Degarelix powder for solution for injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of degarelix.
Drugs List
Therapeutic Indications
Uses
Advanced prostate cancer
Treatment of adult male patients with advanced hormone-dependent prostate cancer.
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Adults
Starting dose
240mg dose (as 2 x 120mg consecutive doses).
Maintenance dose
80mg (1 x 80mg dose) one month after the starting dose. Maintenance doses of 80mg should then be given monthly.
Administration
Degarelix is for subcutaneous injection only.
To be administered in the abdominal region. The injection site should be varied periodically and should be given in areas where the patient will not be exposed to pressure e.g. not close to waistband or belt and not close to the ribs.
Contraindications
Children under 18 years
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Risk factors for cardiovascular disorder
Diabetes mellitus
Electrolyte imbalance
Hepatic disorder
History of torsade de pointes
Severe renal impairment
Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
For subcutaneous use only
Consider monitoring ECG in patients at risk of QT prolongation
Monitor blood glucose closely in patients with diabetes mellitus
Monitor liver function in patients with hepatic impairment
Monitor serum electrolytes
May cause loss of bone mineral density
May precipitate diabetes mellitus
Hepatic impairment
Long-term clinical studies have not been including patients with confirmed or suspected hepatic disease. Mild, transient increases in ALT and AST have been observed, these were not accompanied by an increase in bilirubin or clinical symptoms.
Glucose tolerance
A reduction in glucose tolerance has been observed in patients undergoing orchiectomy or in patients who have been treated with a GnRH agonist.
Development or worsening of diabetes may occur. Diabetic patients may require more frequent monitoring of blood glucose when on an androgen deprivation therapy. There are no studies about the effect of degarelix acetate on insulin and glucose levels.
Changes in bone density
A reduction in bone density has been observed in patients who have had orchiectomy or who have been treated with a GnRH agonist. It can be expected that long periods of testosterone suppression in men will have effects on bone density. During treatment with degarelix acetate, the bone density has not been evaluated.
Pregnancy and Lactation
Pregnancy
No indicated for use in women.
Lactation
No indicated for use in women.
Counselling
Advise patient that side effects such as fatigue and dizziness are common and may affect the ability to drive or operate machinery.
Side Effects
Abdominal discomfort
Abdominal pain
Alopecia
Anaemia
Anaphylactic reaction
Arthralgia
Atrial fibrillation
Blurred vision
Breast pain
Cardiac arrhythmias
Cardiac failure
Changes in serum calcium levels
Chills
Constipation
Decreased appetite
Depression
Diabetes mellitus
Diarrhoea
Dizziness
Dry mouth
Dyspnoea
Dysuria
Erectile disturbance
Erythema
Failure of ejaculation
Fatigue
General discomfort
Genital irritation
Gynaecomastia
Headache
Hot flushes
Hyperglycaemia
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Hypotension
Impairment of mental skills
Incontinence
Increase in alkaline phosphatase
Increase in plasma cholesterol
Increase of liver transaminases
Influenza-like symptoms
Injection site reactions
Insomnia
Joint swelling
Loss of libido
Malaise
Muscle spasm
Muscle weakness
Musculoskeletal pain
Myocardial infarction
Nausea
Neutropenic fever
Night sweats
Nocturia
Osteopenia
Osteoporosis
Pain
Palpitations
Pelvic pain
Peripheral oedema
Pollakiuria
Prolongation of QT interval
Pruritus
Pyrexia
Rash
Reduced libido
Renal impairment
Rhabdomyolysis
Serum bilirubin increased
Skin nodules
Testicular atrophy
Testicular pain
Tinnitus
Urinary urgency
Urticaria
Vasovagal attacks
Vomiting
Weight changes
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: April 2020.
Reference Sources
Summary of Product Characteristics: Firmagon 80mg injection. Ferring Pharmaceuticals. December 2019.
Summary of Product Characteristics: Firmagon 120mg injection. Ferring Pharmaceuticals. December 2019.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.