What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Otezla (Apremilast)
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Product Details
Description
Otezla (apremilast) is an oral tablet taken by adults who have active psoriatic arthritis, plaque psoriasis and are candidates for phototherapy or systemic therapy, and oral ulcers related to Behçet’s Disease.
Fact Table
Formula
C22H24N2O7S
License
US DailyMed, EU EMA, US FDA
Bioavailability
73%
Legal status
Rx-Only
Chemical Name
Apremilast
Elimination half-life
6–9 hours
Dosage (Strength)
10mg, 20mg, 30mg
Pregnancy
Consult Doctor
Brands
Otezla
Protein binding
73%
PubChem CID
11561674
MedlinePlus
a614022
ChEBI
78540
ATC code
L04AA32
DrugBank
DB05676
KEGG
D08860
Routes of administration
By mouth (tablets)
Directions
The instructions that come with your Otezla prescription should be followed. Talk to your doctor or pharmacist if you have any questions or concerns.
Oteza comes in 10 mg, 20 mg, and 30 mg tablets.
Because Otezla can cause gastrointestinal problems, it is recommended to steadily titrate Otezla until a dose of 30 mg by mouth two times a day is reached according to the suggested schedule:
Day 1: 10 mg by mouth in the morning
Day 2: 10 mg by mouth in the morning and 10 mg by mouth in the evening
Day 3: 10 mg by mouth in the morning and 20 mg by mouth in the evening
Day 4: 20 mg by mouth in the morning and 20 mg by mouth in the evening
Day 5: 20 mg by mouth in the morning and 30 mg by mouth in the evening
Day 6 and thereafter: 30 mg by mouth two times a day
The dose may be adjusted based on kidney function.
Ingredients
Apremilast, a phosphodiesterase 4 (PDE4) inhibitor, is the active ingredient in each Otezla tablet. The inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red. The 20 mg and 30 mg tablets also contain iron oxide yellow. The 30 mg tablet also contains iron oxide black.
Contraindications
Do not take Oteza if you are allergic to apremilast or to any of the other ingredients or excipients contained in Otezla tablets.
Cautions
- Before you start treatment with Otezla, be sure to inform your doctor of:
- All the medications you take
- Your allergies
- Your medical history and current medical conditions
- Your pregnancy or breastfeeding status
- Otezla can cause allergic reactions that may be severe. Seek emergency care immediately if you have a rash, a rapid heart rate, trouble breathing, or swelling of your face, lips, tongue, or throat.
- Otezla can cause diarrhea, nausea, and vomiting.
- Otezla can cause mood changes, including depression and suicidal thoughts. Patients, their families, or their caregivers should report any mood changes to the patient's doctor.
- Otezla can cause weight loss. You should monitor your weight regularly.
- Taking Otezla with strong cytochrome P450 enzyme inducers can cause the medication not to work as well. Ask your doctor if you are unsure whether or not you take cytochrome P450 enzyme inducers.
Side Effects
The most common Otezla side effects include diarrhea, nausea, headache, and upper respiratory tract infection; however, these are not all the side effects that can occur with the use of Otezla. Contact your doctor immediately if you have bothersome or persistent side effects.
Reference:
Otezla (apremilast) tablets, for oral use. Thousand Oaks, CA: Amgen Inc.; 2021.
Frequently Asked Questions about Otezla (Apremilast)
What is Otezla for?
Otezla (apremilast) is a medication taken twice daily to reduce inflammation and is used to treat adult patients with active psoriatic arthritis, plaque psoriasis requiring systemic therapy or phototherapy, and oral ulcers associated with Behçet’s Disease.
Is Otezla an immunosuppressant?
Yes, Otezla is considered an immunosuppressant. It reduces inflammation by regulating inflammatory mediators produced by immune cells.
Why is Otezla so expensive?
Otezla is a brand-name drug made by Amgen Inc. It is expensive because it is not yet available as a generic option. The lower-cost generic version called apremilast was approved by the FDA but is not yet on the U.S. market, possibly due to ongoing patent protection.
Is Otezla a steroid?
No, Otezla is not a steroid. It works differently than steroids to reduce inflammation. Otezla belongs to a class of medications called phosphodiesterase 4 (PDE4) inhibitors.
How does Otezla work?
Otezla works inside cells by reducing PDE4 activity. It inhibits an enzyme called PDE4, which plays a role in the speedy cell growth associated with plaque psoriasis. Less PDE4 activity means less inflammation and fewer plaque psoriasis symptoms.
How long does it take for Otezla to work?
The time it takes for Otezla to work can vary. Some people may see improvement in their symptoms within a few weeks, while others may take longer. It’s essential to follow your doctor’s instructions and be patient.
Do Otezla side effects go away?
Mild side effects of Otezla, such as diarrhea, nausea, and headache, may go away within a few days or weeks. Serious side effects are less common but should be reported to your doctor promptly.
Does Otezla cause weight loss?
Yes, Otezla can cause weight loss. Some people experience reduced appetite, leading to gradual weight loss. However, individual responses may vary.
Do you take Otezla forever?
The duration of Otezla treatment depends on your specific condition and how well you respond. Your doctor will guide you on the appropriate duration. Some people may need to take it long-term, while others may use it for shorter periods.
Does Otezla cause hair loss?
Hair loss is not a common side effect of Otezla. If you experience any unusual hair loss, discuss it with your doctor to determine the cause.
Does Otezla help with fatigue?
Yes, Otezla has been associated with improvements in fatigue for patients with psoriatic arthritis. However, fatigue responses can vary, and it’s essential to discuss any concerns with your doctor.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 13206
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