Drugs List

Therapeutic Indications

Uses

Metastatic hormone sensitive prostate cancer
Non-metastatic castration-resistant prostate cancer

Non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.
Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).

Contraindications

Children under 18 years
Brain neoplasm
Cerebral metastases
Cerebral trauma
History of seizures
Long QT syndrome
Recent cerebrovascular accident
Severe hepatic impairment
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Congestive cardiac failure
Electrolyte imbalance
History of torsade de pointes
Pulmonary embolism
Recent myocardial infarction
Severe angina
Severe renal impairment
Unstable angina
Ventricular arrhythmias

Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of oral anti-cancer drugs
Staff: Not to be handled by pregnant staff
Evaluate patient for fracture/fall risk before and during treatment
Consider monitoring ECG in patients at risk of QT prolongation
Discontinue treatment if patient develops seizures
Monitor patients with cardiovascular disease
Monitor serum electrolytes
Interrupt treatment for any grade 3 toxicity
May cause impaired fertility
Male: Additional contraception required in addition to barrier method
Male: Use barrier contraception during and for 3 months after treatment

Medical castration (with gonadotropin releasing hormone analogue) should be continued throughout treatment with apalutamide in patients not surgically castrated.

Pregnancy and Lactation

Pregnancy

Apalutamide is not indicated for use in women.

There is a theoretical risk of foetal harm when apalutamide is administered during pregnancy. There is no human or animal data available on apalutamide use during pregnancy.

Lactation

Apalutamide is not indicated for use in women.

A risk to the nursing infant cannot be excluded.

Side Effects

Arthralgia
Decreased appetite
Falls
Fatigue
Fractures
Hypercholesterolaemia
Hypertriglyceridaemia
Hypothyroidism
Prolongation of QT interval
Pruritus
Rash
Seizures
Toxic epidermal necrolysis
Weight loss

Presentation

Oral formulations of apalutamide.

Drugs List

Therapeutic Indications

Uses

Metastatic hormone sensitive prostate cancer
Non-metastatic castration-resistant prostate cancer

Non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.
Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).

Dosage

Adults

Additional Dosage Information

Contraindications

Children under 18 years
Brain neoplasm
Cerebral metastases
Cerebral trauma
History of seizures
Long QT syndrome
Recent cerebrovascular accident
Severe hepatic impairment
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Congestive cardiac failure
Electrolyte imbalance
History of torsade de pointes
Pulmonary embolism
Recent myocardial infarction
Severe angina
Severe renal impairment
Unstable angina
Ventricular arrhythmias

Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of oral anti-cancer drugs
Staff: Not to be handled by pregnant staff
Evaluate patient for fracture/fall risk before and during treatment
Consider monitoring ECG in patients at risk of QT prolongation
Discontinue treatment if patient develops seizures
Monitor patients with cardiovascular disease
Monitor serum electrolytes
Interrupt treatment for any grade 3 toxicity
May cause impaired fertility
Male: Additional contraception required in addition to barrier method
Male: Use barrier contraception during and for 3 months after treatment

Medical castration (with gonadotropin releasing hormone analogue) should be continued throughout treatment with apalutamide in patients not surgically castrated.

Pregnancy and Lactation

Pregnancy

Apalutamide is not indicated for use in women.

There is a theoretical risk of foetal harm when apalutamide is administered during pregnancy. There is no human or animal data available on apalutamide use during pregnancy.

Lactation

Apalutamide is not indicated for use in women.

A risk to the nursing infant cannot be excluded.

Side Effects

Arthralgia
Decreased appetite
Falls
Fatigue
Fractures
Hypercholesterolaemia
Hypertriglyceridaemia
Hypothyroidism
Prolongation of QT interval
Pruritus
Rash
Seizures
Toxic epidermal necrolysis
Weight loss

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: February 2021

Reference Sources

Summary of Product Characteristics: Erleada film-coated tablets. Janssen-Cilag Ltd. Revised November 2020.