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Important Safety Information
Rx only

IMPORTANT SAFETY INFORMATION

WARNING: CAUSES BIRTH DEFECTS

Causes Birth Defects

Pregnancy Category X

  • ABSORICA must not be used by female patients who are or may become pregnant.
  • There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking ABSORICA in any amount, even for short periods of time.
  • Potentially any fetus exposed during pregnancy can be affected.
  • There are no accurate means of determining whether an exposed fetus has been affected.
  • Birth defects which have been documented following isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion and premature births have been reported.
  • Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain abnormalities previously noted.
  • If pregnancy does occur during the treatment of a female patient who is taking ABSORICA, ABSORICA must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.

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.

For more information, please see Patient Information (Section 17.1) at the end of the full Prescribing Information.

PLEASE SEE FULL PRESCRIBING INFORMATION FOR BOXED WARNING, CONTRAINDICATIONS, AND OTHER IMPORTANT WARNINGS AND PRECAUTIONS.

PATIENTS, PARENTS/LEGAL GUARDIANS OF MINORS SHOULD READ THE MEDICATION GUIDE.

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

Reference: 1. ABSORICA [prescribing information]. Jacksonville, FL: Ranbaxy Laboratories Inc; September 2015. 2. ABSORICA Medication Guide. Jacksonville, FL: Ranbaxy Laboratories Inc.; September 2015.

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