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Big Bear ADADX Adagrasib 200mg

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ADADX Adagrasib 200mg is an AISTIKA-listed generic product from Laos BigBear Pharma. Its active ingredient is Adagrasib. Reference dosage information from public prescribing sources: Recommended dosage as a single agent for NSCLC and in combination with cetuximab for CRC: 600 mg orally twice daily. Swallow tablets whole with or without food. With this 200mg product, that corresponds to 3 x 200mg tablets when that reference dose is clinically appropriate. Actual eligibility, dose adjustment, combination therapy, and treatment duration must be directed by a physician.

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Product Details

Medical information noticeThis page is for product presentation and public label reference only. The generic product name, manufacturer, and strength follow this product page. Reference dosage, storage, and safety information do not replace a physician prescription or the locally approved label.

Product Information

  • Product name: ADADX Adagrasib 200mg
  • Manufacturer / brand: Laos BigBear Pharma
  • Active ingredient: Adagrasib
  • Current strength: 200mg
  • SKU: BB-ITEM-23
  • Site category: KRAS G12C target, other cancer

Product Summary

ADADX Adagrasib 200mg 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

Adagrasib is the active ingredient used for this product page. Public prescribing information for Adagrasib 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

Adagrasib is an irreversible inhibitor of KRAS G12C that covalently binds to the mutant cysteine in KRAS G12C and locks the mutant KRAS protein in its inactive state that prevents downstream signaling without affecting wild-type KRAS protein. Adagrasib inhibited tumor cell growth and viability in cells harboring KRAS G12C mutations and resulted in tumor regression in KRAS G12C-mutated tumor xenograft models with minimal off-target activity.

Reference Indications

Adagrasib is an inhibitor of the RAS GTPase family indicated for: Non-small cell lung cancer (NSCLC)* As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. Colorectal cancer (CRC)* In combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. *These indications are approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR).

Reference Dosage and Administration

Recommended dosage as a single agent for NSCLC and in combination with cetuximab for CRC: 600 mg orally twice daily. Swallow tablets whole with or without food.

With this 200mg product, that corresponds to 3 x 200mg tablets when that reference dose is clinically appropriate.

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

Important Safety Information

Withhold, reduce the dose or permanently discontinue based on severity. ( 2.3 , 5.1 ) QTc Interval Prolongation: Avoid concomitant use of Adagrasib with other products with a known potential to prolong the QTc interval. Monitor ECG and electrolytes particularly potassium and magnesium, in patients at risk, and in patients taking medications known to prolong the QT interval. Correct electrolyte abnormalities. Withhold, reduce the dose, or permanently discontinue based on severity. ( 2.3 , 5.2 ) Hepatotoxicity: Monitor liver laboratory tests prior to the start of Adagrasib and monthly for 3 months after and as clinically indicated. Reduce the dose, withhold, or permanently discontinue based on severity. ( 2.3 , 5.3 ) Interstitial Lung Disease (ILD) / Pneumonitis: Monitor for new or worsening respiratory symptoms.

Common Adverse Reactions and Monitoring

The most common (≥ 2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, decreased hemoglobin, increased alanine aminotransferase, increased aspartate aminotransferase, hypokalemia, hyponatremia, increased lipase, decreased leukocytes, decreased neutrophils and increased alkaline phosphatase. The most common (≥ 2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, decreased potassium, decreased magnesium, decreased hemoglobin, increased aspartate aminotransferase, increased lipase, decreased albumin, and increased alanine aminotransferase.

Drug Interactions and Special Populations

Strong CYP3A4 Inducers : Avoid concomitant use. Strong CYP3A4 Inhibitors : Avoid concomitant use until adagrasib concentrations have reached steady state. Sensitive CYP3A4 Substrates : Avoid concomitant use with sensitive CYP3A4 substrates. Drugs That Prolong QT Interval : Avoid concomitant use with Adagrasib. Adagrasib is a CYP3A4 substrate. Concomitant use of Adagrasib with a strong CYP3A inducer reduces adagrasib exposure , which may reduce the effectiveness of Adagrasib. Strong CYP3A4 Inhibitors Avoid concomitant use of Adagrasib with strong CYP3A inhibitors until adagrasib concentrations have reached steady state (after approximately 8 days). Adagrasib is a CYP3A4 substrate. Adagrasib is a CYP3A inhibitor. Adagrasib is a CYP2C9 inhibitor. Adagrasib is a CYP2D6 inhibitor. Adagrasib is a P-gp inhibitor.

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: KRAZATI 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.

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