Otezla (apremilast)

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What is Otezla (apremilast)?

オテズラスターターパック

Otezla is an oral treatment for psoriasis that was approved in the United States in 2014. It was also approved in Japan in 2017 and is now widely used.
Psoriasis is a disease that causes abnormal inflammation of the skin and joints due to an imbalance of the body’s immune system. It is also characterized by a chronic cycle of symptoms that worsens and subsides.
In psoriasis treatment, mild cases are often treated with local therapy using steroids and topical active vitamin D3. If local therapy fails to produce a therapeutic effect or in severe cases, the introduction of systemic therapy, such as oral medications including keratolytics and immunosuppressants, or injectable medications including biologic agents, is considered. Roughly speaking, the order of treatment is topical medications, oral medications, and injections, in that order of intensity. In addition to these treatments, ultraviolet light exposure is another option.

» Click here for more information on psoriasis.

The pathogenesis of psoriasis is said to involve the excessive expression of phosphodiesterase-4 (PDE4) and the accompanying high production of inflammatory cytokines (chemicals involved in inflammatory responses). In contrast, Otezla works by inhibiting the function of PDE4, thereby regulating the production of inflammatory cytokines and suppressing skin inflammation. Therefore, Otezla is also called a PDE4 inhibitor.

Otezla's Mechanism of Action

Otezla is used in patients with the following conditions

  • Psoriasis vulgaris cases with inadequate response to topical theraphy (in which topical medication does not provide sufficient response and skin rash covers at least 10% of the body surface area)
  • Psoriatic arthritis (psoriasis with symptoms such as joint pain and swelling)
  • Oral ulcers due to Behcet’s disease with inadequate response to topical therapy (the only indication for a disease other than psoriasis)

Characteristics of Otezla

Otezla has been shown to have the following characteristics

  • Itching tends to subside as early as 2-4 weeks after the start of administration. However, it may take up to about 24 weeks for symptoms to subside after the start of administration.
  • Improves joint symptoms
  • Effective for lesions on the head, palms, soles, nails, and other areas that are difficult to heal.
  • Effective for lesions on the head, palms, soles, nails, and other areas that are difficult to heal.

Furthermore, compared to other oral medications for psoriasis vulgaris (e.g., keratosis medications and immunosuppressive drugs), the probability of serious side effects such as liver and kidney dysfunction is low, and regular blood tests are not required.

How to use Otezla

As previously mentioned, Otezla is an oral medication.
Start with a small dose, and gradually increase the dosage as shown in the table below.

Day 1 morning10mg
Day 2 morning10mg、evening10mg
Day 3 morning10mg、evening20mg
Day 4 morning20mg、evening20mg
Day 5 morning20mg、evening30mg
After 6 days morning30mg、evening30mg

After the 6th day, the dosage will basically remain the same, but may be reduced according to symptoms. It can also be used in combination with other treatments.

Side Effects and Precautions

Side effects and precautions for Otezla include the following points

  • Hypersensitivity to Otezla may occur.
  • Although infrequent, the onset of allergic reactions to Otezla may occur rapidly as skin symptoms, such as itching and hives, and respiratory symptoms such as breathlessness. If you experience any of these symptoms, please do consult us immediately rather than handling the reaction on your own.

  • Side effects are likely to occur during the initial period of administration.
  • It is known that side effects such as nausea, diarrhea, and headache occur in more than 5% of cases. The reason for gradually increasing the dosage is to allow the body to become accustomed to the medication. These side effects often improve within about two weeks of their onset.

  • Risk of complications and recurrence of infections
  • For patients with a currently existing infection, a potential infection, or a history of a recurrent infection, Otezla may exacerbate the infectious disease. Thus, if needed, patients should get checked for infection before starting on Otezla.

  • May experience some mood swings.
  • Overseas, there have been some people who reported that Otezla has caused them to become depressed or suicidal. If you notice any change in your mood after starting treatment, such as becoming more depressed or lacking motivation, please consult us as soon as possible.

  • Patients with severe renal dysfunction (less than 30 mL/min on the creatinine clearance level using Cockcroft-Gault equation) should reduce the dosage of Otezla.

Patients who have had impaired renal function will need to be prescribed a reduced dosage of medication. Please be sure to inform us in advance if you have any experience indicating any impaired renal function.

Precautions in daily life

Patients who are taking medications for other illnesses should take caution when taking them together with Otezla. In particular, taking Otezla with rifampicin, phenobarbital, carbamazepine, phenytoin, or methotrexate will dilute the blood concentration of Otezla and make it less effective, while taking it with ketoconazole will increase the concentration of Otezla in the blood and make it more effective than necessary.
Please be sure to inform your doctors if you are taking any of the mentioned medications or if you have received a new prescription from another hospital.
Otezla should not be administered to women who are pregnant or planning to become pregnant. Please note that contraception is required when taking Otezla. While it is not forbidden for nursing mothers to take this medication, animal studies have confirmed that the drug passes into breast milk. Considering the fact that the medication essentially cannot be administered to pediatric patients, we cannot recommend Otezla be administered to nursing mothers.

Copayment and Drug Fees

As of December 2021, the specifications and drug prices for Otezla are respectively as follows: 329.9 yen / 10mg tablet; 659.8 yen / 20mg tablet; 990.0 yen / 30mg tablet. Taking 30 mg tablets orally twice a day will cost 1,980 yen per day. For a patient with 30% copay, the daily drug cost is 594 yen.

Frequently Asked Questions

What should I do if I forget to take my medication?

If you still have a few hours until your next scheduled dose, it is fine to take the one you forgotten as soon as you notice. If your next scheduled dose is coming up soon, just resume from that next dose. Never take two doses at once.

 

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Clinic info

Clinic name
Sugamo Sengoku Dermatology
Address
1-20-10 5F Sugamo Toshima-ku, Tokyo
Train
3 minutes on foot from JR Yamanote Line Sugamo Station, 4 minutes on foot from Sengoku Station on the Toei Mita Line
TEL
03-3941-1241
Practice time
Mon Tue Wed Thu Fri Sat Sun Holiday
9:00~13:00
15:30~18:30

☆Closed day: Wed, Sun, Holiday

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