Daliresp

Daliresp (roflumilast) is a prescription tablet used for severe COPD in adults to help reduce the risk of flare-ups or worsening of COPD symptoms. Daliresp is thought to work by reducing inflammation in the lungs, which is a major part of COPD (chronic obstructive pulmonary disease).

Daliresp is a selective PDE4 inhibitor (phosphodiesterase 4 inhibitor) which blocks an enzyme called PDE4 that is found mainly in lung tissue, and results in a reduction in lung inflammation.

Daliresp is not a bronchodilator and will not treat a bronchospasm attack that has already begun.

Daliresp tablet is usually taken once per day, with or without food. Follow your doctor's instructions.

The starting dose of Daliresp is one 250 mcg tablet once daily for 4 weeks, and then the dose is increased to 500 mcg once daily thereafter. This is to help reduce side effects when first starting this medicine; however, 250 mcg per day is not an effective (therapeutic) dose.

The maintenance dose of Daliresp is one 500 micrograms (mcg) tablet per day, with or without food.

Weight loss is a common side effect of roflumilast. While using this medicine, weigh yourself regularly and tell your doctor if you have any unplanned or unexplained weight loss.

Do not share this medicine with another person, even if they have the same symptoms you have.

Take Daliresp exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Store at room temperature away from moisture and heat.

You should not use Daliresp if you have moderate or severe liver disease (Child-Pugh B or C).

Do not use it for the relief of acute bronchospasm (sudden breathing problems). Your healthcare provider may give you other medicines to use for sudden breathing problems.

Some people have thoughts about suicide while taking Daliresp. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of this medicine.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

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

You should not use Daliresp if you are allergic to roflumilast or if you have moderate or severe liver disease.

To make sure Daliresp is safe for you, tell your doctor if you have ever had:

• liver disease; or
• depression, mental illness, or suicidal thoughts or actions.

Some people have thoughts about suicide while taking Daliresp. Your doctor should check your mood at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Tell your healthcare provider if you are:

• pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Daliresp passes into your breast milk. You and your healthcare provider should decide if you will take this medicine or breastfeed. You should not do both.

Do not give this medicine to a child without medical advice.

Common Daliresp side effects may include nausea, diarrhea, loss of appetite, minor weight loss, headache, dizziness, occasional sleep problems, back pain, or flu symptoms.

Deliresp may cause serious side effects. Get emergency medical help if you have signs of an allergic reaction to Daliresp: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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.

• rapid and unintended weight loss;
• tremors;
• pain or burning when you urinate;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease

Initial dose: 250 mcg once daily for 4 weeks, taken with or without food.Maintenance: 500 mcg once daily (after initial dose of 250 mcg once daily for 4 weeks)Dosage Forms and Strengths: tablets 250 mcg, 500 mcg Use: To reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Many drugs can interact with roflumilast. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Drugs that Induce Cytochrome P450 (CYP) Enzymes

Strong cytochrome P450 enzyme inducers decrease levels of roflumilast and may reduce the effectiveness of Daliresp. Therefore, the use of strong cytochrome P450 inducers (e.g., rifampicin, phenobarbital, carbamazepine, and phenytoin) with Daliresp is not recommended

Drugs that Inhibit Cytochrome P450 (CYP) Enzymes

Using Daliresp (500 mcg) with CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase roflumilast levels and may result in increased side effects. The risk of using Daliresp with these medicines should be weighed carefully against the benefit.

Oral Contraceptives Containing Gestodene and Ethinyl Estradiol

Using Daliresp (500 mcg) with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast levels and may result in increased side effects. The risk of these medicines together should be weighed carefully against the benefit.

Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

Active ingredient: roflumilastInactive ingredients: lactose monohydrate, corn starch, povidone, and magnesium stearate.

AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850