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iPLEDGE™Program

ABOUT THE iPLEDGE® PROGRAM

The iPLEDGE® program is a computer-based risk management program designed to further the public health goal to eliminate fetal exposure to isotretinoin through a special restricted distribution program approved by the FDA. You may also learn about the iPLEDGE® program online at www.ipledgeprogram.com.1,2

The program strives to ensure that:

  • No female patient starts isotretinoin therapy if pregnant
  • No female patient on isotretinoin therapy becomes pregnant

This enhanced program is a risk management program for prescribing and dispensing all isotretinoin products (brand and generic products). The iPLEDGE® program requires registration of all wholesalers distributing isotretinoin, all healthcare professionals prescribing isotretinoin, all pharmacies dispensing isotretinoin, and all patients prescribed isotretinoin. This program is designed to verify the patient's negative pregnancy test in order to approve the dispensing of the isotretinoin prescription to females of reproductive potential. The iPLEDGE® program requires that all patients meet qualification criteria and monthly program requirements. Before the patient receives his/her isotretinoin prescription each month, the prescriber must counsel the patient and document in the iPLEDGE® program that the patient has been counseled about the risks of isotretinoin.

As part of the ongoing risk management of isotretinoin products, it is crucial that Females of reproductive potential select and commit to use two forms of effective contraception simultaneously for one month before, during, and for one month after isotretinoin therapy. Females of reproductive potential must have 2 negative urine or blood (serum) pregnancy tests with a sensitivity of at least 25 mIU/ml before receiving the initial isotretinoin prescription. The first pregnancy test is a screening test and can be conducted in the prescriber's office. The second pregnancy test must be done in a CLIA-certified laboratory according to the package insert. Each month of therapy, the patient must have a negative result from a urine or blood (serum) pregnancy test conducted by a CLIA-certified laboratory prior to receiving each prescription.

Each month, the prescriber must enter the female patient's pregnancy results and the 2 forms of contraception she has been using in the iPLEDGE® program. The iPLEDGE® program verifies that all criteria have been met by the prescriber, patient, and pharmacy prior to granting the pharmacy authorization to fill and dispense isotretinoin. The pharmacist must obtain authorization from the iPLEDGE® program via the program's web site or phone system prior to dispensing each isotretinoin prescription for both male and female patients.


You are encouraged to report all side effects or Adverse Drug Events (ADEs) of prescription drugs to the FDA. Visit MedW‭atch or call 1-800-FDA-1088. You are also ‭encouraged to report side effects or ADEs to our Drug Safety Department at 1‑800‑406‑7984 or drug.safetyUSA@sunpharma‭.com (preferred) with as much information ‭as available.

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.

SUMMARY OF RISK INFORMATION FOR ABSORICA

CONTRAINDICATIONS

  • Pregnancy: Major congenital malformations, spontaneous abortions, and premature births have been documented following pregnancy exposure to isotretinoin in any amount and even for short periods of time.
  • Hypersensitivity (Anaphylactic and Other Allergic Reactions): ABSORICA is contraindicated in patients hypersensitive to ABSORICA or its components, or Vitamin A.

WARNINGS AND PRECAUTIONS

  • Teratogenicity: Major congenital malformations, spontaneous abortions, and premature births have been documented following pregnancy exposure to isotretinoin.
  • Patients must be informed not to donate blood during isotretinoin therapy and for 1 month following discontinuation because the blood may be given to a pregnant female whose fetus must not be exposed to isotretinoin.
  • Unacceptable Contraception: Micro-dosed progesterone preparations are not an acceptable method of contraception during ABSORICA therapy.
  • Psychiatric Disorders: Isotretinoin may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors. No mechanism of action has been established for these reactions. Prescribers should be alert to the warning signs of psychiatric disorders to guide patients to receive the help they need. Therefore, prior to initiation of ABSORICA therapy, patients and family members should be asked about any history of psychiatric disorder, and at each visit during therapy patients should be assessed for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation may be necessary.
  • Pseudotumor Cerebri: Isotretinoin use has been associated with cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines.Concomitant treatment with tetracyclines should therefore be avoided. Early signs and symptoms of pseudotumor cerebri include papilledema, headache, nausea and vomiting, and visual disturbances.
  • Serious Skin Reactions: There have been post-marketing reports of erythema multiforme and severe skin reactions [e.g., Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)] associated with isotretinoin use. These reactions may be serious and result in death.
  • Acute pancreatitis, rarely fatal hemorrhagic pancreatitis, in patients with either elevated or normal serum triglyceride levels.
  • Lipid Abnormalities: Elevations of serum triglycerides in excess of 800 mg/dL have been reported in patients treated with isotretinoin. Some patients taking isotretinoin have developed a decrease in high-density lipoproteins (HDL), and an increase in cholesterol levels has been reported in some patients.
  • Hearing Impairment: Impaired hearing has been reported in patients taking isotretinoin; in some cases, the hearing impairment has been reported to persist after therapy has been discontinued.
  • Inflammatory Bowel Disease: Isotretinoin has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after isotretinoin treatment has been stopped.
  • Bone Mineral Density Changes: Isotretinoin may have a negative effect on bone mineral density (BMD) in some patients. Therefore, physicians should use caution when prescribing ABSORICA to patients with a history of childhood osteoporosis conditions, osteomalacia, or other disorders of bone metabolism.
  • Skeletal Abnormalities: Back pain, arthralgias (in two trials of pediatric patients, back pain and arthralgias occurred in 29% and 22% of patients, respectively, including severe back pain and arthralgias in 13.5% and 7.6%, respectively), premature epiphyseal closure.
  • Ocular Abnormalities: Visual problems should be carefully monitored. Decreased night vision has been reported during isotretinoin therapy and in some instances the event has persisted after therapy was discontinued. Corneal opacities and dry eye have also been reported.
  • Blood lipid determinations should be performed before ABSORICA is given and then at intervals until the lipid response to ABSORICA is established, which usually occurs within 4 weeks. Especially careful consideration must be given to risk/benefit for patients who may be at high risk of triglyceridemia during ABSORICA therapy (patients with diabetes, obesity, increased alcohol intake, lipid metabolism disorder or familial history of lipid metabolism disorder).
  • Hepatotoxicity: Since elevations of liver enzymes have been observed during clinical trials, and hepatitis has been reported in patients on isotretinoin, pretreatment and follow-up liver function tests should be performed at weekly or biweekly intervals until the response to ABSORICA has been established.
  • Glucose control problems and elevated CPK levels, including rare cases of rhabdomyolysis.

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.


You are encouraged to report all side effects or Adverse Drug Events (ADEs) of prescription drugs to the FDA. Visit MedW‭atch or call 1‑800‑FDA‑1088. You are also ‭encouraged to report side effects or ADEs to our Drug Safety Department at 1‑800‑406‑7984 or drug.safetyUSA@sunpharma‭.com (preferred) with as much information ‭as available.‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬