Selumetinib 10mg Capsules — MEK Inhibitor for Neurofibromatosis Type 1 Plexiform Neurofibromas
Koselugo® (Selumetinib) — Targeted MEK Inhibitor for NF1-Associated Tumours
A Sourcing Guide for Hospitals, Oncology Centres, and Pharmacies
Koselugo® (Selumetinib) is a selective MEK1/2 inhibitor indicated, according to the manufacturer’s approved prescribing information, for the treatment of paediatric patients with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas not amenable to complete surgical resection. As with all oncology therapies, the decision to prescribe Koselugo rests entirely with the treating oncologist or specialist managing NF1, 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 Koselugo (Selumetinib) 10mg to hospitals, oncology centres, and pharmacies across India.
Koselugo contains Selumetinib, a small-molecule inhibitor that selectively targets MEK1 and MEK2, key kinases in the RAS/RAF/MEK/ERK signalling pathway.
NF1 and the RAS/MAPK Pathway:
According to published oncology and genetics literature, neurofibromatosis type 1 is caused by mutations in the NF1 gene, which normally encodes neurofibromin, a protein that acts as a negative regulator of RAS signalling. When NF1 function is lost, RAS signalling becomes constitutively active, driving downstream activation of the RAF/MEK/ERK (MAPK) pathway. This dysregulated signalling contributes to the formation of plexiform neurofibromas — benign but often disfiguring and functionally significant tumours that grow along nerve sheaths and can cause pain, disfigurement, and functional impairment depending on their location.
Selumetinib’s Mechanism: By selectively inhibiting MEK1/2, Selumetinib blocks a key downstream node of the dysregulated RAS/MAPK pathway characteristic of NF1-associated tumours, according to the manufacturer’s prescribing information, addressing the pathway driving plexiform neurofibroma growth rather than the NF1 mutation directly.
Full prescribing information is available at the FDA label for Selumetinib.
SPRINT Phase II Trial (Selumetinib in Paediatric NF1 Plexiform Neurofibromas)
Published in the New England Journal of Medicine (2020), the pivotal SPRINT trial evaluated Selumetinib in paediatric patients with NF1 and inoperable symptomatic plexiform neurofibromas. Key findings included a substantial proportion of patients achieving a confirmed partial response (defined as a significant reduction in tumour volume), along with reported improvements in pain and quality-of-life measures. This trial formed the basis for regulatory approval, representing the first systemic therapy approved specifically for NF1-associated plexiform neurofibromas.
Koselugo is available as:
| Presentation | Strength |
|---|---|
| Koselugo 10mg Capsules | 10mg per capsule |
Koselugo is also available in other strengths per the manufacturer’s full product range, with dosing calculated according to body surface area by the prescribing physician, in accordance with the approved label.
Neurofibromatosis Type 1 With Symptomatic Plexiform Neurofibromas:
For detailed indication information refer to MedlinePlus Selumetinib.
First Approved Systemic Therapy for NF1 Plexiform Neurofibromas
Prior to Koselugo’s approval, treatment options for inoperable symptomatic plexiform neurofibromas were limited, with surgery often not feasible given tumour location or extent. Koselugo represented a new systemic treatment pathway for this population.
Meaningful Tumour Response Demonstrated in Trials
The SPRINT trial demonstrated durable partial responses in a substantial proportion of treated patients, along with patient-reported improvements in pain and quality of life, providing an evidence-based option for a historically difficult-to-treat condition.
Targets the Underlying Pathway Biology
By inhibiting MEK1/2 downstream of the dysregulated RAS signalling caused by NF1 mutations, Koselugo addresses a core driver of plexiform neurofibroma growth rather than only managing symptoms.
Dosing of Koselugo is determined by the prescribing physician according to the approved label, based on body surface area. 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 physician.
Koselugo is prescribed by oncologists and NF1 specialists for:
Koselugo is prescribed by specialists managing neurofibromatosis type 1 and associated tumours. A.K. Pharma supplies Koselugo to hospitals and oncology centres across Delhi and India.
Common side effects reported in clinical trials include vomiting, rash, abdominal pain, diarrhoea, nausea, and elevated creatine phosphokinase.
Serious side effects include:
Cardiomyopathy: MEK inhibitors as a class are associated with reduced left ventricular ejection fraction; cardiac monitoring, including echocardiograms, is recommended per the approved prescribing information before and during treatment.
Ocular Toxicity: Visual disturbances, including retinal vein occlusion and retinal pigment epithelial detachment, have been reported with this therapeutic class; ophthalmologic examination is recommended per the approved label.
Gastrointestinal Toxicity: Diarrhoea and vomiting have been reported, with management guidance provided in the approved prescribing information.
Skin Toxicity: Rash and other dermatological reactions have been reported as common adverse events in clinical trials.
Full side effect information is available at FDA Selumetinib Safety Information.
As a responsible medicine distributor in Delhi, A.K. Pharma stores all oncology medicines including Koselugo under manufacturer-recommended conditions ensuring product integrity for every supply.
Koselugo (Selumetinib) is manufactured by AstraZeneca, in collaboration with Merck & Co. Selumetinib received regulatory approval as the first systemic therapy for paediatric NF1 patients with symptomatic, inoperable plexiform neurofibromas. A.K. Pharma supplies only genuine Koselugo sourced from authorised distributors.
Q. What is Koselugo used for?
Koselugo (Selumetinib) is used to treat paediatric patients with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas that cannot be completely surgically removed.
Q. What is the generic name of Koselugo?
The generic name of Koselugo is Selumetinib, a selective MEK1/2 inhibitor.
Q. How does Koselugo work for NF1-associated tumours?
Koselugo inhibits MEK1/2, blocking a key part of the RAS/MAPK signalling pathway that becomes overactive due to NF1 gene mutations, which is understood to drive the growth of plexiform neurofibromas.
Q. Is Koselugo used in adults?
Koselugo’s approved indication, per its current prescribing information, is specifically for paediatric patients with NF1 and symptomatic plexiform neurofibromas; use in other populations would be determined by the treating specialist based on the approved label.
Q. Is Koselugo available in India?
Koselugo 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 Koselugo in India?
Koselugo 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 Koselugo 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 Koselugo in bulk?
Yes. A.K. Pharma supplies Koselugo 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.
