CONTRAINDICATIONS AND WARNINGS
Sotret must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin capsules 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 isotretinoin 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 female patient who is taking isotretinoin capsules, isotretinoin capsules must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Special Prescribing Requirements
Because of isotretinoin’s teratogenicity and to minimize fetal exposure, Sotret is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE™. Sotret must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Sotret capsules 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).
Table 1 Monthly Required iPLEDGE Interactions
| Female Patients of Childbearing Potential | Male Patients, And Female Patients Not of Childbearing Potential |
| PRESCRIBER | | |
| Confirms patient counseling | X | X |
| Enters the 2 contraception methods chosen by the patient | X | |
| Enters pregnancy test results | X | |
| PATIENT | | |
| Answers educational questions before every prescription | X | |
| Enters 2 forms of contraception | X | |
| PHARMACIST | | |
| Calls system to get an authorization | X | X |
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SOTRET SUMMARY
SOTRET®
ISOTRETINOIN CAPSULES
Isotretinoin, a retinoid, is available as Sotret in 10 mg, 20 mg, 30 mg, and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil, hydrogenated vegetable oil, iron oxide black, soybean oil and white wax. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10 mg - iron oxide (red) and titanium dioxide; 20 mg - FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 30 mg - FD&C Yellow No. 6, and titanium dioxide; 40 mg - FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide.
Sotret 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, Sotret should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Sotret is indicated only for those female patients who are not pregnant, because Sotret 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 isotretinoin capsules. 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 Sotret (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 Sotret (Isotretinoin)
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.
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).
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
Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors [Completed]
The purpose of this study is to see if it is safe and effective to give isotretinoin to
HIV-infected women with cervical tumors to prevent these tumors from becoming cancerous.
Cervical tumors are found in both HIV-infected and HIV-negative women. However, HIV-infected
women are at a greater risk, and often their tumors become cancerous more quickly than those
in HIV-negative women. Isotretinoin may be able to prevent this from happening. However,
since these tumors tend to disappear over time, many doctors are hesitant to give their
patients isotretinoin since this drug causes birth defects. This study looks at whether it is
better to treat cervical tumors in HIV-infected women or to wait and see if they will
disappear by themselves.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 6 ratings/reviews, Sotret has an overall score of 8.50. The effectiveness score is 10 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Sotret review by 38 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | acne |
| Dosage & duration: | | 20 mg twice daily taken twice daily for the period of six months |
| Other conditions: | | very oily skin, blackheads on nose |
| Other drugs taken: | | avapro, hydrochlorothiazide, clonidine, lipitor | | |
Reported Results |
| Benefits: | | I took isotretinoin for persistent adult acne. My skin was not by any means awful, but I did have evident pimples on my forehead and chin, and awful, awful blackheads on my nose that despite daily steaming and extraction, were terrible. The drug totally cleared up my face, and my blackhead literally dried up in front of my eyes. My once horribly oily skin changed to almost normal. |
| Side effects: | | First, let me say that I didn't experience the awful side effects that some do with isotretinoin use. I did turn very, very red around the perioral area and especially at the nasolabial folds. My face felt as if I needed to peel it off and scratch deep down in the dermis. In fact, that was my main complaint--the itchiness . . . and of course the dryness. But the dryness was not nearly as bad as I expected. For example, my lips never cracked. However, I'm several years out from treatment , and I still have dry skin problems. It's weird because my skin was always so oily and now it's dry. But that could be attributed to normal aging. Regardless, I've become a real connosiour of facial moisturizers. My skin is also a little more sensitive post isotretinoin. Tazorac one percent, which I used to slather on nightly like lotion, now sets me on fire if I dare to use the half percent version more than twice a week. I know the literature claims there's no anti-aging efficacy if it isn't used daily, but I'm hoping for the best. |
| Comments: | | I have to confess that I'm confused by this section. There were no real "details" associated with my treatment aside from what I've alreay described. |
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| | Sotret review by 26 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | mild but resistant acne |
| Dosage & duration: | | 30mg/day taken 2 doses for the period of 4 months - repeated after 1 year for 3m |
| Other conditions: | | rosacea (mild) |
| Other drugs taken: | | contraceptive pill | | |
Reported Results |
| Benefits: | | Treatment was very effective, effects started to be noticeable after 3 weeks. After 3 months skin had cleared and as additional benefits, hair and skin were much less oily (no longer needed to wash hair daily as it was not so oily any more. Pores shrunk and much less visible.
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| Side effects: | | Side effects started about 3 days after starting treatment. Initially lips became very dry and had to use lip salve continuosly. Then I started getting nosebleeds as the skin inside my nose became very dry and fragile.
Skin became very dry and sensitive during treatment and eyes very sensitive to light.
I had to have regular blood tests to check my lipid profile but it was not affected by the treatment.
During the second course of treatment I also got very mild depression symptoms so I stopped the treatment. |
| Comments: | | I suffered with mild acne and many whiteheads that were resistant to all other topical and antibiotic treatment. My dermatologist was reluctant to prescribe Accutane as I had a mild acne but eventually let me try a course at the lowest dose (0.5/mg/kg). I had 2 courses of treatment with Accutane. The first time it was highly effective (side effects were tolerable and worth it as I got great results) so I stopped after 4 months. after about a year the acne returned (much less than previously) so I took another course and after that it was definitely gone.
There are side effects but if you can tolerate them, it is a very effective treatment.
I had to do a pregnancy test prior to starting each course and full blood test and had to take oral contraceptives throughout the treatment as there is a risk of birth defects. I also had to see dermatologist every 2 weeks initially then monthly and have my blood tests repeated.
Tretment was very expensive (including cost of drugs, blood tests, consultation fees) but worth it. |
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| | Sotret review by 37 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Acne |
| Dosage & duration: | | dont remeber (dosage frequency: once a day) for the period of 4 months |
| Other conditions: | | n/a |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Cleared up my acne - worked very well. Skin was softer. |
| Side effects: | | blood noses, depression, cracked lips - these things where difficult to put up with but it was only for 4 months and the results have lasted for over 10 years |
| Comments: | | while on the tablets - made sure i stayed out of the sun, tried to not drink alcahol and had liver checked. And ensured i did not pregnant |
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Page last updated: 2009-10-20
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