Eligard 22.5 mg/.375mL
Leuprolide acetate · INJECTION, SUSPENSION, EXTENDED RELEASE · TOLMAR Inc.
Eligard is a injection, suspension, extended release containing leuprolide acetate at 22.5 mg/.375mL, taken subcutaneous. Manufactured by TOLMAR Inc..
Key Facts
- Brand Name
- Eligard
- Generic Name
- Leuprolide acetate
- NDC Code (Product)
62935-227- Manufacturer
- TOLMAR Inc.
- Strength
- 22.5 mg/.375mL
- Dosage Form
- INJECTION, SUSPENSION, EXTENDED RELEASE
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA021379
- Marketing Start
- 11/27/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ELIGARD ® is indicated for the palliative treatment of advanced prostate cancer. ELIGARD ® is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced prostate cancer ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION ELIGARD ® is administered subcutaneously and provides continuous release of leuprolide acetate over a one-, three-, four-, or six-month treatment period (Table 1). The injection delivers the dose of leuprolide acetate incorporated in a polymer formulation. Table 1. ELIGARD ® Recommended Dosing Dosage 7.5 mg 22.5 mg 30 mg 45 mg Recommended dose 1 injection every month 1 injection every 3 months 1 injection every 4 months 1 injection every 6 months As with other drugs administered by subcutaneous injection, the injection site should vary periodically. The specific injection location should be an area with sufficient soft or loose subcutaneous tissue. In clinical trials, the injections were administered in the upper- or mid-abdominal area. Avoid areas with brawny or fibrous subcutaneous tissue or locations that could be rubbed or compressed (i.e., with a belt or clothing waistband). 7.5 mg subcutaneously every month ( 2 ) 22.5 mg subcutaneously every 3 months ( 2 ) 30 mg subcutaneously every 4 months ( 2 ) 45 mg subcutaneously every 6 months ( 2 ) 2.1 Mixing Procedure Use aseptic technique throughout the procedure. As with other similar agents, the use of g…
Contraindications
4 CONTRAINDICATIONS Hypersensitivity ELIGARD ® is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs or any of the components of ELIGARD ® . Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature. Known hypersensitivity to GnRH, GnRH agonist analogs or any of the components of ELIGARD ® ( 4.1 )
Drug Interactions
7 DRUG INTERACTIONS No pharmacokinetic drug-drug interaction studies were conducted with ELIGARD ® .
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions in clinical studies (incidence ≥ 5%): Malaise, fatigue, hot flashes/sweats, and testicular atrophy. ( 6.1 ) As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy have been reported. ( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Tolmar Pharmaceuticals, Inc. at 1-888-354-4273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience The safety of all ELIGARD ® formulations was evaluated in clinical trials involving patients with advanced prostate cancer. In addition, the safety of ELIGARD ® 7.5 mg was evaluated in 8 surgically castrated males (Table 5). ELIGARD ® , like other GnRH analogs, caused a transient increase in serum testosterone concentrations during the first one to 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 wo…
Frequently Asked Questions
What is Eligard used for?
Eligard contains Leuprolide acetate. It is a injection, suspension, extended release taken subcutaneous. Consult your doctor for specific uses.
Is Eligard a controlled substance?
Eligard is not classified as a controlled substance by the DEA.
What is the generic name for Eligard?
The generic name for Eligard is Leuprolide acetate. There are 10 other brand versions of Leuprolide acetate.
What is the NDC code for Eligard 22.5 mg/.375mL?
The NDC (National Drug Code) for Eligard 22.5 mg/.375mL is 62935-227, listed by TOLMAR Inc..