In the majority of patients testosterone levels increased
above baseline during the first week, declining thereafter to baseline levels
or below by the end of the second week of treatment.
Potential exacerbations of signs and symptoms during the
first few weeks of treatment is a concern in patients with vertebral metastases
and/or urinary obstruction or hematuria which, if aggravated, may lead to
neurological problems such as temporary weakness and/or paresthesia of the
lower limbs or worsening of urinary symptoms (see WARNINGS section).
In a clinical trial of LUPRON DEPOT 7.5 mg for 1-month
administration, the following adverse reactions were reported in 5% or more of
the patients during the initial 24-week treatment period regardless of
LUPRON DEPOT 7.5 mg for 1-Month Administration (N=56)
|Body as a Whole
| General pain
| Hot flashes/sweats*
| GI disorders
|Metabolic and Nutritional Disorders
| Libido decreased*
| Respiratory disorder
| Urinary disorder
| Testicular atrophy*
|* Due to the expected physiologic effect of decreased
In this same study, the
following adverse reactions were reported in less than 5% of the patients on
LUPRON DEPOT 7.5 mg for 1-month administration.
Body as a Whole -Asthenia, Cellulitis,
Fever, Headache, Injection site reaction, Neoplasm;
Cardiovascular System -Angina, Congestive
Digestive System -Anorexia, Dysphagia,
Eructation, Peptic ulcer;
Hemic and Lymphatic System -Ecchymosis;
Musculoskeletal System -Myalgia;
Nervous System -Agitation,
Insomnia/sleep disorders, Neuromuscular disorders;
Respiratory System -Emphysema,
Hemoptysis, Lung edema, Sputum increased;
Skin and Appendages -Hair disorder, Skin
Urogenital System -Balanitis, Breast
enlargement, Urinary tract infection.
Laboratory: Abnormalities of certain
parameters were observed, but their relationship to drug treatment are
difficult to assess in this population. The following were recorded in
≥ 5% of patients at final visit: 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 (AST, LDH),
increased phosphorus, increased platelets, increased prostatic acid
phosphatase, increased total cholesterol, increased urine specific gravity,
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.
surveillance, which includes other dosage forms and other patient populations,
the following adverse events were reported.
Like other drugs in this class, mood swings, including
depression, have been reported. There have been very 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
Symptoms consistent with an anaphylactoid or asthmatic
process have been rarely (incidence rate of about 0.002%) reported. Rash,
urticaria, and photosensitivity reactions have also been reported.
Changes in Bone Density: Decreased bone density
has been reported in the medical literature in men who have had orchiectomy or
who have been treated with an LH-RH agonist analog. In a clinical trial, 25 men
with prostate cancer, 12 of whom had been treated previously with leuprolide
acetate for at least six months, underwent bone density studies as a result of
pain. The leuprolide-treated group had lower bone density scores than the
nontreated control group. It can be anticipated that long periods of medical
castration in men will have effects on bone density.
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.
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.
Cardiovascular System – Hypotension, Myocardial
infarction, Pulmonary embolism;
Respiratory, thoracic and mediastinal disorder –
Interstitial lung disease;
Hepato-biliary disorder: Serious drug-induced
Hemic and Lymphatic System – Decreased WBC;
Central/Peripheral Nervous System – Convulsion,
Peripheral neuropathy, Spinal fracture/paralysis;
Endocrine System – Diabetes;
Musculoskeletal System – Tenosynovitis-like
Urogenital System – Prostate pain.
See other LUPRON DEPOT and LUPRON Injection package
inserts for other events reported in women and pediatric populations.