Help patients treat their severe recalcitrant nodular acne

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Brought to you by Dermatology Education Foundation and Accutane®

Your patient’s story may start with severe recalcitrant nodular acne, but it can change with Accutane®

Patients may ask for the proven results of the brand name that started it all — Accutane®1-3

INDICATIONS AND USAGE
Accutane® is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, means “many” as opposed to “few or several” nodules. Because of significant adverse reactions associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Accutane is indicated only for those female patients who are not pregnant, because Accutane can cause severe birth defects.

Limitations of Use: A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Accutane is only available through the iPLEDGE® program, in which prescribers, patients, pharmacies, and wholesalers must enroll.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS AND WARNINGS

CAUSES BIRTH DEFECTS | DO NOT GET PREGNANT

Accutane® must not be used by patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.

Birth defects which have been documented following Accutane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported.

Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deﬁcit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deﬁciency. In some cases death has occurred with certain of the abnormalities previously noted.

If pregnancy does occur during treatment of a patient who is taking Accutane, Accutane must be discontinued immediately and the patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Special Prescribing Requirements

Because of Accutane's teratogenicity and to minimize fetal exposure, Accutane is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE®. Accutane must only be prescribed by prescribers who are registered and activated with the iPLEDGE Program. Accutane must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE (see PRECAUTIONS).

Prescribe the Brand Name That
Started it All

Accutane® is available as 20 mg, 30 mg, and
40 mg soft gelatin capsules.

Accutane® - Capsule - 20 mg - 30 - 72143-232-30 | Accutane® - Capsule - 30 mg - 30 - 72143-233-30 | Accutane® - Capsule - 20 mg - 40 - 72143-234-30

SUMMARY OF RISK INFORMATION FOR
ACCUTANE® CONTRAINDICATIONS
Pregnancy: Category X. See Boxed CONTRAINDICATIONS AND WARNINGS.
Allergic Reactions: Accutane® is contraindicated in patients who are hypersensitive to this medication or to any of its components. Accutane should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsule.

Please see additional Important Safety Information below and the full Prescribing Information for Boxed Warning, Contraindications, other important Warnings and Precautions, Drug Interactions, Use in Specific Populations, and other Adverse Reactions.

Accutane® Is Exclusively Available at Participating Journey Total Access Program Pharmacies
Journey Total Access Program (JTAP) specialty pharmacies not only allow your patients to take advantage of the Accutane® Patient Savings Card; they also provide you with additional resources.

Pharmacies participating in the JTAP network:

•	Reduce patient out-of-pocket expenses

•	Provide a white glove customer experience for patients

•	Feature dedicated staffs with expertise in isotretinoin and iPLEDGE®* requirements

•	Take proactive steps to ensure iPLEDGE®* compliance and avoid treatment delays

*	Please visit https://www.ipledgeprogram.com for additional information on the iPLEDGE® program.

IMPORTANT SAFETY INFORMATION (CONT’D)
WARNINGS

•

Psychiatric Disorders: Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors. No mechanism of action has been established for these events. Prescribers should read the brochure, Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Isotretinoin. Prescribers should be alert to the warning signs of psychiatric disorders to guide patients to receive the help they need. Therefore, prior to initiation of Accutane therapy, patients and family members should be asked about any history of psychiatric disorder, and at each visit during therapy patients should be assessed for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation may be necessary. Signs and symptoms of depression include sad mood, hopelessness, feelings of guilt, worthlessness or helplessness, loss of pleasure or interest in activities, fatigue, difficulty concentrating, change in sleep pattern, change in weight or appetite, suicidal thoughts or attempts, restlessness, irritability, acting on dangerous impulses, and persistent physical symptoms unresponsive to treatment. Patients should stop Accutane and the patient or a family member should promptly contact their prescriber if the patient develops depression, mood disturbance, psychosis, or aggression, without waiting until the next visit. Discontinuation of Accutane therapy may be insufficient; further evaluation may be necessary. While such monitoring may be helpful, it may not detect all patients at risk. Patients may report mental health problems or family history of psychiatric disorders. These reports should be discussed with the patient and/or the patient’s family. A referral to a mental health professional may be necessary. The physician should consider whether Accutane therapy is appropriate in this setting; for some patients the risks may outweigh the benefits of Accutane therapy.

Please see additional Important Safety Information below and the full Prescribing Information for Boxed Warning, Contraindications, other important Warnings and Precautions, Drug Interactions, Use in Specific Populations, and other Adverse Reactions.

Eligible Patients Pay as Little as**

Those savings are automatically applied when you send the prescription to a participating JTAP specialty pharmacy.

Journey Medical Corporation Savings Card

Rebates are available by:

Visiting www.rxaccutane.com

This offer is only good with a prescription of ACCUTANE. This Savings Card is valid for ACCUTANE 20mg (NDCs 72143-232-10, 72143-232-30), ACCUTANE 30mg (NDCs 72143-233-10, 72143-233-30), and ACCUTANE 40mg (NDCs 72143-234-10, 72143-234-30). This offer is not valid for prescriptions reimbursed by Medicare, Medicaid, federal or state programs (including any state prescription drug programs). Offer good only in the United States and cannot be redeemed at government subsidized pharmacies. The selling, purchasing, trading, or counterfeiting of this offer is prohibited by law. Not valid with any other offer. Maximum reimbursement limits apply. Void where prohibited.

Sending prescriptions to a participating JTAP pharmacy

To ensure your patients receive Accutane®:

Write or check “DAW-1,” “Brand Medically Necessary,” or other appropriate language on the prescription.

Send the prescriptions to a participating JTAP specialty pharmacy. They are experienced with iPLEDGE®* and equipped to handle those requirements.

Ask your sales representative for a list of
participating JTAP pharmacies.

*	Please visit https://www.ipledgeprogram.com for additional information on the iPLEDGE® program.

IMPORTANT SAFETY INFORMATION (CONT’D)

WARNINGS

•

Pseudotumor Cerebri: Accutane use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines. Concomitant treatment with tetracyclines should therefore be avoided. Early signs and symptoms of pseudotumor cerebri include papilledema, headache, nausea and vomiting, and visual disturbances. Patients with these symptoms should be screened for papilledema and, if present, they should be told to discontinue Accutane immediately and be referred to a neurologist for further diagnosis and care.

•

Serious Skin Reactions: There have been post-marketing reports of erythema multiforme and severe skin reactions [e.g., Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)] associated with isotretinoin use. These events may be serious and result in death, life-threatening events, hospitalization, or disability. Patients should be monitored closely for severe skin reactions, and discontinuation of Accutane should be considered if warranted.

•

Pancreatitis: Acute pancreatitis has been reported in patients with either elevated or normal serum triglyceride levels. In rare instances, fatal hemorrhagic pancreatitis has been reported. Accutane should be stopped if hypertriglyceridemia cannot be controlled at an acceptable level or if symptoms of pancreatitis occur.

•

Lipids: Elevations of serum triglycerides in excess of 800 mg/dL have been reported in patients treated with Accutane. Marked elevations of serum triglycerides and cholesterol levels and a decrease in high-density lipoproteins were reported in clinical trials. Blood lipid determinations should be performed before Accutane is given and then at intervals until the lipid response to Accutane is established, which usually occurs within 4 weeks. Especially careful consideration must be given to risk/benefit for patients who may be at high risk during Accutane therapy (patients with diabetes, obesity, increased alcohol intake, lipid metabolism disorder or familial history of lipid metabolism disorder). If Accutane therapy is instituted, more frequent checks of serum values for lipids and/or blood sugar are recommended. The cardiovascular consequences of hypertriglyceridemia associated with Accutane are unknown.

•

Hearing Impairment: Impaired hearing has been reported in patients taking Accutane; in some cases, the hearing impairment has been reported to persist after therapy has been discontinued. Patients who experience tinnitus or hearing impairment should discontinue Accutane treatment and be referred for specialized care for further evaluation.

•

Hepatotoxicity: Clinical hepatitis considered to be possibly or probably related to Accutane therapy has been reported. Elevations of liver enzymes have been observed in clinical trials, some of which normalized with dosage reduction or continued administration of the drug. If normalization does not readily occur or if hepatitis is suspected during treatment with Accutane, the drug should be discontinued and the etiology further investigated.

•

Inﬂammatory Bowel Disease: Accutane has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after Accutane treatment has been stopped. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Accutane immediately.

•

Bone Mineral Density Changes: Although effects of multiple courses of Accutane on the developing musculoskeletal system are unknown, there is some evidence that Accutane may affect bone mineral density in some patients. Other skeletal conditions such as spontaneous reports of osteoporosis, osteopenia, bone fractures, delayed healing of bone fractures, and premature epiphyseal closure have been seen in the Accutane population. A high prevalence of skeletal hyperostosis was noted in clinical trials for disorders of keratinization.

•

Visual Impairment: Visual problems should be carefully monitored. All Accutane patients experiencing visual difficulties should discontinue Accutane treatment and have an ophthalmological examination. Corneal opacities have been reported in some patients. Decreased night vision has been reported during Accutane therapy and in some instances the event has persisted after therapy was discontinued. Patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night.

ADVERSE REACTIONS

•	Most of the adverse reactions seen in Accutane patients are similar to those described in patients taking very high doses of vitamin A. The common, less serious side effects of Accutane include dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds.

•	Body as a Whole: allergic reactions, including vasculitis, systemic hypersensitivity, edema, fatigue, lymphadenopathy, weight loss.

•	Cardiovascular: palpitation, tachycardia, vascular thrombotic disease, stroke.

•	Endocrine/Metabolic: hypertriglyceridemia, alterations in blood sugar levels.

•	Gastrointestinal: inflammatory bowel disease, hepatitis, pancreatitis, bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea, other nonspecific gastrointestinal symptoms.

•	Hematologic: allergic reactions, anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis. See Laboratory Tests for other hematological parameters.

•

Musculoskeletal: skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, decreases in bone mineral density, musculoskeletal symptoms (sometimes severe) including back pain, myalgia, and arthralgia, transient pain in the chest, arthritis, tendonitis, other types of bone abnormalities, elevations of CPK/rare reports of rhabdomyolysis.

•	Neurological: pseudotumor cerebri, dizziness, drowsiness, headache, insomnia, lethargy, malaise, nervousness, paresthesias, seizures, stroke, syncope, weakness.

•	Psychiatric: suicidal ideation, suicide attempts, suicide, depression, psychosis, aggression, violent behaviors, emotional instability.

•	Reproductive System: abnormal menses.

•	Respiratory: bronchospasms (with or without a history of asthma), respiratory infection, voice alteration.

•

Skin and Appendages: acne fulminans, alopecia (which in some cases persists), bruising, cheilitis (dry lips), dry mouth, dry nose, dry skin, epistaxis, eruptive xanthomas, erythema multiforme, flushing, fragility of skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, infections (including disseminated herpes simplex), nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson syndrome, sunburn susceptibility increased, sweating, toxic epidermal necrolysis, urticaria, vasculitis (including Wegener’s granulomatosis), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting).

•	Hearing: hearing impairment, tinnitus.

•	Vision: corneal opacities, decreased night vision which may persist, cataracts, color vision disorder, conjunctivitis, dry eyes, eyelid inflammation, keratitis, optic neuritis, photophobia, visual disturbances.

•	Urinary System: glomerulonephritis, nonspecific urogenital findings

DRUG INTERACTIONS

•	Vitamin A: Because of the relationship of Accutane to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects.

•	Tetracyclines: Concomitant treatment with Accutane should be avoided because Accutane use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines.

•

Micro-dosed Progesterone Preparations: Micro-dosed progesterone preparations (“minipills” that do not contain an estrogen) may be an inadequate method of contraception during Accutane therapy. It is not known if hormonal contraceptives differ in their effectiveness when used with Accutane. Therefore, it is critically important for patients who can become pregnant to select and commit to use two forms of effective contraception simultaneously, at least one of which must be a primary form.

•

Norethindrone/ethinyl estradiol: In a study, patients receiving Ortho-Novum® 7/7/7 Tablets as an oral contraceptive agent, Accutane at the recommended dose of 1 mg/kg/day, did not induce clinically relevant changes in the pharmacokinetics of ethinyl estradiol and norethindrone and in the serum levels of progesterone, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Prescribers are advised to consult the package insert of medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products.

•

St. John’s Wort: Accutane use is associated with depression in some patients. Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John’s Wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John’s Wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John’s Wort.

•	Phenytoin: Phenytoin is known to cause osteomalacia. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between phenytoin and Accutane. Therefore, caution should be exercised when using these drugs together.

•

Systemic Corticosteroids: Systemic corticosteroids are known to cause osteoporosis. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between systemic corticosteroids and Accutane. Therefore, caution should be exercised when using these drugs together.

USE IN SPECIFIC POPULATIONS

•	Nursing Mother: It is not known whether this drug is excreted in human milk. Because of the potential for adverse effects, nursing mothers should not receive Accutane.

•

Pediatric Use: Accutane in pediatric patients less than 12 years of age has not been studied. The use of Accutane for the treatment of severe recalcitrant nodular acne in pediatric patients ages 12 to 17 years should be given careful consideration, especially for those patients where a known metabolic or structural bone disease exists.

•	Geriatric Use: Studies did not include sufficient patients aged 65 years and over to determine if they respond differently from younger patients, although effects of aging might be expected to increase some risks associated with isotretinoin therapy.

Please see full Prescribing Information for Boxed Warning, Contraindications, other important Warnings and Precautions, Drug Interactions, Use in Specific Populations, and other Adverse Reactions.

To report SUSPECTED ADVERSE REACTIONS, contact JG Pharma, Inc. at 1-844-325-3350 or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.

References

1.	Leyden JJ, Del Rosso JQ, Baum EW. The use of isotretinoin in the treatment of acne vulgaris: Clinical considerations and future directions. J Clin Aesthet Dermatol. 2014;7(2 Suppl):S3-S21.

2.	Layton A. The use of isotretinoin in acne. Dermatoendocrinol. 2009;1(3):162-169.

3.	Accutane [package insert]. JG Pharma. Scottsdale, AZ. 07/20.

Click here to see the full Prescribing Information
for Boxed Warning, Contraindications, other
Important Warnings and Precautions, Drug
Interactions, Use in Specific Populations, and
other Adverse Reactions.

iPLEDGE® is a registered trademark of McKesson Specialty Arizona, Inc.

This promotional email is offered by Accutane®. The content and opinions expressed within this email are those of the company and not of the DEF.

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