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)
Isotretinoin 5 mg daily for low-grade adult acne vulgaris--a placebo-controlled,
randomized double-blind study. [2014]
OBJECTIVES: To assess the efficacy of 5 mg/day isotretinoin in adult acne... CONCLUSIONS: Isotretinoin 5 mg/day is effective in reducing the number of acne
A single blind randomized clinical study: the efficacy of isotretinoin plus narrow band ultraviolet B in the treatment of psoriasis vulgaris. [2011.06]
In this randomized clinical trial, 39 patients with psoriasis vulgaris were randomized in two groups. Intervention group received narrow band ultraviolet B (NBUVB)+isotretinoin (0.5 mg/kg/day), control group received NBUVB+placebo.
A phase I factorial design study of dose-dense temozolomide alone and in combination with thalidomide, isotretinoin, and/or celecoxib as postchemoradiation adjuvant therapy for newly diagnosed glioblastoma. [2010.11]
External beam radiation therapy (XRT) with concomitant temozolomide and 6 cycles of adjuvant temozolomide (5/28-day schedule) improves survival in patients with newly diagnosed glioblastoma compared with XRT alone...
Mortality in the randomized, controlled lung intergroup trial of isotretinoin. [2010.06]
In 2001, we reported that mortality may have been higher with isotretinoin (30 mg/d for 3 years) than with placebo in the subgroup of current smokers among the 1,166 patients with definitively resected early-stage non-small cell lung cancer who participated in the randomized, controlled Lung Intergroup Trial...
A randomized and controlled trial about the use of oral isotretinoin for photoaging. [2010.02]
Topical retinoids are used to treat photoaging; oral isotretinoin is gold standard for acne; "off label" indications, including photoaging, have been reported with insufficient evidence of efficacy. This is a randomized controlled phase II trial with clinical and histological assessment to evaluate efficacy and safety of oral isotretinoin for photoaging...
Clinical Trials Related to Sotret (Isotretinoin)
Aflac ST1001 Prolonged Isotretinoin [Withdrawn]
Neuroblastoma is a cancer of the nervous system and accounts for 15% of cancer related
deaths in children. With the advancement of treatment therapies, the long term survival rate
has progressed to approximately 50%. The therapy used for treatment, however, is very toxic
and associated with serious long-term side effects. Treatment for neuroblastoma typically
includes chemotherapy, surgery, stem cell transplantation, radiation therapy, and
immunotherapy. At the end of this treatment, children with neuroblastoma commonly take the
drug isotretinoin for 6 months. Isotretinoin maintains the response to previous treatments
and helps turn the remaining cancer cells into normal nerve cells.
Most patients often respond to this treatment at first but are at a high-risk for the cancer
coming back. The majority of the children who relapse after treatment or develop recurrent
disease do so in the first two years following the completion of therapy and there are no
current treatments to cure those who relapse. This study will explore whether or not
extending the therapy with isotretinoin from 6 months to 24 months will help prevent the
cancer from coming back without causing severe side effects.
Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea [Recruiting]
Oral isotretinoin is the gold standard drug to treat moderate to severe acne. Other
indications like seborrhea, seborrheic dermatitis have been suggested. There is risk of
reversible mucocutaneous side effects, as well as alterations in lipid profile and
transaminases. The major problem is teratogenicity which demands pregnancy control from
treatment beginning to one month after treatment end. Seborrhea and seborrheic dermatitis
are chronic conditions characterized by oily skin, hair and scalp, erythema, desquamation
and negative impact on quality of life. This will be an interventional, therapeutic and
quality of life randomized, comparative (parallel groups), blinded evaluation clinical
trial, comprising 50 men and women, aged 18 to 40. Treatment with low-dose oral isotretinoin
will be compared to topical anti-seborrheic products to evaluate the reduction of sebaceous
secretion and colonization of affected areas by yeasts of Malassezia gender. Efficacy will
be evaluated by clinical parameters, as well as by sebum secretion measure and application
of quality of life questionnaires. Safety will be evaluated by skin hydration measure, side
effects report and observation. For subjects using oral isotretinoin blood counting,
transaminases, lipid profile and pregnancy test will be requested as selection criteria, on
days 30 and 180. Data will be submitted to statistical analysis.
MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas [Completed]
Phase I trial to study the effectiveness of combining MS-275 with isotretinoin in treating
patients who have metastatic or advanced solid tumors or lymphomas. MS-275 may stop the
growth of cancer cells by blocking the enzymes necessary for their growth. Isotretinoin may
help cancer cells develop into normal cells. MS-275 may increase the effectiveness of
isotretinoin by making cancer cells more sensitive to the drug. MS-275 and isotretinoin may
also stop the growth of solid tumors or lymphomas by stopping blood flow to the cancer.
Combining MS-275 with isotretinoin may kill more cancer cells
Bioequivalence Study for an Isotretinoin [Completed]
The objective of this study was to confirm if two formulations of isotretionin (capsules)
are bioequivalent.
Test product was Oratane® 20 mg (Laboratorios Dermatológicos Darier) and reference product
Roaccutan® 20 mg (Productos Roche). Two capsules administered together were the single
dosage.
The study was prospective, open-label, randomized, crossover, single dose, with 02
treatments, 02 sequences and 02 periods, under fed conditions.
The population was composed of 36 healthy volunteers, male adults between 18-45 years.
The comparative bioavailability of the two formulations was evaluated based in statistical
comparisons of relevant pharmacokinetic parameters, obtained from data of drug
concentrations in blood.
Procarbazine and Isotretinoin in Treating Patients With Recurrent Primary Malignant Gliomas [Withdrawn]
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells. It is
not yet known whether giving procarbazine alone or with isotretinoin is more effective for
recurrent primary malignant glioma.
PURPOSE: Randomized phase III trial to compare the effectiveness of procarbazine alone or
with isotretinoin in treating patients with recurrent primary malignant gliomas.
Reports of Suspected Sotret (Isotretinoin) Side Effects
Inflammatory Bowel Disease (91),
Colitis Ulcerative (47),
Depression (33),
Irritable Bowel Syndrome (29),
Crohn's Disease (28),
Anxiety (23),
Blood Cholesterol Increased (19),
Blood Triglycerides Increased (18),
LIP DRY (13),
DRY Skin (13), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 10 ratings/reviews, Sotret has an overall score of 8. The effectiveness score is 9.40 and the side effect score is 5.80. 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 18 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Acne |
| Dosage & duration: | | 40mg taken twice a day for the period of 6 months |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | Smooth, clear skin. The Roaccutane not only got rid of my acne but also rejuvenated my skin. Pores were finer, blackheads were gone. |
| Side effects: | | Dry lips, red skin for the first month or so. |
| Comments: | | Treatment consisted of orally taking two tablets a day. I was prescribed Cetaphil lotion and lip balm to keep side effects at bay. Roaccutane was an excellent treatment. Before going on it I spent hundreds of dollars on other anti-acne treatments such as Clearasil etc and had no joy. Don't waste your money on other treatments just see your GP and ask for Roaccutane if you have an ongoing acne problem. |
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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 24 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Acne |
| Dosage & duration: | | 80mg per day taken once daily for the period of 20 weeks |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | Cleared active acne very effectively. |
| Side effects: | | Dry, cracked lips. Dark eye are due to thinning of skin. Extreme photosensitivity. Very dry, coarse skin. |
| Comments: | | Four 20 mg capsules taken once daily. Also had to double reccommended daily water intake. Moisturised skin and lips when absolutell necessary although this was not advised by dermatologist due to clogging of pores. |
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Page last updated: 2015-08-10
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