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. Amnesteem must only be dispensed in no more than a 30 day supply.
REFILLS REQUIRE A NEW PRESCRIPTION AND A NEW AUTHORIZATION FROM THE iPLEDGE SYSTEM.
An Amnesteem Medication Guide must be given to the patient each time Amnesteem is dispensed, as required by law. This Amnesteem Medication Guide is an important part of the risk management program for the patient.
Isotretinoin, USP a retinoid, is available as Amnesteem (isotretinoin capsules, USP) in 10 mg, 20 mg and 40 mg soft gelatin capsules for oral administration.
Severe Recalcitrant Nodular Acne
Amnesteem 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, Amnesteem should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Amnesteem is indicated only for those female patients who are not pregnant, because Amnesteem 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 Amnesteem. 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).
Media Articles Related to Amnesteem (Isotretinoin)
Pregnancy Prevention Program in Acne Drug Users Ineffective
Source: Medscape Dermatology Headlines [2016.04.26]
Results suggest one or two children are born each year with birth defects related to isotretinoin and subpar contraceptive use.
Medscape Medical News
Pregnancy guidelines for harmful acne drug not adhered to by many women
Source: Pregnancy / Obstetrics News From Medical News Today [2016.04.25]
A new study suggests around 30-50 percent of women who use the acne drug isotretinoin do not adhere to current pregnancy prevention guidelines.
What's New in Acne and Rosacea
Source: Medscape Dermatology Headlines [2016.04.29]
Dr Hillary Baldwin summarizes the latest acne and rosacea news from the 2016 American Academy of Dermatology meeting.
Contraception Safety Program for Acne Drug Failing in Canada
Source: MedicineNet Acne Specialty [2016.04.26]
Title: Contraception Safety Program for Acne Drug Failing in Canada
Category: Health News
Created: 4/25/2016 12:00:00 AM
Last Editorial Review: 4/26/2016 12:00:00 AM
Acne Drug: FDA Advisors Recommend OTC Adapalene
Source: MedPage Today Dermatology [2016.04.15]
(MedPage Today) -- Panel votes 16-0 that the drug is safe for use without a prescription.
Published Studies Related to Amnesteem (Isotretinoin)
Isotretinoin 5 mg daily for low-grade adult acne vulgaris--a placebo-controlled,
randomized double-blind study. 
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 Amnesteem (Isotretinoin)
Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition [Completed]
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
Belinostat and Isotretinoin in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery [Active, not recruiting]
This phase I trial is studying the side effects and best dose of belinostat when given
together with isotretinoin in treating patients with metastatic or unresectable solid
tumors. Belinostat may stop the growth of tumor cells by blocking blood flow to the tumor
and by blocking some of the enzymes needed for cell growth. Isotretinoin may cause solid
tumor cells to look more like normal cells, and to grow and spread more slowly. Giving
belinostat together with isotretinoin may be an effective treatment for metastatic or
unresectable solid tumors.
Reports of Suspected Amnesteem (Isotretinoin) Side Effects
Inflammatory Bowel Disease (271),
Colitis Ulcerative (85),
Blood Triglycerides Increased (73),
Crohn's Disease (58),
LIP DRY (55),
DRY Skin (54),
Anxiety (54), more >>
Page last updated: 2016-04-29