Big Bear ASIDX Axitinib 5mg

Product Information

• Product name: BIG BEAR ASIDX Axitinib 5mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Axitinib
• Current strength: 5mg
• SKU: BB-ITEM-78
• Site category: other cancer

Product Summary

BIG BEAR ASIDX Axitinib 5mg is an AISTIKA-listed product supplied by Laos BigBear Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Axitinib is the active ingredient used for this product page. Public prescribing information for Axitinib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Axitinib has been shown to inhibit receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3 at therapeutic plasma concentrations. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression. VEGF-mediated endothelial cell proliferation and survival were inhibited by axitinib in vitro and in mouse models. Axitinib was shown to inhibit tumor growth and phosphorylation of VEGFR-2 in tumor xenograft mouse models.

Reference Indications

Axitinib is a kinase inhibitor indicated: in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. Axitinib in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced RCC.

Reference Dosage and Administration

The public label should be checked for the indication-specific recommended dosage. Available administration instructions note that the medicine may be taken Recommended dosage modifications for adverse reactions for Axitinib are provided in Table 2. Administer Axitinib dose approximately 12 hours apart with or without food.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Hypertension: Hypertension including hypertensive crisis has been observed. Blood pressure should be well-controlled prior to initiating Axitinib. Monitor for hypertension and treat as needed. Withhold and then dose reduce Axitinib or permanently discontinue based on severity of hypertension. Arterial and Venous Thromboembolic Events: Arterial and venous thrombotic events have been observed and can be fatal. Use with caution in patients who are at increased risk for these events. Permanently discontinue Axitinib if an arterial thromboembolic event occurs during treatment. Withhold Axitinib and then resume at same dose or permanently discontinue based on severity of VTE. ( 5.2 , 5.3 ) Hemorrhage: Hemorrhagic events, including fatal events, have been reported.

Common Adverse Reactions and Monitoring

Axitinib in combination with pembrolizumab: diarrhea, fatigue/asthenia, hypertension, hepatotoxicity, hypothyroidism, decreased appetite, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation. Axitinib as a single agent: diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, palmar-plantar erythrodysesthesia (hand-foot) syndrome, weight decreased, vomiting, asthenia, and constipation. The safety of Axitinib has been evaluated in combination with avelumab in JAVELIN Renal 101 and pembrolizumab in KEYNOTE-426 for the first-line treatment of patients with advanced RCC .

Drug Interactions and Special Populations

Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce the Axitinib dose. ( 2.2 , 7.1 ) Avoid strong CYP3A4/5 inducers. Co-administration of Axitinib with strong CYP3A4/5 inhibitors should be avoided. Grapefruit or grapefruit juice may also increase axitinib plasma concentrations and should be avoided. Selection of concomitant medication with no or minimal CYP3A4/5 inhibition potential is recommended. If a strong CYP3A4/5 inhibitor must be co-administered, the Axitinib dose should be reduced . Co-administration of Axitinib with strong CYP3A4/5 inducers (e.g., rifampin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, and St. John’s wort) should be avoided. Selection of concomitant medication with no or minimal CYP3A4/5 induction potential is recommended .

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: INLYTA public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.