Inlyta (Axitinib) – RCC | HongKong DengYue Medicine

Axitinib Application Scope

Axitinib is a selective second-generation tyrosine kinase inhibitor that targets VEGF receptors; its primary clinical use is for advanced/metastatic renal cell carcinoma where it is given orally to inhibit tumour angiogenesis and growth.

Axitinib Characteristics

• Ingredients:

  • Active ingredient: Axitinib (amount per tablet depends on strength — 1 mg or 5 mg).

  • Inactive ingredients: typical tablet excipients (microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, film-coating components such as hypromellose, titanium dioxide, iron oxides etc.; see local label for exact composition).

• Properties:​ Film-coated tablet (red tablets for some brands like INLYTA); appearance and excipient list per local product label.

• Packaging Specification:​ Common presentations: 1 mg tablets (various pack sizes) and 5 mg tablets (various pack sizes). Packaging format (blister, bottle, counts) depends on market. See carton/label for exact pack.

• Storage:​ Store at below 30 °C (or as stated on the local label); protect from moisture. For INLYTA in many markets store at Room Temperature per label; follow the local carton instruction.

•  Expiry Date: Refer to the expiry date printed on the carton/vial; typical shelf life on labels is 36 months (confirm on packaging).

• Executive Standard:  ​Product is manufactured to applicable pharmacopeial/industry standards and local registration standards (e.g., JX / registration standard in importer documents). See local registration documents for the exact executive standard identifier.

• Approval Number: Varies by market. Example recent domestic registration (China) for an axitinib product has approval/registration identifiers — always confirm against carton/label. (For global INLYTA, see FDA/EMA dossiers.)

• Date of Revision: See the revision (version) date on the local package insert. (FDA/EMA labels carry revision dates in their headers.)

• Manufacturer: Global brand INLYTA®: Pfizer Inc. / Pfizer Europe (manufacturing sites vary). Domestic manufacturers/importers may exist — e.g., recent Chinese manufacturer/MAH announcements should be checked on the carton/label.

Guidelines for the Use of Axitinib

• Dosage and Administration:

  • Recommended Dose: 5 mg orally twice daily (BID) (i.e., 5 mg in the morning and 5 mg in the evening). This is the usual initial dose for advanced RCC. Dose titration may be considered (increase to 7 mg BID, then 10 mg BID) in patients who tolerate therapy without Grade ≥2 toxicities, and dose reductions are recommended for toxicity per label. (Key clinical dosing reference — FDA label).

  • Administration: Swallow tablets whole with water. Maintain consistent dosing schedule (approximately 12 hours apart). Take with or without food as permitted by local label; follow the specific local leaflet instructions. Monitor blood pressure before and during treatment

  • Missed Dose:​ If a dose is missed, take it as soon as remembered on the same day and resume the regular schedule; do not double the dose. See local label for precise guidance.

• Adverse Reactions:

  • Common Adverse Reactions: Swallow tablets whole with water. Maintain consistent dosing schedule (approximately 12 hours apart). Take with or without food as permitted by local label; follow the specific local leaflet instructions. Monitor blood pressure before and during treatment

  • Serious Adverse Reactions: Severe hypertension (may be life-threatening), arterial and venous thromboembolic events, gastrointestinal perforation/hemorrhage, severe hemorrhage, cardiac ischemic events (MACE), severe hepatic injury — manage per label and interrupt/stop therapy for severe AEs.

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• Contraindications: Known hypersensitivity to axitinib or any excipient listed in the product label. (Follow local contraindication statements.)

• Precautions:

  • Blood pressure monitoring and management are essential (hypertension is common and can be severe).

  • Monitor for proteinuria, hepatic function, thyroid function, wound healing complications, hemorrhagic risk, and cardiac events.

  • Use caution when planning surgery; interrupt therapy prior to major surgical procedures as recommended in label.

Axitinib Interactions

CYP3A4 inducers

• (e.g., rifampin, phenytoin, carbamazepine, St. John’s wort) may reduce axitinib exposure — avoid or adjust dosing.

Strong CYP3A4 inhibitors

• (e.g., ketoconazole, itraconazole) increase exposure; dose reduction may be required. Monitor patients closely when co-administering CYP3A modulators. Axitinib may interact with drugs that increase bleeding risk or affect blood pressure. See full prescribing information for comprehensive interaction tables.

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.