Usual Adult Dose for Prostate Cancer

IM:
LUPRON DEPOT:
7.5 mg IM every 4 weeks
OR
22.5 mg IM every 12 weeks
OR
30 mg IM every 16 weeks
OR
45 mg IM every 24 weeks

IMPLANT:
VIADUR IMPLANT:
65 mg inserted subcutaneously in the inner aspect of the upper arm every 12 months

SUBCUTANEOUS:
CAMCEVI:
42 mg subcutaneously every 6 months

ELIGARD:
7.5 mg subcutaneously once a month
OR
22.5 mg subcutaneously every 3 months
OR
30 mg subcutaneously every 4 months
OR
45 mg subcutaneously every 6 months

Comments:

• Treatment is usually continued in patients who are treated with gonadotropin-releasing hormone (GnRH) analogs and who develop non-metastatic and metastatic castration-resistant prostate cancer.
• Implant: The manufacturer product information should be consulted regarding insertion and removal techniques.

Uses:

• Palliative treatment of advanced prostate cancer
• Treatment of advanced prostate cancer

Usual Adult Dose for Endometriosis

LUPRON DEPOT
Endometriosis:
LUPRON DEPOT 3.75 mg:

• Initial treatment: 3.75 mg IM once a month for up to 6 months
• Retreatment: 3.75 mg IM once a month for 1 to 6 months
• Duration of treatment: Up to 12 months

OR
LUPRON DEPOT 11.25 mg: 11.25 mg IM every 3 months

• Duration of treatment: Up to 12 months

Uterine Leiomyomata:
3.75 mg IM once a month for up to 3 months
OR
11.25 mg IM once

Uses:

• Management of endometriosis (including pain relief and reduction of endometriotic lesions)
• With norethindrone for the initial management of endometriosis symptoms and for management of recurrent symptoms
• Preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata/fibroids

Usual Adult Dose for Uterine Leiomyomata

LUPRON DEPOT
Endometriosis:
LUPRON DEPOT 3.75 mg:

• Initial treatment: 3.75 mg IM once a month for up to 6 months
• Retreatment: 3.75 mg IM once a month for 1 to 6 months
• Duration of treatment: Up to 12 months

OR
LUPRON DEPOT 11.25 mg: 11.25 mg IM every 3 months

• Duration of treatment: Up to 12 months

Uterine Leiomyomata:
3.75 mg IM once a month for up to 3 months
OR
11.25 mg IM once

Uses:

• Management of endometriosis (including pain relief and reduction of endometriotic lesions)
• With norethindrone for the initial management of endometriosis symptoms and for management of recurrent symptoms
• Preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata/fibroids

Usual Pediatric Dose for Precocious Puberty

1 year and older:
IM INJECTION:
1-MONTH DEPOT INJECTION:
25 kg or less: 7.5 mg IM once a month
Greater than 25 kg to 37.5 kg: 11.25 mg IM once a month
Greater than 37.5 kg: 15 mg IM once a month
3-MONTH DEPOT INJECTION:
11.25 or 30 mg IM every 3 months
6-MONTH DEPOT INJECTION:
45 mg IM every 6 months

Comments:

• Doses should be titrated to the individual.
• To ensure adequate pituitary gonadotropin suppression, hormone levels should be assessed after 1 to 2 months (for 1-month injections) or 2 to 3 months (for 3-month injections) of therapy and with each dose change.
• Once a dose that results in adequate hormonal suppression has been determined, it can often be maintained for the duration of therapy in most children; however, hormonal suppression should be verified as weight can increase significantly while on therapy.
• Therapy should be discontinued at the appropriate age of onset of puberty, at the discretion of the physician.

2 years and older:
SUBCUTANEOUS INJECTION:
Fensolvi: 45 mg subcutaneously every 6 months

Comments:

• The dosage should be adjusted for weight changes.
• Central precocious puberty (CPP) is defined as early onset of secondary sexual characteristics (earlier than 8 years in girls and 9 years in boys) associated with pubertal pituitary gonadotropin activation; it may show a significantly advanced bone age that can result in diminished adult height.

Use: Treatment of patients with CPP

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Pediatric patients: If adequate hormonal and clinical suppression is not achieved with the starting dose, the dose should be increased to the next available higher dose (e.g., 11.25 mg or 15 mg at the next monthly injection).

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• Hypersensitivity to gonadotropin-releasing hormone (GnRH), GnRH agonist analogs
• Children (Viadur)
• Female patients (Viadur)
• Pregnancy (Lupron Depot-Ped)
• Lactation
• Undiagnosed abnormal uterine bleeding (Lupron Depot)

Eligard; Lupron Depot; Viadur; Camcevi: Safety and efficacy have not been established in patients younger than 18 years.
LUPRON DEPOT-PED: Safety and efficacy have not been established in patients younger than 1 year.
LUPRON DEPOT 3.75 mg: Safety and efficacy have not been established in premenarcheal pediatric patients.
Fensolvi: Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• The injection site should be varied periodically.
• Avoid areas with brawny or fibrous subcutaneous tissue or locations that could be rubbed or compressed (e.g., with a belt or clothing waistband).
• Discontinuation of therapy should be considered at the appropriate age for the onset of puberty.
• Refer to the respective prescribing information for more information.

Storage requirements:

• Store between 20 to 25C (68 to 77F). Excursions permitted to 15 to 30C (59 to 86F).
• The manufacturer product information should be consulted.

Reconstitution/preparation techniques:

• The manufacturer product information should be consulted.

General:
Limitation of use:

• Subcutaneous formulations should be administered by a healthcare provider.
• Use of LUPRON DEPOT 3.75 mg plus add-back therapy should not exceed 12 months due to the adverse impact on bone mineral density.
• Concurrent use with norethindrone acetate add-back therapy for preoperative hematologic improvement in women with anemia caused by fibroid-related heavy menstrual bleeding is not recommended.
• LUPRON DEPOT 3.75 mg is not indicated in postmenopausal women and has not been studied in this population.

Monitoring:

• Endocrine: Testosterone levels following injection; GnRH stimulation test, basal luteinizing hormone (LH) or serum concentration of sex steroids per manufacturer recommendations
• Metabolic: Blood glucose and/or glycosylated hemoglobin (HbA1c) periodically; body weight, height, and bone age every 6 to 12 months during treatment in pediatric patients
• Musculoskeletal: Bone mineral density
• Cardiovascular: Cardiac function
• Psychiatric: Depression
• Nervous system disorders: Signs and symptoms of pseudotumor cerebri, including headache, papilledema, blurred vision, diplopia, loss of vision, pain behind the eye or pain with eye movement, tinnitus, dizziness, and nausea.

Patient advice:

• Read the FDA-approved patient labeling (Medication Guide).
• This drug can influence the ability to drive and use machines.
• Advise females of reproductive potential to use a non-hormonal method of contraception during treatment with this drug.
• Advise patients and caregivers to monitor for headache and vision issues.
• Contact your healthcare provider if you develop any signs or symptoms of Pseudotumor Cerebri.
• Injection site related adverse reactions may occur.
• Development or worsening of depression and the occurrence of memory disorders are possible.
• Patients should be informed that if any doses are missed, breakthrough bleeding or ovulation may occur, with the possibility of conception.

Frequently asked questions

• Will I get my period while on Lupron?
• What does this drug do for IVF?
• Are Lupron Depot and Eligard the same drug?
• Can you get pregnant on Lupron Depot?
• Is Firmagon (degarelix) the same as Lupron?
• Is Supprelin LA the same as Lupron?