Eligard and Night Sweats
Eligard side effects can include night sweats, nocturnal hydrosis, and
hot flash like symptoms. This page helps to understand the side effects that
cause increased sweating and flushing.
This medication has many warnings associated with it regardless of
purchasing discount online or generic. This information is always subject to
change please consult you doctor before taking this medicine.
DESCRIPTION
Eligard ® 22.5 mg is a sterile polymeric matrix formulation of leuprolide acetate for subcutaneous injection. It is designed to deliver 22.5 mg of leuprolide acetate at a controlled rate over a three-month therapeutic period.
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH) that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular and ovarian steroidogenesis. The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate with the following structural formula:
WARNINGS
Eligard ® 22.5 mg, like other LH-RH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment. Patients may experience worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, or bladder outlet obstruction. Isolated cases of ureteral obstruction and/or spinal cord compression, which may contribute to paralysis with or without fatal complications, have been observed in the palliative treatment of advanced prostate cancer using LH-RH agonists (see PRECAUTIONS ).
If spinal cord compression or renal impairment develops, standard treatment of these complications should be instituted.
PRECAUTIONS
General: Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy (see WARNINGS section).
Laboratory tests: Response to Eligard ® 22.5 mg should be monitored by measuring serum concentrations of testosterone and prostate specific antigen periodically.
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. Castrate levels were generally reached within two to four weeks and once achieved were maintained for the duration of treatment.
Results of testosterone determinations are dependent on assay methodology. It is advisable to be aware of the type and precision of the assay methodology to make appropriate clinical and therapeutic decisions.
ADVERSE REACTIONS
The safety of Eligard ® 22.5 mg was evaluated in 117 patients with advanced prostate cancer. Eligard ® 22.5 mg, like other LH-RH analogs, caused a transient increase in serum testosterone concentrations during the first two weeks of treatment. Therefore, potential exacerbations of signs and symptoms of the disease during the first weeks of treatment are of concern in patients with vertebral metastases and/or urinary obstruction or hematuria. If these conditions are aggravated, it may lead to neurological problems such as weakness and/or paresthesia of the lower limbs or worsening of urinary symptoms (see WARNINGS and PRECAUTIONS ).
In Study AGL9909, 117 patients were dosed with Eligard ® 22.5 mg every three months for up to six months and injection sites were closely monitored. In all, 230 injections of Eligard ® 22.5 mg were administered. Transient burning/stinging was reported following 50 injections (21.7%), with the majority (86%) of these events reported as mild. Pain was reported following 3.5% of study injections (6.0% of patients) and was generally reported as brief in duration and mild in intensity.
Erythema was reported following 2 injections (0.9% of study injections, 1.7% of patients). One of the reports characterized the erythema as mild and resolved within 7 days. The other was moderate and resolved within 15 days. Neither patient experienced erythema at multiple injections. Mild bruising was reported following 4 injections (1.7% of study injections, 3.4% of patients). Mild pruritis was reported following 1 injection (0.4% of study injections, 0.9% of patients).
These localized adverse events were nonrecurrent over time. No patient discontinued therapy due to an injection site adverse event.
The following possibly or probably related systemic adverse events occurred during clinical trials of up to six months of treatment with Eligard ® 22.5 mg, and were reported in >/=2% of patients (Table 1). Often, causality is difficult to assess in patients with metastatic prostate cancer. Reactions considered not drug-related are excluded.
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In addition, the following possibly or probably related systemic adverse events were reported by < 2% of the patients using Eligard ® 22.5 mg in the clinical study.
Gastrointestinal: Dyspepsia
General: Rigors, weakness, lethargy
Renal: Difficulties with urination, pain on urination, scanty urination, bladder spasm, blood in urine and urinary retention
Reproductive: Breast tenderness * , testicular atrophy * , testicular pain, gynecomastia * , impotence *
Skin: Clamminess, night sweats * , sweating increased * Vascular: Hypertension, hypotension
* Expected
pharmacological consequence of testosterone suppression. In the patient
population studied, a total of 84 hot flash/
sweats events were reported in 66 patients. Of these, 73 events (87%) were
described as mild; 11 (13%) as moderate; none were severe.
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