BOX WARNING INFORMATION FOR PHARMACISTS
Access the iPLEDGE system via the internet (www.ipledgeprogram.com)or telephone (1-866-495-0654) to obtain an authorization and the "do not dispense to patient after" date.Accutane must only be dispensed in no more than a 30-day supply.
REFILLS REQUIRE A NEW PRESCRIPTIONAND A NEW AUTHORIZATION FROM THE iPLEDGE SYSTEM.
An Accutane Medication Guide must be given to the patienteach time Accutane is dispensed, as required by law. This AccutaneMedication Guide is an important part of the risk management programfor the patient.
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ACCUTANE SUMMARY
ACCUTANE®
(isotretinoin capsules)
Isotretinoin, a retinoid, is available as Accutane in 10-mg, 20-mg and 40-mg soft gelatin capsules for oral administration.
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,2 means "many" as opposed to "few or several" nodules. Because of significant adverse effects 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 females who are not pregnant, because Accutane can cause severe birth defects (see boxed CONTRAINDICATIONS AND WARNINGS).
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. 1,3,4 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 (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, and Premature Epiphyseal Closure).
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NEWS HIGHLIGHTS
Published Studies Related to Accutane (Isotretinoin)
Comparison of dose-related ocular side effects during systemic isotretinoin administration. [2009.03]
PURPOSE: To compare the effects of high- (Group 1) and low-dose (Group 2) isotretinoin treatments for acne vulgaris on lacrimal functions and other ocular complications... CONCLUSIONS: During systemic isotretinoin treatment, eye dryness was related to the dose used, at least during the period of treatment. Conversely, the rate of conjunctival S aureus colonization was unrelated to the dose of isotretinoin.
Oral isotretinoin in photoaging: clinical and histopathological evidence of efficacy of an off-label indication. [2009.02]
BACKGROUND: Despite evidences of the beneficial clinical effects of oral isotretinoin in the treatment of cutaneous photoaging, scientific evidences are still scarce, mainly supported by histopathological and morphometric studies. OBJECTIVES: To analyse possible clinical and morphological changes resulting from the treatment of photoaging with oral isotretinoin... CONCLUSION: Low dosages of oral isotretinoin seem to be an effective therapeutic option for cutaneous photoaging.
Oral isotretinoin is as effective as a combination of oral isotretinoin and topical anti-acne agents in nodulocystic acne. [2008.03]
BACKGROUND: Due to the late introduction of oral isotretinoin, there is only a single report of the use of this drug from India. AIMS: To evaluate the efficacy, acceptability and side effects of oral isotretinoin in Indian conditions and to compare the efficacy of oral isotretinoin monotherapy with that of a combination of oral isotretinoin and topical anti-acne agents... CONCLUSION: Isotretinoin produces gratifying results in patients of nodulocystic acne in Indian conditions. Addition of topical antiacne agents does not alter the final outcome. This addition is well tolerated but requires careful monitoring.
Beneficial effect of a moisturizing cream as adjunctive treatment to oral isotretinoin or topical tretinoin in the management of acne. [2006.11]
Despite their beneficial effects on the treatment of acne vulgaris, topical and oral retinoids may cause severe local irritation (retinoid dermatitis) due to their mechanism of action, thereby jeopardizing patient adherence, and thus compromising treatment efficacy...
Randomized phase III trial of low-dose isotretinoin for prevention of second primary tumors in stage I and II head and neck cancer patients. [2006.04.05]
BACKGROUND: Isotretinoin (13-cis-retinoic acid) is a synthetic vitamin A derivative, or retinoid, widely used in the treatment of cystic acne. Preclinical and clinical studies of high-dose isotretinoin in patients with head and neck squamous cell cancer (HNSCC) have produced encouraging results. We conducted a phase III randomized trial of low-dose isotretinoin versus placebo in early-stage HNSCC patients to assess its effect on second primary tumor incidence and survival... CONCLUSIONS: Low-dose isotretinoin was not effective in reducing the rate of second primary tumors or death or smoking-related disease. Smoking statistically significantly increased the rate of second primary tumors and death. Ongoing trials are testing higher doses of isotretinoin as part of combination bioadjuvant therapeutic methods for patients with locally advanced HNSCC.
Clinical Trials Related to Accutane (Isotretinoin)
Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies [Terminated]
The purpose of this study is to determine the response rate of patients with T-cell
malignancies to combination therapy using interferon-alpha (Roferon) and Isotretinoin
(Accutane).
Vitamin E in Preventing the Side Effects of Isotretinoin in Former and Current Smokers Who Are Receiving Isotretinoin to Prevent Lung Cancer [Active, not recruiting]
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of isotretinoin may be an effective way to
prevent lung cancer. Vitamin E may prevent the side effects of isotretinoin therapy.
PURPOSE: Randomized clinical trial to study the effectiveness of vitamin E in preventing the
side effects of isotretinoin in former and current smokers who are receiving isotretinoin to
prevent lung cancer.
Oral Isotretinoin for Photoaging: Results of a Randomized Controlled Phase II Trial [Completed]
A clinical and histological randomized controlled phase II trial to evaluate the efficacy and
safety of oral isotretinoin for treating photoaging was performed with 32 menopausal or
sterilized women aged 40-55y. The subjects were included in two randomly selected groups: A-
21 women received 20mg oral isotretinoin 3x week, moisturizer, sunscreen SPF 60 during three
months; B- 11 women received only same moisturizer/sunscreen.
Effects of Roaccutane on Ca, P, PTH and Vitamin D Metabolites in the Treatment of Sever Acne [Completed]
serum levels Ca, P, PTH and vitamin D metabolites before and after treatment with
isotretinoin for sever acne
Vorinostat, Isotretinoin and Carboplatin in Adults With Recurrent Glioblastoma Multiforme (GBM) [Recruiting]
Primary Objective (Phase I):
1. To determine the maximum tolerated dose (MTD) of vorinostat/isotretinoin (cRA),
carboplatin (CBT)/cRA and vorinostat/cRA/CBT combinations in adult patients with recurrent
glioblastoma multiforme (GBM) and anaplastic gliomas.
Primary Objective (Phase II):
- To determine the efficacy of vorinostat/cRA versus CBT/cRA versus vorinostat/cRA/CBT in
patients with recurrent GBM as determined by time to progression (TTP) using an adaptive
randomization phase II trial design.
Secondary Objectives (Phase II):
- To determine the radiological response, progression free survival at 6 months, overall
survival and unexpected toxicity in the three treatment arms.
- To obtain exploratory data regarding histone 3 and 4 acetylation and p21 levels in
tumor tissue and peripheral monocytes in a subset of surgical patients and in
non-surgical patients with available tissue from previous surgical procedures.
- To evaluate the occurrence of symptoms and correlate to disease progression and
tolerance to treatment using the MD Anderson Symptom Inventory-Brain Tumor Module
(MDASI-BT) self-reporting tool.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 38 ratings/reviews, Accutane has an overall score of 7.76. The effectiveness score is 8.89 and the side effect score is 6.37. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Accutane review by 43 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | acne |
| Dosage & duration: | | 40mg daily taken 20 mg 2xday for the period of 4 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Permanently: cured of cystic acne. Temporarily: eliminated blackheads, smoothed skin texture, skin appeared "poreless". |
| Side effects: | | Dry skin and lips, increased susceptibility to developing blisters on feet if walking long distances without careful attention to socks and shoes. Stupidly used "Biore" skin strips early in the treatment to speed up removal of the blackheads and pulled all the skin off my nose. |
| Comments: | | I am 43 now but took Accutane back in my early 20's for moderate cyctic acne. I took a second course in my 30's for mild/moderate non-cystic acne which was probably hormone related. I absolutely loved taking Accutane and wished that I could take it again at a milder dosage to treat blackheads and have that smooth "poreless" skin again. It seems to speed up skin cell sloughing and I didn't need to exfoliate, just use a good cream. After years of taking antibiotics and using awful creams that made my skin dry and red, Accutane was a godsend. My older brother and sister have terrible deep scars from cystic acne (my sister had dermabrasion many years ago before the age of laser) but I do not have one scar from my cyctic acne. |
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| | Accutane review by 18 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Acne |
| Dosage & duration: | | 40mg/day taken daily for the period of 8 months |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | Completely eliminated my acne while I was on the drug, however acne did return once I stopped, though not as bad. |
| Side effects: | | Dry skin, which was easily taken care of with a moisturizer.
Dry lips.
I didn't experience any of the other side effects often mentioned such as depression. |
| Comments: | | I would take 2x20mg pills daily. I needed to moisturize my face once a day also.
When i began I weaned myself onto the drug -- take 20mg for the first week before stepping upto the 40mg dose. |
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| | Accutane review by 34 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | ACNE |
| Dosage & duration: | | NOT SURE (dosage frequency: 1 pill/day) for the period of 5 MONTHS |
| Other conditions: | | NONE |
| Other drugs taken: | | NONE | | |
Reported Results |
| Benefits: | | REDUCED AMOUNT OF CYSTIC ACNE |
| Side effects: | | BALDNESS, SENSITIVITY TO SUNLIGHT, NIGHT VISION BLURRINESS |
| Comments: | | TAKE 1 PILL A DAY, BLOOD TOXICITY TESTS EVERY TWO WEEKS |
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Page last updated: 2009-10-20
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