Orthoclone OKT3 Warnings and Precautions

Specific Precautions and Warnings With Orthoclone OKT3

Some warnings and precautions to be aware of prior to receiving this medication include the following:
  • You should only use this medicine under the supervision of a healthcare provider who has experience prescribing medications that suppress the immune system and in treating people who have had an organ transplant.
  • Many people who receive this medicine will develop a potentially serious reaction known as cytokine release syndrome. This reaction usually occurs within a few hours after receiving the first two to three doses, and is often most severe after the first dose.
Symptoms are usually mild and resemble flu-like illness. However, life-threatening symptoms, such as breathing problems, heart arrhythmias, and heart failure, can also occur. You will be monitored closely for signs of cytokine release syndrome when you receive your Orthoclone OKT3 dose. Tell your healthcare provider if you experience any symptoms of this reaction, such as:
    • High fever and chills
    • Headaches
    • Tremors
    • Aches and pains
    • Nausea and vomiting
    • Diarrhea
    • Abdominal (stomach) pain
    • General weakness
    • Difficulty breathing, including shortness of breath or wheezing
    • Vision problems
    • Seizures
    • A fast or abnormally beating heart
    • Chest pain or tightness.
  • This medicine has been reported to cause nervous system problems, including brain swelling, seizures, and inflammation of the lining of the brain. Some of these problems have even led to death. You will need to be closely monitored for nervous system problems for the first 24 hours following each of your first few Orthoclone OKT3 doses. Tell your healthcare provider if you develop any signs of nervous system problems, such as:
    • Seizures
    • Confusion or problems thinking
    • Tremors, shaking, or abnormal movements
    • Seeing or hearing things that are not real
    • Fever, headaches, neck stiffness, and light sensitivity
    • Mood changes, such as agitation
    • Problems with vision or hearing.
  • Some people may have a serious and life-threatening allergic reaction to Orthoclone OKT3. This type of reaction usually occurs within the first 10 minutes of receiving your dose. You will be closely monitored for such a reaction. If you develop an allergic reaction to this medicine, you should not receive it again.

Tell your healthcare provider if you develop an any symptoms of an allergic reaction, such as:

    • Skin rash
    • Hives
    • Fast heartbeat
    • Tingling
    • Swelling of the face and throat
    • Difficulty breathing or swallowing.
  • Because Orthoclone OKT3 suppresses the immune system, it can make it harder for your body to fight an infection. Therefore, you will be at risk for infection during treatment, including potentially dangerous viral, bacterial, or fungal infections. Contact your healthcare provider immediately if you experience any signs of infection, such as:
    • Fever
    • Chills
    • Body aches
    • Nausea
    • Vomiting
    • Diarrhea
    • A sore throat
    • Coughing.
  • Orthoclone OKT3 may increase your risk for developing certain cancers, especially cancers of the skin and blood (such as lymphoma). Contact your healthcare provider right away if you notice any skin changes or swelling of your lymph nodes.
  • You should know that this medicine could decrease your mental alertness and coordination. Do not operate heavy machinery or drive a car until you know how this medicine affects you.
  • Your healthcare provider will check your temperature before each Orthoclone OKT3 dose. If you have a fever, you will need to take medicine to reduce your temperature before receiving your dose.
  • You will need certain blood tests while receiving this medicine to check your progress and monitor for side effects.
  • This medication may increase your risk for developing blood clots, which can block blood vessels and cause serious problems, including damage to your transplanted organ.
  • Orthoclone OKT3 is a pregnancy Category C medication, which means it may not be safe for use during pregnancy (see Orthoclone OKT3 and Pregnancy).
  • It is unknown if this medicine passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to receiving the drug (see Orthoclone OKT3 and Breastfeeding).

Orthoclone OKT3 Drug Information

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