Registered South Africa · SAHPRA

INLYTA 3mg

AXITINIB

48/26/0606 antineoplastic and immunomodulating agents INN generic

What it does

Axitinib is a medication used to treat certain types of cancer by blocking signals that allow cancer cells to grow.

Commonly used for: kidney cancer (renal cell carcinoma)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Sourcing - Kenya only

Registration & product details

Registration no.
48/26/0606
Registration date
2020/05/19
Expiry date
-
Status
Registered
Active ingredient
AXITINIB
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
L01EK - Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors
RxNorm RxCUI
1242999
Manufacturer / MAH
-
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:20:59 · updated 2026-09-16 04:00:43

Drug Interactions

31
Check interactions

Pharmacodynamic Warnings

Axitinib appears in TABLE 4: Drugs with antiplatelet effects

Axitinib appears in TABLE 15: Drugs that cause myelosuppression

Moderate (6)

Axitinib - increases exposure

Cobicistat is predicted to increase the exposure to axitinib. Avoid or adjust dose.

Moderate Study

Axitinib - increases exposure

Idelalisib is predicted to increase the exposure to axitinib. Avoid or adjust dose.

Moderate Study

Axitinib - decreases exposure

Mitotane is predicted to decrease the exposure to axitinib. Avoid or adjust dose. Also see TABLE 15 p. 1520

Moderate Study

Axitinib - decreases exposure

St John’s wort is predicted to decrease the exposure to axitinib. Avoid or adjust dose.

Moderate Study

Axitinib - increases exposure

Clarithromycin is predicted to increase the exposure to axitinib. Avoid or adjust dose.

Moderate Study

Axitinib - decreases exposure

Rifampicin is predicted to decrease the exposure to axitinib. Avoid or adjust dose.

Moderate Study

Unknown (25)

Agomelatine - increases exposure

Axitinibispredictedtoincreasetheexposuretoagomelatine. oTheoretical

Unknown Theoretical

Aminophylline - increases exposure

Axitinibispredictedtoincreasetheexposuretoaminophylline. oTheoretical

Unknown Theoretical

Anaesthetics,local - increases exposure

Axitinib is predicted to increase the exposure to anaesthetics, local (ropivacaine).

Unknown Theoretical

Antipsychotics, Second Generation - increases exposure

Axitinib is predicted to increase the exposure to antipsychotics, second generation (clozapine, olanzapine).

Unknown Theoretical

Axitinib - increases exposure

Dronedarone is predicted to increase the exposure to axitinib.

Unknown Study

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

Axitinib is a medication used to treat certain types of cancer by blocking signals that allow cancer cells to grow.

What it treats

  • kidney cancer (renal cell carcinoma)

How it works

Axitinib works by blocking specific proteins that help tumors grow and survive.

Who it's for

This medicine is usually prescribed for adults with advanced kidney cancer.

Cautions

  • • Be careful if you are taking medications that prevent blood clotting.
  • • Avoid drugs that may reduce bone marrow function.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Axitinib

BNF-referenced

Axitinib is a selective tyrosine kinase inhibitor that primarily targets vascular endothelial growth factor receptors (VEGFR-1, VEGFR-2, and VEGFR-3). It is utilized in the treatment of advanced renal cell carcinoma, particularly after prior systemic treatment failure. Axitinib acts by inhibiting angiogenesis, which is crucial for tumor growth and metastasis.

Indications

  • Advanced renal cell carcinoma after failure of prior systemic treatment

Dosage

Adults: Consult product literature for specific dosing information.

Mechanism of action

Axitinib selectively blocks the tyrosine kinase receptors VEGFR-1, VEGFR-2, and VEGFR-3, leading to reduced angiogenesis and tumor growth.

Pharmacodynamics

Axitinib prevents cancer progression by inhibiting the formation of new blood vessels (angiogenesis) that tumors require for growth and survival. This action effectively restricts the supply of nutrients and oxygen to the tumor, thereby impeding its growth.

Pharmacokinetics

Axitinib is well absorbed following oral administration, with peak plasma concentrations typically reached within 2 to 6 hours. It is extensively metabolized in the liver, primarily by cytochrome P450 enzymes, and has a half-life of approximately 2 to 5 hours. The drug is excreted mainly in feces, with a smaller percentage eliminated through urine.

Contra-indications

  • History of retinal vein occlusion
  • Left ventricular dysfunction (ejection fraction below 50%)
  • Severe hypersensitivity to axitinib or any component of the formulation

Adverse effects

  • Hypertension
  • Fatigue
  • Diarrhea
  • Nausea
  • Vomiting
  • Anorexia
  • Proteinuria
  • Alopecia
  • Anemia
  • Thrombocytopenia
  • Leukopenia
  • Dizziness
  • Dysphonia
  • Dyspnea
  • Gastrointestinal perforation
  • Fistula formation
  • Heart failure
  • Embolism and thrombosis
  • Gastrointestinal hemorrhage
  • Posterior reversible encephalopathy syndrome

Interactions

  • cobicistat+axitinib: Moderate (increases exposure)
  • idelalisib+axitinib: Moderate (increases exposure)
  • mitotane+axitinib: Moderate (decreases exposure)
  • stjohn’swort+axitinib: Moderate (decreases exposure)
  • clarithromycin+axitinib: Moderate (increases exposure)
  • rifampicin+axitinib: Moderate (decreases exposure)
  • axitinib+agomelatine: Unknown (increases exposure)
  • axitinib+aminophylline: Unknown (increases exposure)
  • axitinib+ropivacaine: Unknown (increases exposure)
  • dronedarone+axitinib: Unknown (increases exposure)

Precautions

  • Monitor for hypertension and manage as necessary
  • Monitor for symptoms of gastrointestinal perforation
  • Monitor for symptoms of fistula
  • Monitor for proteinuria before and during treatment
  • Monitor liver function tests before and during treatment
  • Patients should be advised to reduce modifiable risk factors for aneurysm and arterial dissection

Pregnancy

Axitinib should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. It is classified as a Category D agent.

Breast-feeding

It is not known whether axitinib is excreted in human milk

BNF 85 (British National Formulary) p.1081 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Axitinib

PubChem CID 6450551

Molecular formula: C22H18N4OS

Mechanism of action

Axitinib selectively blocks the tyrosine kinase receptors VEGFR-1 (vascular endothelial growth factor receptor), VEGFR-2, and VEGFR-3.

Pharmacodynamics

Axitinib prevents the progression of cancer by inhibiting angiogenesis and blocking tumor growth.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.