• Contraindications
    • Patients with hypersensitivity to GnRH agonists or any of the excipients in LUPRON DEPOT.
    • Women who are or may become pregnant.

    Reference:
    LUPRON DEPOT 7.5 mg for
    1-month, 22.5 mg for
    3-month, 30 mg for 4-month,
    and 45 mg for 6-month [package insert].

  • Before Starting
    • Hyperglycemia and increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in men receiving a GnRH agonist and manage hyperglycemia or diabetes.
    • An increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in association with the use of GnRH agonists in men, although the risk appears low. Evaluate the risks carefully, including cardiovascular risk factors, when determining prostate cancer treatment. Patients receiving a GnRH agonist should be monitored for signs and symptoms of cardiovascular disease and managed appropriately.
    • Androgen deprivation therapy (ADT) may prolong the QT/QTc interval. Consideration should be given to whether the benefits of ADT outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Correct electrolyte abnormalities and consider periodic monitoring of electrocardiograms and electrolytes.
    • Postmarketing reports of convulsions have been observed in patients on leuprolide acetate therapy, including patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications associated with convulsions, such as bupropion and SSRIs. Convulsions have also been reported in the absence of any of the conditions mentioned above.

    Reference:
    LUPRON DEPOT 7.5 mg for
    1-month, 22.5 mg for
    3-month, 30 mg for 4-month, and 45 mg for 6-month [package insert].

  • What Your
    Patients Can Expect
    • LUPRON DEPOT causes an initial increase in serum testosterone (~50% above baseline) during the first few weeks of treatment. This initial increase can cause:
      • Transient worsening of symptoms, or additional signs and symptoms of prostate cancer.
      • Temporary increase in bone pain in a small number of patients, which can be managed symptomatically.
      • Isolated cases of ureteral obstruction and spinal cord compression, which may contribute to paralysis with or without fatal complications. Observe patients with vertebral metastasis and/or urinary tract obstruction closely.
    • Periodic monitoring of serum testosterone and PSA levels is recommended.
    • LUPRON DEPOT may cause impotence.

    Reference:
    LUPRON DEPOT 7.5 mg for
    1-month, 22.5 mg for
    3-month, 30 mg for 4-month, and 45 mg for 6-month [package insert].

  • Side Effects
    • In controlled clinical trials of advanced prostatic cancer patients receiving LUPRON DEPOT, the following adverse events occurred
      in >10% of patients:
      • LUPRON DEPOT 7.5 mg for 1-month administration: hot flashes/sweats, general pain, edema, urinary disorders, GI disorders, and respiratory disorders.
      • LUPRON DEPOT 22.5 mg for 3-month administration: hot flashes/sweats, general pain, testicular atrophy, GI disorders, urinary disorders, injection site reactions, and joint disorders.
      • LUPRON DEPOT 30 mg for 4-month administration: hot flashes/sweats, injection site reactions, general pain, edema, urinary disorders, joint disorders, GI disorders, asthenia, flu syndrome, skin reactions, and headache.
      • LUPRON DEPOT 45 mg for 6-month administration: hot flush/flushing, upper respiratory tract infection/influenza-like illness, injection site pain/discomfort, and fatigue/lethargy.

    Reference:
    LUPRON DEPOT 7.5 mg for
    1-month, 22.5 mg for
    3-month, 30 mg for 4-month, and 45 mg for 6-month [package insert].

  • Helpful Resources

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    If your patients cannot afford their medication, contact www.pparx.org for assistance.

    View the full Prescribing Information for LUPRON
    DEPOT at http://www.rxabbvie.com/pdf/
    lupronuro_pi.pdf
    .

    Reference:
    LUPRON DEPOT 7.5 mg for
    1-month, 22.5 mg for
    3-month, 30 mg for 4-month, and 45 mg for 6-month [package insert].

Print
Safety Facts
  • LUPRON DEPOT 7.5 mg for 1-month, 22.5 mg for
    3-month, 30 mg for 4-month, and 45 mg for
    6-month administration are indicated for the palliative treatment of advanced prostatic cancer.
  • LUPRON DEPOT is a gonadotropin-releasing hormone (GnRH) agonist administered as a single intramuscular injection under the supervision of a physician.

Reference:
LUPRON DEPOT 7.5 mg for 1-month, 22.5 mg for
3-month, 30 mg for 4-month, and 45 mg for
6-month [package insert].

delivery system iconDelivery System Innovations

Features of Lupron Depot administration

These features can help healthcare professionals administer Lupron Depot to advanced prostate cancer patients1:

23-gauge needle2

on all Lupron Depot dosages—the smallest needle in the GnRH agonist class of treatment

LuproLoc® protective safety device

OSHA-compliant mechanism helps prevent needlestick injuries

Prefilled, dual-chamber syringe (PDS)

no external mixing of ingredients is required

No refrigeration

required for storage

Safety considerations

Hyperglycemia and increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in men receiving a GnRH agonist and manage hyperglycemia or diabetes.

Demonstrating our commitment to innovation

The table below shows various product features of Lupron Depot therapy and other treatments.

Lupron Depot

(leuprolide acetate for depot suspension)1

Eligard®

(leuprolide acetate for injectable suspension)3

Trelstar®

(triptorelin pamoate for injectable suspension)4

Zoladex®

(goserelin acetate implant)5,6

Vantas®

(histerelin implant)7

Firmagon®

(degarelix for injection)8

45 mg

every 6 months

30 mg

every 4 months

22.5 mg

every 3 months

7.5 mg

every month

45 mg

every 6 months

30 mg

every 4 months

22.5 mg

every 3 months

7.5 mg

every month

22.5 mg

every 3 months

11.25 mg

every 3 months

3.75 mg

every month

10.8 mg

every 3 months

3.6 mg

every 28 days

50-mg implant

every 12 months

Starting dose of 240 mg given as two 120 mg injections, followed by maintenance doses of
80 mg every 28 days

Prefilled
dual-chamber
syringe (PDS)

Prefilled
2-syringe system

MIXJECT®
System,

prefilled diluents syringe

Prefilled SafeSystem™ syringe

Implantation kit with insertion tool

Reconstitution required; reconstitution and injection needles provided

23 gauge

(all dosages)

18 gauge

(45 mg)

20 gauge

(all other dosages)

21 gauge

(all dosages)

16 gauge

(3.6 mg)

14 gauge

(10.8 mg)

N/A –
physician
discretion
for local
anesthetic

27 gauge

(injection needle)

None
required

Required

None
required

None
required

Required

N/A – must
be injected
immediately
after
reconstitution

LuproLoc®
protective
safety
device

NONE

Protective
locking
safety
cover

Protective
safety
sleeve
needle
cover

Retractable
trocar
cannula

NONE

LuproLink

NONE

NONE

NONE

NONE

NONE

No conclusions regarding comparative safety or efficacy can be made from this chart. Route of administration varies.

Eligard®, Zoladex®, Trelstar®, Vantas®, Firmagon®, SafeSystem™, and MIXJECT® are trademarks of their respective owners.

References:

  1. Lupron Depot® [package insert].
  2. Data on file, AbbVie Inc.
  3. Eligard 7.5 mg, 22.5 mg, 30 mg, and 45 mg [package insert]. Bridgewater, NJ: Sanofi-Aventis; 2011. http://www.eligard.com/hcp/prescribing-information.aspx. Accessed July 5, 2012.
  4. Trelstar 3.75 mg, 11.25 mg, and 22.5 mg [package insert]. Corona, CA: Watson Pharma, Inc; 2011. http://pi.watson.com/data_stream.asp?product_group=1684&p=pi&language=E. Accessed July 5, 2012.
  5. Zoladex 1-month 3.6 mg Depot [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2011. http://www1.astrazeneca-us.com/pi/zoladex3_6.pdf. Accessed July 5, 2012.
  6. Zoladex 3-month 10.8 mg Depot [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2011. http://www1.astrazeneca-us.com/pi/zoladex10_8.pdf. Accessed July 5, 2012.
  7. Vantas [package insert]. Chadds Ford, PA: Endo Pharmaceuticals, Inc; 2012. http://www.endo.com/File%20Library/Products/Prescribing%20Information/Vantas-PI-PK000003-Rev--09_clean-v2-CMC_20110810.pdf. Accessed July 5, 2012.
  8. Firmagon [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc; 2009. http://www.firmagon.us/full_pi.pdf.