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Arzerra (Generic Ofatumumab Injection (Chronic Lymphocytic Leukemia))

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WARNING

You might already have hepatitis B (a virus that affects the liver and can result in serious liver damage), but you might not be aware of it. The risk that your infection may worsen or become life-threatening in this situation and that you will have symptoms may be increased by the ofatumumab injection. If you have or have ever had hepatitis B virus infection, let your doctor know. To determine whether you have an inactive hepatitis B virus infection, your doctor will request a blood test. Before and throughout your ofatumumab therapy, your doctor may prescribe you medication to treat this infection if necessary. Throughout and for a few months after your treatment, your doctor will continue to keep an eye out for any symptoms of hepatitis B infection. Call your doctor right away if you suffer any of the following symptoms during or following your treatment: extreme fatigue, yellowing of the skin or eyes, appetite loss, nausea or vomiting, aches and pains in the muscles or abdomen, or dark urine.

Progressive multifocal leukoencephalopathy (PML; an uncommon infection of the brain that cannot be treated, avoided, or cured and typically results in death or severe disability) has been reported in some ofatumumab recipients during or after their therapy. Call your doctor right away if you have any of the following symptoms: Dizziness, loss of balance, trouble speaking or walking, new or sudden changes in vision, or any other strange symptoms that appear quickly are examples of new or sudden changes in thinking or confusion.

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to the ofatumumab injection, your doctor will request a few lab tests.

Discuss the dangers of using ofatumumab injection with your doctor.

Why is this medication prescribed?

Ofatumumab injection is used to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells):

  • Combined with chlorambucil in patients who have not undergone fludarabine treatment or who are unable to undergo fludarabine treatment (Fludara).
  • When CLL has recurred following treatment, in combination with fludarabine (Fludara) and alemtuzumab (Campath).
  • As an additional course of treatment for CLL patients whose condition has totally or partially improved following at least two lines of therapy.
  • In patients who have not responded to therapy with alemtuzumab plus fludarabine (Fludara) (Campath).

Ofatumumab injection belongs to the group of drugs known as monoclonal antibodies. It eliminates cancer cells to work.

Ofatumumab, which is used to treat multiple sclerosis, is additionally offered as an injection (Kesimpta) (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Only ofatumumab injection (Arzerra) for the treatment of chronic lymphocytic leukaemia is discussed in this monograph. Read the Ofatumumab Injection monograph if you are getting ofatumumab for multiple sclerosis (Multiple Sclerosis).

How should this medicine be used?

Ofatumumab injection is available as a solution (liquid) that must be mixed with fluid before being administered intravenously (into a vein) by a medical professional in a clinic or hospital. Typically, it is injected once each week. Your health and how well you respond to treatment will determine how long your treatment will last.

Ofatumumab side effects could manifest during or up to 24 hours following your treatment. 30 to 2 hours prior to the administration of each dose of ofatumumab injection, your doctor will administer additional drugs to prevent or treat certain adverse effects. If you suffer fever, chills, rash, or breathing difficulties while receiving ofatumumab, call your doctor right away. As you have your ofatumumab injection treatment, be sure to let your doctor know how you are feeling.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before receiving ofatumumab injection,

  • If you have an allergy to ofatumumab, any other drugs, or any of the ingredients in ofatumumab injection, let your doctor and pharmacist know right once. Request a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • If you have or have previously had chronic obstructive pulmonary disease, let your doctor know (COPD; a group of diseases that affect the lungs and airways)
  • Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor if you fall pregnant while receiving an injection of ofatumumab.
  • Inform your doctor or dentist that you received an injection of ofatumumab if you are having surgery, including dental surgery.
  • Before you start your ofatumumab treatment, check with your doctor to see whether you need any vaccines. Without consulting your doctor, avoid getting any immunizations while you are receiving therapy.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What side effects can this medication cause?

The injection of ofatumumab may have unwanted effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Spasms of muscles
  • Runny or stuffed nose
  • Diarrhea
  • Headache
  • Trouble sleeping

Some adverse effects can be very harmful. Call your doctor right away if you have any of the following symptoms or any of those in the IMPORTANT WARNING section:

  • Breathing or swallowing challenges
  • Heavy perspiration
  • Swelling of the lower legs, hands, feet, ankles, or face, neck, tongue, lips, eyes, or mouth
  • Hoarseness
  • Sudden facial, neck, or upper chest redness
  • Weakness
  • Uncommon bruising or bleeding
  • Light skin
  • Red dots under the skin that are small, flat, and spherical.
  • Rash
  • Hives
  • Fever, chills, a cough, a sore throat, or other infection-related symptoms
  • Arms, back, neck, or jaw pain
  • A chestache,
  • Rapid heart rate
  • Fainting

Other negative effects from ofatumumab injection are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Ask your pharmacist any inquiries you may have regarding the injection of ofatumumab.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Arzerra®
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