Alkixen Capsule contains Crizotinib, a targeted anticancer therapy designed for the treatment of specific molecular subtypes of non-small cell lung cancer (NSCLC). As a kinase inhibitor, Alkixen plays a crucial role in precision oncology by targeting tumors driven by genetic alterations. It is particularly significant as the first FDA-approved biomarker-driven therapy for both ALK-positive and ROS1-positive metastatic NSCLC, and remains the only FDA-approved treatment option for ROS1-positive NSCLC.

রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Therapeutic Class

Targeted Cancer Therapy

Indications

Alkixen is indicated for the treatment of patients with:

• Locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC)

• Locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)

Treatment should be initiated and supervised by physicians experienced in the use of anticancer therapies.

Description

Alkixen represents a major advancement in targeted lung cancer treatment. By specifically inhibiting abnormal signaling pathways caused by ALK and ROS1 gene rearrangements, Alkixen helps control tumor growth and disease progression. Its biomarker-driven approach allows for more effective treatment with reduced impact on normal, healthy cells compared to conventional chemotherapy.

Pharmacology

Crizotinib is an inhibitor of multiple receptor tyrosine kinases, including anaplastic lymphoma kinase (ALK), ROS1, hepatocyte growth factor receptor (c-Met), and RON. Genetic translocations involving the ALK gene can lead to oncogenic fusion proteins that drive uncontrolled cell proliferation and survival. Crizotinib inhibits phosphorylation of these kinases, thereby blocking downstream signaling pathways essential for tumor growth.

Following oral administration, crizotinib is absorbed with peak plasma concentrations achieved within 4 to 6 hours. Steady-state levels are reached within approximately 15 days of twice-daily dosing. Crizotinib is extensively distributed in body tissues and is highly protein bound. It is predominantly metabolized by CYP3A4/5 enzymes, with elimination occurring mainly through feces and, to a lesser extent, urine. The terminal half-life is approximately 42 hours.

Dosage & Administration

• Standard dose: 250 mg orally, twice daily

• In patients with severe renal impairment (creatinine clearance <30 mL/min, not on dialysis): 250 mg once daily

• No dose adjustment is required for mild to moderate renal impairment

• Use with caution in patients with hepatic impairment

• Capsules should be swallowed whole and may be taken with or without food

• Safety and efficacy in pediatric patients have not been established

Drug Interactions

• Avoid concurrent use with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir)

• Avoid concurrent use with strong CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s Wort)

• Avoid co-administration with CYP3A substrates that have narrow therapeutic indices (e.g., cyclosporine, fentanyl, tacrolimus)

  রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Side Effects

Common adverse reactions (≥25%) include:

• Vision disorders

• Nausea and vomiting

• Diarrhea and constipation

• Edema

• Fatigue

• Decreased appetite

• Elevated liver transaminases

• Dizziness

• Peripheral neuropathy

• Upper respiratory tract infections

Pregnancy & Lactation

• Crizotinib may cause fetal harm when administered during pregnancy

• Women of reproductive potential should use effective contraception during treatment

• Breastfeeding is not recommended during therapy and for 45 days after the final dose

Precautions & Warnings

• Regular liver function tests are required; therapy may need dose adjustment or discontinuation

• Permanently discontinue in patients who develop interstitial lung disease or pneumonitis

• Monitor ECG and electrolytes in patients at risk of QT prolongation

• Monitor heart rate and blood pressure due to the risk of bradycardia

• Perform ophthalmologic evaluation if visual disturbances occur; discontinue in severe visual loss

• Advise effective contraception due to risk of fetal harm

Storage Conditions

Store below 30°C.
Protect from light and moisture.
Keep out of the reach of children.