Grc Jali

 Spexib 150 mg — Detailed Overview Generic Name:

Ceritinib

 Brand Name:

Spexib (marketed by Novartis)

 Drug Class:

ALK (Anaplastic Lymphoma Kinase) Inhibitor
A targeted therapy used in non-small cell lung cancer (NSCLC)

 Indications:

Spexib is indicated for:

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

• Patients whose disease has progressed or who are intolerant to crizotinib (another ALK inhibitor)

It is used after molecular testing confirms the presence of ALK gene rearrangements.

 Mechanism of Action:

• Ceritinib is a second-generation ALK inhibitor.

• It binds to and inhibits ALK (a receptor tyrosine kinase), preventing cancer cell proliferation.

• Effective against crizotinib-resistant ALK mutations.

• Has good CNS penetration, offering benefits in brain metastases.

 Dosage & Administration:

• Typical adult dose:
  150 mg orally once daily
  (Total daily dose = 750 mg, i.e., 5 tablets of 150 mg)

• Should be taken with food to improve absorption and reduce GI toxicity.

• Swallow tablets whole, do not crush or split.

 Adverse Effects:

Common side effects include:

• GI symptoms: Nausea, diarrhea, vomiting, abdominal pain

• Elevated liver enzymes (ALT/AST)

• Hyperglycemia

• Fatigue

• Bradycardia

• Pneumonitis (rare but serious)

• QT interval prolongation on ECG

 Monitoring Parameters:

• Liver function tests (ALT, AST, bilirubin)

• ECG monitoring (QTc interval)

• Blood glucose

• Pancreatic enzymes (amylase, lipase)

• Monitor for GI toxicity and signs of interstitial lung disease

 Storage:

• Store at room temperature (15–30°C)

• Protect from moisture and light

• Keep in original packaging

 Precautions:

• Use effective contraception during treatment and for some time after

• Not recommended during pregnancy or breastfeeding

• Avoid grapefruit juice (can alter blood levels)

 Pricing & Availability:

• High-cost medication

• Available under specialized oncology programs

• May be covered by insurance, government schemes, or patient-assistance programs