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Care During Chemotherapy and Beyond

Inotuzumab Ozogamicin

(in-oh-TOOZ-ue-mab oh-zoe-ga-MYE-sin)

Trade Name(s): Besponsa®

Inotuzumab ozogamicin is the generic name for the trade name drug Besponsa® when referring to the generic drug name inotuzumab ozogamicin.

Drug Type: Inotuzumab ozogamicin is a monoclonal antibody combined with an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as an "Anti-CD22 monoclonal antibody and antineoplastic agent." (For more detail, see "How Inotuzumab Ozogamicin Works" below).

What Inotuzumab Ozogamicin Is Used For

  • B-cell acute lymphoblastic leukemia (ALL) that has relapsed or is refractory to treatment

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Inotuzumab Ozogamicin Is Given

  • Inotuzumab ozogamicin is given as an infusion into the vein over 1 hour
  • You will be given acetaminophen, a corticosteroid, and an antihistamine approximately 30 minutes before the infusion to reduce the risk of infusion related reactions
  • Because of side effects, inotuzumab ozogamicin must be administered to you while you are hospitalized (as an inpatient).

The amount of inotuzumab ozogamicin that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.

Side Effects

Important things to remember about the side effects of inotuzumab ozogamicin:

  • Most people will not experience all of the inotuzumab ozogamicin side effects listed.
  • Inotuzumab ozogamicin side effects are often predictable in terms of their onset, duration, and severity.
  • Inotuzumab ozogamicin side effects will improve after therapy is complete.
  • Inotuzumab ozogamicin side effects may be quite manageable. There are many options to minimize or prevent the side effects of inotuzumab ozogamicin.

The following side effects are common (occurring in greater than 30%) for patients taking inotuzumab ozogamicin:

These are less common side effects (occurring in 10-29%) for patients receiving inotuzumab ozogamicin:

This is a rare but serious side effects of inotuzumab ozogamicin:

  • Veno-Occlusive Disease (VOD)
    • A serious, but uncommon side effect of inotuzumab ozogamicin is veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome. VOD is most common in patients who have been treated with high dose chemotherapy followed by bone marrow or stem cell transplant. VOD is characterized by painful enlarged liver, rapid weight gain from fluid retention, and rising bilirubin levels. Two of the three in a post-treatment setting must be present to establish the diagnosis. Additional testing will reveal elevated liver enzymes (alkaline phosphatase and gamma-glutamyl transferase), as well as a reversal of blood flow in the veins of the liver on ultrasound. Once VOD occurs, the chances for other organs to fail increases dramatically and potentially fatal multi-organ failure may occur.

Not all side effects are listed above. Side effects that are very rare - occurring in less than about 10 percent of patients - are not all listed here. But you should always inform your health care provider if you experience any unusual symptoms.

When to Contact Your Doctor or Health Care Provider

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

  • Fever of 100.4º F (38º C) or higher, chills (possible signs of infection)
  • Shortness of breath, wheezing, difficulty breathing, closing up of the throat, swelling of facial features, hives (possible allergic reaction)

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

  • Nausea (interferes with ability to eat and unrelieved with prescribed medication)
  • Vomiting (vomiting more than 4-5 times in a 24-hour period)
  • Diarrhea (4-6 episodes in a 24-hour period)
  • Unusual bleeding or bruising
  • Black or tarry stools, or blood in your stools
  • Blood in the urine
  • Pain or burning with urination
  • Extreme fatigue (unable to carry on self-care activities)
  • Mouth sores (painful redness, swelling or ulcers)

Always inform your health care provider if you experience any unusual symptoms.

Precautions

  • Before starting inotuzumab ozogamicin treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
  • Do not receive any kind of immunization or vaccination without your doctor's approval while taking inotuzumab ozogamicin.
  • Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Inotuzumab ozogamicin may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.
  • For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking inotuzumab ozogamicin. Women of reproductive potential should use effective contraception during therapy and for at least 8 months after the last dose. Effective contraception should also be used for at least 5 months after the last dose when treating males who have female partners of reproductive potential. Barrier methods of contraception, such as condoms, are recommended.
  • Do not breast feed while taking inotuzumab ozogamicin and for at least two months after the last dose.

Self-Care Tips

  • Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
  • You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
  • Wash your hands often.
  • Use an electric razor and soft toothbrush to minimize bleeding.
  • Avoid contact sports or activities that could cause injury.
  • To reduce nausea, take anti-nausea medications as prescribed by your doctor, and east small, frequent meals.
  • Keep you bowels moving. Your healthcare provider may prescribe a stool softener to prevent constipation that may be caused by this medicine (see managing side effects - constipation)
  • Follow regimen of anti-diarrhea medication as prescribed by your health care professional.
  • Eat food that may help reduce diarrhea (see managing side effects - diarrhea)
  • In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
  • Get plenty of rest.
  • Maintain good nutrition.
  • If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing While Taking Inotuzumab Ozogamicin

You will be checked regularly by your doctor while you are taking inotuzumab ozogamizin, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.

Prior to starting treatment, your doctor will also monitor an ECG (electrocardiogram) in order to check for something known as QT prolongation which can increase your risk for heart arrhythmias (irregular heart rhythms). This can also be checked anytime other medications are added to your regimen that are also known to cause QT prolongation.

How Inotuzumab Ozogamicin Works

Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because on feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.

Targeted therapy is about identifying other features of cancer cells. Scientists look for specific difference in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.

There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies.

Researchers agree that targeted therapies are no a replacement for traditional therapies. They may be used best in combination with traditional therapies. More research is needed to identify which cancer may be best treated with targeted therapies and to identify additional targets for more types of cancer.

Inotuzumab ozogamicin is a humanized monoclonal antibody-drug conjugate which targets and binds to CD-22 (found on the surface of B cells). Once the drug attaches to the cancer cells, there is release of something known as calicheamicin. Calicheamicin is very toxic to living cells, therefore is responsible for stopping further cell division, and causing cancer cell death.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

References:

  • Besponsa (inotuzumab ozogamicin) [prescribing information]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; August 2017.
  • Lexicomp Online®. Hudson, Ohio: Lexi-Comp, Inc.; March 13, 2018.

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