10 mg, 20 mg, 30 mg film-coated tablets
apremilast
What Otezla is and what it is used for
What Otezla is
Otezla contains the active substance “apremilast”. It belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help reduce inflammation.
What Otezla is used for
Otezla is used to treat adults with the following diseases:
- active psoriatic arthritis – if you can not use another type of medicine called ‘disease-modifying antirheumatic drugs’ (DMARDs) or if you have tried any of these medicines and it did not work.
- moderate to severe chronic plaque psoriasis – if you can not use any of the following treatments or if you have tried any of these treatments and it did not work:
- phototherapy – a treatment where certain skin areas are exposed to ultraviolet light
- systemic treatment – a treatment that affects the whole body rather than just a local area, such as “ciclosporin”, “methotrexate” or “psoralen”.
- Behçet’s disease – to treat cold sores which is a common problem for people with this disease.
What psoriatic arthritis is
Psoriatic arthritis is an inflammatory disease of the joints that is usually accompanied by psoriasis, which is an inflammatory disease of the skin.
What plaque psoriasis is
Psoriasis is an inflammatory disease of the skin, which can cause red, scaly, thick, itchy, painful spots on the skin and which can also affect the scalp and nails.
What is Behçet’s disease?
Behçet’s disease is a rare type of inflammatory disease that affects many parts of the body. The most common problem is cold sores.
How Otezla works
Psoriatic arthritis, psoriasis, and Behçet’s disease are usually lifelong diseases and there is currently no cure. Otezla works by reducing the activity of an enzyme in the body called “phosphodiesterase 4”, which is involved in the inflammatory process. By reducing the activity of this enzyme, Otezla can help control the inflammation associated with psoriatic arthritis, psoriasis, and Behçet’s disease, and the treatment reduces the signs and symptoms of these diseases.
In psoriatic arthritis, treatment with Otezla leads to an improvement in swollen and painful joints and can improve your overall physical function.
In psoriasis, treatment with Otezla leads to a reduction in psoriatic skin plaques and other signs and symptoms of the disease.
In Behçet’s disease, treatment with Otezla reduces the number of cold sores and can stop them completely. It can also reduce the pain of cold sores.
Otezla has also been shown to improve the quality of life in patients with psoriasis, psoriatic arthritis, or Behçet’s disease. This means that the impact of the disease on daily activities, relationships, and other factors should be less than before.
What you need to know before you take Otezla
Do not take Otezla:
- if you are allergic to apremilast or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or think you may be pregnant.
Warnings and cautions
Talk to your doctor or pharmacist before taking Otezla.
Depression and suicidal ideation
Tell your doctor before starting treatment with Otezla if you have depression that has gotten worse with suicidal thoughts.
You or your healthcare provider should also inform your doctor immediately about any changes in behavior or mood, feelings of depression, and suicidal thoughts you may have after using Otezla.
Serious kidney problems
If you have severe kidney problems, you will receive a different dosage – see section 3.
If you are underweight
Talk to your doctor when taking Otezla if you accidentally lose weight.
Magproblem
If you experience severe diarrhea, nausea or vomiting, talk to your doctor.
Children and young people
Otezla has not been studied in children and adolescents and therefore use in children and adolescents aged 17 years and younger is not recommended.
Other medicines and Otezla
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines, (traditional) herbal medicines, and herbal medicines. This is because Otezla may affect the way some other medicines work. In addition, some other medicines may affect the way Otezla works.
Before taking Otezla in particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- rifampicin – an antibiotic used for tuberculosis
- phenytoin , phenobarbital and carbamazepine – medicines used to treat seizures or epilepsy
- St. John’s wort – a (traditional) herbal remedy for mild anxiety and mild depression.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is limited information on the effects of Otezla in pregnancy. You should not become pregnant while taking this medicine and you should use an effective method of contraception during treatment with Otezla.
It is not known if this medicine passes into breast milk. You should not use Otezla while breastfeeding.
Driving and using machines
Otezla does not affect the ability to drive and use machines.
Otezla contains excipients
Otezla contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Otezla
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How much to take
- When you first start taking Otezla, you will receive a ‘starter pack’ containing all the doses listed in the table below.
- The “starter pack” is clearly marked to ensure that you take the correct tablet at the right time.
- Treatment begins with a lower dose that will be increased gradually over the first 6 days of treatment.
- The ‘starter pack’ also contains a sufficient amount of tablets for a further 8 days with the recommended dose one (days 7 to 14).
- The recommended dose of Otezla is 30 mg twice a day after the end of the dose increase phase – a 30 mg dose in the morning and a 30 mg dose in the evening, at approximately 12-hour intervals, with or without food.
- This will be a daily dose of 60 mg. By the end of day 6, you have reached this recommended dose .
- Once the recommended dose has been reached, you will only receive the tablet strength of 30 mg in your printed packs. You only need to go through this stage of gradual dose increase once, even if you start treatment again.
| Day | Morgondos | Evening dose | Total daily dose |
|---|---|---|---|
| Day 1 | 10 mg (pink) | Do not take any dose | 10 mg |
| Day 2 | 10 mg (pink) | 10 mg (pink) | 20 mg |
| Day 3 | 10 mg (pink) | 20 mg (brown) | 30 mg |
| Day 4 | 20 mg (brown) | 20 mg (brown) | 40 mg |
| Day 5 | 20 mg (brown) | 30 mg (beige) | 50 mg |
| Day 6 and onwards | 30 mg (beige) | 30 mg (beige) | 60 mg |
Patients with severe kidney problems
If you have severe kidney problems, the recommended dose is one of Otezla 30 mg once a day (morning dose). Your doctor will tell you how to increase your dose when you first start taking Otezla.
How and when to take Otezla
- Otezla should be taken by mouth (orally).
- Swallow the tablets whole, preferably with water.
- You can take the tablets either with or without food.
- Take Otezla at about the same time each day, one tablet in the morning and one tablet in the evening.
If your condition has not improved after six months of treatment, talk to your doctor.
If you take more Otezla than you should
If you take more Otezla than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack and this leaflet with you.
If you forget to take Otezla
- If you forget to take a dose of Otezla, take it as soon as you remember. If it’s almost time for your next dose , just skip the missed dose . Take the next dose at the usual time.
- Do not take a double dose to make up for a forgotten dose .
If you stop taking Otezla
- You should continue to take Otezla until your doctor tells you to stop.
- Do not stop taking Otezla without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects – depression and suicidal thoughts
Tell your doctor immediately about any changes in behavior or mood, feelings of depression, suicidal thoughts, or suicidal behavior (this is less common).
Very common side effects ( may affect more than 1 in 10 people)
- diarrhea
- nausea
- headache
- upper respiratory tract infections such as colds, runny nose or sinus infection
Common side effects ( may affect up to 1 in 10 people)
- cough
- back pain
- vomiting
- feeling tired
- abdominal pain
- loss of appetite
- frequent bowel movements
- difficulty sleeping (insomnia)
- stomach upset or heartburn
- inflammation and swelling of the trachea in the lungs ( bronchitis )
- common cold ( nasopharyngitis ).
- Depression
- migraine
- tension headache
Uncommon side effects ( may affect up to 1 in 100 people)
- rash
- hives ( urticaria )
- weight loss
- allergic reaction
- bleeding in the intestine or stomach.
- suicidal thoughts or behaviors
Has been reported (occurs in an unknown number of people):
- severe allergic reaction (may include swelling of the face, lips, mouth, tongue or throat which may lead to difficulty breathing or swallowing)
If you are 65 years or older, you may have a higher risk of complications such as severe diarrhea, nausea, and vomiting.
If your stomach problems become serious, talk to your doctor.
How to store Otezla
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the blister, wallet card or carton after EXP. Expiration date is the last day of the specified month.
- Do not store above 30 ° C.
- Do not use this medicine if you notice any damage or signs of tampering with the medicine pack.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is apremilast.
- Otezla 10 mg film-coated tablets: each film-coated tablet contains 10 mg apremilast.
- Otezla 20 mg film-coated tablets: each film-coated tablet contains 20 mg apremilast.
- Otezla 30 mg film-coated tablets: each film-coated tablet contains 30 mg apremilast.
The other ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate.
- The film coating contains poly (vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc and red iron oxide (E172).
- 20 mg film-coated tablet also contains yellow iron oxide (E172).
- 30 mg film-coated tablet also contains yellow iron oxide (E172) and black iron oxide (E172).
What the medicine looks like and contents of the pack
Otezla 10 mg film-coated tablet is a pink, rhombic film-coated tablet marked with “APR” on one side and “10” on the other side.
Otezla 20 mg film-coated tablet is a brown, rhombic film-coated tablet marked with “APR” on one side and “20” on the other side.
Otezla 30 mg film-coated tablet is a beige, rhombic film-coated tablet marked with “APR” on one side and “30” on the other side.
Pack sizes
- Starter pack one is like a foldable wallet containing 27 film-coated tablets: 4 x 10 mg tablets, 4 x 20 mg tablets and 19 x 30 mg tablets.
- The standard one-month pack contains 56 x 30 mg film-coated tablets.
- The standard three-month pack contains 168 x 30 mg film-coated tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder and Manufacturer
Amgen Europe BV
Minervum 7061
4817 ZK Breda
Netherlands