ELIGARD- leuprolide acetate injection, suspension, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEUPROLIDE ACETATE (UNII: 37JNS02E7V) (LEUPROLIDE - UNII:EFY6W0M8TG)

Available from:

TOLMAR Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ELIGARD is indicated for the treatment of advanced prostate cancer. 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. Risk Summary Based on findings in animal studies and mechanism of action, ELIGARD may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data in pregnant women to inform the drug-associated risk. Expected hormonal changes that occur with ELIGARD treatment increase the risk for pregnancy loss. In animal developmental and reproductive studies, major fetal abnormalities were observed after administration of leuprolide acetate throughout gestation in rats. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus (see Data) . Data Animal Data In animal developmental and reproductive studies, major fetal abnormalities were observed after administration of leuprolide acetate throughout gestation.  There were increased fetal mortality and decreased fetal weights in rats and rabbits.  The effects of fetal mortality are expected consequences of the alterations in hormonal levels brought about by this drug. The safety and efficacy of ELIGARD have not been established in females. There is no information regarding the presence of ELIGARD in human milk, the effects on the breastfed child, or the effects on milk production. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in a breastfed child from ELIGARD, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Infertility Males Based on mechanism of action, ELIGARD may impair fertility in males of reproductive potential [see Clinical Pharmacology (12.1)] . The safety and effectiveness of ELIGARD in pediatric patients have not been established. The majority of the patients (approximately 70%) studied in the clinical trials were age 70 and older.  Clinical studies of ELIGARD did not include sufficient numbers of younger adult patients to determine if patients 65 years of age and older respond differently than younger adult patients. Follow the detailed instructions below to ensure correct preparation of ELIGARD prior to administration: Step 1 Use aseptic technique throughout the procedure.  Gloves are recommended during mixing and administration. Allow the product to reach room temperature before mixing.  Once mixed, the product must be administered within 30 minutes or it should be discarded. On a clean field open the tray by tearing off the foil from the corner and remove the contents. Discard the desiccant pack. Remove the pre-connected syringe system from the tray. Open the sterile safety needle package by peeling back the paper tab. Note: Syringe A and Syringe B should not be lined-up yet. The product should only be administered with the co-packaged, sterile safety needle. Grasp the latching button on the coupling device with your finger and thumb and press until you hear a snapping sound. The two syringes will be aligned. Step 3 Holding the syringes in a horizontal position, transfer the liquid contents of Syringe A into the leuprolide acetate powder contained in Syringe B. Thoroughly mix the product for 60 cycles by pushing the contents back and forth between both syringes to obtain a uniform suspension. - A cycle is one push of the Syringe A plunger and one push of the Syringe B plunger. - 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). Step 4 Step 5 While ensuring the Syringe A plunger is fully pushed down, hold the coupling device and unscrew Syringe B. This will disconnect Syringe B from the coupling device. Syringe A will remain attached to the coupling device. Note:  Small air bubbles will remain in the formulation – this is acceptable. Step 6 Continue to hold Syringe B upright with the open end at the top. Hold back the white plunger on Syringe B to prevent loss of the product and attach the safety needle and cap. Gently screw clockwise with approximately a three-quarter turn until the safety needle and cap are secure. Do not overtighten, as the needle hub may become damaged which could result in leakage of the product during injection. The safety shield may also be damaged if the safety needle and cap are screwed with too much force. Step 7 Move the safety shield away from the needle and towards the syringe. Note: Should the needle hub appear to be damaged, or leak, the product should NOT be used. The damaged safety needle and cap should NOT be replaced and the product should NOT be injected. In the event of damage to the needle hub, use a new replacement ELIGARD carton. Follow the detailed instructions below to ensure correct administration of ELIGARD: 1. Select an injection site on the abdomen, upper buttocks, or another location with adequate amounts of subcutaneous tissue that does not have excessive pigment, nodules, lesions, or hair and hasn’t recently been used. 2. Cleanse the injection-site area with an alcohol swab (not enclosed). 3. Using the thumb and forefinger, grab and bunch the area of skin around the injection site. 5. Inject the drug using a slow, steady push and press down on the plunger until the syringe is empty. Make sure all the drug has been injected before removing the needle. 6. Withdraw the needle quickly at the same 90° angle used for insertion. 7. Immediately following the withdrawal of the needle, activate the safety shield using a finger/thumb or flat surface and push until it completely covers the needle tip and locks into place. 8. An audible and tactile “click” verifies a locked position. 9. Check to confirm the safety shield is fully engaged. Discard all components safely in an appropriate biohazard container. ©2024 Tolmar Manufactured by: Tolmar, Fort Collins, CO 80526     04006512 Rev. 3 01/2024

Product summary:

How Supplied ELIGARD is supplied as a single-dose, two syringe-mixing system with a sterile safety needle and cap. ELIGARD is available as follows (Table 10): Table 10.  ELIGARD Product Presentations Storage Store at 2°C to 8°C (36°F to 46°F) Once outside the refrigerator this product may be stored in its original packaging at room temperature 15°C to 30°C (59°F to 86°F) for up to eight weeks prior to mixing and administration.

Authorization status:

New Drug Application

Summary of Product characteristics

ELIGARD- LEUPROLIDE ACETATE INJECTION, SUSPENSION, EXTENDED RELEASE
TOLMAR INC.
REFERENCE LABEL SET ID: 0F03A91D-37EB-4E91-BF00-7FE097A4BEAD
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ELIGARD SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ELIGARD.
ELIGARD (LEUPROLIDE ACETATE) FOR INJECTABLE SUSPENSION, FOR
SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Indications and Usage (1) 07/2023
Dosage and Administration (2) 08/2023
INDICATIONS AND USAGE
ELIGARD is a gonadotropin releasing hormone (GnRH) agonist indicated
for the treatment of advanced
prostate cancer. (1)
DOSAGE AND ADMINISTRATION
ELIGARD is administered subcutaneously based on the following
recommended dose and schedule:
7.5 mg subcutaneously every month (2.1)
22.5 mg subcutaneously every 3 months (2.1)
30 mg subcutaneously every 4 months (2.1)
45 mg subcutaneously every 6 months (2.1)
See Full Prescribing Information for preparation and administration
instructions. (2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
Injectable suspension: 7.5 mg (3)
Injectable suspension: 22.5 mg (3)
Injectable suspension: 30 mg (3)
Injectable suspension: 45 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to GnRH, GnRH agonist analogs or any of the
components of ELIGARD (4)
WARNINGS AND PRECAUTIONS
Tumor Flare: Transient increase in serum levels of testosterone during
treatment may result in
worsening of symptoms or onset of new signs and symptoms during the
first few weeks of treatment,
including bone pain, neuropathy, hematuria, bladder outlet
obstruction, ureteral obstruction, or spinal
cord compression. Monitor patients at risk closely and manage as
appropriate. (5.1, 5.2)
Hyperglycemia and diabetes: Hyperglycemia and an increased risk of
developing diabetes have been
reported in men receiving GnRH analogs. Monitor blood glucose level
and manage according to current
clinical practice. (5.3)
Cardiovascular diseases: Increased risk of myocardial infarction,
sudden cardiac death a