It is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) (post-bronchodilator FEV1 less than 50% predicted).
Associated with chronic bronchitis in adult patients with a history of frequent exacerbations as an adjunct to bronchodilator treatment.
What is Daxas?
Roflumilast (trade names Daxas, Daliresp) is a drug that acts as a selective long-acting inhibitor of the enzyme phosphodiesterase-4 (PDE-4).
It has anti-inflammatory effects and is used as an orally administered drug for the treatment of inflammatory conditions of the lungs, such as chronic obstructive pulmonary disease (COPD).
In June 2010, it was approved in the European Union (EU) for severe chronic obstructive pulmonary disease associated with chronic bronchitis. In March 2011, he obtained approval from the US Food and Drug Administration. UU To reduce exacerbations of chronic obstructive pulmonary disease.
It is available as tablets (500 micrograms).
Each yellow D-shaped tablet, film coated, with “D” engraved on one side. Non-medicinal ingredients: lactose monohydrate, corn starch, povidone and magnesium stearate; film coating: hypromellose, macrogol 4000, titanium dioxide and yellow iron oxide.
For what do you use it?
It belongs to the class of drugs called phosphodiesterase 4 (PDE4) inhibitors. It is used together with a bronchodilator (eg, salbutamol) to treat severe chronic obstructive pulmonary disease (COPD) with chronic cough and sputum (mucosa) in adults who have frequent outbreaks.
It works by reducing inflammation in the lungs.
Daxas is used to treat severe chronic obstructive pulmonary disease (COPD) in adults who suffer from chronic bronchitis (long-term inflammation of the airways) and whose obstructive pulmonary disease is frequently inflamed.
Obstructive pulmonary disease is a long-term disease in which the airways and alveoli within the lungs become damaged or blocked, causing difficulty in inhaling and extracting air from the lungs.
Daxas is not used alone, but as an “addition” to bronchodilator treatment (drugs that dilate the airways in the lungs).
The medication can only be dispensed with a prescription.
The recommended dose of Daxas is one tablet once a day. The tablets should be swallowed with water at the same time every day. Patients may need to take Daxas for several weeks before it begins to have an effect.
Mechanism of action
The active substance in Daxas, roflumilast, belongs to a group of medicines called phosphodiesterase type 4 (PDE4) inhibitors. It blocks the action of the enzyme inhibitor phosphodiesterase type 4, which is involved in the inflammation process that leads to obstructive lung disease.
By blocking the action of the phosphodiesterase type 4 inhibitor, Daxas reduces inflammation in the lungs, helping to reduce the patient’s symptoms or to prevent them from getting worse.
The recommended dose of Daxas is a 500xg Daxas tablet taken orally once a day, at the same time every day.
If you forget to take a dose at the usual time, take it as soon as possible or take it as soon as you remember that day and continue with your usual schedule.
However, if you forget to take your tablet for an entire day, simply skip the missed dose and take your next scheduled dose as normal. Store this medicine at room temperature and keep it out of the reach of children.
How has Daxas been studied?
Daxas has been compared to placebo (a dummy treatment) in two main studies that included more than 3,000 adults with severe obstructive pulmonary disease who had had at least one outbreak of their disease in the last year.
The main measure of effectiveness was the improvement in forced expiratory volumes (FEV1) and the reduction in the number of moderate or severe outbreaks of their obstructive pulmonary disease during one year of treatment.
Forced expiratory volumes (FEV1) are the largest amount of air that a person can exhale in a second.
Daxas proved to be more effective than placebo in the treatment of obstructive pulmonary disease.
After one year, patients who took Daxas had an average increase of 40ml, while those who received placebo had an average decrease of 9ml.
What is the risk associated with Daxas?
The most common side effects with Daxas (observed between 1 and 10 patients in 100) are weight loss, decreased appetite, insomnia (difficulty sleeping), headache, diarrhea, nausea (feeling sick) and abdominal pain ( stomach ache).
Daxas should not be used in patients who have moderate or severe problems with their liver.
The Committee for Medicinal Products for Human Use noted that there was a need for new treatments for obstructive pulmonary disease and that the main studies showed a modest benefit of Daxas in patients with severe obstructive pulmonary disease.
This benefit was observed in addition to the effects of the treatments that the patients were already receiving. After considering all available data on the effects of the medication, the committee decided that the benefits of Daxas are greater than its risks and recommended that a marketing authorization be granted.
The safety information has been included in the summary of product characteristics and in the Daxas package leaflet, including the appropriate precautions to be followed by health professionals and patients.
In addition, the company that makes Daxas will ensure that health professionals who prescribe the drug in all EU Member States receive educational material that contains information about the side effects of the drug and how it should be used.
The company will also provide cards for patients, telling them what information they need to inform their doctor about their symptoms and past illnesses to help the doctor know if Daxas is appropriate for them. The card will include an area where patients can register their weight.
What side effects are possible from Daxas?
You may experience diarrhea, nausea, abdominal pain or headache during the first weeks of taking this medication. These side effects usually improve with continuous treatment.
Talk to your doctor if they do not improve within the first weeks of treatment. The fact that a side effect is indicated here does not mean that all people who use this drug experience that or any side effect:
Common (affects between 1 in 10 and 1 in 100 people):
- Decreased appetite and weight loss.
- Difficulty sleeping (insomnia).
- Feeling sick.
- Abdominal pain.
Uncommon (affect between 1 in 100 and 1 in 1000 people):
- Tremor, usually from the hands.
- Awareness of the beating of your heart (palpitations).
- Bowel disorders such as vomiting, indigestion, acid reflux .
- Inflammation of the stomach ( gastritis ).
- Muscle spasms, weakness and pain.
- Back pain.
- Feeling weak, tired or generally bad.
- Hypersensitivity reactions such as rash, itching, hives or swelling of the lips and face.
Rare (affect between 1 in 1000 and 1 in 10,000 people):
- Abnormal results in liver function tests.
- Increase in creatinine levels in the blood.
- Constipation .
- Respiratory tract infections.
- Changes in taste.
- Depression .
- Abnormal enlargement of the breasts in men ( gynecomastia ).
- Blood in the stool.
Do not take this medication (Daxas) if you:
- You are allergic to roflumilast or any other ingredient in this medicine (Daxas).
- You have moderate or severe liver disease.
Daxas tablets contain lactose and should not be taken by people with hereditary galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption.
Behavioral changes and suicidal thoughts : people who take Daxas tablets have experienced an increased risk of psychiatric problems, such as anxiety, nervousness, trouble sleeping (insomnia), depression and, rarely, thoughts about suicide.
If you experience behavioral changes or symptoms such as sadness, anxiety, feelings of helplessness, feeling guilty, loss of pleasure or interest in activities, changes in sleep patterns or restlessness while taking this medication (Daxas), then it is very important that talk to your doctor or contact your doctor immediately.
Family members or caregivers of people who are taking Daxas should contact the person’s doctor immediately if they notice unusual behavioral changes.
If you have a history of depression with thoughts of self-harm or suicide, you should avoid this medication.
Continue taking bronchodilators : this medication (Daxas) does not replace your bronchodilator medications (such as Salbutamol), so you should take Daxas and your bronchodilator medication (such as Salbutamol) daily.
Heart disease : This medicine (Daxas) can cause abnormal heart rhythms.
Infections : Stop using Daxas and get immediate medical attention if symptoms of severe acute infection occur (eg, fever, chills or tremors, rapid heartbeat, rapid breathing, confusion and rash).
Severe diseases of the immune system : If you have a serious disease of the immune system, such as HIV infection, multiple sclerosis, lupus erythematosus and progressive multifocal leukoencephalopathy, you should not take Daxas.
Sudden attacks of shortness of breath : This medication (Daxas) does not treat sudden attacks of difficulty breathing. You should always have a bronchodilator medication (such as salbutamol) to treat a sudden attack of dyspnea .
Weight loss : people who take Daxas have experienced weight loss. You should weigh yourself regularly and consult your doctor if you notice that your weight drops unintentionally (that is, not as a result of a diet or increased exercise).
While taking Daxas, you or your health care supervisors should control your weight regularly. You or your health care supervisor should contact your doctor if an unexpected weight loss has occurred.
Children : the safety and efficacy of the use of this medicine (Daxas) have not been established for children.
What other drugs may interact with this medicine?
The following medications may increase the amount of roflumilast in your blood and this may increase the risk of side effects:
- Erythromycin .
- Oral contraceptives containing gestodene and ethinylestradiol.
- Theophylline (not recommended in combination with daxa tablets).
The following medications may decrease the amount of Daxas in your blood and, therefore, may make it less effective. For this reason, Daxas is not recommended for people who take any of these medications:
There may be an interaction between this medicine (Daxas) and any of the following medications:
- Anticancer drugs (eg, carboplatin, cyclophosphamide, doxorubicin , ifosfamide, vincristine).
- Corticosteroids (such as dexamethasone , prednisone )
- Dexamethasone .
- Leflunomide .
- Drugs that suppress the immune system (such as drugs for cancer or organ transplants).
- Mycophenolate .
- Grass of San Juan.
- Theophylline .
Check with your doctor or pharmacist before taking any new medicines while taking Daxas, to make sure the combination is safe.