Leuprolide acetate Dosage & Rx Info

Leuprolide Acetate Generic Name & Formulations

Legal Class

General Description

Leuprolide acetate 1mg/0.2mL; soln for SC inj; contains benzyl alcohol.

Pharmacological Class

GnRH analogue.

How Supplied

Contact supplier

Manufacturer

Various generic manufacturers

Mechanism of Action

Leuprolide acetate, a gonadotropin releasing hormone (GnRH) 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.

Leuprolide Acetate Indications

Indications

Palliative treatment of advanced prostatic carcinoma.

Leuprolide Acetate Dosage and Administration

Adult

1mg SC daily. Rotate inj site.

Children

Not applicable.

Leuprolide Acetate Contraindications

Contraindications

Women. Pregnancy (Cat.X).

Leuprolide Acetate Boxed Warnings

Not Applicable

Leuprolide Acetate Warnings/Precautions

Warnings/Precautions

Metastatic vertebral lesions. Urinary obstruction. Monitor serum testosterone, PSA, acid phosphatase. Increased risk of diabetes, MI, sudden cardiac death, stroke; monitor blood glucose, HbA1c, and for signs/symptoms of CVD during therapy. Risk of QT prolongation: long-term androgen deprivation therapy, congenital long QT syndrome, electrolyte abnormalities, or CHF, and concomitant Class IA or III antiarrhythmics. Instruct patient on correct self administration.

Leuprolide Acetate Pharmacokinetics

Elimination

Half-life: ~3 hours.

Leuprolide Acetate Interactions

Interactions

Concomitant Class IA (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmics may prolong the QT interval.

Leuprolide Acetate Adverse Reactions

Adverse Reactions

Hot flashes/sweats, inj site reaction, initial worsening of signs/symptoms (eg, bone pain, urinary tract obstruction, hematuria), edema, GI upset, pain, cardiovascular events, CNS and antiandrogenic effects, asthenia, spinal cord compression; hyperglycemia, anaphylactoid, photosensitivity.

Leuprolide Acetate Clinical Trials

See Literature

Leuprolide Acetate Note