Pronunciation:

roe-FLUE-mi-last

Brand Names:

• Zoryve

Dosage Forms:

• Foam
• Cream

Classifications:

Therapeutic—

Antipsoriatic

Pharmacologic—

Phosphodiesterase Inhibitor

Uses of This Medicine:

Roflumilast topical cream is used to treat plaque psoriasis, which is a form of skin disease with red patches and white scales that do not go away. It is also used to treat seborrheic dermatitis.

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 topical cream in children younger than 6 years of age and topical foam in children younger than 9 years of age. 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 topical cream and foam in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

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

Proper Use of This Medicine:

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine should only be used on the skin, including areas with skin folds. Do not get it into your eyes, nose, mouth, or vagina. Do not apply this medicine to your nipple or areola, if you are breastfeeding. If it does get on these areas, rinse it off right away.

This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

To use the cream:

• Wash your hands with soap and water before and after you use this medicine, unless you are using it to treat your hands.
• Apply a thin layer to the affected area of the skin. Rub it in gently.

To use the foam:

• Wash your hands with soap and water before and after using this medicine.
• Shake the can well before using. Turn the can upside down and press the nozzle. Dispense a small amount into your hand.
• Apply a thin layer of this medicine to the affected area of the skin or scalp. Rub it in gently.
• If you are treating your scalp, part the hair so that it can be applied directly to the affected area on the skin.
• This medicine is flammable. Do not use it near fire, flame, or while smoking when applying and right after you apply it.

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 topical dosage form (cream):
  • For plaque psoriasis:
    • Adults and children 6 years of age and older—Apply to the affected area of the skin once a day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
• For topical dosage form (foam):
  • For seborrheic dermatitis:
    • Adults and children 9 years of age and older—Apply to the affected area of the skin and scalp once a day.
    • Children younger than 9 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply 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.

Storage—

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.

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

The foam can contents are under pressure and flammable. Do not puncture or burn the can.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for any unwanted effects.

If your condition does not improve or if it becomes worse, check with your doctor.

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:

Less common

Bladder pain

bloody or cloudy urine

difficult, burning, or painful urination

frequent urge to urinate

lower back or side pain

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

Body aches or pain

chills

cough

diarrhea

difficulty in breathing

ear congestion

fever

headache

loss of voice

nausea

pain in the area where the medicine is applied

sneezing

sore throat

stuffy or runny nose

trouble sleeping

unusual tiredness or weakness

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.