Abarelix (4026)
[ a-ba-rel'-iks ]
| Ingredients: |
Abarelix |
| Indications: |
Carcinoma, prostate |
| Pregnancy Category: |
X |
| FDA Approved: |
2003- 11- 01 |
| Classes: |
Antineoplastics, hormones/ hormone modifiers; Gonadotropin- releasing hormone analogs; Hormones/ hormone modifiers |
| HCFA Jcodes: |
S0165 |
| Brand Names: |
Plenaxis
-
US
;
|
| DEA schedules: |
(none)
|
| Cost of therapy: |
$1,888.80
(
Prostate cancer ;
Plenaxis ;
100 mg/2 ml ;
1 injection/month (maintenance) ;
60 day supply
)
$2,833.20
(
Prostate cancer ;
Plenaxis ;
100 mg/2 ml ;
1 injection/2 weeks (initial therapy) ;
29 day supply
)
|
BOXED WARNING
|
| |
- Immediate- onset systemic allergic reactions, some resulting in hypotension and syncope, have occurred after administration
of abarelix. These immediate- onset reactions have been reported to occur following any administration of abarelix, including
after the initial dose. The cumulative risk of such a reaction increases with the duration of treatment (see WARNINGS ). Following each injection of abarelix, patients should be observed for at least 30 minutes in the office and in the event
of an allergic reaction, managed appropriately.
-
| • |
Only physicians who have enrolled in the Plenaxis PLUS Program ( Pl enaxis U ser S afety Program), based on their attestation of qualifications and acceptance of prescribing responsibilities, may prescribe
abarelix (see DOSAGE AND ADMINISTRATION and HOW SUPPLIED ).
|
| • |
Abarelix is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist
therapy is not appropriate and who refuse surgical castration, and have 1 or more of the following: (1) risk of neurological
compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease,
or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia.
|
| • |
The effectiveness of abarelix in suppressing serum testosterone to castrate levels decreases with continued dosing in some
patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics ). Effectiveness beyond 12 months has not been established. Treatment failure can be detected by measuring serum total testosterone
concentrations just prior to administration on Day 29 and every 8 weeks thereafter (see WARNINGS ).
|
|
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DESCRIPTION
|
| |
Abarelix for injectable suspension is a synthetic decapeptide with potent antagonistic activity against naturally occurring
gonadotropin releasing- hormone (GnRH).
Abarelix inhibits gonadotropin and related androgen production by directly and competitively blocking GnRH receptors in the
pituitary.
Abarelix is chemically described as acetyl- D- β- naphthylalanyl- D- 4- chlorophenylalanyl- D- 3- pyridylalanyl- L- seryl-
L- N- methyl- tyrosyl- D- asparagyl- L- leucyl- L- N(ε)- isopropyl- lysyl- L- prolyl- D- alanyl- amide. It is initially manufactured
as an acetate water complex and converted to a carboxymethylcellulose (CMC) water complex in manufacturing the drug product.
The molecular weight for abarelix anhydrous free base is 1416.06.
Abarelix for injectable suspension is supplied as a white to off- white sterile dry powder which, when mixed with the diluent,
0.9% sodium chloride injection, becomes a depot suspension intended for IM injection.
The single- dose vial contains 113 mg of anhydrous free base abarelix peptide (net) supplied in an abarelix CMC complex. This
complex also contains 19.1- 31 mg of CMC. After the vial is reconstituted with 2.2 ml of 0.9% sodium chloride injection, 2
ml is administered to deliver a dose of 100 mg of abarelix (net) as the abarelix CMC complex at a pH of 5 ± 1.
|
CLINICAL PHARMACOLOGY
|
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Mechanism of Action
|
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Abarelix exerts its pharmacological action by directly suppressing luteinizing hormone (LH) and follicle stimulating hormone
(FSH) secretion and thereby reducing the secretion of testosterone by the testes. Due to the direct inhibition of the secretion
of LH by abarelix, there is no initial increase in serum testosterone concentrations.
Saturation binding studies revealed that [125I]- abarelix has a very high affinity (KD = 0.1 nM) for the rat pituitary LHRH receptor.
|
Pharmacokinetics
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A single dose (100 mg IM) of abarelix was given to 14 healthy male volunteers 52- 75 years of age, with body weight of 61.6-
110.5 kg, and the pharmacokinetic information is provided in TABLE 1 .
| TABLE 1
Mean ± SD Pharmacokinetic Parameter Values of 100 mg of Abarelix Following a Single IM Injection (n=14)
|
| Cmax |
Tmax |
AUC(0- ∞) |
CL/ F |
T½ |
| (ng/ ml) |
(days) |
(ng·day/ ml) |
(L/ day) |
(days) |
| 43.4 ± 32.3 |
3.0 ± 2.9 |
500 ± 96 |
208 ± 48 |
13.2 ± 3.2 |
|
Absorption
|
| |
Following IM administration of 100 mg of abarelix, abarelix is absorbed slowly with a mean peak concentration of 43.4 ng/
ml observed approximately 3 days after the injection.
|
Distribution
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The apparent volume of distribution during the terminal phase determined after IM administration of abarelix was 4040 ± 1607
L, implying that abarelix probably distributes extensively within the body.
|
Metabolism
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In vitro hepatocyte (rat, monkey, human) studies and in vivo studies in rats and monkeys showed that the major metabolites of abarelix were formed via hydrolysis of peptide bonds. No
significant oxidative or conjugated metabolites of abarelix were found either in vitro or in vivo. There is no evidence of cytochrome P- 450 involvement in the metabolism of abarelix.
|
Excretion
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In humans, approximately 13% of unchanged abarelix was recovered in urine after a 15 µg/ kg IM injection; there were no detectable
metabolites in urine. Renal clearance of abarelix was 14.4 L/ day (or 10 ml/ min) after administration of 100 mg abarelix.
|
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Pharmacodynamics
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Effects of Abarelix on Serum Testosterone
|
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The effectiveness of abarelix in suppressing serum testosterone was studied in two randomized, open- label, active- comparator
trials. Patients were not those with advanced symptomatic prostate cancer. They were randomized in a 2:1 ratio to abarelix
100 mg IM versus LHRH agonist (Study 1) or to abarelix versus LHRH agonist + nonsteroidal antiandrogen (Study 2). Abarelix
was administered IM on Days 1, 15, 29 (Week 4), then every 4 weeks thereafter for at least 6 months (24 weeks). LHRH agonist
and nonsteroidal antiandrogen were administered in standard fashion. After completing 6 months of treatment, patients could
continue randomized treatment for an additional 6 months.
Avoidance of Testosterone Surge
|
| |
In both studies combined, 100% (348/ 348) of abarelix patients and 16% (28/ 172) of comparator patients avoided a testosterone
surge.
|
Attainment of Medical Castration
|
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The percentage of patients who attained serum testosterone concentration ≤50 ng/ dl on Study Days 2, 8, 15 and 29 are summarized
in TABLE 2 .
| TABLE 2
Percentage of Patients Who Attained Medical Castration (Serum Testosterone Concentration ≤50 ng/ dl) in Studies 1 and 2
|
| |
Abarelix |
| Day |
Total n |
% Castrate |
| 2 |
339 |
24% |
| 4 |
333 |
56% |
| 8 |
348 |
70% |
| 15 |
347 |
73% |
| 29 |
347 |
94% |
|
|
Attainment and Maintenance of Medical Castration
|
| |
Successful response was defined as attainment of medical castration on Day 29 and maintenance through Day 85 (where no 2 consecutive
serum testosterone concentrations between Days 29 and 85 were greater than 50 ng/ dl). In Study 1, 92% on abarelix patients
responded and 96% of LHRH agonist patients responded. In Study 2, 93% of abarelix patients and 95% of LHRH agonist + nonsteroidal
antiandrogen patients responded.
However, when failure was defined as any observed serum testosterone >50 ng/ dl (including transient elevations) just prior
to dosing on Day 29 and every 28 days thereafter, effectiveness of testosterone suppression decreased over time. Results of
this analysis are summarized in TABLE 3 .
| TABLE 3
Percentage of Patients Who Attained and Maintained Medical Castration; (No Serum Testosterone >50 ng/ dl Just Prior to Dosing
on Day 29 and Every 28 Days Thereafter)
|
| |
Study 1 |
Study 2 |
| Day |
Abarelix |
n |
Abarelix |
n |
| 85 |
84% |
176 |
92% |
164 |
| 169 |
75% |
166 |
87% |
155 |
| 365 |
62% |
93 |
71% |
86 |
|
|
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Effects of Abarelix on Cardiac Electrophysiology
|
| |
In a single, active- controlled, clinical study comparing abarelix to LHRH agonist + nonsteroidal antiandrogen, periodic electrocardiograms
were performed. Both therapies prolonged the mean Fridericia- corrected QT interval by >10 msec from baseline. In approximately
20% of patients in both groups, there were either changes from baseline QTc of >30 msec, or end- of- treatment QTc values
exceeding 450 msec. Similar results were observed in two other Phase 3 studies with abarelix and the active- control treatments.
It is unclear whether these changes were directly related to study drugs, to androgen deprivation therapy, or to other variables.
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Special Populations
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Race
|
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Data from Hispanics, Blacks and Caucasians demonstrated that race appeared to have no influence on the pharmacokinetics of
abarelix.
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Renal and Hepatic Insufficiency
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The pharmacokinetics of abarelix in hepatically and/ or renally impaired patients have not been determined.
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Pediatric Use
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There have been no studies of abarelix in pediatric patients.
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CLINICAL STUDIES
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One study of abarelix was conducted in 81 men with advanced symptomatic prostate cancer who were at risk for clinical exacerbation
(“clinical flare”) if treated with an LHRH agonist. The objective of this open- label, multicenter, uncontrolled, single-
arm study was to demonstrate that such patients could avoid orchiectomy through at least 12 weeks of treatment. In this trial,
treatment was to be given for at least 6 months with the option to continue treatment in an extension trial.
Of the 81 patients who enrolled, 9 patients from one site were excluded from the efficacy analysis due to inadequate documentation
by the study investigator. The specific reasons given for enrollment of the 72 patients were: bone pain from prostate cancer
skeletal metastases (n=31); an enlarged prostate gland or pelvic mass causing bladder neck outlet obstruction (n=25); bilateral
retroperitoneal adenopathy with ureteral obstruction (n=9); impending neurological compromise from spinal, spinal cord, or
epidural metastases (n=6); or other (n=1). The median age was 73 years, range 40- 94 years. There were 62 Caucasians, 6 African
Americans and 4 Hispanics.
Abarelix 100 mg was administered via IM injection on Days 1, 15 and 29, then every 4 weeks thereafter. Twelve (12) patients
discontinued prior to Day 169 for the following reasons: adverse event (n=2), voluntary withdrawal (n=3), death (n=4), and
“other” (n=3). Sixty (60) patients were treated for at least 24 weeks; in the extension phase, 33 patients for at least 48
weeks and 15 patients for at least 96 weeks. None (0%) of the 72 patients required orchiectomy while being treated with abarelix,
including the extension phase (median combined duration of therapy was 40 weeks). However, 2 patients were withdrawn before
Week 12 for treatment- related adverse events (immediate- onset systemic allergic reactions consisting of urticaria, and urticaria
and pruritus, respectively) and received alternate therapy. In this trial, medical castration (defined as serum total testosterone
concentration ≤50 ng/ dl) was achieved in 57 of the 72 patients (79%) by Day 8, and by 68 of 71 patients (96%) by Week 4.
Although the study was not designed to assess specific clinical outcomes, the following were observed:
| • |
None (0) of 8 patients with vertebral or epidural metastases and without neurological symptoms developed neurological symptoms.
|
| • |
Ten (10) of 13 patients with bladder outlet obstruction and a bladder drainage catheter had the catheter removed by 12 weeks.
|
| • |
Eleven (11) of 15 patients with pain due to skeletal metastases were able to reduce the potency, dose and/ or frequency of
narcotic analgesia at 12 weeks.
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INDICATIONS AND USAGE
|
| |
Abarelix is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist
therapy is not appropriate and who refuse surgical castration, and have 1 or more of the following: (1) risk of neurological
compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease,
or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia.
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CONTRAINDICATIONS
|
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Abarelix is contraindicated in those patients with a known hypersensitivity to any of the components in abarelix for injectable
suspension.
Abarelix is not indicated in women or pediatric patients. In addition, abarelix may cause fetal harm if administered to a
pregnant woman.
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WARNINGS
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Immediate-Onset Systemic Allergic Reactions
|
| |
See BOXED WARNINGS .
In the clinical trial of patients with advanced, symptomatic prostate cancer, 3 of 81 (3.7%) patients experienced an immediate-
onset systemic allergic reaction within minutes of receiving abarelix. The allergic reactions were urticaria (Day 15), urticaria
and pruritus (Day 29), and hypotension and syncope (Day 141). Patients should be monitored for at least 30 minutes after each injection of abarelix. In the event of an allergic reaction
associated with hypotension and/ or syncope, appropriate supportive measures such as leg elevation, oxygen, IV fluids, antihistamines,
corticosteroids, and epinephrine (alone or in combination) should be employed.
From all the prostate cancer clinical trials with abarelix (mostly in men without advanced, symptomatic disease), immediate-
onset systemic allergic reactions (occurring within 30 minutes of dosing), were observed in 1.1% (15/ 1397) of patients dosed
with abarelix. In 14/ 15 patients who experienced an allergic reaction, each developed symptoms within 8 minutes of injection.
The cumulative risk of such a reaction increased with duration of treatment. The cumulative rates (and 95% confidence intervals)
on Days 56, 141, 365 and 676 were 0.51%, (0.13%, 0.88%) 0.80% (0.30%, 1.29%), 1.24% (0.43%, 2.04%) and 2.91% (0.87%, 4.95%),
respectively. Seven patients experienced hypotension or syncope as part of their allergic reaction, representing 0.5% of all
patients. The cumulative rates (and 95% confidence intervals) for these types of reactions on Days 56, 141, 365, and 617 after
the initial dose were 0.22% (0.0%, 0.46%), 0.32% (0.0%, 0.64%), 0.61% (0.0%, 1.24%) and 1.67% (0.07%, 3.28%), respectively.
|
Decrease in Effectiveness With Continued Dosing
|
| |
A decrease in overall effectiveness with increased duration of treatment, as measured by failure to maintain suppression of
serum testosterone below 50 ng/ dl, was noted (see CLINICAL PHARMACOLOGY, Pharmacodynamics ). Treatment failure can be detected by measuring serum total testosterone concentrations just prior to administration on
Day 29 after the initial dose and every 8 weeks thereafter.
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Prolongation of the QT Interval
|
| |
Because abarelix may prolong the QT interval (see CLINICAL PHARMACOLOGY, Pharmacodynamics ), physicians should carefully consider whether the risks of abarelix outweigh the benefits in patients with baseline QTc
values >450 msec ( e.g., congenital QT prolongation) and in patients taking Class IA ( e.g., quinidine, procainamide) or Class III ( e.g., amiodarone, sotalol) antiarrhythmic medications.
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PRECAUTIONS
|
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General
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Decreased Effectiveness in Patients >225 lbs
|
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The decrease in overall effectiveness of abarelix with increased duration of treatment is greater in patients who weigh more
than 225 lbs. Strict monitoring of serum testosterone in these patients is warranted.
|
Monitoring of Liver Function
|
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Clinically meaningful transaminase elevations were observed in some patients who received abarelix or comparator drugs. Serum
transaminase levels should be obtained before starting treatment with abarelix and periodically during treatment (see ADVERSE REACTIONS ).
|
Decrease in Bone Mineral Density
|
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Extended treatment with GnRH antagonists and LHRH agonists may result in a decrease in bone mineral density.
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Laboratory Tests
|
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Response to abarelix should be monitored by measuring serum total testosterone concentrations just prior to administration
on Day 29 and every 8 weeks thereafter (see WARNINGS ). Serum transaminase levels should be obtained before starting treatment with abarelix and periodically during treatment.
Periodic measurement of serum PSA levels may also be considered.
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Geriatric Use
|
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Prostate cancer occurs primarily in an older patient population. Clinical studies with abarelix have been conducted primarily
in patients ≥65 years of age. No difference in the safety profile, when examined as a function of age, was apparent.
|
Pediatric Use
|
| |
The safety and effectiveness of abarelix in pediatric patients have not been studied. Abarelix is not indicated for use in
pediatric patients.
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Carcinogenesis, Mutagenesis, and Impairment of Fertility
|
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Abarelix was not carcinogenic to mice or rats when administered as a SC depot every 28 days for 2 years at doses up to 300
mg/ kg in mice and 100 mg/ kg in rats. Systemic drug exposures, as measured by mean Cmax , were approximately 210- to 278- fold for mice and 21- to 32- fold for rats the human exposure following SC depot administration
of 100 mg.
Abarelix was not mutagenic in the in vitro bacterial Ames assay or forward mutation assay in mouse lymphoma, or clastogenic in the in vivo mouse micronucleus assay.
No effects on mating or fertility in male and female rats given 1 mg/ kg SC abarelix, a dose 0.114- fold the human therapeutic
dose of 100 mg based on body surface area. Mating and fertility were significantly decreased at doses of 3 and 10 mg/ kg (0.34-
fold and 1.135- fold, respectively, the human therapeutic dose of 100 mg based on body surface area), but the effects were
reversible.
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Pregnancy Category X
|
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See CONTRAINDICATIONS .
Embryolethality occurred in pregnant rats administered a single SC dose of abarelix up to 3 mg/ kg (0.228- fold the human
therapeutic dose of 100 mg based on body surface area). In rabbits a dose- related increase in fetal resorptions and reduced
viability was observed at doses up to 30 mg/ kg (6.81- fold the human therapeutic dose of 100 mg based on body surface area).
No teratogenic effects were observed in rats or rabbits up to doses of 3 mg/ kg or 30 mg/ kg, respectively. A no- observable-
adverse- effect- level (NOAEL) dose was 0.3 mg/ kg (approximately 0.034- fold the human therapeutic dose of 100 mg based on
body surface area) in rats and <0.01 mg/ kg (<0.0023- fold the human therapeutic dose of 100 mg based on body surface area)
in rabbits.
|
Nursing Mothers
|
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It is not known whether abarelix is excreted in human milk. Because many drugs are excreted in human milk, and because the
effects of abarelix on lactation and/ or the breastfed child have not been determined, abarelix should not be used by nursing
mothers.
|
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DRUG INTERACTIONS
|
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No formal drug/ drug interaction studies with abarelix were performed. Cytochrome P- 450 is not known to be involved in the
metabolism of abarelix. Abarelix is highly bound to plasma proteins (96- 99%).
|
ADVERSE REACTIONS
|
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Immediate-Onset Systemic Allergic Reactions
|
| |
See BOXED WARNINGS and WARNINGS .
In the single study of abarelix conducted in men with advanced symptomatic prostate cancer, adverse events reported by ≥10%
of patients are listed in TABLE 4 . Adverse events are listed without regard to causality. Causality is often difficult to assess in elderly patients with multiple
co- morbidities and prostate cancer.
| TABLE 4
Adverse Events in ≥10% of Patients in the Advanced Symptomatic Prostate Cancer Study (Without Regard for Causality)
|
| |
Abarelix |
| Preferred Term |
n=81 |
| Hot flushes* |
64 (79%) |
| Sleep disturbance* |
36 (44%) |
| Pain |
25 (31%) |
| Breast enlargement* |
24 (30%) |
| Breast pain/ nipple tenderness* |
16 (20%) |
| Back pain |
14 (17%) |
| Constipation |
12 (15%) |
| Peripheral edema |
12 (15%) |
| Dizziness |
10 (12%) |
| Headache |
10 (12%) |
| Upper respiratory tract infection |
10 (12%) |
| Diarrhea |
9 (11%) |
| Dysuria |
8 (10%) |
| Fatigue |
8 (10%) |
| Micturition frequency |
8 (10%) |
| Nausea |
8 (10%) |
| Urinary retention |
8 (10%) |
| Urinary tract infection |
8 (10%) |
|
| *
|
Pharmacological consequence of androgen deprivation. |
|
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Changes in Laboratory Values
|
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Clinically meaningful increases in serum transaminases were seen in a small percentage of patients in both treatment groups
in each active- controlled abarelix study. In Study 1 and Study 2 combined, the percentage of abarelix patients reporting
serum ALT >2.5 times upper limit of normal or >200 U/ L was 8.2% and 1.8%, respectively. The percentage reporting serum AST
>2.5 times upper limit of normal or >200 U/ L was 3.1% and 0.8%, respectively. Similar results were reported for active comparators.
Slight decrease in hemoglobin, a pharmacological consequence of castration, were observed in patients receiving abarelix and
active comparator. Mean increases in serum triglycerides of approximately 10% were seen in abarelix- treated patients.
|
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OVERDOSAGE
|
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The maximum tolerated dose of abarelix has not been determined. The maximum dose used in clinical studies was 150 mg. There
have been no reports of accidental overdose with abarelix.
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DOSAGE AND ADMINISTRATION
|
| |
For safety reasons, abarelix is approved with marketing restrictions. Only physicians who attest to the following qualifications and accept the following responsibilities, and on that basis enroll
in Praecis Pharmaceuticals Incorporated’s Plenaxis PLUS Program should prescribe abarelix. Praecis Pharmaceuticals Incorporated
and its agents will provide abarelix to physicians enrolled in the Plenaxis PLUS Program.
To enroll, physicians must attest that they are able and willing to:
| • |
Diagnose and manage advanced symptomatic prostate cancer.
|
| • |
Diagnose and treat allergic reactions, including anaphylaxis.
|
| • |
Have access to medication and equipment necessary to treat allergic reactions, including anaphylaxis.
|
| • |
Have patients observed for development of allergic reactions for 30 minutes following each administration of abarelix.
|
| • |
Understand the risks and benefits of palliative treatment with abarelix, including information from the Package Insert, Patient
Information, and the Physician Attestation.
|
| • |
Educate the patients on the risks and benefits of treatment with abarelix and obtain the patient’s signature on the Patient
Information signature page, sign it, and place the original signed form in the patient’s medical record, and give a copy of
the Patient Information leaflet with the signed page to the patient.
|
| • |
Report serious adverse events, such as any immediate- onset systemic allergic event (including anaphylaxis, hypotension, and
syncope) as soon as possible to Praecis Pharmaceuticals Incorporated at 1- 866- PLENAXIS (1- 866- 753- 6294) or to the Food
and Drug Administration’s MedWatch Program at 1- 800- FDA- 1088.
|
| • |
Understand that they may withdraw their enrollment in the Plenaxis Prescribing Program by a written statement submitted to
Praecis Pharmaceuticals Incorporated (contact information below) or that Praecis Pharmaceuticals Incorporated may withdraw
physicians from the Plenaxis PLUS Program if they do not meet the agreed upon responsibilities.
|
To enroll in the Plenaxis Prescribing Program call 1- 866- PLENAXIS (1- 866- 753- 6294) or visit www.plenaxisplus.com.
Dose
|
| |
The recommended dose of abarelix is 100 mg administered intramuscularly to the buttock on Day 1, 15, 29 (Week 4) and every
4 weeks thereafter. Treatment failure can be detected by measuring serum testosterone concentrations just prior to abarelix
administration, beginning on Day 29 and every 8 weeks thereafter.
|
Plenaxis does not contain a preservative and should be administered within 1 hour following reconstitution.
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HOW SUPPLIED
|
| |
The physician must attest to meeting the qualifications and accepting the responsibilities in the DOSAGE AND ADMINISTRATION of this insert by submitting the Physician’s Attestation form to Praecis Pharmaceuticals Incorporated to be enrolled in the
Plenaxis PLUS Program. Praecis Pharmaceuticals Incorporated and its agents will only provide abarelix to physicians enrolled
in the Plenaxis Prescribing Program. Plenaxis vials are not to be resold or redistributed.
Plenaxis (abarelix for injectable suspension) is supplied as a single- dose, preservative- free vial containing 113 mg of
abarelix (anhydrous free base peptide) as an abarelix CMC complex, a sterile powder which, when reconstituted with 2.2 ml
of 0.9% sodium chloride solution, yields a 2 ml delivered dose of 100 mg (50 mg/ ml). Each single use dispensing pack also
contains: a single- use 10 ml diluent vial of 0.9% sodium chloride injection, one 3 cc syringe with an 18 gauge 1½ inch needle
and one 22 gauge 1½ inch Safety Glide injection needle.
Storage: Store at 25°C (77°F), excursions permitted to 15- 30°C (59- 86°F).
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PRODUCT IDENTIFICATION
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None Available |
PRODUCT LISTING - EQUIVALENTS NOT AVAILABLE
|
| |
| powder for injection - intramuscular - 100 mg -
|
| 1.0 |
$944.40 |
Plenaxis
Praecis Pharmaceuticals Inc
|
68158014901 |
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