Dosing & Uses
Dosage Forms & Strengths
powder for injection
- 80mg
- 120mg
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
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
Postmarketing Reports
Decreased bone density
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
Pregnancy & Lactation
Pregnancy
Safety and efficacy not established in women
Animal data
- Based on findings in animal studies and mechanism of action, drug can cause fetal harm and loss of pregnancy when administered to a pregnant woman; there are no human data on use of drug in pregnant women to inform drug-associated risk; in animal developmental and reproductive toxicity studies in rats and rabbits, oral administration of degarelix during organogenesis caused embryo-fetal lethality and abortion as well as increased post-implantation loss and decreased number of live fetuses in animals at doses less than clinical loading dose based on body surface area; advise pregnant patients and females of reproductive potential of potential risk to fetus
- Based on findings in animals and mechanism of action, degarelix may impair fertility in males and females of reproductive potential
Lactation
Safety and efficacy not established in females; there are no data on presence of drug in human milk, effects on breastfed child, or on milk production; because many drugs are present in human milk and because of potential for serious adverse reactions in a breastfed child from therapy, a decision should be made whether to discontinue nursing or discontinue drug taking into account importance of drug to mother
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.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%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Firmagon subcutaneous - | 120 mg vial |  | |
| Firmagon kit with diluent syringe subcutaneous - | 120 mg vial |  | |
| Firmagon kit with diluent syringe subcutaneous - | 80 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
degarelix subcutaneous
DEGARELIX - INJECTION
(DEG-a-REL-ix)
COMMON BRAND NAME(S): Firmagon
USES: Degarelix is used to treat advanced prostate cancer in men. It is not a cure. Most types of prostate cancer need the male hormone testosterone to grow and spread. Degarelix works by reducing the amount of testosterone that the body makes. This helps slow or stop the growth of cancer cells.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using degarelix and each time you get a refill. If you have any questions, consult your doctor or pharmacist.This medication is given as an injection under the skin (subcutaneously) in the abdominal area by a health care professional. It is usually given once a month or as directed by your doctor.The first dose is given as two injections. The following monthly doses are given as one injection. Make sure your injection site is free of any pressure from belts, waistbands, or other types of clothing. The injection site should not be close to the ribs and should be changed each time to lessen discomfort after the injection.Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to schedule the next dose.
SIDE EFFECTS: Pain/redness/swelling at the injection site, hot flashes (flushing), increased sweating, night sweats, back/joint pain, chills, weight changes, tiredness, fever, and dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Rarely, shrinking of the testicles, breast tenderness/swelling, and reduced sexual interest/ability may also occur as a result of lowered testosterone levels. Talk to your doctor if these effects occur.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn't stop, loss of appetite, dark urine, stomach/abdominal pain, yellowing eyes/skin.Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, fainting.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using degarelix, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Long term use of degarelix may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using degarelix, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using degarelix safely.Degarelix may weaken your bones and increase your risk for bone loss (osteoporosis) if used for a long time. Consult your doctor or pharmacist for details.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).This medication can affect fertility in both males and females. Ask your doctor for more details.This medication is not usually used in women and must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away.It is unknown if degarelix passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Many drugs besides degarelix may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others.This medication may interfere with certain laboratory tests (including pituitary gonadal function), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as blood testosterone level, PSA blood test) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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