Enzalutamide oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of enzalutamide.
Drugs List
Therapeutic Indications
Uses
Metastatic castration-resistant prostate cancer
Non-metastatic castration-resistant prostate cancer
Treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC).
Treatment of adult men with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly symptomatic after androgen deprivation therapy when chemotherapy is not yet clinically indicated.
Treatment of adult men with metastatic castration-resistant prostate cancer (CRPC) that has progressed on or after docetaxel therapy.
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Adults
160mg once daily.
Additional Dosage Information
Missed dose
A missed dose should be taken as soon as remembered if on the same day, with a return to the normal dose schedule the following day. Patients should not take extra tablets to make up for the missed dose.
Dose reductions
Grade 3 or greater toxicity or intolerable adverse reactions: Interrupt treatment for 1 week or until symptoms subside to grade 2 or less. Resume at same dose or at a reduced dose of 120mg or 80mg.
Concomitant use with strong CYP2C8 inhibitors
Concomitant use of strong CYP2C8 inhibitors should be avoided, however if co-administration is necessary reduce dose of enzalutamide to 80mg once daily.
Contraindications
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Predisposition to seizures
Cardiovascular disorder
Electrolyte imbalance
Hereditary fructose intolerance
History of seizures
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
May reduce seizure threshold
Treatment to be initiated and supervised by a specialist
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Consult local policy on the safe use of oral anti-cancer drugs
Staff: Not to be handled by pregnant staff
Consider monitoring ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Advise patient to report headaches, seizures, confusion, visual disturbance
Discontinue if posterior reversible encephalopathy syndrome (PRES) develops
Interrupt treatment and/or reduce dose for any grade 3 toxicity
May cause impaired fertility
Male: Use of condoms required during and for 3 months after treatment
Male: Contraception required for partners for 3 months after treatment
An increased drug half life has been observed in patients with severe hepatic impairment. However, the manufacturer advise no dose adjustment is required.
Posterior Reversible Encephalopathy Syndrome (PRES) also known as Reversible Posterior Leucoencephalopathy Syndrome (RPLS)
Posterior reversible encephalopathy syndrome (PRES) has been reported in some patients treated with this agent. If patients present with symptoms indicating PRES such as headache, altered mental state, seizures and visual disturbances, an MRI should be performed. If PRES is diagnosed, treatment should be discontinued and adequate blood pressure and seizure control administration is advisable. The safety of reinstating treatment in patients previously experiencing PRES is unknown.
Pregnancy and Lactation
Pregnancy
Enzalutamide is not indicated in women.
Lactation
Enzalutamide is not indicated in women.
Side Effects
Amnesia
Anxiety
Attention disturbances
Back pain
Cardiac disorders
Cognitive impairment
Diarrhoea
Dry skin
Facial oedema
Falls
Fatigue
Fractures
Gynaecomastia
Headache
Hot flushes
Hypersensitivity reactions
Hypertension
Leucopenia
Memory disturbances
Muscle spasm
Muscle weakness
Myalgia
Nausea
Neutropenia
Oedema of the lips
Pharyngeal oedema
Posterior reversible encephalopathy syndrome (PRES)
Prolongation of QT interval
Pruritus
Rash
Restless legs
Seizures
Thrombocytopenia
Tongue oedema
Visual hallucinations
Vomiting
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: March 2018
Reference Sources
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 March 2018
Summary of Product Characteristics: Xtandi 40 mg capsules. Astellas Pharma Ltd. Revised October 2018.
Summary of Product Characteristics: Xtandi 40 mg film coated tablets. Astellas Pharma Ltd. Revised October 2018.
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.