HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CAMCEVI™ safely and effectively. See full prescribing information for CAMCEVI.
CAMCEVI (leuprolide) injectable emulsion, for subcutaneous use
Initial U.S. Approval: YYYY
-------------- INDICATIONS AND USAGE -------------
CAMCEVI is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer. (1)
----------DOSAGE AND ADMINISTRATION ---------
• See
Full Prescribing Information for instructions on the preparation and administration of the injectable emulsion in a pre-filled syringe. (2)
• Recommended Dosage: 42 mg subcutaneously every 6 months. (2)
-------- DOSAGE FORMS AND STRENGTHS--------
•
Injectable emulsion: 42 mg (3)
----------------- CONTRAINDICATIONS
----------------
•
Hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of CAMCEVI. (4)
---------- WARNINGS AND PRECAUTIONS ---------
•
Tumor Flare: Transient worsening of bone pain, uretral obstruction, spinal cord compression, or the occurrence of additional signs and symptoms of prostate cancer may develop during the first few weeks of treatment. Monitor patients closely and manage symptoms. (5.1)
• Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor
blood glucose level and manage according to current clinical practice. (5.2)
•
Cardiovascular Diseases: Increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in men receiving GnRH agonists. Monitor for cardiovascular disease and manage according to current clinical practice. (5.3)
• QT/QTc Prolongation: Androgen deprivation therapy may prolong the QT interval. Consider periodic monitoring of electrocardiograms and electrolytes. (5.4)
•
Convulsions: Manage convulsions according to the current clinical practice. (5.5)
• Embryo-Fetal Toxicity: CAMCEVI may cause fetal harm. (5.7, 8.1)
----------------- ADVERSE REACTIONS -----------------
The most common (>10%) adverse reactions were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity. (6.1)
To report SUSPECTED ADVERSE REACTIONS,
contact Foresee Pharmaceuticals at 1-XXX-XXX
XXXX or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
---------- USE IN SPECIFIC POPULATIONS ----------
•
Females and males of reproductive potential: CAMCEVI may impair fertility. (8.3)
• Safety and effectiveness in pediatric patients have not been established. (8.4)
See 17 for PATIENT COUNSELING INFORMATION.
Revised 05/2021
FU
LL
PRESCRIBING INFORMATION
CAMCEVI is indicated for the treatment of adult patients with
advanced prostate cancer.
DOSAGE
AND
ADMINISTRATION
Recommended
Dosage
CAMCEVI must be
administered by a healthcare provider.
The recommended
dose of CAMCEVI is
42 mg administered subcutaneously once every 6 months.
2.2 Preparation
and Administration
Syringe
Assembly
1. Remove CAMCEVI kit
from
refrigerator. Open
carton
and remove blister.
2. Allow prefilled syringe to
sit at room temperature for 30 minutes
prior to subcutaneous
injection.
3. Examine
all contents of
the package. Do
not use if any component
is damaged.
4. Check the expiration date on the
syringe. Do not use if the expiration
date has
passed.
5. The use of gloves
is recommended during
syringe assembly and
administration.
6. On a clean,
dry surface, remove pre-filled
syringe (A) and needle cartridge (B) from
the blister carton. Visually
inspect the contents prior to use.
7. Remove the gray cap from
the syringe (A).
8. Twist the clear cap
off
the bottom of the needle cartridge (B).
9. Attach the needle (B) to the end of
the syringe (A) by pushing and turning the needle until firmly connected
to the syringe. Do not over twist
the needle and strip
the threading.
Remove contents Syringe Assembly Assembled Pre-Filled Syringe
Administration Procedure
1. Choose an injection site on the
upper- or mid-abdominal
area with sufficient soft
or loose subcutaneous tissue that has
not recently been used.
Clean the injection site with an
alcohol
swab. Do NOT inject in areas with
brawny or fibrous subcutaneous
tissue or locations that
can be rubbed or
compressed (i.e.,
with a belt or
clothing waistband). In
addition, avoid applying heat
directly to the site of CAMCEVI injection.
2. Pull the blue cover off the needle (B).
Use
standard sharps
safety techniques to avoid
needle sticks.
3. Use standard aseptic technique when performing
the injection. Grab and
bunch
the skin around the injection
site with one hand. Insert the
needle at a 90° angle to the
skin surface, and
then release the
bunched skin.
4. Inject the full contents
of the syringe with a
slow and steady push on the plunger,
and then withdraw
the needle at the
same 90° angle used for insertion.
Prepare the Injection Site Administer
Treatment
Needle Protection
1. Do not remove the needle from
the syringe. Use the enclosed
Point-Lok® device to prevent
needle sticks.
2. Retrieve the Point-Lok® needle protection
device from the
Camcevi kit and place it on a
secured, flat
surface with its largest surface base touching
the
surface as shown in the
diagram below.
3. Immediately after use of the needle, gently insert
the exposed needle into
the Point-Lok® device opening
at the top of the Point-Lok® device.
(see Figure 1
below)
4. Push the needle into the
top opening until it is fully
inserted into the Point-Lok® device. This
action
will seal the needle tip
and
lock the needle firmly into
the Point-Lok® device. (see Figure 2 below)
5. After use,
place the used syringe with needle protected
in a suitable sharps container. Dispose of
contaminated product in a safe manner according to Centers for Disease Control
and Prevention, USA and
Federal/State/Local
regulations (EPA,OSHA) and
health
care facility
guidelines or local equivalent.
DOSAGE
FORMS
AND
STRENGTHS
Injectable emulsion: 42 mg leuprolide (equivalent
to approximately 48 mg leuprolide mesylate) as
a sterile, off-white to pale yellow,
viscous, and opalescent emulsion
in a single-dose, pre-filled
syringe for subcutaneous injection.
CONTRAINDICATIONS
CAMCEVI is
contraindicated
in patients known to be hypersensitive to GnRH,
GnRH agonist analogs,
or any of the excipients in CAMCEVI. Anaphylactic reactions to GnRH agonist analogs have been reported
in the medical literature.
WARNINGS AND PRECAUTIONS
Tumor Flare
CAMCEVI, like
other GnRH agonists, causes a transient
increase in serum levels of
testosterone during
the first week of treatment,
declining thereafter to baseline levels or
below by the end of
the second week of
treatment. Transient worsening
of symptoms, or the occurrence of additional
signs and symptoms of prostate cancer,
may develop during the first few weeks of
CAMCEVI treatment.
Patients treated with
CAMCEVI may
experience a temporary
increase in
bone pain, which can
be
managed symptomatically.
As with other GnRH agonists,
cases
of ureteral obstruction
and spinal cord compression
have been observed, which may contribute to paralysis
with or without fatal complications.
Patients
with metastatic vertebral
lesions and/or with
urinary tract obstruction should be closely observed
during the first few weeks of
therapy.
Hyperglycemia
and Diabetes
Hyperglycemia and
an increased
risk of developing diabetes have been reported
in men receiving GnRH
agonists. Hyperglycemia may represent the
development of
diabetes mellitus or worsening of
glycemic control
in patients with diabetes. Monitor blood glucose and/or
glycosylated hemoglobin
(HbA1c) periodically in patients receiving a
GnRH agonist and
manage with
current
practice for treatment of hyperglycemia or diabetes.
Cardiovascular Diseases
Increased risk of developing myocardial infarction,
sudden cardiac death,
and stroke has been reported in association
with use of GnRH agonists
in men. The risk appears low
based on the reported
odds ratios, and should be evaluated
carefully along
with
cardiovascular risk factors when determining
a treatment for patients
with prostate cancer. Patients
receiving a GnRH agonist
should be monitored for
symptoms and signs suggestive of development of cardiovascular disease and
be managed
according
to current clinical
practice.
QT/QTc Prolongation
Androgen
deprivation
therapy may prolong the QT/QTc interval. Providers
should consider whether the benefits of
androgen deprivation
therapy 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. Electrolyte abnormalities
should be corrected.
Consider periodic monitoring of electrocardiograms
and electrolytes.
Convulsions
Convulsions have been reported in patients receiving GnRH agonists, like CAMCEVI [see Adverse
Reactions
(6.2)]. Manage patients
receiving a
GnRH agonist who experience convulsions according to current clinical
practice.
Laboratory Tests
Monitor serum
levels
of testosterone following
injection of CAMCEVI. In the majority of
patients treated with
CAMCEVI, testosterone levels increased
above baseline during the first week, and
then declined thereafter to castration
levels
(<50 ng/dL) within 4 weeks [see Clinical
Studies (14) and Adverse Reactions
(6)].
Embryo-Fetal Toxicity
Based
on findings in animal
studies and mechanism
of action, CAMCEVI can
cause fetal
harm when administered to a
pregnant woman. In
animal developmental
and reproductive toxicology studies, administration of
a monthly formulation of
leuprolide on day
6 of pregnancy
(sustained
exposure was
expected
throughout
the period of organogenesis) caused adverse embryo-fetal toxicity in animals at
doses
less than the human dose based on body surface area using
an
estimated daily
dose. Advise pregnant patients and females
of reproductive potential
of the potential risk
to the fetus[see Use in Specific Population (8.1), Clinical
Pharmacology (12.1)].
ADVERSE
REACTIONS
The following
adverse reactions
are
discussed in greater detail in other sections
of the labeling:
•
Tumor Flare[seeWarnings
and Precautions (5.1)]
•
Hyperglycemia and
Diabetes[seeWarnings
and Precautions (5.2)]
•
Cardiovascular Diseases[seeWarnings
and Precautions (5.3)]
•
QT/QTc Prolongation[seeWarnings
and Precautions (5.4)]
•
Convulsions[seeWarnings and Precautions (5.5)]
Clinical Trial
Experience
Because clinical
trials
are conducted under widely
varying conditions, adverse reaction rates
observed in the clinical
trials
of a drug cannot
be directly compared
to rates in the
clinical trials
of another drug and may
not reflect the rates observed in practice. In
an open-label,
non-comparative clinical
trial
(FP01C 13-001), patients with
advanced
prostate cancer received CAMCEVI administered
subcutaneously at
a dose of 42 mg on Day 0 and
Day 168. Of 137 patients
enrolled, 93%
received both doses of CAMCEVI.
Serious adverse reactions
occurred in 15%
of patients who
received CAMCEVI,
including 1% of patients who
experienced subdural hematoma. Fatal adverse reactions occurred
in 2% of patients,
including cerebrovascular accident (0.7%) and pulmonary embolism
(0.7%).
The most common
adverse reactions
(>10%) occurring during
a median follow-up
duration of 336 days were hot flush,
hypertension,
injection site reactions,
upper respiratory
tract
infections, musculoskeletal
pain, fatigue, and pain in extremity.
Table 1 summarizes the adverse reactions
in FP01C-13-001.
|
|
|
|
|
|
|
|
(%)
|
(%)
|
|
Vascular disorders
|
|
Hot flusha
|
50
|
0
|
|
Hypertensionb
|
15
|
0
|
|
General disorders and administration site conditions
|
|
Injection site reactionsc
|
11
|
0
|
|
Fatigued
|
10
|
0
|
|
Infections and infestations
|
|
Upper respiratory tract infectione
|
11
|
0
|
|
Musculoskeletal and connective tissue disorders
|
|
Musculoskeletal painf
|
11
|
0
|
|
Pain in extremity
|
10
|
0
|
|
Arthralgia
|
7
|
0
|
|
Renal and urinary disorders
|
|
Micturition urgencyg
|
6
|
0
|
|
Nocturia
|
6
|
0
|
|
Nervous system disorders
|
|
Dizzinessh
|
5
|
0.7
|
|
|
Table 1. Adverse
Reactions Occurring in ≥5% of Patients - FP01C-13-001
N = 137
Adverse Reaction
All Grades
Grade 3-4
a includes hot flush and flushing
b includes hypertension, essential hypertension, and blood pressure increased
c includes injection site pain, injection site erythema, injection site hemorrhage, injection site nodule, injection site paraesthesia, injection site pruritus, and injection site warmth
d includes fatigue and asthenia
e includes upper respiratory tract infection, sinusitis,
and nasopharyngitis
f includes musculoskeletal pain, back pain, and bone pain
g includes micturition urgency and dysuria
h includes dizziness, dizziness postural, vertigo, and vertigo positional.
Postmarketing Experience
The following
adverse reactions
have been identified
during post approval use of leuprolide. Because
these reactions are reported voluntarily
from a population of
uncertain size, it
is not always possible to reliably estimate their frequency or
establish a causal
relationship
to drug exposure.
During postmarketing
surveillance, which
includes other dosage forms and other patient populations,
the following adverse reactions were reported.
Allergic Conditions:anaphylactoid or
asthmatic process,
rash,
urticaria,
and
photosensitivity reactions
Cardiovascular System: hypotension, myocardial infarction, pulmonary embolism
Central/Peripheral
Nervous
System:convulsion, peripheral neuropathy,
spinal
fracture/paralysis
Endocrine System:pituitary apoplexy, diabetesHepato-biliary disorder:drug-induced
liver injuryHematologic:white blood cells
Psychiatric: mood swings, including
depression,
suicidal ideation and attempt
Respiratory, thoracic and mediastinal
disorder:interstitial
lung disease
Musculoskeletal System:decreased bone density,
tenosynovitis-like symptoms, fibromyalgia
Skin
and Subcutaneous:injection
site reactions
Urogenital System:prostate pain
USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
Based
on findings in animal
studies and mechanism
of action, CAMCEVI can
cause fetal
harm when administered to a
pregnant woman [see Clinical Pharmacology (12.1)]. There are no available data in pregnant women to inform the drug-associated
risk.
In animal
developmental and
reproductive
toxicology studies, administration of
a monthly formulation of
leuprolide on day
6 of pregnancy
(sustained exposure was expected throughout
the period of organogenesis) caused adverse embryo-fetal toxicity in animals at
doses
less than the human dose based on body surface area using
an estimated
daily dose (see data). Advise pregnant
patients and females
of reproductive potential
of the potential risk
to the fetus.
Data
Animal Data
Major
fetal malformations were observed
in developmental and
reproductive toxicology studies in rabbits after a single administration of
a monthly formulation of
leuprolide administered
on day 6 of pregnancy at test
dosages of 0.00024, 0.0024, and 0.024 mg/kg (approximately
1/1500 to 1/15 the human dose based on body
surface area using an estimated
daily dose in animals and
humans). Since a depot
formulation was
utilized
in the study, a sustained exposure to
leuprolide was expected throughout the
period of organogenesis
and to the end of gestation. Similar studies in rats did not demonstrate an
increase in fetal
malformations,
however, there was
increased fetal
mortality and decreased fetal weights
with the two higher doses of the monthly formulation
of leuprolide in rabbits and
with the highest dose in rats.
Lactation
Risk Summary
The safety and
efficacy
of
CAMCEVI have not been established
in females.
There is no information
regarding
the presence of leuprolide
in human milk, the effects on the breastfed child,
or the effects on milk production. Because
many drugs are excreted
in human milk and because of the potential for serious
adverse reactions in a breastfed child,
a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account
the importance of the drug
to the mother.
Females and Males of
Reproductive Potential
Infertility
Males
Based
on findings in animals
and mechanism of action, CAMCEVI may impair
fertility in males of reproductive potential[see Clinical
Pharmacology (12.1),
Nonclinical Toxicology
(13.1)].
Pediatric Use
The safety and
efficacy
of
CAMCEVI in pediatric patients have not been established.
Geriatric Use
Of the 137 patients
who received CAMCEVI in the
FP01C-13-001 study, 74% were 65
years of
age or older, while 37% were 75 years
of age or older.
No overall differences
in safety
or effectiveness
were
observed between
these patients and
younger patients.
DESCRIPTION
CAMCEVI is a sterile formulation
of leuprolide mesylate for subcutaneous
injection. CAMCEVI is designed to deliver approximately 42 mg of leuprolide over 6 months.
Leuprolide
mesylate is a synthetic nonapeptide
analog of naturally
occurring
GnRH and is a GnRH agonist. The analog
possesses greater potency than
the natural hormone.
The
chemical name is
5-oxo-L prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide
mesylate (salt) with
the following structural formula. The pH of 50 mg/mL solution of leuprolide mesylate in
water is approximately
5.7.
n CH₃SO₃H
n = 1.5-1.8
CAMCEVI is
supplied as a kit with a
pre-filled, single-dose,
sterile syringe for subcutaneous injection. Each
pre-filled syringe delivers
42 mg leuprolide (equivalent to approximately 48 mg leuprolide mesylate), poly(D,
L-lactide) (184
mg) polymer and N-methyl-2-pyrrolidone (136 mg).
CLINICAL PHARMACOLOGY
Mechanism of Action
Leuprolide,
a GnRH agonist, acts
as an
inhibitor of gonadotropin secretion.
Animal
and human studies indicate that following an
initial stimulation of gonadotropins, chronic
administration of leuprolide
results in suppression of ovarian and
testicular steroidogenesis.
This effect is
reversible upon discontinuation of
drug therapy.
In humans, subcutaneous administration
of single daily doses of leuprolide result
in an initial increase in
circulating levels of
LH and FSH,
leading to a transient
increase in levels
of the gonadal steroids
(testosterone
and dihydrotestosterone in
males). However, continuous
daily administration of leuprolide results
in decreased levels
of
LH and FSH. In males,
testosterone is reduced
to below castration levels. These decreases generally occur within 2 to 4 weeks after initiation
of treatment, and
castration levels
of testosterone in prostatic cancer patients
have been demonstrated for periods of up to 5 years.
Pharmacodynamics
Mean serum
testosterone concentrations transiently increased,
then fell to below castrate threshold levels (≤ 50 ng/dL) within 3 weeks following administration of
the dose of leuprolide,
and generally remained below castrate thresholds
levels throughout treatment.
Pharmacokinetics
Leuprolide
concentration is variable,
exhibiting an initial rapid
increase followed by a
rapid decline over
the first 3 days before reaching
steady concentrations for the duration of
the dosing interval.
The
mean serum leuprolide
Cmax was 94.5 and 99
ng/mL following the first and
second doses of CAMCEVI, respectively.
The mean
serum
concentration
was
maintained at 0.497–2.57 and 0.507–2.39 ng/ml after
Day
3 post the first and second
doses, respectively. The mean
AUC0-6 mon was 224 and 268
day.ng/mL following the first
and second doses of CAMCEVI, respectively.
Absorption
The median
Tmax of leuprolide
was 3.2 and 2.1 hours
following the first and second
doses of CAMCEVI, respectively.
Distribution
The mean
steady-state volume of distribution of leuprolide
was 27 L following an
intravenous bolus in healthy
male volunteers. Protein binding of leuprolide
ranged from
43% to 49% in vitro.
Elimination
The mean systemic clearance was
7.6 L/h and terminal
elimination half-life of approximately
3 hours following an intravenous bolus
of leuprolide in healthy male volunteers.
Metabolism
Administration of
radiolabeled
leuprolide was
metabolized
to smaller inactive peptides which may
then
be further catabolized.
Excretion
Excretion of leuprolide has not been
evaluated with CAMCEVI. Specific Populations
No clinically
significant differences
in the systemic exposure of leuprolide were observed
based on age (51
to 88 years), race/ethnicity
(White, Black, Asian),
or body weight (54 to 134 kg). The effect of renal or hepatic impairment
on the pharmacokinetics
of leuprolide
has not been evaluated.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
Two-year carcinogenicity studies were conducted with
leuprolide in rats and
mice. In rats, a
dose-related increase of benign
pituitary hyperplasia and benign pituitary
adenomas was noted
at 24 months when the drug was
administered subcutaneously at
high daily doses (0.6 to 4 mg/kg). There was
a significant but not dose-related
increase of pancreatic islet-cell adenomas in females and
of testicular interstitial cell
adenomas in males (highest
incidence in the
low dose group). In
mice,
no pituitary abnormalities were
observed at a dose as high
as 60 mg/kg for 2 years.
Patients have been
treated
with leuprolide for up to
3 years with
doses as high as 10 mg/day and for 2 years
with doses as high as
20 mg/day without demonstrable pituitary abnormalities.
Mutagenicity studies have been
performed with
leuprolide using bacterial and
mammalian systems. These studies provided no
evidence of mutagenic potential.
Leuprolide may
reduce male and
female fertility.
Administration of leuprolide
to male and female rats at
doses of 0.024, 0.24, and 2.4
mg/kg as monthly depot
formulation for up to
3 months (approximately as
low as 1/30 of the human
dose based on body surface area using an estimated
daily dose in animals and
humans) caused
atrophy of the reproductive organs,
and suppression of reproductive function. These changes were reversible
upon cessation of
treatment.
CLINICAL STUDIES
The efficacy of CAMCEVI was
evaluated in an
open
label,
single arm, multinational study FP01C-13 001 (NCT02234115) in patients with
advanced prostate carcinoma
who have a baseline morning serum testosterone level >150
ng/dL
and Eastern Cooperative
Oncology Group performance status ≤ 2. CAMCEVI was administered subcutaneously at
a dose of 42 mg initially on Day
0 and on Week 24.
The population (n
= 137) had a median age of 71 years (range 51
to 88) and was 90%
White, 6% Black, and
4% Asian. Disease stage was
distributed as follows: 23%
metastatic (M1), 27%
locally advanced
(T3/4 NX M0 or any T N1 M0),
26% localized (T1 or T2
N0 M0), and 24% not
classifiable. The median
testosterone concentration
at baseline was 440 ng/dL.
The major efficacy
outcome measure was
medical castration
rate, defined as
achieving and maintaining serum testosterone suppression
to ≤ 50 ng/dL by Week 4 through Week
48 of
treatment. Following
the first injection of CAMCEVI,
serum testosterone levels
were suppressed
to ≤ 50 ng/dL by Week 4 (+/-7 days) in
98.5% of the patients; and
from Week 4 through
Week 48 in 97.0% of patients (95% CI: 92.2
98.9) estimated using the Kaplan-Meier method.
The
time course of percent change from baseline in
testosterone suppression are shown in Figure 1. The percentage of patients with
testosterone suppression to ≤ 20
ng/dL was 69.3% on Day
28.
F
igure 1 CAMCEVI Mean (95% CI) Percentage Change from Baseline in
Serum Testosterone
Concentration
Over Time (N =137)
In the clinical trial, PSA
levels were monitored and were lowered on average by 51%
after 4 weeks after administration of CAMCEVI,
83% after 3
months and remained
suppressed throughout
the 48 weeks of treatment.
These PSA results should be interpreted with
caution because of the heterogeneity
of the patient population studied. No evidence has shown
that the rapidity of PSA decline correlates
with clinical benefit.
HOW SUPPLIED/STORAGE
AND
HANDLING
CAMCEVI is a sterile, off-white
to pale yellow,
viscous
and opalescent
injectable emulsion supplied in a kit as a single-dose,
pre-filled syringe.
CAMCEVI is available as
follows:
|
Kit Contents
|
NDC
|
|
Injectable emulsion in a pre-filled syringe containing 42 mg leuprolide for subcutaneous injection, a sterile 18 gauge needle, a Point-Lok® needle protection device, and Instructions for Use.
|
72851-042-01
|
Store CAMCEVI at 2°C–8°C
(36°F–46°F).
Protect CAMCEVI from light by storing in the original
package until time of use. Do
not freeze or shake.
The rubber used
in syringe tip cap and
plunger stopper is not made of natural rubber latex.
PATIENT COUNSELING INFORMATION
Hypersensitivity
•
Inform patients that
if they have experienced
hypersensitivity with other GnRH
agonist drugs like CAMCEVI,
CAMCEVI is contraindicated [see Contraindications (4)].
Tumor Flare
•
Inform patients that
CAMCEVI can 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
CAMCEVI treatment [see Warnings and Precautions (5.1)].
Hyperglycemia and
Diabetes
•
Advise patients
that there is an increased
risk of hyperglycemia and
diabetes with
CAMCEVI therapy. Inform patients that
periodic monitoring for hyperglycemia and
diabetes is required when being
treated
with CAMCEVI [see Warnings and Precautions (5.2)].
Cardiovascular Disease
•
Inform patients that
there is an
increased risk of
myocardial infarction,
sudden
cardiac death, and
stroke with CAMCEVI treatment. Advise patients to
immediately report
signs and symptoms associated
with these events
to their healthcare provider for evaluation [see Warnings and Precautions (5.3)].
QT/QTc Prolongation
•
Inform patients that
CAMCEVI can cause
QT/QTc prolongation. Advise patients to immediately contact their healthcare provider in the
event of syncope,
presyncopal symptoms, or cardiac palpitations [see Warnings
and Precautions (5.4)].
Convulsions
•
Inform patients that
there is an
increased risk of
convulsions with CAMCEVI treatment. Advise patients to immediately contact their healthcare provider if they experience convulsions [see Warnings and Precautions (5.5)].
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
CAMCEVI may cause impotence. Infertility
•
Inform patients that
CAMCEVI may cause infertility[see Use In
Specific Populations (8.3)].
Manufactured for:
Foresee Pharmaceuticals Co., Ltd.
9F-2,
No. 19-3, Sanchong Rd., Nangang Dist.,
Taipei City 115, Taiwan
By:
Fareva Pau
1
Avenue du Bearn,
64320 Idron, France
Instructions for Use
You must read these complete instructions before you administer CAMCEVI for the first time.
CAMCEVI must be administered by a healthcare provider.
|
What is CAMCEVI?
|
CAMCEVI is a subcutaneous injection that provides long-acting
gonadotropin releasing hormone (GnRH) agonist to patients. CAMCEVI contains a biodegradable polymer formulation dissolved in a biocompatible solvent that provides sustained
release of leuprolide.
CAMCEVI is supplied
as a kit containing one sterile, pre-filled syringe for subcutaneous injection, one sterile 18-gauge needle, one Point-Lok® needle protection device, and Instructions for Use.
|
|
Dosage
|
The recommended dosing is 1 subcutaneous injection (42 mg
leuprolide) every 6 months.
|
|
Before you begin to
prepare CAMCEVI Injection
|
Read these critical instructions.
Do not substitute any of
the components from the kit for
administration.
CAMCEVI is packaged in a blister in the kit. Check to make sure the kit contains:
• One sterile, single-dose prefilled syringe with plunger rod and backstop
• One sterile 18-gauge, 5/8-inch needle
• One Point-Lok® needle protection device
• Instructions for Use and Prescribing Information
|
|
|
Point-Lok®
® Point-Lok is a registered trademark of Smiths Medical
|
|
Bring CAMCEVI to room
temperature
|
STEP
|
To bring CAMCEVI to room temperature:
|
|
|
1
|
Remove CAMCEVI kit from refrigerator. Open carton and
remove blister.
Allow prefilled syringe to sit at room temperature for 30 minutes prior to subcutaneous injection.
|
|
Prepare the syringe
|
STEP
|
Follow these steps to prepare CAMCEVI for use:
|
|
|
1
|
Examine all contents of the package. Do not use if any
component is damaged.
|
|
|
2
|
Check the expiration date on the syringe. Do not use if the
expiration date has passed.
|
|
|
3
|
The use of gloves is recommended during syringe
assembly and administration.
|
|
|
4
|
On a clean, dry surface, remove pre-filled syringe (A) and
needle cartridge (B) from the blister carton. Visually
inspect the contents prior to use.
|
|
|
5
|
Remove the gray cap from the syringe (A). Twist the clear
cap off the bottom of the needle cartridge (B).
|
|
|
6
|
Attach the needle (B) to the end of the syringe (A) by
pushing and turning the needle until firmly connected to the syringe. Do not over twist
the needle and strip the
threading.
|
|
|
|
Assembled Pre-Filled Syringe
|
|
Select an injection site
|
STEP
|
To select an injection site, use these guidelines:
|
|
|
1
|
Choose an injection site on the upper- or
mid-abdominal
area with sufficient soft or loose subcutaneous tissue that has not recently been used. Clean the injection site with an alcohol swab.
Do NOT inject
in areas with brawny or fibrous subcutaneous tissue or locations that can be rubbed or compressed (i.e., with a belt or clothing waistband). In addition, avoid applying heat directly to the site of Camcevi injection.
|
|
Inject CAMCEVI
|
STEP
|
Follow these steps to inject CAMCEVI:
|
|
|
1
|
Pull the blue cover off the needle (B). Use standard sharps
safety techniques to avoid needle sticks.
|
|
|
2
|
Use standard aseptic technique when performing the injection.
|
|
|
|
Grab and bunch the skin around the injection site with
one hand. Insert the needle at
a 90° angle to the skin surface, and then release the bunched skin.
|
|
|
3
|
Inject the full contents of the syringe with a slow and
steady push on the plunger, and then withdraw the needle at the same 90° angle used for insertion.
|
|
|
4
|
Do not remove the needle from the syringe. Use the enclosed Point-Lok® device to prevent needle sticks.
Retrieve the Point-Lok® needle protection device from the Camcevi kit and place it on a secured, flat surface with its largest surface base touching the surface as shown in the diagram below.
Immediately after use of the needle, gently insert the exposed needle into the Point-Lok® device opening at the top of the Point-Lok® device. (see Figure 1 below)
Push the needle into the top opening until it is fully inserted into the Point-Lok® device. This action will seal the needle tip and lock the needle firmly into the Point- Lok® device. (see Figure 2 below)
After use, place the used syringe with needle protected in
a suitable sharps container. Dispose of contaminated product in a safe manner according to Centers for Disease Control and Prevention, USA and Federal/State/Local
regulations (EPA, OSHA) and health care facility guidelines or local equivalent.
|
Manufactured for:
Foresee Pharmaceuticals
Co.
Ltd.
9F-2, No. 19-3,
Sanchong Rd., Nangang Dist., Taipei
City 115, Taiwan
By:
Fareva Pau 1
Avenue du Bearn, 64320 Idron, France
FULL
PRESCRIBING INFORMATION: CONTENTS*