Alectinib

About Alectinib

• Alectinib stands as a pivotal anti-cancer medication, specifically tailored for the treatment of non-small-cell lung cancer (NSCLC). 
• Positioned as an orally bioavailable tyrosine kinase inhibitor, its mechanism of action revolves around the proficient inhibition of ALK and RET proteins, meticulously preventing their phosphorylation. 
• This strategic interference disrupts the activation of ALK, subsequently curtailing downstream signaling pathways that orchestrate cell proliferation. 
• The consequential effect is a noteworthy reduction in tumor survivability.
• This groundbreaking pharmaceutical intervention is meticulously administered through oral ingestion, exemplifying its accessibility and patient-friendly mode of delivery. 
• The development and formulation of Alectinib are attributed to the scientific prowess of Chugai Pharmaceutical Co., Japan, an integral part of the esteemed Hoffmann-La Roche group. 
• The synergy of precision in targeting cancer-specific proteins and the convenience of oral administration underscores Alectinib’s significance in the contemporary landscape of NSCLC treatment, offering a beacon of hope for patients navigating this challenging medical terrain.

Strength: 

Alectinib capsules are available in strengths of 150 mg.

Recommended Dosage:

It is essential to implement strict administration precautions to ensure the safety and well-being of patients. 

• The prescribed dosage for Alectinib entails the administration of 600 mg orally twice daily, preferably with food. 

To address adverse reactions, a systematic dose reduction schedule is recommended.

• Starting dose: 600 mg taken orally twice daily
• First dose reduction: 450 mg taken orally twice daily
• Second dose reduction: 300 mg taken orally twice daily

Patients who are unable to tolerate the reduced dosage of 300 mg twice daily are advised to discontinue Alectinib. These meticulous recommendations for dose adjustments serve as a strategic approach to managing adverse reactions and optimizing the therapeutic benefit of Alectinib in the treatment protocol.

Important: 

Alectinib 150 mg is to be continued until there is evidence of disease progression or the emergence of unacceptable toxicity. It is imperative not to open or dissolve the contents of the capsule. In instances where a dose of Alectinib is inadvertently missed or if vomiting occurs after ingestion, the subsequent dose should be taken at the scheduled time.

Adhering to protocols is crucial in Alectinib treatment. Healthcare providers must monitor and address adverse reactions promptly. Regular follow-ups and open communication ensure a responsible approach.

Warnings & Precaution:

• Hepatotoxicity: Rigorous monitoring of liver laboratory tests is essential, with a frequency of every 2 weeks throughout the initial 3 months of Alectinib treatment. Subsequently, the monitoring should continue every month and as clinically indicated. For patients exhibiting elevations in transaminase and bilirubin levels, especially in severe cases, a strategic approach involves temporary withholding, followed by dose reduction, or permanent discontinuation of Alectinib as deemed necessary.
• Interstitial Lung Disease (ILD)/Pneumonitis: In cases where patients are diagnosed with ILD/pneumonitis, an immediate suspension of Alectinib is recommended. Permanent discontinuation becomes imperative if no alternative causes for ILD/pneumonitis are identified.
• Renal Impairment: For patients with severe renal impairment, a prudent course of action involves the temporary withholding of Alectinib. Upon recovery, the reintroduction of Alectinib at a reduced dose is an option, or permanent discontinuation may be considered.
• Bradycardi: Regular monitoring of heart rate and blood pressure is advised. In cases of symptomatic bradycardia, a systematic approach includes temporarily withholding Alectinib, followed by dose reduction, or permanent discontinuation.
• Severe Myalgia and Creatine Phosphokinase (CPK) Elevation: A proactive measure involves assessing CPK levels every 2 weeks in the initial month of Alectinib treatment. Additionally, in patients reporting unexplained muscle pain, tenderness, or weakness, CPK evaluation is crucial. In instances of severe CPK elevations, a recommended course of action comprises temporary withholding, followed by either resumption or dose reduction.

Common Alectinib Side Effects:

• Edema
• Myalgia
• Anemia
• Constipation (most common)
• Nausea and vomiting
• Diarrhea
• Mouth sores
• Loss of appetite
• Musculoskeletal
• Muscle pain
• Fatigue
• Weakness

Use in Specific Population

• Administration of Alectinib to expectant mothers carries the potential for fetal harm, as indicated by animal studies and the drug’s mechanism of action.
• Information regarding the presence of alectinib or its metabolites in human milk, its impact on breastfeeding infants, and its effects on milk production is unavailable. 
• Lactating women are strongly advised to refrain from breastfeeding during Alectinib treatment and for one week post the final dose due to the potential for severe adverse reactions in infants. 
• Women of reproductive age are recommended to use effective contraception throughout Alectinib treatment and for one week following the final dose.
• Considering genotoxicity findings, males with female partners of reproductive potential should practice effective contraception during Alectinib treatment and for three months after the last dose. 
• The drug’s safety and efficacy in pediatric patients are yet to be established. While no dose adjustment is suggested for those with mild or moderate renal impairment, the safety of Alectinib in severe renal impairment or end-stage renal disease remains unstudied. 
• Similarly, no dose adjustment is proposed for mild hepatic impairment, with the safety of Alectinib in moderate or severe hepatic impairment yet to be explored.

Storage and Handling

Do not store above 30°C (86°F). Store the capsule at its original container. Do not freeze the medicine. Keep the medicine away from pets and children. 

• 240 capsules per bottle