Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common, clinically significant adverse reactions occurring in >10% of men: hot flashes, sexual dysfunction, decreased erections and lower urinary tract symptoms ( 6 ) The adverse event profile was similar for women treated for breast cancer, dysfunctional uterine bleeding or endometriosis and included (>20%): hot flushes, headache, sweating, acne, emotional lability, depression, decreased libido, vaginitis, breast atrophy, seborrhea, and peripheral edema ( 6 ) Tumor flare can occur on the initiation of ZOLADEX for both men and women being treated for cancer ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact TerSera Therapeutics at 1-844-334-4035 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Stage B2-C Prostatic Carcinoma Treatment with ZOLADEX and flutamide did not add substantially to the toxicity of radiation treatment alone.
The following adverse experiences were reported during a multicenter clinical trial comparing ZOLADEX + flutamide + radiation versus radiation alone.
The most frequently reported (greater than 5%) adverse experiences are listed below: Table 1 ADVERSE EVENTS DURING ACUTE RADIATION THERAPY (within first 90 days of radiation therapy) (n=231) flutamide + ZOLADEX + Radiation % All (n=235) Radiation Only % All Rectum/Large Bowel 80 76 Bladder 58 60 Skin 37 37 Table 2 ADVERSE EVENTS DURING LATE RADIATION PHASE (after 90 days of radiation therapy) (n=231) flutamide + ZOLADEX + Radiation % All (n=235) Radiation Only % All Diarrhea 36 40 Cystitis 16 16 Rectal Bleeding 14 20 Proctitis 8 8 Hematuria 7 12 Additional adverse event data was collected for the combination therapy with radiation group over both the hormonal treatment and hormonal treatment plus radiation phases of the study.
Adverse experiences occurring in more than 5% of patients in this group, over both parts of the study, were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%).
6.2 Prostatic Carcinoma ZOLADEX has been found to be generally well tolerated in clinical trials.
Adverse reactions reported in these trials were rarely severe enough to result in the patients’ withdrawal from ZOLADEX treatment.
As seen with other hormonal therapies, the most commonly observed adverse events during ZOLADEX therapy were due to the expected physiological effects from decreased testosterone levels.
These included hot flashes, sexual dysfunction and decreased erections.
Tumor Flare Phenomenon: Initially, ZOLADEX, like other GnRH agonists, causes transient increases in serum levels of testosterone.
5 WARNINGS AND PRECAUTIONS Women of Childbearing Potential and Pregnancy: Pregnancy must be excluded for use in benign gynecological conditions.
Women should avoid pregnancy ( 5.1 ) Tumor Flare Phenomenon: Transient worsening of tumor symptoms may occur during the first few weeks of treatment with ZOLADEX, which may include ureteral obstruction and spinal cord compression.
Monitor patients at risk for complications of tumor flare ( 5.2 , 6.2 ) Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs.
Monitor blood glucose level and manage according to current clinical practice ( 5.3 ) Cardiovascular Diseases: Increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH analogs in men.
Monitor for cardiovascular disease and manage according to current clinical practice ( 5.4 ) Hypercalcemia: Hypercalcemia has been reported in patients with bone metastases treated with ZOLADEX.
Like all medications, Zoladex can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: