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.

How to use Firmagon Vial

Read the Patient Information Leaflet if available from your pharmacist before you start using degarelix and each time you get a refill. If you have any questions, ask 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 given as directed by your doctor, usually once a month.

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.

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.

Consult your pharmacist or physician.

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 lab tests (such as pituitary gonadal function), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
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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.

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.

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.

Not applicable. This medication is given in a clinic and will not be stored at home.