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Gilenya vs Aubagio
Introduction
For patients with multiple sclerosis (MS), a chronic disease that affects the central nervous system, certain drugs can help manage symptoms and slow progression of the disease. Gilenya and Aubagio are two such medications often prescribed for MS. They each impact different cells in body's immune system, aiming to reduce inflammation and damage to nerve fibers.
Gilenya works by trapping specific white blood cells (lymphocytes) in lymph nodes, preventing them from reaching the central nervous system where they could potentially cause damage. On the other hand, Aubagio inhibits a key enzyme pyrimidine synthesis pathway that is necessary for rapid DNA replication in dividing cells like lymphocytes. This results in reduction of T and B immune cell activity which brings down inflammation and reduces potential harm to myelin sheath covering nerves.
It’s important note that while both aim at controlling MS symptoms effectively, their side effects profile differ significantly requiring careful consideration based on individual patient condition.
What is Gilenya?
Fingolimod (the generic name for Gilenya) was the first oral medication approved by the FDA in 2010 to reduce relapses and delay disease progression in patients with relapsing forms of multiple sclerosis (MS). Gilenya works by trapping certain white blood cells in the lymph nodes, preventing them from reaching the central nervous system where they could potentially cause damage. It is prescribed as a once-daily capsule.
Teriflunomide (Aubagio), on the other hand, was approved by FDA later in 2012. It primarily works by inhibiting rapidly dividing cells such as activated T cells which play key roles in MS inflammation. Aubagio is also taken orally once daily but it has a different mechanism of action compared to Gilenya.
While both medications can have side effects like headache, elevated liver enzymes and hair thinning, Aubagio may carry an additional risk of serious liver problems including acute liver failure which might be fatal. Both drugs are effective treatments for MS but they work differently and have different safety profiles so patient condition should dictate their use.
What conditions is Gilenya approved to treat?
Gilenya and Aubagio are both approved by the FDA for treating relapsing forms of multiple sclerosis (MS):
- Gilenya is used to reduce the frequency of clinical exacerbations and delay physical disability.
- Aubagio helps in slowing down the physical problems caused by MS and reduces flare-ups.
How does Gilenya help with these illnesses?
Gilenya works to manage multiple sclerosis by preventing lymphocytes (a type of white blood cell) from exiting the lymph nodes and reaching the central nervous system. It does this by binding to sphingosine-1-phosphate receptors on the surface of lymphocytes, essentially trapping these cells within the lymph nodes. Lymphocytes play a significant role in causing inflammation and damage in multiple sclerosis. By limiting their access to the brain and spinal cord, Gilenya can reduce inflammatory attacks on nerve cells and help patients manage their condition.
In contrast, Aubagio slows down rapidly dividing cells like those involved in an aggressive immune response seen in multiple sclerosis. It inhibits an enzyme called dihydroorotate dehydrogenase that is necessary for pyrimidine synthesis, which is a crucial step for DNA replication during cell division. Slowing down these overactive immune responses can limit damage inflicted upon myelin sheaths protecting nerve fibers—thereby helping control symptoms of multiple sclerosis.
What is Aubagio?
Aubagio is a brand name for teriflunomide, an immunomodulatory drug used primarily in the treatment of multiple sclerosis (MS). It works by inhibiting the mitochondrial enzyme dihydroorotate dehydrogenase, which plays a key role in the proliferation and function of activated T and B lymphocytes. This essentially slows down the rapid division of immune cells that leads to inflammatory damage in MS. Aubagio was approved by the FDA in 2012.
Unlike Gilenya, Aubagio does not lead to bradycardia (slow heart rate) or require first-dose monitoring. Its side effect profile is also somewhat different; while it can cause hair thinning and liver problems like Gilenya, it does not carry risk for macular edema (a type of eye problem), unlike its counterpart. It's usually taken orally once daily which may be more convenient for some patients compared to other drugs requiring more frequent dosing.
The effects on slowing progression of physical disability and reducing frequency of relapse can make Aubagio beneficial particularly for those with relapsing forms of MS who have had an inadequate response to two or more disease-modifying therapies such as Gilenya.
What conditions is Aubagio approved to treat?
Aubagio is an oral medication that has been approved by the FDA for the treatment of adult patients with relapsing forms of multiple sclerosis (MS), which includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It works by suppressing the immune system to reduce inflammation that can damage the nervous system.
How does Aubagio help with these illnesses?
Pyrimidine synthesis is a fundamental process in the body, playing an essential role in cellular division and proliferation. Aubagio works by inhibiting dihydroorotate dehydrogenase, a key enzyme in pyrimidine synthesis pathway thereby reducing the number of harmful cells involved in multiple sclerosis progression. This mechanism of action results in fewer relapses and slows down physical disability progression. Unlike Gilenya which acts by trapping certain white blood cells (lymphocytes) within lymph nodes preventing them from reaching the central nervous system where they could potentially cause damage, Aubagio directly impacts cell production processes. Because it doesn't significantly affect other immune cell types or functions outside this specific pathway, it may be a preferred choice for patients with concerns about overall immune suppression.
How effective are both Gilenya and Aubagio?
Both fingolimod (Gilenya) and teriflunomide (Aubagio) have demonstrated effectiveness in treating patients with relapsing forms of multiple sclerosis, and they were approved by the FDA within a couple years of each other. Since they act on different aspects of immune function, they may be prescribed under different circumstances. The efficacy of fingolimod was directly studied in several large clinical trials which showed significant reductions in relapse rates compared to placebo; these studies also noted that it had an acceptable safety profile.
A 2012 review detailed how fingolimod works to reduce immune system activity by trapping certain white blood cells in lymph nodes, thus preventing them from contributing to MS-related damage. This unique mechanism contributes to its high efficacy but can also lead to side effects like slowed heart rate or increased risk for infections.
Teriflunomide's approval was based on two major clinical trials demonstrating its ability to lower annualized relapse rates compared to placebo. It is generally well-tolerated, although some patients experience minor side effects such as hair thinning or elevation in liver enzymes.
A 2016 review suggested that both medications appear similarly effective at reducing MS symptoms and delaying disease progression when used alone. Nonetheless, choosing between these two options often depends on individual patient factors including potential side effects, method of administration (fingolimod is taken once daily as a pill whereas teriflunomide requires monthly injections), and personal medical history.
At what dose is Gilenya typically prescribed?
Oral dosages of Gilenya are typically 0.5 mg/day, and it has shown to be effective in treating relapsing forms of multiple sclerosis (MS) in adults. On the other hand, Aubagio is usually prescribed at a dosage of 7 or 14 mg once daily for the same condition. Like with Gilenya, this medication can also be used without regard to meals. Children should not take either drug as their safety and effectiveness have not been established in pediatric patients. For both drugs, if there is no response or side effects become intolerable after a certain period, your doctor may reconsider your treatment plan.
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At what dose is Aubagio typically prescribed?
Aubagio treatment for multiple sclerosis is typically initiated at a dosage of 7 mg/day. Depending on the patient's tolerance and response to the medication, this dose may then be increased to 14 mg/day. Unlike some other drugs, Aubagio does not require divided dosing throughout the day; patients can simply take their daily dose all at once, at any time that suits them. However, it's important to note that if there isn't an adequate response or tolerability issues occur at 14 mg/day after several weeks, re-evaluation should be considered as per healthcare provider’s guidance.
What are the most common side effects for Gilenya?
Common side effects of Gilenya include:
- Headache
- Diarrhea
- Back pain
- Liver transaminase elevations (a sign of liver damage)
- Cough
- Influenza virus infection
Common side effects of Aubagio include:
- Hair thinning or loss
- Diarrhea
- Nausea
- Influenza -Liver problems, including elevated liver enzymes on blood tests. -Paresthesia or tingling skin.
Bear in mind that each patient may react differently to these medications and it is always advisable to consult with a healthcare provider regarding potential side effects.
Are there any potential serious side effects for Gilenya?
While comparing Gilenya to Aubagio, it's important to note that both medications have potential severe side effects in rare cases. Here are the serious side effects associated with Gilenya:
- Allergic reactions: Rash, itching or hives on the skin; swelling of the face, lips, tongue or other parts of the body; shortness of breath, wheezing or difficulty breathing
- Vision problems: Blurry vision or loss of vision
- Slowed heart rate (especially after first dose): Dizziness, fatigue and irregular heartbeat
- Breathing problems: Coughing up blood or white mucus from lungs
- Swelling and narrowing of blood vessels in your brain (a condition known as PRES)
- Liver problems: Nausea, vomiting, abdominal pain right upper area , fatigue , loss appetite , dark urine
- Infections including fungal infections
For Aubagio some severe side effect includes:
- Toxicity to fetus if you're pregnant
- Hair thinning : temporary hair loss during early treatment phase.
- Increase risk for infections resulting fever , chills sore throat .
- Numbness tingling lower legs feet due nerve damage.
- Serious liver problem can occur symptoms include: nausea stomach pain tiredness loss appetite dark yellowish urine.
If any these symptoms occur consult immediately healthcare provider.
What are the most common side effects for Aubagio?
When comparing Gilenya to Aubagio, it's important to note that while both are used in the treatment of multiple sclerosis, they do have different side effects. With Aubagio, some common side effects may include:
- Hair thinning or loss
- Diarrhea, nausea
- Flu-like symptoms such as fever and chills
- Abnormal liver test results
- Numbness or tingling in hands or feet (paresthesia)
- Headache -Increased blood pressure -Possibly serious infections due to lowered immune system response.
It is essential for patients taking Aubagio to be aware of these potential outcomes and regularly consult with their healthcare provider regarding any concerns.
Are there any potential serious side effects for Aubagio?
While Aubagio is generally considered a safe medication for treating multiple sclerosis, it does carry potential side effects that can be serious. Some of the more severe possible reactions include:
- Signs of an allergic reaction such as hives, itching, difficulty breathing or swallowing, swelling in your face or throat
- Severe skin reactions: redness, pain, blisters on lips or eyes or mouth; peeling/dead skin
- Unusual bleeding (nosebleeds), bruising under the skin easily
- Changes in liver function leading to yellowing of your eyes and skin (jaundice)
- Sores in your mouth and throat
- Breathing problems like shortness of breath at rest
- High blood pressure with headaches, dizziness/confusion
These symptoms require immediate medical attention. If you're taking Aubagio and start experiencing any of these symptoms, contact a healthcare provider right away.
Contraindications for Gilenya and Aubagio?
Both Gilenya and Aubagio, like most other medications for multiple sclerosis (MS), may exacerbate symptoms in some individuals. If you notice your MS symptoms worsening or experience any unusual side effects, please seek immediate medical attention.
Neither Gilenya nor Aubagio should be taken if you are using, or have recently used certain types of vaccines (such as live attenuated vaccines) and immunosuppressive drugs. Always inform your physician about all the medications that you are currently taking; these can take varying lengths of time to clear from your system and might lead to harmful interactions with both Gilenya and Aubagio.
Patients on either medication need regular blood tests to monitor liver function due to potential hepatotoxicity risks associated with these treatments. Pregnant women or those planning a pregnancy should discuss the use of these medications with their healthcare provider due to potential fetal harm.
How much do Gilenya and Aubagio cost?
For the brand name versions of these drugs:
- The price of 30 capsules of Gilenya (0.5 mg) averages around $8,500, which works out to approximately $283/day.
- The price of a one-month supply (28 tablets) of Aubagio (14mg) is about $6,800, working out to roughly $243 per day.
Thus if you are considering these two medications for relapsing forms of multiple sclerosis, Aubagio is less expensive on a per-day treatment basis than Gilenya. However cost should not be a primary consideration in determining which drug is right for you - effectiveness and side effect profile should certainly play major roles in your decision making process.
As it stands today there are no generic versions available for either Gilenya or Aubagio. Both medications are still protected by patent laws so we can expect the costs to remain high until generics become available after those patents expire.
Popularity of Gilenya and Aubagio
Fingolimod, under the brand name Gilenya, is a disease-modifying therapy for relapsing forms of multiple sclerosis (MS). In 2020, it was estimated that about 90,000 people in the US were prescribed Gilenya. This accounted for around 9% of all prescriptions for MS treatments in the country.
Teriflunomide, sold as Aubagio, is another option to manage relapsing forms of MS. It saw just over 70,000 prescriptions filled in the USA during 2020. This represented approximately 7% of total MS drug prescriptions. Both medications have shown similar effectiveness and side effects profiles; however, they work differently on a molecular level with different potential risks and benefits.
While both drugs are used to treat multiple sclerosis by targeting immune cells implicated in its pathology—albeit via different mechanisms—their use has remained relatively stable over recent years with no significant increases or decreases reported.
Conclusion
Both Gilenya (fingolimod) and Aubagio (teriflunomide) are approved for the treatment of relapsing forms of multiple sclerosis. Their efficacy has been well established in clinical trials, demonstrating a reduction in the frequency of symptomatic exacerbations and slowing disease progression.
Though both medications can be used as first-line treatments, they have different mechanisms of action; Gilenya works by trapping certain immune cells in lymph nodes, preventing them from reaching the central nervous system where they could cause damage. Aubagio, on the other hand, inhibits a specific enzyme that is necessary for rapidly dividing cells like those involved in an active immune response.
Both drugs are available only with a prescription and may require close monitoring particularly at the start of therapy due to potential side effects such as liver damage or increased blood pressure.
The side effect profile between these two drugs differs somewhat: common side effects associated with Gilenya include headache, flu-like symptoms and back pain while Aubagio often leads to hair thinning or loss along with diarrhea and nausea. Both medications carry significant risks if taken during pregnancy so women must ensure effective contraception during treatment. As always when considering medication options it's important to consult closely with your physician about potential risks versus benefits.