Medical Information

Roflumilast is not suitable for all COPD patients. Patients with moderate or greater hepatic impairment and patients with depression are groups requiring special attention, and the risks and benefits must be fully evaluated before medication.

I. Patients with Moderate or Greater Hepatic Impairment

1. Why contraindication is needed

Roflumilast is mainly metabolized by the liver.

In patients with moderate hepatic impairment (Child-Pugh B), drug exposure is significantly increased.

In patients with severe hepatic impairment (Child-Pugh C), drug clearance is further reduced, and the risk of adverse reactions is significantly increased.

2. Specific contraindication scope

Not recommended for patients with moderate hepatic impairment.

Contraindicated in patients with severe hepatic impairment.

Patients with mild hepatic impairment do not require dose adjustment, but should be monitored cautiously.

3. Pre-medication evaluation

Liver function should be tested before medication, and the Child-Pugh class should be determined.

Liver enzymes should be rechecked regularly during treatment.

If symptoms such as loss of appetite, jaundice, or dark urine occur, seek medical attention immediately.

II. Patients with Depression and Psychiatric Disorders

1. Risk notice

Roflumilast may cause mood changes and worsening depression.

A small number of patients may experience suicidal thoughts or behavior.

Patients with a history of depression may be at higher risk.

2. Pre-medication evaluation

A detailed psychiatric history should be obtained before medication.

Assess the current emotional state and severity of depression.

Patients with severe depression or suicidal tendencies should avoid use.

3. Monitoring during medication

Patients and family members should pay attention to emotional changes.

If persistent low mood, anxiety, insomnia, or suicidal thoughts occur, seek medical attention immediately.

If necessary, discontinue the medication and refer for psychiatric evaluation.

III. Other Situations Requiring Caution

1. Low-body-weight patients

Drug exposure may be increased in low-body-weight patients.

Weight changes should be monitored during medication.

Unexplained weight loss should be reported to the doctor.

2. Patients taking concomitant medications

Concomitant use with strong CYP450 enzyme inducers may reduce efficacy.

Concomitant use with inhibitors may increase adverse reactions.

Inform the doctor of all medications currently being used.

3. Summary reminder

Not recommended or contraindicated in patients with moderate or greater hepatic impairment.

Patients with depression require evaluation before medication and close monitoring during medication.

Any emotional abnormalities or symptoms of abnormal liver function should prompt immediate medical attention.