Extavia (interferon beta-1b) is an approved injectable medication intended to lower relapse rates and reduce the number of new brain lesions in people with relapsing forms of multiple sclerosis (MS).
The treatment, marketed by Novartis, has the same active ingredient as Betaseron, another approved MS therapy marketed by Bayer. Novartis gained the right to seek approval for its own branded version of interferon beta-1b through agreements made with Bayer.
In MS, the body’s immune system accidentally attacks the brain and other parts of the nervous system. The active agent in Extavia, interferon beta-1b, is a naturally occurring signaling molecule that immune cells use to communicate with each other and reduce excessive inflammatory responses.
By lowering the activity of the immune system, it is thought Extavia can reduce the autoimmune attack driving MS, but the details of its mechanism of action remain unknown.
The U.S. Food and Drug Administration approved Extavia in 2009 for the treatment of adults with relapsing forms of MS. This includes clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS).
Extavia was approved in the European Union in 2008 for the same indications. Extavia also was approved in Canada, but it was recently discontinued there due to business reasons.
The treatment should not be used in people with known allergies to interferon beta-1b or to albumin or mannitol, the inactive ingredients in Extavia.
Extavia is administered via a subcutaneous, or under-the-skin, injection. It is available as a dry powder that comes in single-dose vials containing 0.3 mg of the medication. The powder must be diluted in 1.2 mL of an appropriate liquid solution that comes in a prefilled syringe.
The removable cap of the syringe contains natural rubber latex, which may cause allergic reactions and should not be handled by latex-sensitive patients.
After being injected with the solution, the vial should be carefully swirled, not shaken, to avoid foaming. If not used immediately after reconstitution, the medication should be refrigerated, but only for a maximum of three hours.
The recommended dose of Extavia is 0.25 mg, or 1 mL of the resuspended solution, given every two days. However, patients receiving this medication for the first time must start with a lower dose and gradually increase their dosage over six weeks. This dose titration period involves:
The therapy may be self-administered, but patients and caregivers should perform the first injection under the supervision of a qualified healthcare provider and receive appropriate training on the injection technique.
Extavia is injected into the fat layer between the skin and muscles. The best areas are those where the skin is loose and soft, such as the stomach, thighs and buttocks, or the outer region of the upper arm. However, very thin people should use only the thigh or outer surface of the arm.
Injection sites should be rotated to minimize the likelihood of severe injection site reactions, including infection or necrosis (death of nearby tissue). Areas where the skin is red, bruised, infected, or is damaged and painful also should be avoided.
Painkillers or anti-fever medications may be used on the day of injections to help relieve flu-like symptoms, common side effects of Extavia.
Regulatory approvals of Extavia were based largely on four clinical trials that tested Betaseron. Results from these trials demonstrated the medication reduced relapse rates and brain lesions in patients with RRMS or active SPMS and delayed the conversion to clinically definite MS in CIS patients.
The most common side effects associated with Extavia include:
Injection site reactions, including those leading to necrosis, have been described in people receiving Extavia and other interferon-based medications. Depending on the extent of necrosis, patients may need to stop treatment, and those who continue the medication should avoid injecting the affected site until the skin fully heals.
Serious allergic reactions also can occur. The medication should not be administered to anyone with a known allergy to any of its components, and it should be stopped if an allergic reaction occurs.
Extavia may sometimes result in a reduction in immune cell levels, with some patients requiring a reduction in their treatment dosage. Routine measurements of blood cell counts are recommended for patients on this therapy.
Some patients on Extavia have experienced liver injury, leading to liver failure in some cases. Patients who regularly drink alcohol or take other medications that can damage this organ should consider the risks. Markers of liver health should be monitored during the treatment, and the medication may be discontinued if serious liver injury occurs.
Treatment with interferon-beta products may increase the frequency of mental health problems such as depression and suicidal ideation. These issues should be immediately discussed with a healthcare provider, and treatment discontinuation may be considered.
While interferon-beta medications are not known to directly affect the heart, some patients have experienced heart failure and other conditions affecting heart muscle. Those with preexisting heart conditions should be closely monitored, and the medication may be stopped if cardiac symptoms worsen.
Thrombotic microangiopathy, a clotting disorder that causes damage to small blood vessels, has been reported in some patients. If symptoms or signs of this condition develop, treatment should be stopped.
Drug-induced lupus erythematosus, a lupus-like disorder caused by certain prescription therapies, also can occur while on Extavia. Patients should stop taking this treatment if symptoms of this condition develop.
According to animal data, the therapy may cause harm to a developing fetus. However, available data in patients — which includes prospective observational studies — suggest using Extavia and other interferon-based medications during pregnancy does not increase the risk of major birth defects.
Extavia has not been rigorously studied during lactation, but there is no evidence that the medication can be found in breast milk. Patients who plan to become pregnant or breastfeed should discuss this with their healthcare team.
Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
Extavia was approved by the U.S. Food and Drug Administration in August 2009 to treat adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. However, the active ingredient in Extavia, interferon beta-1a, was originally approved in 1993 under the brand name Betaseron.
European registries that tracked more than 2,000 pregnancies exposed to Extavia and other interferon beta treatments did not find an increased frequency of major birth defects or other adverse pregnancy outcomes. If clinically necessary, Extavia may be used during pregnancy, but patients should bear in mind that there is limited data regarding its use in the second and third trimesters. A discussion with a healthcare provider is strongly recommended for anyone planning to become pregnant while on Extavia.
There is no known interaction between Extavia and alcohol. However, alcohol or other products with the potential to cause liver damage should be used cautiously during treatment. Patients should talk with their healthcare team about safe alcohol use while on Extavia.
A clinical trial that supported Extavia’s approval, which tested the similar interferon beta-1b product Betaseron in people with clinically isolated syndrome, found evidence of a significant reduction in brain lesions within the first six months. It also found patients had a lower relapse rate after one year on treatment than those on a placebo. However, multiple sclerosis is a disease that manifests differently in each person, and patients should ask their care team how and when the medication is expected to help in their case.
Both hair loss and weight gain have been reported as potential side effects of Extavia in clinical trials and post-marketing studies. Patients who experience any unexpected side effects during treatment should talk with their healthcare team.
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