Axitinib Sandoz: Uses, Dosage & Side Effects
A targeted tyrosine kinase inhibitor (TKI) for the treatment of advanced renal cell carcinoma (kidney cancer) after failure of prior systemic therapy
Axitinib Sandoz is a prescription medicine containing axitinib, a potent and selective vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor. It is used to treat advanced renal cell carcinoma (kidney cancer) in adults after failure of prior treatment with sunitinib or a cytokine-based therapy. Axitinib works by blocking the blood supply to tumors, thereby slowing cancer growth. Axitinib Sandoz is a generic version of the originator product Inlyta and is available as film-coated tablets in four strengths. It is taken orally twice daily and requires careful monitoring of blood pressure and thyroid function throughout treatment.
Quick Facts: Axitinib Sandoz
Key Takeaways
- Axitinib Sandoz contains axitinib, a targeted VEGFR tyrosine kinase inhibitor that blocks tumor blood vessel formation to slow cancer growth in advanced renal cell carcinoma (kidney cancer).
- It is used as a second-line treatment in adults when prior therapy with sunitinib or a cytokine has failed, and is increasingly used in combination with immune checkpoint inhibitors as first-line therapy for advanced RCC.
- Blood pressure must be well-controlled before starting and monitored regularly during treatment, as hypertension is among the most common and clinically significant side effects.
- Strong CYP3A4 inhibitors (e.g., ketoconazole) and inducers (e.g., rifampicin, St. John’s Wort) can significantly alter axitinib levels and should be avoided or used with extreme caution.
- Women of childbearing potential must use effective contraception during treatment and for at least one week after the last dose; the drug must not be used during pregnancy or breastfeeding.
What Is Axitinib Sandoz and What Is It Used For?
Axitinib Sandoz contains the active substance axitinib, a second-generation tyrosine kinase inhibitor (TKI) that specifically targets the vascular endothelial growth factor receptor (VEGFR) family. VEGF signaling is one of the most important pathways through which tumors develop their own blood supply, a process known as angiogenesis. Without adequate blood vessels, tumors cannot grow beyond a few millimeters in diameter because they cannot receive sufficient oxygen and nutrients. By blocking VEGFR-1, VEGFR-2, and VEGFR-3, axitinib effectively shuts down tumor-driven angiogenesis and starves the cancer of its blood supply.
Among the three VEGF receptors, VEGFR-2 is the primary mediator of VEGF-induced endothelial cell proliferation, survival, and migration. Axitinib is approximately 50 to 450 times more potent at inhibiting VEGFR-2 compared with first-generation multi-kinase inhibitors such as sorafenib and sunitinib. This high selectivity for VEGFR means that axitinib has less off-target activity against other kinase pathways, which can translate into a more favorable side effect profile in some patients, though significant toxicities still occur.
Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for approximately 90% of all kidney malignancies. Clear cell RCC, the most prevalent histological subtype, is particularly dependent on VEGF-driven angiogenesis due to frequent inactivation of the von Hippel-Lindau (VHL) tumor suppressor gene, which normally regulates VEGF expression. This biological characteristic makes RCC especially sensitive to anti-VEGF therapies like axitinib.
Axitinib Sandoz is approved by the European Medicines Agency (EMA) for the treatment of advanced renal cell carcinoma in adults after failure of prior treatment with sunitinib or a cytokine-based therapy (such as interleukin-2 or interferon-alpha). In this second-line setting, the pivotal AXIS trial demonstrated that axitinib significantly improved progression-free survival compared with sorafenib (median 6.7 months vs. 4.7 months; hazard ratio 0.665; p < 0.0001). Response rates were also higher with axitinib (19.4% vs. 9.4%).
Beyond the licensed monotherapy indication, axitinib has gained substantial importance in recent years as a combination partner with immune checkpoint inhibitors. The combinations of axitinib with pembrolizumab (KEYNOTE-426 trial) and axitinib with avelumab (JAVELIN Renal 101 trial) have been approved as first-line treatments for advanced RCC and have demonstrated superior overall survival and progression-free survival compared with sunitinib monotherapy. These combination regimens have become standard-of-care options for previously untreated advanced RCC according to ESMO and NCCN guidelines.
Axitinib Sandoz is a generic version of the originator product Inlyta (developed by Pfizer). It has been approved after demonstrating bioequivalence with Inlyta, meaning it is absorbed and acts in the body in the same way. Other approved generic versions include Axitinib Teva, Axitinib Accord, and Axitinib STADA. All contain the same active substance and are expected to produce the same clinical effects.
What Should You Know Before Taking Axitinib Sandoz?
Before starting treatment with Axitinib Sandoz, your healthcare provider will conduct a thorough medical evaluation to identify any conditions that could affect the safety of treatment. This typically includes baseline blood pressure measurements, blood tests to check thyroid function, liver function, kidney function, and blood cell counts, as well as a review of your complete medication list. Understanding the precautions associated with this medicine helps ensure safe and effective treatment.
Contraindications
You must not take Axitinib Sandoz if you are allergic (hypersensitive) to axitinib or to any of the other ingredients in this medicine. These include microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), red iron oxide (E172), and triacetin. If you think you may be allergic, consult your doctor before starting treatment. If you have been told by your doctor that you have an intolerance to certain sugars (such as lactose), contact your doctor before taking this medicine, as the tablets contain lactose monohydrate.
Warnings and Precautions
Talk to your doctor or nurse before taking Axitinib Sandoz if any of the following apply to you:
- High blood pressure (hypertension): Axitinib can significantly increase blood pressure. Your blood pressure must be measured before starting treatment and monitored regularly throughout. If you already have hypertension, your doctor should ensure it is well controlled before initiating Axitinib Sandoz. You may be prescribed antihypertensive medications to manage blood pressure during treatment. Hypertensive crisis (dangerously high blood pressure) has been reported and requires immediate medical attention.
- Thyroid problems: Axitinib can cause thyroid dysfunction, most commonly hypothyroidism (underactive thyroid). Your thyroid function should be tested before starting treatment and monitored regularly. Tell your doctor if you feel more tired than usual, feel cold, or notice that your voice becomes deeper. If your thyroid is not producing enough hormones, you may need thyroid hormone replacement therapy.
- Blood clots (thromboembolic events): Arterial and venous thromboembolic events, including stroke, heart attack, pulmonary embolism, and deep vein thrombosis, have been reported. Seek emergency medical attention immediately if you experience chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, headache, vision changes, or dizziness.
- Bleeding: Axitinib can increase the risk of hemorrhage. Tell your doctor immediately if you experience any bleeding or if you cough up blood or blood-tinged sputum during treatment.
- Aneurysm or artery wall tears: Treatment with VEGFR inhibitors may promote the formation of aneurysms (enlargement and weakening of a blood vessel wall) or arterial dissections (tears in the artery wall), potentially leading to rupture and death. Tell your doctor if you have ever had an aneurysm or an arterial wall tear.
- Gastrointestinal perforation and fistula: Axitinib can increase the risk of developing a hole (perforation) in the stomach or intestines, or a fistula (an abnormal connection between body cavities or to the skin). Tell your doctor immediately if you experience severe or persistent abdominal pain.
- Wound healing complications: Your doctor should stop Axitinib Sandoz at least 24 hours before a planned surgery, as it can impair wound healing. Treatment can be restarted once the wound has healed adequately.
- Posterior reversible encephalopathy syndrome (PRES): This rare neurological condition has been reported. Seek immediate medical attention if you develop headache, confusion, seizures, or visual disturbances, with or without high blood pressure.
- Liver problems: Your doctor should monitor your liver function with blood tests before and during treatment with Axitinib Sandoz. Tell your doctor if you develop yellowing of the skin or eyes, dark urine, or unusual fatigue.
- Heart failure: Axitinib can increase the risk of cardiac events. Your doctor should monitor you for signs and symptoms of heart failure, such as excessive tiredness, swollen abdomen, swollen legs or ankles, shortness of breath, or distended neck veins.
Call your local emergency number or go to the nearest emergency department immediately if you experience: severe chest pain or pressure, sudden severe headache, difficulty breathing, sudden weakness or numbness on one side of your body, seizures, confusion, severe abdominal pain, or coughing up blood.
Children and Adolescents
Axitinib Sandoz is not recommended for use in children and adolescents under 18 years of age. This medicine has not been studied in the pediatric population and its safety and efficacy have not been established in this age group.
Pregnancy and Breastfeeding
Axitinib Sandoz may cause harm to an unborn baby. You must not take this medicine during pregnancy. If you are pregnant, think you may be pregnant, or are planning to become pregnant, talk to your doctor before taking this medicine. Women of childbearing potential must use a reliable method of contraception during treatment and for at least one week after the last dose to prevent pregnancy.
You must not breastfeed while taking Axitinib Sandoz. If you are breastfeeding, your doctor will discuss with you whether to stop breastfeeding or to stop treatment with this medicine, taking into account the importance of the medicine for your health.
Driving and Using Machines
If you feel dizzy or tired during treatment with Axitinib Sandoz, take special care when driving or using machines. You are responsible for assessing whether you are fit to drive or perform tasks that require alertness. The effects and side effects of this medicine may affect your ability to do so.
How Does Axitinib Sandoz Interact with Other Drugs?
Axitinib is extensively metabolized in the liver, primarily by the cytochrome P450 enzyme CYP3A4/5, and to a lesser extent by CYP1A2, CYP2C19, and UGT1A1. Because of this metabolic pathway, many commonly used medicines can interact with axitinib, either by increasing its blood levels (potentially causing more side effects) or by decreasing its levels (potentially reducing its effectiveness). It is essential that you tell your doctor, pharmacist, or nurse about all medicines you are taking, including prescription medicines, over-the-counter medications, vitamins, and herbal products.
Medicines That May Increase Side Effects (CYP3A4 Inhibitors)
The following medicines can inhibit the CYP3A4 enzyme and increase axitinib blood levels, which may lead to more severe or frequent side effects. Your doctor may need to reduce your dose of axitinib if you need to take any of these medicines:
| Drug | Category | Used For | Risk Level |
|---|---|---|---|
| Ketoconazole | Antifungal | Fungal infections | High |
| Itraconazole | Antifungal | Fungal infections | High |
| Clarithromycin | Antibiotic | Bacterial infections | High |
| Erythromycin | Antibiotic | Bacterial infections | High |
| Telithromycin | Antibiotic | Bacterial infections | High |
| Ritonavir | Antiviral | HIV/AIDS | High |
| Atazanavir | Antiviral | HIV/AIDS | High |
| Nefazodone | Antidepressant | Depression | High |
Medicines That May Reduce Effectiveness (CYP3A4 Inducers)
The following medicines can induce the CYP3A4 enzyme and decrease axitinib blood levels, potentially making the treatment less effective. These medicines should generally be avoided during treatment with Axitinib Sandoz. Your doctor may consider alternative medications or adjust your treatment accordingly:
| Drug | Category | Used For | Risk Level |
|---|---|---|---|
| Rifampicin | Anti-tuberculosis | Tuberculosis (TB) | High |
| Rifabutin | Anti-tuberculosis | Tuberculosis (TB) | High |
| Phenytoin | Antiepileptic | Seizures / Epilepsy | High |
| Carbamazepine | Antiepileptic | Seizures / Epilepsy | High |
| Phenobarbital | Antiepileptic | Seizures / Epilepsy | High |
| Dexamethasone | Corticosteroid | Various inflammatory conditions | Moderate |
| St. John’s Wort | Herbal supplement | Mild depression / Anxiety | High |
Additionally, Axitinib Sandoz may increase the side effects associated with theophylline, which is used to treat asthma and other lung conditions. If you take theophylline, tell your doctor, as your theophylline dose may need to be adjusted.
Do not eat grapefruit or drink grapefruit juice while taking Axitinib Sandoz. Grapefruit inhibits CYP3A4 and can increase axitinib blood levels, leading to a higher risk of side effects. This applies to all grapefruit products, including fresh fruit, juice, and grapefruit-containing supplements.
What Is the Correct Dosage of Axitinib Sandoz?
Always take Axitinib Sandoz exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The treatment plan is individualized for each patient based on tolerability, blood pressure response, and overall clinical status. Your oncologist will monitor you regularly and may adjust the dose at scheduled visits.
Adults
Standard Adult Dosage
Starting dose: 5 mg taken orally twice daily (10 mg total daily dose)
Administration: Swallow tablets whole with a glass of water, with or without food. Take doses approximately 12 hours apart (e.g., morning and evening).
Dose escalation: Your doctor may increase the dose to 7 mg twice daily and subsequently to a maximum of 10 mg twice daily if you tolerate the starting dose well (no adverse reactions above grade 2, blood pressure is not above 150/90 mmHg, and you are not on antihypertensive medication).
Dose reduction: Your doctor may reduce the dose to 3 mg twice daily or 2 mg twice daily if needed due to side effects. Treatment may be temporarily interrupted if necessary.
The dose adjustment strategy for axitinib is an important aspect of treatment optimization. Unlike many other oncology medications where dose reductions are the primary management tool, axitinib has a defined dose escalation protocol. Clinical data suggest that patients who tolerate the starting dose without significant toxicity may benefit from dose increases, as higher drug exposure has been associated with improved treatment outcomes. Your doctor will evaluate you for potential dose escalation based on specific clinical criteria at each visit.
Special Populations
Hepatic Impairment
No dose adjustment is required for patients with mild hepatic impairment (Child-Pugh class A). For patients with moderate hepatic impairment (Child-Pugh class B), the starting dose should be reduced to approximately half (e.g., 2–3 mg twice daily). Axitinib has not been studied in patients with severe hepatic impairment (Child-Pugh class C) and should not be used in this population.
Renal Impairment
No dose adjustment is required for patients with renal impairment, including those with mild, moderate, or severe impairment. However, caution is advised, and your doctor will monitor your kidney function during treatment.
Elderly Patients
No specific dose adjustment is required for elderly patients. However, patients aged 65 years and older may be more susceptible to certain side effects, and careful monitoring is recommended. Your doctor will individualize the dose based on your overall health status and tolerability.
Missed Dose
If you forget to take a dose of Axitinib Sandoz, take your next dose at the usual scheduled time. Do not take a double dose to make up for a missed tablet. If you vomit after taking your dose, do not take an additional tablet — simply wait and take your next dose at the regularly scheduled time.
Overdose
If you take more Axitinib Sandoz than you should, or if someone else accidentally takes your medicine, contact your doctor, hospital, or poison control center immediately for an assessment of the risk and advice. Show this product information to the doctor if possible. You may require medical monitoring and supportive care. There is no specific antidote for axitinib overdose.
If you feel you no longer need this medicine or if you are unable to take it as prescribed, contact your doctor immediately. Do not stop treatment on your own, as this could affect the course of your disease.
What Are the Side Effects of Axitinib Sandoz?
Like all medicines, Axitinib Sandoz can cause side effects, although not everybody gets them. Some side effects may be serious and require prompt medical evaluation. Your oncologist will monitor you for side effects at regular visits and may adjust your dose or prescribe additional medications to manage them. It is important to report any new or worsening symptoms to your healthcare team promptly.
Contact your doctor immediately if you experience any of the following: signs of heart failure (excessive tiredness, swollen abdomen or legs, shortness of breath, distended neck veins), blood clots (chest pain, shortness of breath, numbness or weakness on one side of the body, difficulty speaking), significant bleeding (black tarry stools, coughing up blood, changes in mental status), severe abdominal pain (possible perforation or fistula), very high blood pressure (severe headache, chest pain), or neurological symptoms (headache, confusion, seizures, visual disturbances suggesting PRES).
Very Common
- High blood pressure or increased blood pressure
- Diarrhea, nausea, vomiting, abdominal pain, indigestion, mouth pain, tongue soreness, sore throat, constipation
- Shortness of breath, cough, hoarseness
- Fatigue, weakness, tiredness
- Underactive thyroid (hypothyroidism — detected in blood tests)
- Redness and swelling of palms or soles (hand-foot syndrome / palmar-plantar erythrodysesthesia), skin rash, dry skin
- Joint pain, pain in hands or feet
- Decreased appetite
- Protein in the urine (proteinuria — detected in urine tests)
- Weight loss
- Headache, taste changes or loss of taste
Common
- Dehydration
- Kidney failure
- Flatulence, hemorrhoids, bleeding gums, rectal bleeding, burning or stinging sensation in the mouth
- Overactive thyroid (hyperthyroidism — detected in blood tests)
- Sore throat or nose, throat irritation
- Muscle pain
- Nosebleeds
- Itching, skin redness, hair loss
- Ringing in the ears (tinnitus)
- Decreased red blood cells (anemia), decreased platelets (thrombocytopenia)
- Red blood cells in urine (hematuria)
- Changes in blood chemistry / enzyme levels
- Increased red blood cells (polycythemia)
- Heart failure events (swollen abdomen, legs, ankles, shortness of breath, distended neck veins)
- Fistula (abnormal connection between body cavities or to the skin)
- Dizziness
- Inflammation of the gallbladder (cholecystitis)
Uncommon
- Decreased white blood cells (leukopenia — detected in blood tests)
Not Known
- Aneurysm (enlargement and weakening of a blood vessel wall) or arterial dissection (tear in an artery wall)
If you notice any side effects not listed here, or if any of the side effects become serious, please tell your doctor, pharmacist, or nurse. You can also report side effects directly through your national pharmacovigilance reporting system. By reporting side effects, you help provide more information on the safety of this medicine.
How Should You Store Axitinib Sandoz?
Proper storage of Axitinib Sandoz is essential to ensure the medicine remains effective and safe to use throughout its shelf life. Incorrect storage conditions can degrade the active substance and potentially reduce its therapeutic effect or introduce safety concerns.
- Keep out of reach of children: Store this medicine in a place where children cannot see or reach it.
- Check the expiry date: Do not use this medicine after the expiry date (EXP) printed on the carton and blister packaging. The expiry date refers to the last day of the stated month.
- Store in the original packaging: Keep the tablets in the original blister packaging to protect them from moisture. Axitinib is moisture-sensitive, and exposure to humidity can affect tablet quality.
- Inspect before use: Do not use a package that is damaged or shows signs of tampering.
- Disposal: Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help to protect the environment.
If you have any questions about the storage of your medicine, ask your pharmacist for guidance. During treatment, it is helpful to keep your medicine in a consistent, dry location and to check your supply regularly to ensure you do not run out unexpectedly, as interrupting cancer treatment may affect your outcomes.
What Does Axitinib Sandoz Contain?
Understanding the composition of your medicine is important, particularly if you have known allergies or intolerances to specific ingredients. Axitinib Sandoz film-coated tablets are available in four strengths to allow for individualized dosing and dose adjustments during treatment.
| Strength | Appearance | Imprint | Pack Sizes |
|---|---|---|---|
| 1 mg | Red, round | A7TI / 1 | 14, 28, 56, 56 × 1, 60 tablets |
| 3 mg | Red, oval | A7TI / 3 | 14, 28, 56, 56 × 1 tablets |
| 5 mg | Red, oval | A7TI / 5 | 14, 28, 56, 56 × 1, 60 tablets |
| 7 mg | Red, oval | A7TI / 7 | 14, 28, 56, 56 × 1 tablets |
Other ingredients (excipients): microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), red iron oxide (E172), and triacetin.
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. This medicine also contains less than 1 mmol (23 mg) sodium per film-coated tablet, meaning it is essentially sodium-free.
Not all pack sizes may be marketed in your country. The marketing authorization holder is Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark.
Frequently Asked Questions About Axitinib Sandoz
Axitinib Sandoz is used to treat advanced renal cell carcinoma (kidney cancer) in adults when a previous treatment with sunitinib or a cytokine-based therapy is no longer effective at preventing disease progression. Axitinib belongs to a class of drugs called tyrosine kinase inhibitors (TKIs) that work by blocking the growth of new blood vessels that tumors need to grow. It is also used in combination with immune checkpoint inhibitors as first-line therapy for advanced RCC.
The most common side effects (affecting more than 1 in 10 patients) include high blood pressure, diarrhea, nausea, vomiting, fatigue, decreased appetite, weight loss, hand-foot syndrome (redness and soreness of palms and soles), skin rash, dry skin, joint pain, headache, hoarseness, and underactive thyroid (hypothyroidism). Blood pressure should be monitored regularly during treatment, and your doctor may prescribe medications to manage these side effects.
Yes, Axitinib Sandoz can be taken with or without food. Swallow the tablets whole with a glass of water. However, you must avoid grapefruit and grapefruit juice during treatment, as grapefruit can increase axitinib levels in the blood and lead to more severe side effects. Take your doses approximately 12 hours apart for consistent drug levels.
Axitinib Sandoz is a generic version of Inlyta. Both contain the same active ingredient (axitinib) in the same dose and pharmaceutical form. Axitinib Sandoz has been approved after demonstrating bioequivalence with Inlyta, meaning the two medicines are absorbed and act in the body in the same way. Other generic versions include Axitinib Teva, Axitinib Accord, and Axitinib STADA. Your doctor or pharmacist may prescribe any approved axitinib product.
No. Axitinib Sandoz must not be taken during pregnancy because it may harm the unborn baby. Women of childbearing potential must use effective contraception during treatment and for at least one week after the last dose. Breastfeeding must also be stopped during treatment. If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
If you miss a dose, take the next dose at the usual scheduled time. Do not take a double dose to compensate for the missed one. If you vomit after taking your dose, do not take another tablet — simply wait and take the next dose at the regular time. If you are concerned about missed doses or if you frequently forget doses, speak to your doctor or pharmacist about strategies to help you maintain your treatment schedule.
References
- European Medicines Agency (EMA). Axitinib Sandoz – Summary of Product Characteristics. EMA/CHMP, 2024. Available from: www.ema.europa.eu
- U.S. Food and Drug Administration (FDA). Inlyta (axitinib) – Prescribing Information. Pfizer Inc., revised 2024. Available from: www.accessdata.fda.gov
- Rini BI, Escudier B, Tomczak P, et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011;378(9807):1931–1939. doi:10.1016/S0140-6736(11)61613-9
- Rini BI, Plimack ER, Stus V, et al. Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma (KEYNOTE-426). N Engl J Med. 2019;380(12):1116–1127. doi:10.1056/NEJMoa1816714
- Motzer RJ, Penkov K, Haanen J, et al. Avelumab plus axitinib versus sunitinib for advanced renal-cell carcinoma (JAVELIN Renal 101). N Engl J Med. 2019;380(12):1103–1115. doi:10.1056/NEJMoa1816047
- European Society for Medical Oncology (ESMO). Renal Cell Carcinoma: ESMO Clinical Practice Guidelines. Annals of Oncology. 2024.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer. Version 4.2025.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: World Health Organization.
- British National Formulary (BNF). Axitinib. National Institute for Health and Care Excellence (NICE), 2025. Available from: bnf.nice.org.uk
Editorial Team
Medical Oncology Review
Board-certified oncologists specializing in genitourinary malignancies, kidney cancer treatment, and targeted therapy with extensive clinical and research experience.
Clinical Pharmacology Review
Specialist pharmacologists with expertise in anticancer drug interactions, pharmacokinetics, dose optimization, and adverse drug reaction management.
Medical Writing
Experienced medical writers ensuring accuracy, clarity, and accessibility of complex clinical information for patients and caregivers.
Quality Assurance
Independent fact-checking against EMA SmPC, FDA prescribing information, and current ESMO/NCCN clinical practice guidelines.
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