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Lupron Depot 11.25

"Treatment approaches for endometriosis often rely on a combination of evidence-based and experience-based (“unsubstantiated” by systematic data and research) approaches. As a result, women with endometriosis may find only temporary or no relief f"...

Lupron Depot 11.25 mg

Lupron Depot 11.25 mg

Lupron Depot 11.25 Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lupron Depot 11.25 mg (leuprolide acetate for depot suspension) 3-Month Formulation is used in men to treat the symptoms of prostate cancer. It is used in women to treat symptoms of endometriosis (overgrowth of uterine lining outside of the uterus) or uterine fibroids, and is also used to treat precocious (early-onset) puberty in both male and female children. It is a man-made form of a hormone that regulates many processes in the body. Common side effects include hot flashes (flushing), increased sweating, night sweats, tiredness, headache, upset stomach, breast changes, acne, joint/muscle aches, trouble sleeping, reduced sexual interest, vaginal discomfort/dryness, abnormal vaginal bleeding (in girls), swelling of the ankles/feet, dizziness, or mild burning/pain/bruising at the injection site. When this medication is used regularly, it is expected menstrual periods will stop (or decrease to light bleeding/spotting). Menstrual periods usually return within 3 months after treatment is stopped.

Lupron Depot 11.25 mg is given in a single dose. Treatment duration depends on the condition being treated. Other drugs may interact with Lupron Depot. Tell your doctor all prescription and over-the-counter medications and supplements you use. Lupron Depot must not be used during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, inform your doctor. Consult your doctor to discuss birth control. Non-hormonal birth control methods (e.g., condoms, diaphragm with spermicide) are recommended during treatment. It is unknown if this drug passes into breast milk. Because the effects of on a nursing infant are unknown, breastfeeding is not recommended.

Our Lupron Depot 11.25 mg (leuprolide acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lupron Depot 11.25 in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • bone pain, loss of movement in any part of your body;
  • swelling, rapid weight gain;
  • pain, burning, stinging, bruising, or redness where the medication was injected;
  • feeling like you might pass out;
  • painful or difficult urination;
  • urinating more often than usual;
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
  • sudden numbness or weakness (especially on one side of the body), problems with speech or balance;
  • sudden headache with vision problems, vomiting, confusion, slow heart rate, weak pulse, fainting, or slow breathing; or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Rare but serious side effects may include:

  • pain or unusual sensations in your back;
  • numbness, weakness, or tingly feeling in your legs or feet;
  • muscle weakness or loss of use; and
  • loss of bowel or bladder control.

Less serious side effects may include:

  • acne, increased growth of facial hair;
  • breakthrough bleeding in a female child during the first 2 months of leuprolide treatment;
  • dizziness, weakness, tired feeling;
  • hot flashes, night sweats, chills, clammy skin;
  • nausea, diarrhea, constipation, stomach pain;
  • skin redness, itching, or scaling;
  • joint or muscle pain;
  • vaginal itching or discharge
  • breast swelling or tenderness;
  • testicle pain;
  • impotence, loss of interest in sex;
  • depression, sleep problems (insomnia), memory problems; or
  • redness, burning, stinging, or pain where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lupron Depot 11.25 (Leuprolide Acetate for Depot Suspension) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Lupron Depot 11.25 Overview - Patient Information: Side Effects

SIDE EFFECTS: Hot flashes (flushing), increased sweating, night sweats, tiredness, headache, upset stomach, breast changes, acne, joint/muscle aches, trouble sleeping, reduced sexual interest, vaginal discomfort/dryness, abnormal vaginal bleeding (in girls), swelling of the ankles/feet, dizziness, or mild burning/pain/bruising at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

When this medication is used regularly, it is expected that the menstrual period will stop (or decrease to light bleeding/spotting). Menstrual periods usually return within 3 months after treatment is stopped. Tell your doctor promptly if regular periods continue during treatment with leuprolide.

During the first few weeks of treatment, your hormone levels will actually increase before they decrease. This is a normal response by your body to this drug. This may result in a temporary worsening of your symptoms for a few weeks.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., new or worsening depression, thoughts of suicide, mood swings, memory problems, aggression in children), bone pain (in adults), easily broken bones (in adults).

Get medical help right away if you have any very serious side effects, including: seizures.

Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first injection. Get medical help right away if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (e.g., severe confusion, difficulty concentrating), vision changes, severe vomiting, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Lupron Depot 11.25 (Leuprolide Acetate for Depot Suspension)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lupron Depot 11.25 FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials

The monthly formulation of LUPRON DEPOT 3.75 mg was utilized in controlled clinical trials that studied the drug in 166 endometriosis and 166 uterine fibroids patients. Adverse events reported in ≥ 5% of patients in either of these populations and thought to be potentially related to drug are noted in the following table.

Table 2 : ADVERSE EVENTS REPORTED TO BE CAUSALLY RELATED TO DRUG IN ≥ 5% OF PATIENTS

  Endometriosis (2 Studies) Uterine Fibroids (4 Studies)
LUPRON DEPOT 3.75 mg
N=166
Danazol
N=136
Placebo
N=31
LUPRON DEPOT 3.75 mg
N=166
Placebo
N=163
N (%) N (%) N (%) N (%) N (%)
Body as a Whole
  Asthenia 5 (3) 9 (7) 0 (0) 14 (8.4) 8 (4.9)
  General pain 31 (19) 22 (16) 1 (3) 14 (8.4) 10 (6.1)
  Headache* 53 (32) 30 (22) 2 (6) 43 (25.9) 29 (17.8)
Cardiovascular System
  Hot flashes/sweats* 139 (84) 77 (57) 9 (29) 121 (72.9) 29 (17.8)
Gastrointestinal System
  Nausea/vomiting 21 (13) 17 (13) 1 (3) 8 (4.8) 6 (3.7)
  GI disturbances* 11 (7) 8 (6) 1 (3) 5 (3.0) 2 (1.2)
Metabolic and Nutritional Disorders
  Edema 12 (7) 17 (13) 1 (3) 9 (5.4) 2 (1.2)
  Weight gain/loss 22 (13) 36 (26) 0 (0) 5 (3.0) 2 (1.2)
Endocrine System
  Acne 17 (10) 27 (20) 0 (0) 0 (0) 0 (0)
  Hirsutism 2 (1) 9 (7) 1 (3) 1 (0.6) 0 (0)
Musculoskeletal System
  Joint disorder* 14 (8) 11 (8) 0 (0) 13 (7.8) 5 (3.1)
  Myalgia* 1 (1) 7 (5) 0 (0) 1 (0.6) 0 (0)
Nervous System
  Decreased libido* 19 (11) 6 (4) 0 (0) 3 (1.8) 0 (0)
  Depression/emotional lability* 36 (22) 27 (20) 1 (3) 18 (10.8) 7 (4.3)
  Dizziness 19 (11) 4 (3) 0 (0) 3 (1.8) 6 (3.7)
  Nervousness* 8 (5) 11 (8) 0 (0) 8 (4.8) 1 (0.6)
  Neuromuscular disorders* 11 (7) 17 (13) 0 (0) 3 (1.8) 0 (0)
  Paresthesias 12 (7) 11 (8) 0 (0) 2 (1.2) 1 (0.6)
Skin and Appendages
  Skin reactions 17 (10) 20 (15) 1 (3) 5 (3.0) 2 (1.2)
Urogenital System
  Breast changes/tenderness/pain* 10 (6) 12 (9) 0 (0) 3 (1.8) 7 (4.3)
  Vaginitis* 46 (28) 23 (17) 0 (0) 19 (11.4) 3 (1.8)
In these same studies, symptoms reported in < 5% of patients included: Body as a Whole - Body odor, Flu syndrome, Injection site reactions; Cardiovascular System - Palpitations, Syncope, Tachycardia; Digestive System - Appetite changes, Dry mouth, Thirst; Endocrine System -Androgen-like effects; Hemic and Lymphatic System - Ecchymosis, Lymphadenopathy; Nervous System Anxiety*, Insomnia/Sleep disorders*, Delusions, Memory disorder, Personality disorder; Respiratory System - Rhinitis; Skin and Appendages - Alopecia, Hair disorder, Nail disorder; Special Senses - Conjunctivitis, Ophthalmologic disorders*, Taste perversion; Urogenital System - Dysuria*, Lactation, Menstrual disorders.
* = Possible effect of decreased estrogen.

In one controlled clinical trial utilizing the monthly formulation of LUPRON DEPOT, patients diagnosed with uterine fibroids received a higher dose (7.5 mg) of LUPRON DEPOT. Events seen with this dose that were thought to be potentially related to drug and were not seen at the lower dose included glossitis, hypesthesia, lactation, pyelonephritis, and urinary disorders. Generally, a higher incidence of hypoestrogenic effects was observed at the higher dose.

In a pharmacokinetic trial involving 20 healthy female subjects receiving LUPRON DEPOT-3 Month 11.25 mg, a few adverse events were reported with this formulation that were not reported previously. These included face edema, agitation, laryngitis, and ear pain.

In a Phase IV study involving endometriosis patients receiving LUPRON DEPOT 3.75 mg (N=20) or LUPRON DEPOT-3 Month 11.25 mg (N=21), similar adverse events were reported by the two groups of patients. In general the safety profiles of the two formulations were comparable in this study.

Table 3 lists the potentially drug-related adverse events observed in at least 5% of patients in any treatment group, during the first 6 months of treatment in the add-back clinical studies, in which patients were treated with monthly LUPRON DEPOT 3.75 mg with or without norethindrone acetate co-treatment.

Table 3 : TREATMENT-RELATED ADVERSE EVENTS OCCURRING IN ≥ 5% OF PATIENTS

Adverse Events Controlled Study Open Label Study
LD- Only*
N=51
LD/N†
N=55
LD/N†
N=136
N (%) N (%) N (%)
Any Adverse Event 50 (98) 53 (96) 126 (93)
Body as a Whole
  Asthenia 9 (18) 10 (18) 15 (11)
  Headache/Migraine 33 (65) 28 (51) 63 (46)
  Injection Site Reaction 1 (2) 5 (9) 4 (3)
  Pain 12 (24) 16 (29) 29 (21)
Cardiovascular System
  Hot flashes/Sweats 50 (98) 48 (87) 78 (57)
Digestive System
  Altered Bowel Function 7 (14) 8 (15) 14 (10)
  Changes in Appetite 2 (4) 0 (0) 8 (6)
  GI Disturbance 2 (4) 4 (7) 6 (4)
  Nausea/Vomiting 13 (25) 16 (29) 17 (13)
Metabolic and Nutritional Disorders
  Edema 0 (0) 5 (9) 9 (7)
  Weight Changes 6 (12) 7 (13) 6 (4)
Nervous System
  Anxiety 3 (6) 0 (0) 11 (8)
  Depression/Emotional Lability 16 (31) 15 (27) 46 (34)
  Dizziness/Vertigo 8 (16) 6 (11) 10 (7)
  Insomnia/Sleep Disorder 16 (31) 7 (13) 20 (15)
  Libido Changes 5 (10) 2 (4) 10 (7)
  Memory Disorder 3 (6) 1 (2) 6 (4)
  Nervousness 4 (8) 2 (4) 15 (11)
  Neuromuscular Disorder 1 (2) 5 (9) 4 (3)
Skin and Appendages
  Alopecia 0 (0) 5 (9) 4 (3)
  Androgen-Like Effects 2 (4) 3 (5) 24 (18)
  Skin/Mucous Membrane Reaction 2 (4) 5 (9) 15 (11)
Urogenital System
  Breast Changes/Pain/Tenderness 3 (6) 7 (13) 11 (8)
  Menstrual Disorders 1 (2) 0 (0) 7 (5)
  Vaginitis 10 (20) 8 (15) 11 (8)
* LD-Only = LUPRON DEPOT 3.75 mg
† LD/N = LUPRON DEPOT 3.75 mg plus norethindrone acetate 5 mg

In the controlled clinical trial, 50 of 51 (98%) patients in the LD group (LUPRON DEPOT 3.75 mg) and 48 of 55 (87%) patients in the LD/N group (LUPRON DEPOT 3.75 mg plus norethindrone acetate 5 mg daily) reported experiencing hot flashes on one or more occasions during treatment. During Month 6 of treatment, 32 of 37 (86%) patients in the LD group and 22 of 38 (58%) patients in the LD/N group reported having experienced hot flashes. The mean number of days on which hot flashes were reported during this month of treatment was 19 and 7 in the LD and LD/N treatment groups, respectively. The mean maximum number of hot flashes in a day during this month of treatment was 5.8 and 1.9 in the LD and LD/N treatment groups, respectively.

Changes in Bone Density

In controlled clinical studies, patients with endometriosis (six months of therapy) or uterine fibroids (three months of therapy) were treated with LUPRON DEPOT 3.75 mg. In endometriosis patients, vertebral bone density as measured by dual energy x-ray absorptiometry (DEXA) decreased by an average of 3.2% at six months compared with the pretreatment value. Clinical studies demonstrate that concurrent hormonal therapy (norethindrone acetate 5 mg daily) and calcium supplementation is effective in significantly reducing the loss of bone mineral density that occurs with LUPRON treatment, without compromising the efficacy of LUPRON in relieving symptoms of endometriosis. LUPRON DEPOT 3.75 mg plus norethindrone acetate 5 mg daily was evaluated in two clinical trials. The results from this regimen were similar in both studies. LUPRON DEPOT 3.75 mg was used as a control group in one study. The bone mineral density data of the lumbar spine from these two studies are presented in Table 4.

Table 4 : MEAN PERCENT CHANGE FROM BASELINE IN BONE MINERAL DENSITY OF LUMBAR SPINE

  LUPRON DEPOT 3.75 mg LUPRON DEPOT 3.75 mg plus norethindrone acetate 5 mg daily
Controlled Study Controlled Study Open Label Study
N Change (Mean, 95% CI)# N Change (Mean, 95% CI)# N Change (Mean, 95% CI)#
Week 24* 41 -3.2%
(-3.8, -2.6)
42 -0.3%
(-0.8, 0.3)
115 -0.2%
(-0.6, 0.2)
Week 52† 29 -6.3%
(-7.1, -5.4)
32 -1.0%
(-1.9, -0.1)
84 -1.1%
(-1.6, -0.5)
* Includes on-treatment measurements that fell within 2-252 days after the first day of treatment.
† Includes on-treatment measurements > 252 days after the first day of treatment.
# 95% CI: 95% Confidence Interval

In the Phase IV, six-month pharmacokinetic/pharmacodynamic study in endometriosis patients who were treated with LUPRON DEPOT 3.75 mg or LUPRON DEPOT-3 Month 11.25 mg, vertebral bone density measured by DEXA decreased compared with baseline by an average of 3.0% and 2.8% at six months for the two groups, respectively.

When LUPRON DEPOT 3.75 mg was administered for three months in uterine fibroid patients, vertebral trabecular bone mineral density as assessed by quantitative digital radiography (QDR) revealed a mean decrease of 2.7% compared with baseline. Six months after discontinuation of therapy, a trend toward recovery was observed. Use of LUPRON DEPOT for longer than three months (uterine fibroids) or six months (endometriosis) or in the presence of other known risk factors for decreased bone mineral content may cause additional bone loss and is not recommended.

Changes in Laboratory Values During Treatment

Liver Enzymes

Three percent of uterine fibroid patients treated with LUPRON DEPOT 3.75 mg, manifested posttreatment transaminase values that were at least twice the baseline value and above the upper limit of the normal range. None of the laboratory increases were associated with clinical symptoms.

In two other clinical trials, 6 of 191 patients receiving LUPRON DEPOT 3.75 mg plus norethindrone acetate 5 mg daily for up to 12 months developed an elevated (at least twice the upper limit of normal) SGPT or GGT. Five of the 6 increases were observed beyond 6 months of treatment. None were associated with an elevated bilirubin concentration.

Lipids

Triglycerides were increased above the upper limit of normal in 12% of the endometriosis patients who received LUPRON DEPOT 3.75 mg and in 32% of the subjects receiving LUPRON DEPOT-3 Month 11.25 mg.

Of those endometriosis and uterine fibroid patients whose pretreatment cholesterol values were in the normal range, mean change following therapy was +16 mg/dL to +17 mg/dL in endometriosis patients and +11 mg/dL to +29 mg/dL in uterine fibroid patients. In the endometriosis treated patients, increases from the pretreatment values were statistically significant (p < 0.03). There was essentially no increase in the LDL/HDL ratio in patients from either population receiving LUPRON DEPOT 3.75 mg.

In two other clinical trials, LUPRON DEPOT 3.75 mg plus norethindrone acetate 5 mg daily were evaluated for 12 months of treatment. LUPRON DEPOT 3.75 mg was used as a control group in one study. Percent changes from baseline for serum lipids and percentages of patients with serum lipid values outside of the normal range in the two studies are summarized in the tables below.

Table 5 : SERUM LIPIDS: MEAN PERCENT CHANGES FROM BASELINE VALUES AT TREATMENT WEEK 24

  LUPRON DEPOT 3.75 mg LUPRON DEPOT 3.75 mg plus norethindrone acetate 5 mg daily
Controlled Study (n=39) Controlled Study (n=41) Open Label Study (n=117)
Baseline Value* Wk 24 % Change Baseline Value* Wk 24 % Change Baseline Value* Wk 24 % Change
Total Cholesterol 170.5 9.2% 179.3 0.2% 181.2 2.8%
HDL Cholesterol 52.4 7.4% 51.8 -18.8% 51.0 -14.6%
LDL Cholesterol 96.6 10.9% 101.5 14.1% 109.1 13.1%
LDL/HDL Ratio 2.0† 5.0% 2.1† 43.4% 2.3† 39.4%
Triglycerides 107.8 17.5% 130.2 9.5% 105.4 13.8%
* mg/dL
† ratio

Changes from baseline tended to be greater at Week 52. After treatment, mean serum lipid levels from patients with follow up data returned to pretreatment values.

Table 6 : PERCENTAGE OF PATIENTS WITH SERUM LIPID VALUES OUTSIDE OF THE NORMAL RANGE

  LUPRON DEPOT 3.75 mg LUPRON DEPOT 3.75 mg
plus norethindrone acetate 5 mg daily
Controlled Study (n=39) Controlled Study (n=41) Open Label Study(n=117)
Wk 0 Wk 24* Wk 0 Wk 24* Wk 0 Wk 24*
Total Cholesterol ( > 240 mg/dL) 15% 23% 15% 20% 6% 7%
HDL Cholesterol ( < 40 mg/dL) 15% 10% 15% 44% 15% 41%
LDL Cholesterol ( > 160 mg/dL) 0% 8% 5% 7% 9% 11%
LDL/HDL Ratio ( > 4.0) 0% 3% 2% 15% 7% 21%
Triglycerides ( > 200 mg/dL) 13% 13% 12% 10% 5% 9%
* Includes all patients regardless of baseline value.

Low HDL-cholesterol ( < 40 mg/dL) and elevated LDL-cholesterol ( > 160 mg/dL) are recognized risk factors for cardiovascular disease. The long-term significance of the observed treatment-related changes in serum lipids in women with endometriosis is unknown. Therefore assessment of cardiovascular risk factors should be considered prior to initiation of concurrent treatment with LUPRON and norethindrone acetate.

Chemistry

Slight to moderate mean increases were noted for glucose, uric acid, BUN, creatinine, total protein, albumin, bilirubin, alkaline phosphatase, LDH, calcium, and phosphorus. None of these increases were clinically significant. In the hormonal add-back studies LUPRON DEPOT in combination with norethindrone acetate was associated with elevations of GGT and SGPT in 6% to 7% of patients.

Postmarketing

The following adverse reactions have been identified during postapproval use of LUPRON DEPOT. 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 with other dosage forms and in the same and/or different populations, the following adverse events were reported. Like other drugs in this class, mood swings, including depression, have been reported. There have been rare reports of suicidal ideation and attempt. Many, but not all, of these patients had a history of depression or other psychiatric illness. Patients should be counseled on the possibility of development or worsening of depression during treatment with LUPRON.

Symptoms consistent with an anaphylactoid or asthmatic process have been rarely reported. Rash, urticaria, and photosensitivity reactions have also been reported.

Localized reactions including induration and abscess have been reported at the site of injection.

Symptoms consistent with fibromyalgia (eg: joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath) have been reported individually and collectively.

Other events reported are:

Hepato-biliary disorder: Rarely reported serious liver injury

Injury, poisoning and procedural complications: Spinal fracture

Investigations: Decreased WBC

Musculoskeletal and Connective tissue disorder: Tenosynovitis-like symptoms

Nervous System Disorder: Convulsion, peripheral neuropathy, paralysis

Vascular Disorder: Hypotension

Cases of serious venous and arterial thromboembolism have been reported, including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, and transient ischemic attack. Although a temporal relationship was reported in some cases, most cases were confounded by risk factors or concomitant medication use. It is unknown if there is a causal association between the use of GnRH analogs and these events.

Pituitary apoplexy

During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone 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.

See other LUPRON DEPOT and LUPRON Injection package inserts for other events reported in the same and different patient populations.

Read the entire FDA prescribing information for Lupron Depot 11.25 (Leuprolide Acetate for Depot Suspension) »

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Lupron Depot 11.25 mg - User Reviews

Lupron Depot 11.25 mg User Reviews

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