Shop
Cart Details

Firmagon 80 Mg Kit 1

  • Manufacturer Name : FERRING LABS
  • MFG # : 55566830301
  • NDC : 55566830301
  • Distributor Name : AmeriSource Bergen
PID UOM Price Qty
253192 UN
$842.58
421945 1/EA Register For Member Price
Register For Member Price

 

Product Information

NDC Package Code55566-8303-1
Proprietary NameFirmagon
Non-Proprietary NameDegarelix
Package1 KIT in 1 CARTON (55566-8303-1) * 4 mL in 1 VIAL, GLASS * 4.2 mL in 1 SYRINGE
Dosage FormKIT

Description

FIRMAGON® is indicated for treatment of patients with advanced prostate cancer.

FIRMAGON is a sterile lyophilized powder for injection containing degarelix (as the acetate) and mannitol. Degarelix is a synthetic linear decapeptide amide containing seven unnatural amino acids, five of which are D-amino acids. The acetate salt of degarelix is a white to off-white amorphous powder of low density as obtained after lyophilization. The chemical name of degarelix is D-Alaninamide, N-acetyl-3-(2-naphthalenyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridinyl)-D-alanyl-L-seryl-4-[[[(4S)-hexahydro-2,6-dioxo-4-pyrimidinyl]carbonyl]amino]-L phenylalanyl-4-[(aminocarbonyl)amino]-D-phenylalanyl-L-leucyl-N6–(1-methylethyl)-L-lysyl-L-prolyl. It has an empirical formula of C82H103N18O16Cl and a molecular weight of 1632.3 Da. Degarelix acetate has the following structural formula. FIRMAGON is available in two packaging configurations: 1 Starting Dose: Two vial carton with each vial delivering 120 mg of degarelix (equivalent to the median value of 126 mg degarelix acetate). Each 120 mg dose contains 150 mg mannitol., 2 Maintenance Dose: One-vial carton delivering 80 mg of degarelix (equivalent to the median value of 84 mg degarelix acetate). Each 80 mg dose contains 200 mg mannitol.

Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind NR
Drug Category -
Drug Type Code S
FDA Approval Date 03/03/2009
FDA Therap Equiv EA
HCPCS Degarelix inj, 1 MG
Market Entry Date -
Medical Coverage J9155
Termination Date 1
Unit 1
Units Per Pkg 12/24/2008
Active Ingredients 12980 degarelix acetate 934016190
AHFS Class 68180400 ANTIGONADTROPINS; 10000000 ANTINEOPLASTIC AGENTS
DEA Class NC
Dose Form VIAL (EA)
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 64872 degarelix acetate SUBCUT VIAL 80 MG
Inactive Ingredients 18822 rubber, unspecified; 2272 mannitol 69658
OMP Family -
Product Category RX Pharmaceuticals
Strength 80MG
Common Brand Name COMMON BRAND NAME(S): Firmagon
Drug Interaction 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.
Allocation Period -
Case Quantity 232
Drug Form Pack Size 1
Form KIT
Hazard Code -
Listed Chemical -
NIOSH Code NT1 ANTINEOPLASTIC DRUGS INCLUDING THOSE WITH MANUFACTURER'S SAFE HANDLING GUIDANCE (MSHG)
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size -
How to Use 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.
Missed Dose 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.
Notes 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.
Overdose 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.
Phonetic Pronunciation (DEG-a-REL-ix)
Precautions 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.
Side Effects 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.
Storage STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
Uses 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.

Frequently Asked Questions(FAQs)

The cost of FIRMAGON 80 MG KIT 1 is $ 0.00.
FIRMAGON 80 MG KIT 1 is manufactured by FERRING LABS.
Read More

Subscribe to Our Newsletter