Lupron Depot
(Leuprolide Acetate)Dosage & Administration
LUPRON DEPOT 11.25mg for 3-month administration, given by a healthcare provider as a single intramuscular injection.
LUPRON DEPOT 11.25 mg has different release characteristics than LUPRON 3.75 mg and is dosed differently. (
LUPRON DEPOT 11.25 mg must be administered by a healthcare professional.
LUPRON DEPOT 11.25 mg for 3-month administration has different release characteristics than LUPRON 3.75 mg for 1-month administration and is dosed differently.
The initial and retreatment dosage regimens for LUPRON DEPOT 11.25 mg for the management of women with endometriosis are outlined in Table 1.
Treatment Phase | LUPRON DEPOT 11.25 mg Dosing | Maximum Treatment Duration |
| Initial Treatment1 | 11.25 mg IM every 3 months for 1 to 2 doses | 6 months |
| Retreatment2 | 11.25 mg IM every 3 months for 1 to 2 doses | 6 months |
| 12 MONTHS3 TOTAL TREATMENT DURATION |
1May use LUPRON DEPOT 11.25 mg with or without norethindrone acetate 5 mg tablet taken daily.
2Use LUPRON DEPOT 11.25 mg with norethindrone acetate for retreatment 5 mg tablet taken daily
3Treatment should not exceed 12 months due to concerns about adverse impact on bone mineral density.
The recommended dosage of LUPRON DEPOT 11.25 mg is one IM injection of 11.25 mg which provides a three-month treatment course.
Reconstitute LUPRON DEPOT 11.25 mg prior to use. (
1. Visually inspect the LUPRON DEPOT 11.25 mg powder.
2. To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn (see Figure Aand Figure B).
Figure A:
Figure B:
3. Hold the syringe UPRIGHT. Release the diluent by SLOWLY PUSHING the plunger for 6 to 8 seconds until the first middle stopper is
Figure C:
4. Keep the syringe
Figure D:
5. Keep the syringe
6. Keep the syringe
7. After cleaning the injection site with an alcohol swab, administer the IM injection by inserting the needle at a 90-degree angle into the gluteal area, anterior thigh, or deltoid. Injection sites should be alternated (see Figure E).
Figure E:
Figure F:
8. Inject the entire contents of the syringe intramuscularly.
9. Withdraw the needle. Once the syringe has been withdrawn, immediately activate the LuproLoc®safety device by pushing the arrow on the lock upward towards the needle tip with the thumb or finger, as illustrated, until the needle cover of the safety device over the needle is fully extended and a
Figure G:
10. Dispose of the syringe according to local regulations/procedures.
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Lupron Depot Prescribing Information
Warnings and Precautions, Severe Cutaneous Adverse Reactions (5.3 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCARs) have been reported in patients receiving GnRH agonists, including LUPRON DEPOT. These reactions include Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), including cases with visceral involvement and/or requiring skin grafts [see Adverse Reactions ( 6.2 )]. Monitor patients for the signs and symptoms of SCARs such as fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy. Advise patients of the signs and symptoms of SCARs. If a SCAR is suspected, discontinue LUPRON DEPOT 11.25 mg. Consult with a healthcare provider with expertise in the diagnosis and management of SCARs. If a diagnosis of SCAR is confirmed, permanently discontinue LUPRON DEPOT 11.25 mg. | 9/2025 |
LUPRON DEPOT 11.25 mg is a gonadotropin-releasing hormone (GnRH) agonist indicated for:
- Management of endometriosis, including pain relief and reduction of endometriotic lesions. ()1.1 EndometriosisMonotherapy
LUPRON DEPOT 11.25 mg is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions.
In Combination with Norethindrone AcetateLUPRON DEPOT 11.25 mg in combination with norethindrone acetate is indicated for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms.
Use of norethindrone acetate in combination with LUPRON DEPOT 11.25 mg is referred to as add-back therapy, and is intended to reduce the loss of bone mineral density (BMD) and reduce vasomotor symptoms associated with use of LUPRON DEPOT 11.25 mg.
Limitations of Use:The total duration of therapy with LUPRON DEPOT 11.25 mg plus add-back therapy should not exceed 12 months due to concerns about adverse impact on bone mineral density
[see Dosage and Administration(2.1)andWarnings and Precautions(5.1)]. - In combination with a norethindrone acetate for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms. ()1.1 EndometriosisMonotherapy
LUPRON DEPOT 11.25 mg is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions.
In Combination with Norethindrone AcetateLUPRON DEPOT 11.25 mg in combination with norethindrone acetate is indicated for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms.
Use of norethindrone acetate in combination with LUPRON DEPOT 11.25 mg is referred to as add-back therapy, and is intended to reduce the loss of bone mineral density (BMD) and reduce vasomotor symptoms associated with use of LUPRON DEPOT 11.25 mg.
Limitations of Use:The total duration of therapy with LUPRON DEPOT 11.25 mg plus add-back therapy should not exceed 12 months due to concerns about adverse impact on bone mineral density
[see Dosage and Administration(2.1)andWarnings and Precautions(5.1)].
- The total duration of therapy with LUPRON DEPOT 11.25 mg plus add-back therapy should not exceed 12 months due to concerns about adverse impact on bone mineral density. (,1.1 EndometriosisMonotherapy
LUPRON DEPOT 11.25 mg is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions.
In Combination with Norethindrone AcetateLUPRON DEPOT 11.25 mg in combination with norethindrone acetate is indicated for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms.
Use of norethindrone acetate in combination with LUPRON DEPOT 11.25 mg is referred to as add-back therapy, and is intended to reduce the loss of bone mineral density (BMD) and reduce vasomotor symptoms associated with use of LUPRON DEPOT 11.25 mg.
Limitations of Use:The total duration of therapy with LUPRON DEPOT 11.25 mg plus add-back therapy should not exceed 12 months due to concerns about adverse impact on bone mineral density
[see Dosage and Administration(2.1)andWarnings and Precautions(5.1)].,2.1 Important Use InformationLUPRON DEPOT 11.25 mg must be administered by a healthcare professional.
LUPRON DEPOT 11.25 mg for 3-month administration has different release characteristics than LUPRON 3.75 mg for 1-month administration and is dosed differently.
- Do not substitute LUPRON DEPOT 11.25 mg for LUPRON DEPOT 3.75 mg.
- Do not administer LUPRON DEPOT 11.25 mg more frequently than every 3 months.
- Do not give a fractional dose of the LUPRON DEPOT 11.25 mg, as it is not equivalent to the same dose of the LUPRON DEPOT 3.75 mg monthly formulation.
EndometriosisThe initial and retreatment dosage regimens for LUPRON DEPOT 11.25 mg for the management of women with endometriosis are outlined in Table 1.
Table 1. LUPRON DEPOT 11.25 mg, Management of Endometriosis Treatment PhaseLUPRON DEPOT 11.25 mg DosingMaximum Treatment DurationInitial Treatment1 11.25 mg IM every 3 months
for 1 to 2 doses6 months Retreatment2 11.25 mg IM every 3 months
for 1 to 2 doses6 months 12 MONTHS3
TOTAL TREATMENT DURATION1May use LUPRON DEPOT 11.25 mg with or without norethindrone acetate 5 mg tablet taken daily.
2Use LUPRON DEPOT 11.25 mg with norethindrone acetate for retreatment 5 mg tablet taken daily
[see Warnings and Precautions(5.1)]and assess bone mineral density (BMD) prior to retreatment.3Treatment should not exceed 12 months due to concerns about adverse impact on bone mineral density.
FibroidsThe recommended dosage of LUPRON DEPOT 11.25 mg is one IM injection of 11.25 mg which provides a three-month treatment course.
)5.1 Loss of Bone Mineral DensityLUPRON DEPOT 11.25 mg induces a hypoestrogenic state that results in loss of bone mineral density (BMD), some of which may not be reversible after stopping treatment. In women with major risk factors for decreased BMD such as chronic alcohol use (> 3 units per day), tobacco use, strong family history of osteoporosis, or chronic use of drugs that can decrease BMD, such as anticonvulsants or corticosteroids, use of LUPRON DEPOT 11.25 mg may pose an additional risk. Carefully weigh the risks and benefits of LUPRON DEPOT 11.25 mg use in these populations.
The duration of LUPRON DEPOT 11.25 mg treatment is limited by the risk of loss of bone mineral density
[see Dosage and Administration (2.1)].When using LUPRON DEPOT 11.25 mg for the management of endometriosis, combination use of norethindrone acetate (add-back therapy) is effective in reducing the loss of BMD that occurs with leuprolide acetate
[see Clinical Studies (14.2)]. Do not retreat with LUPRON DEPOT 11.25 mg without combination norethindrone acetate. Assess BMD before retreatment. - Do not substitute LUPRON DEPOT 11.25 mg for LUPRON DEPOT 3.75 mg.
- Concomitant use with iron therapy for preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary. ()1.2 Uterine Leiomyomata (Fibroids)
LUPRON DEPOT 11.25 mg, used concomitantly with iron therapy, is indicated for the preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary.
Consider a one-month trial period on iron alone, as some women will respond to iron alone
[see Clinical Studies (14.2)].LUPRON DEPOT 11.25 mg may be added if the response to iron alone is considered inadequate.Limitations of Use:LUPRON DEPOT 11.25 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
[see Dosage and Administration (2.1)].
- LUPRON DEPOT 11.25 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. ()1.2 Uterine Leiomyomata (Fibroids)
LUPRON DEPOT 11.25 mg, used concomitantly with iron therapy, is indicated for the preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary.
Consider a one-month trial period on iron alone, as some women will respond to iron alone
[see Clinical Studies (14.2)].LUPRON DEPOT 11.25 mg may be added if the response to iron alone is considered inadequate.Limitations of Use:LUPRON DEPOT 11.25 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
[see Dosage and Administration (2.1)].
LUPRON DEPOT 11.25mg for 3-month administration, given by a healthcare provider as a single intramuscular injection.
LUPRON DEPOT 11.25 mg has different release characteristics than LUPRON 3.75 mg and is dosed differently. (
LUPRON DEPOT 11.25 mg must be administered by a healthcare professional.
LUPRON DEPOT 11.25 mg for 3-month administration has different release characteristics than LUPRON 3.75 mg for 1-month administration and is dosed differently.
- Do not substitute LUPRON DEPOT 11.25 mg for LUPRON DEPOT 3.75 mg.
- Do not administer LUPRON DEPOT 11.25 mg more frequently than every 3 months.
- Do not give a fractional dose of the LUPRON DEPOT 11.25 mg, as it is not equivalent to the same dose of the LUPRON DEPOT 3.75 mg monthly formulation.
The initial and retreatment dosage regimens for LUPRON DEPOT 11.25 mg for the management of women with endometriosis are outlined in Table 1.
Treatment Phase | LUPRON DEPOT 11.25 mg Dosing | Maximum Treatment Duration |
| Initial Treatment1 | 11.25 mg IM every 3 months for 1 to 2 doses | 6 months |
| Retreatment2 | 11.25 mg IM every 3 months for 1 to 2 doses | 6 months |
| 12 MONTHS3 TOTAL TREATMENT DURATION |
1May use LUPRON DEPOT 11.25 mg with or without norethindrone acetate 5 mg tablet taken daily.
2Use LUPRON DEPOT 11.25 mg with norethindrone acetate for retreatment 5 mg tablet taken daily
3Treatment should not exceed 12 months due to concerns about adverse impact on bone mineral density.
The recommended dosage of LUPRON DEPOT 11.25 mg is one IM injection of 11.25 mg which provides a three-month treatment course.
- Do not substitute LUPRON DEPOT 11.25 mg for LUPRON DEPOT 3.75 mg.
- Do not administer LUPRON DEPOT 11.25 mg more frequently than every 3 months.
- Do not give a fractional dose of the LUPRON DEPOT 11.25 mg, as it is not equivalent to the same dose of the LUPRON DEPOT 3.75 mg monthly formulation.
Reconstitute LUPRON DEPOT 11.25 mg prior to use. (
- Reconstitute and administer the lyophilized microsphere as a single IM injection as directed below. Visually inspect the drug product for particulate matter and discoloration prior to administration, whenever solution and container permit.
- Inject the LUPRON DEPOT 11.25 mg suspension immediately or discard if not used within two hours as the suspension does not contain a preservative.
1. Visually inspect the LUPRON DEPOT 11.25 mg powder.
2. To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn (see Figure Aand Figure B).
Figure A:
Figure B:
3. Hold the syringe UPRIGHT. Release the diluent by SLOWLY PUSHING the plunger for 6 to 8 seconds until the first middle stopper is
Figure C:
4. Keep the syringe
Figure D:
5. Keep the syringe
6. Keep the syringe
7. After cleaning the injection site with an alcohol swab, administer the IM injection by inserting the needle at a 90-degree angle into the gluteal area, anterior thigh, or deltoid. Injection sites should be alternated (see Figure E).
Figure E:
Figure F:
8. Inject the entire contents of the syringe intramuscularly.
9. Withdraw the needle. Once the syringe has been withdrawn, immediately activate the LuproLoc®safety device by pushing the arrow on the lock upward towards the needle tip with the thumb or finger, as illustrated, until the needle cover of the safety device over the needle is fully extended and a
Figure G:
10. Dispose of the syringe according to local regulations/procedures.
- LUPRON DEPOT 11.25 mg administered as a single intramuscular (IM) injection once every three months for up to two injections (6 months of therapy). LUPRON DEPOT may be administered alone or in combination with daily 5 mg tablet of norethindrone acetate (add-back). ()2.1 Important Use Information
LUPRON DEPOT 11.25 mg must be administered by a healthcare professional.
LUPRON DEPOT 11.25 mg for 3-month administration has different release characteristics than LUPRON 3.75 mg for 1-month administration and is dosed differently.
- Do not substitute LUPRON DEPOT 11.25 mg for LUPRON DEPOT 3.75 mg.
- Do not administer LUPRON DEPOT 11.25 mg more frequently than every 3 months.
- Do not give a fractional dose of the LUPRON DEPOT 11.25 mg, as it is not equivalent to the same dose of the LUPRON DEPOT 3.75 mg monthly formulation.
EndometriosisThe initial and retreatment dosage regimens for LUPRON DEPOT 11.25 mg for the management of women with endometriosis are outlined in Table 1.
Table 1. LUPRON DEPOT 11.25 mg, Management of Endometriosis Treatment PhaseLUPRON DEPOT 11.25 mg DosingMaximum Treatment DurationInitial Treatment1 11.25 mg IM every 3 months
for 1 to 2 doses6 months Retreatment2 11.25 mg IM every 3 months
for 1 to 2 doses6 months 12 MONTHS3
TOTAL TREATMENT DURATION1May use LUPRON DEPOT 11.25 mg with or without norethindrone acetate 5 mg tablet taken daily.
2Use LUPRON DEPOT 11.25 mg with norethindrone acetate for retreatment 5 mg tablet taken daily
[see Warnings and Precautions(5.1)]and assess bone mineral density (BMD) prior to retreatment.3Treatment should not exceed 12 months due to concerns about adverse impact on bone mineral density.
FibroidsThe recommended dosage of LUPRON DEPOT 11.25 mg is one IM injection of 11.25 mg which provides a three-month treatment course.
- Do not substitute LUPRON DEPOT 11.25 mg for LUPRON DEPOT 3.75 mg.
- If endometriosis symptoms recur after initial course of therapy, retreatment for no more than six months may be considered but onlywith the addition of norethindrone acetate add-back therapy. Do not re-treat with LUPRON DEPOT 11.25 mg alone. ()2.1 Important Use Information
LUPRON DEPOT 11.25 mg must be administered by a healthcare professional.
LUPRON DEPOT 11.25 mg for 3-month administration has different release characteristics than LUPRON 3.75 mg for 1-month administration and is dosed differently.
- Do not substitute LUPRON DEPOT 11.25 mg for LUPRON DEPOT 3.75 mg.
- Do not administer LUPRON DEPOT 11.25 mg more frequently than every 3 months.
- Do not give a fractional dose of the LUPRON DEPOT 11.25 mg, as it is not equivalent to the same dose of the LUPRON DEPOT 3.75 mg monthly formulation.
EndometriosisThe initial and retreatment dosage regimens for LUPRON DEPOT 11.25 mg for the management of women with endometriosis are outlined in Table 1.
Table 1. LUPRON DEPOT 11.25 mg, Management of Endometriosis Treatment PhaseLUPRON DEPOT 11.25 mg DosingMaximum Treatment DurationInitial Treatment1 11.25 mg IM every 3 months
for 1 to 2 doses6 months Retreatment2 11.25 mg IM every 3 months
for 1 to 2 doses6 months 12 MONTHS3
TOTAL TREATMENT DURATION1May use LUPRON DEPOT 11.25 mg with or without norethindrone acetate 5 mg tablet taken daily.
2Use LUPRON DEPOT 11.25 mg with norethindrone acetate for retreatment 5 mg tablet taken daily
[see Warnings and Precautions(5.1)]and assess bone mineral density (BMD) prior to retreatment.3Treatment should not exceed 12 months due to concerns about adverse impact on bone mineral density.
FibroidsThe recommended dosage of LUPRON DEPOT 11.25 mg is one IM injection of 11.25 mg which provides a three-month treatment course.
- Do not substitute LUPRON DEPOT 11.25 mg for LUPRON DEPOT 3.75 mg.
- Recommended dose of LUPRON DEPOT 11.25 mg is one IM injection. ()2.1 Important Use Information
LUPRON DEPOT 11.25 mg must be administered by a healthcare professional.
LUPRON DEPOT 11.25 mg for 3-month administration has different release characteristics than LUPRON 3.75 mg for 1-month administration and is dosed differently.
- Do not substitute LUPRON DEPOT 11.25 mg for LUPRON DEPOT 3.75 mg.
- Do not administer LUPRON DEPOT 11.25 mg more frequently than every 3 months.
- Do not give a fractional dose of the LUPRON DEPOT 11.25 mg, as it is not equivalent to the same dose of the LUPRON DEPOT 3.75 mg monthly formulation.
EndometriosisThe initial and retreatment dosage regimens for LUPRON DEPOT 11.25 mg for the management of women with endometriosis are outlined in Table 1.
Table 1. LUPRON DEPOT 11.25 mg, Management of Endometriosis Treatment PhaseLUPRON DEPOT 11.25 mg DosingMaximum Treatment DurationInitial Treatment1 11.25 mg IM every 3 months
for 1 to 2 doses6 months Retreatment2 11.25 mg IM every 3 months
for 1 to 2 doses6 months 12 MONTHS3
TOTAL TREATMENT DURATION1May use LUPRON DEPOT 11.25 mg with or without norethindrone acetate 5 mg tablet taken daily.
2Use LUPRON DEPOT 11.25 mg with norethindrone acetate for retreatment 5 mg tablet taken daily
[see Warnings and Precautions(5.1)]and assess bone mineral density (BMD) prior to retreatment.3Treatment should not exceed 12 months due to concerns about adverse impact on bone mineral density.
FibroidsThe recommended dosage of LUPRON DEPOT 11.25 mg is one IM injection of 11.25 mg which provides a three-month treatment course.
- Do not substitute LUPRON DEPOT 11.25 mg for LUPRON DEPOT 3.75 mg.
For Injection: 11.25 mg of leuprolide acetate as a white lyophilized microsphere powder for reconstitution in a single dose prefilled dual chamber syringe; with one chamber containing the lyophilized powder and the other chamber containing the clear diluent.
LUPRON DEPOT 11.25 mg is contraindicated in pregnancy
LUPRON DEPOT 11.25 mg is contraindicated 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 11.25 mg[see Warnings and Precautions(5.4)and Adverse Reactions(6.2)]
- Undiagnosed abnormal uterine bleeding
- Pregnancy[see Warnings and Precautions(5.2)and Use in Specific Populations(8.1)]
When norethindrone acetate is administered with LUPRON DEPOT 11.25 mg, the contraindications to the use of norethindrone acetate also apply to this combination regimen. Refer to the norethindrone acetate prescribing information for a list of contraindications for norethindrone acetate.
- Hypersensitivity to GnRH, GnRH agonist analogs, including leuprolide acetate, or any of the excipients in LUPRON DEPOT 11.25 mg.
- Undiagnosed abnormal uterine bleeding.
- Pregnancy.
If LUPRON DEPOT 11.25 mg is administered with norethindrone acetate, the contraindications for norethindrone acetate also apply.
LUPRON DEPOT 11.25 mg may cause fetal harm based on findings from animal studies and the drug’s mechanism of action
Leuprolide acetate is a long-acting GnRH analog. A single injection of LUPRON DEPOT 11.25 mg results in an initial stimulation followed by a prolonged suppression of pituitary gonadotropins. Repeated dosing of LUPRON DEPOT 11.25 mg at quarterly intervals results in decreased secretion of gonadal steroids. Consequently, tissues and functions that depend on gonadal steroids for their maintenance become quiescent. This effect is reversible on discontinuation of drug therapy.
Leuprolide acetate is not active when given orally.
LUPRON DEPOT 11.25 mg is contraindicated in pregnancy
LUPRON DEPOT 11.25 mg may cause fetal harm based on findings from animal studies and the drug’s mechanism of action
When administered on day 6 of pregnancy at test dosages of 0.00024 mg/kg, 0.0024 mg/kg, and 0.024 mg/kg (1/300 to 1/3 of the human dose) to rabbits, leuprolide acetate produced a dose-related increase in major fetal abnormalities. Similar studies in rats failed to demonstrate an increase in fetal malformations. There was increased fetal mortality and decreased fetal weights with the two higher doses of LUPRON DEPOT in rabbits and with the highest dose (0.024 mg/kg) in rats.
When administered on day 6 of pregnancy at test dosages of 0.00024 mg/kg, 0.0024 mg/kg, and 0.024 mg/kg (1/300 to 1/3 of the human dose) to rabbits, leuprolide acetate produced a dose-related increase in major fetal abnormalities. Similar studies in rats failed to demonstrate an increase in fetal malformations. There was increased fetal mortality and decreased fetal weights with the two higher doses of LUPRON DEPOT in rabbits and with the highest dose (0.024 mg/kg) in rats.
LUPRON DEPOT 11.25 mg is contraindicated 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 11.25 mg [see Warnings and Precautions(5.000000000000000e+004Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, have been reported with LUPRON DEPOT use. LUPRON DEPOT 11.25 mg is contraindicated in women with a history of hypersensitivity to gonadotropin-releasing hormone (GnRH) or GnRH agonist analogs
[see Adverse Reactions (6.2)].In clinical trials of LUPRON DEPOT 11.25 mg, adverse events of asthma were reported in women with pre-existing histories of asthma, sinusitis, and environmental or drug allergies. Symptoms consistent with an anaphylactoid or asthmatic process have been reported postmarketing.
)and Adverse Reactions(6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use of LUPRON DEPOT monotherapy or LUPRON DEPOT with norethindrone acetate add-back therapy. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
During postmarketing surveillance which includes other dosage forms and other populations, the following adverse reactions were reported:
- Skinand Subcutaneous Tissue:rash, urticaria, photosensitivity, erythema multiforme, bullous dermatitis, dermatitis exfoliative, drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), and acute generalized exanthematous pustulosis (AGEP).
- Body as a whole:Hypersensitivity reactions including anaphylaxis
- Nervous/Psychiatric System:Mood swings, including depression; suicidal ideation and attempt; convulsion, peripheral neuropathy, paralysis
- Hepato-biliary system:Serious liver injury
- General disorders and administration site conditions: Injection site reactions including induration, abscess, and necrosis
- Injury, poisoning and procedural complications:Spinal fracture
- Investigations:Decreased white blood count
- Musculoskeletal and connective tissue system:Tenosynovitis-like symptoms
- Vascular system:Hypotension, hypertension, deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack
- Respiratory system:Symptoms consistent with an asthmatic process
- Multi-system disorders:Symptoms consistent with fibromyalgia (e.g., joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath), individually and collectively.
Pituitary apoplexyDuring postmarketing surveillance, cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of leuprolide acetate and other GnRH agonists. In a majority of these cases, a pituitary adenoma was diagnosed, with a majority of pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.
)] - Undiagnosed abnormal uterine bleeding
- Pregnancy [see Warnings and Precautions(5.2 Embryo-Fetal Toxicity
Based on animal reproduction studies and the drug’s mechanism of action, LUPRON DEPOT 11.25 mg may cause fetal harm if administered to a pregnant woman and is contraindicated in pregnant women. Exclude pregnancy prior to initiating treatment with LUPRON DEPOT 11.25 mg if clinically indicated. Discontinue LUPRON DEPOT 11.25 mg if the woman becomes pregnant during treatment and inform the woman of potential risk to the fetus
[see Contraindications(4)andUse in Specific Populations(8.1)]. Advise women to notify their healthcare provider if they believe they may be pregnant.When used at the recommended dose and dosing interval, LUPRON DEPOT 11.25 mg usually inhibits ovulation and stops menstruation. Contraception, however, is not ensured by taking LUPRON DEPOT 11.25 mg. If contraception is indicated, advise women to use non-hormonal methods of contraception while on treatment with LUPRON DEPOT 11.25 mg.
)and Use in Specific Populations(8.1 PregnancyRisk SummaryLUPRON DEPOT 11.25 mg is contraindicated in pregnancy
[see Contraindications(4)].LUPRON DEPOT 11.25 mg may cause fetal harm based on findings from animal studies and the drug’s mechanism of action
[see Clinical Pharmacology(12.1)]. There are limited human data on the use of LUPRON DEPOT in pregnant women. Based on animal reproduction studies, LUPRON DEPOT 11.25 mg may be associated with an increased risk of pregnancy complications, including early pregnancy loss and fetal harm. In animal reproduction studies, subcutaneous administration of leuprolide acetate to rabbits during the period of organogenesis caused embryo-fetal toxicity, decreased fetal weights and a dose-dependent increase in major fetal abnormalities in animals at doses less than the recommended human dose based on body surface area using an estimated daily dose. A similar rat study also showed increased fetal mortality and decreased fetal weights but no major fetal abnormalities at doses less than the recommended human dose based on body surface area using an estimated daily dose[seeData].DataAnimal DataWhen administered on day 6 of pregnancy at test dosages of 0.00024 mg/kg, 0.0024 mg/kg, and 0.024 mg/kg (1/300 to 1/3 of the human dose) to rabbits, leuprolide acetate produced a dose-related increase in major fetal abnormalities. Similar studies in rats failed to demonstrate an increase in fetal malformations. There was increased fetal mortality and decreased fetal weights with the two higher doses of LUPRON DEPOT in rabbits and with the highest dose (0.024 mg/kg) in rats.
)]
When norethindrone acetate is administered with LUPRON DEPOT 11.25 mg, the contraindications to the use of norethindrone acetate also apply to this combination regimen. Refer to the norethindrone acetate prescribing information for a list of contraindications for norethindrone acetate.