• Advanced prostate cancer.
• Central precocious puberty.
• Endometriosis (as monotherapy or in combination with norethindrone).
• Uterine fibroids (in combination with iron).

Contraindicated in:

• Hypersensitivity to GnRH agonists
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Hypersensitivity to benzyl alcohol (results in induration and erythema at SUBQ site)
• Congenital long QT syndrome, HF, electrolyte abnormalities, or concurrent use of other drugs known to prolong the QT interval
• Seizures, cerebrovascular disorders, CNS tumor, or concurrent use of bupropion or SSRIs
• Rep: Women of reproductive potential
• Pedi: Children <1 yr (safety and effectiveness not established).

CV: angina, arrhythmias, MI.
Depot: QT interval prolongation, vasodilation.

Derm: Depot: hair growth, rash, ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS (AGEP), DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN).
SUBQ: dry skin, hair loss, pigmentation, skin cancer, skin lesions.

EENT: blurred vision.
Depot: epistaxis, throat nodules.
SUBQ: hearing disorder.

Endo: breast swelling, breast tenderness, hot flushes, hyperglycemia.

F and E: hypercalcemia, lower extremity edema.

GI: anorexia, diarrhea, dysphagia, nausea, vomiting.
Depot: gingivitis, HEPATOTOXICITY, nonalcoholic fatty liver disease.
SUBQ: GI BLEEDING, hepatic impairment, peptic ulcer, rectal polyps.

GU: ↓fertility (males), ↓ libido, ↓ testicular size, dysuria, incontinence, testicular pain.
Depot: cervix disorder.
SUBQ: bladder spasm, penile swelling, prostate pain, urinary obstruction.

Local: burning, itching, swelling at injection site.

Metab: Depot: ↓bone density, hyperlipidemia, hyperuricemia.

MS: fibromyalgia, transient ↑ in bone pain (prostate cancer only).
SUBQ: ankylosing spondylitis, joint pain, pelvic fibrosis, temporal bone pain.

Neuro: SUBQ: aggression, anger, anxiety, dizziness, dysgeusia, headache, impatience, intracranial hypertension (children), irritability, lethargy, memory disorder, mood swings, peripheral neuropathy, SEIZURES, STROKE, syncope.
Depot: depression, drowsiness, intracranial hypertension (children), personality disorder.

Resp: hemoptysis, PULMONARY EMBOLISM.
SUBQ: cough, pleural rub, pulmonary fibrosis, pulmonary infiltrate.

Misc: chills, fever, tumor flare.
Depot: body odor.

Drug-Drug:

• ↑antineoplastic effects with antiandrogens (megestrol, flutamide).
• Bupropion or SSRIs may ↑ risk of seizures.
• QT interval prolonging drugs may ↑ risk of QT interval prolongation.

(Generic available)

• Emulsion for injection (Camcevi) (prefilled syringe): 42 mg;
• Lyophilized microspheres for depot injection (Lupron Depot): 3.75 mg; 7.5 mg; 11.25 mg; 22.5 mg; 30 mg; 45 mg;
• Lyophilized microspheres for depot injection (Lupron Depot-Ped): 7.5 mg; 11.25 mg; 15 mg; 30 mg; 45 mg;
• Lyophilized powder for injection (Fensolvi): 45 mg/vial;
• Polymeric matrix injectable formulation for injection (Eligard): 7.5 mg; 22.5 mg; 30 mg; 45 mg;
• Solution for injection (leuprolide acetate): 1 mg/0.2 mL;

Advanced Prostate Cancer

• SC (Adults): Leuprolide acetate: 1 mg/day; Eligard: 7.5 mg once monthly, 22.5 mg every 3 mo, 30 mg every 4 mo, or 45 mg every 6 mo. Camcevi: 42 mg every 6 mo.
• IM (Adults): Lupron Depot: 7.5 mg once monthly or 22.5 mg every 3 mo or 30 mg every 4 mo or 45 mg every 6 mo.

Endometriosis

• IM (Adults): Lupron Depot: 3.75 mg once monthly for up to 6 mo or 11.25 mg every 3 mo for up to 2 doses; if symptoms recur after initial course of therapy, may administer a 2nd course of therapy.

Uterine Fibroids

• IM (Adults): Lupron Depot: 3.75 mg once monthly for up to 3 mo or 11.25 mg single injection.

Central Precocious Puberty

• SC (Children 2 yr): Leuprolide acetate: 50 mcg/kg/day, may ↑ by 10 mcg/kg/day as required. Fensolvi: 45 mg every 6 mo.
• IM (Children 1 yr and >37.5 kg): Lupron Depot-Ped (monthly formulation): 15 mg every 4 wk; may ↑ by 3.75 mg every 4 wk as required.
• IM (Children 1 yr and 26–37.5 kg): Lupron Depot-Ped (monthly formulation): 11.25 mg every 4 wk; may ↑ by 3.75 mg every 4 wk as required.
• IM (Children 1 yr and 25 kg): Lupron Depot-Ped (monthly formulation): 7.5 mg every 4 wk; may ↑ by 3.75 mg every 4 wk as required.
• IM (Children 1 yr): Lupron Depot-Ped (3-month formulation)11.25 or 30 mg every 3 mo.
• IM (Children 1 yr): Lupron Depot-Ped (6-month formulation)45 mg every 6 mo.

Camcevi, Eligard, Fensolvi, Lupron, Lupron Depot, Lupron Depot-Ped

• Acts as an agonist of gonadotropin releasing hormone (GnRH) receptors.
• Initially causes a transient increase in testosterone; however, with continuous administration, testosterone levels are decreased.
• Reduces gonadotropins, testosterone, and estradiol.

• Decreased testosterone levels and resultant decrease in spread of prostate cancer.
• Reduction of pain/lesions in endometriosis.
• Decreased growth of fibroids.
• Delayed puberty.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: hormones, gonadotropin releasing hormones

Absorption: Rapidly and almost completely absorbed following SUBQ administration. More slowly absorbed following IM administration of depot form.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: 3 hr.

Zeulide Depot

(effect on hormone levels)

†Initial transient ↑ in testosterone and estradiol levels.

†Maximum decline in testosterone and estradiol levels.

iRestoration of normal pituitary-gonadal function; in amenorrheic patients, normal menses usually returns 60–90 days after treatment is discontinued.

• Explain purpose and side effects of leuprolide to patient.
• Advise patient to readPatient Information before starting therapy.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
• Advise patient that medication may cause hot flushes. Notify health care professional if these become bothersome.
• Leuprolide depot usually causes a temporary discontinuation of menstruation. Advise patient to notify health care professional if menstruation persists or if intermittent bleeding occurs.
• Inform patient of the possibility of the development or worsening of depression and occurrence of memory disorders.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during therapy. Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Advise patient that leuprolide may impair fertility.
• Prostate Cancer: Instruct patient and family on SUBQ injection technique. Review patient insert provided with leuprolide patient administration kit.
  • Instruct patient to take medication exactly as directed. Take missed doses as soon as remembered unless not remembered until next day.
  • Inform patient that bone pain may ↑ at initiation of therapy, but will resolve with time. Advise patient to discuss use of analgesics to control pain with health care professional.
  • Instruct patient to notify health care professional promptly if difficulty urinating, weakness, or numbness occurs.
• Endometriosis: Advise patient to use a form of contraception other than oral contraceptives during therapy. Inform patient that amenorrhea is expected but does not guarantee contraception. Advise patient that breastfeeding should be avoided during therapy.
• Central Precocious Puberty: Instruct patient and family on the proper technique for SUBQ injection. Emphasize the importance of administering the medication at the same time each day. Rotate injection sites periodically.
  • Inform patient and parents that if injections are not given daily, pubertal process may be reactivated.
  • Advise patient and parents that during the first 2 mo of therapy, patient may experience a light menstrual flow or spotting. Health care professional should be notified if this continues beyond 2nd mo.
  • Instruct patient and parents to notify health care professional immediately if irritation at the injection site or unusual signs or symptoms occur.

loo-PROE-lide

NDC Code^*

• 0074- AbbVie Inc.
  • 0074-2108- Lupron Depot-PED
    • 0074-2108-03- 1 KIT in 1 CARTON (0074-2108-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET

• 0074- AbbVie Inc.
  • 0074-2282- Lupron Depot-PED
    • 0074-2282-03- 1 KIT in 1 CARTON (0074-2282-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET

• 0074- AbbVie Inc.
  • 0074-2440- Lupron Depot-PED
    • 0074-2440-03- 1 KIT in 1 CARTON (0074-2440-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET

• 0074- AbbVie Inc.
  • 0074-3346- Lupron Depot
    • 0074-3346-03- 1 KIT in 1 CARTON (0074-3346-03) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET

• 0074- AbbVie Inc.
  • 0074-3473- Lupron Depot
    • 0074-3473-03- 1 KIT in 1 CARTON (0074-3473-03) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET

• 0074- AbbVie Inc.
  • 0074-3641- Lupron Depot
    • 0074-3641-03- 1 KIT in 1 CARTON (0074-3641-03) * 1 mL in 1 PACKET * 1 mL in 1 SYRINGE

• 0074- AbbVie Inc.
  • 0074-3641- Lupron Depot
    • 0074-3641-71- 1 KIT in 1 CARTON (0074-3641-71) * 1 mL in 1 PACKET * 1 mL in 1 SYRINGE

• 0074- AbbVie Inc.
  • 0074-3642- Lupron Depot
    • 0074-3642-03- 1 KIT in 1 CARTON (0074-3642-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET

• 0074- AbbVie Inc.
  • 0074-3663- Lupron Depot
    • 0074-3663-03- 1 KIT in 1 CARTON (0074-3663-03) * 1 mL in 1 PACKET * 1.5 mL in 1 SYRINGE

• 0074- AbbVie Inc.
  • 0074-3683- Lupron Depot
    • 0074-3683-03- 1 KIT in 1 CARTON (0074-3683-03) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET

• 0074- AbbVie Inc.
  • 0074-3779- Lupron Depot-PED
    • 0074-3779-03- 1 KIT in 1 CARTON (0074-3779-03) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET

• 0074- AbbVie Inc.
  • 0074-9694- Lupron Depot-PED
    • 0074-9694-03- 1 KIT in 1 CARTON (0074-9694-03) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET

• 0781- Sandoz Inc
  • 0781-4003- Leuprolide Acetate
    • 0781-4003-32- 1 KIT in 1 CARTON (0781-4003-32) * 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3006-42) > 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET

• 47335- Sun Pharmaceutical Industries, Inc.
  • 47335-936- leuprolide acetate
    • 47335-936-40- 1 KIT in 1 CARTON (47335-936-40) * 1 mL in 1 PACKET * 1 VIAL, MULTI-DOSE in 1 CARTON > 2.8 mL in 1 VIAL, MULTI-DOSE

• 62935- TOLMAR PHARMACEUTICALS INC.
  • 62935-223- ELIGARD
    • 62935-223-05- 1 KIT in 1 CARTON (62935-223-05) *.375 mL in 1 SYRINGE (62935-224-05) *.375 mL in 1 SYRINGE (62935-221-04)

• 62935- TOLMAR PHARMACEUTICALS INC.
  • 62935-303- ELIGARD
    • 62935-303-30- 1 KIT in 1 CARTON (62935-303-30) *.5 mL in 1 SYRINGE (62935-305-29) *.5 mL in 1 SYRINGE (62935-304-30)

• 62935- TOLMAR PHARMACEUTICALS INC.
  • 62935-453- ELIGARD
    • 62935-453-45- 1 KIT in 1 CARTON (62935-453-45) *.375 mL in 1 SYRINGE (62935-455-45) *.375 mL in 1 SYRINGE (62935-454-44)

• 62935- TOLMAR PHARMACEUTICALS INC.
  • 62935-753- ELIGARD
    • 62935-753-75- 1 KIT in 1 CARTON (62935-753-75) *.25 mL in 1 SYRINGE (62935-755-75) *.25 mL in 1 SYRINGE (62935-154-50)