Patient Medication Information: uses, side effects, how to take - Uvadex
What is UVADEX used for?
UVADEX is used to treat adults with skin symptoms of Cutaneous T-cell lymphoma (CTCL) when other treatments are not effective. CTCL is a blood disorder causing abnormal growths affecting the skin.
How does UVADEX work?
UVADEX is used with the THERAKOS CELLEX Photopheresis System.
A small amount of your blood is collected during treatment. The white blood cells from the collected blood are mixed with a calculated dose of UVADEX. This mixture is exposed to UV light in the THERAKOS CELLEX Photopheresis System, then your blood is returned to you. The UV light activates UVADEX. This process may help your CTCL skin symptoms.
What are the ingredients in UVADEX?
Medicinal ingredients: methoxsalen
Non-medicinal ingredients: Alcohol 95%, glacial acetic acid, propylene glycol, sodium acetate trihydrate, sodium chloride, sodium hydroxide, and water for injection
Serious Warnings and Precautions
Possible serious side effects with UVADEX include:
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UVADEX comes in the following dosage forms:
Sterile Solution, 20 mcg/mL
Do not use UVADEX if:
- You are allergic to methoxsalen or any other ingredient in UVADEX.
- You are allergic to psoralen compounds.
You have a history of a light sensitive disease state, such as:
- Lupus erythematosus, a severe form of skin inflammation.
- Porphyria cutanea tarda, a disorder that causes the skin to be very sensitive to light.
- Erythropoietic protoporphyria, a disorder that causes a burning and itching sensation on the surface of the skin.
- Variegate porphyria, a disorder that causes vomiting, diarrhea, constipation, and skin damage.
- Xeroderma pigmentosum, a very rare skin disorder that causes a high sensitivity to sunlight, premature skin aging and the development of skin cancers.
- Albinism, a disorder that causes a lack of pigmentation in the hair, skin and eyes.
- You have aphakia. This is a condition where you are missing the lens in your eye(s).
- You have severe heart problems.
- You have anemia (a low red blood cell count).
- You have a high white blood cell count (greater than 25,000 mm3).
- You have had your spleen surgically removed. The spleen is an organ that helps filter your blood.
- You have coagulation disorders (your blood has trouble forming clots).
- You have an existing skin cancer.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take UVADEX. Talk about any health conditions or problems you may have, including if you:
- Are taking medicines that make you sensitive to the sun.
- Have cataracts.
- Have liver problems.
- Are pregnant or think you might be pregnant. It is not known if UVADEX will harm your unborn baby.
- Are breast-feeding. It is not known if UVADEX passes into breast milk.
Other warnings you should know about:
Before starting treatment with UVADEX, your healthcare professional will check your health status. They will review your medical conditions, medicines you are taking and platelet count.
During treatment with UVADEX, the needle may stop working. Your healthcare professional is trained to recognize and manage this possible side effect should it occur.
Skin problems
After treatment with UVADEX, exposure to sunlight and/or ultraviolet radiation may cause skin damage. For example, skin burning, premature skin aging, or skin cancer (in the long term).
For 24 hours after each treatment, you are recommended to avoid sun exposure by:
- Wearing UVA absorbing, wrap-around sunglasses; and
- Covering exposed skin or using a sun-block (SPF 15 or higher).
Follow these steps any time you are exposed to direct or indirect sunlight, indoors and outdoors.
Birth control
Men and women should use an effective method of birth control both during and after completion of UVADEX treatment.
Fertility
It is not known if UVADEX has an effect on fertility. Talk to your doctor if this is a concern for you.
Driving and using machines
Do NOT drive or use machines immediately after treatment with UVADEX.
Treatment with UVADEX is likely to affect your ability to drive or use machines. Before you do tasks that require special attention, wait until you know how UVADEX affects you.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with UVADEX:
- Fluoroquinolones, nalidixic acid, sulfonamides tetracyclines – medicines used to treat bacterial infections
- Antipyrine, paracetamol – medicines used to treat pain
- Tolbutamide and other sulfonylureas – medicines used to control blood sugar
- Phenytoin – medicine used to treat seizures
- Dicoumarol, warfarin – medicines used to thin the blood
- Promethazine – medicine used to treat allergies
- Furosemide, thiazides – medicines used to treat fluid retention, increased blood pressure and cardiac disorders
- Phenothiazine – medicine to treat agitation
- Anthralin, coal tar or coal tar derivatives, retinoids – medicines used to treat skin conditions
- Halogenated salicylanilides – soaps that inhibit the growth of bacteria
- Griseofulvin – medicine used to treat skin infections
- Methylene blue, methyl orange, toluidine blue, rose Bengal – organic staining dyes used to identify certain body tissues
- Caffeine – used to increase alertness and wakefulness
How to take UVADEX:
UVADEX will be given to you by a healthcare professional using the THERAKOS CELLEX Photopheresis System, in a healthcare setting.
Usual dose:
- Your healthcare professional will calculate the amount of UVADEX that your cells will be treated with during the procedure.
- The usual treatment schedule is 2 consecutive days once a month for six months.
- After around 3 months of treatment, your healthcare professional will assess your response to the treatment. If they decide you need to be treated more frequently, your schedule may be adjusted to 2 treatments every 2 weeks.
- You may receive a total of 40 treatments.
Overdose:
In the event of overdosage, you should remain in a darkened room for at least 24 hours.
| If you think you, or a person you are caring for, have been given too much UVADEX, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
What are possible side effects from using UVADEX?
These are not all the possible side effects you may have when taking UVADEX. If you have any side effects not listed here, tell your healthcare professional.
Side effects of UVADEX and/or the treatment procedure (photopheresis) may include:
- Dizziness
- Nausea
- Vomiting
- Pain or swelling at the site of injection
- Sensitivity to sunlight
- Altered taste
Contact your doctor if you begin to show signs of infection such as fever, chills, or pain or swelling at the site of injection.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue [may occur when you go from lying or sitting to standing up] | X | ||
| UNKNOWN | |||
| Anemia (low red blood cell levels): shortness of breath, fatigue, having pale skin, irregular heartbeats, loss of energy, or weakness. | X | ||
| Allergic reaction: itchiness, redness of skin, swelling, flushing, labored breathing, heart racing, chest pain, high blood pressure | X | ||
| Skin cancer: unusual, skin growths that do not go away or heal; changes in size, shape, or color of an existing spot on the skin. | X | ||
| Cataract (a clouding of the lens inside the eye which leads to reduced vision): clouded, blurred, or dim vision | X | ||
| Skin burning: red skin, skin blisters, or skin peeling after exposure to sunlight or UV light | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
UVADEX will be managed and stored by healthcare professionals. The information on how to store UVADEX is meant for your healthcare professional.
Store between 15 to 30oC.
Keep out of reach and sight of children.
If you want more information about UVADEX:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website mallinckrodt.ca/products/therakos, or by calling 1-877-566-9466.