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ELIGARD- leuprolide acetate kit


Patient Information

Hypersensitivity

  • Inform patients that if they have experienced hypersensitivity with other GnRH agonist drugs like ELIGARD, ELIGARDis contraindicated[see Contraindications (4)].

Tumor Flare

  • Inform patients that ELIGARDcan cause tumor flare during the first weeks of treatment. Inform patients that the increase in testosterone can cause an increase in urinary symptoms or pain. Advise patients to contact their healthcare provider if uretral obstruction, spinal cord compression, paralysis, or new or worsened symptoms occur after beginning ELIGARDtreatment[see Warnings and Precautions (5.1)].

Hyperglycemia and Diabetes

  • Advise patients that there is an increased risk of hyperglycemia and diabetes with ELIGARDtherapy. Inform patients that periodic monitoring for hyperglycemia and diabetes is required when being treated with ELIGARD[see Warnings and Precautions (5.3)].

Cardiovascular Disease

  • Inform patients that there is an increased risk of myocardial infarction, sudden cardiac death, and stroke with ELIGARDtreatment. Advise patients to immediately report signs and symptoms associated with these events to their healthcare provider for evaluation[see Warnings and Precautions (5.4)].

Injection Site Reactions

  • Inform patients that injection site related adverse reactions may occur such as transient burning/stinging, pain, bruising, and redness. Advise patients to contact their healthcare provider if they experience rash or severe injection site reactions[see Adverse Reactions (6.1)].

Urogenital Disorders

  • Advise patients that ELIGARDmay cause impotence.

Infertility

  • Inform patients that ELIGARDmay cause infertility[see Use In Specific Populations (8.3)].

Rx only

Revised 04/2019

Manufactured by: Tolmar, Inc.
Fort Collins, CO 80526
for: Tolmar Therapeutics, Inc.
Fort Collins, CO 80526

Distributed by: Tolmar Pharmaceuticals, Inc.
Fort Collins, CO 80526

2019 Tolmar Pharmaceuticals, Inc.

04005921 Rev. 4 04/19



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