Isotretinoin

ABSORICA and ABSORICA LD are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use If a second course of ABSORICA/ABSORICA LD treatment is needed, it is not recommended before a 2-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of treatment [see Dosage and Administration (2.2) ]. ABSORICA and ABSORICA LD are retinoids indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. (1) Limitations of Use: If a second course of ABSORICA/ABSORICA LD treatment is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of treatment. (1)

ABSORICA and ABSORICA LD have different dosage regimens [see Dosage and Administration (2.1) ] . Although ABSORICA and ABSORICA LD have a 20 mg strength, these strengths have different bioavailability and are not substitutable. ABSORICA is available in 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg capsules. 10 mg: Dark yellow, opaque, capsule imprinted with black ink “ G240 ” on cap and “ 10 ” on the body 20 mg: Red, opaque, capsule imprinted with black ink “ G241 ” on cap and “ 20 ” on the body 25 mg: Green, opaque, capsule imprinted with white ink “ G342 ” on cap and “ 25 ” on the body 30 mg: Brown, opaque, capsule imprinted with white ink “ G242 ” on cap and “ 30 ” on the body 35 mg: Dark blue, opaque, capsule imprinted with white ink “ G343 ” on cap and “ 35 ” on the body 40 mg: Brown and red, capsule imprinted with white ink “ G325 ” on cap and “ 40 ” on the body ABSORICA LD is available in 8 mg, 16 mg, 20 mg, 24 mg, 28 mg and 32 mg opaque-printed, hard-gelatin capsules. 8 mg: A size 3, light green with a colorless band (the cap is printed in white with “ RL29 ” and the body is printed in white with “ RL29 ”). 16 mg: A size 2, dark blue with a colorless band (the cap is printed in white with “ RL30 ” and the body is printed in white with “ RL30 ”). 20 mg : A size 1, dark pink with a colorless band (the cap is printed in black with “ RL33 ”and the body is printed in black with “ RL33 ”). 24 mg: A size 1, yellow with a colorless band (the cap is printed in white with “ RL31 ” and the body is printed in white with “ RL31 ”). 28 mg: A size 0, light blue, with a colorless band (the cap is printed in black with “ RL34 ” and the body is printed in black with “ RL34 ”). 32 mg: A size 0, caramel with a colorless band (the cap is printed in white with “ RL32 ” and the body is printed in white with “ RL32 ”). ABSORICA Capsules: 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg (3) ABSORICA LD Capsules: 8 mg, 16 mg, 20 mg, 24 mg, 28 mg and 32 mg (3)

ABSORICA/ABSORICA LD is contraindicated in: Pregnancy [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] . Patients with hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other allergic reactions have occurred) [see Warnings and Precautions ( 5.14 )] . ABSORICA/ABSORICA LD is contraindicated in: Pregnancy ( 8.1 ) Patients with hypersensitivity to isotretinoin (or Vitamin A) or any of its components ( 5.14 )

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. […]

The following adverse reactions with ABSORICA/ABSORICA LD or other isotretinoin capsule products are described in more detail in other sections of the labeling: Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.1 )] Psychiatric Disorders [see Warnings and Precautions ( 5.4 )] Intracranial Hypertension (Pseudotumor Cerebri) [see Warnings and Precautions ( 5.5 )] Serious Skin Reactions [see Warnings and Precautions ( 5.6 )] Pancreatitis [see Warnings and Precautions ( 5.7 )] Lipid Abnormalities [see Warnings and Precautions ( 5.8 )] Hearing Impairment [see Warnings and Precautions ( 5.9 )] Hepatotoxicity [see Warnings and Precautions ( 5.10 )] Inflammatory Bowel Disease [see Warnings and Precautions ( 5.11 )] Musculoskeletal Abnormalities [see Warnings and Precautions ( 5.12 )] Ocular Abnormalities [see Warnings and Precautions ( 5.13 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.14 )] The following adverse reactions associated with the use of isotretinoin capsules were identified in clinical trials or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Dose Relationship Cheilitis and hypertriglyceridemia were dose related. Body as a Whole Fatigue, irritability, pain, allergic reactions, systemic hypersensitivity, edema, lymphadenopathy, weight loss. Cardiovascular Vascular thrombotic disease, stroke, palpitation, tachycardia. Endocrine/Metabolism and Nutritional Decreased appetite, weight fluctuation, alterations in blood sugar. Gastrointestinal Dry lips, chapped lips, cheilitis, nausea, constipation, diarrhea, abdominal pain, vomiting, inflammatory bowel disease, hepatitis, pancreatitis, bleeding and inflammation of the gums, colitis, esophagitis, esophageal ulceration, ileitis. Hematologic Anemia and decreased RBC parameters, thrombocytopenia, increased platelet counts, decreased WBC counts, severe neutropenia, rare reports of agranulocytosis. Infections and Infestations Nasopharyngitis, hordeolum, infections (including disseminated herpes simplex and upper respiratory tract infection). Laboratory Abnormalities The following lab tests were increased: creatine phosphokinase (CPK), triglycerides, alanine aminotransferase (SGPT), aspartate aminotransferase (SGOT), gamma-glutamyltransferase (GGTP), cholesterol, low density lipoprotein (LDL), alkaline phosphatase, bilirubin, LDH, fasting blood glucose, uric acid, and sedimentation rate. However, high density lipoprotein (HDL) was decreased. Urine findings included increased white cells, proteinuria, microscopic or gross hematuria. Musculoskeletal and Connective Tissue Decreases in bone mineral density, musculoskeletal symptoms (sometimes severe) including back pain, arthralgia, musculoskeletal pain, neck pain, extremity pain, myalgia, musculoskeletal stiffness [see Warnings and Precautions (5.12)] , skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, tendonitis, arthritis, transient chest pain, and rare reports of rhabdomyolysis. Neurological Headache, syncope, intracranial hypertension (pseudotumor cerebri), dizziness, drowsiness, lethargy, malaise, nervousness, paresthesia, seizures, stroke, weakness. Psychiatric Suicidal ideation, insomnia, anxiety, depression, irritability, panic attack, anger, violent behaviors, emotional instability, suicide attempts, suicide, aggression, psychosis and auditory hallucinations. Of the patients reporting depression, some reported that the depression subsided with discontinuation of treatment and recurred with reinstitution of treatment. Reproductive System Abnormal menses and sexual dysfunction that may continue after discontinuation of treatment (including erectile dysfunction, decreased libido, decreased vaginal lubrication, and vaginal dryness). Respiratory Epistaxis, nasal dryness, bronchospasm (with or without a history of asthma), respiratory infection, voice alteration. Skin and Subcutaneous Tissue Dry skin, dermatitis, eczema, rash, contact dermatitis, alopecia, pruritus, sunburn, erythema, acne fulminans, alopecia(which in some cases persisted), bruising, dry nose, eruptive xanthomas, erythema multiforme, flushing, skin fragility, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson syndrome, increased sunburn susceptibility, sweating, toxic epidermal necrolysis, urticaria,vasculitis (including granulomatosis with polyangiitis), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting). Senses Hearing: tinnitus and hearing impairment. Ocular : dry eyes, reduced visual acuity, blurred vision, eye pruritis, eye irritation, asthenopia, decreased night vision, ocular hyperemia, increased lacrimation, conjunctivitis, corneal opacities, decreased night vision which may persist, cataracts, color vision disorder, conjunctivitis, eyelid inflammation, keratitis, optic neuritis, photobia, visual disturbances. Renal and Urinary Glomerulonephritis. Most common adverse reactions (incidence ≥5%) are: dry lips, dry skin, back pain, dry eye, arthralgia, epistaxis, headache, nasopharyngitis, chapped lips, dermatitis, increased creatine kinase, cheilitis, musculoskeletal discomfort, upper respiratory tract infection, reduced visual acuity. (6) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or iPLEDGE at (1-866-495-0654).

Vitamin A: avoid concomitant use (7.1) Tetracyclines: avoid concomitant use (7.2)

7.1 Vitamin A Avoid concomitant use of ABSORICA/ABSORICA LD with supplements containing vitamin A. ABSORICA/ABSORICA LD is closely related to vitamin A. Therefore, concomitant use of ABSORICA/ABSORICA LD with vitamin A may lead to ABSORICA/ABSORICA LD-associated adverse reactions.

7.2 Tetracyclines Avoid concomitant use of ABSORICA/ABSORICA LD with tetracyclines because isotretinoin use has been associated with a number of cases of intracranial hypertension ( pseudotumor cerebri) , some of which involved concomitant use of tetracyclines [see Warnings and Precautions (5.5) ] .

7.3 Oral Contraceptives Isotretinoin Capsules did not result in clinically significant changes in the pharmacokinetics of norethindrone and ethinyl estradiol when used concomitantly with a norethindrone and ethinyl estradiol oral contraceptive [see Clinical Pharmacology ( 12.3 )]. It is not known if there is an interaction with the concomitant use of ABSORICA/ABSORICA LD with other oral contraceptives.

Lactation : Breastfeeding not recommended (8.2) . In Patients Who Can Get Pregnant : Pregnancy testing is required prior to, during, and after ABSORICA/ABSORICA LD treatment. See the Full Prescribing Information for the detailed pregnancy test and contraception requirements. ( 8.3 ).

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that documents pregnancies in patients exposed to isotretinoin during pregnancy. Report any suspected fetal exposure during or 1 month after ABSORICA/ABSORICA LD treatment immediately 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) . Risk Summary ABSORICA/ABSORICA LD are contraindicated during pregnancy because isotretinoin can cause fetal harm when administered to a pregnant patient. There is an increased risk of major congenital malformations, spontaneous abortions, and premature births following isotretinoin exposure during pregnancy in humans. If ABSORICA/ABSORICA LD is used during pregnancy, or if the patient becomes pregnant while taking ABSORICA/ABSORICA LD, apprise the patient of the potential hazard to a fetus. If pregnancy occurs during treatment of a patient who is taking ABSORICA/ABSORICA LD, immediately discontinue ABSORICA/ABSORICA LD and refer the patient to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling. Data Human Data: Major congenital malformations that have been documented following isotretinoin exposure include malformations of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. External malformations include: skull; ear (including anotia, micropinna, small or absent external auditory canals); eye (including microphthalmia); facial dysmorphia and cleft palate. Internal abnormalities include: central nervous system (including cerebral and cerebellar malformations, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular; thymus gland; parathyroid hormone deficiency. In some cases, death has occurred as a result of the malformations. Cases of IQ scores less than 85 with or without other abnormalities have been reported in children exposed in utero to isotretinoin. An increased risk of spontaneous abortion and premature births have been reported with isotretinoin exposure during pregnancy.

8.2 Lactation Risk Summary There are no data on the presence of isotretinoin in either animal or human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in nursing infants from isotretinoin, advise patients that breastfeeding is not recommended during treatment with ABSORICA/ABSORICA LD, and for at least 8 days after the last dose of ABSORICA/ABSORICA LD.

8.3 Females and Males of Reproductive Potential All patients who can become pregnant must comply with the iPLEDGE program requirements [see Warnings and Precautions (5.2) ]. Pregnancy Testing All patients who can get pregnant must comply with the iPLEDGE REMS requirements [see Warnings and Precautions ( 5.2 )] . Pregnancy Testing In patients who can get pregnant, pregnancy testing is required prior to, during, and after ABSORICA/ABSORICA LD treatment. Pregnancy Testing Prior to Prescribing ABSORICA/ABSORICA LD: In patients who can get pregnant, only prescribe ABSORICA/ABSORICA LD after verification and documentation that they are not pregnant: Complete the first urine or serum pregnancy test (screening test) in a medical setting (e.g., prescriber’s office, clinic, laboratory) and verify and document that the test is negative, AND For patients with: Regular menstrual cycles, complete the second urine or serum pregnancy test (confirmatory test) in a medical setting (1) at least 30 days after the screening test and during the first five days of their menstrual period immediately preceding the beginning of ABSORICA/ABSORICA LD treatment, AND (2) after the patient has used their chosen pregnancy prevention methods (i.e., two forms of contraception or committed to abstinence) for at least 30 days. Verify and document that the confirmatory test is negative, OR Amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding , complete the second urine or serum pregnancy test (confirmatory test) in a medical setting (1) at least 30 days after the screening test and immediately preceding the beginning of ABSORICA/ABSORICA LD treatment, AND (2) after the patient has used their chosen pregnancy prevention methods (i.e., two forms of contraception or committed to abstinence) for at least 30 days. Verify and document that the confirmatory test is negative. If a patient who can get pregnant has had negative screening and confirmatory pregnancy tests but they missed the 7-day prescription window (the patient has not obtained their ABSORICA/ABSORICA LD prescription within 7 days of the pregnancy test collection) and has not started ABSORICA/ABSORICA LD treatment, repeat the urine or serum pregnancy test in a medical setting and verify and document that this repeat test is negative prior to prescribing ABSORICA/ABSORICA LD. The confirmatory pregnancy test must be repeated, as needed, until the patient receives ABSORICA/ABSORICA LD. Pregnancy Testing During Treatment with ABSORICA/ABSORICA LD: In patients who can get pregnant who are being treated with ABSORICA/ABSORICA LD, within 7 days before each prescription, obtain a urine or serum pregnancy test in a medical setting (e.g., prescriber’s office, laboratory, clinic) or instruct patients to use a home pregnancy test. If the patient who can get pregnant missed the 7-day prescription window (the patient has not obtained their ABSORICA/ABSORICA LD prescription within 7 days of the pregnancy test collection), repeat the urine or serum pregnancy test within 7 days before the next prescription in a medical setting or instruct patients to use a home pregnancy test. Verify and document the negative pregnancy test result prior to prescribing additional ABSORICA/ABSORICA LD treatment. Pregnancy Testing in Patients Who Have Completed ABSORICA/ABSORICA LD Treatment: In patients who can get pregnant who have completed ABSORICA/ABSORICA LD treatment, complete a urine or serum pregnancy test in a medical setting (e.g., prescriber’s office, laboratory, clinic) or instruct patients to use a home pregnancy test: At the end of the entire course of ABSORICA/ABSORICA LD treatment, and 1 month after the discontinuation of ABSORICA/ABSORICA LD. Contraception Patients who can get pregnant must use 2 forms of contraception simultaneously, at least 1 of which must be a primary form, for at least 1 month prior to initiation of ABSORICA/ABSORICA LD treatment, during ABSORICA/ABSORICA LD treatment, and for 1 month after discontinuing ABSORICA/ABSORICA LD treatment. However, 2 forms of contraception is not required if the patient commits to continuous abstinence from not having any sexual contact with a partner which may result in pregnancy, has undergone a hysterectomy or bilateral oophorectomy, or has been medically confirmed to be post-menopausal. Micro-dosed progesterone preparations (“minipills” that do not contain an estrogen) are an inadequate form of contraception during ABSORICA/ABSORICA LD treatment. Any birth control method can fail. There have been reports of pregnancy from patients who have used combination oral contraceptives, as well as contraceptive vaginal systems, vaginal inserts, transdermal systems, and injections; these pregnancies occurred while taking isotretinoin capsules. These reports are more frequent for patients who use only a single method of contraception. Therefore, it is critically important that patients who can get pregnant use two forms of contraception simultaneously. […]

The exact mechanism of action of ABSORICA/ABSORICA LD in the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater who are unresponsive to conventional therapy, including systemic antibiotics is unknown. ABSORICA/ABSORICA LD is a retinoid, which inhibits sebaceous gland function and keratinization. Clinical improvement in nodular acne patients occurs in association with a reduction in sebum secretion. The decrease in sebum secretion is temporary and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation.