Drug Interactions And Cyp450
In the body, Otezla undergoes oxidative metabolism. Metabolism is how drugs are broken down for excretion from the body. An enzyme family known as the cytochrome P450 3A4 is responsible for this action and can lead to important drug interactions with Otezla.
Have your pharmacist or doctor review for Otezla drug interactions, as some medications that greatly boost the action of CYP450 3A4 enzymes may lower the effectiveness of Otezla. Use of Otezla with these types of drugs is not recommended.
Examples include:
Depression Anxiety And Suicidal Tendencies
Depression, anxiety, and suicidal tendencies are common comorbidities among psoriasis patients which may be a result of psychosocial difficulties as well as common inflammatory pathways.35,46,47 However, little is known about whether systemic treatment for psoriasis is associated with an increased risk of anxiety and depression, and whether these risks differ between the various treatments.48
The results of short-term clinical trials and post-marketing cases suggested that apremilast was associated with an elevated risk of depression, anxiety, and suicidal thoughts, to a certain extent.48 According to post-marketing data, out of 105,000 patients who received apremilast, only 65 patients reported either depression and/or suicidal thoughts or behavior, of whom 32 patients improved after discontinuation of therapy.49 Based on these reports, precaution is recommended when prescribing apremilast in patients with a history of depression and/or suicidal thoughts or behavior, as per prescribing information.41
However, Crowley et al, in their long-term safety and tolerability study, reported that apremilast did not increase the incidence of depression.42 Similarly, Vasilakis-Scaramozza et al reported that patients treated with apremilast had a similar risk of depression and anxiety compared to patients on conventional disease-modifying anti-rheumatic drugs or biologic monotherapies.48
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Otezla For Psoriatic Arthritis
Otezla is approved to treat active psoriatic arthritis in adults. Psoriatic arthritis is a condition that has both the swollen, sore joints of arthritis and the skin lesions of psoriasis. Skin lesions caused by psoriasis are usually itchy, scaly red patches. In some cases, the lesions can affect your scalp.
Effectiveness for psoriatic arthritis
In clinical studies, Otezla improved symptoms of this condition by 20% in about 30% to 40% of people who took it. In comparison, 18% to 19% of people taking a placebo had that same result.
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Is Otezla A Biologic Drug
No, Otezla isnt a biologic drug. Biologics are drugs made from living cells. They work against a specific part of your immune system.
Certain nonbiologic drugs, including Otezla, also act on your immune system. But they dont target a specific part of your immune system. Nonbiologic drugs are made from chemicals rather than from living cells.
If you have more questions about how Otezla works, talk with your doctor or pharmacist.
What Are Side Effects Associated With Using Apremilast
Common side effects of Apremilast include:
- swelling in the face or throat,
- severe diarrhea,
Rare side effects of Apremilast include:
- none
This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.
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What Are Warnings And Precautions For Apremilast
Contraindications
- Hypersensitivity to apremilast or to any of the excipients in the formulation
Effects of drug abuse
- See What Are Side Effects Associated with Using Apremilast?
Long-Term Effects
- See What Are Side Effects Associated with Using Apremilast?
Cautions
How Does Apremilast Work In Psoriasis
- Psoriasis plaque formation is thought to be caused by dysregulated immune activity within the skin.
- This dysregulation can lead to an increase in production of proinflammatorycytokines such as tumournecrosis factor -, interleukin -17, and IL-23 which promote chronic inflammation of the epidermis and proliferation of keratinocytes.
- These changes result in redness, itching, epidermal thickening and scalyplaques.
- PDE4 is the predominant intracellularcyclic adenosine monophosphate -degrading enzyme within a variety of inflammatory cells, including eosinophils, neutrophils, macrophages, T cells, and monocytes.
- PDE4 degrades cAMP into its inactive form AMP, thus allowing these immune cells to produce elevated levels of proinflammatory cytokines and decreased levels of anti-inflammatory cytokines.
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More Common Side Effects
The more common side effects of Otezla include:
- diarrhea
- weight loss
- back pain
Most of these effects may go away within a few days or a couple of weeks. If theyre more severe or dont go away, talk to your doctor or pharmacist.
* This is a partial list of mild side effects from Otezla. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Otezlas prescribing information.
How Is Psoriatic Arthritis Treated
Today, there are many treatment options for psoriatic arthritis. A treatment plan often includes several of the following:
-
Therapy
-
Medicine
-
Surgery
Therapy : These therapies can reduce pain. They can make it easier to move and do everyday tasks. If therapy can help, your doctor will write a prescription for the type of therapy you need. Your therapist will work with your doctor and report your progress.
Patient education: Learning about psoriatic arthritis is important. The more you know, the better you can control this disease. Take time to learn the signs and symptoms. Ask your doctor what you should do when the arthritis flares. Learn about arthritis-friendly exercises and exercises that you should not do, at least for a while.
Exercise and rest: Each plays an important role. Arthritis-friendly exercises can help reduce pain, make it easier to move, and sometimes restore lost movement. Rest is important when psoriatic arthritis flares.
Devices to protect joints: Braces, splints, and supports can protect affected joints and prevent further damage. They offer support for painful areas and can stop painful movements. You should not buy one without first talking with your doctor. The device must fit you properly. It must support the area that needs support. Your doctor may recommend that a physical or occupational therapist fit you.
When psoriatic arthritis is mild, patients usually can reduce signs and symptoms with:
Tip: Take medicine after a meal
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Otezla: What You Need To Know About The New Pill For Psoriasis And Psoriatic Arthritis
The last few years have brought new treatments for the chronic skin condition psoriasis, and the inflammatory arthritis that may come along with it. Psoriasis can begin at any age, but there are two peaks for age of onset: one between 30 and 39 years and another between the ages of 50 and 69 years. Now there is a new pill that treats both the skin lesions and the arthritis: Otezla . Taken twice a day it works, and works well. Here are ten things to know about Otezla.
1) Otezla works for both for the skin lesions from psoriasis and the arthritis associated with it .
2) How does it work? Otezla is a new type of medication called a phosphodiesterase 4 inhibitor. By inhibiting phosphodiesterase 4, we can reduce cytokines and halt the inflammatory response that causes psoriasis and psoriatic arthritis.
3) Otezla has FDA approval for people with moderate to severe plaque psoriasis and those with psoriatic arthritis.
4) Does it work for the skin lesions from psoriasis? Yes. In trials done over 4 months, patients had 75 percent improvement in the severity of their skin lesions.
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5) How do I take it?Otezla is a pill you take twice a day, starting low and increasing your dose over a week to limit side effects. Typical doses are a 20 mg tablet or a 30 mg tablet, twice a day.
Dr O.
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What Is Cdc Doing About Psoriasis
In 2010, CDC worked with experts in psoriasis, psoriatic arthritis, and public health to develop a public health perspective that considers how these conditions affect the entire population. The resulting report is Developing and Addressing the Public Health Agenda for Psoriasis and Psoriatic Arthritis pdf icon. You can read a short article about the agendaexternal icon in The American Journal of Preventive Medicine.
CDCs National Health and Nutrition Examination Survey , an intermittent source of national psoriasis data, has included questions about psoriasis as late as the 2013-2014 cycle. A recent analysis of NHANES data estimates that 7.4 million adults had psoriasis in 2013external icon.
- Psoriasis causes patches of thick red skin and silvery scales. Patches are typically found on the elbows, knees, scalp, lower back, face, palms, and soles of feet, but can affect other places . The most common type of psoriasis is called plaque psoriasis.
- Psoriatic arthritis is an inflammatory type of arthritis that eventually occurs in 10% to 20% of people with psoriasis. It is different from more common types of arthritis and is thought to be related to the underlying problem of psoriasis.
- Psoriasis and psoriatic arthritis are sometimes considered together as psoriatic disease.
Who is at risk for psoriasis?
Anyone can get psoriasis. It occurs mostly in adults, but children can also get it. Men and women seem to have equal risk.
Can I get psoriasis from someone who has it?
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Questions About Taking Otezla
Here youll find answers to common questions about Otezla.
- What if I miss a dose of Otezla? If you miss a dose of Otezla, take the missed dose right away. If you dont remember to take the missed dose until its time for your next dose, just skip the missed dose. Take your next dose as usual. But dont take two doses at once to catch up for a missed dose.
- Will I need to use Otezla long term? Otezla is used to treat certain long-lasting conditions. If the drug is working well for you, your doctor may recommend that you take Otezla long term.
- Can Otezla be chewed, crushed, or split? No, you shouldnt chew, crush, or split Otezla tablets. If you have trouble swallowing Otezla pills, let your doctor or pharmacist know.
- Should I take Otezla with food? You can take Otezla with or without food.
- How long does Otezla take to work? How long it takes for Otezla to work is different for each condition its used to treat. In studies, some people with plaque psoriasis or psoriatic arthritis had improvements after just 16 weeks. Some people with Behçets disease had improvements after 12 weeks. Talk with your doctor to learn how soon Otezla may work for your condition.
Dont take more Otezla than your doctor prescribes. Using more than this can lead to serious side effects.
What Are The Adverse Effects Of Apremilast
- Diarrhoea , nausea , and upper respiratory tract infection were the most commonly reported adverse reactions in clinical trials in 1426 adult patients with moderate to severe plaque psoriasis treated with apremilast compared with placebo.
- The most common adverse reactions leading to discontinuation of apremilast were nausea , diarrhoea , and headache .
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How Is Soriatane Used
Soriatane comes in 10 mg and 25 mg capsules. The prescribed dose is taken once a day with food. Several factors determine the initial dosage for each individual, including the type of psoriasis present.
Doses may be reduced after symptoms improve, depending on the personâs response. Ordinarily, retinoid treatment is stopped when lesions have cleared significantly. When lesions or other symptoms reappear, the drug may be taken again.
Soriatane tends to work slowly for plaque psoriasis. Psoriasis may worsen before individuals start to see clearing. After eight to 16 weeks of treatment, the skin lesions usually will improve. It may take up to six months for the drug to reach its peak effect.
Soriatane is indicated for use in adults with severe plaque, guttate, pustular, erythrodermic, or palmoplantar psoriasis.
Otezla Is Proven To Help Get Clearer Skin On The Scalp
In a clinical trial, 201 people taking Otezla were compared to 102 people taking a placebo .
Some people also experienced a reduction in scalp and whole body itch after just 4 months of treatment. See the charts below for a closer look at the percentage of people that experienced an improvement while taking Otezla.
The more common side effects of Otezla include:
- diarrhea
- weight loss
- back pain
Most of these effects may go away within a few days or a couple of weeks. If theyre more severe or dont go away, talk to your doctor or pharmacist.
* This is a partial list of mild side effects from Otezla. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Otezlas prescribing information.
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Effectiveness Of Apremilast With Biologics
According to the LIBERATE trial, the use of apremilast can be considered in biologic-experienced or biologic-naïve patients. However, it is preferred more in biologic-naïve patients, because its efficacy appears to be better in this subgroup of patients.4 Clinical trials reported significantly higher response rates with the use of apremilast in biologic-naïve patients.2
According to published reports,18,19 the cost of biologics is a deterrent in their use in needy patients. Its long-term use adds further to the economic burden on the patients. Considering these factors, panel experts pointed out that in India, there is sparse use of biologics among dermatologists and hence a combination with apremilast would be a sustainable choice for keeping the cost low over long-term therapy.
Regarding the combination therapy of apremilast and biologics, there was a general opinion that it can provide more effective disease control than biologic monotherapy alone. Apremilast could serve as an effective therapeutic option for maintaining remission, induced by biologics. This is corroborated by the findings of two case reports on the effectiveness of combination therapy of apremilast with adalimumab20 and secukinumab,21,22 as well as the personal clinical experience of some of the experts.
Otezla For Other Conditions
In addition to the uses listed above, Otezla may be used off-label for other uses. Off-label drug use is when a drug thats approved for one use is used for a different one thats not approved. And you may wonder if Otezla is used for certain other conditions. Below is information on other possible uses for Otezla.
Otezla for other forms of psoriasis
There are several forms of psoriasis, but Otezla is only approved to treat plaque psoriasis.
However, Otezla is used off-label for adults with guttate psoriasis, nail psoriasis, palmoplantar psoriasis, pustular psoriasis, and scalp psoriasis. Its not recommended for off-label use in treating erythrodermic psoriasis.
If you have questions about treatment options for psoriasis, talk with your doctor.
Otezla for eczema
Eczema, also called atopic dermatitis, can result in long-lasting or recurring rashes on the face, head, or arms and legs.
In 2012, one small evaluated Otezla for treating adults with eczema and found that it reduced itching and the severity of eczema. However, currently the American Academy of Dermatology doesnt recommend Otezla for treating eczema.
If youd like to know about treatment options for eczema, talk with your doctor.
Otezla for rheumatoid arthritis
Currently, the American College of Rheumatology doesnt recommend Otezla for treating rheumatoid arthritis .
If youd like to learn about treatment options for RA, talk with your doctor.
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Otezla For Mouth Ulcers Caused By Behets Disease
Otezla is approved to treat mouth ulcers that occur with Behçets disease.
Behçets disease is an autoimmune disease. It causes damage to certain blood vessels that can lead to sores in your mouth, rashes, and other symptoms.
Effectiveness for Behçets disease
In a clinical study, 53% of people who took Otezla had their mouth ulcers completely cleared after 12 weeks. In comparison, 22% of people taking a placebo had that same result.
For 30% of people who took Otezla for 6 weeks, their mouth ulcers completely cleared and stayed cleared for another 6 weeks. In comparison, 5% of people taking a placebo had the same result.
Also, during the study, people taking Otezla had an average of 1.5 mouth ulcers. People taking the placebo had an average of 2.6 mouth ulcers.
How Does Otezla Work To Treat Psoriasis
Psoriasis is a chronic autoimmune condition in which a persons immune system is overactive and produces too much inflammation in the body. This inflammation triggers the production of an excessive amount of new skin cells that are created more quickly than older skin cells can die and be shed naturally. The skin cells build up and cause plaques to form on the surface of the skin.
Otzela works differently than other types of oral systemic medicines for psoriasis, which affect the entire immune system. Instead, Otezla works by specifically targeting only certain molecules within immune system cells that are involved in causing inflammation, an enzyme called phosphodiesterase 4 . By affecting the inflammatory processes within cells, Otezla can reduce the activity in the immune system that causes chronic inflammation and the formation of plaques, and thus reduce flaking and scaling of skin1.
Clinical studies were carried out to test the effectiveness of Otezla. After 4 months, around 1 in 3 patients who were treated with the medicine had a 75% reduction in symptoms such as redness, thickening, and scaliness2.
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