Columvi

Generic name: Glofitamab-gxbm
Dosage form: intravenous infusion
Drug class: CD20 monoclonal antibodies

Usage of Columvi

Columvi (glofitamab-gxbm) is an immunotherapy treatment that may be used to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after at least 2 lines of systemic therapy.

Large B-cell lymphoma is an aggressive type of non-Hodgkin’s lymphoma (NHL) resulting from the malignant proliferation of B cells during their various stages of development. LBCL is one of the most prevalent types of blood cancer among adults.

The approval of Columvi represents a much-needed further treatment option for B-cell lymphoma patients and was based on impressive results including a 56% overall response rate and a complete response rate of 43%. 68.5% of patients experienced a long-lasting response of 9 months or longer (median duration of response, 18.4 months).

Columvi belongs to a new class of medicines known as CD20×CD3 T-cell engaging bispecific monoclonal antibodies. It was granted accelerated approval by the FDA on June 15, 2023.

Columvi side effects

The most common side effects include:

Cytokine release syndrome (CRS)

Musculoskeletal pain

Rash

Fatigue.

Other side effects include:

Constipation

Diarrhea

Edema

Fever

Nausea

Abdominal pain

Tumor flare

Headache.

May also cause Grade 3 to 4 laboratory abnormalities such as decreases in lymphocytes, phosphate, potassium, sodium, calcium, neutrophils, and fibrinogen. Uric acid levels and gamma-glutamyl transferase may increase. Anemia and thrombocytopenia can also occur.

Before taking Columvi

Before each dose of Columvi, you will be given premedication to reduce the risk of CRS. The step-up dosing schedule of glofitamab-gxbm outlined in the product information will also be followed. If CRS occurs, then Columvi will be withheld until it resolves or permanently discontinued depending on severity.

You will be monitored for neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which can be severe.

Columvi can cause serious or fatal infections. You will be monitored for signs and symptoms of infection and treated appropriately.

Can cause serious tumor flare reactions.

Patients at risk of tumor lysis syndrome should be adequately hydrated before treatment and administered anti-hyperuricemics.

Your doctor may prescribe antiviral prophylaxis to prevent herpes virus reactivation or to reduce the risk of cytomegalovirus. Pneumocystis jirovecii Pneumonia (PJP) prophylaxis may also be considered.

May cause fetal harm. If you are a female of reproductive potential, there is a risk to the unborn baby if you become pregnant and you must use effective contraception while being administered Columvi and for at least one month after the last dose.

Do not breastfeed while being administered Columvi.

Relate drugs

How to use Columvi

Columvi must be administered by a healthcare professional in an appropriate facility with immediate access to medical support including supportive medications to manage cytokine release syndrome (CRS).

Seven days before treatment with Columvi, patients should be pretreated with a single 1,000mg dose of Obinutuzumab (Gazyva) administered by intravenous infusion. This depletes circulating and lymphoid tissue B cells.

Patients should be adequately hydrated before Columvi administration.

Premedicate with dexamethasone IV, oral acetaminophen, and an antihistamine (such as diphenhydramine 50mg oral/IV) at least 30 minutes to 1 hour before the Columvi infusion as detailed in the product information.

Administer Columvi as an intravenous infusion according to the step-up dosing schedule detailed in the product information. Patients should remain hospitalized during and for 24 hours post-infusion of step-up dose 1 because of the risk of CRS. The infusion is usually given over 4 hours for the first 2 cycles. This may be increased to 8 hours in those experiencing CRS.

For subsequent doses, patients who experienced CRS of at least Grade 2 should be hospitalized for 24 hours post-infusion.

Warnings

Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving Columvi. CRS happens when there is a large release of messenger proteins (cytokines) from immune cells that have been activated by immunotherapy treatment. Symptoms can be mild to moderate such as fever, chills, nausea, headache, rash, irritated throat, nausea, and vomiting. Severe symptoms can be life-threatening and include low blood pressure, cardiovascular problems, and reduced oxygen levels.

Your doctor should provide you with a Patient Wallet Card that describes the symptoms of CRS and what to do about them.

What other drugs will affect Columvi

Columvi causes the release of cytokines that may suppress the activity of CYP enzymes, resulting in higher concentrations of the many other medications that are broken down by these enzymes.

This is most likely to happen after the first dose of Columvi on Cycle 1 and up to 14 days after the first 30 mg dose on Cycle 2. It can also happen during and after CRS.

Tell your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Popular FAQ

Monoclonal antibodies (mAbs) are man-made proteins that mimic the natural antibodies produced by our immune systems. Monoclonal antibodies can be formulated into medicines to treat various types of illnesses, such as cancer, rheumatoid arthritis or psoriasis. Continue reading

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.