What is Exdensur® (depemokimab-ulaa)?
Exdensur® is a biologic medication. Its generic name is depemokimab-ulaa. It belongs to a drug class known as monoclonal antibodies.
Exdensur is approved by the U.S. Food and Drug Administration (FDA) to treat severe asthma with an eosinophilic phenotype.
The medication is given as an injection under the skin (subcutaneous) once every 6 months (twice-yearly dosing). It can only be taken in a doctor’s office or clinic and administered by a healthcare provider.
Exdensur is designed to stop or reduce inflammation in the airways. The drug can reduce the risk of asthma attacks and provide symptom relief.
What is Exdensur used for?
Exdensur is an add-on maintenance treatment for adults and children ages 12 years and older who have severe asthma with an eosinophilic phenotype.
It is not intended for use to treat sudden asthma symptoms or asthma attacks.
How does Exdensur work?
Exdensur works by targeting and blocking a protein called interleukin-5 (IL-5). IL-5 plays a key role in the growth, activation and survival of eosinophils, a type of white blood cell. Eosinophils can cause inflammation in the airways of people with severe eosinophilic asthma.
Exdensur binds to IL-5, preventing it from attaching to receptors on eosinophils. This lowers the number of eosinophils in people with severe eosinophilic asthma. It helps reduce airway inflammation and improves asthma control, leading to fewer asthma attacks.
Exdensur is an add-on maintenance treatment, meaning that it can be taken along with other prescribed asthma medications. People on Exdensur should continue taking daily inhaled medications (such as inhaled corticosteroids) as prescribed by their doctor. This drug combination can help optimize asthma control and improve breathing.
If you’re prescribed Exdensur, work together with your doctor on a treatment plan. Regular appointments and communication with your doctor can help ensure your treatment plan is effective.
What is the Exdensur dosage?
The recommended dosage is 100 mg administered once every 6 months, delivered at the doctor’s office.
Exdensur may be most helpful for people who want a less frequent biologic treatment. The other available asthma biologics require a dosage every 2-4 weeks. The Exdensur dosage is every 24 weeks (6 months).
How is Exdensur Given?
Exdensur is administered as an injection under the skin (subcutaneous) two times per year. It can be given in the upper arm, thigh or abdomen. The medication must be delivered in the tissue between the skin and the muscle.
Exdensur can only be taken in a doctor’s office or clinic (called an “alternate site of care,” or ASOC). It must be administered by a healthcare provider. The medication is not available for self-injection at home.
Exdensur Ingredients
Active ingredient: depemokimab-ulaa
Inactive ingredients: arginine HCI, edetate disodium, histidine, L-histidine HCI monohydrate, polysorbate-80, trehalose, water for injection
Exdensur Side Effects
Side effects can be mild or severe. Here are the most common side effects:
- upper respiratory tract infection (cold, sinus infection)
- nasal congestion
- sneezing
- itchy nose
- sore throat
- flu or flu-like symptoms
- joint pain
Some people may experience an allergic reaction soon after the Exdensur injection. Tell your doctor if this happens and get emergency help right away if the allergic reaction is severe. This is anaphylaxis, a potentially life-threatening condition. Symptoms of anaphylaxis may include:
- hives on the skin
- swelling of your face, mouth and/or tongue
- breathing problems
- nausea, abdominal cramps or vomiting
- low blood pressure
- fainting, dizziness, feeling lightheaded
Before taking Exdensur, tell your doctor about all your medical conditions. Provide a list of any medications you’re taking that could cause a drug interaction. Do not stop taking other asthma medicines unless instructed to do so by your healthcare provider.
How Much Does Exdensur Cost?
Biologics are expensive medications due to their complex production process. The Exdensur list price is $25,400 for one injection. Most people will not pay the list price. The actual cost will vary based on your insurance coverage.
Check your health insurance plan to see if it covers Exdensur.
The Exdensur Copay Program can help with out-of-pocket costs, subject to an annual copay program maximum. If eligible for the program, patients could pay as little as $0 per dose for Exdensur.
Eligibility requirements for the Exdensur Copay Program:
- You must have a commercial or prescription insurance plan.
- You must be a resident of the United States (this includes Puerto Rico and the U.S. Virgin Islands).
- You’re not eligible for, or enrolled in, a government-funded healthcare program.
Patients are not eligible for the program if they are covered by any federal or state prescription insurance program. This includes patients enrolled in Medicare, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DoD) programs or TriCare.
GSK, which makes Exdensur, also offers a GSK Patient Assistance Program for Exdensur.
Eligibility requirements for the GSK Patient Assistance Program:
- You meet financial income eligibility criteria.
- You are uninsured OR have Medicare and meet other program requirements.
- You live in the United States, Puerto Rico or the U.S. Virgin Islands.
- You are being treated by a licensed healthcare provider.
Exdensur is covered under Medicare Part B since it is administered in a doctor’s office or clinic. It is also covered under some Medicaid programs with prior authorization. The Medicaid costs may vary depending on the state.
Charitable organizations such as The Assistance Fund, Inc., Patient Advocate Foundation and The HealthWell Foundation are dedicated to offering financial support to patients with medical conditions, irrespective of their chosen treatment. People with commercial or public insurance, including those under Medicare and Medicaid, can reach out directly to these foundations for financial assistance.
