"The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).
CLL is a blood and bone ma"...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
OFATUMUMAB - INJECTION
COMMON BRAND NAME(S): Arzerra
WARNING: This drug may cause serious (possibly fatal) liver disease. Also, if you have a current or past infection with hepatitis B, this drug may cause the infection to return or worsen. This may occur during treatment or up to 1 year after treatment is finished. Before starting treatment with this medication, your doctor may order a test to see if you have the hepatitis B infection. Your doctor may also order blood tests and watch for symptoms of liver disease during treatment and for months after your last dose of this medication. Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.
Ofatumumab increases your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you develop any signs of PML, including: loss of balance/dizziness, confusion, difficulty walking/talking, seizure, vision changes.
USES: Ofatumumab is used to treat a certain type of leukemia (CLL - chronic lymphocytic leukemia) in patients who have not responded to other cancer chemotherapy drugs (such as fludarabine, alemtuzumab). Ofatumumab belongs to a class of drugs known as monoclonal antibodies. This medication works by stopping the growth of cancer cells.
HOW TO USE: This medication is given by injection into a vein by a health care professional. It is usually given once a week for the first 8 doses, then once every 4 weeks for the last 4 doses or as directed by your doctor.
The dosage is based on your medical condition and response to treatment. To prevent side effects, your doctor may prescribe other medications before each treatment, including acetaminophen, an antihistamine (such as diphenhydramine), and a corticosteroid (such as methylprednisolone).
This medication may cause very serious (rarely fatal) infusion-related reactions during or up to 24 hours after treatment. These reactions occur more often during the first and second treatments. Your doctor will monitor you closely and increase your dose slowly to reduce the chances of these serious side effects. If you have a reaction, your treatment will be temporarily stopped. Tell your doctor or nurse immediately if any of these effects occur: chest pain, flushing, wheezing, trouble breathing, dizziness, fainting, pounding/irregular heartbeat, fever, chills, back/stomach pain, or rash/itching.
Additional Arzerra Information
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