Roflumilast Tablets (Daxas) is a selective phosphodiesterase 4 (PDE4) inhibitor. It is indicated for patients with severe chronic obstructive pulmonary disease (COPD) who have a history of chronic bronchitis and acute exacerbations, for the purpose of reducing the risk of COPD acute exacerbations.

Adverse Reactions of Roflumilast Tablets (Daxas)

Common Adverse Reactions

Diarrhea: The incidence rate is approximately 9.5%, and it is one of the main causes of treatment discontinuation (accounting for about 2.4%).

Weight loss: The incidence rate is about 7.5%. Some patients may experience moderate weight loss (5%-10% reduction in body weight) or even severe weight loss (more than 10% reduction).

Nausea: The incidence rate is around 4.7%, which is also a common reason for treatment withdrawal (about 1.6%).

Headache: The incidence rate is roughly 4.4%.

Back pain: The incidence rate is approximately 3.2%.

Severe Adverse Reactions

Psychiatric Events (Including Suicidal Tendency)

The use of roflumilast tablets is associated with an increased risk of psychiatric adverse reactions.

Patients, their family members and caregivers should closely monitor for the occurrence or exacerbation of insomnia, anxiety, depression, suicidal ideation or other emotional and behavioral changes.

For patients with a history of depression and/or suicidal tendency, the benefits and risks of treatment must be carefully weighed before administration.

If the above symptoms occur, the doctor should be contacted immediately to evaluate whether to continue the medication.

Significant Weight Loss

Body weight should be monitored regularly during treatment.

In case of unexplained or significant weight loss, the cause should be evaluated and discontinuation of the drug should be considered.

After drug withdrawal, the weight of most patients can be partially recovered.

Non-bronchodilator; Not for Acute Bronchospasm

Roflumilast tablets are not bronchodilators and should not be used for relieving acute bronchospasm or sudden dyspnea.

Patients should have other emergency medications (such as short-acting β₂ agonists) available for the management of acute symptoms.

Precautions for Roflumilast Tablets (Daxas)

Drug Interactions

Concomitant use with potent CYP450 inducers is prohibited: Drugs such as rifampicin, phenobarbital, carbamazepine and phenytoin can reduce the plasma concentration of roflumilast and affect its efficacy.

CYP3A4/1A2 inhibitors should be used with caution: Drugs like erythromycin, ketoconazole, fluvoxamine, enoxacin and cimetidine may increase the plasma concentration of roflumilast, thereby increasing the risk of adverse reactions.

Oral contraceptives: Contraceptives containing gestodene and ethinylestradiol may increase the exposure of roflumilast, so caution should be exercised when used concomitantly.

Medication in Special Populations

Pregnant and lactating women: No clinical studies on the use of this drug in pregnant women have been conducted. Animal experiments have shown a risk of embryonic loss. Pregnancy should be avoided during medication. Roflumilast and its metabolites may pass into breast milk, so lactating women are prohibited from using this drug.

Pediatric patients: COPD usually does not occur in children, and the efficacy of this drug in children has not been established.

Elderly patients: No dosage adjustment is required for patients aged ≥ 65 years, but some elderly patients may be more sensitive to the drug.

Patients with renal impairment: No dosage adjustment is needed.

Patients with hepatic impairment: This drug should be used with caution only in patients with mild hepatic impairment, and is prohibited in those with moderate to severe hepatic impairment.