Contenido Del Envase E Informacin Adicional
Composición deOtezla
El principio activo es apremilast.
- Otezla 10 mg comprimidos recubiertos con película: cada comprimido recubierto con película contiene 10 mg de apremilast.
- Otezla 20 mg comprimidos recubiertos con película: cada comprimido recubierto con película contiene 20 mg de apremilast.
- Otezla 30 mg comprimidos recubiertos con película: cada comprimido recubierto con película contiene 30 mg de apremilast.
Los demás componentes del núcleo del comprimido son celulosa microcristalina, lactosa monohidrato, croscarmelosa sódica y estearato de magnesio.
- El recubrimiento contiene poli , dióxido de titanio , macrogol , talco, óxido de hierro rojo .
- El comprimido recubierto con película de 20 mg contiene también óxido de hierro amarillo .
- El comprimido recubierto con película de 30 mg contiene también óxido de hierro amarillo y óxido de hierro negro .
Aspecto del producto y contenido del envase
Otezla 10 mg comprimido recubierto con película es un comprimido recubierto con película con forma de rombo, de color rosa, con APR grabado en una cara y 10 en la otra cara.
Otezla 20 mg comprimido recubierto con película es un comprimido recubierto con película con forma de rombo, de color marrón con APR grabado en una cara y 20 en la otra cara.
Otezla 30 mg comprimido recubierto con película es un comprimido recubierto con película con forma de rombo, de color beige, con APR grabado en una cara y 30 en la otra cara.
Tamaños de envase
Amgen Europe B.V.
What Are Otezlas Side Effects
Like most drugs, Otezla may cause mild or serious side effects. The lists below describe some of the more common side effects that Otezla may cause. These lists dont include all possible side effects.
Your doctor or pharmacist can tell you more about the potential side effects of Otezla. They can also suggest ways to help reduce side effects.
Otezla Now Approved For All Severity Levels Of Psoriasis
- The U.S. Food and Drug Administration recently approved a new use for Otezla .
- A clinical trial found that apremilast improved psoriasis signs and symptoms in people with milder disease cases.
The FDA recently approved Otezla as a treatment for adults with mild to moderate plaque psoriasis who are eligible to receive phototherapy or systemic therapy . The decision was announced on Dec. 20.
Otezla was originally approved in March 2014 to treat psoriatic arthritis. A few months later, the FDA approved the drug as a treatment option for people with moderate to severe plaque psoriasis.
This expanded approval is good news for people with milder cases of psoriasis, according to Dr. David M. Reese, executive vice president of research and development at Amgen the company that makes Otezla.
A substantial unmet need remains for mild to moderate plaque psoriasis patients for whom topical therapies may not be sufficient, especially for those with difficult-to-treat areas, like the scalp, said Dr. Reese in a recent press release. With this expanded indication for Otezla, patients across all levels of disease severity now have an oral, systemic option that has already been used by more than 650,000 people worldwide.
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Causes Of Psoriatic Arthritis
Almost 1 in 3 people with psoriasis also have psoriatic arthritis.
It tends to develop 5 to 10 years after psoriasis is diagnosed, although some people may have problems with their joints before they notice any skin-related symptoms.
Like psoriasis, psoriatic arthritis is thought to happen as a result of the immune system mistakenly attacking healthy tissue.
But its not clear why some people with psoriasis develop psoriatic arthritis and others do not.
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What Are Some Alternatives To Otezla
Your doctor may recommend that you take something other than Otezla, depending on the condition youre treating.
Alternatives for plaque psoriasis, psoriatic arthritis, or mouth ulcers caused by Behçets disease may include biologics and nonbiologics. Biologics are drugs made from parts of living cells. Nonbiologics are drugs made from chemicals.
Alternative drugs for plaque psoriasis or psoriatic arthritis include the following:
- other nonbiologic drugs such as:
Note: Some of the drugs listed above are used off-label for these conditions. With off-label use, a drug thats approved for certain conditions is used for another condition.
If youd like to know more about treatments other than Otezla, talk with your doctor. They can help you find the treatment thats best for you.
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Key Facts About Otezla
- Otezla is a small molecule phosphodiesterase 4 inhibitor approved by the FDA for the treatment of plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçets Disease.
- Otezla is taken as an oral tablet twice a day. Your doctor will start your dose slowly to help lessen side effects like stomach upset or diarrhea. If you have severe kidney disease, you will need a lower dose of Otezla.
- Otezlas generic name is apremilast, but a generic is not yet available for this drug. Amgen is the manufacturer for Otezla and it was first approved by the FDA in 2014.
- Otezla works in your immune system by blocking the phosphodiesterase type 4 enzyme in the cell to lower inflammation in the body. The PDE4 enzyme is a type of immune system protein that can be overactive in some people, leading to symptoms.
When To Get Medical Advice
See a GP if you have persistent pain, swelling or stiffness in your joints even if you have not been diagnosed with psoriasis.
If youve been diagnosed with psoriasis, you should have check-ups at least once a year to monitor your condition. Make sure you let the doctor know if youre experiencing any problems with your joints.
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How Does Otezla Compare To Humira
Otezla and Humira are both used to treat plaque psoriasis and psoriatic arthritis. They each also have other uses.
Unlike Otezla, Humira is a biologic drug. This means Humira is made from parts of living cells. Otezla, on the other hand, is made from chemicals.
Otezla comes as tablets that youll take by mouth twice each day. But youll take Humira as an injection under your skin. Usually, its taken once every 2 weeks, after the first week of treatment.
If you have more questions about the differences between Otezla and Humira, talk with your doctor.
Oral Therapy For Psoriatic Arthritis And Plaque Psoriasis
On March 21, 2014, the FDA approved apremilast for the treatment of adults with active psoriatic arthritis. Apremilast, an oral inhibitor of phosphodiesterase -4, is the first oral therapy to receive FDA approval for the treatment of adults with active psoriatic arthritis.,
According to Curtis Rosebraugh, MD, MPH, Director of the Office of Drug Evaluation II at the FDA Center for Drug Evaluation and Research, Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis. Otezla provides a new treatment option for patients suffering from this disease.
On September 23, 2014, apremilast received a new indication by the FDA for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Apremilast is the first and the only PDE-4 agent approved for the treatment of patients with plaque psoriasis.
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How Do I Use Otezla
After an initial titration starting at 10 mg per day and increasing your dose over 5 days, the recommended maintenance dosage is 30 mg twice daily starting on Day 6.
Slowly increasing your dose of Otezla when you first start will help to reduce the gastrointestinal symptoms.
Side effects
Most stomach side effects, like diarrhea, nausea and vomiting and stomach pain, occur within the first weeks of starting Otezla treatment, if they occur. In some cases, patients were hospitalized for these effects.
In addition, weight loss can be a significant side effect with Otezla. Your doctor will monitor your body weight regularly, and decide if it is safe for you to remain on Otezla.
Tell your doctor if you have ever had problems with mood or depression. You and your family members should be on the alert for signs of worsening depression, suicidal thoughts or other mood changes. If such changes should occur with your treatment, your doctor should be contacted immediately.
What Treatment Is Right For Me
The type of treatment will depend on how severe your symptoms are at the time of diagnosis with the goal being to control the disease to the point of remission and avoid complications. Medications may need to be changed over time to continue to maintain control and avoid disease progression and systemic effects. Some early indicators of more severe disease include onset at a young age, multiple joint involvement, and spinal involvement. Good control of the skin is important in the management of psoriatic arthritis. In many cases, you may be seen by two different types of healthcare providers, one in rheumatology and one in dermatology.
Early diagnosis and treatment can relieve pain and inflammation and help prevent progressive joint involvement and damage. Without treatment psoriatic arthritis can potentially be disabling, cause chronic pain, affect quality of life, and increase risk of heart disease. It is important to update your healthcare provider when you have a change in symptoms or if your medication regimen is no longer effective.
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What Is Otezla Used For
Your doctor may prescribe Otezla for you if you have certain conditions. This drug is used in adults to treat:
- Plaque psoriasis. With plaque psoriasis, you have patches on your skin that are red or darker colored. Sometimes, they can look scaly and white. This condition is an inflammatory skin disease thats caused by your immune system attacking your own cells. For this use, Otezla is prescribed for people who could have used systemic therapy or light therapy.
- Psoriatic arthritis. With psoriatic arthritis, you have arthritis, which causes achy, stiff joints. And you have psoriasis, which causes the skin issues described just above. This condition is also caused by your immune system attacking certain cells in your body.
- Mouth sores in people with Behçets disease. With Behçets disease, you can have several symptoms, such as problems with your eyes and skin, and joint pain. Mouth sores are one of the earliest symptoms of the condition. Otezla can be used to treat these mouth sores. Behçets disease is also caused by your immune system attacking certain cells in your body.
Otezla treats these conditions by helping to lower the activity of your immune system.
How Much Does Otezla Cost
Otezla is a specialty medication, which means it can be expensive. It’s filled at a specialty pharmacy and mailed to your front door or a pharmacy near you. Otezla isnt filled at a regular community pharmacy.
According to Amgen, Otezlas manufacturer, the list price for a 30-day supply of Otezla is about $4,000. But there are ways you can save.
If you need help with the cost of Otezla and have commercial insurance, Amgen has a $0 copay savings program. If you have government insurance or are uninsured, Otezla SupportPlus can help connect you to the Amgen Safety Net Foundation, a nonprofit financial assistance program sponsored by Amgen that helps qualifying people access Otezla. For more information, call or visit the Amgen Safety Net Foundation online.
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A New Oral Therapy For Psoriasis Could Be Coming Soon
Photo by Towfiqu barbhuiya on Unsplash
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The $23 billion psoriasis drug market has a number of well-known pharmaceutical companies vying to get patients to use their drugs.
AbbVie Inc. with its Skyrizi and Humira options, Amgen Inc. with Otezla, and with Cosentyx are just some of the companies and drugs on offer to treat the chronic autoimmune condition that has approximately eight million US cases and 125 million worldwide cases annually.
While Amgens Otezla is an oral drug, the others are injectable biologics. Injectables can make patients more susceptible to pathogens such as COVID-19 because they actively lower a persons immune response as the means of combating the chronic condition. Israeli drug company Can-Fite Biopharmas piclidenoson, like Amgens Otezla, is an oral treatment, and studies have shown it does not have a profile indicating it would lower a persons immune response to pathogens such as COVID-19, the company says.
Inverse Psoriasis Vs Jock Itch
They can affect the same area, but there are differences between inverse psoriasis and jock itch.
- Jock itch shows up as reddened skin in the crease between your thigh and groin. It gradually spreads to your upper thigh in a half-moon shape. There could be blisters at the edges. You might also see a ring-shaped rash on your thighs and buttocks. Your skin might itch or burn, and it could get flaky or scaly. Jock itch is a fungus, and you can treat it with an antifungal medicine and by keeping the area clean and dry.
- Inverse psoriasis also can show up in the crease between your thigh and groin, but itâll just be red and white, and not scaly. You might also have cracks in your skin. And you could have scaly round patches on your upper thighs. If youâre overweight, you might also get intertrigo, a painful rash that results from skin rubbing together. Unlike jock itch, which tends to affect the crease between your thighs and groin and your buttocks and upper thighs, you can get psoriasis anywhere in your genital area. Learn what you can do about psoriasis in unexpected places on your body.
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What About Side Effects
Some patients taking Otezla reported depression. Before you start Otezla, tell your doctor if you have had feelings of overwhelming sadness, thoughts or behaviors like wanting to killing yourself or, or other mood changes. After starting Otezla, tell your doctor if any of these symptoms develop or worsen.
The most common side effects of Otezla were diarrhea, headache, and nausea. Side effects usually occur within the first 2 weeks of treatment, and get better as you continue to take it. You may use over-the-counter medication such as immodium to treat diarrhea, or Tylenol® to treat headaches.
Tell your doctor about any side effect that bothers you or does not go away.
How Is Apremilast Taken
When you first start taking apremilast, youll be given a special starter pack which contains all the doses for the first six days. The pack is clearly labelled to make sure you take the right dose at the right time, starting with a low dose and working up to the maximum.
Once youve finished the starter pack, youll remain on the higher dose. Most people will take one tablet in the morning and one in the evening. However, if you have kidney problems, your specialist may suggest just taking one tablet a day.
If you miss a dose, contact your specialist team immediately for advice on when to take the next one.
Because apremilast is a long-term treatment, its important to keep taking it, unless you have severe side effects:
- even if it doesnt seem to be working at first
- even when your symptoms improve, to help keep your condition under control.
Your doctor may decide to stop the treatment after four months if there hasnt been enough improvement in your symptoms.
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Otezla Now Approved For Plaque Psoriasis Across All Severities
The Food and Drug Administration has expanded the approval of Otezla® to include treatment of plaque psoriasis across all severities in adults who are candidates for phototherapy or systemic therapy. Previously, the treatment was approved only for moderate to severe plaque psoriasis.
The approval was based on data from the multicenter, double-blind, placebo-controlled phase 3 ADVANCE trial , which evaluated the efficacy and safety of apremilast, a phosphodiesterase 4 inhibitor, in 595 adults with mild to moderate plaque psoriasis. Patients were randomly assigned 1:1 to receive either apremilast 30mg orally twice daily or placebo for the first 16 weeks all patients then received apremilast in an open-label extension phase through week 32. The primary endpoint was the proportion of patients with static Physicians Global Assessment response of clear or almost clear with at least a 2-point reduction from baseline at week 16.
Results showed that 21.6% of patients treated with apremilast achieved an sPGA response at week 16 compared with 4.1% of those who received placebo . Statistically significant improvements were also observed with apremilast in key secondary endpoints, including Whole Body Itch Numeric Rating Scale response and Scalp Physician Global Assessment response . These improvements were observed as early as week 2 and maintained through week 32.
Otezla tablets are available in 10mg, 20mg, and 30mg strengths.
References
Effects On Other Treatments
You may be taking other disease-modifying drugs as well as apremilast. However, apremilast can interact with some medicines, so check with your doctor or a pharmacist before starting any new medicines. Remember to mention you’re on apremilast if youre treated by anyone other than your usual rheumatology team.
You can carry on taking non-steroidal anti-inflammatory drugs or painkillers, if needed, unless your doctor tells you otherwise.
Don’t take over-the-counter or herbal medicines without discussing it first with your doctor. Some of these, including St Johns Wort, can interfere with the treatment.
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What Are The Symptoms Of Psoriatic Arthritis
The symptoms of psoriatic arthritis may be gradual and subtle in some patients in others, they may be sudden and dramatic. It may be mild, affecting only one joint or can be severe, affecting multiple joints. Not all patients experience all symptoms.
The most common symptoms of psoriatic arthritis are:
Joint symptoms
- Pain or aching, tenderness, and/or swelling in one or more joints – most commonly hands, feet, wrists, ankles, knees.
- Joint stiffness most notable in the morning or with prolonged inactivity such as sitting for a long time.
- Reduced range of motion in affected joints.
- Pain or stiffness in the lower back.
- Tenderness, pain, or swelling where tendons and ligaments attach to the bone , such as the Achilles tendon of the heel.
- Swelling of an entire finger or toe with a sausage-like appearance .
Skin symptoms
- Silver or gray scaly spots on the scalp, elbows, knees, and/or the lower spine.
- Small, round spots called papules that are raised and sometimes scaly on the arms, legs and torso.
- Pitting of the nails.
- Detachment or lifting of fingernails or toenails.
Other symptoms
- Anemia.