Isotretinoin

Aka: Isotretinoin, Accutane

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II. Indications

  1. Severe Acne Vulgaris Management ( Cystic Acne)
  2. Treatment resistant Acne Vulgaris

III. Mechanism

  1. Vitamin A derivative (Retinoid) that inhibits sebum production and comedolysis

IV. Dosing

  1. Course: 20 weeks
  2. Cummulative dose target: 120 mg/kg total over entire 20 week course
  3. Precautions
    1. Acne may worsen for the first 4 to 6 weeks before it starts to improve
    2. Accutane best absorption is when taken with food
      1. Absorica may be taken with or without food
  4. Initial dosing
    1. Start 0.25 to 0.4 mg/kg/day (or 0.5 mg/kg/day if severe)
    2. Titrate to 1 mg/kg/day as tolerated after the first month
      1. May also maintain at lower dose for moderate Acne Vulgaris
  5. Moderate acne or flares
    1. Lower dosing: 0.3 to 0.5 mg/kg divided twice daily
  6. Facial Acne
    1. Standard dosing: 1 mg/kg divided bid)
  7. Truncal Acne
    1. Higher dosing: 2 mg/kg divided twice daily
    2. Consider repeat 4 month course after 2 month rest
      1. Indicated for severe, refractory truncal acne

V. Adverse Effects

  1. Very Teratogenic (even 1 pill)
    1. See Precautions below
  2. Cheilitis (90%)
    1. Use lip balm
  3. Dry or chapped skin (90%)
    1. Use Skin Lubricant (Moisturizing Lotion)
  4. Dry nose and eyes (80%)
    1. Use artificial tears
    2. Use Nasal Saline and consider petroleum jelly at nasal septum to prevent Epistaxis
  5. Elevated Serum Triglycerides (25%)
  6. Arthralgias and Myalgias (15%)
    1. Take Ibuprofen or Acetaminophen
  7. Elevated liver transaminases (15%)
  8. Hair shedding (10%)
  9. Peeling of palms and soles (5%)
  10. Intracranial Hypertension
    1. Stop medication and return for evaluation if persistent Headache or Vision changes
  11. Night blindness

VI. Precautions

  1. Major Depression exacerbation
    1. Increased Suicidality was seen in early studies but have not been confirmed
  2. Teratogenicity
    1. Associated with anomalies of the head, CNS, Cardiovascular System, Thymus and pararthyroid glands
    2. Needs two forms Contraception while taking
    3. Counsel extensively before use
    4. Requires prescribers to to enter into the iPLEDGE program (see below)

VII. Drug Interactions

  1. No supplemental Vitamin A intake while on Accutane
  2. Stop topical acne medications (e.g. Benzoyl Peroxide, Keratolytics) to limit skin irritation

VIII. Monitoring

  1. Serum testing at baseline, 2 months and then as needed (if abnormal labs on initial testing)
    1. Liver transaminases
    2. Lipid panel (esp. Serum Triglycerides)
  2. iPLEDGE Program
    1. http://www.ipledgeprogram.com
    2. Only iPLEDGE registrants can administer Isotretinoin in the United States
    3. Replaces System Manage Accutane Related Teratogenicity (SMART)
      1. Required a Yellow Accutane Qualification Sticker
    4. Pregnancy prevention program per Roche and FDA
    5. Presciption limited to 30 days
    6. Mandates 2 forms of Birth Control
      1. Both forms started >1 month before Accutane
      2. Continue Contraception for 1 month after stopping
      3. One form must be primary Contraception
        1. Tubal Ligation or partner's Vasectomy
        2. Intrauterine Device
        3. Oral Contraceptive
        4. Depo Provera, Norplant or similar
    7. Mandates urine pregnancy timing
      1. Initial Urine Pregnancy Test
      2. Urine Pregnancy Test immediately before Accutane
        1. First five days of Menstrual Cycle
        2. 11 days after last intercourse if Amenorrhea
      3. Urine Pregnancy Test monthly at time of refill

IX. References

  1. (2021) Presc Lett 28(12): 70-1
  2. Oge (2019) Am Fam Physician 100(8): 475-84 [PubMed]

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Related Studies

Cost: Medications

isotretinoin (on 6/21/2023 at Medicaid.Gov Survey of pharmacy drug pricing)
ISOTRETINOIN 10 MG CAPSULE Generic $1.92 each
ISOTRETINOIN 20 MG CAPSULE Generic $19.10 each
ISOTRETINOIN 30 MG CAPSULE Generic $16.72 each
ISOTRETINOIN 40 MG CAPSULE Generic $15.19 each
FPNotebook does not benefit financially from showing this medication data or their pharmacy links. This information is provided only to help medical providers and their patients see relative costs. Insurance plans negotiate lower medication prices with suppliers. Prices shown here are out of pocket, non-negotiated rates. See Needy Meds for financial assistance information. GoodRx is another tool for finding lower drug prices.

Ontology: Isotretinoin (C0022265)

Definition (NCI_NCI-GLOSS) A drug that is used in the treatment of acne and psoriasis and is being studied in cancer prevention. It is a type of retinoid.
Definition (NCI) A naturally-occurring retinoic acid with potential antineoplastic activity. Isotretinoin binds to and activates nuclear retinoic acid receptors (RARs); activated RARs serve as transcription factors that promote cell differentiation and apoptosis. This agent also exhibits immunomodulatory and anti-inflammatory responses and inhibits ornithine decarboxylase, thereby decreasing polyamine synthesis and keratinization.
Definition (CSP) a topical dermatologic agent that is used in the treatment of acne vulgaris and several other skin diseases.
Definition (PDQ) A naturally-occurring retinoic acid with potential antineoplastic activity and teratogenic properties. 13-cis retinoic acid binds to and activates nuclear retinoic acid receptors (RAR), thereby regulating cell proliferation and differentiation. This agent also exhibits immunomodulatory and anti-inflammatory responses and inhibits ornithine decarboxylase, thereby decreasing polyamine synthesis and keratinization. Check for "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=42657&idtype=1" active clinical trials or "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=42657&idtype=1&closed=1" closed clinical trials using this agent. ("http://nciterms.nci.nih.gov:80/NCIBrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C603" NCI Thesaurus)
Definition (MSH) A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.
Concepts Organic Chemical (T109) , Pharmacologic Substance (T121)
MSH D015474
SnomedCT 429464002, 332363004, 38314008, 387208003
LNC LP17250-9, MTHU023118
English 13 cis Retinoic Acid, 13-cis-Retinoic Acid, Isotretinoin, 13 cis retinoate, Retinoic acid, 13-cis-, Isotretinoin [topical], 3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)2-cis-4-trans-6-trans-8-trans-nonatetraenoic Acid, isotretinoin, 13-cis Retinoic Acid, 13-cis-Retinoate, Neovitamin A Acid, Isotretinoinum, 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexene-1-yl)2cis-4-trans-6-trans-8-trans-nonatetraenoic Acid, RETINOIC ACID A CIS 013, Topical form isotretinoin (product), Topical form isotretinoin, isotretinoin (medication), ISOTRETINOIN, Isotretinoin [Chemical/Ingredient], acid cis retinoic, isotretinoin topical, topical isotretinoin, 13 cis acid retinoic, ISOtretinoin, Isotretinoin [topical] (product), 13-cis retinoic acid, 13 cis retinoic acid, 13-cis-Retinoic acid, Isotretinoin (product), Isotretinoin (substance), 13-cis-retinoic acid, 13-cis-vitamin A acid, cis-retinoic acid, 13-CRA, Isotretinoin [topical] (substance), 13-cRA, 13-cis-Vitamin A Acid, Retinoicacid-13-cis, cis-Retinoic Acid
Swedish Isotretinoin
Czech isotretinoin
Finnish Isotretinoiini
Russian IZOTRETINON, ИЗОТРЕТИНОН
Japanese イソトレチノイン, 13-シス-レチノイン酸, アックタン
French Acide 13-cis-rétinoïque, Isotrétinoïne
German RETINSÄURE A CIS 013, Isotretinoin, 13-cis-Retinsäure
Spanish isotretinoína, forma farmacéutica de uso tópico, isotretinoína, forma farmacéutica tópica (producto), isotretinoína, forma farmacéutica de uso tópico (producto), isotretinoína, forma farmacéutica tópica, Isotretinoína, isotretinoína (uso tópico), isotretinoína (uso tópico) (producto), isotretinoína (producto), isotretinoína (sustancia), isotretinoína (tópica) (producto), isotretinoína (tópica), isotretinoína, ácido retinoico 13-cis, Ácido 13-cis-Retinoico
Polish Izotretynoina
Norwegian Isotretinoin, Roaccutan
Croatian Izotretinoin
Portuguese Ácido 13-cis-Retinoico, Isotretinoína
Italian Isotretinoina
Derived from the NIH UMLS (Unified Medical Language System)

Ontology: Accutane (C0699581)

Concepts Pharmacologic Substance (T121) , Organic Chemical (T109)
MSH D015474
English accutanes, accutane, Accutane
Derived from the NIH UMLS (Unified Medical Language System)

Related Topics in Pharmacology

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