Advanced prostate cancer

HR+ advanced breast cancer | Advanced prostate cancer | Endometriosis

ZOLADEX for advanced prostate cancer
Practice support and reimbursement resources
Patient education and FAQs
Resources

ZOLADEX for advanced prostate cancer

Consider ZOLADEX for your appropriate patients with advanced prostate cancer. ZOLADEX is a gonadotropin-releasing hormone (GnRH) agonist indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.

ZOLADEX is also indicated for use in the palliative treatment of advanced carcinoma of the prostate. For the management of advanced prostate cancer, ZOLADEX is intended for long-term administration unless clinically inappropriate.

ZOLADEX is available in two dosages. At a dose of 10.8 mg, ZOLADEX should be administered subcutaneously every 12 weeks into the anterior abdominal wall below the navel line, using an aseptic technique. At a dose of 3.6 mg, ZOLADEX should be administered subcutaneously every 28 days. While a delay of a few days is permissible, every effort should be made to adhere to the dosing schedule (every 12 weeks for the 10.8-mg implant and every 28 days for the 3.6-mg implant). Instructions for proper administration are demonstrated in the administration video.

The most commonly observed adverse reactions during ZOLADEX treatment for prostatic carcinoma were due to the expected physiological effects from decreased testosterone levels. The most common adverse reactions (incidence of >5% in prostate clinical trials) were:

  • For ZOLADEX 3.6 mg: Hot flashes (62%), sexual dysfunction (21%), decreased erections (18%), lower urinary tract symptoms (13%), lethargy (8%), pain (worsened in the first 30 days) (8%), edema (7%), upper respiratory infection (7%), rash (6%), and sweating (6%)
  • For ZOLADEX 10.8 mg: Hot flashes (64%), pain (general) (14%), gynecomastia (8%), pelvic pain (6%), and bone pain (6%)

In the locally advanced carcinoma of the prostate clinical trial, additional adverse event data were collected for the combination therapy with radiation group during both the hormonal treatment and hormonal treatment plus radiation phases of this study. Adverse experiences (incidence >5%) in both phases of this study were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%). Treatment with ZOLADEX and flutamide did not add substantially to the toxicity of radiation treatment alone.

Please see additional Important Safety Information below and the full Prescribing Information for ZOLADEX 10.8 mg and ZOLADEX 3.6 mg.

Practice support and reimbursement resources

For information on practice support and reimbursement resources, click here.

FAQs

See and share the answers to frequently asked questions about ZOLADEX that patients may ask. These answers can help patients understand what ZOLADEX is, how it works, and what they may expect from therapy with ZOLADEX for advanced prostate cancer. Go to the patient FAQs.

Resources

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.


Professional resources to support you

www.auanet.org

The American Urological Association is a premier urologic association, providing invaluable support to the urologic community. Their mission is to promote the highest standards of urological clinical care through education, research, and the formulation of health care policy.

www.cancer.gov

The National Cancer Institute is part of the National Institutes of Health. The NCI is the federal government's principal agency for cancer research and training. The National Cancer Act of 1971 broadened the scope and responsibilities of the NCI and created the National Cancer Program. Over the years, legislative amendments have maintained the NCI authorities and responsibilities and added new information dissemination mandates as well as a requirement to assess the incorporation of state-of-the-art cancer treatments into clinical practice.


Resources to help you support your patients

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

3170005 Last Updated 9/15

Important Safety Information About ZOLADEX

  • Anaphylactic reactions to ZOLADEX have been reported in the medical literature. ZOLADEX is contraindicated in patients with a known hypersensitivity to GnRH, GnRH agonist analogues, or any of the components in ZOLADEX
  • ZOLADEX is contraindicated during pregnancy unless used for palliative treatment of advanced breast cancer. ZOLADEX can cause fetal harm when administered to a pregnant woman. If used during pregnancy, the patient should be apprised of the potential hazard to the fetus. There is an increased risk for pregnancy loss due to expected hormonal changes that occur with ZOLADEX treatment. ZOLADEX should not be given to women with undiagnosed abnormal vaginal bleeding
  • Pregnancy must be excluded for use in benign gynecological conditions. Women should be advised against becoming pregnant while taking ZOLADEX. Effective nonhormonal contraception must be used by all premenopausal women during ZOLADEX therapy and for 12 weeks following discontinuation of therapy
  • Transient worsening of tumor symptoms, or the occurrence of additional signs and symptoms of breast cancer, may occasionally develop during the first few weeks of treatment. Some patients may experience a temporary increase in bone pain. Monitor patients at risk for complications of tumor flare
  • Hyperglycemia and an increased risk of developing diabetes or worsening of glycemic control in patients with diabetes have been reported in men receiving GnRH agonists like ZOLADEX. Monitor blood glucose levels and glycosylated hemoglobin (HbA1c) periodically and manage according to current clinical practice
  • Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists like ZOLADEX in men. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice
  • Hypercalcemia has been reported in some prostate and breast cancer patients with bone metastases after starting treatment with ZOLADEX. If hypercalcemia does occur, appropriate treatment measures should be initiated
  • Hypersensitivity, antibody formation and acute anaphylactic reactions have been reported with GnRH agonist analogues
  • ZOLADEX may cause an increase in cervical resistance. Therefore, caution is recommended when dilating the cervix for endometrial ablation
  • Androgen deprivation therapy may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes
  • Injection site injury and vascular injury including pain, hematoma, hemorrhage and hemorrhagic shock, requiring blood transfusions and surgical intervention, have been reported with ZOLADEX. Extra care should be taken when administering ZOLADEX to patients with low BMI and/or to patients receiving full dose anticoagulation
  • Treatment with ZOLADEX may be associated with a reduction in bone mineral density over the course of treatment. Data suggest a possibility of partial reversibility. In women, current available data suggest that recovery of bone loss occurs on cessation of therapy in the majority of patients
  • In women the most frequently reported adverse reactions were related to hypoestrogenism. The adverse reaction profile was similar for women treated for breast cancer, dysfunctional uterine bleeding, and endometriosis
  • The most commonly reported adverse reactions with ZOLADEX in clinical trials for endometriosis were: hot flashes (96%), vaginitis (75%), headache (75%), decreased libido (61%), emotional lability (60%), depression (54%), sweating (45%), acne (42%), breast atrophy (33%), seborrhea (26%), and peripheral edema (21%)
  • The most commonly reported adverse reactions with ZOLADEX in clinical trials for endometrial thinning were: vasodilation/hot flashes (57%), headache (32%), sweating (16%), and abdominal pain (11%)
  • The most commonly reported adverse reactions with ZOLADEX in breast cancer clinical trials were hot flashes (70%), decreased libido (47.7%), tumor flare (23%), nausea (11%), edema (5%), and malaise/fatigue/lethargy (5%). Injection site reactions were reported in less than 1% of patients
  • The most commonly observed adverse reactions during ZOLADEX treatment for prostatic carcinoma were due to the expected physiological effects from decreased testosterone levels. The most common adverse reactions (incidence of >5% in prostate clinical trials) were:
    • For ZOLADEX 3.6-mg: Hot flashes (62%), sexual dysfunction (21%), decreased erections (18%), lower urinary tract symptoms (13%), lethargy (8%), pain (worsened in the first 30 days) (8%), edema (7%), upper respiratory infection (7%), rash (6%), and sweating (6%)
    • For ZOLADEX 10.8-mg: Hot flashes (64%), pain (general) (14%), gynecomastia (8%), pelvic pain (6%), and bone pain (6%)
  • In the locally advanced carcinoma of the prostate clinical trial, additional adverse event data were collected for the combination therapy with radiation group during both the hormonal treatment and hormonal treatment plus radiation phases of this study. Adverse experiences (incidence >5%) in both phases of this study were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%). Treatment with ZOLADEX and flutamide did not add substantially to the toxicity of radiation treatment alone

Indications

  • Management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate in combination with flutamide. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy
  • Palliative treatment of advanced carcinoma of the prostate
  • Management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. Experience with ZOLADEX for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months
  • Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding
  • Palliative treatment of advanced breast cancer in pre- and perimenopausal women

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.