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ZOLADEX
Breast cancer
Endometriosis
Prostate and other male cancers
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Drug Name:

ZOLADEX Rx

Generic Name and Formulations:
Goserelin (as acetate) 3.6mg; SC implant.

Company:
TerSera Therapeutics

Therapeutic Use:

Indications for ZOLADEX:

Palliative treatment of advanced breast cancer in pre- and perimenopausal women.

Adult:

Implant SC into anterior abdominal wall. One 3.6mg implant every 28 days.

Children:

Not established.

Warnings/Precautions:

Males: 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 1st month of therapy. Females: nondiagnosed abnormal vaginal bleeding: not recommended. Risk factors for decreased bone mineral density (eg, chronic alcohol, tobacco, anticonvulsants, corticosteroids). Premenopausal women: use nonhormonal contraception during and for 12 weeks after discontinuation of therapy. 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. Pregnancy (Cat.D). Nursing mothers: not recommended.

Interactions:

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

Pharmacological Class:

GnRH agonist.

Adverse Reactions:

Females: hypoestrogenism (eg, hot flashes, headache, sweating, acne, emotional lability, depression, decreased libido, vaginitis, breast atrophy, seborrhea, peripheral edema). Males: decreased testosterone levels (eg, hot flashes, sexual dysfunction, decreased erections, gynecomastia), lower urinary tract symptoms. Both: transient worsening of symptoms (eg, bone pain), tumor flare, diarrhea, nausea, edema, malaise, hyperglycemia, hypercalcemia, decreased bone mineral density, QT prolongation.

How Supplied:

Implant (in syringe)—1

Indications for ZOLADEX:

Management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. Endometrial thinning prior to endometrial ablation for dysfunctional uterine bleeding.

Adult:

Implant SC into anterior abdominal wall. ≥18yrs: Endometriosis: one 3.6mg implant every 28 days, for up to 6 months. Retreatment: not recommended. Endometrial thinning: one 3.6mg implant, do surgery at 4 weeks. Or, may give a second 3.6mg implant 4 weeks after the first, and do surgery within 2–4 weeks after the second implant.

Children:

<18yrs: not established.

Contraindications:

Pregnancy (Cat.X).

Warnings/Precautions:

Nondiagnosed abnormal vaginal bleeding: not recommended. Use nonhormonal contraception during and for 12 weeks after discontinuation 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. Hyperlipidemia. Nursing mothers: not recommended.

Interactions:

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

Pharmacological Class:

GnRH agonist.

Adverse Reactions:

Endometriosis: hot flushes, headache, sweating, acne, emotional lability, depression, decreased libido, vaginitis, breast atrophy, seborrhea, peripheral edema. Endometrial thinning: headache, hot flushes, hypertension, vasodilatation, sweating, vulvovaginitis, increased cervical resistance. Hyperglycemia, decreased bone mineral density, elevated liver enzymes and lipids, QT prolongation.

How Supplied:

Implant (in syringe)—1

Indications for ZOLADEX:

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

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.

Contraindications:

Pregnancy (Cat.X).

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 1st 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.

Interactions:

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

See Also:

ZOLADEX 3-MONTH 10.8mg

Pharmacological Class:

GnRH agonist.

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.

How Supplied:

Implant (in syringe)—1

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