Rafinlar® (Dabrafenib) — BRAF Inhibitor for BRAF V600-Mutated Cancers

The Essential BRAF Inhibitor Backbone — Used in Combination With Meqsel (Trametinib) for Dual MAPK Pathway Blockade Across Multiple BRAF V600-Mutated Tumour Types

Rafinlar® (Dabrafenib) is a selective, potent ATP-competitive inhibitor of BRAF kinase — specifically targeting BRAF V600E and V600K mutant kinases — used in combination with Meqsel (Trametinib) as the Dabrafenib + Trametinib dual MAPK pathway blockade regimen for treatment of BRAF V600-mutated unresectable or metastatic melanoma, BRAF V600E-mutated metastatic non-small cell lung cancer (NSCLC), BRAF V600E-mutated locally advanced or metastatic anaplastic thyroid cancer (ATC), and other BRAF V600E-mutated unresectable or metastatic solid tumours after prior therapy.

As the BRAF inhibitor component of the Dabrafenib + Trametinib combination — the most comprehensively evidenced dual MAPK pathway blockade regimen in oncology — Rafinlar directly inhibits the mutant BRAF V600 kinase that constitutively drives MAPK pathway signalling in BRAF-mutated cancers. Combined with Meqsel (Trametinib) — the MEK inhibitor that blocks downstream MAPK pathway reactivation — the Dabrafenib + Trametinib combination provides synergistic and sustained MAPK pathway suppression that significantly outperforms either agent alone across all BRAF V600-mutated indications.

A.K. Pharma is a trusted medicine distributor in Delhi supplying genuine Rafinlar (Dabrafenib) in both 50mg and 75mg capsule strengths alongside Meqsel (Trametinib) — enabling complete procurement of both Dabrafenib + Trametinib combination regimen components from a single distributor. Manufactured by Novartis India Ltd, Rafinlar is an essential precision oncology medicine for BRAF V600-mutated cancers requiring mandatory companion diagnostic BRAF testing before prescribing.

What is Rafinlar (Dabrafenib)?

Rafinlar contains Dabrafenib — a selective, ATP-competitive small molecule inhibitor that targets the BRAF V600E and V600K mutant kinase — blocking its constitutive kinase activity and suppressing downstream MAPK signalling in BRAF-mutated cancer cells.

BRAF V600 Mutations — The Oncogenic Driver:

The BRAF proto-oncogene encodes a serine/threonine kinase that is a critical component of the RAS/RAF/MEK/ERK (MAPK) signalling cascade — controlling cell proliferation, survival, and differentiation in response to growth factor stimulation.

BRAF V600 mutations — most commonly V600E (valine → glutamate substitution at codon 600) and V600K — occur in the BRAF kinase domain activation loop, disrupting the autoinhibitory DFG-in conformation → constitutively active BRAF kinase that drives continuous MEK → ERK signalling independent of upstream RAS activation.

Consequences of constitutive BRAF V600 activation:

• Continuous ERK phosphorylation → continuous transcription factor activation (ETS family, AP-1)
• Continuous cyclin D1 upregulation → CDK4/6 activation → Rb hyperphosphorylation → uncontrolled cell cycle entry
• Continuous anti-apoptotic gene expression (BCL-2, MCL-1) → cancer cell survival
• Continuous tumour cell proliferation → cancer growth, invasion, and metastasis

BRAF V600 Mutation Frequencies:

• Cutaneous melanoma: ~50% (V600E ~80%, V600K ~15-20% of BRAF-mutated)
• Anaplastic thyroid cancer: ~40-60%
• NSCLC (adenocarcinoma): ~2-4%
• Colorectal cancer: ~10%
• Hairy cell leukaemia: ~100%
• Glioma (paediatric): ~15-20%

Dabrafenib vs Vemurafenib — Key Structural Distinctions: Dabrafenib and Vemurafenib are both BRAF V600 inhibitors but differ structurally:

• Dabrafenib preferentially inhibits BRAF V600E and V600K — activity against both the most common BRAF mutations
• Dabrafenib has selectivity advantages in the combination setting — the Dabrafenib + Trametinib combination has the most extensive Phase 3 evidence across multiple tumour types
• Dabrafenib is used exclusively in combination with Trametinib in current clinical practice — monotherapy is obsolete given the dramatically superior combination data

Full prescribing information is available at the FDA label for Dabrafenib.

Clinical Studies and Evidence

COMBI-d Trial (Dabrafenib + Trametinib vs Dabrafenib Monotherapy in Melanoma) Published in the New England Journal of Medicine (2014) with 5-year OS data in The Lancet (2019), COMBI-d was a Phase 3 randomised controlled trial of 423 patients with BRAF V600E/K-mutated unresectable or metastatic melanoma — comparing Dabrafenib + Trametinib vs Dabrafenib + placebo. Key results at 5-year follow-up:

• Progression-free survival — median PFS 11.0 months (combination) vs 8.8 months (Dabrafenib alone) — HR 0.67 — significantly improved
• Overall survival — median OS 25.1 months (combination) vs 18.7 months (Dabrafenib alone) — HR 0.71 — significantly improved
• 5-year OS rate — 27% (combination) vs 22% (Dabrafenib alone)
• 5-year PFS rate — 19% (combination) vs 12% (Dabrafenib alone)
• Established that combining Trametinib with Dabrafenib provides significantly superior PFS and OS vs Dabrafenib alone — making the combination the mandatory approach in BRAF-mutated melanoma

COMBI-v Trial (Dabrafenib + Trametinib vs Vemurafenib in Melanoma) Published in the New England Journal of Medicine (2015) with 5-year OS data, COMBI-v was a Phase 3 randomised controlled trial of 704 patients with BRAF V600E/K-mutated metastatic melanoma — comparing Dabrafenib + Trametinib vs Vemurafenib (BRAF inhibitor monotherapy). Key results:

• Overall survival — median OS 25.6 months (combination) vs 18.0 months (Vemurafenib) — HR 0.66 — significantly improved
• 5-year OS rate — 27% (combination) vs 20% (Vemurafenib)
• PFS — median PFS 12.6 months vs 7.3 months — significantly improved
• Established Dabrafenib + Trametinib as superior to BRAF inhibitor monotherapy — confirming dual MAPK pathway blockade as the standard of care for BRAF V600-mutated metastatic melanoma

Pooled COMBI-d and COMBI-v 5-Year Analysis: The pooled 5-year analysis of 563 patients from both COMBI trials — published in the New England Journal of Medicine (2019) — demonstrated:

• 5-year OS rate — 34% with Dabrafenib + Trametinib
• 5-year PFS rate — 19%
• Patients achieving complete response: 5-year OS 71%, 5-year PFS 49%
• Established that approximately 1 in 3 BRAF V600-mutated metastatic melanoma patients treated with Dabrafenib + Trametinib are alive at 5 years — an unprecedented long-term survival outcome in metastatic melanoma — a disease where 5-year survival was historically <5%

BRF113928 Trial (Dabrafenib + Trametinib in BRAF V600E NSCLC) Published in the New England Journal of Medicine (2017), this Phase 2 trial demonstrated:

• ORR — 64.2% (Dabrafenib + Trametinib) vs 27.2% (Dabrafenib monotherapy)
• Median PFS — 10.9 months (combination) vs 5.5 months (monotherapy)
• Median OS — 18.2 months
• Established Dabrafenib + Trametinib as the first approved targeted therapy for BRAF V600E-mutated NSCLC — a biomarker-defined subset with no prior targeted option

BRF117019 Trial (Dabrafenib + Trametinib in BRAF V600E Anaplastic Thyroid Cancer) Published in the Journal of Clinical Oncology (2018):

• ORR — 69% (Dabrafenib + Trametinib) in BRAF V600E-mutated ATC
• Complete response rate — 38%
• Median OS — 14.5 months — remarkable in ATC where historical median survival was 3-5 months
• Established Dabrafenib + Trametinib as the first approved targeted therapy for BRAF V600E ATC — transforming a rapidly fatal disease

ROAR and NCI-MATCH Basket Trials (Tumour-Agnostic BRAF V600E): These tumour-agnostic basket trials demonstrated Dabrafenib + Trametinib activity across multiple BRAF V600E-mutated solid tumours — including biliary tract cancer, colorectal cancer, glioma, and others — leading to the first tumour-agnostic approval for any BRAF V600E-mutated solid tumour after prior therapy.

Available Strengths

Rafinlar is available in the following capsule strengths:

Standard dose: 150mg (two 75mg capsules) orally twice daily — approximately 12 hours apart — on an empty stomach.

Storage — Critical: Rafinlar capsules must be stored in a refrigerator at 2°C to 8°C — protected from moisture and light. This cold chain storage requirement is the same as Meqsel (Trametinib) — both components of the combination regimen require cold chain management.

Both strengths are available from A.K. Pharma — enabling standard dosing and dose reduction as required for toxicity management.

Indications — What Rafinlar is Used For

BRAF V600E/K-Mutated Unresectable or Metastatic Melanoma:

• In combination with Meqsel (Trametinib) — BRAF V600E or V600K mutation confirmed
• First-line — no prior BRAF or MEK inhibitor therapy
• Dabrafenib + Trametinib is the standard targeted therapy for BRAF V600-mutated metastatic melanoma

BRAF V600E-Mutated Metastatic NSCLC:

• In combination with Meqsel (Trametinib) — BRAF V600E mutation confirmed
• After prior platinum-based chemotherapy (or as first-line per updated indications)

BRAF V600E-Mutated Locally Advanced or Metastatic Anaplastic Thyroid Cancer:

• In combination with Meqsel (Trametinib) — BRAF V600E mutation confirmed
• No satisfactory locoregional treatment options

BRAF V600E-Mutated Unresectable or Metastatic Solid Tumours (Tumour-Agnostic):

• In combination with Meqsel (Trametinib) — BRAF V600E mutation confirmed
• After prior therapy — no satisfactory alternative treatment options

Mandatory BRAF V600 Mutation Testing: BRAF V600 mutation testing by a validated diagnostic test is mandatory before prescribing Rafinlar. BRAF V600E testing is required for all non-melanoma indications. Both V600E and V600K testing is recommended for melanoma (as V600K also responds to Dabrafenib + Trametinib). NGS-based comprehensive genomic profiling is the preferred testing approach.

For detailed indication information refer to MedlinePlus Dabrafenib.

Key Benefits of Rafinlar

34% 5-Year Survival in Metastatic Melanoma — A Historic Achievement The pooled COMBI 5-year analysis demonstrates 34% of BRAF V600-mutated metastatic melanoma patients treated with Dabrafenib + Trametinib are alive at 5 years — compared to historically <5% 5-year survival in metastatic melanoma before targeted therapy. This represents one of the most dramatic improvements in long-term cancer survival ever achieved — transforming metastatic melanoma from a near-uniformly fatal disease to one with meaningful long-term survival for a significant proportion of patients.

Superior to BRAF Inhibitor Monotherapy — Combination is Mandatory COMBI-d and COMBI-v demonstrate that Dabrafenib + Trametinib is significantly superior to Dabrafenib monotherapy and Vemurafenib monotherapy — in PFS, OS, and 5-year survival. BRAF inhibitor monotherapy is now clinically obsolete for BRAF V600-mutated melanoma. Rafinlar should always be used in combination with Meqsel (Trametinib).

Dramatically Reduced Cutaneous Toxicity vs BRAF Monotherapy BRAF inhibitor monotherapy causes paradoxical ERK activation in RAS wild-type keratinocytes → cutaneous squamous cell carcinoma (cuSCC) in 15-20% of patients. Adding Trametinib blocks this paradoxical ERK activation in skin → cuSCC rate falls from 15-20% to <1% with the combination. This is one of the most clinically important safety advantages of the combination over BRAF inhibitor monotherapy.

First Targeted Therapy for ATC — Transforming a Fatal Disease Anaplastic thyroid cancer historically had median survival of 3-5 months with no effective systemic therapy. Dabrafenib + Trametinib achieves 69% ORR and 14.5-month median OS in BRAF V600E ATC — fundamentally changing the natural history of this rapidly fatal cancer.

Tumour-Agnostic Activity — Applicable Across BRAF V600E-Mutated Tumours The tumour-agnostic approval reflects the oncogene-driven nature of BRAF V600 signalling — the same mutation driving the same pathway in melanoma, lung cancer, thyroid cancer, and other solid tumours all respond to the same targeted combination. Rafinlar + Meqsel can be used across any BRAF V600E solid tumour after prior therapy.

Both BRAF and MEK Components Available From A.K. Pharma A.K. Pharma supplies both Rafinlar (Dabrafenib) and Meqsel (Trametinib) — both components of the Dabrafenib + Trametinib combination regimen from a single distributor. This simplifies procurement logistics for oncology centres managing BRAF-mutated cancer patients.

How Rafinlar Works — BRAF Inhibition in BRAF V600-Mutated Cancers

Normal MAPK Pathway Regulation:

Growth factor → receptor tyrosine kinase → RAS activation (RAS-GTP) → RAF kinase recruitment and dimerisation → MEK1/2 phosphorylation → ERK1/2 phosphorylation → nucleus translocation → transcription factor activation → proliferation gene expression → cell cycle entry.

This pathway is tightly regulated — RAS-GTP is quickly hydrolysed to RAS-GDP → pathway is switched off after transient growth factor stimulation.

BRAF V600 Mutation — Constitutive “On” Switch:

BRAF V600E/K mutations destabilise the inactive DFG-out conformation of BRAF → BRAF adopts a constitutively active DFG-in conformation → continuous kinase activity independent of upstream RAS. Mutant BRAF V600 can signal as a monomer (unlike wild-type BRAF which requires dimerisation) — this monomeric signalling is key to the pharmacology of BRAF inhibitors.

Dabrafenib’s Mechanism:

Step 1 — ATP-Competitive BRAF Binding: Dabrafenib binds to the ATP-binding cleft of BRAF V600E/K — with selectivity for the active (DFG-in) conformation stabilised by the V600 mutation. This selective binding for the active mutant conformation (vs the inactive conformation of wild-type BRAF) contributes to Dabrafenib’s selectivity for mutant over wild-type BRAF.

Step 2 — Mutant BRAF Kinase Inhibition: Without ATP binding, mutant BRAF V600 cannot phosphorylate MEK → MEK → ERK signalling cascade is interrupted → ERK phosphorylation falls → ERK-driven transcription of proliferation genes is suppressed.

Step 3 — Cancer Cell Growth Arrest: Without ERK-driven transcription:

• Cyclin D1 expression falls → CDK4/6 activity reduced → Rb hypophosphorylation → G1 cell cycle arrest
• Anti-apoptotic gene expression (BCL-2, MCL-1, BCL-XL) falls → increased apoptosis sensitivity
• VEGF expression falls → anti-angiogenic contribution

The Paradox — Why BRAF Inhibitors Fail as Monotherapy:

Paradoxical MAPK Reactivation (the key resistance mechanism):

• BRAF inhibitors suppress mutant BRAF → initial tumour response
• BRAF inhibition → paradoxically activates wild-type RAS in RAS wild-type cells (through disruption of wild-type RAF negative feedback)
• Activated RAS → drives CRAF dimerisation → CRAF drives MEK → ERK reactivation independent of mutant BRAF → drug resistance
• In BRAF-mutant cancer cells: acquired resistance through RAS mutations, BRAF amplification, BRAF splice variants, MEK mutations, and other mechanisms → ERK reactivation → disease progression

Why Combination With Trametinib (Meqsel) Overcomes This: Adding MEK inhibition (Trametinib) blocks MEK activation regardless of the upstream driver — whether by mutant BRAF (initial driver) or by CRAF-driven paradoxical reactivation (resistance mechanism). This comprehensive MAPK pathway suppression:

• Prevents paradoxical reactivation resistance
• Eliminates paradoxical ERK activation in RAS wild-type keratinocytes (preventing cuSCC)
• Provides synergistic anti-tumour activity through dual pathway blockade
• Significantly extends duration of response and survival vs BRAF inhibitor monotherapy

For detailed mechanism overview refer to ESMO Melanoma Guidelines and NCCN Melanoma Guidelines.

The Dabrafenib + Trametinib Combination — Complete Protocol

At A.K. Pharma both components are available:

Standard Combination Dosing:

• Dabrafenib 150mg orally twice daily — approximately 12 hours apart — on an empty stomach (≥1 hour before or ≥2 hours after food)
• Meqsel (Trametinib) 2mg orally once daily — on an empty stomach — can be taken with the morning or evening Dabrafenib dose
• Both require cold chain storage — refrigerate between 2°C and 8°C

BRAF Testing Before Starting: BRAF V600 mutation testing is mandatory. Appropriate testing platforms:

• Tissue NGS (comprehensive genomic profiling) — preferred; identifies all BRAF V600 variants including V600E and V600K
• COBAS 4800 BRAF V600 Mutation Test — FDA-approved companion diagnostic for melanoma indication
• Liquid biopsy (ctDNA) — if tissue unavailable

Dosage and Administration

Standard Dose:

• Dabrafenib 150mg (two 75mg capsules) orally twice daily — approximately 12 hours apart
• On an empty stomach — at least 1 hour before or 2 hours after a meal
• Swallow capsules whole — do not open, crush, or chew
• Take at approximately the same times each day for consistent drug levels

Dose Reduction Schedule (for toxicity):

• Starting dose: 150mg twice daily
• First reduction: 100mg twice daily (two 50mg capsules)
• Second reduction: 75mg twice daily (one 75mg capsule)
• If 75mg twice daily not tolerated — permanently discontinue

Missed Dose:

• If a dose is missed and it is more than 6 hours until the next scheduled dose — take the missed dose
• If less than 6 hours until next scheduled dose — skip the missed dose

Duration:

• Continue until disease progression or unacceptable toxicity
• Do not interrupt treatment unnecessarily — treatment interruptions allow MAPK pathway reactivation and may accelerate acquired resistance

Monitoring Schedule:

Full dosing guidelines available at Drugs.com Dabrafenib Dosage.

Who Should Use Rafinlar

Rafinlar is prescribed for:

• Adults with BRAF V600E or V600K-mutated unresectable or metastatic melanoma — Dabrafenib + Trametinib — always in combination
• Adults with BRAF V600E-mutated metastatic NSCLC — Dabrafenib + Trametinib
• Adults with BRAF V600E-mutated locally advanced or metastatic anaplastic thyroid cancer — Dabrafenib + Trametinib
• Adults with BRAF V600E-mutated unresectable or metastatic solid tumours after prior therapy — tumour-agnostic indication — Dabrafenib + Trametinib

Pre-Treatment Requirements:

• BRAF V600 mutation confirmation by validated test — mandatory
• Baseline dermatological assessment — for cuSCC monitoring
• Baseline echocardiogram/LVEF — Trametinib-driven cardiac monitoring
• Baseline ophthalmological assessment — for RPED monitoring

Rafinlar is prescribed by medical oncologists, dermatologists (for melanoma), thoracic oncologists, and thyroid cancer specialists. A.K. Pharma supplies Rafinlar alongside Meqsel to hospitals, oncology centres, and pharmacies across Delhi and India.

Possible Side Effects

Common side effects include pyrexia/fever (51% — the most distinctive Dabrafenib-specific side effect), fatigue (41%), nausea (35%), headache (29%), arthralgia (27%), alopecia (24%), palmar-plantar erythrodysaesthesia (22%), and rash (17%).

Dabrafenib-Specific Side Effects:

Pyrexia (Fever) — The Most Common and Distinctive Toxicity: Fever occurs in approximately 51% of patients on Dabrafenib + Trametinib — the most common reason for dose interruption. Fever often occurs within the first few weeks of treatment. Management:

• Withhold Dabrafenib (and Trametinib) at first fever ≥38.5°C
• Investigate for infection (sepsis workup including blood cultures)
• Paracetamol for symptomatic relief
• If fever resolves within 3 days → restart Dabrafenib at same dose; consider prophylactic corticosteroids for recurrent fever
• If severe or recurrent → dose reduce

Cutaneous Squamous Cell Carcinoma (cuSCC): cuSCC occurs in approximately 9-11% of patients on Dabrafenib monotherapy — but drops to <1% with Dabrafenib + Trametinib combination (Trametinib blocks paradoxical ERK activation in skin). Dermatological monitoring every 2 months is mandatory. New skin lesions should be biopsied; cuSCC excised; continue Dabrafenib (cuSCC is managed surgically, not by stopping treatment).

Hyperglycaemia: Blood glucose elevation in approximately 58% of patients — dose-dependent. Monitor blood glucose monthly. Manage with anti-diabetic therapy as needed. Dose reduce or interrupt for severe hyperglycaemia.

Haemorrhage: Major haemorrhagic events reported — predominantly CNS haemorrhage and gastrointestinal haemorrhage. Monitor for signs of bleeding.

Full side effect information available at FDA Dabrafenib Safety Information.

Precautions

• Mandatory BRAF V600 testing — do not prescribe without confirmed BRAF V600E or V600K mutation
• Always combine with Trametinib — Dabrafenib monotherapy is clinically obsolete; Rafinlar must always be prescribed alongside Meqsel (Trametinib)
• Pyrexia management — withhold at first significant fever; infection workup; restart with prophylactic corticosteroids for recurrent fever
• Dermatological monitoring — every 2 months; biopsy any new suspicious skin lesions; new primary melanoma monitoring required
• Cardiac monitoring — echocardiogram every 3 months (Trametinib-driven cardiac toxicity monitoring)
• Ophthalmological monitoring — for RPED; urgent evaluation for any new visual symptoms
• Hyperglycaemia — monthly blood glucose monitoring; manage aggressively in diabetic patients
• Empty stomach requirement — both Dabrafenib and Trametinib require empty stomach administration
• Cold storage — refrigerate at 2°C-8°C — do not leave at room temperature for extended periods
• Strong CYP3A4/CYP2C8 inhibitors — avoid; significantly increase Dabrafenib exposure
• Strong CYP3A4 inducers — avoid; significantly reduce Dabrafenib levels
• Dabrafenib is a CYP3A4/CYP2C9/CYP2C8 inducer — reduces levels of many concomitant medicines; review all co-medications
• Pregnancy — highly teratogenic; effective contraception mandatory during treatment and for 4 months after last dose
• Refer to ESMO Melanoma Guidelines for complete management context

Storage and Handling

• Store in refrigerator between 2°C and 8°C — cold chain required
• Do not freeze
• Protect from moisture — keep tightly closed with desiccant
• Keep in original bottle
• Keep out of reach of children
• Take capsules immediately before administration — do not leave at room temperature for extended periods

As a responsible medicine distributor in Delhi, A.K. Pharma maintains full cold chain requirements during storage and supply of Rafinlar ensuring product integrity for every unit supplied.

Manufacturer Information

Rafinlar (Dabrafenib) is manufactured by Novartis India Ltd — the Indian subsidiary of Novartis AG, which acquired the Dabrafenib and Trametinib portfolio through its acquisition of GlaxoSmithKline’s oncology assets. Dabrafenib received FDA approval in May 2013 for BRAF V600E/K-mutated unresectable or metastatic melanoma. A.K. Pharma supplies only genuine Rafinlar sourced from authorized Novartis distributors.

Related Cancer Medicines Available at A.K. Pharma

• Meqsel (Trametinib) — MEK inhibitor — the essential combination partner for Rafinlar in all BRAF V600-mutated indications
• Zelbaoraf (Vemurafenib) — alternative BRAF inhibitor for BRAF V600E-mutated melanoma
• Tagrisso (Osimertinib) — EGFR inhibitor for EGFR-mutant NSCLC
• Imfinzi (Durvalumab) — anti-PD-L1 immunotherapy for lung cancer
• Browse all Cancer Medicines available at A.K. Pharma

Frequently Asked Questions

Q. What is Rafinlar used for? Rafinlar (Dabrafenib) is used in combination with Meqsel (Trametinib) for BRAF V600E or V600K-mutated unresectable or metastatic melanoma, BRAF V600E-mutated metastatic NSCLC, BRAF V600E-mutated anaplastic thyroid cancer, and other BRAF V600E-mutated solid tumours. BRAF testing is mandatory. More information available at MedlinePlus.

Q. What is the generic name of Rafinlar? The generic name of Rafinlar is Dabrafenib. It is a selective BRAF V600 kinase inhibitor manufactured by Novartis India Ltd — the same active ingredient as the originator Tafinlar.

Q. Can Rafinlar be used without Meqsel (Trametinib)? No — Dabrafenib monotherapy is clinically obsolete. The COMBI-d and COMBI-v trials demonstrate Dabrafenib + Trametinib is significantly superior to Dabrafenib alone in both PFS and OS. Current guidelines mandate the combination for all BRAF V600-mutated indications. Rafinlar should always be prescribed alongside Meqsel (Trametinib). Both are available from A.K. Pharma.

Q. Why does Rafinlar cause fever and how is it managed? Fever (pyrexia) occurs in approximately 51% of patients on Dabrafenib — it is the most distinctive and common side effect, often occurring in the first weeks of treatment. The mechanism is not fully understood but involves inflammatory cytokine release. Management: withhold Dabrafenib at fever ≥38.5°C, perform infection workup, use paracetamol for symptom relief, and restart at the same dose once fever resolves. For recurrent fever, prophylactic corticosteroids before restarting and dose reduction may be needed.

Q. What is the difference between Rafinlar and Zelbaoraf (Vemurafenib)? Both are BRAF V600 inhibitors but Rafinlar (Dabrafenib) is specifically used with Meqsel (Trametinib) as the Dabrafenib + Trametinib combination — the most extensively evidenced dual MAPK blockade regimen with 5-year OS data in melanoma. Zelbaoraf (Vemurafenib) is another BRAF inhibitor for BRAF V600E melanoma and hairy cell leukaemia. Dabrafenib + Trametinib has demonstrated superior OS vs Vemurafenib monotherapy in the COMBI-v trial.

Q. Does Rafinlar need to be stored in a fridge? Yes — Rafinlar (Dabrafenib) requires refrigeration between 2°C and 8°C — the same cold chain requirement as Meqsel (Trametinib). Do not leave at room temperature for extended periods. A.K. Pharma maintains cold chain storage for both Rafinlar and Meqsel throughout storage and supply.

Q. Is BRAF testing required before prescribing Rafinlar? Yes — BRAF V600 mutation testing is mandatory before prescribing Rafinlar. Melanoma requires V600E and V600K testing. All other indications require V600E testing specifically. NGS-based comprehensive genomic profiling is the preferred testing approach. Patients without confirmed BRAF V600 mutations should not receive Dabrafenib.

Q. Is Rafinlar available in India? Rafinlar can be supplied to hospitals, oncology centres, and pharmacies across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi — for availability and pricing.

Q. What is the price of Rafinlar in India? Rafinlar price in India varies by strength (50mg or 75mg) and 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 Rafinlar 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. Please also enquire about Meqsel (Trametinib) when ordering Rafinlar to procure both combination components together.

Q. Does A.K. Pharma supply Rafinlar in bulk? Yes. A.K. Pharma supplies Rafinlar in bulk alongside Meqsel (Trametinib) to oncology centres, hospitals, and pharmacies across Delhi and India. Contact us for bulk pricing and availability.

Why Order Rafinlar from A.K. Pharma?

• Licensed medicine distributor in Delhi with all required drug licenses
• 100% genuine Rafinlar sourced from authorized Novartis distributors
• Cold chain maintained throughout storage and delivery — essential for Dabrafenib
• Both 50mg and 75mg strengths available — complete dose management support
• Available alongside Meqsel (Trametinib) — both Dabrafenib + Trametinib combination components from one supplier
• Bulk supply available for hospitals and oncology centres
• Prompt response to all quote requests
• Serving oncologists and melanoma specialists across Delhi NCR and India

Contact A.K. Pharma for Rafinlar Supply 📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052 📞 011 4172 6999 📱 WhatsApp: +91 9810034827 🌐 akpharma.in