Helping patients reach their isotretinoin goal.

INFORMATION FOR ABSORICA®:

INDICATIONS AND USAGE

ABSORICA is a retinoid indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, means "many" as opposed to "few or several" nodules. Because of significant adverse reactions associated with its use, ABSORICA should be reserved for patients with multiple severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, ABSORICA is indicated only for those female patients who are not pregnant, because ABSORICA can cause severe birth defects.


Limitations of Use: 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. 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 with isotretinoin has shown that patients may continue to improve following treatment with isotretinoin. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. ABSORICA is available only through the iPLEDGE™ program, in which prescribers, patients, pharmacies, and distributors must enroll.


Rx only

IMPORTANT SAFETY INFORMATION

Special Prescribing Requirements

  • Because of the risk of teratogenicity and to minimize fetal exposure, ABSORICA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called iPLEDGE™. Under the ABSORICA REMS, prescribers, patients, pharmacies, and distributors must enroll and be registered in the program.

ADVERSE REACTIONS

  • Most common adverse reactions (incidence ≥5%) are: lip dry, dry skin, back pain, dry eye, arthralgia, epistaxis, headache, nasopharyngitis, chapped lips, dermatitis, blood creatine kinase increased, cheilitis, musculoskeletal discomfort, upper respiratory tract infection, visual acuity reduced.

Please see full Prescribing Information for Boxed WARNING, Contraindications, and other important Warnings and Precautions.

PARENTS/PATIENTS SHOULD BE REMINDED TO READ THE MEDICATION GUIDE


The information presented in this website is intended for healthcare professionals only.
If you are a healthcare professional, please verify by checking the box and clicking the button below.

I have read and fully understand the safety information.

If you are not a healthcare professional, please ask your healthcare provider about ABSORICA isotretinoin capsules.


If you experience any Adverse Events you are encouraged to report them to the Drug Safety Department at 1-800-406-7984 or email Drug.Safety@ranbaxy.com. You can also report to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Copyright © 2017 Ranbaxy Laboratories Inc, a SUN PHARMA company.
ABSORICA is a trademark of Ranbaxy Laboratories Inc. All other trademarks are property of their respective owners.