absorica

Important safety information

Psychiatric Disorders (depression, psychosis, suicidal thoughts and behavior, and aggressive and/or violent behaviors): Prior to and during treatment assess for these conditions; stop if these conditions occur on treatment (5.4) Intracranial Hypertension ( Pseudotumor Cerebri ): Avoid concomitant use with tetracyclines ( 5.5 ) Serious Skin Reactions : Monitor for Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious skin reactions and discontinue treatment if they occur ( 5.6 ) Acute Pancreatitis : If pancreatitis symptoms occur, discontinue treatment ( 5.7 ) Lipid Abnormalities (hypertriglyceridemia, low HDL, and elevation of cholesterol): Monitor lipid levels at regular intervals; stop if hypertriglyceridemia cannot be controlled ( 5.8 ) Hearing Impairment : Discontinue and refer to specialized care ( 5.9 ) Hepatotoxicity : Monitor liver function tests prior to and during treatment ( 5.10 , 5.15 ) Inflammatory Bowel Disease : Discontinue for abdominal pain, rectal bleeding, or severe diarrhea ( 5.11 ) Musculoskeletal Abnormalities : Arthralgias, back pain, decreases in bone mineral density and premature epiphyseal closure ( 5.12 ) Ocular Abnormalities e.g., corneal opacities, decreased night vision: If visual symptoms occur, discontinue and refer for an ophthalmological exam ( 5.13 ) 5.1 Embryo-Fetal Toxicity ABSORICA/ABSORICA LD is contraindicated in pregnancy [see Contraindications (4.1) ] . Based on human data, ABSORICA/ABSORICA LD can cause fetal harm when administered to a pregnant patient. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking any amount of ABSORICA/ABSORICA LD even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining prenatally whether an exposed fetus has been affected. Major congenital malformations, spontaneous abortions, and premature births have been documented following exposure to isotretinoin during pregnancy [see Use in Specific Populations (8.1) ] . If a pregnancy occurs during ABSORICA/ABSORICA LD treatment, immediately discontinue ABSORICA/ABSORICA LD and refer the patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. Immediately report any suspected fetal exposure during or 1 month after ABSORICA/ABSORICA LD treatment to the FDA via the MedWatch telephone number 1-800-FDA-1088, and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the internet (www.ipledgeprogram.com). Patients must be informed not to donate blood during ABSORICA/ABSORICA LD treatment and for 1 month following discontinuation because the blood might be given to a pregnant patient whose fetus must not be exposed to isotretinoin. ABSORICA/ABSORICA LD is available only through a restricted program under a REMS [see Warnings and Precautions (5.2) ]. 5.2 iPLEDGE REMS ABSORICA/ABSORICA LD are available only through a restricted program under a REMS called the iPLEDGE REMS because of the risk of embryo-fetal toxicity [see Warnings and Precautions (5.1) ] . Notable requirements of the iPLEDGE REMS include the following: Prescribers must be certified in the REMS and comply with the REMS requirements, including the following: Assess the reproductive status of all patients prior to initiating treatment and during treatment. Counsel patients who cannot get pregnant on the risk and REMS requirements prior to initiating treatment. Counsel patients who can get pregnant on the risk and REMS requirements prior to and during treatment. Counsel patients who can get pregnant on pregnancy prevention requirements prior to and during treatment, or refer patients who can get pregnant to an expert for such counseling. Comply with the pregnancy testing requirements. Assess the pregnancy status for patients who can get pregnant by reviewing pregnancy tests and documenting a negative result prior to each prescription. Report all pregnancies to the REMS. Patients who can get pregnant must be enrolled in the REMS and must comply with the REMS requirements, including the following Comply with the pregnancy testing and pregnancy prevention requirements [see Use in Specific Populations ( 8.3 )]. Demonstrate comprehension of the risk and REMS requirements before each prescription is dispensed. Obtain the prescription within the 7-day prescription window (i.e., within 7 days of the pregnancy test collection). Patients who cannot get pregnant must be enrolled in the REMS and must comply with the REMS requirements, including to not share isotretinoin and not donate blood. Pharmacies that dispense ABSORICA/ABSORICA LD must be certified in the REMS and must comply with the REMS requirements, including the following: Obtain authorization to dispense and only dispense to patients who are authorized to receive ABSORICA/ABSORICA LD. Dispense a maximum of a 30-day supply with a Medication Guide. Do not dispense refills. Wholesalers and distributors must be registered in the REMS and must only distribute to certified pharmacies. Further information, including a list of qualified pharmacies and distributors, is available at www.ipledgeprogram.com or 1-866-495-0654. 5.3 ABSORICA and ABSORICA LD are Not Substitutable Given that the bioavailability and the recommended dosage of ABSORICA and ABSORICA LD are different, ABSORICA and ABSORICA LD are not substitutableon a mg per mg basis. For example, ABSORICA and ABSORICA LD have a 20 mg strength; however, these strengths have different bioavailability and are not substitutable. 5.4 Psychiatric Disorders ABSORICA/ABSORICA LD may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors [see Adverse Reactions ( 6 )] . Be alert to the warning signs of psychiatric disorders to help ensure patients receive the help they need (Prescribers should read the REMS educational material on recognizing psychiatric disorders ). Prior to initiation of ABSORICA/ABSORICA LD treatment, ask patients and family members about any history of psychiatric disorder, and at each visit during treatment assess patients for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation is necessary. If a patient develops depression, mood disturbance, psychosis, or aggression, instruct patients (or caregivers) to immediately stop ABSORICA/ABSORICA LD and promptly contact their health care provider. Discontinuation of ABSORICA/ABSORICA LD may be insufficient; further evaluation may be necessary such as a referral to a mental healthcare professional. 5.5 Intracranial Hypertension (Pseudotumor Cerebri) Isotretinoin use has been associated with cases of intracranial hypertension ( pseudotumor cerebri) , some of which involved concomitant use of tetracyclines. Avoid concomitant use of ABSORICA/ABSORICA LD with tetracyclines [see Drug Interactions ( 7.2 )]. Early signs and symptoms of intracranial hypertension include papilledema, headache, nausea and vomiting, and visual disturbances. Screen patients with these symptoms for papilledema and, if present, immediately discontinue ABSORICA/ABSORICA LD and refer the patient to a neurologist for further diagnosis and care [see Adverse Reactions ( 6 )] . 5.6 Serious Skin Reactions There have been postmarketing reports of erythema multiforme and severe skin reactions [e.g., Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)] associated with isotretinoin use. These reactions may be serious and result in death, life-threatening events, hospitalization, or disability. Patients should be monitored closely for severe skin reactions, and ABSORICA/ABSORICA LD should be discontinued if they occur. 5.7 Pancreatitis Acute pancreatitis has been reported with isotretinoin use in patients with either elevated or normal serum triglyceride levels. In rare instances, fatal hemorrhagic…