Mixing and Administering

Lupron Depot

Please see Indications and Important Safety Information

on pages 2-3. Please click here for full Prescribing
Information provided or visit www.Lupron.com.
Syringe Features
Use the prefilled dual-chamber
syringe (PDS) to mix and
administer Lupron Depot. Indications2,3

Uterine Leiomyomata (Fibroids)

LUPRON DEPOT (leuprolide acetate for depot suspension)
3.75 mg and 3-month 11.25 mg concomitantly with iron
therapy are indicated for the preoperative hematologic
improvement of patients with anemia caused by uterine
leiomyomata. The clinician may wish to consider a 1-month
23-gauge trial period on iron alone inasmuch as some of the patients will
needle1 respond to iron alone. LUPRON DEPOT may be added if the
response to iron alone is considered inadequate. Recommended
duration of therapy with LUPRON DEPOT 3.75 mg is up to
3 months. The 3-month 11.25 mg dosage form is indicated
only for women for whom 3 months of hormonal suppression
is deemed necessary. Experience with LUPRON DEPOT in
LuproLoc females has been limited to women 18 years of age and older.
Safety Device Endometriosis
To help reduce LUPRON DEPOT 3.75 mg and 3-month 11.25 mg are indicated
needlestick for the management of endometriosis, including pain relief
accidents and and reduction of endometriotic lesions. LUPRON DEPOT with
injuries, the PDS daily norethindrone acetate 5 mg is also indicated for initial
has a safety device management of endometriosis and for management of
called LuproLoc recurrence of symptoms. Duration of initial treatment or
that is integrated retreatment should be limited to 6 months.
into the PDS.
Advanced Prostate Cancer
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 prostate cancer.
Central Precocious Puberty
Prefilled LUPRON DEPOT-PED (leuprolide acetate for depot suspension)
Dual-Chamber 7.5 mg, 11.25 mg, and 15 mg for 1-month and 11.25 mg and
Syringe (PDS) 30 mg for 3-month administration are indicated in the
treatment of children with central precocious puberty
The PDS contains a
(CPP). CPP is defined as early onset of secondary sexual
powder that, when
characteristics (generally earlier than 8 years of age in girls
mixed with diluent,
and 9 years of age in boys) associated with pubertal pituitary
becomes a suspension.
gonadotropin activation. It may show a significantly advanced
The suspension is then
bone age that can result in diminished adult height. Prior to
administered as a single
initiation of treatment, confirm diagnosis of CPP by testing
intramuscular (IM)
luteinizing hormone (LH) and sex steroid levels, and assess
injection.2
bone age versus chronological age. Baseline evaluations
should be done to rule out intracranial tumor, steroid secreting
tumors, a chorionic gonadotropin secreting tumor, and
congenital adrenal hyperplasia.

Please see Indications and Important Safety Information

on pages 2-3. Please click here for full Prescribing
Information provided or visit www.Lupron.com.
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Important Safety Information2,3
General Information: LUPRON DEPOT, including LUPRON
DEPOT-PED, is contraindicated in patients with hypersensitivity
to GnRH agonists or any of the excipients in LUPRON DEPOT;
females who are or may become pregnant; women with
undiagnosed abnormal vaginal bleeding; and women who are
breastfeeding. LUPRON DEPOT may cause fetal harm when
administered to pregnant women. If used during pregnancy, the
patient should be apprised of the potential hazard to the fetus,
and that spontaneous abortion may occur. Before starting
treatment with LUPRON DEPOT, pregnancy must be excluded.
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 not
indicated for use in women. Transient worsening of symptoms or
the occurrence of additional signs and symptoms may develop
during the first few weeks of LUPRON DEPOT treatment in all
indications. Due to the suppression of the pituitary-gonadal
system by LUPRON DEPOT, diagnostic tests of pituitary
gonadotropic and gonadal functions conducted during treatment,
and for up to 6 months after discontinuation, may be affected. It
usually inhibits ovulation and stops menstruation. Females should
use non-hormonal methods of contraception. 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. LUPRON DEPOT must
be administered under the supervision of a physician.
Uterine Leiomyomata (Fibroids): Patients who have a history
of depression should be carefully observed and counseled on
the possibility of the development or worsening of depression
and the occurrence of memory disorders. Mean changes in
cholesterol, LDL, HDL, and the LDL/HDL ratios were observed.
Induced hypoestrogenic state resulted in bone loss (average of
2.7% compared with the pretreatment value) over a course of
treatment, which may not be reversible. In patients with major risk
factors for decreased bone mineral content, LUPRON DEPOT
therapy may pose an additional risk. Experience with LUPRON
DEPOT in females has been limited to women 18 years of age and
older. In controlled clinical trials of fibroid patients, adverse events
occurring in >10% of patients were headache, vasomotor flushes,
depression/emotional lability, and vaginitis.
Endometriosis: Patients who have a history of depression should
be carefully observed and counseled on the possibility of the
development or worsening of depression and the occurrence of
memory disorders. Mean changes in cholesterol, LDL, HDL, and
the LDL/HDL ratios were observed. Induced hypoestrogenic state
resulted in bone loss (average of 3.2% compared with the
pretreatment value) over a course of treatment, which may not be
reversible. LUPRON DEPOT therapy alone may pose an additional
risk in patients with major risk factors for bone loss. In these
patients, concomitant treatment with daily norethindrone acetate
5 mg should be considered and retreatment beyond an initial
6-month course is not advisable. In patients who are candidates
for retreatment with LUPRON DEPOT, bone density should be
assessed before retreatment and concomitant treatment with
norethindrone acetate is recommended. LUPRON DEPOT plus
norethindrone acetate-treated patients had significantly
decreased HDL levels and significantly increased LDL/HDL ratios
in clinical trials. After discontinuation of treatment, mean serum
lipid levels in clinical trial patients with follow-up data returned to
pretreatment values. Experience with LUPRON DEPOT for
treatment of endometriosis has been limited to women 18 years
of age and older.
Hormonal add-back therapy: Norethindrone acetate is
contraindicated in women with a history of thrombophlebitis,
thromboembolic disorders, cerebral apoplexy, markedly
impaired liver function or liver disease, or known or suspected
carcinoma of the breast. Assessment and management of risk
factors for cardiovascular disease is recommended prior to
initiation of add-back therapy with norethindrone acetate and
should be used with caution in women with risk factors,
Please click here for full Prescribing Information provided
or visit www.Lupron.com. For more information about
Lupron Depot, visit www.Lupron.com.
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including lipid abnormalities or cigarette smoking. LUPRON
DEPOT plus norethindrone acetate treatment should be
discontinued if there is a sudden partial or complete loss of
vision; if there is sudden onset of proptosis, diplopia, or
migraine; or if examination reveals papilledema or retinal
vascular lesions. In controlled clinical trials of endometriosis
patients, with or without add-back therapy with norethindrone
acetate, adverse events occurring in >20% of patients were
headache, vasomotor flushes, depression/emotional lability,
vaginitis, pain, nausea/vomiting, and insomnia/sleep disorder.
Advanced Prostate Cancer: 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.
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. Men 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.
In controlled clinical trials of advanced prostatic cancer patients
receiving any formulation of LUPRON DEPOT, the following
adverse events occurred in >10% of patients: hot flashes/sweats,
general pain, edema, urinary disorders, GI disorders, respiratory
disorders, testicular atrophy, injection site reactions, joint
disorders, asthenia, flu syndrome, skin reactions, headache,
and fatigue/lethargy.
Central Precocious Puberty: Monitor adequate response
initially and also with each dose change, or as judged clinically
appropriate, with a GnRHa stimulation test, basal LH, or serum
concentration of sex steroid levels:
After 1-2 months of initiating therapy for 1-month formulations
After 2-3 months of initiating therapy and at month 6 for
3-month formulations
Measure for height and bone advancement every 6-12 months
Noncompliance with drug regimen or inadequate dosing may
result in inadequate control of the pubertal process with
gonadotropins and/or sex steroids increasing above prepubertal
levels.
The most common adverse reactions with GnRH agonists,
including LUPRON DEPOT-PED, are injection site reactions/pain
including abscess and swelling, general pain, headache,
emotional lability, hot flushes/sweating, acne/seborrhea, vaginitis/
vaginal bleeding/vaginal discharge, rash including erythema
multiforme, vasodilation, and increased weight.
LUPRON DEPOT-PED in children under 2 years of age is not
recommended.
Preparing for Administration
What is included in this kit?
Your Lupron Depot kit should contain the following items:

One prefilled dual-chamber syringe (PDS)

One plunger

LuproLoc Safety Device

Complete prescribing information enclosed in kit

(Not displayed in this image)
Two alcohol swabs

You should also have a few basic supplies on hand: Appropriate injection sites
gauze pads, adhesive bandages, latex or latex-free
Before administering the IM injection, assess your patient for the
surgical gloves, and a puncture-resistant container
most appropriate injection site. As with other drugs administered
to safely dispose of syringes and needles after use.
by injection, the injection site should be varied periodically.2
Store Lupron Depot at room temperature Questions?
No refrigeration is required to store Lupron Depot.
If you have any questions regarding the drug or the mixing
You may store it at room temperature prior to mixing
and administration procedure, please see the accompanying
and administration. Since Lupron Depot does not
full prescribing information or call 1-800-633-9110 for
contain a preservative, the reconstituted suspension
further assistance.
should be injected immediately or discarded if not
used within 2 hours.2

Verify appropriate formulations

Lupron Depot is available in different strengths and
formulations. Prior to preparation for administration,
please verify patient dose.

Please see Indications and Important Safety Information

on pages 2-3. Please click here for full Prescribing
Information provided or visit www.Lupron.com.
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Mixing and Administration
Using the PDS to mix and administer Lupron Depot (leuprolide acetate for depot suspension)
is a 9-step process. Review these steps carefully before using the PDS. Please follow them closely
to ensure proper results.

STEP 1 STEP 2 STEP 3

1. Visually inspect the Lupron Depot powder
DO NOT USE the syringe if you see any clumping or caking.
A thin layer of powder on the wall of the syringe is considered
normal. The diluent should appear clear.2
2. Screw plunger into end stopper
To prepare for injection, screw the white plunger into the end
stopper until the stopper begins to turn.2
Slowly push plunger 68 seconds
To help avoid needle tip leakage, hold the syringe UPRIGHT. To
release the diluent, SLOWLY PUSH the plunger for 68 seconds
until the first stopper is at the blue line in the middle of the barrel.2
Do not pull the plunger back (or downward) at any time during
the mixing process. This will help prevent stopper separation.

STEP 4 STEP 5

Mix powder to form a uniform suspension Pull needle cap upward without twisting
Keep the syringe upright. Thoroughly mix the powder by gently Keep holding the syringe UPRIGHT. With your other hand, pull
shaking the syringe until the powder forms a uniform suspension. the needle cap upward without twisting.2 This may help minimize
To help avoid leakage, do not shake the syringe too vigorously. the potential for product leakage.
The suspension should appear milky. If the powder adheres to
the stopper, or if you see caking or clumping, tap the syringe
with your finger to disperse. DO NOT USE the syringe if any of
the powder has not gone into suspension.2

Please see Indications and Important Safety Information on pages 2-3.

Please click here for full Prescribing Information provided or visit www.Lupron.com.
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 STEP 6 STEP
Advance plunger to expel air from syringe
Keeping the syringe UPRIGHT, advance the plunger
to expel the air from the syringe. Now the syringe
is ready for injection.2
STEP 8 STEP
Immediately inject the contents of the syringe
Inject the entire contents of the syringe intramuscularly
immediately after reconstitution. The suspension settles very
quickly following reconstitution, so Lupron Depot should be
mixed and used immediately.2
Please see Indications and Important
Safety Information on pages 2-3. Please
click here for full Prescribing Information
provided or visit www.Lupron.com.
2014 AbbVie Inc. North Chicago, IL 60064 953486-1521605 June 2014
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7
Insert the needle at a 90-degree angle into the
intramuscular injection site
Clean the injection site with an alcohol swab and insert the
needle at a 90-degree angle into the chosen intramuscular
injection site. Remember: injection sites should be alternated.
Note that if a blood vessel is accidentally penetrated, you may
see aspirated blood just below the luer-lock connection, through
the transparent LuproLoc safety device. If this occurs, remove
the needle immediately. Do not inject the medication.2
9
Withdraw the needle and activate LuproLoc
After the injection, withdraw the needle. Immediately activate the
LuproLoc safety device by pushing the arrow upward toward the
needle tip with your thumb or finger until the needle cover of the
safety device is fully extended over the needle and you hear or
feel a click.2 Then dispose of the syringe according to applicable
regulations or procedures.
REFERENCES: 1. Data on file, AbbVie Inc. 2. Lupron Depot [package inserts].
3. Lupron Depot-PED [package insert].