iPLEDGE® Program— Taking steps toward managing side effects
Isotretinoin medications, like
NOT ACTUAL PATIENT
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Isotretinoin medications, like
NOT ACTUAL PATIENT
The iPLEDGE® Program requires that 2 forms of birth control be used by patients who can get pregnant for at least 1 month before, during, and 1 month after stopping treatment. Patients are also required to take pregnancy tests before, during, and after treatment. All patients will need to enroll in iPLEDGE® and follow the requirements of the program. The goal of this program is to lower the risk of serious side effects, such as birth defects, associated with patients taking isotretinoin medications like ABSORICA LD.
Sign the Patient Information/Informed Consent form(s). Your dermatologist will go over these with you. Be sure to ask any questions you may have at this time.
Keep appointments.
Keep in mind that treatment usually lasts for 5 months.
Fulfill the iPLEDGE® Program requirements. For details, talk to your dermatologist or visit the iPLEDGE® Program site.
ABSORICA LD can harm your unborn baby. Avoid ABSORICA LD if pregnant. ABSORICA LD can cause serious mental health problems including depression and psychosis. See additional safety information below.
ABSORICA LD is a prescription medication used in patients 12 years of age and older for the treatment of severe nodular acne that cannot be cleared up by any other acne treatments, including antibiotics.
Do not change between ABSORICA and ABSORICA LD or other isotretinoin products.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ABSORICA LD?
ABSORICA LD can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Patients who are pregnant or who plan to become pregnant must not take ABSORICA LD.
Patients must not get pregnant:
If you get pregnant during treatment with ABSORICA LD, stop taking it right away and call your healthcare provider.
Patients taking ABSORICA LD must register in the iPLEDGE® Pregnancy Registry at 1-866-495-0654 or www.ipledgeprogram.com. See your healthcare provider for further information.
ABSORICA LD can cause serious mental health problems, including:
Stop taking ABSORICA LD and call your healthcare provider right away if you or a family member notices any signs or symptoms of depression or psychosis.
What are the possible side effects of ABSORICA LD?
ABSORICA LD can cause serious side effects, including:
Stop ABSORICA LD and call your healthcare provider right away if you have muscle weakness, which can be a sign of serious muscle damage.
ABSORICA LD may stop long bone growth in teenagers who are still growing.
The most common side effects of ABSORICA LD include:
These are not all of the possible side effects of ABSORICA LD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Sun Pharmaceutical Industries, Inc. at 1-800-818-4555.