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degarelix (Rx)Brand and Other Names:Firmagon

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 80mg
  • 120mg
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Hormone-dependent Advanced Prostate Carcinoma (Stage D)

Initial: 120 mg SC for 2 doses (ie, 2 separate injections totaling 240 mg), THEN after 28 days, begin maintenance dose of 80 mg SC q28Days

Renal Impairment

≥50 mL/min: Dose adjustment not necessary

<50 mL/min: Use caution

Hepatic Impairment

Mild-to-moderate: Dose adjustment not necessary

Severe: Safety and efficacy not established; use caution

Administration

Initiation pack contains 2 vials each with 120 mg per vial & 6 mL sterile water for injection diluent

Withdraw 3 mL of sterile water for injection diluent (supplied) & add to 1 of the 2 vials, swirl to mix - keep vial vertical at all times, do not shake

Inject SC in abdomen within 1 hour of reconstitution

Repeat for 2nd injection and use different injection site

Maintenance pack contains 1 vial of 80 mg per vial & 4.2 mL sterile water for injection diluent

Use 4.2 mL to reconstitute, withdraw 4 mL for dose of 80 mg

Not indicated

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Adverse Effects

>10%

Hot flashes (26%)

Injection site erythema (17%)

Injection site pain (28%)

Weight gain (11%)

Elev liver enzymes (10%)

1-10% (selected)

Arthralgia

Back pain

Fatigue

HTN

Injection site induration/swelling

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Warnings

Contraindications

Hypersensitivity

Pregnancy or in women who may become pregnant

Cautions

Severe hepatic impairment

Long-term androgen deprivation treatment prolongs QT interval, this is increased risk with congenital long QT syndrome, electrolyte abnormalities, CHF, coadministration with antiarrhythmic agents from Class IA [eg, quinidine, procainamide)]or Class III [eg, amiodarone, sotalol]); consider whether benefits of androgen deprivation therapy outweigh potential risks

Bone mineral density may decrease due to androgen deprivation therapy

Risk for diabetes may increase due to androgen deprivation, which may cause obesity and insulin resistance

Hypersensitivity reactions (eg, anaphylaxis, urticaria, angioedema) reported; if a serious hypersensitivity reaction occurs, discontinue drug immediately if the injection has not been completed, and manage as clinically indicated; do not rechallenged

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Pregnancy & Lactation

Pregnancy Category: X

Lactation: excretion in milk unknown/not recommended

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

GnRH receptor antagonist, suppresses testosterone production by decreasing LH and FSH

Pharmacokinetics

Protein Bound: 90%

Vd: >1000 L

Onset of action: Within 3 days

Metabolism: Liver by peptide hydrolysis

Excretion: Feces (70-80%), urine (20-30%)

Half-life elimination: Feces (75%); urine (25%)  

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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