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Proven Efficacy: Surge-Free Biochemical Suppression
Starting Day 11,2

In a pivotal study (CS21), FIRMAGON® was demonstrated to be effective in achieving and maintaining testosterone suppression to castrate levels (≤50 ng/dL) during 12 months of treatment.1

See for yourself.  Examine important study findings below.
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Unlike Leuprolide, FIRMAGON® induces Surge-Free
Testosterone Suppression Starting Day 11,2

Stand firm for testosterone suppression from Day 1 with FIRMAGON

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FIRMAGON Has Proven Efficacy

Primary endpoint:

In the pivotal CS21 study, FIRMAGON was shown to maintain testosterone suppression below castration level (≤50 ng/dL) during 12 months of treatment.1

Secondary endpoint:

Use of LHRH agonist, leuprolide, led to an initial 65% increase in testosterone over the first 3 days.1
     •  By Day 28, both groups achieved equivalent testosterone levels1

FIRMAGON® Has Proven Efficacy

PATIENTS ACHIEVED CASTRATE LEVELS STARTING DAY 12

In most cases, patients receiving FIRMAGON achieved testosterone castrate levels (≤50 ng/dL) within 3 days of administration.2

Patients receiving leuprolide, a traditional LHRH agonist, took 7-28 days to reach the same castrate levels (≤50 ng/dL) of testosterone.1

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FIRMAGON® Has Proven Efficacy

REDUCTION IN PSA LEVELS2

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PSA levels were monitored as a secondary endpoint of the pivotal trial. FIRMAGON lowered PSA levels by*:
• 64% after 2 weeks
• 85% after 4 weeks
• 95% after 12 weeks

PSA remained suppressed throughout 1 year of treatment.2

* PSA is a nonspecific measurement which may indicate cancer progression.3

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 is related to a clinical benefit.2

Therefore, PSA data should not be viewed independently as evidence of the effectiveness of FIRMAGON.

Safety Results from
Clinical Trials2

Adverse Reactions Reported in ≥5% of Patients in an Active-Controlled Study2*

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FIRMAGON®
240/80 mg (deep subcutaneous)
n = 207
Leuprolide
7.5 mg (intramuscular)
n = 201
Percentage of subjects with adverse events 79% 78%
Body as a whole
Injection site adverse events 35% <1%
Weight increase 9% 12%
Fatigue 3% 6%
Chills 5% 0%
Cardiovascular system
Hot flash 26% 21%
Hypertension 6% 4%
Musculoskeletal system
Back pain 6% 8%
Arthralgia 5% 9%
Urogenital system
Urinary tract infection 5% 9%
Digestive system
Increases in transaminases and GGT 10% 5%
Constipation 5% 5%
*The third arm, 240 mg starting dose followed by 160 mg maintenance dose, of the clinical trial [n=206] was studied but was not
brought to market. See package insert for further information about third arm of study.

Stand Firm For Your Patients FROM DAY 1

Prefilled Kits Redesigned to Help
Make Reconstitution More Efficient

The redesigned kits have one less step to reconstitution.
The kits include:

  • FIRMAGON powder for injection
  • Vial adapters
  • Prefilled syringes containing sterile water for injection, USP
  • OSHA-approved safety administration needles
Watch Injection Video

Reconstitution required. No refrigeration needed.

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Dosing2

FIRMAGON® is administered as a deep subcutaneous injection in the abdominal region. As with other drugs administered this way, the injection site should vary periodically.

Use product-specific HCPCS code J9155 for both doses of FIRMAGON.

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Dose preparation2

Use only sterile water and other materials provided in kit for reconstitution and injection.

Caution should be exercised in handling and preparing the solution of FIRMAGON®. To minimize the risk of dermal exposure, always wear impervious gloves when handling FIRMAGON. If FIRMAGON solution contacts the skin, immediately wash the skin thoroughly with soap and water. If FIRMAGON contacts mucous membranes, the membranes should be flushed immediately and thoroughly with water.

For starting doses, repeat the reconstitution procedure for the second 120 mg vial to complete 240 mg starter dose.

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Step 1

Wipe the rubber stopper on the vial with an alcohol pad.

Attach vial adapter (provided in the kit) to the vial by pressing adapter down until the spike pushes through the rubber stopper and the adapter snaps into place.

Step 2

Syringe assembly is required. Attach the plunger to the prefilled syringe and screw the syringe onto the adapter on the vial.
Transfer all Sterile Water for Injection, USP, slowly into the vial.

Step 3

Keep the vial upright with the syringe attached. Then gently swirl it until the liquid looks clear (free of powder or particles). Avoid shaking it to prevent foam formation.

Reconstitution may take up to 15 minutes, but usually takes approximately 5 minutes.

Step 4

Invert the vial and draw in 3 mL (starting dose) or 4 mL (maintenance dose) into syringe. Always withdraw the precise volume. Expel the air bubbles, detach the syringe, and attach the provided needle.

Images shown are for illustrative purposes only.

INJECTION TECHNIQUE2

Reconstituted drug must be administered within one hour after addition of sterile water, USP.

The starting dose is 2 injections of 120 mg each. Choose a different injection site for the second dose.

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Step 1

FIRMAGON® is administered as a deep subcutaneous injection in the abdominal region. The injection site should vary periodically between the areas shown.

Step 2

In one of the areas of the abdomen indicated in Step 1, gently pinch the skin in the vicinity of the navel and elevate the subcutaneous tissue.

No injection should be given in areas exposed to pressure (ie, around belt, waistband or close to ribs).

Step 3

At a 45° angle, insert the needle halfway between the peak of the elevated skin and the skin line. Needle should be inserted deeply.

The injection should not be in a vein or muscle.

Step 4

Before depressing plunger, gently aspirate to check for blood. If blood appears in the syringe, the product cannot be used and a new dose should be reconstituted. If no blood appears, you may proceed with injection.

Your Partner Every Step Of The Way

FIRMAGON® (degarelix for injection) PROMISE Support Services is designed
to Teach, Guide, and Support you throughout the process of treating with
FIRMAGON. We offer a wealth of specialized product-related services—
around the clock.
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For patients & caregivers

Get starter kits, educational materials,
coverage support, and more.
> Go to Our Website for Patients & Caregivers
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For Nurses

You’ll get detailed training and advice, and
helpful information to share with patients.
> Go to Injection Training
> Download Patient Materials

For practice managers

We’ll help with ordering FIRMAGON,
reimbursement, coverage, and more.
> Get Reimbursement Assistance
> Download Educational Materials

For Nurses

Training for Administering
FIRMAGON®
(degarelix for injection)

FIRMAGON PROMISE Support Services provides several ways to learn to
administer FIRMAGON to your patients. Our goal is to Teach, Guide, and Support
you so that you can become comfortable with the injection process.

Injection Technique

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FIRMAGON is administered as a deep subcutaneous injection in the abdominal region.1
Instructions button

Interactive Training Options

Lunch-and-learn conference calls
Attend an informative lunch where registered nurses will provide product training via conference bridge.
DVD and one-on-one review
Watch and learn at your own pace. Then, if you like, set up a personal review session with a PROMISE registered nurse.
Monthly Webinars
Participate in convenient online product-related training sessions, led by registered nurses via web conference.

For Nurses

Resources for
supporting Your Patients

To help your patients and their loved ones better understand treatment with FIRMAGON®
(degarelix for injection), share the helpful resources below. They can also enroll in
FIRMAGON PROMISE Support Services
for around the clock support at FerringPromise.com.

Order Patient Starter Kits

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We’ll mail you this instructive kit, which is designed to
help your patients throughout their FIRMAGON
treatment journey. The kit contains useful brochures
about prostate cancer, treatment expectations, and
advice for caregivers, plus a Treatment Workbook for
recording therapy progress.
To receive Patient Starter Kits and/or the additional materials by mail,
call 855-URO-SERVICES
(876-7378).
Use product-specific
HCPCS
code J9155
for both doses
of FIRMAGON

For Practice Managers

Reimbursement
Assistance

To help with reimbursement, FIRMAGON® (degarelix for injection) has a
product-specific HCPCS code for both doses of FIRMAGON: J9155.

The FIRMAGON Reimbursement
& Support Portal

Enroll in the FIRMAGON Reimbursement & Support Portal to get:

• Live-answer customer service

• In-depth review of a patient's deductibles, copays, and
out-of-pocket expenses

• Comprehensive benefit investigation reports for every
patient, with coverage alerts and action step information

To start using these great services today,
go to the FIRMAGON Reimbursement & Support Portal
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For Practice Managers

Educational
Resources

These informative materials are part of our effort to Teach, Guide, and Support
healthcare professionals, patients, and their loved ones throughout
the FIRMAGON® (degarelix for injection) treatment journey.

REFERENCES

  1. Klotz L, Boccon-Gibod L, Shore ND, et al. The efficacy and safety of degarelix: a 12-month,comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008;102:1531-1538.
  2. FIRMAGON [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc; 2013.
  3. National Cancer Institute. Fact Sheet. Prostate-specific antigen [PSA] test. 2012. http://www.cancer.gov/cancertopics/factsheet/detection/PSA. Accessed December 19, 2013.

FIRMAGON® is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.

Important Safety Information

FIRMAGON is contraindicated in patients with a known hypersensitivity to degarelix or to any of the product components and in women who are or may become pregnant. FIRMAGON can cause fetal harm when administered to a pregnant woman.

Hypersensitivity reactions, including anaphylaxis, urticaria and angioedema, have been reported post-marketing with FIRMAGON. In case of a serious hypersensitivity reaction, discontinue FIRMAGON immediately if the injection has not been completed, and manage as clinically indicated. Patients with a known history of serious hypersensitivity reactions to FIRMAGON should not be re-challenged with FIRMAGON.

Long-term androgen deprivation therapy (ADT) prolongs the QT interval. Physicians should consider whether the benefits of ADT outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA or Class III antiarrhythmic medications.

Therapy with FIRMAGON results in suppression of the pituitary gonadal system. Results of diagnostic tests of the pituitary gonadotropic and gonadal functions conducted during and after FIRMAGON may be affected. The therapeutic effect of FIRMAGON should be monitored by measuring serum concentrations of prostate-specific antigen (PSA) periodically. If PSA increases, serum concentrations of testosterone should be measured.

The most common adverse reactions (≥10%) during FIRMAGON therapy included injection site reactions (eg, pain, erythema, swelling or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase. The majority of adverse reactions were Grade 1 or 2; 1% or less were Grade 3/4. Injection site reactions were mostly transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%).

Please see full Prescribing Information.

Patients & Caregivers: please click here to enroll > Close button

For nurses & practice Managers

To Enroll in FIRMAGON® (degarelix for injection) PROMISE
Support Services,
please fill out the form below.

All fields are required.
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