Goserelin

Cervical resistance may be increased; use caution when dilating the cervix for endometrial ablation.

Has been reported in women and may be irreversible; use caution if other risk factors are present; evaluate and institute preventive treatment if necessary.

Hypercalcemia has been reported in prostate and breast cancer patients with bone metastases. Initiate appropriate management if hypercalcemia occurs.

Hyperglycemia has been reported in males and may manifest as diabetes or worsening of preexisting diabetes (worsening glycemic control). Monitor blood glucose and HbA1c and manage diabetes appropriately.

Hypersensitivity reactions (including acute anaphylactic reactions) and antibody formation may occur; monitor.

Injection site and vascular injury, including pain, hematoma, hemorrhage and hemorrhagic shock (requiring blood transfusions or surgical intervention) have been reported with goserelin. Use extra caution when administering to patients with a low BMI and/or to patients receiving full dose anticoagulation. Use caution while injecting goserelin into the anterior abdominal wall (due to the proximity of underlying inferior epigastric artery and its branches). Monitor for signs/symptoms of abdominal hemorrhage. Inform patient to immediately report abdominal pain, abdominal distention, dyspnea, dizziness, hypotension, and/or altered level of consciousness.

Rare cases of pituitary apoplexy (frequently secondary to pituitary adenoma) have been observed with GnRH agonist administration (onset from 1 hour to usually • Tumor flare: Transient increases in serum testosterone (in men with prostate cancer) and estrogen (in women with breast cancer) may result in a worsening of disease signs and symptoms (tumor flare) during the first few weeks of treatment. Some patients experienced a temporary worsening of bone pain, which may be managed symptomatically. Spinal cord compression and urinary tract obstruction have been reported when used for prostate cancer; closely observe patients for symptoms (eg, ureteral obstruction, weakness, paresthesias) in first few weeks of therapy. Manage with standard treatment; consider orchiectomy for extreme cases. Disease-related concerns:

Androgen deprivation therapy may increase the risk for cardiovascular disease (Levine, 2010). An increased risk for MI, sudden cardiac death, and stroke has been observed. Monitor for signs/symptoms of cardiovascular disease; manage according to current clinical practice. Androgen deprivation therapy may cause prolongation of the QT/QTc interval; evaluate risk versus benefit in patients with congenital long QT syndrome, heart failure, frequent electrolyte abnormalities, and in patients taking medication known to prolong the QT interval. Correct electrolytes prior to initiation and consider periodic electrolyte and ECG monitoring. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

A decreased AUC may be observed when using the 3-month implant in obese patients. Monitor testosterone levels if desired clinical response is not observed.

Use extra care when administering to patients with a low BMI.

Women of childbearing potential should not receive therapy until pregnancy has been excluded. Nonhormonal contraception is recommended during therapy and for 12 weeks after therapy is discontinued. Chronic administration may result in effects on reproductive function due to antigonadotropic properties. Dosage form specific issues:

If removal is necessary, implant may be located by ultrasound.