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by Bayer Pharmaceuticals Pvt Ltd
Darolutamide 300MG Tablet
₹49,150
300MG · 16 TABLET(s) IN A STRIP
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Darolutamide is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). metastatic castration-sensitive prostate cancer (mCSPC). metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. Darolutamide is indicated for the treatment of adult patients with: non-metastatic castration resistant prostate cancer (nmCRPC) metastatic castration-sensitive prostate cancer (mCSPC) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.
Ischemic Heart Disease: Optimize management of cardiovascular risk factors. Monitor for signs and symptoms of coronary artery disease. Discontinue Darolutamide for Grade 3-4 events. Seizure: Consider discontinuation of Darolutamide in patients who develop a seizure during treatment. Embryo-Fetal Toxicity: Darolutamide can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception. Ischemic Heart Disease Ischemic heart disease, including fatal cases, occurred in patients receiving Darolutamide. In a pooled analysis of ARAMIS and ARANOTE, ischemic heart disease occurred in 3.4% of patients receiving Darolutamide and 2.2% receiving placebo, including Grade 3-4 events in 1.4% and 0.3%, respectively. Ischemic events led to death in 0.4% of patients receiving Darolutamide and 0.4% receiving placebo. In ARASENS, ischemic heart disease occurred in 3.2% of patients receiving Darolutamide with docetaxel and 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% and 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving Darolutamide with docetaxel and 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue Darolutamide for Grade 3-4 ischemic heart disease. Seizure Seizure occurred in patients receiving Darolutamide. In a pooled analysis of ARAMIS and ARANOTE, Grade 1-3 seizure occurred in 0.2% of patients receiving Darolutamide. Seizure occurred from 261 to 665 days after initiation of Darolutamide. In ARASENS, seizure occurred in 0.8% of patients receiving Darolutamide with docetaxel, including two Grade 3 events. Seizure occurred from 38 to 1754 days after initiation of Darolutamide. It is unknown whether anti-epileptic medications will prevent seizures with Darolutamide. Advise patients of the risk of developing a seizure while receiving Darolutamide and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of Darolutamide in patients who develop a seizure during treatment. Embryo-Fetal Toxicity The safety and efficacy of Darolutamide have not been established in females. Based on its mechanism of action, Darolutamide can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose of Darolutamide.
Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.
In nmCRPC and mCSPC: The most common adverse reactions (>10% with a ≥2% increase over placebo), including laboratory test abnormalities, are increased AST, decreased neutrophil count, increased bilirubin, fatigue, and increased ALT. In mCSPC in combination with docetaxel: The most common adverse reactions (≥10% with a ≥2% increase over placebo) are constipation, rash, decreased appetite, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) are anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled data in WARNINGS and PRECAUTIONS reflect two randomized clinical trials [ARAMIS, ARANOTE] in patients with nmCRPC (N = 954) and mCSPC (N = 445) treated with Darolutamide. In these trials, the median duration of treatment was 18.2 months (range 0.03 to 44.3) for patients who received Darolutamide. In this pooled safety population, the most common adverse reactions (>10% with a ≥2% increase over placebo), including laboratory test abnormalities were increased AST, decreased neutrophil count, increased bilirubin, fatigue and increased ALT. The safety of Darolutamide in combination with docetaxel in mCSPC is based on data from 1302 patients of whom 652 received at least one dose of Darolutamide in the ARASENS study. Non-Metastatic Castration Resistant Prostate Cancer ARAMIS The safety of Darolutamide in nmCRPC patients was evaluated in ARAMIS, a randomized (2:1), double-blind, placebo-controlled, multi-center clinical study. Patients received either Darolutamide at a dose of 600 mg, or a placebo, twice a day. All patients in the ARAMIS study received a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. Among patients who received Darolutamide, the median duration of exposure was 14.8 months (range: 0 to 44.3 months). Serious adverse reactions occurred in 25% of patients receiving Darolutamide and in 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received Darolutamide included urinary retention, pneumonia and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving Darolutamide and 3.2% of patients receiving placebo. Abridged from the full prescribing information.
Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.
