Pronunciation:

roe-FLUE-mi-last

Brand Names:

• Daliresp

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Respiratory Agent

Pharmacologic—

Phosphodiesterase Inhibitor

Uses of This Medicine:

Roflumilast is used to prevent the symptoms (flare-ups) of chronic obstructive pulmonary disease (COPD).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of roflumilast in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of roflumilast in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Amprenavir
• Aprepitant
• Atazanavir
• Avacopan
• Boceprevir
• Carbamazepine
• Ceritinib
• Cilostazol
• Cimetidine
• Ciprofloxacin
• Clarithromycin
• Clofazimine
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclosporine
• Darunavir
• Delavirdine
• Diltiazem
• Dronedarone
• Duvelisib
• Enoxacin
• Erythromycin
• Fluconazole
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Idelalisib
• Imatinib
• Indinavir
• Itraconazole
• Ivacaftor
• Ketoconazole
• Larotrectinib
• Letermovir
• Lomitapide
• Lonafarnib
• Maribavir
• Mifepristone
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Palbociclib
• Paritaprevir
• Phenobarbital
• Phenytoin
• Posaconazole
• Primidone
• Ranitidine
• Ranolazine
• Ribociclib
• Rifampin
• Ritlecitinib
• Ritonavir
• Saquinavir
• Schisandra sphenanthera
• Telaprevir
• Telithromycin
• Troleandomycin
• Tucatinib
• Verapamil
• Viloxazine
• Vonoprazan
• Voriconazole
• Voxelotor

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ethinyl Estradiol
• Gestodene

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression, history of or
• Mental illness, history of—Use with caution. May make these conditions worse.

• Liver disease, moderate to severe—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take this medicine with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For prevention of COPD:
    • Adults—One 500 microgram (mcg) tablet per day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine is used to prevent acute flare-ups of COPD. It is not used to stop a flare-up that has already started. You should use an inhaled medicine for the acute flare-ups that will work quickly to help you breathe better. If you do not have an inhaled medicine for acute COPD flare-ups, or if you have any questions about this, check with your doctor.

This medicine may cause some people to be agitated or display other abnormal behaviors, such as feeling sad or hopeless, getting upset easily, having trouble sleeping, or feeling nervous or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause you to lose weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Unexplained weight loss

Less common

Chills

cough

diarrhea

discouragement

fear or nervousness

feeling sad or empty

fever

general feeling of discomfort or illness

headache

irritability

joint pain

loss of appetite

loss of interest or pleasure

muscle aches and pains

nausea

runny nose

shivering

sleeplessness

sore throat

sweating

thoughts of killing oneself or changes in behavior

tiredness

trouble concentrating

trouble sleeping

unable to sleep

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Abdominal or stomach pain

back pain

bladder pain

bloody or cloudy urine

burning feeling in the chest or stomach

decreased appetite

difficult, burning, or painful urination

dizziness

frequent urge to urinate

indigestion

lower back or side pain

muscle spasm

pain or tenderness around the eyes and cheekbones

shakiness in the legs, arms, hands, or feet

shortness of breath or troubled breathing

sneezing

stomach upset

stuffy or runny nose

sweating

tenderness in the stomach area

tightness of the chest or wheezing

trembling or shaking of the hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.