ELIGARD- leuprolide acetate kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

TOLMAR Inc.

INN (International Name):

LEUPROLIDE ACETATE

Composition:

LEUPROLIDE ACETATE 7.5 mg in 0.25 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ELIGARD® is indicated for the palliative 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) . Animal Data In animal developmental and reproduc

Product summary:

ELIGARD® is available in a single-dose kit of a two syringe-mixing system with a sterile safety needle in the following strengths: ELIGARD® 7.5 mg – NDC 62935-753-75 ELIGARD® 22.5 mg – NDC 62935-223-05 ELIGARD® 30 mg – NDC 62935-303-30 ELIGARD® 45 mg – NDC 62935-453-45 Store at 2 - 8 °C (35.6 - 46.4 °F) Once outside the refrigerator this product may be stored in its original packaging at room temperature 15 – 30 °C (59 – 86 °F) for up to eight weeks prior to mixing and administration.

Authorization status:

New Drug Application

Summary of Product characteristics

ELIGARD- LEUPROLIDE ACETATE
TOLMAR PHARMACEUTICALS INC.
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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
Dosage and Administration, Administration Procedure (2.2) 04/2019
Warnings and Precautions, Embryo-Fetal Toxicity (5.6) 02/2019
INDICATIONS AND USAGE
ELIGARD is a gonadotropin releasing hormone (GnRH) agonist indicated
for the palliative treatment of
advanced prostate cancer (1)
DOSAGE AND ADMINISTRATION
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)
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 (4.1)
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 and stroke has
been reported in men. Monitor for cardiovascular disease and manage
according to current clinical
practice. (5.4)
Effect on QT/QTc Interval: Androgen deprivation therapy may prolong
the QT interva