leuprolide (Rx)

Brand and Other Names:Lupron, Lupron Depot, more...Lupron Depot 3 Month, Lupron Depot 4 Month, Lupron Depot 6 Month, Lupron Depot-Ped, Eligard, Fensolvi
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Eligard

  • 7.5mg (monthly)
  • 22.5mg (3 months)
  • 30mg (4 months)
  • 45mg (6 months)

Lupron Depot

  • 3.75mg (monthly)
  • 7.5mg (monthly)
  • 11.25mg (3 months)
  • 22.5mg (3 months)
  • 30mg (4 months)
  • 45mg (6 months)

Leuprolide acetate

  • 5mg/mL

Advanced Prostate Cancer

Lupron: 7.5 mg IM monthly, 22.5 mg IM every 3 months, 30 mg IM every 4 months, or 45 mg IM every 6 months

Eligard: 7.5 mg SC monthly, 22.5 mg SC every 3 months, 30 mg SC every 4 months, 45 mg SC every 6 months

Leuprolide acetate: 1 mg/0.2 mL/day SC

Monitoring

  • Measure prostate-specific antigen (PSA) in first few weeks of therapy; measure luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels and serum testosterone after 4 weeks of therapy

Endometriosis

3.75 mg IM monthly for up to 6 months or 11.25 mg IM every 3 months for 2 doses (6 months total)

Recommended duration of treatment is 6 months; may treat again for additional 6 months, but with concomitant administration of norethindrone

Uterine Leiomyomata (Fibroids)

3.75 mg IM monthly for up to 3 months or 11.25 mg IM once

Use concomitant iron treatment

Breast Cancer in Premenopausal Ovarian Ablation (Off-label)

3.75 mg IM every 28 days or 11.25 mg IM every 3 months for up to 24 months

Dosage Modifications

Renal or hepatic impairment

  • Pharmacokinetics of leuprolide have not been studied in renally and hepatically impaired patients

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • Reconstitution results in suspension for IM injection
  • monthly
    • 7.5 mg (Lupron Depot-Ped)
    • 11.25 mg (Lupron Depot-Ped)
    • 15 mg (Lupron Depot-Ped)
  • 3-month
    • 11.25 mg (Lupron Depot-Ped)
    • 30 mg (Lupron Depot-Ped)

kit, injectable suspension

  • Reconstitution results in suspension for IM injection
  • Kit contains 2 syringes (Fensolvi)
    • Syringe A contains diluent for reconstitution
    • Syringe B contains 45 mg lyophilized leuprolide acetate powder

injectable solution

  • 5mg/mL (generic)

Central Precocious Puberty

Indicated when signs of sexual maturity begin to develop in girls <8 years old and boys <9 years old; may be discontinued at appropriate age of onset of puberty (eg, 11 years in females and 12 years in males), at physician's discretion

<2 years old: Safety and efficacy not established

Lupron Depot-Ped (monthly dose)

  • <25 kg: 7.5 mg IM monthly
  • >25 kg to 37.5 kg: 11.25 mg IM monthly
  • >37.5 kg: 15 mg IM monthly
  • Assess response 1-2 months after initial injection; if adequate hormonal and clinical suppression not achieved with starting doses, increase next monthly dose to the next higher level

Lupron Depot-Ped (3-month dose)

  • 11.25 mg or 30 mg as single IM injection every 3 months (dose not based on weight)
  • Regardless of dose chosen, goals are to suppress pituitary gonadotropins and peripheral sex steroids and to arrest progression of secondary sexual characteristics
  • Assess response 2-3 months after initial injection and 6 months after injection

Leuprolide acetate

  • 50 mcg/kg/day SC; may be titrated upward by 10 mcg/kg/day if downregulation not achieved  

Fensolvi

  • 45 mg SC once q6months
  • Discontinue treatment at appropriate age of onset of puberty
  • If dose is not adequate, switching to an alternative GnRH agonist may be necessary

Dosage Modifications

Renal or hepatic impairment

  • Pharmacokinetics of leuprolide have not been studied in renally and hepatically impaired patients

Dosing Considerations

Monitoring

  • Monitor response with a GnRH agonist stimulation test, basal serum luteinizing hormone (LH) levels or serum concentration of sex steroid levels at 1-2 months following initiation and as needed to confirm adequate suppression of pituitary gonadotropins, sex steroids, and progression of secondary sexual characteristics
  • Measure height (for calculation of growth velocity) q3-6 months and monitor bone age periodically

  • Noncompliance with drug regimen or inadequate dosing may lead to gonadotropins and/or sex steroids increasing above prepubertal levels resulting in inadequate control of the pubertal process

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Interactions

Interaction Checker

and leuprolide

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            Adverse Effects

            >10%

            Fensolvi

            • Injection site pain (31%)
            • Nasopharyngitis (22%)
            • Pyrexia (17%)
            • Headache (16%)
            • Cough (13%)

            Lupron Depot-Ped (monthly)

            • Injection site reactions including abscess (37%)
            • Emotional lability (19%)
            • Acne/seborrhea (13%)
            • Vaginitis/vaginal bleeding or discharge (13%)
            • Rash including erythema multiforme (12%)
            • General pain (12%)
            • Headache (11%)

            Lupron Depot-Ped (q3months)

            • Injection site pain (19-21%)

            Lupron Depot (22.5 mg q3months)

            • Hot flashes/sweats (58.5%)
            • General pain (26.6%)
            • Testicular atrophy (20.2%)
            • Gastrointestinal disorders (16%)
            • Urinary disorders (14.9%)
            • Injection site reaction (13.8%)
            • Joint disorders (11.7%)

            1-10%

            Fensolvi

            • Abdominal pain (9%)
            • Injection site erythema (9%)
            • Nausea (8%)
            • Constipation (6%)
            • Vomiting (6%)
            • Upper respiratory tract infection (6%)
            • Bronchospasm (6%)
            • Productive cough (6%)
            • Hot flush (5%)
            • Emotional disorder (2%)
            • Irritability (2%)

            Eligard

            • <2%
              • General: Sweating, insomnia, syncope, rigors, weakness, lethargy
              • Gastrointestinal: Flatulence, constipation, dyspepsia
              • Hematologic: Decreased red blood cell count, hematocrit and hemoglobin
              • Metabolic: Weight gain
              • Musculoskeletal: Tremor, backache, joint pain, muscle atrophy, limb pain
              • Nervous: Disturbance of smell and taste, depression, vertigo
              • Psychiatric: Insomnia, depression, loss of libido
              • Renal/urinary: Difficulties with urination, pain on urination, scanty urination, bladder spasm, blood in urine, urinary retention, urinary urgency, incontinence, nocturia, nocturia aggravated
              • Reproductive/ urogenital: Testicular soreness/pain, impotence, decreased libido, gynecomastia, breast soreness/tenderness, testicular atrophy, erectile dysfunction, penile disorder, reduced penis size
              • Skin: Alopecia, clamminess, night sweats, sweating increased
              • Vascular: Hypertension, hypotension

            Lupron Depot-Ped (monthly)

            • Vasodilation (9%)
            • <2%
              • Body as a whole: Aggravation of preexisting tumor and decreased vision, allergic reaction, body odor, fever, flu syndrome, hypertrophy, infection
              • Cardiovascular system: Bradycardia, hypertension, peripheral vascular disorder, syncope
              • Digestive System: Constipation, dyspepsia, dysphagia, gingivitis, increased appetite, nausea/vomiting
              • Endocrine system: Accelerated sexual maturity, feminization, goiter
              • Hemic and lymphatic system: Purpura
              • Metabolic and nutritional disorders: Growth retarded, peripheral edema, weight gain
              • Musculoskeletal system: Arthralgia, joint disorder, myalgia, myopathy
              • Nervous system: Hyperkinesia, somnolence
              • Psychiatric system: Depression, nervousness
              • Respiratory system: Asthma, epistaxis, pharyngitis, rhinitis, sinusitis
              • Integumentary system (skin and appendages): Alopecia, hair disorder, hirsutism, leukoderma, nail disorder, skin hypertrophy
              • Urogenital system: Cervix disorder/neoplasm, dysmenorrhea, gynecomastia/breast disorders, menstrual disorder, urinary incontinence
              • Laboratory abnormality: Antinuclear antibody present and increased sedimentation rate

            Lupron Depot-Ped (q3months)

            • Increased weight (7%)
            • Headache (2-7%)
            • Altered mood (5%)
            • Injection site swelling (2%)

            Lupron Depot (7.5mg SC monthly)

            • <5%
              • Body as a whole: Asthenia, cellulitis, fever, headache, injection site reaction, neoplasm
              • Cardiovascular system: Angina, congestive heart failure
              • Digestive system: Anorexia, dysphagia, eructation, peptic ulcer
              • Hemic and lymphatic system: Ecchymosis
              • Laboratory abnormalities: Decreased albumin, decreased hemoglobin/hematocrit, decreased prostatic acid phosphatase, decreased total protein, decreased urine specific gravity, hyperglycemia, hyperuricemia, increased BUN, increased creatinine, increased liver function tests, increased phosphorus, increased platelets, increased prostatic acid phosphatase, increased total cholesterol, increased urine specific gravity, leukopenia
              • Musculoskeletal system: Myalgia
              • Nervous system: Agitation, insomnia/sleep disorders; neuromuscular disorders
              • Respiratory system: Emphysema, hemoptysis, lung edema, and sputum increased
              • Skin and appendages: Hair disorder, skin reaction
              • Urogenital system: Balanitis, breast enlargement, urinary tract infection

            Lupron Depot (22.5 mg q3months)

            • Neuromuscular disorders (9.6%)
            • Skin reaction (8.5%)
            • Insomnia/sleep disorders (8.5%)
            • Asthenia (7.4%)
            • Headache (6.4%)
            • Vertigo (6.4%)
            • Respiratory disorders (6.4%)
            • <5%

              • Body as a whole: Enlarged abdomen, fever
              • Cardiovascular system: Arrhythmia, bradycardia, heart failure, hypertension, hypotension, varicose vein
              • Digestive system: Anorexia, duodenal ulcer, increased appetite, thirst/dry mouth
              • Hemic and lymphatic system: anemia, lymphedema
              • Laboratory abnormalities: Increased BUN, hyperglycemia, hyperlipidemia, hyperphosphatemia, abnormal liver function tests, increased PT, increased PTT; decreased platelets, decreased potassium, increased WBC
              • Metabolic and nutritional disorders: dehydration, edema
              • Nervous system: Anxiety, delusions, depression, hypesthesia, libido decreased, nervousness, paresthesia
              • Respiratory system: Epistaxis, pharyngitis, pleural effusion, pneumonia
              • Special senses: Abnormal vision, amblyopia, dry eyes, tinnitus
              • Urogenital system - Gynecomastia, impotence, penis disorders, testis disorders

            Frequency Not Reported

            Lupron Depot-Ped (q3months)

            • Gastrointestinal disorders: Abdominal pain, nausea
            • General disorders and administration site conditions: Asthenia, gait disturbance, injection site abscess sterile, injection site hematoma, injection site induration, injection site warmth, irritability
            • Metabolic and nutritional disorders: Decreased appetite, obesity
            • Musculoskeletal and connective tissue disorders: Musculoskeletal pain, pain in extremity
            • Nervous system disorders: Dizziness
            • Psychiatric disorders: Crying, tearfulness
            • Respiratory, thoracic, and mediastinal disorders: Cough
            • Skin and SC tissue disorders: Hyperhidrosis
            • Vascular disorders: Pallor

            Postmarketing Reports

            Fensolvi

            • Allergic Reactions: Anaphylactic, rash, urticaria, and photosensitivity reactions
            • General: Chest pain, weight increase, weight decrease, decreased appetite, fatigue
            • Laboratory abnormalities: Decreased WBC
            • Metabolic: Diabetes mellitus.
            • Musculoskeletal and connective tissue: Arthralgia, epiphysiolysis, muscle spasms, myalgia
            • Neurologic: Neuropathy peripheral, convulsion, paralysis, insomnia
            • Psychiatric: Emotional lability, depression; rare reports of suicidal ideation and attempt, has been reported for GnRH agonists in pediatric patients treated for CPP
            • Skin and SC tissue: Injection-site reactions (eg, induration and abscess, flushing, hyperhidrosis)
            • Reproductive system: Vaginal bleeding, breast enlargement
            • Vascular: Hypertension, hypotension
            • Respiratory: Dyspnea

            Eligard

            • Pituitary apoplexy occurred within 2 weeks of the first dose, and some within the first hour; patients presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse; immediate medical attention has been required.
            • Nervous System-Convulsions
            • Respiratory System-Interstitial lung disease

            Lupron Depot

            • Cardiovascular system: Hypotension, myocardial infarction, pulmonary embolism
            • Respiratory, thoracic and mediastinal disorder: Interstitial lung disease
            • Hepatobiliary disorder: Serious drug-induced liver injury
            • Hemic and lymphatic system: Decreased WBC
            • Central/peripheral nervous system: Convulsion, peripheral neuropathy, spinal fracture/paralysis
            • Endocrine system: Diabetes
            • Musculoskeletal system: Tenosynovitis-like symptoms
            • Urogenital system: Prostate pain
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            Warnings

            Contraindications

            Hypersensitivity

            Pregnancy

            Cautions

            May cause fetal harm when administered to pregnant females

            Children and young adults

            • During early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug; therefore, an increase in clinical signs and symptoms of puberty including vaginal bleeding may be observed during the first weeks of therapy or after subsequent doses
            • Psychiatric adverse events or emotional lability, including crying, irritability, impatience, anger, and aggression, reported; many, but not all, patients had a history of psychiatric illness or other comorbidities with an increased risk of depression
            • Postmarketing reports of convulsions reported, including patients with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies, and patients on concomitant medications associated with convulsions such as bupropion and SSRIs

            Adults

            • Spinal cord compression reported; observe patients closely for weakness and paresthesias in first few weeks of therapy; observe patients with metastatic vertebral lesions closely
            • Tumor flare resulting from transient increases in testosterone, leading to bone pain, hematuria, bladder outlet obstruction, and neuropathy in prostate cancer patients reported during first few weeks of therapy
            • Closely observe patients for urinary tract obstruction and hematuria in first few weeks of therapy
            • Orchiectomy or luteinizing hormone agonists recommended as initial treatment for androgen deprivation in patients with advanced androgen sensitive prostate cancer
            • Decrease in bone density reported when drug used for >6 months; use caution if there are additional risk factors for bone loss, including corticosteroid therapy or chronic alcohol use
            • Worsening of endometriosis or uterine leiomyomata symptoms with therapy reported initially
            • Rare cases of pituitary apoplexy, frequently secondary to pituitary adenoma reported (onset 1hr to usually <2 weeks): may present as sudden headache, vomiting, visual or mental status changes and cardiovascular collapse (rare), requiring immediate medical attention
            • Worsening of glycemic control reported in men receiving GnRH agonists; monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving a GnRH agonist and manage with current practice for treatment of hyperglycemia or diabetes
            • Prostate cancer symptoms may worsen during initial treatment period
            • Androgen deprivation therapy may prolong the QT/QTc interval; consider whether benefits of androgen deprivation outweighs potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and patients taking drugs known to prolong the QT interval; correct electrolyte abnormalities and monitor ECG and electrolytes periodically
            • Men receiving GnRH agonists for prostate cancer have slightly increased risk of diabetes, heart attack, stroke, and sudden death
            • In women, duration of treatment with GnRH agonists not to exceed 1 year, except in treatment of breast cancer

            Therapy for hormone receptor-positive breast cancer

            • Ovarian suppression recommended for the following
              • Premenopausal women with higher-risk disease in addition to adjuvant endocrine therapy,
              • Addition to adjuvant chemotherapy in premenopausal women with stage II or stage III breast cancers
              • Stage I or II breast cancers at higher risk of recurrence in addition to endocrine therapy, who might consider chemotherapy
              • Women with stage I disease, which does not require chemotherapy should receive endocrine therapy but not ovarian suppression
              • Women with node-negative cancers <1 cm (T1A< T1B) should receive endocrine therapy, but not ovarian suppression

            Drug interaction overview

            • When using drug for management of endometriosis, combination use of norethindrone acetate (add-back therapy) is effective in reducing loss of BMD that occurs with leuprolide acetate; do not retreat with drug without combination norethindrone acetate; assess BMD before retreatment
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            Pregnancy & Lactation

            Pregnancy

            Contraindicated

            Based on animal data and mechanism of action, fetal harm may occur

            Insufficient data available to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

            Exclude pregnancy in females of reproductive potential prior to initiation

            Animal data

            • Associated with an increased risk of pregnancy complications may
            • SC administration to rabbits during organogenesis caused embryofetal toxicity, decreased fetal weights, and a dose-dependent increase in major fetal abnormalities in animals at doses less recommended human dose based on body surface area using an estimated daily dose

            Contraception

            • Females of reproductive potential: Not a contraceptive; if contraception is indicated, use a nonhormonal contraception during treatment

            Infertility

            • Based on its pharmacodynamic effects of decreasing secretion of gonadal steroids, fertility is expected to be decreased during treatment
            • Clinical and pharmacologic studies in adults (>18 years) with leuprolide acetate and similar analogs have shown reversibility of fertility suppression when discontinued after continuous administration for periods of up to 24 weeks
            • There is no evidence that pregnancy rates are affected following discontinuation
            • Animal studies (prepubertal and adult rats and monkeys) with leuprolide acetate and other GnRH analogs have shown functional recovery of fertility suppression

            Lactation

            No data available on presence of leuprolide acetate in either animal or human milk, effects on breastfed infants, or effects on milk production

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Agonist analogue of luteinizing hormone-releasing hormone (LHRH)

            When administered continuously, decreases LH and FSH levels by acting as potent inhibitor of gonadotropin secretion; decrease in LH and FSH levels followed by suppression of ovarian and testicular steroidogenesis; testosterone levels reduced to below castrated levels in males

            Absorption

            Mean trough plasma level

            • Lupron Depot-Ped: 0.77 ng/mL (7.5-mg monthly dose); 1.25 ng/mL (11.25-mg monthly dose); 1.59 ng/mL (15-mg monthly dose)

            Peak plasma concentration

            • Fensolvi: 212.3 ng/mL (4-hr postdose)

            Distribution

            VD (steady-state): 27 L (healthy males)

            Protein bound: 43-49% (healthy males)

            Metabolism

            Metabolized to smaller inactive peptides, a pentapeptide (metabolite I), tripeptides (metabolites II and III), and a dipeptide (metabolite IV); these fragments may be further catabolized

            Elimination

            Half-life: 3 hr

            Clearance: 8.34 L/hr

            Excretion

            • Lupron Depot-Ped: Urine (<5% as parent and major pentapeptide metabolite)
            • Fensolvi or Eligard: Not studied
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            Administration

            Preparation

            Lupron Depot-Ped or Lupron

            • Screw in plunger into end until stopper begins to turn
            • Hold syringe upright; release diluent by slowly pushing (6-8 sec) plunger is at the blue line
            • Keep syringe upright; mix thoroughly by gently shaking syringe until powder forms into uniform suspension; suspension should appear milk
            • Visually inspect syringe; do not use if clumping or caking is evident; a thin layer of powder on the wall of the syringe and diluent should appear clear
            • Does not contain preservatives; use suspension immediately or discard within 2 hr

            Fensolvi

            • Allow product to reach room temperature before reconstitution to allow for easier administration
            • Join the 2 syringes together by pushing and gently screwing until secure
            • Inject liquid contents of Syringe A into the leuprolide acetate powder contained in Syringe B
            • Thoroughly mix for ~45 seconds by pushing the contents back and forth between both syringes to obtain a uniform suspension; the suspension will appear pale yellow
            • Once reconstituted, the concentration is 45 mg/0.375 mL
            • Administer within 30 minutes or discard

            Eligard

            • Allow product to reach room temperature before reconstitution to allow for easier administration
            • Join the 2 syringes together by pushing and gently screwing until secure
            • Inject liquid contents of Syringe A into the leuprolide acetate powder contained in Syringe B
            • Thoroughly mix for ~45 seconds by pushing the contents back and forth between both syringes to obtain a uniform suspension; the suspension will appear light tan to tan, or colorless to pale yellow; DO NOT shake
            • After mixing, hold syringes vertically with Syringe B on the bottom; draw entire mixed product into Syringe B by depressing the Syringe A plunger; unscrew Syringe A to decouple the syringes
            • Note: Small air bubbles will remain in the formulation which is acceptable
            • Hold Syringe B vertically; attach needle to Syringe B; do not over twist the needle onto the syringe because the thread may become stripped

            IM Administration

            Lupron Depot-Ped or Lupron

            • Administer IM by inserting needle at a 90º angle into gluteal area, anterior thigh, or shoulder; alternate injection sites
            • Discard all components safely in an appropriate biohazard container

            SC Administration

            Fensolvi or Eligard

            • Select SC injection site on the abdomen, upper buttocks, or another location with adequate amounts of SC tissue that does not have excessive pigment, nodules, lesions, or hair
            • Avoid areas with brawny or fibrous SC or locations that could be rubbed or compressed (eg, by a belt or clothing waistband); rotate injection sites with each injection
            • Using dominant hand, insert the needle quickly at a 90° angle to the skin surface; slowly inject; press down on the plunger until the syringe is empty
            • Discard all components safely in an appropriate biohazard container

            Storage

            Leuprolide acetate (generic)

            • Unused vial: Store below 25ºC (77ºF); do not freeze; protect from light; store vial in carton until use

            Lupron Depot-Ped or Lupron

            • Undiluted: Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
            • Reconstituted suspension: If not used immediately, discard after 2 hr

            Eligard or Fensolvi

            • Refrigerate at 2-8ºC (35.6-46.4ºF)
            • Once outside the refrigerator, store at room temperature 15-30ºC (59-86ºF) in its original packaging for up to 8 weeks before reconstitution and administration
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            Images

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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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