Description
Delgocitinib topical cream is used to treat moderate to severe chronic hand eczema in patients whose condition is not well controlled or cannot use topical steroid treatments.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Cream
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of delgocitinib topical cream in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of delgocitinib topical cream in the elderly.
Breastfeeding
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.
Drug Interactions
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:
- Heart or blood vessel disease or
- Hepatitis B, history of or
- Hepatitis C, history of or
- Herpes zoster (shingles), history of or
- High cholesterol or fats in the blood or
- Skin cancer, history of or
- Tuberculosis, or history of—Use with caution. May make these conditions worse.
- Liver disease (eg, hepatitis B or C), active or
- Serious infections, active—Use is not recommended in patients with these conditions.
Proper Use
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 come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
This medicine is for use on the skin of your hands and wrists only. Do not get it in your eyes, nose, mouth, or vagina. If it does get on these areas, rinse it off right away with water.
To use the cream:
- Wash your hands with soap and water before and after using this medicine.
- Clean and dry affected areas before applying this medicine.
- Apply a thin layer of this medicine to the affected area on the hands and wrists. Rub it in gently.
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 moderate to severe chronic hand eczema:
- Adults—Apply to the affected area of the skin on the hands and wrists 2 times a day. Do not use more than 30 grams per 2 weeks or 60 grams per month of this medicine.
- Children—Use and dose must be determined by your doctor.
- For moderate to severe chronic hand eczema:
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
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
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.
Your body's ability to fight infections may be reduced while you are using this medicine. It is very important that you call your doctor at the first sign of an infection. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.
This medicine may increase your risk of cancer, including non-melanoma skin cancer, basal cell carcinoma. Check with your doctor right away if you have a persistent non-healing sore, pink growth, reddish patch or irritated area, shiny bump, or white, yellow, or waxy scar-like area.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
Do not have any live vaccines (immunizations) before, during, and after treatment with this medicine. Check with your doctor before having any vaccines.
This medicine may increase your risk for serious heart or blood vessel problems (eg, heart attack, stroke) and blood clots (eg, deep vein thrombosis, pulmonary embolism), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. Call your doctor right away if you have anxiety, chest pain or discomfort, confusion, cough, difficulty in speaking, dizziness, lightheadedness, or fainting, double vision, fast heartbeat, headache, inability to move arms, legs, or facial muscles, nausea, pain, redness, or swelling in the arm or leg, pain or discomfort in the arms, jaw, back, or neck, pains in the chest, groin, or legs, especially calves of the legs, sudden loss of coordination, sudden onset of slurred speech, sudden vision changes, sweating, trouble breathing, or vomiting.
This medicine may increase the level of cholesterol and fat in your blood. Talk to your doctor if you have concerns.
Side Effects
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:
Rare
- Black, tarry stools
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- burning, itching, redness, skin rash, swelling, or soreness at the application site
- chest pain
- chills
- cough
- fever
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- loosening of the fingernails
- painful or difficult urination
- pale skin
- redness or soreness around the fingernails
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Anxiety
- confusion
- difficulty speaking
- dizziness or lightheadedness
- double vision
- fainting
- fast heartbeat
- headache
- inability to move the arms, legs, or facial muscles
- inability to speak
- lower back or side pain
- pain, redness, or swelling in the arm or leg
- painful blisters on trunk of the body
- persistent non-healing sore
- pink growth
- reddish patch or irritated area
- shiny bump
- slow speech
- trouble breathing
- white, yellow, or waxy scar-like area
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.
DRG-80008481
