ofatumumab (Intravenous route)

oh-FAT-oo-moo-mab

Commonly used brand name(s):

In the U.S.

• Arzerra

Available Dosage Forms:

• Solution

Pharmacologic Class: Monoclonal Antibody

Uses For ofatumumab

Ofatumumab injection is used to treat a type of cancer of the white blood cells called chronic lymphocytic leukemia (CLL). ofatumumab is used in patients with CLL who have already been treated with other medicines (e.g., 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 good ofatumumab will do as well as the risks of using it.

ofatumumab is available only with your doctor's prescription.

Before Using ofatumumab

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 ofatumumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ofatumumab 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.

Pediatric

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.

Geriatric

Although appropriate studies on the relationship of age to the effects of ofatumumab injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy

Breast Feeding

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.

Interactions with Medicines

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.

Interactions with Food/Tobacco/Alcohol

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 ofatumumab. Make sure you tell your doctor if you have any other medical problems, especially:

• Bowel blockage or
• Hepatitis B—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight infection.

Proper Use of ofatumumab

You will receive ofatumumab while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you ofatumumab. ofatumumab 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.

Precautions While Using ofatumumab

It is very important that your doctor check your progress at regular visits to make sure ofatumumab is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects.

ofatumumab 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.

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:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

ofatumumab 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 ofatumumab or soon after you receive it.

ofatumumab Side Effects

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:

• Black, tarry stools
• bloating or swelling of the face, arms, hands, lower legs, or feet
• body aches or pain
• chest pain
• chills
• confusion
• cough or hoarseness
• cough producing mucus
• difficult or labored breathing
• dizziness
• ear congestion
• facial swelling
• fainting
• fast heartbeat
• headache
• increased sweating
• lightheadedness
• loss of voice
• lower back or side pain
• nasal congestion
• nausea or vomiting
• painful blisters on the trunk of the body
• painful or difficult urination
• pale skin
• rapid weight gain
• rapid, shallow breathing
• runny nose
• shortness of breath
• skin rash
• sneezing
• sore throat
• tightness in the chest
• tingling of the hands or feet
• troubled breathing
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• weakness
• wheezing

• Blurred vision
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• nervousness
• pounding in the ears
• slow or fast heartbeat
• sweating

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:

• Back pain
• hives or welts
• itching
• muscle aches
• redness of the skin
• sleeplessness
• stuffy nose
• trouble with sleeping
• unable to sleep

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• muscle spasms
• pain or tenderness around the eyes and cheekbones

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.

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