TM Owner AbbVie
Lupron Depot 22.5mg Kit (prefilled dual-chamber syringe, depot suspension for IM injection)
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Indications & Clinical Uses
- Lupron Depot 22.5 mg (leuprolide acetate for depot suspension) is a long-acting gonadotropin-releasing hormone (GnRH) agonist given as a single INTRAMUSCULAR injection ONCE EVERY 12 WEEKS, that is every 3 months, by a healthcare provider.
- At this strength it is indicated for the treatment of advanced prostate cancer in adult men, where it lowers testosterone to castrate levels; the same prostate-cancer label also covers 7.5 mg every 4 weeks, 30 mg every 16 weeks and 45 mg every 24 weeks.
- CRITICAL DISTINCTIONS: Lupron Depot strengths are matched to specific dosing intervals and are NOT interchangeable with one another, the prostate-cancer strengths are separate from the 3.75 mg and 11.25 mg gynaecological products used for endometriosis and fibroids and from Lupron Depot-PED, and Lupron Depot is NOT interchangeable with daily subcutaneous Lupron injection, which is discontinued in the United States.
- It is reconstituted and injected by a clinician, never self-administered.
Side Effects
- This Lupron Depot label carries NO boxed warning, and its absence is stated here deliberately so that it is not mistaken for an omission.
- The commonest effects follow the loss of testosterone: hot flushes and sweats were reported by roughly 46% to 58% of men across the formulations, with general pain, injection-site reactions, tiredness, reduced libido and impotence, testicular atrophy, breast tenderness, stomach and urinary symptoms, and mood change.
- Because testosterone rises by about 50% above baseline before it falls, a tumour flare can occur in the first weeks.
- Seek urgent help for new leg weakness, numbness, difficulty walking or loss of bladder or bowel control, which may mean spinal cord compression, or for a sudden fall in urine output.
- Also report chest pain, breathlessness, palpitations, fainting, or signs of stroke, since androgen deprivation is linked to heart attack, sudden cardiac death, stroke and QT prolongation.
- Severe skin reactions and convulsions have been reported.
- Blood sugar and bone density should be watched.
Precautions & Warnings
- Lupron Depot 22.5 mg is a depot suspension for INTRAMUSCULAR injection only, reconstituted immediately before use and given by a healthcare provider - it is never self-injected, never given subcutaneously and never given intravenously.
- Check the strength against the intended interval before every dose: 22.5 mg is the 12-week product and giving it monthly would be a serious overdose.
- It is contraindicated in pregnancy and in women who may become pregnant, because it can cause fetal harm, and in hypersensitivity to GnRH agonists.
- Men with vertebral metastases or urinary tract obstruction need close observation during the first few weeks of treatment.
- Monitor testosterone and prostate-specific antigen, blood glucose and HbA1c, lipids, blood pressure and bone mineral density, and assess cardiovascular risk before and during treatment.
- Report a history of QT prolongation, electrolyte disturbance, heart failure, seizures, depression or diabetes.
- Store the kit between 20C and 25C, with excursions permitted from 15C to 30C.
Avoid Interactions
- Tell your healthcare provider about every medicine, herbal product and supplement you take.
- No drug-drug interaction studies have been conducted with Lupron Depot; leuprolide acetate is a peptide and is not expected to interact through cytochrome P450 enzymes, so pharmacokinetic interactions are unlikely.
- The interaction that matters clinically is additive QT prolongation: extra care is needed with class IA and class III antiarrhythmics such as quinidine, procainamide, amiodarone and sotalol, with methadone, and with QT-prolonging antipsychotics, antidepressants, macrolides and fluoroquinolones, and any low potassium or magnesium should be corrected first.
- Effectiveness is reduced by androgens and testosterone supplements, which oppose the intended fall in testosterone, so these must be avoided.
- Bone loss is increased by long-term corticosteroids, anticonvulsants, heavy alcohol and smoking.
- Because the depot suppresses the pituitary-gonadal system, results of pituitary gonadotropic and gonadal function tests taken during treatment and for up to three months afterwards can be misleading.
- The reconstituted suspension must not be mixed with any other medicine.
References
Frequently Asked Questions
Lupron Depot 22.5 mg (leuprolide acetate) treats advanced prostate cancer in adult men. This GnRH agonist lowers testosterone to castrate levels, slowing cancer growth. The 22.5 mg strength is the 3-month depot; other strengths cover 4-week, 16-week and 24-week intervals.
Lupron Depot 22.5 mg (leuprolide acetate) is given as a single intramuscular injection once every 12 weeks, that is every 3 months, by a healthcare provider. It is mixed immediately before use and is never self-injected, never given under the skin and never into a vein.
Hot flushes and sweats affect roughly half of men on Lupron Depot (leuprolide acetate), along with general pain, injection-site reactions, tiredness, reduced sex drive, impotence and testicular shrinkage. Report leg weakness, trouble walking or loss of bladder control urgently, as these can signal spinal cord compression.
Avoid testosterone supplements and androgens, which oppose Lupron Depot (leuprolide acetate). Extra care is needed with QT-prolonging medicines such as amiodarone, sotalol, methadone and some antipsychotics and antibiotics. Long-term steroids, anticonvulsants, heavy alcohol and smoking worsen bone loss. It must never be used in pregnancy.
No. Each Lupron Depot (leuprolide acetate) strength is matched to one interval: 7.5 mg every 4 weeks, 22.5 mg every 12 weeks, 30 mg every 16 weeks and 45 mg every 24 weeks. Giving the 22.5 mg depot monthly would be a serious overdose. Always check strength against interval.
Men on Lupron Depot (leuprolide acetate) have testosterone and prostate-specific antigen checked regularly, plus blood glucose and HbA1c, blood lipids, blood pressure and bone mineral density. Cardiovascular risk is reviewed because androgen deprivation is linked to heart attack, sudden cardiac death and stroke.
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