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Amnesteem (Isotretinoin) - Summary




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.


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).  

See all Amnesteem indications & dosage >>


Media Articles Related to Amnesteem (Isotretinoin)

Acne Pictures Slideshow: Quick Cover-ups, Do's and Don'ts
Source: MedicineNet Acne Specialty [2015.08.14]
Title: Acne Pictures Slideshow: Quick Cover-ups, Do's and Don'ts
Category: Slideshows
Created: 8/1/2012 12:00:00 AM
Last Editorial Review: 8/14/2015 12:00:00 AM

Experimental Treatment Uses Nitric Oxide for Acne
Source: MedicineNet Acne Specialty [2015.08.03]
Title: Experimental Treatment Uses Nitric Oxide for Acne
Category: Health News
Created: 7/31/2015 12:00:00 AM
Last Editorial Review: 8/3/2015 12:00:00 AM

Could a Vitamin Play a Role in Acne Outbreaks?
Source: MedicineNet Acne Specialty [2015.06.25]
Title: Could a Vitamin Play a Role in Acne Outbreaks?
Category: Health News
Created: 6/24/2015 12:00:00 AM
Last Editorial Review: 6/25/2015 12:00:00 AM

Acne patients: 'substantial proportion' fail to collect prescribed treatment
Source: Compliance News From Medical News Today [2015.03.22]
Dermatologist-prescribed treatments are being left on pharmacy shelves by up to a quarter of people with acne, according to a new study.

Better Contraceptive Knowledge Can Aid in Safe Use of Acne Drug: Study
Source: MedicineNet isotretinoin Specialty [2015.02.05]
Title: Better Contraceptive Knowledge Can Aid in Safe Use of Acne Drug: Study
Category: Health News
Created: 2/4/2015 12:00:00 AM
Last Editorial Review: 2/5/2015 12:00:00 AM

more news >>

Published Studies Related to Amnesteem (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...

more studies >>

Clinical Trials Related to Amnesteem (Isotretinoin)

Aflac ST1001 Prolonged Isotretinoin [Recruiting]
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.

Erlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma [Recruiting]
RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Isotretinoin may help cells that are involved in the body's immune response to work better. Giving erlotinib hydrochloride together with isotretinoin may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given with isotretinoin in treating patients with recurrent malignant glioma.

Vorinostat and Isotretinoin in Treating Patients With High-Risk Refractory or Recurrent Neuroblastoma [Recruiting]
This phase I trial is studying the side effects and the best dose of vorinostat when given together with isotretinoin to see how well it works in treating patients with high-risk refractory or recurrent neuroblastoma. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Isotretinoin may help vorinostat work better by making tumor cells more sensitive to the drug. Giving vorinostat together with isotretinoin may be an effective treatment for neuroblastoma

A Feasibility Study of SAHA Combined With Isotretinoin and Chemotherapy in Infants With Embryonal Tumors of the Central Nervous System [Recruiting]
Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. A peripheral blood stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed. This clinical trial is studying the side effects of giving vorinostat and isotretinoin together with combination chemotherapy and to see how well it works in treating young patients who have undergone surgery for embryonal tumors of the central nervous system

Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM) [Recruiting]

Phase I

1. To determine the maximum tolerated dose (MTD) of vorinostat/isotretinoin (cRA), temozolomide (TMZ)/cRA and vorinostat/cRA/TMZ combinations in adult patients with recurrent glioblastoma multiforme (GBM) and anaplastic gliomas.

Phase II

Primary objective:

1. To determine the efficacy of vorinostat/cRA versus TMZ/cRA versus vorinostat/cRA/TMZ in patients with recurrent GBM as determined by Progression Free Survival (PFS) using an adaptive randomization phase II trial design.

Secondary objectives:

2. To determine the radiological response, progression free survival at 6 months, overall survival and unexpected toxicity in the three treatment arms.

3. 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.

4. 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.

more trials >>

Reports of Suspected Amnesteem (Isotretinoin) Side Effects

Inflammatory Bowel Disease (271)Colitis Ulcerative (85)Depression (83)Arthralgia (77)Blood Triglycerides Increased (73)Crohn's Disease (58)Headache (55)LIP DRY (55)DRY Skin (54)Anxiety (54)more >>

Page last updated: 2015-08-14

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