Description
Ingenol topical is used to treat a skin condition called actinic keratosis on the face, scalp, body, arms, or legs.
This medicine is available only with your doctor's prescription.
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 on the relationship of age to the effects of ingenol topical for actinic keratosis have not been performed 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 ingenol topical 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:
- Other skin problems (eg, patients who have received treatment with other medicine, procedure, or surgery)—Should not be used until your skin has healed from other treatments.
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. To do so may cause unwanted side effects or skin irritation.
This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. 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 with water.
Be careful not to get any of this medicine in your eyes, because it can cause severe eye disorders (eg, severe eye pain, swelling of the eyes or eyelids, or drooping of the eyelids). If any of the medicine does get in the eyes, wash the eyes with water and check with your doctor or other healthcare professional right away.
This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.
This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present.
To use the gel:
- Wash your hands with soap and water before and after using the medicine.
- Apply a thin layer to the affected area of the skin. Rub it in gently. Wash your hands again.
- Allow the gel to dry for 15 minutes.
- Avoid washing and touching the treated area, or participating in activities that may cause heavy sweating for 6 hours after treatment.
- After 6 hours, you may wash the area with a mild soap and water.
- Do not bandage or otherwise wrap the skin being treated, unless directed to do so by your doctor. Materials that are not airtight, such as cotton gauze or cotton underwear, may be used if needed.
- Throw out any unused gel from the single-dose tube.
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 (gel):
- For treatment of actinic keratosis on the face and scalp:
- Adults—Apply a thin film of 0.015% gel to the affected area once a day for 3 consecutive days.
- Children—Use and dose must be determined by your doctor.
- For treatment of actinic keratosis on the body, arms, and legs:
- Adults—Apply a thin film of 0.05% gel to the affected area once a day for 2 consecutive days.
- Children—Use and dose must be determined by your doctor.
- For treatment of actinic keratosis on the face and scalp:
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 in the refrigerator. Do not freeze.
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 for any unwanted effects that may be caused by this medicine.
If your condition does not improve or if it become worse, check with your doctor.
This medicine may cause serious allergic reactions (eg, anaphylaxis), which may require immediate medical attention. Check with your doctor right away if you have cough, difficulty swallowing, dizziness, fast heartbeat, hives or itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, tightness in the chest, trouble breathing, or unusual tiredness or weakness.
Check with your doctor right away if you have persistent non-healing sore, pink growth, reddish patch or irritated area, shiny bump, or white, yellow or waxy scar-like area. These may be symptoms of skin cancer (eg, non-melanoma skin cancer).
This medicine may cause serious skin reactions. Check with your doctor right away if you have blisters, peeling, pus, ulcers, cracking, redness, flaking, scaling, crusting, or swelling of the skin.
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:
More common
- Cracking of the skin
- flushing, redness of the skin
- pain and itching at the application site
- redness, blistering, peeling, or loosening of the skin
- skin ulcers
- swelling of the skin
- unusually warm skin
Less common
- Burning, dry, or itching eyes
- discharge or excessive tearing
- eye pain
- infection at the application site
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- swelling around the eyes
Incidence not known
- Burning, crusting, dryness, flaking of the skin
- chills
- cough
- diarrhea
- fast heartbeat
- fever
- hoarseness
- irritations
- itching, scaling, severe redness, or soreness of the skin
- joint or muscle pain
- painful blisters on the trunk of the body
- persistent non-healing sore
- pink growth
- red irritated eyes
- red skin lesions, often with a purple center
- reddish patch or irritated area
- redness, irritation, or itching of the eye, eyelid, or inner lining of the eyelid
- shiny bump
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- tightness in the chest
- trouble breathing or swallowing
- unusual tiredness or weakness
- white, yellow or waxy scar-like area
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
- Headache
- muscle aches
- stuffy or runny nose
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-20075414
