Fatal cases of progressive multifocal leukoencephalopathy or reactivation of hepatitis B virus, including fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including ofatumumab .
Ofatumumab injection is used in combination with chlorambucil to treat a type of cancer of the white blood cells called chronic lymphocytic leukemia (CLL) in patients who have not received any treatments in the past. This medicine is also used in patients with CLL who have already been treated with other medicines (eg, alemtuzumab, fludarabine) that did not work well.
Ofatumumab interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected by ofatumumab, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor. Some unwanted effects, such as a skin rash, may not be serious but may cause concern. Some of the unwanted effects do not occur until months or years after the medicine is used.
Before you begin treatment with ofatumumab, you and your doctor should talk about the benefits this medicine will do as well as the risks of using it.
This medicine is to be given only by or under the direct supervision of your doctor.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of ofatumumab injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ofatumumab injection in the elderly. However, elderly patients are more likely to have unwanted side effects (eg, neutropenia, pneumonia) which may require caution.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.
Ofatumumab needs to be given slowly, so the needle will remain in place for at least an hour. You may also receive medicines to help prevent allergic reactions.
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause chest pain, fever, chills, itching, hives, flushing of the face, rash, dizziness, fainting, or lightheadedness, troubled breathing, or swelling of the face, tongue, and throat within a few hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.
This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.
Ofatumumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.
Check with your doctor immediately if you have any symptoms of liver problems including skin and eyes turning yellow, dark brown-colored urine, right-sided abdominal or stomach pain, fever, or severe tiredness.
While you are being treated with ofatumumab, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given with this medicine or soon after you receive it.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.