Details for: ACTIKERALL
Company: CIPHER PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02428946 | ACTIKERALL | FLUOROURACIL; SALICYLIC ACID | 0.5 % / W/W; 10 % / W/W | SOLUTION | TOPICAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
ACTIKERALL is used for the topical treatment of mild to moderate actinic keratosis (AK) of the face, forehead, and balding scalp in adults with a normal immune system (immunocompetent).
What it does
ACTIKERALL contains fluorouracil and salicylic acid. Fluorouracil is an antimetabolite which prevents the growth of cells, and salicylic acid is a keratolytic agent which works to soften hard skin, thereby increasing the penetration of fluorouracil.
When it should not be used
DO NOT use ACTIKERALL if you:
- Are allergic to fluorouracil, capecitabine, salicylic acid, other salicylates or any of the other ingredients in ACTIKERALL or its container,
- Are pregnant or might be pregnant,
- Are breast-feeding,
- Are taking brivudine*, sorivudine*, or any similar drugs that may prevent fluorouracil from being eliminated from your body,
- Have a kidney problem,
- Have a condition called dihydropyrimidine, dehydrogenase (DPD) deficiency.
*Note brivudine and sorivudine are not available in Canada
Avoid getting ACTIKERALL in the eyes, inside the mouth or nostrils, or on the genitals (mucous membranes)
What the medicinal ingredient is
- Fluorouracil and salicylic acid.
What the non-medicinal ingredients are
- Dimethyl sulfoxide, ethanol, ethyl acetate, pyroxyline, poly(butyl methacrylate, methyl methacrylate).
What dosage form it comes in
- ACTIKERALL is a solution available in 25mL bottles.
Warnings and precautions
Warnings and Precautions
BEFORE you use ACTIKERALL talk to your doctor or pharmacist if you have any of the following conditions:
- Reduced levels of an enzyme called dihydropyrimidine dehydrogenase (DPD). This enzyme helps to break down fluorouracil in your body. Symptoms of high levels of fluorouracil include: stomach pain, cramp, nausea, vomiting, diarrhea, swelling and soreness of the mouth, tongue or throat, or any unusual bleeding or bruising, or black stool. If you experience any of these symptoms, wash ACTIKERALL off the treated areas with warm water and get medical help immediately.
- Other skin diseases or skin problems. The treatment with ACTIKERALL may be affected if you have AK and other skin diseases.
- A reduced ability to sense touch, pain, and temperature (such as diabetic neuropathy). You need to be closely monitored by your doctor if you use ACTIKERALL.
- Areas of skin with thin epidermis (the outermost layer of cells in the skin). In those areas ACTIKERALL should be applied less frequently and the treatment should be closely monitored by your doctor.
ACTIKERALL has not been used in the following conditions:
- Treatment of other body areas apart from the face, forehead, and bald scalp,
- Skin cancers such as rodent ulcer (BCC), and Bowen’s disease,
- Repeated treatment cycles for AK or re-treatment when a lesion comes back,
- Bleeding lesions,
- Under 18 years of age.
During the treatment with ACTIKERALL, the treated skin areas should be protected against direct sunlight and artificial light such as sunlamps, tanning lamps or tanning beds, and other skin products.
ACTIKERALL also contains dimethylsulfoxide that may cause skin irritation.
ACTIKERALL is flammable. Keep away from fire and flames.
Interactions with this medication
Tell your doctor or pharmacist if you are using, have recently taken or might take any other medicines. If several medicines are taken at the same time, the effect of individual medicines can be intensified or weakened.
In particular tell your doctor if you take any of the following:
- Medicines to treat viruses such as chicken pox or shingles (brivudine*, sorivudine* or similar medicines). You must not use ACTIKERALL if you are using or have used any of these medicines in the past 4 weeks as it may result in increased side effects.
- Epilepsy medicine (phenytoin). Using ACTIKERALL may lead to elevated blood levels of phenytoin if your DPD activity is decreased. In this case, your phenytoin levels should be checked.
- Medicine used to treat cancer and auto-immune diseases (methotrexate). This medicine may interact with ACTIKERALL causing undesirable effects.
- Medicine used to treat diabetes (sulfonylureas). This medicine may interact with ACTIKERALL causing undesirable effects. *Note brivudine and sorivudine are not available in Canada
Proper use of this medication
Always use ACTIKERALL exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Usual Dose
Apply a thin film of ACTIKERALL once daily to the actinic keratosis until the lesions have completely cleared or for up to 12 weeks. Your doctor may decrease your dose to one application three times a week to reduce the reactions at the application sites. You may notice some improvement as early as 6 weeks after starting treatment and the improvement should continue over time for up to 12 weeks. However, complete healing of AK lesions may not be seen for up to 8 weeks after stopping treatment.
How to Apply ACTIKERALL:
- Clean the affected area with warm water and wait until completely dry.
- If you apply ACTIKERALL the day before, remove the white film on your skin by simply peeling it off. Warm water may help to remove the film.
- To open the bottle, press the lid down and turn.
- Remove excess solution from the brush by wiping it in the neck of the bottle.
- Dab the solution on the actinic keratosis lesion and a small area of healthy skin surrounding it once daily. This rim of healthy skin should be no more than 0.5 cm wide.
- ACTIKERALL can be applied on up to 10 lesions at the same time. The total area of the skin being treated is not to be larger than 25 cm2 (5 cm x 5 cm).
- Let the solution dry for at least 3 minutes, to form a film. Do not remove until it is time for the next application.
- Do not cover with a dressing.
- Do not touch the treatment area yourself and do not allow it to come into contact with pets, children, or other adults
- Close the bottle tightly to prevent it drying out. Do not use ACTIKERALL if it dries out or forms any crystals.
ACTIKERALL must not be allowed to come in contact with the eyes, inside of the mouth or nose or the genitals (mucous membranes).
ACTIKERALL solution may permanently stain clothing, fabric, or acrylics (such as acrylic bathtubs), so avoid contact with them.
Overdose
Missed Dose
Do not use a double dose to make up for a forgotten dose. Continue your treatment as before.
Side effects and what to do about them
Like all medicines, ACTIKERALL can cause side effects.
The possible side effects of ACTIKERALL include the following:
Very common (may affect more than 1 in 10 people)
- Mild to moderate irritation and inflammation at the site of application occur in most patients (92%)
- Reactions at the application site: skin redness (erythema), inflammation, irritation, burning, pain, itch
Common (may affect up to 1 in 10 people)
- Headache, skin discoloration, skin scaling (exfoliation)
- Reactions at the application site: bleeding, loss of the top layer of skin (erosion), scab
Uncommon (may affect up to 1 in 100 people)
- Dry eye, itching eye, increased watery eyes (lacrimation)
- Reactions at the application site: skin inflammation (dermatitis), swelling (edema), and ulcer.
- Stomach flu-like symptoms (e.g. diarrhea, nausea, vomiting)
If any of these side effects get severe, please contact your doctor.
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | |
|---|---|---|---|
| Common | |||
| Severe skin irritation (e.g. bleeding, scab, redness) | ✔ | ||
| Frequency Unknown | |||
| Contact skin reactions (e.g. rash, itch, blisters, redness) | ✔ | ||
| Symptoms of high blood levels of fluorouracil (e.g. stomach pain, cramp, nausea, vomiting, diarrhea, swelling and soreness of the mouth, tongue or throat, or any unusual bleeding or bruising, or black stool) | ✔ | ||
| Symptoms of high blood levels of salicylic acid (e.g. ringing in the ears, hyperventilation, fast heartbeat, confusion or lethargy) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking ACTIKERALL, contact your doctor or pharmacist.
How to store
Keep this medicine out of the sight and reach of children.
Do not use ACTIKERALL after the expiry date which is stated on the label and on the carton after EXP. The expiry date refers to the last day of that month.
Store between 15 to 25 ºC. Do not refrigerate or freeze. Keep the bottle tightly closed to prevent drying up.
Caution flammable: keep away from fire or flames.
Do not use ACTIKERALL 3 months after first opening of the bottle.
Do not use ACTIKERALL if you notice crystals.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared
for health professionals can be obtained by contacting
Cipher Pharmaceuticals Inc. at:
1-888-361-7207
This leaflet was prepared by Cipher Pharmaceuticals Inc.
Last revised: August 7, 2015