Degarelix

Degarelix is a prescription medicine used to treat the symptoms of hormone-dependent advanced prostate carcinoma (stage D).

• Degarelix is available under the following different brand names: Firmagon

Adult dosage

Powder for injection

• 80mg
• 120mg

Hormone-dependent Advanced Prostate Carcinoma (Stage D)

Adult dosage

• Initial: 120 mg SC for 2 doses (i.e., 2 separate injections totaling 240 mg), then after 28 days, begin maintenance dose of 80 mg SC every 28 Days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Degarelix include:

• difficulty having a bowel movement,
• flushing (warmth),
• weight gain,
• redness of the face, neck, arms, or upper chest,
• sudden sweating,
• unusual tiredness or weakness,
• diarrhea,
• weakness,
• nausea,
• night sweats,
• sleeplessness,
• swelling of the breast,
• breast soreness,
• trouble sleeping, and
• unable to sleep (insomnia).

Serious side effects of Degarelix include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• back pain,
• blurred vision,
• dizziness,
• fever,
• flushing or redness of the skin,
• hard lump,
• headache,
• nervousness,
• pain,
• pounding in the ears,
• slow or fast heartbeat,
• small lumps under the skin,
• swelling,
• unusually warm skin,
• bladder pain,
• bloody or cloudy urine,
• chills,
• decrease in testicle size,
• decreased sexual intercourse,
• difficult or painful urination,
• burning when urinating,
• difficulty moving,
• frequent urination,
• inability to have or keep an erection,
• increased sweating,
• lower back or side pain,
• muscle pain or stiffness,
• pain in the joints,
• chest pain or discomfort,
• fainting,
• irregular heartbeat,
• pounding heartbeat, and
• shortness of breath.

Rare side effects of Degarelix include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Degarelix has no noted severe interactions with any other drugs.
• Degarelix has no noted serious interactions with any other drugs.
• Degarelix has no noted moderate interactions with any other drugs.
• Degarelix has no noted minor interactions with any other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Pregnancy or in women who may become pregnant

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Degarelix?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Degarelix?”

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 the benefits of androgen deprivation therapy outweigh potential risks
• Bone mineral density may decrease due to androgen deprivation therapy
• The risk for diabetes may increase due to androgen deprivation, which may cause obesity and insulin resistance
• Hypersensitivity reactions (eg, anaphylaxis, urticaria, angioedema) are reported; if a serious hypersensitivity reaction occurs, discontinue the drug immediately if the injection has not been completed, and manage as clinically indicated; do not rechallenge

Pregnancy and Lactation

• Safety and efficacy not established in women
• Lactation
  • Safety and efficacy are not established in females; there are no data on the presence of the drug in human milk, effects on the breastfed child, or milk production; because many drugs are present in human milk and because of the potential for serious adverse reactions in a breastfed child from therapy, a decision should be made whether to discontinue nursing or discontinue the drug taking into account importance of the drug to mother