Murine monoclonal antibody that targets the CD3 receptor on T-cells.
Used to treat acute episodes of renal allograft rejection.

No longer licensed within the United Kingdom. Has a license in the united states of America.


Unlicensed product - ORTHOCLONE® OKT3.

5mg total in a 5ml ampule.
Administer by bolus IV injection in less than 1 minute.

Once opened, use immediately.


Do not administer if the patient:

Has a hypersensitivity reaction towards murine proteins or to excipients.
Has an anti-mouse antibody titer equal to or exceeding 1:1000.
Is pregnant or is breast feeding.
Has severe and uncontrolled hypertension.
Has heart failure and/or fluid overload.

Experiences seizures or has had a history of seizures.



For heart failure or fluid overload before drug administration as this could lead to pulmonary oedema.

Serum levels to ascertain the anti-mouse antibody titer (should not equal or exceed 1:1000). IgG antibodies are most prevalent (86%) and typically occur around 20 +/- days after the first dose.

For Cytokine Release Syndrome – symptoms may start to appear typically around 30-60 minutes after administration of the first dose. Cytokine Release Syndrome results within high cytokine levels in the serum and this is most noticeable between 1 and 4 hours after administration (monitor serum levels).
For malignancies by sampling for and undertaking histological staining on potential lymphoid tissue. Undertake regular physical examinations for neoplasms.
For neurological symptoms within the first 24 hours after administration.
For symptoms of hypersensitivity reactions. Anaphylaxis can occur within 10 minutes of drug administration.  Anaphylaxis can be fatal and so life support equipment and epinephrine should be readily available.
WBC and platelet counts.
Liver function tests (such as alkaline phosphatase).

Renal function tests (such as serum creatinine).


Neurological symptoms:  headaches, seizures, cerebral oedema, encephalopathy and aseptic meningitis. Other symptoms may include; aphasia, cerebrovascular accident, transient ischemic attack, loss in hearing and deafness, loss in vision and permanent blindness and paraplegia.
Cytokine Release Syndrome (CRS): symptoms can range in severity, with the most severe being likely to occur after administration of the first dose of ORTHOCLONE® OKT3. The most common symptoms include; abdominal pain, malaise, nausea, headaches, high fever, chills, rigor, diarrhea and fatigue. Less common but very severe symptoms can affect the nervous system and cardiorespiratory system. Skin reactions such as wheals and rashes may also occur but are uncommon.
Increased risk of infection: There can be a possible primary infection by cytomegalovirus (CMV), herpes simplex virus (HSV) or Epstein-Barr virus (EBV) 1-6 months after transplant. There can be the reactivation of a previous CMV or EBV infection 1-4 months after transplant. Pediatric patients have an increased risk of being infected by viruses not normally found within adults, including; adenovirus, varicella zoster virus (VZV) and respiratory syncytial virus (RSV).
Hypersensitivity reactions: Anaphylaxis and Cytokine Release Syndrome share similar symptoms. Symptoms include hypotension, skin reactions, circulatory collapse, tachycardia, cardiac arrest, angioedema, dyspnea, bronchospasm and urticaria.

Increased risk of malignancies: Lymphomas and sarcomas.


In adult patients:

The first dose can be administered as soon as acute rejection has been diagnosed.
Administer a bolus intravenous (IV) injection – 5mg in less than 1 minute.
Repeat for 10-14 days.
Start maintenance therapy 3 days before the final dose of ORTHOCLONE® OKT3.

In paediatric patients:

The first dose can be administered as soon as acute rejection has been diagnosed.
In patients weighing below or equal to 30kg – 2.5mg bolus IV injection in less than 1 minute.
In patients weighing above 30kg – 5mg bolus IV injection in less than 1 minute.
Repeat for 10-14 days.
As paediatric patients have a higher number of T-cells, they may require a higher dose to achieve less than 25 CD3+ T-cells per mm3.
Can increase the dose daily such as by 2.5mg.
Start maintenance therapy 3 days before the final dose of ORTHOCLONE® OKT3.

To reduce the effects of CRS

Administer 8mg/kg methylprednisolone sodium succinate by IV 1-4 hours before the first dose of ORTHOCLONE® OKT3.

Can also administer anti-histamines and paracetamol alongside ORTHOCLONE® OKT3.

Dose in renal impairment

As in normal renal function.


As with all immunosuppressants, avoid live vaccines, advise patients to avoid sunbathing and use a high factor sun screen due to the increased risk of skin cancer, advise women to have yearly cervical smears due to the increased risk of cervial cancer.

Possible drug interactions with other immunosuppressant drugs

How to Prescribe View Details
Patient comment

Advise patients on the range of symptoms associated with taking the drug.
Advise patients to report any symptoms immediately.
Pregnant women should be advised on the possible harmful effects to the foetus and alternative medications.
Women should be advised on the potential risk of transmission of the drug through breast feeding.

Advise males and females that there could be reduced reproductive capability.


Further information:-


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