Lupron Depot

What is Lupron Depot?

• Lupron Depot 3.75 mg(leuprolide acetate) is a gonadotropin-releasing hormone (GnRH) agonist is used alone or with another medication (norethindrone) to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms).
• Leuprolide injection 3.75 mg (Lupron Depot) is also used with other medication to treat anemia (a lower than normal number of red blood cells) caused by uterine fibroids (noncancerous growths in the uterus).
• LUPRON DEPOT 7.5 mg is used for the treatment of advanced prostatic cancer.

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Leuprorelin

Leuprorelin ball-and-stick

What are the uses of this medicine?

• Lupron Depot 3.75 mg(leuprolide acetate) is used alone or with another medication (norethindrone) to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms).
• Leuprolide injection 3.75 mg(Lupron Depot) is also used with other medication to treat anemia (a lower than normal number of red blood cells) caused by uterine fibroids (noncancerous growths in the uterus).
• LUPRON DEPOT 7.5 mg is used for the treatment of advanced prostatic cancer.

Limitations of Use:

• The total duration of therapy with LUPRON DEPOT 3.75 mg plus add-back therapy should not exceed 12 months due to concerns about adverse impact on bone mineral density.
• LUPRON DEPOT 3.75 mg is not indicated for combination use with norethindrone acetate add-back therapy for the preoperative hematologic improvement of women with anemia caused by heavy menstrual bleeding due to fibroids.

How does this medicine work?

• Leuprolide acetate is a long-acting GnRH analog.
• A single monthly injection of LUPRON DEPOT 3.75 mg results in an initial stimulation followed by a prolonged suppression of pituitary gonadotropins.
• Repeated dosing of LUPRON DEPOT 3.75 mg at monthly intervals results in decreased secretion of gonadal steroid.
• Leuprolide acetate is not active when given orally.

Who Should Not Use this medicine ?

This medicine cannot be used in women with the following:

• Hypersensitivity to gonadotropin-releasing hormone (GnRH), GnRH agonist analogs, including leuprolide acetate, or any of the excipients in LUPRON DEPOT 3.75 mg
• Undiagnosed abnormal uterine bleeding
• Pregnancy

What drug interactions can this medicine cause?

• No formal drug-drug interaction studies have been conducted with LUPRON DEPOT.

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: Endometriosis:

• LUPRON DEPOT 3.75 mg administered as a single intramuscular (IM) injection once every month for up to six injections (6 months of therapy).
• LUPRON DEPOT may be administered alone or in combination with daily 5 mg tablet of norethindrone acetate (add-back).
• If endometriosis symptoms recur after initial course of therapy, retreatment for no more than six months may be considered but only with the addition of norethindrone acetate add-back therapy.
• Do not re-treat with LUPRON DEPOT 3.75 mg alone.

Fibroids:

• Recommended dose of LUPRON DEPOT 3.75 mg is one IM injection every month for up to three months.

Administration:

• LUPRON DEPOT 3.75 mg for 1-month administration, given as a single intramuscular injection.
• Do not substitute LUPRON DEPOT 3.75 mg for LUPRON DEPOT 11.25 mg.
• Do not administer LUPRON DEPOT 3.75 mg more frequently than once a month.
• Do not give a fractional dose of the LUPRON DEPOT 11.25 mg 3-month formulation, as it is not equivalent to a single dose of the LUPRON DEPOT 3.75 mg.
• Do not give a triple dose of the LUPRON DEPOT 3.75 mg, as it is not equivalent to a single dose of the LUPRON DEPOT 11.25 mg 3- month formulation.
• Reconstitute LUPRON DEPOT 3.75 mg prior to use.

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

This medicine is available in fallowing doasage form:

• As Depot suspension for injection: 3.75 mg lyophilized powder for reconstitution in a dual-chamber syringe
• As 7.5 mg, 22.5 mg, 30 mg, and 45 mg injections in a kit with prefilled dual chamber syringe.
• Depot suspension for injection: 11.25 mg lyophilized powder for reconstitution in a dual-chamber syringe.

This medicine is available in fallowing brand namesː

• LUPRON DEPOT

What side effects can this medication cause?

The most common side effects of this medicine include:

• hot flashes/sweats, headache/migraine, vaginitis, depression/emotional lability, general pain, weight gain/loss, nausea/vomiting, decreased libido, and dizziness

What special precautions should I follow?

• LUPRON DEPOT 3.75 mg results in loss of bone mineral density (BMD), some of which may not be reversible after stopping treatment. Duration of treatment is limited by risk of bone mineral density. When using for management of endometriosis: combination use with norethindrone acetate is effective in reducing loss of BMD; do not retreat without combination norethindrone acetate. Assess BMD before retreatment.
• LUPRON DEPOT May cause fetal harm. Exclude pregnancy before initiating treatment if clinically indicated and discontinue use if pregnancy occurs. Use non-hormonal methods of contraception only.
• Hypersensitivity reactions, including anaphylaxis, have been reported with LUPRON DEPOT 3.75 mg. LUPRON DEPOT 3.75 mg is contraindicated in women with a history of hypersensitivity to gonadotropin-releasing hormone (GnRH) or GnRH agonist analogs.
• If LUPRON is administered with norethindrone acetate, the warnings and precautions for norethindrone acetate apply to the combination regimen.
• There have been postmarketing reports of convulsions in women on GnRH agonists, including leuprolide acetate. These included women with and without concurrent medications and comorbid conditions.
• Depression may occur or worsen during treatment with GnRH agonists including LUPRON DEPOT 3.75 mg. Carefully observe women for depression, especially those with a history of depression and consider whether the risks of continuing LUPRON DEPOT 3.75 mg outweigh the benefits.

What to do in case of emergency/overdose?

• 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.

Can this medicine be used in pregnancy?

• LUPRON DEPOT 3.75 mg is contraindicated in pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of LUPRON DEPOT 3.75 mg for these indications have not been established in premenarcheal pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• LEUPROLIDE ACETATE

Inactive ingredients:

• ACETIC ACID
• WATER
• POLYSORBATE 80
• MANNITOL
• GELATIN, UNSPECIFIED
• CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED

Who manufactures and distributes this medicine?

Manufactured for:

• AbbVie Inc.
• North Chicago, IL 60064
• by Takeda Pharmaceutical Company Limited
• Osaka, Japan

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

• Store between 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F).

• Dailymed label info on Lupron Depot
• FDA Lupron Depot

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