Orthocone OKT3 (Muromonab-CD3) – Prevention and Treatment of Acute Rejection | HongKong DengYue Medicine

Muromonab-CD3 Application Scope

Muromonab-CD3 is a mouse-derived anti-human T lymphocyte CD3 monoclonal antibody used primarily to prevent and treat acute organ transplant rejection. It is especially indicated for patients undergoing kidney transplantation and other solid organ transplants, where it helps modulate the immune response, reduce T-cell–mediated rejection, and improve graft survival.

Muromonab-CD3 Characteristics

• Ingredients: Mouse anti-human T lymphocyte CD3 monoclonal antibody.

• Properties:​ Sterile, clear solution; immune-modulating.

• Packaging Specification:​ 5mg per vial.

• Storage:​ 4–10°C, protected from light.

• Expiry Date: 3 years.

• Executive Standard: As per NMPA standards. ​

• Approval Number: S19990012.

• Date of Revision: To be confirmed.

• Manufacturer: Wuhan Institute of Biological Products Co., Ltd.

Guidelines for the Use of Orthocone OKT3

• Dosage and Administration:

  • Recommended Dose: 5–10 mg/day, 5–14 consecutive days; adjust per clinician discretion.

  • Administration: IV drip only, do not mix with other drugs.

  • Missed Dose:​ Resume under medical supervision.

• Adverse Reactions:

  • Common Adverse Reactions: Fever, rash, leukopenia, nausea, vomiting, diarrhea, mild respiratory symptoms.

  • Serious Adverse Reactions: Severe pulmonary edema (<2%), cytokine release syndrome, anaphylactic reactions during first dose.

• Contraindications:

  • Allergic to mouse-derived products.

  • Significant fluid overload (>3% body weight increase before therapy).

  • Pre-existing severe pulmonary edema.

• Precautions:

  • Must be administered under experienced transplant immunosuppression supervision.

  • Monitor for cytokine release syndrome, infection, and vital signs.

  • Avoid repeated administration unless benefits outweigh risks.

  • Not recommended for pregnant or lactating women.

  • Pediatric safety and efficacy not established.

  • Regular monitoring of T-cell subsets, CD3 expression, and drug serum concentration recommended.

Muromonab-CD3 Interactions

• Concomitant immunosuppressants may enhance risk of infection.

• Monitor carefully when used with other T-cell modulating drugs.

 

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.