Tibremciclib Application Scope

Tibremciclib is a novel, selective cyclin-dependent kinase 4/6 (CDK4/6) inhibitor indicated for the treatment of adult patients with hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer, particularly in patients who have progressed on prior endocrine therapy. It is being investigated and used in combination with endocrine agents (e.g., fulvestrant) and has shown improvement in progression-free survival in clinical trials.

Tibremciclib Characteristics

Ingredients: Tibremciclib (active ingredient).
Properties: Oral solid dosage form — film-coated capsules.
Packaging Specification: 0.1 g (100 mg) per capsule.
Storage: Store in a cool, dry place; protect from moisture and light; recommended below 25 °C.
Expiry Date: 24 months from manufacture (check carton for exact date)
Executive Standard: Conforms to national pharmaceutical quality standards / local monograph
Approval Number: Refer to local regulatory label / registration (country-specific).
Date of Revision: See latest prescribing information.
Manufacturer: Betta Pharmaceuticals (originator / developer).

Guidelines for the Use of Kangmeina

Dosage and Administration:
- Recommended Dose: 400 mg orally once daily when combined with fulvestrant (RP2D in dose-expansion studies).
- Administration: Take orally, with or without food; swallow whole; at consistent time each day.
- Missed Dose: Take the missed dose as soon as remembered unless it is almost time for the next dose; do not double dose.
Adverse Reactions:
- Common Adverse Reactions:
  - Neutropenia / leukopenia
  - Anemia
  - Increased serum creatinine
  - Hypertriglyceridemia / dyslipidemia
  - Nausea, diarrhea, vomiting
  - Fatigue, asthenia
- Serious Adverse Reactions:
  - Severe neutropenia and febrile neutropenia
  - Serious infections secondary to myelosuppression
  - Hepatotoxicity (ALT/AST elevations; rare severe liver injury)
  - Thromboembolic events (class effect may occur)
Contraindications:
- Known hypersensitivity to tibremciclib or any excipient.
- Pregnancy — potential fetal harm; contraindicated in pregnancy.
Precautions:
- Hematologic monitoring: CBC prior to treatment and periodically during therapy; manage neutropenia per guidelines.
- Liver monitoring: Check LFTs regularly; interrupt or reduce dose for clinically significant transaminase elevations.
- Lipid monitoring: Monitor triglycerides; manage hyperlipidemia as needed.
- Infection vigilance: Promptly evaluate febrile neutropenia or infections.
- Contraception: Advise effective contraception during treatment and for a recommended period after last dose.
- Use in special populations: Use caution and adjust/monitor in hepatic impairment per local label.

Tibremciclib Interactions

CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase tibremciclib exposure → consider dose adjustment / monitor closely.
CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce exposure and efficacy → avoid or monitor.
Other myelosuppressive agents: additive hematologic toxicity → use caution and monitor CBC.
Drugs affecting QT or strong P-glycoprotein modulators: use caution and monitor as clinically indicated.

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.