Degarelix, Injection

________________________________________________________________________

KEY POINTS

• This medicine is given by injection to treat symptoms of advanced prostate cancer.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: gonadotropin-releasing hormone receptor antagonist (hormone therapy for prostate cancer)

Generic and brand names: degarelix, injection; Firmagon

What is this medicine used for?

This medicine is given by injection (shots) to treat advanced prostate cancer. It helps lessen the symptoms of prostate cancer, but it is not a cure.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or hormone, or to benzyl alcohol
• Diabetes
• Heart rhythm problems, long QT syndrome, or other heart disease
• Liver or kidney problems
• Osteoporosis
• Problems with blood levels of sodium, potassium, calcium, and magnesium

This medicine should not be given to women or children. Women should not take this medicine if they are pregnant or may become pregnant because it may cause a miscarriage or birth defects.

How do I use it?

Your healthcare provider will give you the shots just under the skin in the abdomen every 28 days. Make sure your injection site area is free of any pressure from belts, waistbands, or other types of clothing. Keep all your appointments.

What if I miss a dose?

Do not miss any doses. If you miss an appointment for a dose, contact your healthcare provider.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may cause impotence (trouble having and keeping an erection), decrease your sex drive, or reduce the amount of semen released during sexual intercourse. These effects are usually temporary.

Continued treatment with this medicine may affect bone density. Your healthcare provider may order tests to check if this medicine is affecting your bones. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Chest pain, irregular heartbeat, sudden dizziness or fainting, sudden shortness of breath, yellowing of the eyes or skin, problems urinating, unexplained bone pain.

Other: Hot flashes, tiredness, mild dizziness, headache, trouble sleeping, joint pain, back pain, constipation, nausea, change in sexual ability or desire, weight gain, night sweats, chills; injection site pain, redness, itching, or swelling.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alfuzosin (Uroxatral)
• Anagrelide (Agrylin)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, ibutilide (Corvert), procainamide, propafenone (Rythmol), quinidine, and sotalol (Betapace, Sorine)
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin, pentamidine (NebuPent, Pentam), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), nortriptyline (Pamelor), sertraline (Zoloft), and trazodone
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Apomorphine (Apokyn)
• Cancer medicines such as arsenic trioxide (Trisenox), ceritinib (Zykadia), crizotinib (Xalkori), lapatinib (Tykerb), nilotinib (Tasigna), pazopanib (Votrient), sorafenib (Nexavar), sunitinib (Sutent), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cisapride
• Cyclobenzaprine (Amrix)
• Dextromethorphan/quinidine (Nuedexta)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Ezogabine (Potiga)
• Fingolimod (Gilenya)
• HIV medicines such as atazanavir (Reyataz), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and saquinavir (Invirase)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to treat breathing or lung problems such as arformoterol (Brovana), formoterol (Perforomist), salmeterol (Serevent), and vilanterol (Breo Ellipta)
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as dolasetron (Anzemet), granisetron (Sancuso), ondansetron (Zofran), and promethazine
• Pain medicines such as buprenorphine (Buprenex, Butrans) and methadone (Dolophine, Methadose)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pasireotide (Signifor)
• Ranolazine (Ranexa)
• Tetrabenazine (Xenazine)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.