Download Mixing and Administering Lupron Depot

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
trial period on iron alone inasmuch as some of the patients will
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
females has been limited to women 18 years of age and older.
23-gauge
needle1
LuproLoc®
Safety Device
Endometriosis
To help reduce
needlestick
accidents and
injuries, the PDS
has a safety device
called LuproLoc
that is integrated
into the PDS.
LUPRON DEPOT 3.75 mg and 3-month 11.25 mg are indicated
for the management of endometriosis, including pain relief
and reduction of endometriotic lesions. LUPRON DEPOT with
daily norethindrone acetate 5 mg is also indicated for initial
management of endometriosis and for management of
recurrence of symptoms. Duration of initial treatment or
retreatment should be limited to 6 months.
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
Dual-Chamber
Syringe (PDS)
LUPRON DEPOT-PED® (leuprolide acetate for depot suspension)
7.5 mg, 11.25 mg, and 15 mg for 1-month and 11.25 mg and
30 mg for 3-month administration are indicated in the
treatment of children with central precocious puberty
(CPP). CPP is defined as early onset of secondary sexual
characteristics (generally earlier than 8 years of age in girls
and 9 years of age in boys) associated with pubertal pituitary
gonadotropin activation. It may show a significantly advanced
bone age that can result in diminished adult height. Prior to
initiation of treatment, confirm diagnosis of CPP by testing
luteinizing hormone (LH) and sex steroid levels, and assess
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.
The PDS contains a
powder that, when
mixed with diluent,
becomes a suspension.
The suspension is then
administered as a single
intramuscular (IM)
injection.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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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,
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.
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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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:
gauze pads, adhesive bandages, latex or latex-free
surgical gloves, and a puncture-resistant container
to safely dispose of syringes and needles after use.
Store Lupron Depot at room temperature
No refrigeration is required to store Lupron Depot.
You may store it at room temperature prior to mixing
and administration. Since Lupron Depot does not
contain a preservative, the reconstituted suspension
should be injected immediately or discarded if not
used within 2 hours.2
Appropriate injection sites
Before administering the IM injection, assess your patient for the
most appropriate injection site. As with other drugs administered
by injection, the injection site should be varied periodically.2
Questions?
If you have any questions regarding the drug or the mixing
and administration procedure, please see the accompanying
full prescribing information or call 1-800-633-9110 for
further assistance.
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.
-4-
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
Slowly push plunger 6–8 seconds
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
To help avoid needle tip leakage, hold the syringe UPRIGHT. To
release the diluent, SLOWLY PUSH the plunger for 6–8 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.
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
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
shaking the syringe until the powder forms a uniform suspension.
To help avoid leakage, do not shake the syringe too vigorously.
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
Keep holding the syringe UPRIGHT. With your other hand, pull
the needle cap upward without twisting.2 This may help minimize
the potential for product leakage.
Please see Indications and Important Safety Information on pages 2-3.
Please click here for full Prescribing Information provided or visit www.Lupron.com.
-5-
STEP
6
STEP
Advance plunger to expel air from syringe
Insert the needle at a 90-degree angle into the
intramuscular injection site
Keeping the syringe UPRIGHT, advance the plunger
to expel the air from the syringe. Now the syringe
is ready for injection.2
STEP
7
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
8
STEP
9
Immediately inject the contents of the syringe
Withdraw the needle and activate LuproLoc
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
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.
Please see Indications and Important
Safety Information on pages 2-3. Please
click here for full Prescribing Information
provided or visit www.Lupron.com.
REFERENCES: 1. Data on file, AbbVie Inc. 2. Lupron Depot [package inserts].
3. Lupron Depot-PED [package insert].
©2014 AbbVie Inc. North Chicago, IL 60064 953486-1521605 June 2014
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