comprehensive Cancer Network® (NCCN®), a respected group of cancer centers in the United States. They recommend 5 years of ovarian suppression treatment for women with certain types of breast cancer.3

Side effects

Because Zoladex blocks your ovaries from making estrogen, the side effects may feel like you are going through menopause.

Most common side effects include:

  • Hot flashes
  • Headaches
  • Vaginal dryness
  • Mood swings
  • Change in sex drive
  • Depression
  • Sweating
  • Change in breast size
  • Injection site problems (only occurs in less than 1% of women1)

If you have side effects that bother you, your doctor may be able to help you manage them.

Managing side effects

Many effects of your cancer and treatment can be managed, so it’s important to talk to your health care team about any side effects, pain, or discomfort you are having. Your doctor may prescribe medicines to help or recommend other things to help you feel better during treatment, such as acupuncture or massage therapy. Making good diet and exercise choices could also help.3

How Zoladex works

Because medicines for blocking estrogen work differently from one another, your doctor will consider this when recommending the right treatment for you.3

Endocrine therapy2
  • Tamoxifen—prevents estrogen from connecting to estrogen receptors on breast cancer cells
  • Aromatase inhibitors (AIs)—block a protein that makes estrogen in places such as fat cells, the liver, and the adrenal glands, but can’t stop the ovaries from making estrogen
Ovarian suppression2
  • GnRH agonists such as Zoladex block estrogen from being produced in the ovaries

There are other possible treatment options for HR+ breast cancer, including chemotherapy, targeted therapy, and radiation. Your doctor may recommend one or more of these treatments, depending on your specific breast cancer.3

Estrogen-blocking strategies

There are 2 widely accepted strategies for blocking estrogen—with Zoladex and other medicines—for premenopausal women diagnosed with estrogen-receptor-positive breast cancer who have had chemotherapy or are young at diagnosis2,3:

1) Zoladex with an aromatase inhibitor (AI)

Illustration of how Zoladex works with AI Illustration of how Zoladex works with AI

Zoladex reduces estrogen (E) made by the ovaries

AIs reduce the estrogen (E) made by tissues other than the ovaries, such as fat cells, the liver, and the adrenal glands

These 2 therapies work together to reduce estrogen produced in different sources

2) Zoladex with tamoxifen

Illustration of how Zoladex works with tamoxifen Illustration of how Zoladex works with tamoxifen

Zoladex reduces estrogen (E) made by the ovaries

Tamoxifen (T) blocks the estrogen (E) from breast cancer cells

If your doctor recommends tamoxifen, he/she may or may not recommend Zoladex, depending on your breast cancer

Zoladex for the treatment of prostate cancer1

Prostate cancer often relies on testosterone to grow. Most of testosterone is produced by the testes. A GnRH-A, like Zoladex, is used to stop the testes from producing testosterone.4

Testosterone, and testosterone-like chemicals that can be changed to testosterone in the body, are produced by the adrenal glands even when you are taking Zoladex. That is why Zoladex is sometimes used with an antiandrogen, like flutamide. This will block the cancer from receiving the remaining testosterone. When a GnRH-A and an antiandrogen are used together, it is known as combined androgen blockade, or CAB therapy.4

Zoladex for the treatment of endometriosis1

The rise and fall of hormones, like estrogen, during the menstrual cycle cause endometrial lesions (or wounds) to thicken, break down, and bleed during menstruation.

Most of the estrogen in your body is produced by the ovaries. A GnRH-A, like Zoladex, prevents estrogen production by the ovaries, which prevents menstruation. Without estrogen, the growth of endometrial tissue will slow down and may shrink.5

References
  1. ZOLADEX® (goserelin acetate implant) [prescribing information]. Lake Forest, IL: TerSera Therapeutics LLC; 2017.
  2. Referenced with permission from the NCCN Guidelines for Patients, Breast Cancer. © National Comprehensive Cancer Network, Inc 2018. All rights reserved. Accessed December 18, 2018. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.3.2018. © National Comprehensive Cancer Network, Inc 2018. All rights reserved. Accessed December 18, 2018. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
  4. Referenced with permission from the NCCN Guidelines for Patients, Prostate Cancer. © National Comprehensive Cancer Network, Inc 2018. All rights reserved. Accessed December 28, 2018. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
  5. Mayo Clinic. Endometriosis diagnosis and treatment. https://www.mayoclinic.org/diseases-conditions/endometriosis/diagnosis-treatment/drc-20354661. Accessed January 14, 2019.

Important Safety Information About ZOLADEX

  • If you are pregnant, ZOLADEX can cause harm to your unborn child. You should not receive ZOLADEX if you are pregnant, could become pregnant, or are nursing unless you are being treated to relieve symptoms of advanced breast cancer
  • In both men and women ZOLADEX should not be administered if you are allergic to it, to any of its ingredients, or to similar hormone therapies
  • Temporary worsening of symptoms of prostate or breast cancer including bone pain may sometimes develop during the first few weeks of ZOLADEX treatment. Also, rare cases of urinary tract blockage or spinal cord compression have been seen in men being treated for prostate cancer. Your doctor will monitor your condition closely for the first month of treatment
  • In women, menstruation should stop with effective doses of ZOLADEX. Notify your doctor if regular menstruation persists
  • In men, there is an increased risk for developing diabetes or worsening of glucose control, if you already have diabetes, if you are treated with drugs like ZOLADEX
  • In men, there is a small increased risk of heart attack, sudden cardiac death, and stroke if you are treated with drugs like ZOLADEX
  • Injection site injury has been reported following injection of ZOLADEX. Contact your doctor immediately if you experience any of the following symptoms: abdominal pain, abdominal bloating, shortness of breath, dizziness, light-headedness and/or any signs of confusion
  • In women, the most common side effects are those resulting from reduction of estrogen. Those seen are hot flashes (flushes), headaches, vaginal dryness, emotional lability, change in libido, depression, sweating, and change in breast size
  • In men, the most common side effects are those related to a loss of testosterone. Those seen are hot flashes, sexual dysfunction, decreased erections, pain, urinary tract symptoms, enlarged breasts, body weakness, upper respiratory infection, and loss of appetite

Approved Uses for ZOLADEX

  • ZOLADEX is approved by the FDA for use in combination with another drug, flutamide, for the management of Stage T2b-T4 (Stage B2-C) prostate cancer. Treatment with ZOLADEX and flutamide should start 8 weeks before the start of radiation therapy and continue during radiation therapy.
  • ZOLADEX is also approved by the FDA to lessen or relieve symptoms in patients with advanced prostate cancer.
  • ZOLADEX is approved by the FDA to lessen or relieve symptoms of HR+ advanced breast cancer in premenopausal and perimenopausal women. Estrogen and progesterone receptor values may help predict whether ZOLADEX therapy is likely to be beneficial.
  • ZOLADEX is indicated for the management of endometriosis, including pain relief and reducing endometrial lesions, for 6 months of therapy.
  • ZOLADEX is also approved to thin the lining of the uterus (i.e., the endometrium) before a procedure that destroys this lining (a process called endometrial ablation), which helps with extreme uterine bleeding.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.FDA.gov/medwatch or call 1-800-FDA-1088 or contact TerSera Therapeutics at 1-844-334-4035 or medicalinformation@tersera.com.