Briumvi

This medication is used to treat multiple sclerosis (MS). Ublituximab is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. Ublituximab belongs to a class of drugs known as monoclonal antibodies. It helps decrease the number of episodes of disease worsening (relapses) and may prevent or delay disability.

Read the Medication Guide provided by your pharmacist before you start using ublituximab and each time you get an infusion. If you have any questions, ask your doctor or pharmacist.

This medication is given by a health care professional. It is given as directed by your doctor on a treatment schedule. It is injected slowly into a vein over 1 to 4 hours depending on your treatment schedule. The first 2 infusions are usually given 2 weeks apart. After that, an infusion is usually given once every 24 weeks. Follow your doctor's treatment schedule.

Infusion reactions may happen while you are receiving this medication and for up to 24 hours after treatment. To prevent these side effects, your doctor will prescribe other medications (such as methylprednisolone, diphenhydramine) for you to receive before each injection. Carefully follow your doctor's instructions. Your health care professional will also closely monitor you during the infusion and for at least 1 hour afterward. Tell your doctor right away if you have symptoms such as rash, itching, trouble breathing, throat swelling/pain, fever, chills, fainting, flushing of the face, nausea, headache, dizziness, or fast heartbeat. Your doctor may slow down or stop your infusion if you have infusion reactions. You should not receive ublituximab again if you had a life-threatening infusion reaction.

The dosage and treatment schedule are based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, mark the days on a calendar you need to receive this medication.

See also How to Use section.

Cold symptoms such as stuffy/runny nose or cough may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infections (such as sore throat or cough that doesn't go away, fever, chills, painful urination).

This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these new or worsening side effects clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using ublituximab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of current/past/returning infections (including hepatitis B, herpes, tuberculosis).

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Ublituximab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Your doctor may direct you to have any required vaccines at least 2 to 4 weeks before starting this medication. Tell your health care professional that you are using ublituximab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ublituximab. Ublituximab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 6 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Lab and/or medical tests (such as immunoglobulin levels, tests for hepatitis B) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.