New Psoriasis Medications: 8 Drugs Seeking FDA Approval
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Otezla
Used for Plaque Psoriasis, Psoriatic Arthritis
Used for Plaque Psoriasis, Psoriatic Arthritis
Otezla (apremilast) is a tablet that's taken by mouth. It treats plaque psoriasis and psoriatic arthritis in people 6 years and older. The medication can also treat mouth sores from Behçet’s disease in adults. It works as a phosphodiesterase-4 (PDE4) inhibitor to reduce inflammation. Immediate-release tablets called Otezla are taken twice daily. You start at a low dose, then it gets raised over a few days to a maintenance dose. Some people can switch to once-daily, extended-release tablets called Otezla XR. Side effects include nausea and diarrhea.
What is Otezla (apremilast)?
What is Otezla (apremilast) used for?
- Psoriatic arthritis in people 6 years and older
- Plaque psoriasis in people 6 years and older
- Mouth sores from Behçet’s disease in adults
How Otezla (apremilast) works
Otezla (apremilast) is a phosphodiesterase-4 (PDE4) inhibitor. It works by blocking a protein called PDE4. This protein plays a role in causing inflammation in your body. Blocking PDE-4 is thought to help lower inflammation.
When does Otezla (apremilast) start working?Time passed since treatment started:
Drug facts
| Common Brands | Otezla, Otezla XR |
|---|---|
| Drug Class | PDE-4 inhibitor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
More on Otezla (apremilast) essentials
Side effects of Otezla (apremilast)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Diarrhea (17%)
- Nausea (17%)
- Upper respiratory tract infection (e.g., common cold; 9%)
- Headache (up to 8%)
Less Common Side Effects
- Vomiting
- Stomach pain
- Indigestion
- Lower appetite
- Tiredness
- Back pain
- Migraine
Note: Side effects were from adults with plaque psoriasis. Side effects might differ for people with other medical conditions.
Otezla (apremilast) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Depression
- Suicidal thoughts or behavior
- Severe allergic reaction: hives; trouble breathing; swelling of the lips, tongue, or throat
When do Otezla (apremilast) possible side effects begin and end?
Time passed since treatment started:
H
D
W
M
Diarrhea
Nausea
Vomiting
Headache
More on Otezla (apremilast) side effects
The following Otezla (apremilast) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Thoughts of suicide or self-harm, worsening mood, feelings of depression
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Diarrhea
- Headache
- Loss of appetite with weight loss
- Nausea
- Vomiting
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Pros and cons of Otezla (apremilast)
Pros
- Taken by mouth
- Can take with or without food
- Option to switch to once-daily extended-release tablets for some people
Cons
- Dosing schedule can be confusing in the beginning
- Common to have nausea or diarrhea when starting
- Might not be a good option for people who've had depression or suicidal behavior
Pharmacist tips for Otezla (apremilast)
- You can take Otezla (apremilast) with or without food. Swallow the tablets whole. Don't crush, split, or chew them.
- When you start Otezla (apremilast), you're usually given a starter pack. It has clear instructions on what strength(s) to take each day to slowly raise your dose. This helps your body get used to the medication. And it helps lower your chance of nausea, vomiting, and diarrhea. Carefully follow the directions in the starter pack. Ask your prescriber or pharmacist if you have any questions.
- If you vomit or have diarrhea while taking Otezla (apremilast), drink plenty of fluids to avoid dehydration. Also try eating simpler foods and avoiding greasy, fried, or spicy foods to calm your stomach. In general, these side effects should go away in a few weeks. But tell your prescriber if they happen often or bother you a lot. They might lower your dose or pause your treatment to help.
- It's best to limit how much alcohol you drink while taking Otezla (apremilast). Alcohol can make side effects like nausea and headache worse. Talk to your prescriber about your drinking habits and how to take this medication safely.
- For Otezla XR (apremilast): After you take the medication, you might see a tablet shell in your stool. This is normal and harmless. Your body has already absorbed all the medication from the tablet by the time you see the tablet shell. If you're worried, talk to your prescriber.
- Give your care team a list of all the medications you take. Some, like carbamazepine (Tegretol), interact with Otezla (apremilast). These drug interactions can make Otezla (apremilast) not work as well. Your care team can check that your medications are safe to take together.
- If you become pregnant while taking Otezla (apremilast): Tell your prescriber. It's not clear if the medication can harm an unborn baby, but there might be a risk. Your prescriber can help go over the risks and benefits of treatment. They can help choose a safe option for you.
Risks and warnings for Otezla (apremilast)
Otezla (apremilast) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Allergic reaction
Rarely, Otezla (apremilast) can cause a serious allergic reaction. Stop taking the medication and get medical help right away if you have an allergic reaction. Look out for hives; trouble breathing; or swelling in your lips, tongue, or throat.
Diarrhea, nausea, and vomiting
- Risk factors: Older adults | Taking diuretics (water pills) | Taking medications that can dehydrate you or cause low blood pressure
Nausea, vomiting, and diarrhea are common when you first start taking Otezla (apremilast). These side effects usually happen within the first few weeks of treatment. But they should get better and go away with time.
These side effects can be severe and sometimes lead to dehydration (when your body loses too much fluid). The chance of dehydration from these side effects can be higher for older adults. People who take medications that remove fluid from the body or lower blood pressure can also be at risk.
Tell your care team if you have a lot of nausea, vomiting, or diarrhea while taking Otezla (apremilast). Your prescriber might lower your dose or pause your treatment.
Depression
- Risk factors: History of depression | History of suicidal thoughts or behavior
Some people who took Otezla (apremilast) reported having depression or feeling depressed. Before starting this medication, let your prescriber know if you've ever had depression or suicidal thoughts. They can help weigh the risks and benefits of taking Otezla (apremilast).
During treatment, watch for any unusual changes in your behavior or mood. Call your prescriber if you or someone close to you notices this. If you have suicidal thoughts or actions, call 911 right away.
Possible weight loss
Keep an eye on your weight while taking Otezla (apremilast). Tell your prescriber if you notice unexplained weight loss while taking this medication. In studies, some adults and children lost weight during treatment. Talk to the prescriber if you're worried about this possible side effect.
Drug interactions
Some medications can lower the amount of Otezla (apremilast) in the body. One example is the antibiotic rifampin (Rifadin). Others are seizure medications like phenobarbital, carbamazepine (Tegretol), and phenytoin (Dilantin). They can make Otezla (apremilast) work less well. So, it's not recommended to take them with Otezla (apremilast).
Tell your prescriber about all the medications and supplements you take. Also talk to them before starting any new ones while taking Otezla (apremilast). Your prescriber can make sure your medications are safe to take together.
Otezla (apremilast) dosage
The average cost for 60 tablets of 30mg of Otezla (apremilast) is $0.00 with a free GoodRx coupon. This is 100.00% off the average retail price of $11,743.77.
Typical dosage for Otezla (apremilast)
Usually, you start the medication at a low dose. Your prescriber will slowly raise the dose over 5 days to help lower your risk of stomach upset.
The recommended dosing schedules are outlined below.
-
Adults and children 6 years and older weighing 110 lbs or more
- Day 1: Take Otezla 10 mg by mouth in the morning.
- Day 2: Take Otezla 10 mg in the morning and Otezla 10 mg in the evening.
- Day 3: Take Otezla 10 mg in the morning and Otezla 20 mg in the evening.
- Day 4: Take Otezla 20 mg in the morning and Otezla 20 mg in the evening.
- Day 5: Take Otezla 20 mg in the morning and Otezla 30 mg in the evening.
- Day 6 and beyond: Take Otezla 30 mg once in the morning and Otezla 30 mg in the evening. Or, you can switch to Otezla XR 75 mg once a day.
-
Children 6 years and older weighing 44 lbs to less than 110 lbs
- Day 1: Take Otezla 10 mg by mouth in the morning.
- Day 2: Take Otezla 10 mg in the morning and Otezla 10 mg in the evening.
- Day 3: Take Otezla 10 mg in the morning and Otezla 20 mg in the evening.
- Day 4: Take Otezla 20 mg in the morning and Otezla 20 mg in the evening.
- Day 5: Take Otezla 20 mg in the morning and Otezla 20 mg in the evening.
- Day 6 and beyond: Take Otezla 20 mg in the morning and Otezla 20 mg in the evening.
Your dose might differ if you have kidney problems.
More on Otezla (apremilast) dosage
How much does Otezla (apremilast) cost?
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Otezla (brand)
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What are alternatives to Otezla (apremilast)?
There are a number of medications that your doctor can prescribe in place of Otezla (apremilast). Compare a few possible alternatives below.
Used for:
Moderate-to-severe inflammatory conditions in which other treatments haven't worked:
$3,273.52View prices
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