Soriatane causes severe birth defects. Do not take Soriatane if you are pregnant or if you may become pregnant during therapy or at any time within 3 years after you stop taking Soriatane . Women who are able to become pregnant should use Soriatane only if they are unable to use other medicines to treat psoriasis or if they have severe psoriasis that is not helped by other medicines.
The Do Your P.A.R.T. (Pregnancy Prevention Actively Required During and After Treatment) program provides information about the serious risks associated with Soriatane . It also provides information about preventing pregnancy while you use Soriatane and for at least 3 years after you stop. Ask your doctor or pharmacist any questions that you may have about the information, the program, or Soriatane . Do not take Soriatane if there is anything you do not understand.
You must have at least 2 negative pregnancy tests before you start Soriatane . You must also have monthly pregnancy tests while you take Soriatane . You must also have a pregnancy test every 3 months for at least 3 years after you stop taking Soriatane . Contact your doctor immediately if you think you may be pregnant.
The risk of birth defects lasts for at least 3 years after you stop Soriatane . Do not become pregnant while you take Soriatane and for at least 3 years after you stop taking it. You must use 2 effective forms of birth control for at least 1 month before you start Soriatane , while you take it, and for at least 3 years after you stop treatment.
Do not drink alcohol or take medicines that contain alcohol while you take Soriatane and for 2 months after you stop treatment. The risk of birth defects may last longer after you stop treatment if you drink alcohol or take any product that contains alcohol.
Women must sign a Patient Agreement/Informed Consent for Female Patients form before they start to take Soriatane . This form contains information on the risk of birth defects, birth control failure, and the need to avoid alcohol. Contact your doctor before you take Soriatane if you have any questions or if you have not signed this form.
Small amounts of Soriatane are found in semen. It is not known if this poses any risk to the fetus. Discuss any questions that you may have with your doctor.
Patients must not donate blood during treatment and for at least 3 years after treatment is stopped.
Serious liver problems have occurred in some patients taking Soriatane . Contact your doctor right away if you develop dark urine, pale stools, severe or persistent stomach pain, or yellowing of the skin or eyes.
Soriatane comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Soriatane refilled.
Treating severe psoriasis.
Soriatane is a kit that contains a vitamin A derivative (retinoid) and moisturizing foam. Exactly how the retinoid works is not known. The moisturizing foam relieves dry and chapped skin.
Contact your doctor or health care provider right away if any of these apply to you.
Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Soriatane . Tell your health care provider if you are taking any of the following medicines.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Soriatane may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Soriatane as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Soriatane .
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Dry mouth, lips, or nose; dry or irritated eyes; hair loss; runny nose; thinning of the eyebrows or eyelashes; thinning, peeling, or scaling of the skin; weak nails.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back or joint pain or stiffness; blurred vision or other vision changes; bone pain; calf or leg pain or swelling; chest pain; dark urine; eye pain; loss of appetite; mental or mood changes (eg, aggressiveness, depression); muscle pain, stiffness, or weakness; numbness or tingling of the hands or feet; one-sided weakness; pale stools; red, blistered, swollen skin; severe dizziness; severe or persistent headache; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; signs of high blood sugar (eg, frequent hunger, thirst, or urination); slurred speech; suicidal thoughts or actions; vaginal itching, odor, or discharge; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include severe or persistent headache or dizziness.Proper storage of Soriatane :
Store Soriatane at room temperature, between 59 and 77 degrees F (15 and 25 degrees C) in a tightly closed container. Avoid temperatures above 120 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Soriatane out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Soriatane . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.