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

In the 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.2

See for yourself.  Examine important study findings below.
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STUDY DESIGN

CS21: A PIVOTAL PHASE 3 TRIAL FOR FIRMAGON2,4

  • The pivotal phase 3 trial (CS21) was a 3-armed, randomized (1:1:1), active-controlled, open-label, parallel-group, 12-month study2
  • The primary objective was to demonstrate the efficacy of FIRMAGON in achieving and maintaining castrate levels of testosterone during 12 months of treatment4
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*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.

TESTOSTERONE TAKEDOWN

FIRMAGON rapidly suppresses testosterone starting on day 11,2

Results obtained from a pivotal, randomized (1:1:1), active-controlled, open-label, parallel-group, 12-month clinical trial.2 Serum levels of testosterone were measured at screening, on days 0, 1, 3, 7, 14, and 28 in the first month, and then monthly until the end of the study.1

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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.2

Secondary endpoint:

Use of LHRH agonist, leuprolide, led to an initial 65% increase in testosterone over the first 3 days.2
     •  By day 28, both groups achieved equivalent testosterone levels

TESTOSTERONE TAKEDOWN

FIRMAGON patients achieved castrate levels starting day 1 vs leuprolide (≤50 ng/dL)1

Results obtained from a pivotal, randomized (1:1:1), active-controlled, open-label, parallel-group, 12-month clinical trial.2

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  • 52% rate of achieving castrate level
    after 1 day; 96% after 3 days; 99% after
    7 days1
  • In most cases, patients receiving
    FIRMAGON achieved testosterone
    castrate levels within 3 days of
    administration1
  • Patients receiving leuprolide took 7 to 28
    days to reach similar levels1

REDUCE PSA LEVELS1

FIRMAGON lowered prostate-specific antigen (PSA) levels

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  • As a secondary endpoint, FIRMAGON
    lowered PSA levels vs baseline
  • – Reductions in median PSA levels by
    • 64% after 2 weeks
    • 85% after 1 month
    • 95% after 3 months
  • FIRMAGON maintained PSA
    suppression through 12 months of
    treatment

PSA is a nonspecific measurement that may indicate cancer progression.

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.

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

SAFETY

Adverse reactions reported in ≥5% of patients in an active-controlled study

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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.

GGT = gamma-glutamyltransferase.

The most common observed adverse reactions (≥10%) during clinical trials included1:

  • Injection site reactions (eg, pain, erythema, swelling, or induration)
  • Hot flashes
  • Increased weight
  • Increases in serum levels of transaminases and GGT

INITIAL REASSURANCE THROUGH MONTHLY DOSING1

Designed for more efficient FIRMAGON reconstitution, the FIRMAGON Prefilled Kit now includes:

  • FIRMAGON powder for injection
  • Vial adapter(s)
  • 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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Dosing1

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 preparation1

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 TECHNIQUE1

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 PRACTICE.

OUR PROMISE.

Our promise is to support you every step of the way with specially
designed tools and educational materials.

Enrollment in FIRMAGON PROMISE Support Services

Enables nurses and practice managers to “start smart”
with FIRMAGON therapy
Offers quick answers to frequently asked questions about treatment
with FIRMAGON and ongoing support
Provides integration support for your practice: Ordering options, billing codes,
and benefits investigations*
Supports your patient counseling efforts to help teach, guide, and support your patients throughout their treatment journey on FIRMAGON
* PROMISE does not file claims or appeal claims and cannot guarantee you will be successful in obtaining reimbursement. Third-party payment for medical products and services is affected by numerous factors, none of which can be anticipated or resolved by PROMISE.

REFERENCES

  1. FIRMAGON [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.
  2. 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(11):1531-1538.
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.

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