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May 26, 2013
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ofatumumab (cont.)

What should I discuss with my healthcare provider before receiving ofatumumab (Arzerra)?

Ofatumumab increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

FDA pregnancy category C. It is not known whether ofatumumab is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether ofatumumab passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is ofatumumab given (Arzerra)?

Ofatumumab is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and one dose can take up to several hours to complete.

Ofatumumab is usually given in a series of 12 doses. The first 8 doses are given 1 week apart. The last 4 doses are given 4 weeks apart. Your dosing schedule may be different. Follow your doctor's instructions.

You will be given other IV or oral (by mouth) medications to prevent certain side effects of ofatumumab. You may need to start using these medications up to 2 hours before the start of your ofatumumab infusion.

To be sure this medication is not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested on a regular basis. Ofatumumab can have long-lasting effects on your body. Do not miss any follow-up visits to your doctor for blood or urine tests.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using ofatumumab. Do not miss any scheduled appointments.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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