Arzerra
Pronunciation: ah-zeer-ah
Generic name: ofatumumab
Brand name: Arzerra (discontinued)
Dosage form: injection for intravenous infusion
Drug classes: CD20 monoclonal antibodies, Selective immunosuppressants
What is Arzerra?
Arzerra is used to treat chronic lymphocytic leukemia (CLL), usually in combination with other medicines, such as chlorambucil, or with fludarabine and cyclophosphamide for those with relapsed CLL. The Arzerra brand has been discontinued.
Arzerra's mechanism of action involves targeting CD20-positive B lymphocytes and it binds to a different part of the CD20 protein than other monoclonal antibodies, which can make it effective even when similar treatments have failed. This activates the complement system to destroy cancer cells and also helps natural killer cells identify and destroy marked B cells. Arzerra infusion also directly triggers cell death in targeted cells. Through these multiple mechanisms of action, Arzerra depletes both normal and malignant B cells that express CD20. Arzerra belongs to the drug class called CD20 monoclonal antibodies.
Arzerra first gained FDA approval on October 26, 2009.
Arzerra (ofatumumab) contains the same active ingredient as Kesimpta (ofatumumab) but they are NOT to be used interchangeably. They are used to treat different conditions (Arzerra is used for CLL and Kesimpta is used for MS) and are given by a different route of administration (Arzerra is given by intravenous infusion and Kesimpta is given by subcutaneous injection).
Arzerra uses
Arzerra (ofatumumab) is used for CLL:
- in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate
- in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL
- for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL
- for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.
Arzerra is sometimes given after other medications have been tried without success.
The safety and effectiveness of Arzerra in children has not been established.
Arzerra side effects
The most common Arzerra side effects are:
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infusion-related reactions;
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irritation where the injection was given;
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fever, low blood cell counts;
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cold symptoms such as stuffy nose, sneezing, sore throat;
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cough, chest tightness, trouble breathing, lung infection;
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diarrhea, nausea;
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rash; or
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headache, tiredness.
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Serious side effects and warnings
Arzerra can cause the following serious side effects.
Infusion-related reactions. Some side effects may occur during the injection or up to 24 hours later. Tell your caregiver right away if you feel dizzy, tired, nauseated, light-headed, feverish, chilled, sweaty, itchy, or have a skin rash, headache, muscle pain, back pain, stomach pain, irregular heartbeats, chest tightness, trouble breathing, or swelling and irritation in your throat.
Infections. Serious infections can happen during treatment with Arzerra. If you have an active infection, your healthcare provider should delay your treatment until your infection is gone. Arzerra taken before or after other medicines that weaken the immune system may increase your risk of getting infections. Tell your healthcare provider right away if you have any infections or get any symptoms, including painful and frequent urination, nasal congestion, runny nose, sore throat, fever, chills, cough, or body aches.
Hepatitis B virus (HBV) reactivation. Before starting treatment, your healthcare provider will do blood tests to check for HBV. If you have ever had HBV infection, the HBV may become active again during or after treatment. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death. You should not receive this medicine if you have active hepatitis B liver disease. Your healthcare provider will monitor you for HBV infection during and after you stop using this medicine. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes during treatment.
Progressive Multifocal Leukoencephalopathy (PML). PML may happen with Arzerra. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks. PML can result in death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include weakness on one side of your body, loss of coordination in arms and legs, vision problems, and changes in thinking and memory which may lead to confusion and personality changes.
Weakened immune system. Arzerra taken before or after other medicines that weaken the immune system could increase your risk of getting infections.
Arzerra may cause an allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Arzerra: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- signs and symptoms of infusion reactions including fever, chills, rash, or breathing problems within
24 hours of the infusion -
pain, redness, swelling, or itching where the medicine was injected;
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symptoms of hepatitis including worsening fatigue, yellow discoloration of skin or eyes, right-sided upper stomach pain, vomiting, loss of appetite, or not feeling well;
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signs of a lung or other infection - fever, chills, cough, chest pain, feeling short of breath;
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low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath, petechiae, pallor, worsening weakness, or fatigue ;
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signs of tumor cell breakdown - tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.
- new neurological symptoms such as confusion, dizziness or loss of balance, difficulty talking or walking, or vision problems.
To be sure Arzerra is not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested for several months, even after you stop using it. Do not miss any follow-up visits to your doctor.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Before taking this medicine
Do not receive an Arzerra infusion if you are allergic to ofatumumab, Arzerra, Kesimpta, or any of the inactive ingredients in the injection.
Tell your healthcare provider about all your medical conditions including if you have ever had:
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an active or chronic infection;
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a condition for which you have used an immunosuppressant medication; or
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hepatitis B
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are pregnant or planning to become pregnant
- are breastfeeding or plan to breastfeed.
You may need to take antiviral medicine if you are found to have any risk factors for hepatitis B. Follow your doctor's dosing instructions very carefully.
You should be current on all vaccines before you start using Arzerra. Tell your doctor if you have received any vaccines within the past 4 weeks.
Pregnancy
Arzerra may harm an unborn baby. Use effective birth control to prevent pregnancy while using Arzerra.
If you receive Arzerra while you are pregnant, make sure any doctor caring for your new baby knows that you used the medicine during pregnancy. Using Arzerra during pregnancy could affect the immune system of the unborn baby and your baby's vaccination schedule during the first 6 months of life. Tell your doctor if you are pregnant or if you become pregnant while using this medicine.
Breastfeeding
It is not known whether Arzerra passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How is Arzerra given?
Arzerra is given as an infusion into a vein. A healthcare provider will give you this injection. You may be given other medications to help prevent a reaction to the infusion. You may need to start using these medications up to 2 hours before the start of your Arzerra infusion.
Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Arzerra.
Arzerra is usually given in a 28-day treatment cycle. You may need to use the medicine only during the first 1 or 2 weeks of each cycle. Your dosing schedule may change with further doses. Your doctor will determine how long to treat you with ofatumumab.
Arzerra must be given slowly, and one infusion can take up to several hours to complete.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Arzerra injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving Arzerra?
You should not receive a vaccine while using Arzerra. Some vaccines may not work as well and may not fully protect you from disease. Other vaccines may not be safe for you while you are using Arzerra. Vaccines include shots to prevent influenza, measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and herpes zoster (shingles).
What other drugs will affect Arzerra?
Tell your doctor about all your other medicines, especially:
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drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.
This list is not complete. Other drugs may interact with ofatumumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Who makes Arzerra?
Novartis Pharmaceuticals Corporation makes Arzerra.
Arzerra Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Arzerra.
Arzerra (ofatumumab) - Novartis Pharmaceuticals Corporation
Formulation type | Strength |
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Single-Dose Vial | 1,000 mg/50 mL Discontinued |
Single-Dose Vial | 100 mg/5 mL Discontinued |
Kesimpta (ofatumumab) - Novartis Pharmaceuticals Corporation
Formulation type | Strength |
---|---|
Autoinjector | 20 mg/0.4 mL |
Pre-Filled Syringe | 20 mg/0.4 mL Discontinued |
View Kesimpta information in detail.
Popular FAQ
How is Arzerra administered and how long to work?
Arzerra (ofatumumab) is administered by an intravenous infusion. It is diluted into a sterile bag of 1000mL sodium chloride for intravenous infusion which is then hung up and the infusion administered into one of your veins via an intravenous line. How long the infusion takes depends on your stage of Chronic Lymphocytic Leukemia (CLL) and if you have had treatment before, but initially Arzerra is usually administered over about 6 hours. The time of the infusion may be shortened, depending on how well you tolerate Arzerra. Continue reading
What is Arzerra used for and how does it work?
Arzerra (ofatumumab) is approved by the FDA to treat patients with chronic lymphocytic leukemia (CLL), a type of slowly progressing cancer in your blood and bone marrow. It's an antibody therapy that works with the immune system to attack and destroy cancerous CD20-positive B cells. Continue reading
References
More about Arzerra (ofatumumab)
- Check interactions
- Compare alternatives
- Side effects
- Dosage information
- Patient tips
- During pregnancy
- FDA approval history
- Drug class: CD20 monoclonal antibodies
- Breastfeeding
- En español
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