Tafolecimab Application Scope

Tafolecimab is indicated in adults with:

Primary hypercholesterolemia (including heterozygous familial hypercholesterolemia)
Mixed dyslipidemia

It is used as an adjunct to diet and/or other lipid-lowering therapies (e.g., statins), or alone when other therapies are not tolerated or are contraindicated.

Tafolecimab Characteristics

Ingredients: Tafolecimab
Properties: A clear, colorless to pale yellow solution
Packaging Specification:
- Pre-filled syringe (with or without an automatic injector)
- Pack size: 1 syringe per carton
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F)
Expiry Date: 24 months when stored under recommended conditions
Executive Standard: National Drug Standards
Approval Number: Drug Registration Number: S20230032
Date of Revision: The latest version of the prescribing information should be consulted
Manufacturer: Innovent Biologics (Suzhou) Co., Ltd.

Guidelines for the Use of Tafolecimab

Dosage and Administration:
- Recommended Dose:
  - 150 mg every two weeks, OR
  - 300 mg every four weeks (administered as two consecutive 150 mg injections).
- Administration:
  - For subcutaneous use only.
  - It can be injected into the thigh, abdomen, or upper arm.
  - The injection should be administered by a healthcare professional or by a patient/caregiver after proper training.
- Missed Dose:
  - If a dose is missed, administer the injection as soon as possible within 7 days.
  - If more than 7 days have passed, skip the missed dose and administer the next dose on the original scheduled day.
  - Do not administer a double dose to make up for a missed one.
Adverse Reactions:
- Common Adverse Reactions:
  - Injection site reactions (e.g., pain, redness, rash, swelling).
  - Upper respiratory tract infection.
  - Urinary tract infection.
  - Dizziness.
- Serious Adverse Reactions:
  - Hypersensitivity reactions (e.g., rash, urticaria) have been reported. Serious events are rare.
Contraindications:
- Known hypersensitivity to tafolecimab or any excipient listed in the product label.
- For any other absolute contraindications, check the approved product leaflet—press materials do not list additional formal contraindications.
Precautions:
- Lipid levels should be monitored before initiating therapy.
- Patients should be trained on proper injection technique and aseptic procedures.
- Counsel patients on the importance of adhering to a lipid-lowering diet during treatment.
- Use during pregnancy and lactation: There is limited data. Use only if the potential benefit justifies the potential risk to the fetus or infant.

Tafolecimab Interactions

No clinically significant drug-drug interactions have been observed with statins (e.g., atorvastatin, rosuvastatin) or other commonly co-administered drugs.
As Tafolecimab reduces LDL-C by a mechanism distinct from other lipid-lowering agents, additive effects are expected when used in combination.

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.