Skip to main content

iPLEDGE^® Program— Taking steps toward managing side effects

Isotretinoin medications, like ABSORICA LD™, have been prescribed to more than 2 million people. But, as with all isotretinoin medications, ABSORICA LD may cause side effects. That’s why there’s an online program for people taking any isotretinoin medications called the iPLEDGE^® Program.

NOT ACTUAL PATIENT

About iPLEDGE^®

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.

Before receiving your ABSORICA LD prescription, you’ll need to:

1

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.

2

Keep appointments.
Keep in mind that treatment usually lasts for 5 months.

3

Fulfill the iPLEDGE^® Program requirements. For details, talk to your dermatologist or visit the iPLEDGE^® Program site.

View all View less

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:

for 1 month before starting ABSORICA LD
during treatment with ABSORICA LD
for 1 month after stopping ABSORICA LD

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:

depression, psychosis (seeing or hearing things that are not real)
suicide. Some patients taking ABSORICA LD have had thoughts about hurting themselves or suicide. Consult your healthcare provider if you have such thoughts.

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:

increased pressure in the brain (intracranial hypertension). ABSORICA LD can increase the pressure in your brain. This can lead to permanent loss of eyesight, and in rare cases, death. Stop taking ABSORICA LD and call your healthcare provider right away if you get any of these signs of increased brain pressure:
- bad headache
- blurred vision
- dizziness
- nausea or vomiting
- seizures (convulsions)
- stroke
serious skin problems. Skin rash can occur in patients taking ABSORICA LD. Sometimes rash can be serious and may lead to death. Stop using ABSORICA LD and call your healthcare provider right away if you get:
- conjunctivitis (red or inflamed eyes, like “pink eye”)
- rash with a fever
- blisters on legs, arms or face
- sores in your mouth, throat, nose or eyes
- peeling of your skin
inflammation of your pancreas (pancreatitis) can happen in patients who take ABSORICA LD and can lead to death. Call your healthcare provider right away if you have any of the following symptoms of pancreatitis:
- severe upper stomach (abdomen) pain
- swelling of your stomach
- nausea and vomiting
- fever
increased blood fat (lipid) levels. ABSORICA LD can raise blood fat levels (cholesterol and triglycerides). Your healthcare provider will do blood tests to check your lipids before and during treatment. These problems usually go away when ABSORICA LD treatment is finished.
hearing problems. Stop using ABSORICA LD and call your healthcare provider if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
liver problems, including hepatitis. Your healthcare provider will do tests to check your liver before and during treatment with ABSORICA LD.
inflammation of your digestive tract (inflammatory bowel disease). Stop taking ABSORICA LD and call your healthcare provider.
bone and muscle problems. Bone problems include bone pain, softening or thinning (which may lead to fractures). Tell your healthcare provider if you plan hard physical activity during treatment with ABSORICA LD.

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.

vision problems. Stop taking ABSORICA LD and call your healthcare provider right away if you have any vision changes. ABSORICA LD may affect your ability to see in the dark. Some patients get dry eyes during treatment. If you wear contact lenses, you may have trouble wearing them during and after you stop treatment with ABSORICA LD.
serious allergic reactions. Stop taking ABSORICA LD and get emergency medical help right away if you get hives, a swollen face or mouth, or have trouble breathing. Stop taking ABSORICA LD and call your healthcare provider if you get a fever, rash, or red patches or bruises on your legs.
blood sugar problems, including diabetes. Tell your healthcare provider if you are very thirsty or urinate more than usual.

The most common side effects of ABSORICA LD include:

dry lips
dry skin
back pain
dry eyes
joint pain
nose bleeds
headache
upper respiratory tract infection (common cold)
chapped lips or swelling of the lips
skin reactions
muscle problems
eye problems, including decreased vision

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.