Ofatumumab (Intravenous)

Overview

When patients have chronic lymphocytic leukemia (CLL), their bone marrow produces too much of a certain type of white blood cell. Although these lymphocytes are produced in abundance, they aren't normally developed and fail to work properly. As a result, patients can be more prone to infections and may suffer from extreme fatigue, unusual bruising or bleeding, swollen lymph nodes in the armpits, groin or neck, night sweats or unexplained weight loss.

As chronic lymphocytic leukemia tends to progress fairly slowly, patients may be diagnosed with the conditions via routine blood screenings and may not experience any symptoms at first. Although treatment cannot normally cure this type of cancer, it can slow the progress of the disease and lead to periods with the patient is asymptomatic.

Ofatumumab is a monoclonal antibody which inhibits B lymphocyte activation at an early stage. By adhering to the CD20 antigen on the B lymphocyte cells, Ofatumumab effectively stops them from replicating and spreading further. In addition to this, Ofatumumab often enables the patient's body to destroy the non-functional lymphocyte cells.

Delivered intravenously, Ofatumumab may be prescribed alongside an antineoplastic chemotherapy drug called Chlorambucil. When used in conjunction, these medications can be successful in reducing the patient's symptoms and slowing the spread of the disease.

Although Ofatumumab is usually prescribed to patients who have yet to undergo treatment for chronic lymphocytic leukemia, it may also be used in patients who have not found treatment with other medicines, such as Fludarabine and Alemtuzumab, beneficial.

Conditions Treated

  • Chronic lymphocytic leukemia (CLL)

Type Of Medicine

  • Monoclonal antibody

Side Effects

When patients are given medication, it's not unusual for them to experience some adverse effects. Side effects may occur more often when treatment is first administered and then reduce over time. When patients are treated with Ofatumumab, they may experience the following side effects:

  • Back pain
  • Redness of the skin
  • Muscle aches
  • Trouble sleeping
  • Muscle spasms
  • Tenderness or pain around the cheekbones or eyes
  • Burning, hives, inflammation, numbness, redness or pain at the injection site
  • Warmth, bleeding, discoloration of the skin, infection or itching at the injection site
  • Soreness, lumps, stinging, feeling of pressure, rash or scarring at the injection site
  • Ulceration, bleeding, swelling, coldness, tingling or tenderness at the injection site

If the above side effects are relatively mild and are not troublesome to the patient, they may not require medical attention. However, if the above side effects are persistent or severe, patients should obtain medical advice.

Patients will also need to access immediate medical assistance if they experience the following side effects while they are being treated with Ofatumumab:

  • Tarry, black stools
  • Swelling or bloating of the arms, face, hands, feet or lower legs
  • Blurred vision
  • Pale skin
  • Body pain or aches
  • Difficult or painful urination
  • Chest pain
  • Painful blisters on the trunk of the body
  • Chills
  • Nausea and/or vomiting
  • Confusion
  • Hoarseness or cough
  • Cough producing mucus
  • Labored or difficult breathing
  • Pain in lower back or side
  • Dizziness
  • Nasal congestion
  • Lightheadedness, dizziness or faintness when getting up suddenly from a sitting or lying position
  • Increased sweating
  • Ear congestion
  • Welts
  • Itching
  • Hives
  • Rash on the skin
  • Facial swelling
  • Loss of voice
  • Fainting
  • Rapid weight gain
  • Fast heartbeat
  • Redness of the neck, arms, face and, sometimes, the upper chest
  • Feeling of warmth
  • Runny nose
  • Headache
  • Shallow, rapid breathing
  • Lightheadedness
  • Sneezing
  • Unusual bruising or bleeding
  • Sore throat
  • Unusual weight loss or gain
  • Tightness in the chest
  • Weakness
  • Tingling of the feet or hands
  • White spots, ulcers or sores in the mouth
  • Unusual weakness or tiredness
  • Troubled breathing
  • Nervousness
  • Troubled breathing with exertion
  • Irregular, pounding or fast pulse or heartbeat
  • Pounding in the ears
  • Loosening, peeling or blistering of the skin
  • Slow heartbeat
  • Dark urine
  • Yellowing of the skin or eyes
  • Diarrhea
  • Unconsciousness
  • Fluid-filled skin blisters
  • Muscle or joint pain
  • Stopping of heart
  • Light-colored stools
  • Skin thinness
  • No pulse or blood pressure
  • Red skin lesions, sometimes with a purple center
  • Irritated, red eyes
  • Sensitivity to the sun

If patients exhibit any symptoms that are not listed above whilst being treated with Ofatumumab, they should also seek medical advice.

Dosage

In most cases, treatment with Ofatumumab is on a cyclic basis. If patients have not previously received treatment for chronic lymphocytic leukemia, they will normally be given 300mg of Ofatumumab as their first dose, followed by 1000mg one week later (day eight of their treatment). Patients may then be given doses of 1000mg on the first day of each twenty eight day cycle, for a minimum of three cycles and a maximum of twelve cycles.

If patients are prescribed Ofatumumab for the extended treatment of chronic lymphocytic leukemia, they are usually given 300mg of medication as their initial dose, followed by 1000mg one week later. Patients may be given another 1000mg dose seven weeks later and subsequent 1000mg doses every eight weeks for a period of two years.

When treatment with other medications has failed, Ofatumumab may be prescribed instead. For these patients, an initial dose of 300mg is normally prescribed, followed by a dose of 2000mg one week later. Patients may then be given 2000mg doses of Ofatumumab per week for a further period of six weeks. After this level of treatment, patients should be given 2000mg of Ofatumumab every four weeks for sixteen weeks. In total, patients receiving Ofatumumab in this way should be given twelve doses of medication.

Often, patients will be given medication, such as corticosteroids and oral acetaminophen, prior to Ofatumumab being administered.

As patients are given Ofatumumab via an intravenous infusion, they will be given this medication in a clinical setting. An experienced healthcare professional will administer the medicine and the patient will not be required to calculate their own dose of Ofatumumab or administer it.

Potential Drug Interactions:

As some drugs can interact with each other when they are used at the same time, patients may not be prescribed Ofatumumab if they are currently taking other medications. Alternatively, their existing treatments may be modified to enable them to begin using Ofatumumab.

When patients are being treated with Ofatumumab, they should not be given the following medications:

  • Measles virus vaccine, live
  • Varicella virus vaccine
  • Rotavirus vaccine, live
  • Mumps virus vaccine, live
  • Rubella virus vaccine, live

Similarly, using the following medicines in conjunction with Ofatumumab is not usually advisable:

  • Adenovirus vaccine
  • Smallpox vaccine
  • Bacillus of Calmette and Guerin vaccine, live
  • Typhoid vaccine
  • Poliovirus vaccine, live
  • Cholera vaccine, live
  • Yellow Fever vaccine
  • Influenza virus vaccine, live

Interactions can also occur between prescribed medications, over the counter medicines, supplements and vitamins. Patients should tell their physician if they are using any of these substances prior to receiving treatment with Ofatumumab. Similarly, patients should obtain medical advice before using any new medicines, vitamins or supplements once they have started treatment with Ofatumumab.

Warnings

If patients have other health conditions or a history of certain conditions, it may affect their treatment with Ofatumumab. Due to this, patients should discuss any current health concerns or conditions with their physician before Ofatumumab is administered. The following conditions, in particular, are relevant if treatment with Ofatumumab is proposed:

  • Infection
  • Hepatitis B

If is not known how Ofatumumab affects pediatric patients. As the efficacy and safety of this drug has not been tested on children or infants, Ofatumumab is not usually prescribed to pediatric patients.

Ofatumumab may be prescribed to geriatric patients, but these patients may be more likely to experience side effects as a result of treatment. Due to this, elderly patients should be carefully monitored when they are being treated with this medication.

During treatment with Ofatumumab, patients will need to have regular check ups and regular blood and urine tests. This helps to confirm that the medication is working and that the patient isn't suffering from any unwanted effects.

On occasion, Ofatumumab can cause patients to suffer a serious reaction known as tumor lysis syndrome. Patients may be given prophylactic medication to try and prevent this, but should obtain immediate medical help if they experience the following symptoms:

  • Joint pain
  • Change or decrease in urine amount
  • Pain in side, lower back or stomach
  • Swelling and stiffness
  • Swelling of the lower legs or feet
  • Rapid weight gain
  • Unusual weakness or tiredness

Treatment with Ofatumumab can temporarily lower the number of platelets and white blood cells in the patient's blood. As a result, patients may be more prone to infections and may experience problems with blood clotting.

Due to this, patients will need to take steps to avoid cutting themselves or sustaining any injuries. Patients should not take part in contact sports, for example, may want to avoid crowds, should take extra care when using a razor or nail scissors and should modify their oral hygiene routine to reduce the risk of bleeding gums. Patients should also avoid people that they know are unwell and should seek immediate medical attention if they feel ill or develop symptoms associated with an infection.

Ofatumumab can increase the risk of patients developing progressive multifocal leukoencephalopathy (PML). This is a rare and serious brain infection. Patients must obtain immediate medical help if they experience more than one of the following symptoms:

  • Clumsiness
  • Loss of coordination
  • Memory loss
  • Vision changes
  • Difficulty understanding what others are saying
  • Difficulty speaking
  • Weakness in the legs

If patients exhibit any of the following symptoms when using Ofatumumab, they may be suffering from a liver problem and should obtain immediate medical assistance:

  • Fever
  • Right-sided abdominal pain
  • Dark brown urine
  • Severe tiredness
  • Yellowing of the skin or eyes
  • Stomach pain

When patients are being treated with Ofatumumab, they should not have any live vaccines without their doctors express approval.

Ofatumumab should be used with caution in pregnant patients as it may pose a risk to the unborn fetus. This medicine should only be used to treat pregnant patients if the benefits clearly outweigh the risks.

It is not known whether Ofatumumab is transferred via breastmilk and if it could cause harm to an infant. Due to this, patients are usually advised not to breastfeed whilst they are receiving treatment with Ofatumumab. If patients are planning to breastfeed after treatment with Ofatumumab, they should obtain medical advice, as the drug may remain in their system for some time.

If patients experience the following symptoms after being treated with Ofatumumab, they should alert their physician immediately and obtain emergency medical assistance:

  • Lightheadedness
  • Dizziness
  • Chills
  • Fever
  • Chest pain
  • Itching
  • Flushing of the face
  • Rash on the skin
  • Hives
  • Fainting
  • Troubled breathing
  • Swelling of the tongue, throat or face

Storage

In order to store Ofatumumab safely, vials should kept in accordance with the manufacturer's instructions or the medication guideline.

Generally, undiluted and unused vials of Ofatumumab can usually be stored in a refrigerator. They should be kept between a temperature of 2?-8?C (36?-46?F) and must be protected from the light. Once Ofatumumab vials have been diluted and prepared for use, they must be kept in a refrigerator, between temperatures of 2?-8?C (36?-46?F). The prepared solution should be administered within twelve hours and should be discarded after a period of twenty four hours.

As Ofatumumab is only administered in a clinical setting, such as a hospital or a treatment center, patients should not be required to store this medication at home at any time.

Summary

As chronic lymphocytic leukemia does not always cause symptoms, patients may not realize that they have the disease until it is diagnosed via unrelated medical tests. Although CLL is a serious condition, the disease tends to progress fairly slowly. In some cases, physicians may decide to monitor the patient's condition before beginning treatment with Ofatumumab and similar medications.

When Ofatumumab is used, it can successfully slow the disease down and stop it progressing at its normal rate. In addition to this, Ofatumumab can reduce the patient's symptoms (if they are symptomatic) and enable the patient to continue with their life as normal.

Although Ofatumumab is usually prescribed to patients who have yet to receive treatment for CLL, it can also be appropriate for patients who have failed to respond to other medications. If patients have previously been treated with Fludarabine, for example, and have not responded, Ofatumumab may be used as an alternative.

Whilst Ofatumumab can be used in isolation, it is often prescribed in conjunction with Chlorambucil. By administering a monoclonal antibody in the form of Ofatumumab and chemotherapy in Chlorambucil, physicians can increase the effectiveness of treatment and help to prevent the patient's condition from worsening.