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goserelin (Rx)Brand and Other Names:Zoladex, Zoladex LA

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

implant

  • 3.6mg
  • 10.8mg
more...

Prostate Cancer

Monthly implant: 3.6 mg SC q28days

3-months implant: 10.8 mg SC q12week

Treat long-term

Place in upper abdominal wall

Breast Cancer

3.6 mg implant SC q28days

Treat long-term

Place in upper abdominal wall

Endometriosis

3.6 mg implant SC q28days

Treat for 6 months

Place in upper abdominal wall

Endometrial Thinning

3.8 mg SC q28days for 1 or 2 doses

Renal Impairment

Dose adjustment not necessary

Hepatic Impairment

Dose adjustment not necessary

Safety and efficacy not established

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Interactions

Interaction Checker

goserelin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Flushing (46-96%)

            Vaginitis (5-75%)

            Hot flashes (62%)

            Reduced libido (47-61%)

            Mood swings (60%)

            Depression (women 54%)

            Sweating (16-45%)

            Acne (42%)

            Diarrhea (40%)

            Breast atrophy (33%)

            Headache (women 32-75%)

            Seborrhea (26%)

            Tumor flare (23%)

            Sexual dysfunction (21%)

            Peripheral edema (21%)

            Erectile dysfunction (18%)

            Pain (8-17%)

            UTI (13%)

            1-10%

            Nausea (9%)

            Lethargy (8%)

            Rash (6%)

            Chronic obstructive pulmonary disease (5%)

            Congestive heart failure(5%)

            Cerebrovascular accident (1-5%)

            Renal impairment (1-5%)

            Headache (men 1-5%)

            Depression (men 1-5%)

            Immune hypersensitivity reaction (>1%)

            Frequency Not Defined

            Asthenia

            Hypercalcemia

            Cystitis

            Dysmenorrhea

            Hirsutism

            Dyspareunia

            Breast changes

            Implant site reactions

            Bone pain

            Spinal cord compression (rare)

            Postmarketing Reports

            Bone mineral density: Osteoporosis, decreased bone mineral density, bony fracture in men

            Cardiovascular: DVT, PE, MI, stroke, TIA observed in women treated with GnRH agonists

            Ovarian cyst: Ovarian cyst formation and, in combination with gonadotropins, ovarian hyperstimulation syndrome

            Changes in blood pressure: Hypotension and hypertension

            Pituitary apoplexy and tumors: Pituitary apoplexy

            Acne: Usually within 1 month of starting treatment

            Other: Psychotic disorders, convulsions, mood swings

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            Warnings

            Contraindications

            Hypersensitivity to LHRH, LHRH-agonists, any component of product

            Pregnancy (for endometriosis), lactation, undiagnosed abnormal vaginal bleeding

            Cautions

            Manifestations of disease may worsen at beginning of therapy

            Increase in cervical resistance may occur; caution is recommended when dilating the cervix for endometrial ablation

            Avoid pregnancy; premenopausal women should use nonhormonal contraception until >12 wk following end of treatment

            Risk of reduced glucose tolerance in men

            Males at risk of ureteral obstruction or spinal compression

            Risk of pituitary apoplexy (rare)

            Ongoing analysis found that men receiving GnRH agonists for prostate cancer were at a small increased risk for diabetes, heart attack, stroke, and sudden death

            Do not exceed 1 year treatment duration with GnRH angonists in women except when treating breast cancer

            Androgen deprivation therapy may prolong the QT interval; consider risks and benefits

            Hypercalcemia has been reported in patients with bone metastases treated with goserelin; monitor and manage appropriately

            Increased risk of myocardial infarction, sudden cardiac death and stroke reported in association with use of GnRH analogs in men; monitor for cardiovascular disease and manage according to current clinical practice

            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

            Pregnancy must be excluded for use in benign gynecological conditions

            Transient worsening of tumor symptoms may occur during first few weeks of therapy, which may include ureteral obstruction and spinal cord compression; monitor patients at risk for complications of tumor flare

            Injection site injury and vascular injury including pain, hematoma, hemorrhage and hemorrhagic shock, requiring blood transfusions and surgical intervention, reported; use extra care when administering to patients with low BMI and/or to patients receiving full dose anticoagulation

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            Pregnancy & Lactation

            Pregnancy Category: D (advanced breast cancer); X (endometriosis, endometrial thinning)

            Lactation: excretion in milk unknown; not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Gonadotropin-releasing hormone (LHRH) analog; chronic stimulation of goserelin results in suppresion of LH, FSH serum levels

            Pharmacokinetics

            Half-Life: 2-4 hr

            Protein Bound: 27%

            Time to Peak: 12-15 days (male); 8-22 days (female)

            Vd: 44.1 L (Male); 20.3 L (female)

            Excretion: Urine (90%)

            Absorption

            • 3.6 mg: absorbed slowly during first 8 days, then more rapid continuous release
            • 10.8 mg: peak level within 24 hr, then decline until day 4, then concentrations stabilize
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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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