Ceritinib 150mg Capsules — ALK Inhibitor for ALK-Positive Metastatic Non-Small Cell Lung Cancer
Spexib® (Ceritinib) — Targeted ALK Inhibitor for Non-Small Cell Lung Cancer
A Sourcing Guide for Hospitals and Oncology Centres
Spexib® (Ceritinib) is a selective inhibitor of anaplastic lymphoma kinase (ALK) indicated, according to the manufacturer’s approved prescribing information, for the treatment of adults with ALK-positive metastatic non-small cell lung cancer (NSCLC). As with all oncology therapies, the decision to prescribe Spexib, including ALK biomarker testing and patient selection, rests entirely with the treating oncologist, in accordance with the approved label. This page provides sourcing and procurement information for hospitals and pharmacies, not clinical or treatment guidance.
As both a trusted medicine distributor in Delhi and a licensed pharmaceutical distributor in Delhi, A.K. Pharma supplies genuine Spexib (Ceritinib) 150mg to hospitals, oncology centres, and pharmacies across India, manufactured by Novartis India Ltd.
Spexib contains Ceritinib, a small-molecule tyrosine kinase inhibitor that selectively targets ALK, a receptor tyrosine kinase implicated in a subset of non-small cell lung cancers.
ALK Rearrangements in NSCLC:
According to published oncology literature, approximately 3 to 5 percent of NSCLC cases harbour a rearrangement involving the ALK gene, most commonly the EML4-ALK fusion. This genetic rearrangement produces a constitutively active fusion protein that drives uncontrolled cell proliferation and survival signalling, independent of normal upstream regulatory control. ALK-positive NSCLC is recognised as a distinct molecular subtype, generally identified through companion diagnostic testing on tumour tissue.
Ceritinib’s Mechanism: By selectively inhibiting the ALK kinase domain, Ceritinib blocks the constitutively active signalling driven by ALK gene rearrangements, according to the manufacturer’s prescribing information. Ceritinib was developed as a next-generation ALK inhibitor, with activity demonstrated in tumours that have progressed on or are intolerant to earlier ALK-targeted therapy, in addition to its use in ALK inhibitor-naive patients per the approved label.
Full prescribing information is available at the FDA label for Ceritinib.
ASCEND-4 Trial (Ceritinib vs Chemotherapy in First-Line ALK-Positive NSCLC)
Published in the Lancet (2017), the ASCEND-4 trial compared first-line Ceritinib against standard platinum-based chemotherapy in patients with previously untreated ALK-positive advanced NSCLC. Key results demonstrated significantly longer progression-free survival with Ceritinib compared to chemotherapy, supporting its use as a first-line treatment option in this molecular subgroup.
ASCEND-5 Trial (Ceritinib in Previously Treated ALK-Positive NSCLC)
Published in the Lancet Oncology (2017), ASCEND-5 evaluated Ceritinib in patients with ALK-positive NSCLC who had previously progressed on chemotherapy and an earlier ALK inhibitor, demonstrating significantly improved progression-free survival compared to chemotherapy in this pretreated population.
Spexib is available as:
| Presentation | Strength |
|---|---|
| Spexib 150mg Capsules | 150mg per capsule |
Dosing regimen, including total daily dose and administration schedule, is determined by the prescribing oncologist in accordance with the approved prescribing information.
ALK-Positive Metastatic Non-Small Cell Lung Cancer:
ALK biomarker testing is required before initiating Spexib therapy, using a validated companion diagnostic test, per the approved prescribing information.
For detailed indication information refer to MedlinePlus Ceritinib.
Demonstrated First-Line Efficacy
The ASCEND-4 trial established Ceritinib’s efficacy compared to standard chemotherapy in treatment-naive ALK-positive NSCLC patients, providing an evidence-based targeted therapy option ahead of chemotherapy in this molecular subgroup.
Option After Progression on Prior ALK Inhibitor Therapy
ASCEND-5 data supports Ceritinib’s use in patients who have progressed on an earlier ALK inhibitor, providing a further treatment option in this setting per the approved label.
Biomarker-Directed Precision Approach
By requiring ALK testing before treatment, Spexib represents a precision oncology approach, directing therapy specifically toward tumours confirmed to carry the relevant molecular alteration.
Dosing of Spexib is determined by the prescribing oncologist according to the approved label. General administration information from the manufacturer’s prescribing information includes:
Monitoring (per manufacturer prescribing information):
Full dosing guidelines are available in the manufacturer’s official prescribing information and should always be followed exactly as directed by the treating oncologist.
Spexib is prescribed by oncologists for:
Spexib is prescribed by oncologists specialising in lung cancer management. A.K. Pharma supplies Spexib to hospitals and oncology centres across Delhi and India.
Common side effects reported in clinical trials include diarrhoea, nausea, vomiting, elevated liver enzymes, fatigue, and abdominal pain.
Serious side effects include:
Hepatotoxicity: Elevated liver enzymes have been reported; liver function monitoring is recommended per the approved prescribing information, particularly during the early treatment period.
Interstitial Lung Disease/Pneumonitis: Severe pulmonary adverse events have been reported with this therapeutic class; prompt evaluation of new or worsening respiratory symptoms is recommended per the approved label.
QT Interval Prolongation: ECG monitoring is recommended per the approved prescribing information, particularly in patients with risk factors or concomitant use of other QT-prolonging medicines.
Hyperglycaemia: Elevated blood glucose has been reported; monitoring is recommended per the approved label, particularly in patients with pre-existing diabetes.
Pancreatitis: Elevated pancreatic enzymes and pancreatitis have been reported; monitoring per the approved prescribing information.
Full side effect information is available at FDA Ceritinib Safety Information.
As a responsible medicine distributor in Delhi, A.K. Pharma stores all oncology medicines including Spexib under manufacturer-recommended conditions ensuring product integrity for every supply.
Spexib (Ceritinib) is manufactured by Novartis India Ltd. Ceritinib received regulatory approval for ALK-positive metastatic NSCLC, both as first-line therapy and for patients previously treated with an ALK inhibitor. A.K. Pharma supplies only genuine Spexib sourced from authorised distributors.
Q. What is Spexib used for?
Spexib (Ceritinib) is used to treat adults with ALK-positive metastatic non-small cell lung cancer, either as first-line therapy or following progression on prior ALK-targeted therapy.
Q. What is the generic name of Spexib?
The generic name of Spexib is Ceritinib, a next-generation ALK inhibitor manufactured by Novartis India.
Q. Why is ALK testing required before starting Spexib?
Spexib is approved specifically for tumours with an ALK gene rearrangement, which drives a distinct molecular subtype of NSCLC. Testing confirms whether a patient’s tumour carries this alteration before treatment is considered.
Q. Can Spexib be used if a patient has already tried another ALK inhibitor?
The ASCEND-5 trial demonstrated efficacy in patients who had previously progressed on chemotherapy and an earlier ALK inhibitor, supporting its use in this pretreated population per the approved label, at the discretion of the treating oncologist.
Q. Is Spexib available in India?
Spexib can be supplied to hospitals and oncology centres across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi and pharmaceutical distributor in Delhi — for availability and pricing.
Q. What is the price of Spexib in India?
Spexib price in India varies by pack size. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.
Q. How to order Spexib from A.K. Pharma?
You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.
Q. Does A.K. Pharma supply Spexib in bulk?
Yes. A.K. Pharma supplies Spexib in bulk to hospitals and oncology centres across Delhi and India.
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Disclaimer: This page is intended for informational and sourcing/procurement purposes only and does not constitute medical or clinical advice. All treatment decisions, including drug selection and dosing, should be made by a qualified healthcare professional in accordance with the approved prescribing information. A.K. Pharma is a licensed medicine distributor and does not provide clinical guidance.
