Roflumilast Tablets (Daxas) are a selective phosphodiesterase 4 inhibitor, primarily indicated for reducing the risk of acute exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) complicated by chronic bronchitis and a history of acute exacerbations. This drug is not a bronchodilator and is not indicated for the relief of acute bronchospasm.

What are the Precautions for Taking Roflumilast Tablets (Daxas)?

Indicated Population and Contraindications

Roflumilast is indicated for adult patients diagnosed with severe COPD, complicated by chronic bronchitis and with a history of acute exacerbations in the past.

This drug is not indicated for patients with mild or moderate COPD, nor is it used for the treatment of asthma or other respiratory diseases.

Absolute Contraindications

Moderate to severe hepatic impairment (Child-Pugh Class B or C).

Use in patients with hepatic impairment may result in a significant increase in drug exposure and an elevated risk of adverse reactions.

Special Population Warnings

Pregnant and lactating women: Insufficient human research data are available to confirm its safety. Roflumilast and its metabolites may pass into breast milk, and use during lactation should be avoided.

Elderly patients: No dosage adjustment is required, but close monitoring for adverse reactions is recommended.

Patients with renal impairment: No dosage adjustment is required.

Patients with mild hepatic impairment: A rigorous risk-benefit assessment should be conducted; use is contraindicated in patients with moderate to severe hepatic impairment.

Medication Monitoring for Roflumilast Tablets (Daxas)

Psychiatric Status Monitoring

Patients, their family members, and caregivers should closely monitor for changes in mood, sleep patterns, and behavior.

Immediate medical attention should be sought if symptoms such as depressed mood, worsening anxiety, or suicidal ideation occur.

A strict risk-benefit assessment must be performed before administration in patients with a history of depression or suicide attempts.

Body Weight Change Monitoring

Body weight should be measured regularly during treatment (e.g., once every 1–2 months).

In case of unexplained or clinically significant weight loss (e.g., > 5% of body weight), the underlying cause should be evaluated, and consideration should be given to dose adjustment or discontinuation of treatment.

Most patients may experience partial recovery of body weight after drug withdrawal.

Key Patient Education Points

Roflumilast is a prophylactic medication and is not intended for the management of acute dyspnea episodes. Patients should carry a rescue bronchodilator at all times.

Regular follow-up visits are required during treatment to assess efficacy and safety.

Patients must inform their physicians of all medications they are taking during consultations, including prescription drugs, over-the-counter drugs, and dietary supplements.

The drug should be stored at room temperature between 20°C and 25°C, and kept out of the reach of children.