Obinutuzumab

Generic name: Obinutuzumab
Brand names: Gazyva
Dosage form: intravenous (infusion) injection
Drug class: CD20 monoclonal antibodies

Usage of Obinutuzumab

Obinutuzumab is a type of targeted chemotherapy drug for the treatment of certain blood cancers.

Obinutuzumab is a biological drug called a monoclonal antibody that targets and attaches to CD20, a protein found on the surface of a type of white blood cells called B-cells.

B-cells, or B-lymphocytes as they are also known, usually help your body fight off infection, but some people produce abnormal numbers of B-cells which leads to cancer.

Obinutuzumab works by binding to normal and cancerous B-cells, marking them for destruction. Obinutuzumab works by calling in your own immune system cells to attack and break apart the marked B-cells, and by activating processes within the B-cells that instruct them to die.

Obintuzumab was approved by the US Food and Drug Administration (FDA) in 2013. No biosimilars of obintuzumab have been approved. Biosimilars are highly similar versions of the drug that are designed to have the SAMe effect on a person, but a biosimilar is not identical to the original version of the drug.

Obinutuzumab side effects

Obinutuzumab can cause serious side effects including:

  • See "Important information" above
  • Hepatitis B virus Reactivation
  • Progressive multifocal leukoencephalopathy
  • Infusion-Related Reactions (IRRs): These side effects may occur during or within 24 hours of any obinutuzumab infusion. Some IRRs can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening IRRs. If you have a reaction, the infusion is either slowed or stopped until your symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the IRR is life-threatening, the infusion of obinutuzumab will be permanently stopped. Your healthcare team will take steps to help lessen any side effects you may have to the infusion process. You may be given medicines to take before each obinutuzumab treatment. Symptoms of IRRs may include:
  • fast heartbeat
  • tiredness
  • dizziness
  • headache
  • redness of the face
  • nausea, chills
  • fever
  • vomiting
  • diarrhea
  • rash
  • high blood pressure
  • low blood pressure,
  • difficulty breathing
  • chest discomfort
  • Hypersensitivity Reactions Including Serum Sickness: Some people receiving obinutuzumab may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, your doctor will stop the infusion and permanently discontinue obinutuzumab.
  • Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including fatal cases, has been reported in patients receiving obinutuzumab. Obintuzumab works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart and may lead to kidney failure requiring the need for dialysis treatment. Your doctor may prescribe medication to help prevent TLS. Your doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include:
  • nausea
  • vomiting
  • diarrhea
  • tiredness
  • Infections: While you’re taking obinutuzumab, you may develop infections. Some of these infections may be fatal and severe, so be sure to talk to your doctor if you think you have an infection. Patients administered obinutuzumab in combination with chemotherapy, followed by obintuzumab alone are at a high risk of infections during and after treatment. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with obinutuzumab. Patients taking obinutuzumab plus Bendamustine may be at higher risk for fatal or severe infections compared to patients taking obintuzumab plus CHOP or CVP.
  • Low White Blood Cell Count: When you have an abnormally low count of infection-fighting white blood cells, it is called Neutropenia. While you are taking obinutuzumab, your doctor will do blood work to check your white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with obinutuzumab. Some cases of neutropenia can last for more than one month. If your white blood cell count is low, your doctor may prescribe medication to help prevent infections.
  • Low Platelet Count: Platelets help stop bleeding or blood loss. Obinutuzuamb may reduce the number of platelets you have in your blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While you are taking obinutuzumab, your doctor will do blood work to check your platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with obinutuzumab. Fatal bleeding events have occurred in patients treated with obinutuzumab. If your platelet count gets too low, your treatment may be delayed or reduced

    • The most common side effects seen with obinutuzumab in a study that included previously untreated follicular lymphoma patients were:

  • infusion-related reactions
  • low white blood cell count
  • upper respiratory tract infections
  • cough
  • constipation
  • diarrhea

    • These are not all of the possible side effects of obinutuzumab. Tell your healthcare provider about all of your side effects. Call your doctor or pharmacist for medical advice about side effects. You may report side effects to Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Before taking Obinutuzumab

    Tell your doctor if you are pregnant, think that you might be pregnant, or plan to become pregnant. Obinutuzumab may harm your unborn baby. Speak to your doctor about using obinutuzumab while you are pregnant. Talk to your doctor or your child’s doctor about the safety and timing of live virus vaccinations to your infant if you received obinutuzumab during pregnancy. Women of childbearing potential should use effective contraception while taking obinutuzumab and for 6 months after your treatment.

    Tell your doctor if you are breastfeeding or plan to breastfeed. Because of the potential risk of serious side reactions in breastfed children, women should not breastfeed while taking obinutuzumab and for 6 months after your last dose.

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    How to use Obinutuzumab

  • Before administration of obinutuzumab, you will receive medication to help prevent infusion-related reactions and tumor lysis syndrome.
  • Obinutuzumab is administered by intravenous infusion. It is not administer as an intravenous push or bolus.
  • The recommended doSage for chronic lymphocytic leukemia is obinutuzumab 100 mg on day 1 and 900 mg on day 2 of Cycle 1, 1,000 mg on day 8 and 15 of Cycle 1, and 1,000 mg on day 1 of Cycles 2–6.
  • The recommended dosage for follicular lymphoma is obinutuzumab 1,000 mg on day 1, 8 and 15 of Cycle 1, 1,000 mg on day 1 of Cycles 2-6 or Cycles 2-8, and then 1,000 mg every 2 months for up to 2 years.
  • See the full prescribing information for further details about obinutuzumab dosing.

    • Warnings

    Obintuzumab can cause serious side effects including:

  • Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If you have a history of hepatitis B infection, obintuzumab could cause it to return. You should not receive obintuzumab if you have active hepatitis B liver disease. Your doctor or healthcare team will need to screen you for hepatitis B before, and monitor you during and after, your treatment with obintuzumab. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. Your weakened immune system could put you at risk. Your doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems

    • What other drugs will affect Obinutuzumab

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    Especially tell your doctor if you take medication:

  • for high blood pressure (hypertension). Your doctor may tell you not to take your medication for high blood pressure on the day of you obinutuzumab infusion.
  • that may increase your risk of bleeding, such as blood thinners or medications to prevent clots. Check with your pharmacist if you are not sure. Your doctor may tell you not to take these medications, especially during your first treatment cycle.

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