TM Owner Accord BioPharma (US MAH)
Leuprolide Mesylate Depot 42mg Injectable emulsion, prefilled syringe (subcutaneous)
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Indications & Clinical Uses
- "Leuprolide Mesylate Depot" is not itself an approved brand name.
- The only leuprolide mesylate depot product is CAMCEVI, a 42 mg injectable emulsion supplied in a single prefilled syringe, and the information here comes from the CAMCEVI United States prescribing information and the European CAMCEVI EPAR.
- CAMCEVI contains leuprolide mesylate (leuprorelin mesilate), a gonadotropin-releasing hormone agonist that suppresses testosterone to castrate levels.
- In the United States it is approved for the treatment of adults with advanced prostate cancer; in the European Union it is approved for hormone-dependent advanced prostate cancer and, together with radiotherapy, for high-risk localised and locally advanced hormone-dependent prostate cancer.
- One 42 mg dose is injected under the skin by a healthcare professional once every six months.
- CAMCEVI is NOT interchangeable with Eligard or Lupron Depot, which are leuprolide acetate products with different strengths, such as 7.5 mg monthly, and different schedules.
Side Effects
- In the CAMCEVI study the commonest reactions were hot flushes in about 50 out of 100 men, high blood pressure in about 15, injection site reactions in about 11, upper respiratory infections in about 11, muscle and joint pain in about 11, tiredness in about 10, pain in the arms or legs in about 10, joint pain in about 7, urinary urgency and night-time urination in about 6 each, and dizziness in about 5.
- Blood tests can show raised triglycerides, liver enzymes and blood sugar.
- CAMCEVI has NO boxed warning.
- In the first weeks testosterone rises briefly before it falls, which can temporarily worsen bone pain or make passing urine difficult — this is tumour flare.
- Get urgent help for numbness, weakness or trouble walking, which can signal spinal cord compression, and for chest pain, breathlessness, sudden weakness, fainting or a severe blistering rash.
Precautions & Warnings
- CAMCEVI is given only by a healthcare professional, as a subcutaneous injection once every six months.
- It is never self-injected and must not be given into a vein or a muscle.
- It must not be used by anyone with a known allergy to gonadotropin-releasing hormone, to GnRH agonist analogues or to any ingredient, and it is not for women or children.
- Testosterone and PSA are measured to confirm that treatment is working.
- Because androgen deprivation increases the risk of heart attack, sudden cardiac death and stroke, and can prolong the QT interval, cardiovascular risk factors and blood electrolytes are reviewed, and blood sugar and HbA1c are monitored because hyperglycaemia and new diabetes have been reported.
- Convulsions and severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
- CAMCEVI can cause fetal harm and can impair fertility.
- The prefilled syringe is stored at 2°C to 8°C in its original packaging, protected from light.
Avoid Interactions
- Tell the treating team about every medicine and supplement, including over-the-counter products.
- The CAMCEVI label describes no specific drug interaction studies, but medicines that prolong the QT interval — including class IA and class III antiarrhythmics, methadone, moxifloxacin and some antipsychotics — should be reviewed, because androgen deprivation therapy can itself prolong the QT interval.
- Medicines that lower blood potassium or magnesium add to that risk.
- Diabetes medicines may need adjusting if blood sugar rises.
- CAMCEVI alters pituitary and gonadal hormone results, so tell any laboratory or clinician interpreting hormone tests that you are receiving it.
- Do not substitute CAMCEVI for Eligard or Lupron Depot, or the other way round: the salt, the strength and the dosing interval all differ and the products are not interchangeable.
References
Frequently Asked Questions
Camcevi 42 mg, the only leuprolide mesylate depot product, treats advanced prostate cancer in adult men. In the European Union it is also used with radiotherapy for high-risk localised and locally advanced hormone-dependent prostate cancer. It lowers testosterone to castrate levels by acting as a GnRH agonist.
Camcevi is given as a single 42 mg subcutaneous injection once every six months by a healthcare professional. It comes ready to use in a prefilled syringe and is never self-injected or given into a vein or muscle. Keeping to the six-month appointment maintains testosterone suppression.
The commonest Camcevi side effects are hot flushes, in about 50 out of 100 men, high blood pressure in about 15, injection site reactions in about 11, and tiredness, muscle and joint pain in about 10 to 11 each. Blood tests may show raised triglycerides, liver enzymes and blood sugar.
Avoid Camcevi if you are allergic to GnRH or GnRH agonist analogues; it is not for women or children. Medicines that prolong the QT interval, such as certain antiarrhythmics, methadone and some antipsychotics, need review because androgen deprivation can prolong QT. Tell laboratories that hormone results will be altered.
No. Camcevi contains leuprolide mesylate 42 mg given every six months, while Eligard and Lupron Depot contain leuprolide acetate in strengths such as 7.5 mg given monthly. The salt, strength and dosing interval all differ, so these products are not interchangeable and must never be substituted.
Testosterone and PSA are checked to confirm Camcevi is working. Blood sugar and HbA1c are monitored because hyperglycaemia and new diabetes have been reported, and cardiovascular risk factors and electrolytes are reviewed because androgen deprivation raises the risk of heart attack and stroke.
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