Uplizna

This medication is used to treat a certain nervous system disorder that affects the eye (optic) nerve and spinal cord (neuromyelitis optica spectrum disorder-NMOSD). Inebilizumab belongs to a class of drugs known as monoclonal antibodies. It is not a cure for NMOSD but is thought to help by preventing immune system cells from attacking the nerves in your brain and spinal cord. This effect may help to reduce the risk of attacks and delay or slow disability.

This monograph is about the following inebilizumab product: inebilizumab-cdon.

Read the Medication Guide provided by your pharmacist before you start receiving inebilizumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Before each dose, your doctor will direct you to take other medications (such as acetaminophen, diphenhydramine, corticosteroids) to help prevent side effects. Also, your doctor will monitor you for about an hour after each injection. Carefully follow your doctor's directions for all your medications.

This medication is given by slow injection into a vein as directed by your doctor. The injection is given by a health care professional, usually over about 90 minutes. The first 2 doses are usually given 2 weeks apart. Later doses are usually given every 6 months.

Tell your health care professional if you have symptoms during or right after the injection such as nausea, fever, flushing, mild rash/itching, shortness of breath, tiredness, headache, or muscle aches. Your doctor may temporarily stop or slow down the injection, or give you medication to help decrease symptoms.

Tell your doctor if your condition does not get better or if it gets worse.

Joint pain, back pain, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 infection (such as sore throat that doesn't go away, fever, chills, cough, painful/frequent 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 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 inebilizumab, 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/recent infection (especially of hepatitis B).

Inebilizumab 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.

Do not have immunizations/vaccinations without the consent of your doctor. Your doctor may direct you to have any required vaccines at least 4 weeks before starting this medication. 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 inebilizumab. Inebilizumab may harm an unborn baby. 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 drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for at least 6 months after the last dose is not recommended. Consult your doctor before breast-feeding.

Not applicable. This medication is given in a clinic or hospital 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.

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 complete blood count, 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.