In the treatment of advanced prostate cancer

ZOLADEX
supports you.

If you have advanced prostate cancer, and are considering ZOLADEX as a treatment option with your doctor, learn more here.

 

What is advanced prostate cancer?

Advanced prostate cancer is cancer that has spread outside the prostate gland to nearby tissues, lymph nodes, bones, or other parts of the body. It may also be referred to as “stage IV” or “metastatic” prostate cancer. Some men who first receive a diagnosis for prostate cancer may have advanced prostate cancer. In others, they may develop advanced prostate cancer after they were diagnosed and treated for primary prostate cancer (cancer that is only in the prostate gland).

Cancer spreads to other parts of the body when cancer cells break away from the original tumor and enter the blood stream or lymphatic system. This allows them to travel to other parts of the body. Wherever these cells spread and form a tumor, that tumor is made of the same cancerous cells as the original tumor in the prostate gland. So it is the same cancer. For example, tumors that have spread to your bone are metastatic prostate cancer cells, not bone cancer.

Metastatic prostate cancer is not a curable condition. But treatment can help to control the cancer for long periods of time and relieve symptoms. Testosterone, a hormone produced in the testicles, can stimulate the growth of some prostate cancers. Hormone therapy may slow the growth of tumors by interfering with the body’s production of testosterone.

FAQs about ZOLADEX

Here are answers to frequently asked questions about ZOLADEX therapy for advanced prostate cancer. These answers may help you better understand what ZOLADEX is, how it works, and what you may expect from your therapy.

ZOLADEX is a prescription medication that is approved for use in combination with flutamide (an antiandrogen) plus radiation therapy for locally advanced prostate cancer. Treatment with ZOLADEX in combination with flutamide should begin 8 weeks before starting radiation therapy and continue during radiation therapy.

ZOLADEX is also approved to lessen or relieve symptoms of advanced prostate cancer. In these clinically appropriate cases, ZOLADEX is used alone as long-term treatment.

Do not take ZOLADEX if you are sensitive to GnRH, GnRH hormone therapy drugs, or are allergic to any of the ingredients in ZOLADEX.

Please see Important Safety Information below.

ZOLADEX is a gonadotropin-releasing hormone agonist, or GnRH-A. It is an implant that is injected under the skin (subcutaneously). The implant gradually dissolves and releases the drug over the time between injections. There are two dosages of ZOLADEX: ZOLADEX 10.8 mg, which is injected once every 3 months, and ZOLADEX 3.6 mg, which is injected once a month. Your doctor will confirm which dosage is right for you.

Prostate cancer often relies on testosterone to grow. The majority of testosterone is produced by the testes. A GnRH-A, like ZOLADEX, is used to prevent testosterone production by the testes.

Testosterone, and testosterone-like chemicals that can be converted to testosterone, are produced by the adrenal glands even when ZOLADEX is being used. That is why ZOLADEX is sometimes used with an antiandrogen, like flutamide, which works to block the remaining testosterone. When a GnRH-A and an antiandrogen are used together, it is known as combined androgen blockade, or CAB therapy.

The most commonly reported side effects in men were related to a decrease in testosterone levels. Adverse effects that were reported in advanced prostate cancer clinical trials of ZOLADEX 3.6-mg implant were hot flashes, sexual dysfunction, decreased erections, lower urinary tract symptoms, lethargy, pain that worsened in the first 30 days of ZOLADEX use, swelling due to accumulation of fluid, upper respiratory infection, rash, and sweating. Among patients who received ZOLADEX 10.8-mg implant, the most commonly reported adverse effects were hot flashes, generalized pain, increased breast size (gynecomastia), pelvic pain, and bone pain.

In a prostate cancer (T2b-T4) clinical trial, ZOLADEX in combination with another drug, flutamide, was studied before and during radiation therapy. Side effects were similar in both groups. The most common side effects were hot flashes, diarrhea, nausea, and skin rash.

GnRH is an abbreviation for gonadotropin-releasing hormone. Both men and women have GnRH, which controls sex hormones. “A” stands for “agonist.” An agonist is a pharmaceutical compound that behaves in a similar way to a natural compound in the body. ZOLADEX is a GnRH agonist that mimics GnRH to help control testosterone hormones.

Elevated blood sugar and an increased risk of developing diabetes or worsening of blood sugar control in patients with diabetes have been reported in men who take ZOLADEX and drugs that work the same way as ZOLADEX. Your doctor will check your blood sugar levels and glycosylated hemoglobin (HbA1c), an indicator of long-term blood sugar control, as part of your treatment.

Increased risk of heart attack, sudden cardiac death, and stroke has been reported in men who have taken ZOLADEX and drugs that work the same way as ZOLADEX. Inform your doctor immediately if you develop any unusual symptoms.

ZOLADEX is injected by a doctor just under the skin (subcutaneously) in the lower abdominal area below the navel (belly button). The implant gradually dissolves and releases the drug over the time between injections.

ZOLADEX 3.6 mg is administered once a month (every 28 days).

For prostate cancer, ZOLADEX 10.8 mg may be administered every 3 months rather than once a month. You and your doctor can decide which dosage is right for you. Both are equally effective in reducing testosterone levels.

It is very important for you to get your injections as your doctor schedules to keep ZOLADEX levels consistently high enough to block testosterone production. Keep in mind that although a delay of a few days is permissible, every effort should be made to adhere to the dosing schedule your doctor has recommended.

If you need to be out of town when you are scheduled for a ZOLADEX injection, ask your doctor to help you arrange to receive your injection at a medical facility near where you will be staying. A few days late may be okay, but it’s important to stick to your overall injection schedule.

ZOLADEX is a type of long-acting medicine called an implant injection. When ZOLADEX is injected under the skin in your lower abdomen (below the belly button), the medicine is gradually released over the time until the next injection.

The difference between monthly ZOLADEX 3.6 mg and ZOLADEX 10.8 mg is that you will receive an injection every 3 months with ZOLADEX 10.8 mg rather than once a month. You and your doctor can decide which dosage is right for you. Both are equally effective in reducing testosterone levels.

Tumor flare is a temporary worsening of tumor-related symptoms, or an increase in bone pain that can occur soon after starting treatment with ZOLADEX. It is caused by temporary increases in testosterone levels. Your doctor will monitor your condition closely.

The combination of radiation with hormonal therapy can be effective in treating prostate cancer. Radiation can help shrink and kill prostate cancer cells, while hormonal therapy can help starve prostate cancer cells of the testosterone they need to grow. A hormonal injection/implant, like ZOLADEX, is used to reduce the testosterone produced by the testes. However, a small amount of testosterone, which is produced by the adrenal glands, may remain.

This is why, along with the ZOLADEX implant, your doctor may also prescribe another type of hormonal therapy, an oral antiandrogen such as flutamide. Antiandrogens do not prevent testosterone production. They work to block the remaining testosterone from reaching the cancer cells.

Support resources for advanced prostate cancer

The following list of resources is provided as a convenience to you. TerSera takes no responsibility for the content of, or services provided by, these resources and makes no representation as to the accuracy or completeness of any information provided by these resources. TerSera shall have no liability for any damage or injuries of any kind arising from the information provided by the resources listed. The descriptions of the organizations are all directly from their respective Web sites.

www.cancer.org

The American Cancer Society is the largest volunteer organization in the United States and is committed to saving lives from cancer by helping people stay well, helping people get well, finding cures, and fighting back against cancer. There are 900 local offices nationwide to deliver lifesaving programs and services at the community level.

Phone: 1-800-ACS-2345 (1-800-227-2345)

www.urologyhealth.org

The Urology Care Foundation is committed to advancing urologic research and education to improve patients' lives. The UCF is the official foundation of the American Urological Association and was formerly known as the AUA Foundation.

Phone: 1-800-828-7866

www.cancercare.org

CancerCare is a national nonprofit organization that provides free professional support services to anyone affected by cancer: People with cancer, caregivers, children, loved ones, and the bereaved. CancerCare programs—including counseling, education, financial assistance, and practical help—are provided by trained oncology social workers and are completely free of charge. Founded in 1944, CancerCare provides individual help to 1 million people each year throughout the US.

Phone: 1-800-813-HOPE (1-800-813-4673)

www.ustoo.org

This education and support network includes 325 support group chapters worldwide. They provide men and their families with free information, materials, and peer-to-peer support so they can make informed choices on detection, treatment options, and coping with ongoing survivorship.

Phone: 1-800-80-UsTOO (1-800-808-7866)

www.menshealthnetwork.org

The Men’s Health Network provides information about disease prevention, screening programs, and disease education materials for a number of diseases affecting men’s health. The MHN, which currently has a board of advisors including more than 800 physicians and key thought leaders, was founded in 1992 by a group of health professionals and others interested in improving the health and well-being of men, boys, and families.

Phone: 202-543-MHN-1 (202-543-6461)

www.prostatecancerfoundation.org

The Prostate Cancer Foundation is the world’s largest philanthropic source of support for prostate cancer research to fund better treatments and a cure for prostate cancer. PCF pursues its mission by soliciting and selecting promising research programs and rapid deployment of resources. Founded in 1993, the PCF has raised more than $370 million and has provided funding for more than 1500 research projects at nearly 200 institutions worldwide.

Phone: 1-800-757-CURE (1-800-757-2873)

www.prostateconditions.org

The Prostate Conditions Education Council provides information on prostate health. The Council, founded in 1989, is made up of a consortium of leading physicians, health educators, scientists, and prostate cancer advocates. The aim of the Council is to provide information, conduct nationwide screenings for men, and perform research that will aid in the detection and treatment of prostate and men’s health conditions.

Phone: 1-866-477-6788

www.theprostatenet.org

The Prostate Net develops and maintains an interactive network of educational tools and services for consumers. These services are offered to educate, inform, and motivate consumers to make informed choices about prostate cancer and other prostate diseases.

Phone: 1-888-477-6763

www.zerocancer.org

ZERO – The End of Prostate Cancer is a national nonprofit organization with the mission to end prostate cancer. They lead the fight to end the disease by advancing research, encouraging action, and providing education and support to men and their families.

Phone: 1-888-245-9455

www.nccn.org

The National Comprehensive Cancer Network is an alliance of 25 of the world’s leading cancer centers. The NCCN is dedicated to improving the quality, effectiveness, and efficiency of care provided to patients with cancer.

Phone: 1-215-690-0300

3107506 Last Updated 9/15

Important Safety Information About ZOLADEX

  • 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 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 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.

Read full Prescribing Information for ZOLADEX 10.8 mg

Read full Prescribing Information for ZOLADEX 3.6 mg

 

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.

This site is intended for US consumers only.

The information on this Web site should not take the place of talking with your doctor or health care professional. If you have any questions about your condition, or if you would like more information about ZOLADEX, talk to your doctor or pharmacist. Only you and your health care professional can decide if ZOLADEX is right for you.