Fovinaciclib Application Scope

Fovinaciclib is an oral, selective CDK4/6 inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer. Fovinaciclib is approved for use in combination with an aromatase inhibitor as initial endocrine-based therapy and in combination with fulvestrant for patients who have progressed following prior endocrine therapy. Treatment should be supervised by physicians experienced in oncology.

Fovinaciclib Characteristics

Ingredients: Fovinaciclib citrate (active ingredient).
Properties: Hard gelatin capsules; oral solid dosage form.
Packaging Specification: 25 mg (as C₂₉H₄₀N₈OS) and 100 mg capsule presentations (marketed strengths may vary by manufacturer).
Storage: Store in a cool, dry place; protect from light. Recommended storage: below 25 °C.
Expiry Date: 24 months from manufacture (refer to carton for exact expiry).
Executive Standard: Conforms to national drug quality standards (local monograph).
Approval Number: National registration number (example format): H20250023 (refer to local label for specific country code).
Date of Revision: See most recent local prescribing information.
Manufacturer: Jinzhou Aohong Pharmaceutical Co., Ltd. (commercialized and promoted by relevant affiliates).

Guidelines for the Use of Futuoning

Dosage and Administration:
- Recommended Dose: 200 mg orally once daily.
- Administration: Oral; may be taken with or without food; take at approximately the same time each day.
- Missed Dose: If ≤8 hours until next scheduled dose, skip the missed dose; otherwise take as soon as remembered. Do not double dose.
Adverse Reactions:
- Common Adverse Reactions:
  - Neutropenia / decreased neutrophil count
  - Leukopenia
  - Anemia
  - Thrombocytopenia
  - Nausea, diarrhea, vomiting
  - Elevated AST / ALT (liver transaminases)
  - Hypertriglyceridemia
  - Fatigue
- Serious Adverse Reactions:
  - Severe neutropenia and febrile neutropenia (monitor CBC)
  - Hepatotoxicity (transaminase elevations; rare severe liver injury)
  - Venous thromboembolism (reported with CDK4/6 inhibitors class effect)
  - Severe infections secondary to myelosuppression
Contraindications:
- Known hypersensitivity to fovinaciclib or any excipient.
- Pregnancy (avoid — teratogenic risk); effective contraception required for patients of reproductive potential.
Precautions:
- Hematologic monitoring: CBC prior to and periodically during treatment; manage neutropenia per guidelines.
- Liver function: Monitor AST/ALT and bilirubin; interrupt or discontinue for significant hepatic impairment.
- Infection risk: Evaluate and treat infections promptly; consider dose interruption for severe infection.
- Embryo-fetal risk: Women of childbearing potential must use effective contraception during treatment and for a defined period after last dose.
- Use in special populations: Adjust/monitor in hepatic impairment per label; limited data in severe renal impairment.

Fovinaciclib Interactions

CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase fovinaciclib exposure → monitor and consider dose adjustment.
CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce exposure and efficacy → avoid or monitor closely.
Other myelosuppressive agents: additive hematologic toxicity — use caution.
Statins / fibrates: monitor lipids when combined (hypertriglyceridemia risk).

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.