ZOLADEX 3-MONTH 10.8mg Dosage & Rx Info

Zoladex 3-month 10.8mg Generic Name & Formulations

Legal Class

General Description

Goserelin (as acetate) 10.8mg; SC implant.

Pharmacological Class

GnRH agonist.

How Supplied

Implant (in syringe)—1

Manufacturer

TerSera Therapeutics

Mechanism of Action

Zoladex is a synthetic decapeptide analogue of GnRH. It acts as an inhibitor of pituitary gonadotropin secretion when administered in the biodegradable formulation.

Zoladex 3-month 10.8mg Indications

Indications

Palliative treatment of advanced prostate carcinoma. In combination with flutamide for management of locally confined Stage T2b-T4 (Stage B2-C) prostate carcinoma.

Zoladex 3-month 10.8mg Dosage and Administration

Adult

Implant SC into anterior abdominal wall. Prostate cancer: one 3.6mg implant every 28 days or one 10.8mg implant every 12 weeks. Stage B2-C prostatic carcinoma (in combination with flutamide): Treat 8 weeks prior to and during radiotherapy. Initially one 3.6mg implant, followed in 28 days by one 10.8mg implant; or may use one 3.6mg implant every 28 days (two before and two during radiotherapy).

Children

Not established.

Zoladex 3-month 10.8mg Contraindications

Contraindications

Pregnancy.

Zoladex 3-month 10.8mg Boxed Warnings

Not Applicable

Zoladex 3-month 10.8mg Warnings/Precautions

Warnings/Precautions

Increased risk of diabetes, MI, sudden cardiac death, stroke; monitor blood glucose and for signs/symptoms of CVD during therapy. Risk of ureteral obstruction or spinal cord compression; monitor during 1^st month of therapy. Risk factors for decreased bone mineral density (eg, chronic alcohol, tobacco, anticonvulsants, corticosteroids). Risk of QT prolongation in congenital long QT syndrome, CHF, electrolyte abnormalities; monitor EKG and correct electrolyte abnormalities if needed. Risk of inj site injury in patients with low BMI and/or receiving full dose anticoagulation. Obesity; monitor testosterone if no clinical response. Nursing mothers: not recommended.

Zoladex 3-month 10.8mg Pharmacokinetics

Distribution

Plasma protein bound: 27.3%.

Metabolism

Hepatic.

Elimination

Renal (>90%). Half-life: 4–5 hours.

Zoladex 3-month 10.8mg Interactions

Interactions

Avoid concomitant drugs known to prolong the QT interval. May affect tests of pituitary-gonadotropic and gonadal functions.

Zoladex 3-month 10.8mg Adverse Reactions

Adverse Reactions

Decreased testosterone levels (eg, hot flashes, sexual dysfunction, decreased erections, gynecomastia), lower urinary tract symptoms, transient worsening of symptoms (eg, bone pain), tumor flare, diarrhea, nausea, edema, malaise, hyperglycemia, hypercalcemia, decreased bone mineral density, QT prolongation.

Zoladex 3-month 10.8mg Clinical Trials

See Literature

Zoladex 3-month 10.8mg Note