(oh fa TOOM yoo mab)

Trade Names: Arzerra ™

Ofatumumab is the generic name for the trade chemotherapy drug Arzerra. In some cases, health care professionals may use the trade name Arzerra when referring to the generic drug name Ofatumumab.

Drug Type:

Ofatumumab is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Ofatumumab is classified as a "monoclonal antibody" (For more detail, see "How Ofatumumab Works" section below).

What Ofatumumab Is Used For:

• Ofatumumab is used for the treatment of chronic lymphocytic leukemia (CLL)

Note: If a drug has been approved for one use, physicians sometimes elect to use this same drug for other problems if they believe it might be helpful.

How Ofatumumab Is Given:

• Ofatumumab is given as an injection or infusion into the vein (intravenous, IV) over about 6 hours. The time of the infusion may be shortened, depending on whether or not you have received ofatumumab in the past, or how well you tolerate ofatumumab
• Medications may be given just before the infusion to reduce the occurrence of infusion-related symptoms.
• There is no pill form of ofatumumab.
• The amount of ofatumumab and the schedule that it is given will receive depend on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.

Side Effects:

Important things to remember about the side effects of ofatumumab:

• Most people do not experience all of the side effects listed.
• Side effects are often predictable in terms of their onset and duration.
• Side effects are almost always reversible and will go away after treatment is complete.
• There are many options to help minimize or prevent side effects.
• There is no relationship between the presence or severity of side effects and the effectiveness of ofatumumab.

The following are common (occurring in greater than 30%) side effects for patients taking Ofatumumab:

• Infection
• Low blood counts:Your white and red blood cells and platelets may temporarily decrease. This can put you at increased risk for infection, anemia and/or bleeding. The nadir counts are delayed with this drug.
  • Nadir: Meaning low point, nadir is the point in time in which you experience low blood counts (may be prolonged over 2 weeks).
• A serious side effect of ofatumumab is potential for a severe infusion reaction, typically with the first infusion (during infusion or within 30-120 minutes of infusion).  You will be given medication prior to the infusion to decrease this reaction and monitored carefully during the infusion.  If signs of reaction occur, the infusion is stopped.  In most cases, the infusion can be restarted at a slower rate once symptoms subside.

These are less common side effects (occurring in 10-29%) for patients receiving Ofatumamab:

• Cough
• Diarrhea
• Fatigue
• Fever
• Nausea
• Shortness of Breath (Dyspnea)
• Rash
• Pneumonia
• Bronchitis
• Upper respiratory tract infection (see cold symptoms)

Not all side effects are listed above, some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms

When To Contact Your Doctor or Health Care Provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38° C), chills (possible signs of infection)
• Shortness of breath, wheezing, difficulty breathing, closing up of the throat, swelling of facial features, hives (possible allergic reaction).
• Confusion

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Signs of infection such as redness or swelling, pain on swallowing, mouth sores, sore throat, coughing up mucous, or burning with urination.
• Nausea (interferes with ability to eat and unrelieved with prescribed medication)
• Vomiting (vomiting more than 4-5 times in a 24 hour period)
• Diarrhea (4-6 episodes in a 24-hour period)
• Unusual bleeding or bruising
• Black or tarry stools, or blood in your stools or urine
• Extreme fatigue (unable to carry on self-care activities)
• Mouth sores (painful redness, swelling or ulcers)
• Yellowing of the skin or eyes
• Swelling of the feet or ankles. Sudden weight gain

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting ofatumumab treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, or products containing aspirin unless your doctor specifically permits this.
• Do not receive any kind of immunization or vaccination without your doctor's approval while taking ofatumumab.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category C (use in pregnancy only when benefit to the mother outweighs risk to the fetus).
• For both men and women: Do not conceive a child (get pregnant) while taking ofatumumab. Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking ofatumumab.

Self-Care Tips:

• You will be closely monitored during the infusion, report immediately any pain, burning or swelling at the infusion site, chest pain or palpitations; difficulty breathing or swallowing; chills.  These may be signs of an infusion reaction.  If signs of reaction occur, the infusion is stopped.  In most cases, the infusion can be restarted at a slower rate once symptoms subside.
• Drink 2 to 3 quarts of fluid for the first 48 hours after each infusion, unless you were told to restrict your fluid intake.
• This medication infrequently causes nausea. But if you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals. Sucking on lozenges and chewing gum may also help.
• You may experience drowsiness or dizziness; avoid driving or engaging in tasks that require alertness until your response to the drug is known.
• In general, drinking alcoholic beverages should be avoided. You should discuss this with your doctor.
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your health care professional while you are taking Ofatumumab, to monitor side effects and check your response to therapy. Periodic blood work to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.

How Ofatumumab Works:

Ofatumumab is classified as a monoclonal antibody.  Monoclonal antibodies are a type of "targeted" cancer therapy.

Antibodies are an integral part of the body's immune system.  Normally, the body creates antibodies in response to an antigen (such as a protein in a germ) that has entered the body.  The antibodies attach to the antigen in order to mark it for destruction by the immune system.

To make anti-cancer monoclonal antibodies in the laboratory, scientists analyze specific antigens on the surface of cancer cells (the targets).  Then, using animal and human proteins, they create a specific antibody that will attach to the target antigen on the cancer cells. When given to the patient, these monoclonal antibodies will attach to matching antigens like a key fits a lock.

Since monoclonal antibodies target only specific cells, they may cause less toxicity to healthy cells.   Monoclonal antibody therapy is usually given only for cancers in which antigens (and the respective antibodies) have been identified already.

Ofatumumab works by targeting the CD20 antigen on normal and malignant B-cells.  Then the body's natural immune defenses are recruited to attack and kill the marked B-cells.  Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen.  This allows healthy B-cells to regenerate after treatment.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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