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.
OVERDOSAGE
In clinical trials using daily subcutaneous injections of leuprolide acetate in patients with prostate cancer, doses as high as 20 mg/day for up to two years caused no adverse effects differing from those observed with the 1 mg/day dose.
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 8). The injection delivers the dose of leuprolide acetate incorporated in a polymer formulation.
Table 8 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
Once mixed, ELIGARD® should be discarded if not administered within 30 minutes.
As with other drugs administered by subcutaneous injection, the injection site should vary periodically. The specific injection location chosen should be an area with sufficient soft or loose subcutaneous tissue. In clinical trials, the injection was 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).
Mixing Procedure
IMPORTANT: Allow the product to reach room temperature before using. Once mixed, the product must be administered within 30 minutes.
Follow the instructions as directed to ensure proper preparation of ELIGARD® prior to administration:
ELIGARD® is packaged in either thermoformed trays or pouches. Each carton contains:
On sterile Syringe A pre-filled with the ATRIGEL® Delivery System
One Syringe B pre-filled with leuprolide acetate powder
One long white plunger rod for use with Syringe B
One sterile needle
Desiccant pack(s)
1.On a clean field, open all of the packages and remove the contents. Discard the desiccant pack(s).
2.Pull out the blue-tipped short plunger rod and attached stopper from Syringe B and discard (Figure 9). Gently insert the long, white replacement plunger rod into the gray primary stopper remaining in Syringe B by twisting it in place (Figure 10).
3.Unscrew the clear cap from Syringe A (Figure 11). Remove the gray rubber cap from Syringe B (Figure 12).
4.Join the two syringes together by pushing in and twisting until secure (Figure 13).
5.Inject the liquid contents of Syringe A into Syringe B containing the leuprolide acetate. Thoroughly mix the product by pushing the contents of both syringes back and forth between syringes (approximately 45 seconds) to obtain a uniform suspension (Figure 14). (7.5 mg PI, 22.5 mg PI, 30 mg PI, 45 mg PI) When thoroughly mixed, the suspension will appear light tan to tan (ELIGARD® 7.5 mg) or colorless to pale yellow (ELIGARD®, 22.5 mg, 30 mg and 45 mg) in color. PleaseNote: Product must be mixed as described; shaking will not provide adequate m |
