DESCRIPTION

ELIGARD® is a sterile polymeric matrix formulation of leuprolide acetate for subcutaneous injection. It is designed to deliver leuprolide acetate at a controlled rate over a one-, three-, four- or six-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 (salt) with the following structural formula:

ELIGARD® is prefilled and supplied in two separate, sterile syringes whose contents are mixed immediately prior to administration. The two syringes are joined and the single dose product is mixed until it is homogenous. ELIGARD® is administered subcutaneously, where it forms a solid drug delivery depot.

One syringe contains the ATRIGEL® Delivery System and the other contains leuprolide acetate. ATRIGEL® is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable poly (DL-lactide-co-glycolide) (PLGH or PLG) polymer formulation dissolved in a biocompatible solvent, N-methyl-2-pyrrolidone (NMP).

Refer to Table 1 for the delivery system composition and constituted product formulation for each ELIGARD® product.

Table 1. ELIGARD® Delivery System Composition and Constituted Product Formulation

		ELIGARD® 7.5 mg	ELIGARD® 22.5 mg	ELIGARD® 30 mg	ELIGARD® 45 mg
ATRIGEL® Delivery System Syringe	Polymer	PLGH	PLG	PLG	PLG
	Polymer description	Copolymer containing carboxyl endgroups	Copolymer with hexanediol	Copolymer with hexanediol	Copolymer with hexanediol
	Polymer DL-lactide to Glycolide Molar Ratio	50:50	75:25	75:25	85:15
Constituted Product	Polymer delivered	82.5 mg	158.6 mg	211.5 mg	165 mg
	NMP delivered	160.0 mg	193.9 mg	258.5 mg	165 mg
	Leuprolide acetate delivered	7.5 mg	22.5 mg	30 mg	45 mg
	Approximate Leuprolide free base equivalent	7.0 mg	21 mg	28 mg	42 mg
	Approximate administered formulation weight	250 mg	375 mg	500 mg	375 mg
	Approximate injection volume	0.25 mL	0.375 mL	0.5 mL	0.375 mL

CLINICAL PHARMACOLOGY

Leuprolide acetate, an LH-RH agonist, acts as a potent inhibitor of gonadotropin secretion when given continuously in therapeutic doses. Animal and human studies indicate that after an initial stimulation, chronic administration of leuprolide acetate results in suppression of testicular and ovarian steroidogenesis. This effect is reversible upon discontinuation of drug therapy.

In humans, administration of leuprolide acetate results in an initial increase in circulating levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH), leading to a transient increase in levels of the gonadal steroids (testosterone and dihydrotestosterone in males, and estrone and estradiol in premenopausal females). However, continuous administration of leuprolide acetate results in decreased levels of LH and FSH. In males, testosterone is reduced to below castrate threshold (≤ 50 ng/dL). These decreases occur within two to four weeks after initiation of treatment. Long-term studies have shown that continuation of therapy with leuprolide acetate maintains testosterone below the castrate level for up to seven years.

CLINICAL STUDIES

One open-label, multicenter study was conducted with each ELIGARD® formulation (7.5 mg, 22.5 mg, 30 mg, and 45 mg) in patients with Jewett stage A though D prostate cancer who were treated with at least a single injection of study drug (Table 3). These studies evaluated the achievement and maintenance of castrate serum testosterone suppression over the duration of therapy (Figures 5–8).

During the AGL9904 study using ELIGARD® 7.5 mg, once testosterone suppression was achieved, no patients (0%) demonstrated breakthrough (concentration >50 ng/dL) at any time in the study.

During the AGL9909 study using ELIGARD® 22.5 mg, once testosterone suppression was achieved, only one patient (< 1%) demonstrated breakthrough following the initial injection; that patient remained below the castrate threshold following the second injection.

During the AGL0001 study using ELIGARD® 30 mg, once testosterone suppression was achieved, three patients (3%) demonstrated breakthrough. In the first of these patients, a single serum testosterone concentration of 53 ng/dL was reported on the day after the second injection. In this patient, castrate suppression was reported for all other timepoints. In the second patient, a serum testosterone concentration of 66 ng/dL was reported immediately prior to the second injection. This rose to a maximum concentration of 147 ng/dL on the second day after the second injection. In this patient, castrate suppression was again reached on the seventh day after the second injection and was maintained thereafter. In the final patient, serum testosterone concentrations > 50 ng/dL were reported at 2 and at 8 hours after the second injection. Serum testosterone concentration rose to a maximum of 110 ng/dL on the third day after the second injection. In this patient, castrate suppression was again reached eighteen days after the second injection and was maintained until the final day of the study, when a single serum testosterone concentration of 55 ng/dL was reported.

During the AGL0205 study using ELIGARD® 45 mg, once testosterone suppression was achieved, one patient (<1%) demonstrated breakthrough. This patient reached castrate suppression at Day 21 and remained suppressed until Day 308 when his testosterone level rose to 112 ng/dL. At Month 12 (Day 336), his testosterone was 210 ng/dL.

Table 3. Summary of ELIGARD® Clinical Studies

			7.5 mg	22.5 mg	30 mg	45 mg
* One patient received less than a full dose at Baseline, never suppressed, and was withdrawn at Day 73 and given an alternate treatment. † All non-evaluable patients who attained castration by Day 28 maintained castration at each timepoint up to and including the time of withdrawal. ‡ One patient withdrew on Day 14. All 7 non-evaluable patients who had achieved castration by Day 28 maintained castration at each timepoint, up to and including the time of withdrawal. § Two patients were withdrawn prior to the Month 1 blood draw. One patient did not achieve castration and was withdrawn on Day 85. All 5 non-evaluable patients who attained castration by Day 28, maintained castration at each timepoint up to and including the time of withdrawal. ¶ Two patients withdrew for reasons unrelated to drug.
Study number			AGL9904	AGL9909	AGL0001	AGL0205
Total Number of patients			120 (117 completed)	117* (111 completed†)	90 (82 completed‡)	111 (103 completed§)
Jewett Stages	Stage A		-	2	2	5
	Stage B		-	19	38	43
	Stage C		89	60	16	19
	Stage D		31	36	34	44
Treatment			6 monthly injections	1 injection (4 patients)	1 injection (5 patients)	1 injection (5 patients)
				2 injections, one every three months (113 patients)	2 injections, one every four months (85 patients)	2 injections, one every six months (106 patients)
Duration of therapy			6 months	6 months	8 months	12 months
Mean testosterone concentration (ng/dL)		Baseline	361.3	367.1	385.5	367.7
		Day 2	574.6 (Day 3)	588.0	610.0	588.6
		Day 14	Below Baseline (Day 10)	Below Baseline	Below Baseline	Below Baseline
		Day 28	21.8	27.7 (Day 21)	17.2	16.7
		Conclusion	6.1	10.1	12.4	12.6
Number of patients below castrate threshold (≤ 50 ng/dL)		Day 28	112 of 119 (94.1%)	115 of 116 (99%)	85 of 89 (96%)	108 of 109 (99.1%)
		Day 35	-	116 (100%)	-	-
		Day 42	119 (100%)	-	89 (100%)	-
		Conclusion	117¶ (100%)	111 (100%)	81 (99%)	102 (99%)

Figure 5 ELIGARD® 7.5 mg Mean Serum Testosterone Concentrations (n=117)

 

Figure 6 ELIGARD® 22.5 mg Mean Serum Testosterone Concentrations (n=111)

 

Figure 7 ELIGARD® 30 mg Mean Serum Testosterone Concentrations (n=90)

 

Figure 8 ELIGARD® 45 mg Mean Serum Testosterone Concentrations (n=103)

Serum PSA decreased in all patients in all studies whose Baseline values were elevated above the normal limit. Refer to Table 4 for a summary of the effectiveness of ELIGARD® in reducing serum PSA values.

Table 4 Effect of ELIGARD® on Patient Serum PSA Values

ELIGARD®	7.5 mg	22.5 mg	30 mg	45 mg
* Among patients who presented with elevated levels at Baseline
Mean PSA Reduction at Study Conclusion	94%	98%	86%	97%
Patients with Normal PSA at Study Conclusion*	94%	91%	93%	95%

Other secondary efficacy endpoints evaluated included WHO performance status, bone pain, urinary pain and urinary signs and symptoms. Refer to Table 5 for a summary of these endpoints.

Table 5 Secondary Efficacy Endpoints

		ELIGARD® 7.5 mg	ELIGARD® 22.5 mg	ELIGARD® 30 mg	ELIGARD® 45 mg
* WHO Status = 0 classified as "fully active." † WHO Status = 1 classified as "restricted in strenuous activity but ambulatory and able to carry out work of a light or sedentary nature." ‡ WHO Status = 2 classified as "ambulatory but unable to carry out work activities." § Pain score scale: 1 (no pain) to 10 (worst pain possible).
Baseline	WHO Status = 0*	88%	94%	90%	90%
	WHO Status = 1†	11%	6%	10%	7%
	WHO Status = 2‡				3%
	Mean Bone Pain§ (range)	1.22 (1–9)	1.20 (1–9)	1.20 (1–7)	1.38 (1–7)
	Mean Urinary Pain (range)	1.12 (1–5)	1.02 (1–2)	1.01 (1–2)	1.22 (1–8)
	Mean Urinary Signs and Symptoms (range)	Low	1.09 (1–4)	Low	Low
	Number of Patients with Prostate Abnormalities	102 (85%)	96 (82%)	66 (73%)	89 (80%)
		Month 6	Month 6	Month 8	Month 12
Follow-up	WHO Status = 0	Unchanged	96%	87%	94%
	WHO Status = 1	Unchanged	4%	12%	5%
	WHO Status = 2			1%	1%
	Mean Bone Pain (range)	1.26 (1–7)	1.22 (1–5)	1.19 (1–8)	1.31 (1–8)
	Mean Urinary Pain (range)	1.07 (1–8)	1.10 (1–8)	1.00 (1–1)	1.07 (1–5)
	Mean Urinary Signs and Symptoms (range)	Modestly Decreased	1.18 (1–7)	Modestly Decreased	Modestly Decreased
	Number of Patients with Prostate Abnormalities	77 (64%)	76 (65%)	54 (60%)	60 (58%)

INDICATIONS AND USAGE

ELIGARD® is indicated for the palliative treatment of advanced prostate cancer.

CONTRAINDICATIONS

1. 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.2
2. ELIGARD® is contraindicated in women and in pediatric patients and was not studied in women or children. Moreover, leuprolide acetate can cause fetal harm when administered to a pregnant woman. Major fetal abnormalities were observed in rabbits but not in rats after administration of leuprolide acetate throughout gestation. There were increased fetal mortality and decreased fetal weights in rats and rabbits. The effects on fetal mortality are expected consequences of the alterations in hormonal levels brought about by this drug. The possibility exists that spontaneous abortion may occur.

---

2

MacLeod TL et al. Anaphylactic reaction to synthetic luteinizing hormone releasing hormone. Fertil Steril 1987 Sept; 48(3): 500–502.

WARNINGS

ELIGARD® 7.5 mg 22.5 mg 30 mg, like other LH-RH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment. ELIGARD® 45 mg causes a transient increase in serum concentrations of testosterone during the first two weeks 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 ureteral obstruction develops, standard treatment of these complications should be instituted.

PRECAUTIONS

ADVERSE REACTIONS

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 7). ELIGARD®, like other LH-RH 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 worsening of urinary symptoms (see WARNINGS and PRECAUTIONS).

During the clinical trials, injection sites were closely monitored. Refer to Table 6 for a summary of reported injection site events.

Table 6 Reported Injection Site Adverse Events

	7.5 mg	22.5 mg	30 mg	45 mg
* Following injection of ELIGARD® 30 mg, three of the 35 burning/stinging events were reported as moderate. † A single event reported as moderate pain resolved within two minutes and all 3 mild pain events resolved within several days following injection of ELIGARD® 30 mg. ‡ Transient pain was reported as mild in intensity in nine of ten (90%) events and moderate in intensity in one of ten (10%) events following injection of ELIGARD® 45 mg. § Erythema was reported following 2 injections of ELIGARD® 22.5 mg. One report characterized the erythema as mild and it resolved within 7 days. The other report characterized the erythema as moderate and it resolved within 15 days. Neither patient experienced erythema at multiple injections. ¶ Mild bruising was reported following 5 (2.3%) study injections and moderate bruising was reported following 2 (<1%) study injections of ELIGARD® 45 mg.
Study Number	AGL9904	AGL9909	AGL0001	AGL0205
Number of patients	120	117	90	111
Treatment	1 injection every month up to 6 months	1 injection every 3 months up to 6 months	1 injection every 4 months up to 8 months	1 injection every 6 months up to 12 months
Number of injections	716	230	175	217
Transient burning/stinging	248 (34.6%) injections;84% reported as mild	50 (21.7%) injections; 86% reported as mild	35 (20%) injections; 100% reported as mild	35 (16%) injections; 91.4% reported as mild*
Pain (generally brief and mild)	4.3% of injections (18.3% of patients)	3.5% of injections (6.0% of patients)	2.3% of injections† (3.3% of patients)	4.6% of injections‡
Erythema (generally brief and mild)	2.6% of injections (12.5% of patients)	0.9% of injections§ (1.7% of patients)	1.1% of injections (2.2% of patients)
Bruising (Mild)	2.5% of injections (11.7% of patients)	1.7% of injections (3.4% of patients)		2.3% of injections¶
Pruritis	1.4% of injections (9.2% of patients)	0.4% of injections (0.9% of patients)
Induration	0.4% of injections (2.5% of patients)
Ulceration	0.1% of injections (> 0.8% of patients)

These localized adverse events were non-recurrent 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 with ELIGARD®, and were reported in > 2% of patients (Table 7). Often, causality is difficult to assess in patients with metastatic prostate cancer. Reactions considered not drug-related are excluded.

Table 7 Summary of Possible or Probably Related Systemic Adverse Events Reported by > 2% of Patients treated with ELIGARD®

		7.5 mg	7.5 mg	22.5 mg	30 mg	45 mg
In the patient populations studied with ELIGARD® 7.5 mg, a total of 86 hot flashes/sweats adverse events were reported in 70 patients. Of these, 71 events (83%) were mild; 14 (16%) were moderate; 1 (1%) was severe. In the patient population studied with ELIGARD® 22.5 mg, a total of 84 hot flashes/sweats adverse events were reported in 66 patients. Of these, 73 events (87%) were mild; 11 (13%) were moderate; none were severe. In the patient population studied with ELIGARD® 30 mg, a total of 75 hot flash adverse events were reported in 66 patients. Of these, 57 events (76%) were mild; 16 (21%) were moderate; 2 (3%) were severe. In the patient population studied with ELIGARD® 45 mg, a total of 89 hot flash adverse events were reported in 64 patients. Of these, 62 events (70%) were mild; 27 (30%) were moderate; none were severe.
* Expected pharmacological consequences of testosterone suppression.
Study Number		AGL9904	AGL9802	AGL9909	AGL0001	AGL0205
Number of patients		120	8	117	90	111
Treatment		1 injection every month up to 6 months	1 injection (surgically castrated patients)	1 injection every 3 months up to 6 months	1 injection every 4 months up to 8 months	1 injection every 6 months up to 12 months
Body System	Adverse Event	Number (Percent)
Body as a Whole	Malaise and Fatigue	21 (17.5 %)		7 (6.0%)	12 (13.3%)	13 (11.7%)
	Weakness					4 (3.6%)
Nervous System	Dizziness	4 (3.3%)			4 (4.4%)
Vascular	Hot flashes/sweats	68 (56.7%)*	2 (25.0%)*	66 (56.4%)*	66 (73.3%)*	64 (57.7%)*
Renal/Urinary	Urinary frequency			3 (2.6%)	2 (2.2%)
	Nocturia				2 (2.2%)
Gastrointestinal	Nausea			4 (3.4%)	2 (2.2%)
	Gastroenteritis/colitis	3 (2.5%)
Skin	Pruritis			3 (2.6%)
	Clamminess				4 (4.4%)*
	Night sweats				3 (3.3%)*	3 (2.7%)*
	Alopecia				2 (2.2%)
Musculoskeletal	Arthralgia			4 (3.4%)
	Myalgia				2 (2.2%)	5 (4.5%)
	Pain in limb					3 (2.7%)
Reproductive	Testicular atrophy	6 (5.0%)			4 (4.4%)*	8 (7.2%)*
	Gynecomastia				2 (2.2%)*	4 (3.6%)*
	Testicular pain				2 (2.2%)
Psychiatric	Decreased libido				3 (3.3%)*

In addition, the following possibly or probably related systemic adverse events were reported by < 2% of the patients treated with ELIGARD® in these clinical studies.

Body System	Adverse Event
* Expected pharmacological consequences of testosterone suppression.
General	Sweating, insomnia, syncope, rigors, weakness, lethargy
Gastrointestinal	Flatulence, constipation, dyspepsia
Hematologic	Decreased red blood cell count, hematocrit and hemoglobin
Metabolic	Weight gain
Musculoskeletal	Tremor, backache, joint pain, muscle atrophy, limb pain
Nervous	Disturbance of smell and taste, depression, vertigo
Psychiatric	Insomnia, depression, loss of libido*
Renal/Urinary	Difficulties with urination, pain on urination, scanty urination, bladder spasm, blood in urine, urinary retention, urinary urgency, incontinence, nocturia, nocturia aggravated
Reproductive/ Urogenital:	Testicular soreness/pain, impotence*, decreased libido*, gynecomastia*, breast soreness/tenderness*, testicular atrophy*, erectile dysfunction, penile disorder*, reduced penis size
Skin	Alopecia, clamminess, night sweats*, sweating increased*
Vascular	Hypertension, hypotension

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).

HOW SUPPLIED

ELIGARD® is available in a single use kit. The kit consists of a two-syringe mixing system, a sterile needle (Table 9), a silicone desiccant pouch to control moisture uptake, and a package insert for constitution and administration procedures. Each syringe is individually packaged. One contains the ATRIGEL® Delivery System and the other contains leuprolide acetate. When constituted, ELIGARD® is administered as a single dose.

Table 9. ELIGARD® Needle specifications

ELIGARD® formulation	Gauge	Length
7.5 mg	20-gauge	½-inch
22.5 mg	20-gauge	½-inch
30 mg	20-gauge	5/8-inch
45 mg	18-gauge	5/8-inch

ELIGARD® 7.5 mg – NDC 0024-0793-75
ELIGARD® 22.5 mg – NDC 0024-0222-05
ELIGARD® 30 mg – NDC 0024-0610-30
ELIGARD® 45 mg – NDC 0024-0605-45

Manufactured by: TOLMAR, Inc.
Fort Collins, CO 80526
for: TOLMAR Therapeutics, Inc.
Fort Collins, CO 80526
Distributed by: sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

44380, Rev 1 11/09      Revised 11/2009

PRINCIPAL DISPLAY PANEL - 7.5 mg Carton

E-907

NDC 0024-0793-75

Eligard® 7.5 mg

leuprolide acetate for
injectable suspension

7.5 mg Every month

Sterile

For subcutaneous injection

Must be constituted before use

Store refrigerated 2 to 8°C
(36 to 46°F)

Rx Only

sanofi aventis

PRINCIPAL DISPLAY PANEL - 7.5 mg Syringe

Rx Only
NDC 0024-0794-75
E-907
Syringe A

Eligard® 7.5 mg
leuprolide acetate for injectable suspension

330 mg ATRIGEL® Delivery System
This syringe does not contain the active drug

Sterile
For subcutaneous injection

sanofi aventis

LOT:
EXP:

PRINCIPAL DISPLAY PANEL - 7.5 mg Diluent

Syringe B

E-907

Rx Only

NDC 0024-0793-74

Eligard® 7.5 mg

leuprolide acetate for
injectable suspension

Delivers 7.5 mg
leuprolide acetate

Actual content 10.2 mg
lyophilized leuprolide acetate

Dist. by: sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

04100 Rev. 5 2/08

50088124

Lot #

Exp.

PRINCIPAL DISPLAY PANEL - 22.5 mg Carton

E-922

NDC 0024-0222-05

Eligard® 22.5 mg

leuprolide acetate for
injectable suspension

22.5 mg Every 3 months

Sterile

For subcutaneous injection

Must be constituted before use

Store refrigerated 2 to 8°C
(36 to 46°F)

Rx Only

sanofi aventis

PRINCIPAL DISPLAY PANEL - 22.5 mg Syringe

Rx Only
NDC 0024-0223-05
E-922
Syringe A

Eligard® 22.5 mg
leuprolide acetate for injectable suspension

440 mg ATRIGEL® Delivery System
This syringe does not contain the active drug

Sterile
For subcutaneous injection

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PRINCIPAL DISPLAY PANEL - 22.5 mg Diluent

Syringe B

E-922

Rx Only

NDC 0024-0222-04

Eligard® 22.5 mg

leuprolide acetate for
injectable suspension

Delivers 22.5 mg
leuprolide acetate

Actual content 28.2 mg
lyophilized leuprolide acetate

Dist. by: sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

04107 Rev. 4 2/08

50088123

Lot #

Exp.

PRINCIPAL DISPLAY PANEL - 30 mg Carton

E-130

NDC 0024-0610-30

Eligard® 30 mg

leuprolide acetate for
injectable suspension

30 mg Every 4 months

Sterile

For subcutaneous injection

Must be constituted before use

Store refrigerated 2 to 8°C
(36 to 46°F)

Rx Only

sanofi aventis

PRINCIPAL DISPLAY PANEL - 30 mg Syringe

Rx Only
NDC 0024-0611-30
E-130
Syringe A

Eligard® 30 mg
leuprolide acetate for injectable suspension

560 mg ATRIGEL® Delivery System
This syringe does not contain the active drug

Sterile
For subcutaneous injection

sanofi aventis

LOT:
EXP:

PRINCIPAL DISPLAY PANEL - 30 mg Diluent

Syringe B

E-130

Rx Only

NDC 0024-0610-29

Eligard® 30 mg

leuprolide acetate for
injectable suspension

Delivers 30 mg
leuprolide acetate

Actual content 35.8 mg
lyophilized leuprolide acetate

Dist. by: sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

04202 Rev. 4 2/08

50088122

Lot #

Exp.

PRINCIPAL DISPLAY PANEL - 45 mg Carton

E-045

NDC 0024-0605-45

Eligard® 45 mg

leuprolide acetate for
injectable suspension

45 mg Every 6 months

Sterile

For subcutaneous injection

Must be constituted before use

Store refrigerated 2 to 8°C
(36 to 46°F)

Rx Only

sanofi aventis

PRINCIPAL DISPLAY PANEL - 45 mg Syringe

Rx ONLY
NDC 0024-0606-45
E-045
Syringe A

Eligard® 45 mg
leuprolide acetate for injectable suspension

434 mg ATRIGEL® Delivery System
This syringe does not contain the active drug

Sterile
For subcutaneous injection

sanofi aventis

LOT:
EXP:

PRINCIPAL DISPLAY PANEL - 45 mg Diluent

Syringe B

E-045

Rx Only

NDC 0024-0605-44

Eligard® 45 mg

leuprolide acetate for
injectable suspension

Delivers 45 mg leuprolide acetate

Actual content 59.2 mg
lyophilized leuprolide acetate

Dist. by: sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

44503 Rev. 0 5/09

50091082

Lot #

Exp.