OFATUMUMAB

(OH fa TOO mue mab) Brand: Arzerra

What is the most significant information I must know about ofatumumab?

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 determined medicines. Call your doctor right away if you have symptoms such as change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

• Till you receive ofatumumab, speak your doctor if you have hepatitis or severe COPD.

• To be certain this medicine is not causing deleterious effects, your blood cells, kidney function, and liver function may need to be tested for different months, even after you stop using ofatumumab. Do not miss any follow-up visits to your doctor.

• Call your doctor at once if you develop any symptoms of liver hurt, such as nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

• You must also call your doctor right away if you develop any signs of infection such as fever, chills, body aches, flu symptoms, mouth and throat ulcers, light bruising or bleeding, or cough with mucus and stabbing chest pain.

• Avoid being around people who have colds, the flu, or another contagious illnesses. Contact your doctor at once if you develop signs of infection. Do not receive a "live" vaccine while you are being treated with ofatumumab.

What is ofatumumab?

Ofatumumab is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only determined cells in the body. This may help to protect healthy cells from damage.

Ofatumumab is used in to treat chronic lymphocytic leukemia.

Ofatumumab is generally given after another medications have been tried without successful treatment of symptoms.

Ofatumumab may also be used for another purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till receiving ofatumumab?

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 determined medicines.

• If you have any of these another conditions, you may need a doze adjustment or particular trials to safely use this medication:

· hepatitis;

· severe COPD (chronic obstructive pulmonary disease);

• FDA pregnancy category C. It is not known whether ofatumumab is deleterious to an unborn child. Till taking this medicine, speak 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 child. Do not use this medicine without telling your doctor if you are breast-feeding a baby.

How is ofatumumab given?

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 medication should be given slowly through an IV infusion, and one doze can take up to different hours to complete.

Ofatumumab is generally given in a series of 12 doses. The first 8 doses are given 1 week separately. The recent 4 doses are given 4 weeks separately. Your dosing schedule may be various. Follow your doctor's instructions.

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

• To be certain this medicine is not causing deleterious 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 medicine, even months after stopping. Your doctor may want to check your liver function at regular visits for different months after you stop using ofatumumab. Do not miss any scheduled appointments.

What happens if I miss a dose?

• Contact your doctor if you miss an appointment for your ofatumumab injection.

What happens if I overdose?

• Search abnormal medical attention if you think you have received too many of this medication. Symptoms of a ofatumumab overdose are unknown.

What must I avoid while receiving ofatumumab?

• Avoid being around people who have colds, the flu, or another contagious illnesses. Contact your doctor at once if you develop signs of infection.

• Do not receive a "live" vaccine while you are being treated with ofatumumab. The live vaccine may not work as well during this time, and may not fully protect you from malady. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

What are the possible side effects of ofatumumab?

• Some people receiving a ofatumumab injection have had a reaction to the infusion (when the medication is injected into the vein). Speak your caregiver right away if you feel dizzy, nauseated, light-headed, confused, itchy, tingly, or have chest pain, jaw or hand pain, back pain, stomach pain, wheezing, chest tightness, or trouble breathing. These reactions can occur during the injection or within 24 hours afterward..

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Call your doctor at once if you have any of these serious side effects:

· change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);

· nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

· fever, chills, body aches, flu symptoms, mouth and throat ulcers, rapid heart course, rapid and shallow breathing, fainting;

· light bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

· cough with yellow or green mucus, stabbing chest pain, feeling short of breath;

· confusion, weakness on one side of the body, loss of balance or coordination; or

· severe constipation.

• Smaller serious side effects may include:

· mild nausea, diarrhea;

· swelling in your hands or feet.

· cool symptoms such as stuffy nose, sneezing, sore throat;

· weary feeling; or

· mild skin rash.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect ofatumumab?

• There may be another drugs that can interact with ofatumumab. Speak your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal commodity, and drugs predesigned by another doctors. Do not start using a new medicine without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about ofatumumab.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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