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APALUTAMIDE
Generic Name: APALUTAMIDE
ABSTRACT -
Apalutamide is an oral androgen receptor inhibitor marketed as ERLEADA.
It is used for non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer in combination with ongoing androgen-deprivation therapy or after orchiectomy.
It blocks androgen-receptor signaling, nuclear translocation, DNA binding, and transcriptional activation.
DOSAGE -
- Dosage should be determined only by a qualified healthcare professional.
- Recommended dose is 240 mg orally once daily.
- It may be taken with or without food; patients should continue a GnRH analog unless they have had bilateral orchiectomy.
- Dose interruption, reduction, or discontinuation may be required for severe toxicity.
SIDE EFFECTS–
- Possible side effects may include:
- Fatigue
- Rash
- Hypertension
- Hot flush
- Arthralgia
- Diarrhea
- Weight loss
- Falls and fractures
- Hypothyroidism
- Seizure is uncommon but serious
ALLRGIC REACTIONS–
- Hypersensitivity to the active compound or excipients is possible.
- Symptoms may include skin rash, urticaria, pruritus, facial swelling, wheezing, dizziness, or anaphylaxis.
- Patients with a suspected allergic reaction should stop treatment and seek urgent medical attention.
DRUG INTERACTIONS–
- Strong CYP2C8 or CYP3A4 inhibitors may alter exposure.
- Apalutamide can reduce exposure of drugs metabolized by CYP3A4, CYP2C19, CYP2C9 and some transporters.
- Review anticoagulants, antiepileptics, thyroid replacement, and narrow-therapeutic-index drugs.
PREAUTIONS–
- Assess seizure history, fall risk, fracture risk, cardiovascular status, and skin reaction history.
- Monitor blood pressure, thyroid function, rash severity, and bone health.
- Use effective contraception due to embryo-fetal risk.
- Avoid in patients with uncontrolled serious toxicity until medically reviewed.
WARNINGS –
- Seizure, severe cutaneous adverse reactions, ischemic cardiovascular events, falls, fractures, and embryo-fetal toxicity are important risks.
- Do not use in women who are or may become pregnant.
- Patients should report rash, neurologic symptoms, chest pain, or falls promptly.
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