Eligard

What is Eligard?

• Eligard (leuprolide acetate) is a gonadotropin releasing hormone (GnRH) agonist used for the palliative treatment of advanced prostate cancer.

Leuprorelin

Leuprorelin ball-and-stick

What are the uses of this medicine?

• Eligard (leuprolide acetate) is used for the palliative treatment of advanced prostate cancer.

How does this medicine work?

• Leuprolide acetate, a gonadotropin releasing hormone (GnRH) agonist, acts as a potent inhibitor of gonadotropin secretion when given continuously in therapeutic doses.
• In humans, administration of leuprolide acetate results in an initial increase in circulating levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH), leading to a transient increase in levels of the gonadal steroids (testosterone and dihydrotestosterone in males, and estrone and estradiol in premenopausal females).
• However, continuous administration of leuprolide acetate results in decreased levels of LH and FSH.
• These decreases occur within two to four weeks after initiation of treatment.
• Long-term studies have shown that continuation of therapy with leuprolide acetate maintains testosterone below the castrate level for up to seven years.
• This may stop the growth of cancer cells that need testosterone to grow.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• hypersensitivity to GnRH, GnRH agonist analogs or any of the components of Eligard

What drug interactions can this medicine cause?

• No pharmacokinetic drug-drug interaction studies were conducted with Eligard.

Is this medicine FDA approved?

• Leuprorelin was patented in 1973 and approved for medical use in the United States in 1985.

How should this medicine be used?

Recommended dosage:

• 7.5 mg subcutaneously every month.
• 22.5 mg subcutaneously every 3 months.
• 30 mg subcutaneously every 4 months.
• 45 mg subcutaneously every 6 months.

Administration:

• Eligard is administered subcutaneously and provides continuous release of leuprolide acetate over a one-, three-, four-, or six-month treatment period.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injectable suspension: 7.5 mg
• Injectable suspension: 22.5 mg
• Injectable suspension: 30 mg
• Injectable suspension: 45 mg

This medicine is available in fallowing brand namesː

• Eligard

What side effects can this medication cause?

The most common side effects of this medicine include:

• Malaise
• fatigue
• hot flashes/sweats
• testicular atrophy
• decreased bone density
• rare cases of pituitary apoplexy

What special precautions should I follow?

• Transient increase in serum levels of testosterone during treatment may result in worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, bladder outlet obstruction, ureteral obstruction, or spinal cord compression. Monitor patients at risk closely and manage as appropriate.
• 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.
• Response to Eligard® should be monitored by periodic measurement of serum concentrations of testosterone and prostate specific antigen. In the majority of patients, testosterone levels increased above Baseline during the first week, declining thereafter to Baseline levels or below by the end of the second or third week.
• Increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in men. Monitor for cardiovascular disease and manage according to current clinical practice.
• Androgen deprivation therapy may prolong the QT interval. Consider risks and benefits.
• Based on findings in animal studies and mechanism of action, leuprolide acetate may cause fetal harm when administered to a pregnant woman. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.
• Convulsions have been observed in patients with or without a history of predisposing factors. Manage convulsions according to the current clinical practice.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Management of overdosage:

Can this medicine be used in pregnancy?

• Based on findings in animal studies and mechanism of action, Eligard may cause fetal harm when administered to a pregnant woman.
• Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.

Can this medicine be used in children?

• The safety and effectiveness of Eligard in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• LEUPROLIDE ACETATE

Inactive ingredients:

• METHYL PYRROLIDONE
• POLY(DL-LACTIC-CO-GLYCOLIC ACID)

Who manufactures and distributes this medicine?

Manufactured by:

• Tolmar, Inc.
• Fort Collins, CO
• for: Tolmar Therapeutics, Inc.
• Fort Collins, CO

Distributed by:

• Tolmar Pharmaceuticals, Inc.
• Fort Collins, CO

What should I know about storage and disposal of this medication?

• Store at 2 - 8 °C (35.6 - 46.4 °F)
• Once outside the refrigerator this product may be stored in its original packaging at room temperature 15 – 30 °C (59 – 86 °F) for up to eight weeks prior to mixing and administration.

• Dailymed label info on Eligard
• FDA Eligard