Daxas 500 microgram film-coated tablets

See also: Stiolto

Daxas 500 microgram film-coated tablets Tablets are indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Limitations of Use

Daxas 500 microgram film-coated tablets Tablets are not bronchodilators and are not indicated for the relief of acute bronchospasm.

Daxas 500 microgram film-coated tablets (Daxas 500 microgram film-coated tablets) reduces inflammation in the lungs that leads to COPD (chronic obstructive pulmonary disease).

Daxas 500 microgram film-coated tablets is used to prevent worsening of symptoms in people with severe chronic obstructive pulmonary disease (COPD).

Daxas 500 microgram film-coated tablets is not a bronchodilator. It will not treat a bronchospasm attack that has already begun.

Daxas 500 microgram film-coated tablets may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance

To reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations: 500 mcg orally once a day, with or without food

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild liver impairment (Child-Pugh A): Data not available; the risk-benefit of administering Daxas 500 microgram film-coated tablets to patients with this degree of liver impairment should be considered

Moderate to severe liver impairment (Child-Pugh B or C): Contraindicated

Precautions

Daxas 500 microgram film-coated tablets is not a bronchodilator and should not be used for the relief of acute bronchospasm.

An increase in psychiatric adverse reactions has been reported with Daxas 500 microgram film-coated tablets. Before use, prescribers should carefully weigh the risks and benefits of Daxas 500 microgram film-coated tablets therapy in patients with a history of depression and/or suicidal thoughts or behavior. Patients, their caregivers, and families should be advised to contact their healthcare provider if insomnia, anxiety, depression, suicidal thoughts, or other mood changes develop or worsen. If such events occur, prescribers should carefully evaluate the risks and benefits of continuing Daxas 500 microgram film-coated tablets therapy.

Weight loss was common during clinical trials. Patients treated with Daxas 500 microgram film-coated tablets should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, weight loss should be evaluated, and discontinuation of Daxas 500 microgram film-coated tablets should be considered.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

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What is the most important information I should know about Daxas 500 microgram film-coated tablets?

You should not use Daxas 500 microgram film-coated tablets if you are allergic to it, or if you have moderate or severe liver disease.

There are many other drugs that can make Daxas 500 microgram film-coated tablets less effective and should not be used at the same time. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Before you take Daxas 500 microgram film-coated tablets, tell your doctor if you have liver disease or a history of depression, mental illness, or suicidal thoughts or actions.

You may have unusual thoughts or behavior, or thoughts about suicide, while taking this medicine. Tell your doctor if you have new or worsening depression, or suicidal thoughts. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, depression, trouble sleeping, or if you feel impulsive, or you have thoughts about suicide or hurting yourself.

Call your doctor at once if you have rapid and unintended weight loss.

Use Daxas 500 microgram film-coated tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Daxas 500 microgram film-coated tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Daxas 500 microgram film-coated tablets refilled.
• Take Daxas 500 microgram film-coated tablets by mouth with or without food.
• If you miss a dose of Daxas 500 microgram film-coated tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Daxas 500 microgram film-coated tablets.

Daxas 500 microgram film-coated tablets is used to control and prevent symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis). It should be used along with other medications (bronchodilators such as salmeterol, ipratropium) to treat COPD. It works by reducing the irritation and swelling of the airways. Controlling symptoms of breathing problems can decrease time lost from work or school.

This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath or wheezing. If sudden breathing problems occur, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

How to use Daxas 500 microgram film-coated tablets

Read the Medication Guide and, if available, the Patient Information Leaflet from your pharmacist before you start taking Daxas 500 microgram film-coated tablets and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

Use this medication regularly in order to get the most benefit from it. This medication works best if used at evenly spaced intervals. To help you remember, use it at the same time each day. Do not increase your dose, use this medication more frequently, or stop using it without first consulting your doctor.

Tell your doctor if your condition does not improve or if it worsens.

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What other drugs will affect Daxas 500 microgram film-coated tablets?

Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Cimetidine: May increase serum concentrations of the active metabolite(s) of Daxas 500 microgram film-coated tablets. Cimetidine may increase the serum concentration of Daxas 500 microgram film-coated tablets. Monitor therapy

Ciprofloxacin (Systemic): May increase the serum concentration of Daxas 500 microgram film-coated tablets. Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Daxas 500 microgram film-coated tablets. Management: Daxas 500 microgram film-coated tablets U.S. prescribing information recommends against combining strong CYP3A4 inducers with Daxas 500 microgram film-coated tablets. The Canadian product monograph makes no such recommendation but notes that such agents may reduce Daxas 500 microgram film-coated tablets therapeutic effects. Avoid combination

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

FluvoxaMINE: May increase serum concentrations of the active metabolite(s) of Daxas 500 microgram film-coated tablets. FluvoxaMINE may increase the serum concentration of Daxas 500 microgram film-coated tablets. Monitor therapy

Immunosuppressants: Daxas 500 microgram film-coated tablets may enhance the immunosuppressive effect of Immunosuppressants. Exceptions: Beclomethasone (Oral Inhalation); Cytarabine (Liposomal); Fluticasone (Oral Inhalation). Consider therapy modification

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination

RifAMPin: May decrease the serum concentration of Daxas 500 microgram film-coated tablets. Management: Daxas 500 microgram film-coated tablets U.S. prescribing information recommends against combining rifampin with Daxas 500 microgram film-coated tablets. The Canadian product monograph makes no such recommendation but notes that rifampin may reduce Daxas 500 microgram film-coated tablets therapeutic effects. Avoid combination

Riociguat: Daxas 500 microgram film-coated tablets may enhance the hypotensive effect of Riociguat. Management: Riociguat is contraindicated with nonselective phosphodiesterase (PDE) inhibitors and PDE type 5 inhibitors. Other types of PDE inhibitors are not contraindicated, but caution is advised and patients should be monitored for hypotension. Monitor therapy

Tobacco (Smoked): May decrease the serum concentration of Daxas 500 microgram film-coated tablets. Monitor therapy

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What are the possible side effects of Daxas 500 microgram film-coated tablets?

The following adverse reactions are described in greater detail in other sections:

• Psychiatric Events Including Suicidality
• Weight Decrease

Adverse Reactions In Clinical Studies

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflect exposure of 4438 patients to Daxas 500 microgram film-coated tablets 500 mcg once daily in four 1year placebo-controlled trials, two 6-month placebo-controlled trials, and two 6-month drug add-on trials. In these trials, 3136 and 1232 COPD patients were exposed to Daxas 500 microgram film-coated tablets 500 mcg once daily for 6 months and 1-year, respectively.

The population had a median age of 64 years (range 40-91), 73% were male, 92.9% were Caucasian, and had COPD with a mean pre-bronchodilator forced expiratory volume in one second (FEV) of 8.9 to 89.1% predicted. In these trials, 68.5% of the patients treated with Daxas 500 microgram film-coated tablets reported an adverse reaction compared with 65.3% treated with placebo.

The proportion of patients who discontinued treatment due to adverse reaction was 14.8% for Daxas 500 microgram film-coated tablets-treated patients and 9.9% for placebo-treated patients. The most common adverse reactions that led to discontinuation of Daxas 500 microgram film-coated tablets were diarrhea (2.4%) and nausea (1.6%).

Serious adverse reactions, whether considered drug-related or not by the investigators, which occurred more frequently in Daxas 500 microgram film-coated tablets-treated patients include diarrhea, atrial fibrillation, lung cancer, prostate cancer, acute pancreatitis, and acute renal failure.

Table 1 summarizes the adverse reactions reported by ≥ 2% of patients in the Daxas 500 microgram film-coated tablets group in 8 controlled COPD clinical trials.

Table 1: Adverse Reactions Reported by ≥ 2% of Patients Treated with Daxas 500 microgram film-coated tablets 500 mcg daily and Greater Than Placebo

Adverse reactions that occurred in the Daxas 500 microgram film-coated tablets group at a frequency of 1 to 2% where rates exceeded that in the placebo group include:

Gastrointestinal disorders -abdominal pain, dyspepsia, gastritis, vomiting

Infections and infestations -rhinitis, sinusitis, urinary tract infection,

Musculoskeletal and connective tissue disorders -muscle spasms

Nervous system disorders -tremor

Psychiatric disorders -anxiety, depression

Postmarketing Experience

The following adverse reactions have been identified from spontaneous reports of Daxas 500 microgram film-coated tablets received worldwide and have not been listed elsewhere. These adverse reactions have been chosen for inclusion due to a combination of seriousness, frequency of reporting or potential causal connection to Daxas 500 microgram film-coated tablets. Because these adverse reactions were reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency or establish a causal relationship to Daxas 500 microgram film-coated tablets exposure: hypersensitivity reactions (including angioedema, urticaria and rash), gynecomastia.

Daxas 500 microgram film-coated tablets is a phosphodiesterase-4 (PDE-4) inhibitor. Due to its selective inhibition of the PDE4 isoenzyme in lung cells, Daxas 500 microgram film-coated tablets is indicated for the management of chronic obstrtuctive pulmonary disease (COPD) exacerbations. Treatment with Daxas 500 microgram film-coated tablets is associated with an increase in psychiatric adverse reactions, including suicide and suicidal attempts.