ERLEADA- apalutamide tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

APALUTAMIDE (UNII: 4T36H88UA7) (APALUTAMIDE - UNII:4T36H88UA7)

Available from:

Janssen Products, LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ERLEADA is indicated for the treatment of patients with - Metastatic castration-sensitive prostate cancer (mCSPC) - Non-metastatic castration-resistant prostate cancer (nmCRPC) None. Risk Summary The safety and efficacy of ERLEADA have not been established in females. Based on findings from animals and its mechanism of action, ERLEADA can cause fetal harm and loss of pregnancy when administered to a pregnant female [see Clinical Pharmacology (12.1)] . There are no available data on ERLEADA use in pregnant women to inform a drug-associated risk. In an animal reproduction study, oral administration of apalutamide to pregnant rats during and after organogenesis resulted in fetal abnormalities and embryo-fetal lethality at maternal exposures ≥ 2 times the human clinical exposure (AUC) at the recommended dose (see Data) . Data Animal Data In a pilot embryo-fetal developmental toxicity study in rats, apalutamide caused developmental toxicity when administered at oral doses of 25, 50 or 100 mg/kg/day throughout and after the period of organogenesis (gestational days 6–20). Findings included embryo-fetal lethality (resorptions) at doses ≥50 mg/kg/day, decreased fetal anogenital distance, misshapen pituitary gland, and skeletal variations (unossified phalanges, supernumerary short thoracolumbar rib(s), and small, incomplete ossification, and/or misshapen hyoid bone) at ≥25 mg/kg/day. A dose of 100 mg/kg/day caused maternal toxicity. The doses tested in rats resulted in systemic exposures (AUC) approximately 2, 4 and 6 times, respectively, the AUC in patients. Risk Summary The safety and efficacy of ERLEADA have not been established in females. There are no data on the presence of apalutamide or its metabolites in human milk, the effect on the breastfed child, or the effect on milk production. Contraception Males Based on the mechanism of action and findings in an animal reproduction study, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ERLEADA [see Use in Specific Populations (8.1)] . Infertility Males Based on animal studies, ERLEADA may impair fertility in males of reproductive potential [see Nonclinical Toxicology (13.1)] . Safety and effectiveness of ERLEADA in pediatric patients have not been established. Of the 1327 patients who received ERLEADA in clinical studies, 19% of patients were less than 65 years, 41% of patients were 65 years to 74 years, and 40% were 75 years and over. No overall differences in effectiveness were observed between older and younger patients. Of patients treated with ERLEADA (n=1073), Grade 3–4 adverse reactions occurred in 39% of patients younger than 65 years, 41% of patients 65–74 years, and 49% of patients 75 years or older. Falls in patients receiving ERLEADA with androgen deprivation therapy was elevated in the elderly, occurring in 8% of patients younger than 65 years, 10% of patients 65–74 years, and 19% of patients 75 years or older. - ERLEADA comes in 2 different strengths, 60 mg tablets and 240 mg tablets. Please find the instructions below that refer to your prescribed ERLEADA strength for how to prepare and take ERLEADA tablets if you cannot swallow tablets whole. - ERLEADA 240 mg tablet can be prepared and given through a feeding tube 8 French or larger. - Store ERLEADA at room temperature between 68 °F to 77 °F (20 °C to 25 °C). - ERLEADA comes in a child-resistant bottle. - Store ERLEADA in the original package to protect from light and moisture. - The bottle of ERLEADA contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not throw away (discard) the desiccant.

Product summary:

ERLEADA ® (apalutamide) tablets are available in the strengths and packages listed below: Storage and Handling Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature] . Store in original package to protect from light and moisture. Do not discard desiccant.

Authorization status:

New Drug Application

Summary of Product characteristics

ERLEADA- APALUTAMIDE TABLET, FILM COATED
JANSSEN PRODUCTS, LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ERLEADA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ERLEADA.
ERLEADA
(APALUTAMIDE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL – 2018
RECENT MAJOR CHANGES
Dosage and Administration, Recommended Dosage ( 2.1)
02/2023
Dosage and Administration, Alternate Methods of Administration ( 2.3)
02/2023
INDICATIONS AND USAGE
ERLEADA is an androgen receptor inhibitor indicated for the treatment
of patients with
metastatic castration-sensitive prostate cancer. ( 1)
non-metastatic castration-resistant prostate cancer. ( 1)
DOSAGE AND ADMINISTRATION
ERLEADA 240 mg administered orally once daily. Swallow tablets whole.
ERLEADA can be taken with or
without food. ( 2.1, 2.3)
Patients should also receive a gonadotropin-releasing hormone (GnRH)
analog concurrently or should
have had bilateral orchiectomy. ( 2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 240 mg ( 3)
Tablets: 60 mg ( 3)
CONTRAINDICATIONS
None. ( 4)
WARNINGS AND PRECAUTIONS
Cerebrovascular and ischemic cardiovascular events occurred in
patients receiving ERLEADA. Monitor
for signs and symptoms of cerebrovascular disorders and ischemic heart
disease. Optimize
management of cardiovascular risk factors. ( 5.1).
Fractures occurred in patients receiving ERLEADA. Evaluate patients
for fracture risk and treat patients
with bone-targeted agents according to established guidelines. ( 5.2)
Falls occurred in patients receiving ERLEADA with increased incidence
in the elderly. Evaluate patients
for fall risk. ( 5.3)
Seizure occurred in 0.4% of patients receiving ERLEADA. Permanently
discontinue ERLEADA in patients
who develop a seizure during treatment. ( 5.4)
Severe Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson
syndrome/toxic epidermal
necrolysis (SJS/TEN) and drug reaction with eosinophilia and systemic
symptoms (DRESS), occurred in
patients treated with ERLEADA. Interrupt ERL