Uplizna
Medication Quick Facts
📋Overview
Uplizna is a monoclonal antibody that targets the CD19 protein found on the surface of B-lymphocytes. By binding to these specific immune cells, the medication triggers their removal from the circulation.
This depletion of B cells is the primary mechanism by which the therapy exerts its effects on the immune system. It is designed to reduce the number of these cells circulating throughout the body.
Educational information only
This content is provided for general health education and awareness and is based on publicly available medical information. It is not intended to replace professional medical advice, diagnosis, or treatment, and should not be used to make healthcare decisions. Always seek the guidance of a qualified healthcare professional regarding any medical condition, medication, supplement, or procedure.
Neuromyelitis Optica Spectrum Disorder (NMOSD)
Uplizna is a prescription medication used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults. NMOSD is a rare autoimmune disease that affects the central nervous system, specifically the optic nerves and the spinal cord.
This treatment is only for individuals who are anti-aquaporin-4 (AQP4) antibody positive. A blood test is required to confirm the presence of these antibodies before treatment begins.
Prevention of Attacks
Uplizna is used to reduce the risk of NMOSD attacks, also known as relapses. These attacks can cause various neurological symptoms, such as:
- Vision loss or pain in the eyes
- Weakness or paralysis in the arms or legs
- Numbness or loss of sensation
- Problems with bladder or bowel function
The medication is designed for ongoing use to help prevent future episodes and is not used to treat an active attack that is already in progress.
Targeting B Cells
Uplizna is a monoclonal antibody designed to target a specific protein called CD19. This protein is found on the surface of B cells, which are white blood cells that are part of the immune system.
How It Protects the Nervous System
In patients with neuromyelitis optica spectrum disorder (NMOSD), the immune system incorrectly attacks the central nervous system, including the optic nerves and spinal cord. This attack is often driven by B cells that produce harmful antibodies.
When Uplizna binds to the CD19 protein on these B cells, it causes the body to deplete or remove them from circulation. By reducing the number of these specific immune cells, the medication helps to:
- Lower the production of antibodies that cause inflammation and nerve damage.
- Decrease the likelihood of disease relapses or attacks.
- Limit the damage to the protective coating of the nerves.
The exact way the drug works to improve the condition is through this targeted depletion of B cells, which calms the overactive immune response characteristic of NMOSD.
Common Side Effects
The most common side effects reported by patients using Uplizna include:
- Urinary tract infections
- Joint pain (arthralgia)
- Headache
- Back pain
Serious Side Effects
Uplizna can cause serious side effects that may require medical intervention. These include:
- Infusion reactions: These reactions can occur during the infusion or within 24 hours after treatment. Symptoms may include fever, chills, headache, nausea, rash, muscle aches, or sleepiness.
- Increased risk of infections: Uplizna affects the immune system, which can increase the risk of serious or life-threatening infections. This includes new bacterial, fungal, or viral infections, as well as the reactivation of existing conditions like hepatitis B or tuberculosis.
- Low white blood cell counts: A decrease in certain white blood cells (neutrophils or lymphocytes) can occur, making it harder for the body to fight off germs.
- Low antibody levels: The medication may lower the levels of immunoglobulins (antibodies) in the blood, which can further increase the risk of infection.
- Progressive Multifocal Leukoencephalopathy (PML): Although rare, this serious brain infection is a potential risk for medications that suppress the immune system.
The side effects listed here are not exhaustive. Individual reactions may vary. For complete safety information, consult official prescribing resources or a healthcare professional.
Infusion Reactions
Infusion reactions can occur during or after the administration of Uplizna. Symptoms may include headache, nausea, sleepiness, rash, or muscle pain. To reduce this risk, healthcare providers usually give premedications, such as a corticosteroid, an antihistamine, and a fever reducer, before the infusion.
Risk of Infections
Uplizna can increase the risk of infections, including respiratory tract infections and urinary tract infections. Treatment is generally delayed in individuals with an active infection until it is resolved. There is also a potential risk of progressive multifocal leukoencephalopathy (PML), a rare and serious brain infection, which has been associated with other similar medications.
Hepatitis B and Monitoring
Before starting treatment, screening for Hepatitis B virus is required. Uplizna should not be used in individuals with an active Hepatitis B infection. Additionally, healthcare providers may monitor levels of immunoglobulins (antibodies) in the blood, as these levels can decrease during treatment.
Vaccinations
All required vaccinations should be completed at least four weeks before starting Uplizna. Live-attenuated or live vaccines are not recommended during treatment and should be avoided until B-cell levels have recovered.
Pregnancy and Fetal Risk
Based on how the medication works, Uplizna may cause harm to an unborn baby. Individuals who can become pregnant are encouraged to use effective contraception during treatment and for several months after the last dose.
Administration
Uplizna is given as an infusion into a vein (intravenous infusion) by a healthcare provider. The procedure typically takes place in a clinical setting such as a doctor's office, hospital, or infusion center.
Dosing Schedule
The treatment begins with two initial doses given a few weeks apart. After these starting doses, maintenance infusions are typically scheduled once every six months.
Before the Infusion
To help prevent infusion-related reactions, your healthcare provider will likely give you other medications before each treatment. These pre-medications may include:
- A corticosteroid
- An antihistamine
- A fever-reducing medication
During and After the Infusion
A healthcare professional will monitor you closely during the infusion and for a period of time afterward to check for any signs of a reaction.
Missed Dose
If you miss an appointment for your infusion, contact your healthcare provider immediately to reschedule. It is important to receive your doses as scheduled to manage your condition effectively.
❗Suspected Overdose
Taking more than the prescribed amount of Uplizna can be dangerous. If an overdose is suspected, seek emergency medical care immediately. Call 911 or contact Poison Control at 800-222-1222 for immediate guidance.
Pregnancy
Data regarding the use of Uplizna in pregnant women are limited, and it is not yet known if the medication can cause fetal harm. Because Uplizna is a monoclonal antibody, it can cross the placenta, particularly during the second and third trimesters. This may lead to a reduction in B-cells (a type of white blood cell) in the newborn, which could temporarily affect the infant's immune system.
Individuals who are able to become pregnant should use effective contraception during treatment and for at least 6 months after the final dose of Uplizna. Healthcare providers typically perform a pregnancy test before starting this medication to ensure the patient is not pregnant.
Breastfeeding
It is currently unknown whether Uplizna passes into human breast milk or if it has any effect on a breastfed infant or milk production. While many antibodies are known to be present in human milk, the specific risks associated with Uplizna are not established. Patients should discuss the potential benefits and risks of breastfeeding with their healthcare provider when considering this treatment.
Available Forms
Uplizna is supplied as a sterile, preservative-free solution in single-dose vials. This medication is intended for intravenous use and must be administered by a healthcare provider in a clinical setting.
The solution is typically clear to slightly opalescent and colorless to slightly yellow. Before administration, the medication is diluted into an infusion bag for delivery into a vein.
FDA Approval History
The U.S. Food and Drug Administration (FDA) approved Uplizna on June 11, 2020. It was the second treatment approved by the FDA for its specific indication and was developed by Horizon Therapeutics.
Approved Indications
Uplizna is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD is a rare autoimmune disease that affects the central nervous system, primarily the optic nerves and spinal cord.
Regulatory Designations
During its clinical development, Uplizna received Orphan Drug designation from the FDA. This status is granted to drugs intended for the treatment of rare diseases or conditions that affect fewer than 200,000 people in the United States.
Safety and Monitoring
There are currently no Boxed Warnings or Risk Evaluation and Mitigation Strategy (REMS) programs required for Uplizna. However, the FDA-approved labeling requires healthcare providers to confirm the presence of AQP4 antibodies before initiating treatment, as the drug's efficacy has only been established in patients who are antibody-positive.
Cost Factors
The total cost of treatment with Uplizna depends on your insurance plan, your location, and the specific fees charged by the infusion center or clinic where you receive the medication.
Insurance and Prior Authorization
Because Uplizna is administered by a healthcare professional, it is usually covered under your medical insurance benefit. Most insurance plans require prior authorization, which is a process where your doctor must get approval from the insurer before the drug will be covered.
Financial Assistance Programs
The manufacturer provides support programs to help eligible patients manage the cost of Uplizna. These may include co-pay assistance for those with private insurance or patient assistance programs for individuals who are uninsured or meet certain financial criteria.
Biosimilar Status
Uplizna is a brand-name biologic medication. There are currently no biosimilars available, which are the biologic equivalent of generic drugs. This means there is no lower-cost version of the medication currently on the market.
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