Alunib 180mg Tablet is prescribed for adults with non-small cell lung cancer (NSCLC).
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When a person breathes in, the lungs absorb oxygen from the air and transport it into the bloodstream for distribution throughout the body. As the body's cells utilize oxygen, they release carbon dioxide, which is carried back to the lungs by the bloodstream and expelled from the body during exhalation.
The lungs consist of various cell types, with epithelial cells being the predominant ones. Epithelial cells line the airways and produce mucus, serving to lubricate and protect the lungs. Additionally, the lungs contain nerve cells, hormone-producing cells, blood cells, and structural or supporting cells.
Regarding non-small cell lung cancer (NSCLC), there are two primary classifications of lung cancer, the other being small cell lung cancer, each requiring different treatment approaches. NSCLC originates when healthy lung cells undergo abnormal growth, forming a mass known as a tumor, lesion, or nodule. These growths can be either benign or cancerous. Cancerous lung tumors may shed cells that travel through the bloodstream or lymphatic fluid, potentially leading to metastasis in lymph nodes or distant parts of the body.
NSCLC comprises different subtypes, and understanding the specific type is crucial for determining appropriate treatment strategies. The classification is based on microscopic examination and the cell origin of the cancer. The main types of NSCLC include:
NSCLC-NOS (not otherwise specified) or NSCLC undifferentiated: In certain instances, determining the specific NSCLC subtype remains challenging even after testing.
Non-Small Cell Lung Cancer
Anaplastic lymphoma kinase positive metastatic non-small cell lung cancer (ALK+ NSCLC) is a relatively rare subtype, constituting only 3-5% of all non-small cell lung cancer (NSCLC) cases. Despite its low prevalence, the significance of ALK mutations and their presence in various oncogenic fusion proteins, both in solid tumors and hematologic malignancies, underscores their importance as potential targets for cancer therapy. The primary driver of ALK-related NSCLC cases is the fusion gene EML4-ALK, which results from the fusion of the ALK gene with the echinoderm microtubule-associated protein like-4 (EML4). The original function of EML4 involves the proper formation of microtubules.
The presence of the EML4-ALK fusion gene leads to the formation of an aberrant fusion protein, disrupting normal signaling pathways. This abnormal signaling contributes to increased cell growth, proliferation, and survival. Crizotinib is a drug indicated for the treatment of ALK+ NSCLC; however, its efficacy is compromised in cases where ALK kinase domain mutations are present, as they confer resistance to the treatment.
In such instances, brigatinib emerges as a therapeutic option for patients with ALK+ NSCLC who either exhibit intolerance to Crizotinib or have experienced disease progression on this treatment. Brigatinib's role lies in its ability to target ALK, providing an alternative treatment avenue for patients with ALK+ NSCLC.
Brigatinib is a tyrosine kinase inhibitor that exhibits in vitro activity at clinically achievable concentrations against multiple kinases.
Initial Dosing:
Dose Adjustment:
Duration of Treatment:
Treatment Interruption:
Administration Instructions:
Missed Dose or Vomiting:
Pediatric Use:
Brigatinib metabolism is affected by cytochrome P450 3A (CYP3A) enzymes, and interactions with drugs that modulate CYP3A activity can impact its plasma concentrations and efficacy. Here are some important considerations:
Increased Plasma Concentrations and Adverse Reactions with Strong CYP3A Inhibitors:
Decreased Plasma Concentrations and Efficacy with Strong CYP3A Inducers:
Decreased Concentrations and Loss of Efficacy of CYP3A Substrates:
Hypersensitivity to Brigatinib or any other components.
The use of brigatinib during pregnancy can potentially cause fetal harm, as demonstrated by findings in animal studies. Administration to pregnant rats during the organogenesis period resulted in dose-related skeletal anomalies at relatively low doses. Specifically, skeletal anomalies were observed at doses as low as 12.5 mg/kg/day, which is approximately 0.7 times the human exposure at a dose of 180 mg once daily. Additionally, higher doses (25 mg/kg/day or greater) were associated with increased postimplantation loss, malformations, and reduced fetal body weight.
Regarding fertility, brigatinib may lead to reduced fertility in males based on findings in male reproductive organs in animal studies. Therefore, individuals of reproductive potential, both males and females, should use effective nonhormonal contraception during treatment with brigatinib. Females need to continue contraception for at least 4 months after the final dose, and males should use effective contraception for at least 3 months after the last dose due to potential genotoxicity.
The distribution of brigatinib in human breast milk is unknown. Due to the potential for adverse reactions in breastfed infants, lactating women are advised not to breastfeed during treatment with brigatinib and for at least 1 week following the final dose. This precaution is taken to minimize the risk of exposing the infant to the medication and its potential effects.
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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