Romvimza | Tenosynovial Giant Cell Tumor | HongKong DengYue Medicine

Romvimza Application Scope

Romvimza (generic name: vimseltinib) is an oral medication approved by the U.S. Food and Drug Administration (FDA) on February 14, 2025, for the treatment of symptomatic tenosynovial giant cell tumor (TGCT) in adults when surgical resection is likely to cause worsening functional limitation or severe morbidity.

Characteristics

• Ingredients:

  • Vimseltinib

• Properties: Romvimza is a kinase inhibitor that selectively targets the colony-stimulating factor 1 receptor (CSF1R), thereby inhibiting tumor growth in tenosynovial giant cell tumor (TGCT).

• Packaging Specification: 30 mg; each carton contains one child-resistant blister pack with 8 capsules (a four-week supply).

• Storage:

  • Store at controlled room temperature 20°C to 25°C (68°F to 77°F)

  • Excursions permitted to 15°C to 30°C (59°F to 86°F)

  • Keep capsules in their original blister packs until ready to use

 

• Expiry Date: ​Refer to the packaging for the specific expiration date

• Executive Standard: ​As per FDA approval standards

• Approval Number: FDA approval granted on February 14, 2025

• Date of Revision: ​April 4, 2025

• Manufacturer: Deciphera Pharmaceuticals, Inc.

Guidelines for the Use of Ensartinib

• Dosage and Administration:

  • The recommended dosage is 30 mg orally, taken twice weekly with a minimum of 72 hours between doses
  • Romvimza may be taken with or without food
  • Swallow capsules whole; do not open, break, or chew

 

• Adverse Reactions: Common side effects include periorbital edema, fatigue, rash, increased cholesterol levels, peripheral edema, facial edema, decreased neutrophils, decreased leukocytes, pruritus, and elevated liver enzymes (AST/ALT).

• Contraindications: None identified

• Precautions:

  • Monitor liver function tests before initiation, twice monthly for the first two months, then quarterly for the first year, and as clinically indicated thereafter.

  • Use effective contraception during treatment and for one month after the last dose.

  • Avoid use in patients with known hypersensitivity to FD&C Yellow No. 5 or No. 6

Interactions

• Drug Interactions:

  • Avoid concomitant use with P-glycoprotein (P-gp), Breast Cancer Resistance Protein (BCRP), or Organic Cation Transporter 2 (OCT2) substrates.

  •  If unavoidable, administer Romvimza at least 4 hours before P-gp substrates.

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.