OBINUTUZUMAB

Background and Date of Approval

Obinutuzumab is an anticancer medication classified as an anti-CD20 monoclonal antibody. The FDA approved it in 2013 for treating chronic lymphocytic leukaemia (CLL) and non-Hodgkin's lymphoma (NHL) in adults.

Uses

Obinutuzumab is an intravenously administered drug. It is used in combination with other anticancer medicines to treat chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL) in adults. It works by killing and stopping cancer cells from growing.

How is it administered?

Obinutuzumab is a prescription medicine available as an injection. It will be given to you by a doctor or nurse in a hospital or clinic setting trained in cancer chemotherapy. It is given as an intravenous infusion drip (into your vein) for several hours. Do not self-administer the injection. Your doctor will decide the dose and duration of the treatment based on your disease severity, body weight, and other factors. Your doctor will give you certain medications to lessen the chance of getting side effects from the obinutuzumab treatment.

Side Effects

The common side effects of Obinutuzumab are hair fall, constipation, diarrhea, anemia, decreased WBC and platelets, infection, muscle pain, headache, insomnia, urinary tract infections, cough, fever, tiredness, and decreased appetite. Other side effects are bleeding in the stomach, anemia, hypersensitivity reactions, brain problems, and severe infections.

Warnings

This drug is intended to reactivate hepatitis B infection. Inform your doctor if you have or had hepatitis B. Obituzumab may cause severe infusion reactions including dizziness, nausea, chills, fever, vomiting, diarrhea, breathing problems, or chest pain. Notify your physician immediately if you experience any of the symptoms mentioned above. Report to your doctor if you face any symptoms of memory loss, trouble speaking, difficulty walking, or problems with your eyesight during the treatment with obinutuzumab because these may indicate rare and life-threatening side effects.

Precautions

Inform your physician if you have an active infection, or suffered from any infections, weak immune system, have or had heart problems, brain disorders, eye disorders, breathing problems, and liver diseases. Onibutuzumab should not be used in pregnant and breastfeeding women. Inform your physician if you are pregnant or breastfeeding. Use effective contraception throughout the therapy to avoid pregnancy. Do not take this injection if you are allergic to Onibutuzumab or any other ingredients of this medicine. Your healthcare professional may advise you to take certain blood tests to monitor the effectiveness and side effects of the therapy. Inform your healthcare provider about all the medicines you take, including prescription medications, over-the-counter medications, vaccinations, nutritional and vitamin supplements, and herbal products. Certain medications may interact with obinutuzumab and reduce its effectiveness by causing undesirable side effects.

Word of Advice

Store obinutuzumab in the refrigerator between 2°C and 8°C. Do not freeze. Keep the injection out of reach of children and pets. If you have missed any dosing appointments, inform your doctor and arrange to reschedule immediately. Obinutuzumab may interfere with vaccines; inform your physician before receiving any flu vaccine or other vaccines. This injection may cause severe birth defects if administered during pregnancy. Female patients with reproductive potential should use effective contraception during treatment. Do not breastfeed during treatment and for 6 months after your last dose. This medicine may increase bleeding, bruising, or susceptibility to infections. Take precautions to prevent illness and injury. Wash your hands frequently. Your doctor may recommend certain tests to monitor the effectiveness of therapy.

References

Gazyvaro 1,000 mg concentrate for solution for infusion - Patient Information Leaflet (PIL) - (emc). www.medicines.org.uk. [Revised 2022] [cited 2023 Apr 25]. Available from: https://www.medicines.org.uk/emc/product/3279/pil GAZYVA-obinutuzumab injection. [revised on 2017] [cited 2023 Apr 25]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125486s017s018lbl.pdf Jenny O’Nions, William Townsend et al; The role of obinutuzumab in the management of follicular lymphoma; Future Oncology; Published on Nov 2019; Accessed on 25/04/2023; https://pubmed.ncbi.nlm.nih.gov/31538821/

Frequently Asked Questions

What are the infusion reactions that might happen during obinutuzumab infusion?

Allergic reactions like itching, swelling in your face or hands, tingling in mouth or throat, chest tightness, difficulty in breathing, fever, chills, cough, sore throat, body aches, unusual bleeding, bruising, or weakness should be informed to your doctor immediately.

How long should I have to take Obinutuzumab?

Obinutuzumab is given as a cycle therapy. Your doctor will decide the dose and duration of the therapy based on your disease severity and condition.

What is the infusion time of obinutuzumab?

Generally, obinutuzumab is given as an infusion intravenously (into your vein). The infusion should be not given for more than 4 hours. Your doctor will decide the duration of the infusion based on your disease condition, and other factors.

Is obinutuzumab better than rituximab?

The anti-CD20 monoclonal antibodies rituximab and obinutuzumab differ in their mechanisms of action, with obinutuzumab evoking greater direct B cell death. Your doctor will decide the best therapy that works for you based on the condition and severity of the disease.

Can obinutuzumab cause shortness of breath?

Obinutuzumab can cause infusion-related reactions like shortness of breath. If you face any symptoms inform your doctor immediately and seek medical advice.

Available Brands 1

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS