Gavreto (Pralsetinib) – NSCLC | HongKong DengYue Medicine

Gavreto Application Scope

Gavreto is an oral, selective RET kinase inhibitor used to treat RET fusion–positive cancers.

Characteristics

• Ingredients: Pralsetinib

• Properties:

  • Oral kinase inhibitor targeting RET fusions and mutations

  • Capsules are light blue, opaque HPMC hard shells printed with “BLU‑667 100 mg”

• Packaging Specification: Supplied as 100 mg capsules in bottles (e.g., 30-count) or blister packs

• Storage: Store at room temperature; no special handling needed

• Expiry Date: Use the expiry date printed on the packaging

• Executive Standard: U.S. FDA-approved label; EMA and other agencies’ summaries align

• Approval Number: FDA initial approval for NSCLC: September 4, 2020 (NDA 213721)

• Date of Revision:

  • Latest U.S. label revision: July 2023 updates for CYP3A dose adjustments

  • Canadian revision May 30, 2024

• Manufacturer:

  • Developed by Blueprint Medicines; marketed by Genentech (Roche) in the U.S.

  • Hoffmann‑La Roche in Canada, and Roche in other countries

Guidelines for the Use of Gavreto

• Dosage and Administration:

  • 400 mg orally once daily on an empty stomach (2 hours before and 1 hour after food)

  • Continue until disease progression or unacceptable toxicity

• Adverse Reactions:

  • Common (≥ 25%):

    • fatigue, constipation, musculoskeletal pain, hypertension, peripheral edema

  • Lab abnormalities:

    • decreased blood counts, low calcium, sodium, phosphate; elevated liver enzymes

• Contraindications: None specified in U.S. label

• Precautions:

  • Interstitial lung disease (12% incidence; 3.3% Grade 3–4)

  • Monitor blood pressure (common hypertension)

  • Hepatotoxicity and hemorrhagic events require dose modifications or discontinuation

Gavreto Interactions

• Drug Interactions:

  • Avoid strong/moderate CYP3A and P-gp inhibitors (reduce dose)

  • Avoid inducers (consider doubling the dose)

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.