| Drug Class |
Selective, orally‑active phosphodiesterase‑4 (PDE4) inhibitor |
| Indication |
Maintenance treatment of moderate‑to‑severe chronic obstructive pulmonary disease (COPD) in adults at high risk of exacerbations who are already on inhaled corticosteroid (ICS) therapy and who have had at least one moderate or severe COPD exacerbation in the past 12 months. |
| Contraindications |
• Known hypersensitivity to any component of the formulation.
• Active infection, especially systemic infection, as the drug can worsen infections.
• Severe hepatic impairment (Child‑Pugh C). |
| Warnings & Precautions |
1. Serious infections (e.g., bacterial, fungal, viral). Monitor for fever, chills, cough, sore throat, or any infection‑related symptoms; treat promptly.
2. Cardiovascular: Potential for heart failure, arrhythmias, hypertension, or thromboembolic events—especially in patients with pre‑existing cardiovascular disease.
3. Respiratory: Potential worsening of asthma or bronchospasm; use with caution in asthmatics.
4. Weight loss: May cause significant weight loss; monitor weight, especially in patients with BMI <18.5 kg/m².
5. Neuropsychiatric: Rare reports of depression, anxiety, insomnia, or suicidal ideation—monitor mental health. |
| Adverse Reactions (≥2% in patients) |
• Nausea, vomiting, diarrhea, abdominal pain
• Weight loss
• Insomnia, anxiety
• Depression, mood changes
• Headache
• Cough, upper respiratory tract infections |
| Drug Interactions |
• Macrolide antibiotics (clarithromycin, erythromycin) may increase Nexlizet levels; monitor for side effects.
• Other PDE4 inhibitors (e.g., roflumilast) – concurrent use not recommended.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may elevate serum levels; consider dose adjustment.
• Corticosteroids: Use as directed; monitor for additive immunosuppression. |
| Dosage & Administration |
Adults (≥18 yr)
1. Initiation: 100 mg once daily in the morning for the first 4 weeks.
2. Titration: Increase to 200 mg once daily after 4 weeks if clinically indicated and tolerated.
3. Maximum: 200 mg once daily.
4. Administration: With or without food.
5. Re‑titration: If adverse reactions occur, revert to 100 mg; consider discontinuation if symptoms persist. |
| Monitoring |
• Baseline: CBC, CMP, liver function tests, weight, BMI.
• Follow‑up: Weight, liver enzymes at 4 weeks, then every 3 months.
• Monitor for signs of infection, depression, or cardiovascular events. |
| Pregnancy & Lactation |
• Pregnancy Category B (limited animal data).
• No established safety in humans; use only if benefit outweighs risk.
• Excretion into breast milk is unknown; avoid if possible. |
| Storage |
25 °C ±5 °C (77 °F ± 5 °F). Keep out of reach of children. |
| Patient Counseling Points |
• Take daily at the same time each day; do not skip doses.
• If a dose is missed, take as soon as remembered; do not double‑dose.
• Report any fever, chills, sore throat, or other signs of infection promptly.
• Keep track of weight; inform your clinician if you lose >5 % of body weight in 1 month.
• Report new or worsening mood changes, anxiety, or suicidal thoughts to your healthcare provider immediately.
• Do not stop the medication abruptly; consult your provider. |