Cerixen 150 mg (Ceritinib) Tablets

Introduction

Cerixen 150 mg (Ceritinib) is a highly potent, second-generation, targeted tyrosine kinase inhibitor (TKI). Manufactured by Everest Pharmaceuticals Ltd. and supplied globally by Onco Solution, Cerixen is an advanced precision medicine designed for the treatment of non-small cell lung cancer (NSCLC). It specifically targets and blocks abnormal anaplastic lymphoma kinase (ALK) proteins that drive cancer cell growth. Cerixen is engineered to overcome resistance to first-generation ALK inhibitors and features excellent blood-brain barrier penetration, making it highly effective against central nervous system (CNS) metastases.

Indications

Cerixen 150 mg (Ceritinib) is indicated for:

• ALK-Positive Metastatic NSCLC: Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test.
• First-line and Secondary Treatment: It is approved for both newly diagnosed patients and patients who have progressed on or are intolerant to initial ALK inhibitor therapies (such as crizotinib).

Pharmacology

Ceritinib, the active ingredient in Cerixen, is an oral, selective small-molecule inhibitor of ALK tyrosine kinase.

• Mechanism: It inhibits autophosphorylation of ALK, ALK-mediated phosphorylation of downstream signaling proteins (such as STAT3 and AKT), and ALK-dependent proliferation of cancer cells.
• Overcoming Resistance: Ceritinib demonstrates significantly higher potency than first-generation inhibitors and is active against mutated forms of ALK that typically cause clinical resistance to crizotinib. It also inhibits the insulin-like growth factor 1 receptor (IGF-1R) and ROS1 kinases.

Dosage & Administration

Oral Administration for Adults:

• Standard Recommended Dose: 450 mg (three 15 mg tablets) taken orally once daily.
• Administration: Must be taken with food (a light to full meal). Taking it with food improves absorption and significantly reduces gastrointestinal side effects compared to taking it on an empty stomach.
• Method: Swallow tablets whole with water. Do not chew, crush, or dissolve the tablets.
• Missed Dose: If a dose is missed, it can be taken as soon as remembered, unless it is within 12 hours of the next scheduled dose. Do not take a double dose to make up for a missed one.

Drug Interactions

• Strong CYP3A Inhibitors: Co-administration (e.g., Ketoconazole, Ritonavir) increases Ceritinib plasma concentrations. Avoid concomitant use; if unavoidable, reduce the Cerixen dose by approximately one-third.
• Strong CYP3A Inducers: Avoid co-administration (e.g., Rifampin, Carbamazepine) as they drastically lower Cerixen levels and reduce clinical efficacy.
• Gastric Acid Reducing Agents: Proton pump inhibitors (PPIs), H2 blockers, and antacids may alter the solubility and absorption of Ceritinib. Avoid PPIs during treatment if possible.
• Grapefruit Products: Avoid consuming grapefruit juice or grapefruit products, as they can significantly increase toxicity risks.

Contraindications

• Hypersensitivity: Known severe hypersensitivity to Ceritinib or any of the inactive excipients present in the tablet.
• Pregnancy: Categorized as a known risk to fetal development.

Side Effects

Patients receiving Cerixen 150 mg may experience:

• Gastrointestinal: Diarrhea, nausea, vomiting, abdominal pain, and decreased appetite.
• Hepatotoxic: Elevated liver enzymes (ALT, AST) and increased blood bilirubin.
• Systemic: Fatigue, weight decreased, and generalized weakness.
• Metabolic: Hyperglycemia (high blood sugar) and elevated lipase or amylase levels.
• Cardiac: QT interval prolongation and bradycardia (slow heart rate).

Pregnancy & Lactation

• Pregnancy: Can cause severe fetal harm. Females of reproductive potential must use highly effective non-hormonal contraception during treatment and for at least 6 months following the final dose.
• Lactation: Advise lactating women not to breastfeed during treatment and for at least 2 weeks after the last dose due to safety risks for the infant.

Precautions & Warnings

• Gastrointestinal Toxicity: Severe diarrhea or vomiting can cause dehydration. Dose interruption or reduction may be necessary if standard antidiarrheal treatments fail.
• Hepatotoxicity: Liver function tests (ALT, AST, Bilirubin) must be monitored prior to the start of therapy, every 2 weeks for the first 2 months, and monthly thereafter.
• Hyperglycemia: Monitor fasting blood glucose levels prior to starting Cerixen and periodically during treatment, especially in diabetic patients.
• Pneumonitis/ILD: Monitor for acute onset of unexplained pulmonary symptoms (cough, dyspnea, fever). Permanently discontinue if Interstitial Lung Disease (ILD) is confirmed.
• QT Prolongation: Periodic ECG monitoring and electrolyte checks (potassium, magnesium) are advised, especially in patients with pre-existing cardiac conditions.

Use in Special Populations

• Hepatic Impairment: For patients with severe hepatic impairment (Child-Pugh Class C), a dose reduction of approximately one-third is recommended.
• Pediatric Use: Safety and effectiveness in pediatric patients under 18 years of age have not been established.

Overdose Effects

Overdose may result in severe gastrointestinal distress, elevated liver enzymes, or cardiac arrhythmias (QT prolongation). Treatment involves immediate cessation of the drug and initiating general supportive and symptomatic care.

Storage

• Condition: Store at controlled room temperature (15°C to 30°C).
• Protection: Keep the medication in its original blister packaging or tightly sealed container to protect it from moisture and direct light. Keep out of reach of children.

Supplier Information

Onco Solution is a premier global oncology medicine supplier dedicated to bridging the gap in advanced cancer care. We ensure secure, reliable, and authentic global distribution of breakthrough therapies like Cerixen 150 mg. For medical quotes or wholesale inquiries, visit www.oncosolution.com.

Manufacturer Information

Cerixen 150 mg is manufactured by Everest Pharmaceuticals Ltd., a leading high-tech pharmaceutical company based in Bangladesh, recognized for its strict adherence to international standards in the production of specialized generic oncology medications.