Goserelin
ZOLADEX
Pronunciation: GOE-se-rel-in
“Goose’s Solar (rolo)dex”
What it isGnRH receptor agonist implant; prostate and breast cancer, endometriosis.
Why this oneA subcutaneous depot gives one to three months of suppression from a single implant.
What limits itAn initial testosterone or estrogen flare requires cover. Bone loss and vasomotor symptoms with prolonged use.
FDA-approved for
- Prostate cancer (1989)
- breast cancer (1989)
- endometriosis (1989)
- endometrial thinning (1989)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Stage B2-C (T2b-T4) prostate cancer, with radiotherapy + flutamide | Men | 3.6 mg SC implant 8 weeks pre-radiotherapy | 3.6 mg depot then 10.8 mg depot 28 days later; OR four 3.6 mg depots q28 days (2 before, 2 during radiotherapy) | Per regimen |
| Advanced prostate cancer | Men | 3.6 mg SC implant q28 days | 3.6 mg SC q28 days, long-term | 3.6 mg q28 days |
| Endometriosis | Women >=18 yr | 3.6 mg SC implant q28 days | 3.6 mg SC q28 days x 6 months | 6-month course (retreatment not recommended) |
| Endometrial thinning before ablation | Women | 3.6 mg SC implant x 1-2 depots (4 weeks apart) | 1 depot: surgery at 4 weeks; 2 depots: surgery 2-4 weeks after second | 2 depots |
| Advanced breast cancer | Women | 3.6 mg SC implant q28 days | 3.6 mg SC q28 days, long-term | 3.6 mg q28 days |
Renal No adjustment needed
Hepatic No adjustment needed
Endometriosis limited to 6 months; retreatment not recommended (no safety data)
Instructions
- SC implant into anterior abdominal wall below navel, by physician, aseptic technique; every effort to keep 28-day schedule (few days' delay permissible)
- Caution: inferior epigastric artery proximity; extra care with low BMI or full-dose anticoagulation; do not penetrate muscle/peritoneum
- If a vessel is penetrated (blood in chamber), withdraw and inject new syringe elsewhere; monitor for abdominal hemorrhage
- Endometriosis: consider HRT add-back to reduce bone mineral loss
Available strengths
- implant 3.6, 10.8 mg
- inj 3.6, 10.8 mg
Contraindications
- Pregnancy, unless used for palliative treatment of advanced breast cancer (fetal harm; pregnancy-loss risk)
- Known hypersensitivity to GnRH, GnRH agonist analogues, or any component (anaphylaxis reported)
Cautions
- Exclude pregnancy before use for benign gynecologic conditions; nonhormonal contraception during and 12 weeks after therapy
- Tumor flare: transient testosterone/estrogen surge; ureteral obstruction and spinal cord compression reported
- Hyperglycemia/new diabetes in men on GnRH agonists — monitor glucose/HbA1c
- Increased MI, sudden cardiac death, stroke risk in men — monitor
- Hypercalcemia in patients with bone metastases
- Severe cutaneous adverse reactions (SJS/TEN, DRESS, AGEP) — interrupt if suspected; discontinue permanently if confirmed
- QT/QTc prolongation with androgen deprivation therapy
- Injection site/vascular injury incl. hemorrhage and hemorrhagic shock
- Depression may occur or worsen in women
- Increased cervical resistance — care when dilating cervix
- Bone mineral density loss (endometriosis use)
Adverse reactions
- Men (>10%): hot flashes, sexual dysfunction, decreased erections, lower urinary tract symptoms
- Women (>20%): hot flushes, headache, sweating, acne, emotional lability, depression, decreased libido, vaginitis, breast atrophy, seborrhea, peripheral edema
- Tumor flare at initiation (both sexes)
Pregnancy Contraindicated unless palliative advanced breast cancer; can cause fetal harm and pregnancy loss
Lactation Unknown if in human milk; discontinue nursing or drug, weighing importance to mother
Cost
| Strength | #/mo | generic $/unit | CostPlus | |
|---|---|---|---|---|
| 3.6 mg | implant | per unit | not offered | |
| 10.8 mg | implant | per unit | not offered |
NO BOXED WARNINGS
Principal riskInitial hormone flare; bone loss with prolonged use
Classes and tags
Clinical profile
Defining liabilityBone loss, hypogonadism and initial tumor flare