Erleada

Dosing

Oral: 240 mg once daily (4 pills daily).

Administration

Oral: Administer at the same time each day, either with or without food. Swallow tablets whole.

If a patient is unable to swallow tablets whole, tablets may be mixed in 120 mL of applesauce; do not crush tablets when mixing.

Side Effects

Hypertension, fatigue, skin rash, anemia, decreased appetite, hot flashes, joint pain, increased risk for falls, nausea, and diarrhea.

Missed Dose

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. If you miss more than one dose, talk to your doctor right away.

Reproductive Considerations

Males with female partners of reproductive potential should use effective contraception during therapy and for 3 months after the last apalutamide dose.

Monitoring

  • CBC w diff, CMP (baseline and every 3 months thereafter).
  • PSA every 3 months or as clinically indicated.
  • Monitor thyroid function (e.g., thyroid-stimulating hormone [TSH]) as clinically necessary (TSH was monitored at baseline and every 4 months in studies).
  • Monitor for signs/symptoms of cardiovascular events, seizure, and dermatologic toxicity and assess for fall and fracture risk.

Mechanism of Action

Apalutamide is a nonsteroidal androgen receptor inhibitor; apalutamide binds directly to the androgen receptor ligand-binding domain to prevent androgen-receptor translocation, DNA binding, and receptor-mediated transcription.

In layman’s terms: This medication is an anti-androgen (anti-testosterone). When testosterone binds to an androgen receptor, it causes the tumor cells to grow. You are taking this medication to block the effects of testosterone by slowing down the growth and spread of prostate cancer. As a result, the prostate tumor may stop growing, and the cancer cells die.

Storage

Store in the original package at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Other Considerations

Be sure to let other prescribers know that you are taking this medication. This drug may interact with other drugs prescribed; such as antifungals and hepatitis C drugs. You may be at a higher risk for hypertension.

Notify MD of any new or worrisome side effects.