Leuprolide Acetate Kit
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Questions & Answers
Side Effects & Adverse Reactions
Initially, leuprolide acetate injection, like other LH-RH agonists, causes increases in serum levels of testosterone. Transient worsening of symptoms, or the occurrence of additional signs and symptoms of prostate cancer, may occasionally develop during the first few weeks of leuprolide acetate injection treatment. A small number of patients may experience a temporary increase in bone pain, which can be managed symptomatically. As with other LH-RH agonists, isolated cases of ureteral obstruction and spinal cord compression have been observed, which may contribute to paralysis with or without fatal complications.
Safe use of leuprolide acetate in pregnancy has not been established clinically. Before starting treatment with leuprolide acetate injection, pregnancy must be excluded (see CONTRAINDICATIONS section).
Periodic monitoring of serum testosterone and prostate-specific antigen (PSA) levels is recommended, especially if the anticipated clinical or biochemical response to treatment has not been achieved. It should be noted that 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.
During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the natural stimulatory effect of the drug. Therefore, an increase in clinical signs and symptoms may be observed (see CLINICAL PHARMACOLOGY section).
Noncompliance with drug regimen or inadequate dosing may result in inadequate control of the pubertal process. The consequences of poor control include the return of pubertal signs such as menses, breast development, and testicular growth. The long-term consequences of inadequate control of gonadal steroid secretion are unknown, but may include a further compromise of adult stature.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.
Leuprolide acetate injection is indicated in the treatment of children with central precocious puberty. Children should be selected using the following criteria:
- Clinical diagnosis of CPP (idiopathic or neurogenic) with onset of secondary sexual characteristics earlier than 8 years in females and 9 years in males.
- Clinical diagnosis should be confirmed prior to initiation of therapy:
- Confirmation of diagnosis by a pubertal response to a GnRH stimulation test. The sensitivity and methodology of this assay must be understood.
- Bone age advanced 1 year beyond the chronological age.
- Baseline evaluation should also include:
- Height and weight measurements.
- Sex steroid levels.
- Adrenal steroid level to exclude congenital adrenal hyperplasia.
- Beta human chorionic gonadotropin level to rule out a chorionic gonadotropin secreting tumor.
- Pelvic/adrenal/testicular ultrasound to rule out a steroid secreting tumor.
- Computerized tomography of the head to rule out intracranial tumor.
History
There is currently no drug history available for this drug.
Other Information
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). 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 (salt) with the following structural formula:
Leuprolide acetate injection is a sterile, aqueous solution intended for subcutaneous injection. It is available in a 2.8 mL multiple-dose vial containing leuprolide acetate [leuprorelin Ph Eur] (5 mg/mL), sodium chloride, USP (6.3 mg/mL) for tonicity adjustment, benzyl alcohol, NF as a preservative (9 mg/mL), and water for injection, USP. The pH may have been adjusted with sodium hydroxide, NF and/or glacial acetic acid, USP.
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). 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 (salt) with the following structural formula:
Leuprolide acetate injection is a sterile, aqueous solution intended for daily subcutaneous injection.
It is available in a 2.8 mL multiple dose vial containing leuprolide acetate [leuprorelin Ph Eur] (5 mg/mL), sodium chloride, USP (6.3 mg/mL) for tonicity adjustment, benzyl alcohol, NF as a preservative (9 mg/mL), and water for injection, USP. The pH may have been adjusted with sodium hydroxide, NF and/or glacial acetic acid, USP.
Sources
Leuprolide Acetate Kit Manufacturers
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Sun Pharma Global Inc.
![Leuprolide Acetate Kit [Sun Pharma Global Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Leuprolide Acetate Kit | Sun Pharma Global Inc.
The recommended dose is 1 mg (0.2 mL or 20 unit mark) administered as a single daily subcutaneous injection. As with other drugs administered chronically by subcutaneous injection, the injection site should be varied periodically. Each 0.2 mL contains 1 mg of leuprolide acetate, sodium chloride for tonicity adjustment, 1.8 mg of benzyl alcohol as preservative and water for injection. The pH may have been adjusted with sodium hydroxide and/or glacial acetic acid.
Follow the pictorial directions on the reverse side of this package insert for administration.
NOTE: As with all parenteral products, inspect the solution for discoloration and particulate matter before each use.
Leuprolide acetate injection can be administered by a patient/parent or health care professional.
The dose of leuprolide acetate injection must be individualized for each child. The dose is based on a mg/kg ratio of drug to body weight. Younger children require higher doses on a mg/kg ratio.
After 1 to 2 months of initiating therapy or changing doses, the child must be monitored with a GnRH stimulation test, sex steroids, and Tanner staging to confirm downregulation. Measurements of bone age for advancement should be monitored every 6 to 12 months. The dose should be titrated upward until no progression of the condition is noted either clinically and/or by laboratory parameters.
The first dose found to result in adequate downregulation can probably be maintained for the duration of therapy in most children. However, there are insufficient data to guide dosage adjustment as patients move into higher weight categories after beginning therapy at very young ages and low dosages. It is recommended that adequate downregulation be verified in such patients whose weight has increased significantly while on therapy.
As with other drugs administered by injection, the injection site should be varied periodically.
Discontinuation of leuprolide acetate injection should be considered before age 11 for females and age 12 for males.
The recommended starting dose is 50 mcg/kg/day administered as a single subcutaneous injection. If total downregulation is not achieved, the dose should be titrated upward by 10 mcg/kg/day. This dose will be considered the maintenance dose.
Follow the pictorial directions at the end of this package insert for administration.
NOTE: As with other parenteral products, inspect the solution for discoloration and particulate matter before each use.
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Sandoz Inc
Leuprolide Acetate Kit | Sandoz Inc
The recommended dose is 1 mg (0.2 mL or 20 unit mark) administered as a single daily subcutaneous injection. As with other drugs administered chronically by subcutaneous injection, the injection site should be varied periodically. Each 0.2 mL contains 1 mg of leuprolide acetate, sodium chloride for tonicity adjustment, 1.8 mg of benzyl alcohol as preservative and water for injection. The pH may have been adjusted with sodium hydroxide and/or acetic acid. Follow the pictorial directions on the Administering the Injection Insert. NOTE: As with all parenteral products, inspect the solution for discoloration and particulate matter before each use.
Leuprolide acetate injection can be administered by a patient/parent or health care professional.
The dose of leuprolide acetate injection must be individualized for each child. The dose is based on a mg/kg ratio of drug to body weight. Younger children require higher doses on a mg/kg ratio.
After 1-2 months of initiating therapy or changing doses, the child must be monitored with a GnRH stimulation test, sex steroids, and Tanner staging to confirm downregulation. Measurements of bone age for advancement should be monitored every 6-12 months. The dose should be titrated upward until no progression of the condition is noted either clinically and/or by laboratory parameters.
The first dose found to result in adequate downregulation can probably be maintained for the duration of therapy in most children. However, there are insufficient data to guide dosage adjustment as patients move into higher weight categories after beginning therapy at very young ages and low dosages. It is recommended that adequate downregulation be verified in such patients whose weight has increased significantly while on therapy.
As with other drugs administered by injection, the injection site should be varied periodically.
Discontinuation of leuprolide acetate injection should be considered before age 11 for females and age 12 for males.
The recommended starting dose is 50 mcg/kg/day administered as a single subcutaneous injection. If total downregulation is not achieved, the dose should be titrated upward by 10 mcg/kg/day. This dose will be considered the maintenance dose.
Follow the pictorial directions on the reverse side of this package insert for administration.
NOTE: As with other parenteral products, inspect the solution for discoloration and particulate matter before each use.
![Leuprolide Acetate Kit [Sandoz Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8bd72c1e-2751-4498-a346-bc5e3acbba0b&name=82a87281-0a93-420c-93e1-1e982b57142f-15.jpg)
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