Adult Dosing
Severe recalcitrant nodular acne
- 0.5-1 mg/kg/day PO div bid x 15-20 wks
- Max: 2 mg/kg/day for severe disease
Notes:- On reduction of total nodule count by >70% prior to completing 15-20 wks of treatment discontinue the drug
- Initiate a second course of therapy on persistent or recurring severe nodular acne after a period of 2 months or more off therapy
- Restricted Distribution in US. Call 1-866-495-0654 or visit www.ipledgeprogram.com for more info
Pediatric Dosing
Severe recalcitrant nodular acne [Non FDA approved]
- 0.5-1 mg/kg/day PO div bid x 15-20 wks
- Max: 2 mg/kg/day for severe disease
Note:
- On reduction of total nodule count by >70% prior to completing 15-20 wks of treatment discontinue the drug
- Initiate a second course of therapy on persistent or recurring severe nodular acne after a period of 2 months or more off therapy
[Outline]
- This therapy is associated with causing depression, psychosis and, rare events of suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors
- Prescribers are advised for reading brochure for recognizing psychiatric disorders in adolescents and young adults
- Prescribers should remain alert to the warning, signs of psychiatric disorders to guide patients to receive the help they need. Prior to initiation of therapy ask patients and family members for any history of psychiatric disorder, and assess patients during each site visit for symptoms of depression, mood disturbance, psychosis, or aggression
- Discontinue this drug and advise patient or a family member to promptly contact their prescriber if the patient develops depression, mood disturbance, psychosis, or aggression, without waiting until the next visit. Discontinuation of therapy with this drug may be insufficient requiring further evaluation
- Mental health problems may occur in patients requiring referral to a mental health professional. Consider whether therapy with this drug is appropriate in this setting; for some individuals the risks may outweigh the potential benefits of isotretinoin therapy
- Therapy with this drug is associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involving concurrent use of tetracyclines. Avoid concomitant therapy with tetracyclines. Screen patients having signs and symptoms of pseudotumor cerebri for papilledema and on presence of such events immediately discontinue therapy with this drug and refer patients to a neurologist for further diagnosis and care
- Erythema multiforme and severe skin reactions [e.g. Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) has been reported on post marketing surveillance. Closely monitor patients for severe skin reactions, and discontinue therapy if warranted
- Acute pancreatitis may occur in patients with either elevated or normal serum triglyceride levels. Fatal hemorrhagic pancreatitis has also occurred in some patients. Discontinue therapy if hypertriglyceridemia cannot be controlled at an acceptable level or on occurrence of symptoms of pancreatitis
- Elevations of serum triglycerides >800 mg/dl, decrease in high-density lipoproteins, an increase in cholesterol levels have occurred in association with this drug. Perform blood lipid determinations before this drug is given and then at intervals until the lipid response is established. Carefully consider risk/benefit in patients in patients who are at high risk during duration of therapy. Conduct more frequent checks of serum values for lipids and/or blood sugar on institution of therapy
- Discontinue therapy in patients experiencing tinnitus or hearing impairment and refer them for specialized care for further evaluation
- Hepatitis, mild to moderate elevations of liver enzymes have occurred in association with this drug. On suspection of hepatitis or failure for occurrence of normalization discontinue therapy with this drug and investigate for further etiology
- Inflammatory bowel disease including regional ileitis has occurred in patients. Immediately discontinue therapy if patients experience abdominal pain, rectal bleeding or severe diarrhea
- Prolong use, high dose, or multiple courses of therapy with isotretinoin are associated with musculoskeletal effects. Decrease in lumbar spine bone mineral density and total hip bone mineral density have occurred in association with usage of this drug
- A high prevalence of skeletal hyperostosis has occurred in patients. Minimal skeletal hyperostosis and calcification of ligaments and tendons have occur in association with this drug
- Premature epiphyseal closure have occurred in acne patients receiving recommended doses of this drug
- Corneal opacities and decreased night vision have developed in patients. Carefully monitor patients for visual problems. Discontinue therapy in patients experiencing visual difficulties and refer them for ophthalmological examination
- Only pharmacist registered and activated with iPLEDGE are eligible for dispensing this drug to patients who are registered and meeting all the requirements of iPLEDGE [US Black Box Warning]
- Prescribe this drug only to female patients who are known not to be pregnant as confirmed by a negative CLIA-certified laboratory conducted pregnancy test
Cautions: Use cautiously in
Pregnancy Category:X
Breastfeeding: Information on the use of isotretinoin during breastfeeding is unavailable. Prefer agents that are less likely to be absorbed by the mother during breastfeeding, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 15 March 2011). According to manufacturer's data women who are breastfeeding should avoid use of this drug.
