Description
Axinix 1 MG & 5 MG (Axitinib) is an oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) available in two tablet strengths: 1 mg in a 180’s pot and 5 mg in a 60’s pot, manufactured by Beacon Pharmaceuticals Limited and registered in Bangladesh since 08.07.2021. Its active ingredient, axitinib, is a potent and selective second-generation VEGFR-TKI that inhibits all three vascular endothelial growth factor receptors (VEGFR-1, VEGFR-2, and VEGFR-3), the primary molecular drivers of tumor angiogenesis and vasculogenesis in solid tumors, blocking the formation of new tumor blood vessels and starving tumor cells of oxygen and nutrients.
The standard reference-label starting dose of axitinib is 5 mg (one 5 mg tablet) taken orally twice daily approximately 12 hours apart, with or without food, with dose escalation to 7 mg or 10 mg twice daily in eligible patients, and dose reduction to 3 mg or 2 mg twice daily (achieved using the 1 mg tablets) for toxicity management. In the pivotal AXIS Phase 3 trial, axitinib produced a median progression-free survival (PFS) of 6.7 months versus 4.7 months with sorafenib in 723 adults with advanced renal cell carcinoma (RCC) after one prior systemic therapy (hazard ratio 0.665; 95% CI 0.544 to 0.812; p<0.0001), with an objective response rate (ORR) of 19.4% versus 9.4% with sorafenib. In the KEYNOTE-426 Phase 3 trial, axitinib combined with pembrolizumab produced a median PFS of 15.7 months versus 11.1 months with sunitinib (HR 0.68; p<0.0001) and an ORR of 59.3% versus 35.7% in first-line advanced RCC. Searching for Axinix 1 MG & 5 MG Axitinib? Mediaid Pharmacy lists this product within its comprehensive kidney cancer medicines portfolio and ships it worldwide.
Basic Product Information of Axinix 1 MG & 5 MG (Axitinib)
| Brand Name | Axinix 1 MG & 5 MG (Axitinib) |
| Product Name | Axinix (Axitinib) |
| Generic Name | Axitinib INN |
| Drug Class | VEGFR Tyrosine Kinase Inhibitor (TKI), Anti-Angiogenic Targeted Therapy, VEGF Pathway Inhibitor |
| Formulation | Tablet |
| Available Strengths | 1 mg and 5 mg |
| Available Pack Sizes | 180’s Pot (Axinix 1 MG, 180 tablets per pot) and 60’s Pot (Axinix 5 MG, 60 tablets per pot) |
| Primary Indications | Advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy (second-line monotherapy, reference dose 5 mg orally twice daily approximately 12 hours apart, with or without food, continuous schedule). Advanced RCC in combination with pembrolizumab (first-line; KEYNOTE-426) or in combination with avelumab (first-line; JAVELIN Renal 101). The 1 mg tablet supports dose reduction to 3 mg or 2 mg twice daily and dose escalation steps to 7 mg twice daily (combined with 5 mg tablet). The 5 mg tablet supports the standard 5 mg and escalated 10 mg twice-daily doses. |
| Manufacturer | Beacon Pharmaceuticals Limited, Bangladesh |
| Registration Date | 08.07.2021 (Bangladesh) |
| Originator Reference Brand | Inlyta (axitinib) by Pfizer |
| Global Supplier | Mediaid Pharmacy, Worldwide Shipping Available |
| Storage Conditions | Store in a dry place away from light and moisture, at the temperature printed on the pack. Keep out of the reach of children. |
How Axinix 1 MG & 5 MG (Axitinib) Works: VEGFR Inhibition and Anti-Angiogenic Tumor Suppression
Axitinib, the active ingredient in Axinix 1 MG & 5 MG, is a potent, selective, oral inhibitor of vascular endothelial growth factor receptors VEGFR-1, VEGFR-2, and VEGFR-3, the receptor tyrosine kinases that serve as the primary transducers of VEGF-driven tumor angiogenesis signaling in solid tumors including renal cell carcinoma (RCC). Solid tumors, including clear-cell RCC (ccRCC), depend critically on continuous recruitment of new blood vessels through angiogenesis to supply the oxygen and nutrients required for rapid tumor cell proliferation, survival, and metastatic spread.
In RCC, tumor angiogenesis is driven predominantly through constitutive overexpression of vascular endothelial growth factor-A (VEGF-A), VEGF-C, and VEGF-D, which bind their cognate receptors VEGFR-1, VEGFR-2, and VEGFR-3 on the surface of endothelial progenitor cells and established vascular endothelial cells, triggering receptor dimerization, intracellular kinase domain autophosphorylation, and activation of downstream pro-angiogenic signaling cascades including the RAS/MEK/ERK (proliferative), PI3K/AKT (survival), and PLCgamma/PKC (permeability and migration) pathways.
In clear-cell RCC specifically, constitutive VEGF pathway activation is mechanistically driven by biallelic loss-of-function mutation or epigenetic silencing of the von Hippel-Lindau (VHL) tumor suppressor gene, which occurs in approximately 70 to 90% of sporadic ccRCC tumors; loss of VHL protein function prevents ubiquitin-mediated degradation of hypoxia-inducible factors HIF-1 alpha and HIF-2 alpha, allowing HIF to accumulate under normoxic conditions and transcriptionally activate VEGF, PDGF, TGF-alpha, and other pro-angiogenic target genes at high levels continuously, establishing a constitutive pseudohypoxic state that drives relentless tumor vascularization regardless of tissue oxygen availability.
A VEGFR tyrosine kinase inhibitor (VEGFR-TKI) is a targeted oncology drug class that competitively occupies the ATP-binding cleft of the VEGFR kinase domains, preventing ATP binding, blocking receptor autophosphorylation, and suppressing downstream angiogenic signaling cascades. Axitinib inhibits VEGFR-1, VEGFR-2, and VEGFR-3 with half-maximal inhibitory concentrations (IC50) of 0.1, 0.2, and 0.1 to 0.3 nM respectively, making it one of the most potent VEGFR inhibitors in clinical use, with approximately 50- to 450-fold greater selectivity for the VEGFR kinases relative to all other kinase targets tested, including PDGFR alpha, PDGFR beta, and c-Kit, which are secondary targets inhibited at higher axitinib concentrations.
Axinix 1 MG & 5 MG provides oncology teams with the complete axitinib tablet dose range required to execute the full axitinib dosing algorithm across the standard starting dose, dose escalation, and dose reduction ladder as specified in the reference label. The Axinix 5 MG tablet is the foundational dose unit: the reference-label starting dose of 5 mg (one tablet) twice daily approximately 12 hours apart, with or without food, is delivered by the 5 mg pot; dose escalation to 10 mg twice daily (two 5 mg tablets per dose) also uses the 5 mg tablet. At 5 mg twice daily (two tablets per day), the 60’s pot of Axinix 5 MG provides a 30-day supply, aligning with the standard monthly oncology dispensing cycle.
The Axinix 1 MG tablet in the 180’s pot serves a distinct clinical role: it enables precise dose reduction below 5 mg twice daily and intermediate dose escalation between 5 mg and 10 mg twice daily: 3 mg twice daily (three 1 mg tablets per dose, six tablets per day, 180 tablets = 30-day supply), 2 mg twice daily (two 1 mg tablets per dose, four tablets per day, 180 tablets = 45-day supply), and 7 mg twice daily (one 5 mg tablet plus two 1 mg tablets per dose).
The axitinib dose escalation and reduction algorithm in the AXIS trial was individualized by hypertension and adverse event response, and having both the 1 mg and 5 mg tablet strengths available simultaneously is essential for implementing these dose adjustments without interrupting the continuity of anti-angiogenic therapy. Oncologists managing comprehensive kidney cancer programs can review the complete portfolio of kidney cancer medicines at Mediaid Pharmacy for companion and combination therapy options alongside axitinib.
In the pivotal AXIS Phase 3 randomized, open-label trial, axitinib 5 mg twice daily (with dose escalation permitted per protocol) was compared with sorafenib 400 mg twice daily in 723 adults with advanced RCC who had received and failed one prior systemic therapy (sunitinib, bevacizumab plus interferon-alpha, temsirolimus, or cytokine-based therapy); prior sunitinib was the most common prior regimen (389 of 723 patients). The primary endpoint, independently assessed median PFS, was 6.7 months with axitinib versus 4.7 months with sorafenib (HR 0.665; 95% CI 0.544 to 0.812; p<0.0001).
The PFS benefit was especially pronounced in cytokine-pretreated patients: 12.1 months with axitinib versus 6.5 months with sorafenib (HR 0.464), while in sunitinib-pretreated patients the advantage was 4.8 versus 3.4 months (HR 0.741). ORR was 19.4% with axitinib versus 9.4% with sorafenib (p=0.0001). In the KEYNOTE-426 Phase 3 trial, axitinib 5 mg twice daily combined with pembrolizumab 200 mg intravenously every 3 weeks was compared with sunitinib 50 mg once daily (4 weeks on/2 weeks off) in 861 adults with previously untreated advanced RCC; the combination produced a median PFS of 15.7 months versus 11.1 months with sunitinib (HR 0.68; 95% CI 0.58 to 0.80; p<0.0001) and an ORR of 59.3% versus 35.7%, establishing axitinib plus pembrolizumab as a preferred first-line standard of care for advanced RCC across all International Metastatic RCC Database Consortium (IMDC) risk categories.
Approved Indications of Axitinib (Reference Label for Axinix 1 MG & 5 MG (Axitinib))
Axitinib, the active ingredient in Axinix 1 MG & 5 MG, carries reference-label indications for advanced renal cell carcinoma (RCC) across both second-line monotherapy and first-line combination therapy settings. The 5 mg tablet strength supports the standard 5 mg twice-daily starting dose and the escalated 10 mg twice-daily dose, while the 1 mg tablet strength supports the 7 mg twice-daily escalation level (with the 5 mg tablet) and the 3 mg and 2 mg twice-daily dose reduction levels. Both strengths are required to execute the complete reference-label dose escalation and reduction algorithm without requiring pill splitting. Prescribers should confirm the exact locally approved indications and dose escalation criteria on the Axinix product label and applicable national oncology guidelines before initiating treatment.
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Advanced RCC After One Prior Systemic Therapy: Second-Line Axitinib Monotherapy (5 mg Twice Daily) Indicated for adults with advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy, validated by the AXIS Phase 3 trial (n=723): axitinib 5 mg twice daily produced a median PFS of 6.7 months versus 4.7 months with sorafenib (HR 0.665; 95% CI 0.544 to 0.812; p<0.0001) and an ORR of 19.4% versus 9.4%. Efficacy was most pronounced in prior cytokine-treated patients (median PFS 12.1 months with axitinib vs 6.5 months with sorafenib; HR 0.464). Dose escalation from 5 mg BID to 7 mg BID and then to 10 mg BID is permitted in patients who tolerate the starting dose without any adverse reaction above Grade 2, no antihypertensive therapy required for blood pressure control, and no dose reductions in 2 consecutive weeks. For a comprehensive selection of kidney cancer targeted agents available from Mediaid Pharmacy, browse the kidney cancer medicines collection. |
First-Line Advanced RCC in Combination With Pembrolizumab or Avelumab (Axitinib 5 mg Twice Daily) Axitinib 5 mg twice daily in combination with pembrolizumab 200 mg IV every 3 weeks is indicated for first-line advanced RCC based on KEYNOTE-426 (n=861): median PFS 15.7 months vs 11.1 months with sunitinib (HR 0.68; p<0.0001); ORR 59.3% vs 35.7%; complete response rate 9.9% vs 3.3%. Axitinib 5 mg twice daily in combination with avelumab 800 mg IV every 2 weeks is also indicated for first-line advanced RCC based on JAVELIN Renal 101 (n=886): median PFS 13.8 months vs 7.2 months with sunitinib in the PD-L1-positive population (HR 0.61; p<0.0001); ORR 55.2% vs 25.5% in PD-L1-positive patients. Both combination regimens position axitinib as the anti-angiogenic backbone of immuno-oncology-based first-line RCC doublet strategies. For companion oncology and supportive care medicines, browse the oncology medicines portfolio at Mediaid Pharmacy. |
Key Clinical Benefits of Axinix 1 MG & 5 MG (Axitinib)
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Validated PFS Superiority Over Sorafenib in Second-Line RCC Across All Prior Therapy Subgroups AXIS demonstrated statistically significant PFS improvement with axitinib over sorafenib across all evaluated prior therapy subgroups in second-line advanced RCC. In the overall intent-to-treat population, median PFS was 6.7 versus 4.7 months (HR 0.665; p<0.0001). In the cytokine-pretreated subgroup (n=126 axitinib, n=125 sorafenib), the PFS benefit was most pronounced at 12.1 versus 6.5 months (HR 0.464), representing a more than 5.6-month median PFS advantage; the ORR in this subgroup was 32.5% versus 13.6% with axitinib versus sorafenib. Even in the sunitinib-pretreated subgroup where overall outcomes were more modest, axitinib maintained statistically significant PFS superiority (4.8 vs 3.4 months; HR 0.741), confirming clinically meaningful anti-tumor activity in the post-sunitinib setting where VEGFR-pathway cross-resistance could theoretically diminish axitinib efficacy. |
Transformative ORR of 59.3% as IO-TKI Combination Partner With Pembrolizumab in First-Line RCC KEYNOTE-426 established axitinib plus pembrolizumab as a first-line standard of care for advanced RCC by demonstrating a 59.3% ORR (vs 35.7% with sunitinib), a complete response rate of 9.9% (vs 3.3%), and a median PFS of 15.7 months (vs 11.1 months; HR 0.68; p<0.0001), with benefits observed across all IMDC risk groups (favorable, intermediate, and poor risk) and regardless of PD-L1 expression status. The combination simultaneously delivers VEGFR-mediated anti-angiogenic activity via axitinib, which normalizes tumor vasculature and improves tumor immune infiltration and T-cell trafficking, while pembrolizumab reinvigorates exhausted tumor-infiltrating T-cells by blocking PD-1-mediated immune checkpoint suppression, creating a mechanistically synergistic immuno-oncology plus anti-angiogenic combination that surpasses either monotherapy in the first-line advanced RCC setting. |
Dual-Strength Tablet Range Enables the Complete Axitinib Dose Escalation and Reduction Algorithm Axinix 1 MG and Axinix 5 MG together provide the complete dose range required to implement the full reference-label axitinib dose algorithm without pill splitting or compounding: 2 mg BID (2 x 1 mg tablets per dose), 3 mg BID (3 x 1 mg tablets per dose), 5 mg BID (1 x 5 mg tablet per dose), 7 mg BID (1 x 5 mg tablet plus 2 x 1 mg tablets per dose), and 10 mg BID (2 x 5 mg tablets per dose). The 60’s pot of Axinix 5 MG provides a 30-day supply at the standard 5 mg BID starting dose (two tablets per day), while the 180’s pot of Axinix 1 MG provides a 30-day supply at the most common first dose-reduction level of 3 mg BID (six tablets per day), making both pack sizes clinically aligned with a standard monthly dispensing cycle for uninterrupted continuous RCC therapy. |
Clinical Monitoring Requirements During Axinix 1 MG & 5 MG (Axitinib) Treatment
Blood pressure monitoring and hypertension management are the most critical ongoing safety requirements for axitinib therapy, arising from the pharmacological consequence of VEGFR-2 inhibition in systemic vascular endothelial cells, which reduces nitric oxide production and increases systemic vascular resistance, elevating blood pressure across the entire class of VEGFR-TKIs. The reference label requires blood pressure assessment before initiating axitinib and throughout treatment, and all patients must be well-controlled on antihypertensive therapy before starting axitinib. Blood pressure must be measured at least every 2 weeks during the first 2 months of therapy and monthly thereafter.
A clinically important and well-validated observation in RCC patients treated with VEGFR-TKIs, including axitinib, is that the development of treatment-emergent hypertension is a positive pharmacodynamic biomarker of drug exposure and anti-tumor activity: patients who develop hypertension on axitinib consistently demonstrate longer PFS and OS than normotensive patients, suggesting that hypertension reflects adequate systemic VEGFR inhibition and that antihypertensive management should focus on dose optimization of the antihypertensive rather than dose reduction of axitinib, except in cases of hypertensive urgency or emergency.
Prescribers should use the axitinib dose escalation criteria (no hypertension requiring antihypertensive treatment for 2 consecutive weeks; no adverse events above Grade 2 for 2 consecutive weeks) as a dose-escalation checkpoint, and should reduce the axitinib dose only when blood pressure cannot be controlled medically, per the dose-reduction algorithm (5 mg BID to 3 mg BID using Axinix 1 MG tablets). Thyroid function assessment (TSH and free T4) is mandatory at baseline and every 4 to 6 weeks during axitinib therapy, as hypothyroidism is a class effect of all VEGFR-TKIs, occurring in 19% of axitinib-treated patients in AXIS, and can be managed with standard levothyroxine replacement without requiring axitinib dose modification. Untreated hypothyroidism causes fatigue, weight gain, and cognitive impairment that may be misattributed to axitinib toxicity if thyroid function is not monitored systematically.
Urinary protein monitoring is required throughout axitinib treatment, as proteinuria is a class effect of VEGFR inhibition at glomerular endothelial cells. A spot urine protein-to-creatinine ratio (UPCR) or 24-hour urine protein collection should be performed at baseline and every 4 to 8 weeks during treatment; patients with Grade 2 or higher proteinuria (UPCR greater than 2.0, or 24-hour urine protein greater than 2 g) require dose interruption until recovery to Grade 1 or below, followed by dose reduction on restart.
Liver function tests (ALT, AST, and bilirubin) should be evaluated at baseline and every 4 weeks during the first 8 weeks of treatment, then every 8 weeks thereafter, as asymptomatic transaminase elevation occurs in a subset of patients. Complete blood count (CBC) should be assessed at baseline and every 8 weeks. Clinical evaluation for arterial and venous thromboembolic events (chest pain, shortness of breath, limb swelling, neurological changes) is recommended at every clinic visit because myocardial infarction, stroke, DVT, and PE have all been reported with axitinib; axitinib should not be initiated within 24 hours before or after major surgery, and should be withheld for at least 24 hours before elective procedures, as wound healing complications can occur. Neurological symptoms including headache, seizure, confusion, or visual changes should prompt evaluation for reversible posterior leukoencephalopathy syndrome (RPLS), a rare but serious CNS toxicity associated with VEGFR-TKI class; discontinue axitinib permanently if RPLS is confirmed by MRI.
Drug Interactions and Important Safety Information for Axinix 1 MG & 5 MG (Axitinib)
The most clinically consequential drug interactions for axitinib are mediated through CYP3A4/5 inhibition and induction. Axitinib is primarily metabolized by CYP3A4/5 (approximately 79% of its metabolism), with minor contributions from CYP1A2, CYP2C19, and UGT1A1. Strong CYP3A4 inhibitors (including azole antifungals such as ketoconazole, itraconazole, and voriconazole; macrolide antibiotics such as clarithromycin; ritonavir-containing antiretroviral regimens; and grapefruit or grapefruit juice) significantly increase axitinib plasma exposure and systemic drug concentrations, potentially exacerbating hypertension, proteinuria, hand-foot syndrome, and other VEGFR-TKI toxicities; co-administration with strong CYP3A4 inhibitors should be avoided throughout axitinib therapy.
When co-administration with a strong CYP3A4 inhibitor is clinically unavoidable, the reference label recommends reducing the axitinib dose by approximately 50% (for example, from 5 mg BID to 2 mg BID using two Axinix 1 MG tablets per dose), with subsequent dose adjustment guided by individual tolerability. Strong CYP3A4 inducers (including rifampin, rifabutin, carbamazepine, phenytoin, phenobarbital, and St. John’s Wort) substantially reduce axitinib plasma exposure, potentially rendering therapy sub-therapeutic; co-administration with strong CYP3A4 inducers must be avoided.
If a strong CYP3A4 inducer is clinically unavoidable, the reference label permits a gradual dose escalation of axitinib over several weeks (beyond the 10 mg BID escalated dose in selected patients), though specific dose guidance requires prescriber judgment supported by tolerability monitoring; the strong inducer should be discontinued and axitinib dose returned to its established level as soon as the inducing drug can be safely stopped. Moderate CYP3A4 inhibitors (including fluconazole, diltiazem, verapamil, and erythromycin) may modestly increase axitinib exposure; co-administration requires more frequent blood pressure and toxicity monitoring but does not mandate preemptive dose reduction in most cases.
CYP1A2 inhibitors (including ciprofloxacin, fluvoxamine, and mexiletine) may also increase axitinib plasma concentrations by inhibiting the minor CYP1A2 metabolic pathway; patients co-prescribed strong CYP1A2 inhibitors should be monitored for increased axitinib toxicity signals. Antihypertensive agents represent a clinically important pharmacodynamic interaction category: multiple antihypertensive medications may be required to control axitinib-induced hypertension, and any antihypertensive with CYP3A4 inhibitory potential (amlodipine has weak inhibitory activity; non-dihydropyridine calcium channel blockers diltiazem and verapamil have moderate CYP3A4 inhibitory activity) may modestly increase axitinib exposure alongside their primary antihypertensive effect.
Preferred antihypertensives for axitinib-induced hypertension include ACE inhibitors (e.g., lisinopril), angiotensin receptor blockers (e.g., olmesartan, telmisartan), and dihydropyridine calcium channel blockers (e.g., amlodipine) without significant CYP3A4 inhibitory activity. Food interactions with axitinib are clinically negligible: a high-fat, high-calorie meal modestly increases axitinib Cmax and AUC (within 10 to 20%) compared with the fasted state, but this difference is not considered clinically meaningful; the reference label permits axitinib administration with or without food, and no specific dietary restrictions regarding meal timing or composition are required beyond avoidance of grapefruit or grapefruit juice. Patients must provide a complete medication list to their prescribing oncologist before and throughout Axinix 1 MG & 5 MG treatment. For the complete range of oncology medicines available at Mediaid Pharmacy, visit the oncology medicines category page for companion treatment options.
Side Effects and Precautions of Axinix 1 MG & 5 MG (Axitinib)
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Common Side Effects Diarrhea (the most common adverse event in AXIS, reported in 55% of axitinib-treated patients; dose modification guidance applies for Grade 3 or 4 diarrhea) Hypertension (reported in 40% of axitinib-treated patients in AXIS; mandatory blood pressure monitoring required; treatment-emergent hypertension is associated with improved clinical outcomes) Fatigue and asthenia Decreased appetite and weight loss Nausea and vomiting Dysphonia (hoarseness of voice; occurs due to VEGFR inhibition in laryngeal mucosal vasculature and is a class effect of VEGFR-TKIs) Palmar-plantar erythrodysesthesia (hand-foot syndrome; redness, peeling, pain, and blistering on palms and soles) Hypothyroidism (requires mandatory TSH and free T4 monitoring; managed with levothyroxine replacement without axitinib dose modification in most cases) Constipation, abdominal pain, and stomatitis Proteinuria (requires regular spot urine protein-to-creatinine ratio monitoring) |
Serious Warnings and Precautions Hypertension and hypertensive crisis: blood pressure must be well-controlled before initiation of axitinib and monitored throughout treatment. Grade 4 hypertension (life-threatening hypertensive crisis) requires permanent discontinuation of axitinib. Dose reduction is required for Grade 3 hypertension not responsive to antihypertensive therapy optimization. Administer axitinib with caution in patients with pre-existing cardiovascular disease, uncontrolled hypertension, or recent (within 12 months) cardiovascular events. Arterial thromboembolic events (ATE): myocardial infarction, ischemic stroke, transient ischemic attack, and retinal artery occlusion have been reported in axitinib-treated patients. Use with caution in patients at elevated cardiovascular risk. Permanently discontinue axitinib for Grade 3 or 4 ATE. Venous thromboembolic events (VTE): deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported. Monitor for signs and symptoms of thromboembolism throughout treatment. Discontinue axitinib for life-threatening VTE events. Reversible posterior leukoencephalopathy syndrome (RPLS): cases of RPLS, a rare neurological condition presenting with headache, seizure, confusion, or visual disturbances and confirmed by brain MRI, have been reported. Withhold axitinib and evaluate urgently; permanently discontinue if RPLS is confirmed. Gastrointestinal perforation and fistula: cases of gastrointestinal perforation and fistula formation have been reported. Evaluate patients reporting abdominal pain promptly. Embryo-fetal toxicity: axitinib can cause fetal harm based on its mechanism of action and animal reproductive toxicology data. Females of reproductive potential must use effective contraception during treatment and for at least 1 week after the final dose. Males must use contraception during treatment and for at least 1 week after the last dose. Breastfeeding is not recommended during treatment and for at least 2 days after the final dose. Withhold axitinib for at least 24 hours before elective procedures due to wound healing impairment risk. |
Who Should Use Axinix 1 MG & 5 MG (Axitinib)?
Axinix 1 MG & 5 MG (Axitinib) is indicated for adult patients with advanced renal cell carcinoma (RCC) across two clinical settings. In the second-line setting, axitinib monotherapy at 5 mg twice daily is indicated for adults who have received and failed one prior systemic therapy (sunitinib, bevacizumab plus interferon-alpha, temsirolimus, or cytokine-based therapy), validated in the AXIS Phase 3 trial (median PFS 6.7 months with axitinib vs 4.7 months with sorafenib; HR 0.665; p<0.0001; ORR 19.4% vs 9.4% in 723 patients).
In the first-line setting, axitinib 5 mg twice daily in combination with pembrolizumab is a preferred standard of care across all IMDC risk categories based on KEYNOTE-426 (median PFS 15.7 months; ORR 59.3%; CR rate 9.9%), and axitinib 5 mg twice daily in combination with avelumab is indicated for first-line advanced RCC based on JAVELIN Renal 101 (median PFS 13.8 months in PD-L1-positive population; ORR 55.2%). Before initiating Axinix 1 MG & 5 MG therapy, prescribers must assess blood pressure (requiring good control before starting), TSH and free T4, urinary protein, hepatic function, CBC, and cardiovascular risk factors.
Patients with uncontrolled hypertension, recent (within 12 months) arterial thromboembolism, active gastrointestinal bleeding, or untreated brain metastases should be carefully evaluated before starting axitinib. Both the Axinix 1 MG and Axinix 5 MG strengths should be available to each patient before treatment initiation to enable proactive dose escalation or reduction without delay. Oncologists building comprehensive RCC treatment programs can source companion medicines alongside Axinix through the Mediaid Pharmacy kidney cancer medicines and broader oncology medicines portfolios for consolidated worldwide supply.
Global Supplier: Mediaid Pharmacy Worldwide Shipping for Axinix 1 MG & 5 MG (Axitinib)
Mediaid Pharmacy is a Dhaka-based supplier of oncology and specialty medicines with worldwide shipping. Axinix 1 MG (Axitinib) in a 180’s pot and Axinix 5 MG (Axitinib) in a 60’s pot, manufactured by Beacon Pharmaceuticals Limited in Bangladesh (registration date 08.07.2021), are available at Mediaid Pharmacy, with all orders supported by pricing quotations, stock confirmation, regulatory documentation, and end-to-end delivery tracking. Hospitals, specialist oncology and urology clinics, distributors, and patients can contact the Mediaid Pharmacy team through WhatsApp, phone, or WeChat for all inquiries about Axinix 1 MG & 5 MG Axitinib stock, pricing, and international delivery timelines. Buyers sourcing axitinib for second-line RCC monotherapy programs, first-line axitinib plus pembrolizumab or avelumab combination regimens, or co-sourcing multiple kidney cancer or oncology medicines in a single shipment can browse the complete kidney cancer medicines collection and the broader oncology medicines collection at Mediaid Pharmacy before requesting a consolidated quotation.
Why Choose Axinix 1 MG & 5 MG (Axitinib) from Mediaid Pharmacy?
Axinix 1 MG & 5 MG (Axitinib) provides oncology teams with the complete reference-label axitinib tablet dose range in a single product line: the 5 mg tablet anchors the standard starting dose and maximum escalated dose (5 mg and 10 mg BID respectively), while the 1 mg tablet enables all intermediate escalation and reduction steps (7 mg, 3 mg, and 2 mg BID) that the full axitinib dose algorithm demands. This dual-strength product availability eliminates the need to source two separate products from different suppliers for dose titration management, simplifying pharmacy procurement and inventory management for RCC oncology programs that routinely execute axitinib dose escalation in tolerant patients and dose reduction for VEGFR-TKI toxicity (most commonly hypertension, hand-foot syndrome, and diarrhea).
At the standard 5 mg BID starting dose, the 60’s pot of Axinix 5 MG delivers a precisely aligned 30-day supply; at the most common first reduction level of 3 mg BID, the 180’s pot of Axinix 1 MG also delivers a 30-day supply, ensuring both pack sizes fit standard monthly oncology dispensing cycles. Axinix is manufactured by Beacon Pharmaceuticals Limited, a Bangladesh-registered pharmaceutical company, and has been registered in Bangladesh since 08.07.2021. Mediaid Pharmacy supplies Axinix 1 MG & 5 MG with full product documentation, specialist supply support, and worldwide shipping from Dhaka, with every order beginning from a prescription-based inquiry that aligns supply with clinical need. To co-source companion kidney cancer or oncology medicines alongside Axinix, contact the Mediaid Pharmacy team or browse the kidney cancer medicines section for a personalized worldwide supply quotation.
Frequently Asked Questions About Axinix 1 MG & 5 MG (Axitinib)
What is Axinix 1 MG & 5 MG (Axitinib) used for?
Axinix 1 MG & 5 MG (Axitinib) is an oral VEGFR tyrosine kinase inhibitor (TKI) indicated for advanced renal cell carcinoma (RCC) in two settings. As second-line monotherapy, axitinib 5 mg twice daily is used after failure of one prior systemic therapy, validated in the AXIS Phase 3 trial (median PFS 6.7 months vs 4.7 months with sorafenib; HR 0.665; p<0.0001; ORR 19.4% vs 9.4% in 723 patients). As first-line combination therapy, axitinib 5 mg twice daily is used with pembrolizumab (KEYNOTE-426: median PFS 15.7 months; ORR 59.3%) or with avelumab (JAVELIN Renal 101: median PFS 13.8 months in PD-L1-positive patients). Axitinib inhibits VEGFR-1, VEGFR-2, and VEGFR-3 with IC50 values of 0.1 to 0.3 nM, blocking tumor angiogenesis by suppressing VEGF-driven endothelial cell proliferation, migration, and new blood vessel formation required for tumor growth and metastatic spread in RCC.
What is the generic name of Axinix 1 MG & 5 MG?
The generic name of Axinix 1 MG & 5 MG is axitinib INN. Axinix 1 MG is available in a 180’s pot (180 tablets per pot) and Axinix 5 MG is available in a 60’s pot (60 tablets per pot), both manufactured by Beacon Pharmaceuticals Limited in Bangladesh and registered in Bangladesh since 08.07.2021. The originator reference brand for axitinib is Inlyta, developed and commercialized by Pfizer. Axinix is the brand name assigned to axitinib by Beacon Pharmaceuticals Limited and distributed globally by Mediaid Pharmacy.
How many tablets of Axinix are taken per dose, and what is each strength used for?
The reference-label starting dose is one Axinix 5 MG tablet (5 mg) twice daily. At this dose, the 60’s pot provides a 30-day supply (two tablets per day). The dose escalation and reduction algorithm using both Axinix strengths is as follows: 2 mg BID: two Axinix 1 MG tablets per dose; 3 mg BID: three Axinix 1 MG tablets per dose (180’s pot provides 30 days at this level); 5 mg BID: one Axinix 5 MG tablet per dose; 7 mg BID: one Axinix 5 MG tablet plus two Axinix 1 MG tablets per dose; 10 mg BID: two Axinix 5 MG tablets per dose (60’s pot provides 15 days at this level). Always confirm the exact dose, number of tablets, and dose-escalation criteria with your prescribing oncologist before starting or adjusting treatment.
What is the difference between Axinix (Axitinib) and Inlyta (Axitinib)?
Axinix (axitinib) manufactured by Beacon Pharmaceuticals Limited in Bangladesh and Inlyta (axitinib) manufactured by Pfizer contain the same active ingredient, axitinib INN, at the same 1 mg and 5 mg tablet strengths. Inlyta is the originator brand name approved by the FDA for axitinib. Axinix is the Beacon Pharmaceuticals-branded formulation of axitinib, registered in Bangladesh since 08.07.2021 and distributed globally by Mediaid Pharmacy. The same reference doses, indications, dose escalation and reduction algorithms, and safety monitoring requirements apply to both. Confirm prescribing requirements and local regulatory status with your treating oncologist and the relevant regulatory authority in your country before initiating Axinix therapy.
What are the side effects of Axinix 1 MG & 5 MG (Axitinib)?
Common side effects of axitinib 5 mg twice daily include diarrhea (55% of patients in AXIS), hypertension (40%), fatigue, decreased appetite, nausea, dysphonia (hoarseness), hand-foot syndrome (palmar-plantar erythrodysesthesia), hypothyroidism, vomiting, constipation, abdominal pain, and proteinuria. Serious adverse effects include hypertensive crisis, arterial thromboembolic events (myocardial infarction, stroke, retinal artery occlusion), venous thromboembolic events (DVT, PE), reversible posterior leukoencephalopathy syndrome (RPLS), gastrointestinal perforation and fistula formation, wound healing complications, and embryo-fetal toxicity. Blood pressure monitoring, thyroid function assessment, urinary protein measurement, liver function tests, and cardiovascular risk evaluation are all required throughout treatment. Consult your prescribing oncologist about your individual risk profile before and during treatment with Axinix 1 MG & 5 MG.
Can Axinix 1 MG & 5 MG (Axitinib) be taken with food?
Yes. Axinix 1 MG & 5 MG (Axitinib) may be taken with or without food; no specific meal timing or food restriction applies. A high-fat, high-calorie meal modestly increases axitinib Cmax and AUC within a clinically non-meaningful range, so both fed and fasted administration are acceptable. However, patients should avoid grapefruit or grapefruit juice throughout axitinib therapy, as grapefruit is a strong CYP3A4 inhibitor that significantly increases axitinib plasma exposure and may exacerbate toxicity. Swallow Axinix tablets whole with water; do not crush, split, or chew. Take each dose approximately 12 hours apart to maintain consistent twice-daily plasma drug levels. If a dose is missed, skip the missed dose and take the next dose at the regularly scheduled time; do not double up on a missed dose.
What monitoring tests are required during Axinix 1 MG & 5 MG (Axitinib) treatment?
Blood pressure must be assessed before initiating axitinib, every 2 weeks for the first 2 months of treatment, and monthly thereafter; all patients must have well-controlled blood pressure before starting. Thyroid function tests (TSH and free T4) are required at baseline and every 4 to 6 weeks throughout treatment. Spot urine protein-to-creatinine ratio (UPCR) should be measured at baseline and every 4 to 8 weeks. Liver function tests (ALT, AST, bilirubin) should be evaluated at baseline, every 4 weeks during the first 8 weeks, then every 8 weeks. CBC should be assessed at baseline and every 8 weeks. Cardiovascular risk factors (blood pressure, lipids, glucose) and clinical evaluation for thromboembolic events (limb swelling, chest pain, dyspnea, neurological changes) are recommended at every oncology clinic visit. Your oncology team will specify the precise monitoring schedule based on your clinical status and any dose modifications that occur during treatment.
Is Axinix 1 MG & 5 MG (Axitinib) safe during pregnancy or while breastfeeding?
No. Axitinib can cause fetal harm based on its mechanism of action, which disrupts angiogenesis that is essential for normal placental and fetal vascular development, and based on animal reproductive toxicology studies. Females of reproductive potential must use effective contraception during treatment with Axinix 1 MG & 5 MG and for at least 1 week after the final dose. Males with female partners of reproductive potential must use contraception during treatment and for at least 1 week after the last dose. Breastfeeding is not recommended during axitinib treatment and for at least 2 days after the final dose. Speak with your prescribing oncologist before starting treatment if you are pregnant, planning a pregnancy, or currently breastfeeding.
Can I order Axinix 1 MG & 5 MG (Axitinib) online with worldwide shipping?
Yes. Mediaid Pharmacy supplies Axinix 1 MG & 5 MG (Axitinib) to patients and healthcare providers globally. Contact Mediaid Pharmacy via WhatsApp, phone, or WeChat at +8801773428128, or email info@mediaidpharmacy.com for pricing, current stock availability for both the 1 mg (180’s pot) and 5 mg (60’s pot) strengths, and international delivery details for your country.
Order Axinix 1 MG & 5 MG (Axitinib) with Worldwide Shipping
Phone / WhatsApp / WeChat: +8801773428128 | Email: info@mediaidpharmacy.com
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