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Safety with ABSORICA

Possible side effects

While helping to treat your acne, ABSORICA isotretinoin capsules may cause other serious side effects.

  • Your acne may get worse when you first start taking ABSORICA. This should last only a short while. Talk with your prescriber if this is a problem for you.
  • Common, less serious side effects of ABSORICA include dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Call your prescriber if you have any side effects that bother you or that do not go away.
  • People who wear contact lenses may have trouble wearing them while taking ABSORICA and for a while after therapy has stopped. Consider avoiding contact lenses during treatment.
  • ABSORICA may cause serious brain problems, skin problems, stomach area (abdomen) problems, bone and muscle problems, hearing problems, vision problems, blood sugar problems, and decreased red and white blood cells. These are not all of the possible side effects with ABSORICA. Your prescriber or pharmacist can give you more detailed information.

Decreased red and white blood cells
Call your prescriber if you have trouble breathing, if you faint, or feel weak.

Lipid (fats and cholesterol in blood) problems
ABSORICA can raise the level of fats and cholesterol in your blood. This can be a serious problem. Return to your prescriber for blood tests to check your lipid levels and to get any needed treatment. These problems associated with fats or cholesterol while taking ABSORICA usually go away when ABSORICA treatment is finished.

Blood sugar problems
ABSORICA may cause blood sugar problems, including diabetes. Tell your prescriber if you are very thirsty or urinate a lot.

Stomach area (abdomen) problems
Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking ABSORICA. Stop taking ABSORICA and call your prescriber if you have:

  • Severe stomach, chest, or bowel pain
  • Trouble swallowing or painful swallowing
  • New or worsening heartburn
  • Diarrhea
  • Bleeding from the rectum
  • Yellowing of your skin or eyes
  • Dark urine

Bone and muscle problems
ABSORICA may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your prescriber if you plan to engage in hard physical activity, including sports, during treatment with ABSORICA. Tell your prescriber if you have back pain, joint pain, or a broken bone. Tell your prescriber, or any other healthcare providers, that you take ABSORICA if you break a bone.

Stop ABSORICA treatment and call your prescriber right away if you have muscle weakness. Muscle weakness, with or without pain, can be a sign of serious muscle damage.

ABSORICA may stop long bone growth in teenagers who are still growing.

Hearing problems
Stop ABSORICA treatment and call your prescriber if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.

Vision problems
ABSORICA may affect your ability to see in the dark. Other serious eye effects can occur. Stop taking ABSORICA and call your prescriber right away if you have any problems with your vision or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them during and after ABSORICA treatment. Do not drive at night until you know if ABSORICA isotretinoin capsules have affected your vision.

ABSORICA isotretinoin capsules cause birth defects. There is a very high risk of birth defects (deformed babies) if a pregnant woman takes medication that contains isotretinoin. There are additional risks to pregnant women taking isotretinoin, including premature (early) birth, miscarriage (loss of the baby), and stillbirth (death of the baby). Female patients must not get pregnant:

  • For 1 month before starting ABSORICA
  • While taking ABSORICA
  • For 1 month after stopping ABSORICA

For female patients, stop using ABSORICA isotretinoin capsules and call your prescriber right away if you:

  • Have sex at any time without using 2 forms of effective birth control
  • Get pregnant
  • Miss your expected period

Serious mental health problems
ABSORICA may cause depression, psychosis (seeing or hearing things that are not real), and suicide. Some patients taking ABSORICA have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives, and some people have ended their own lives.

Stop ABSORICA treatment and call your prescriber right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis:

  • Start to feel sad or have crying spells.
  • Lose interest in activities you once enjoyed.
  • Sleep too much or have trouble sleeping.
  • Become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence).
  • Have a change in your appetite or body weight.
  • Have trouble concentrating.
  • Withdraw from your friends or family.
  • Feel like you have no energy.
  • Have feelings of worthlessness or guilt.
  • Start having thoughts about hurting yourself or taking your own life (suicidal thoughts).
  • Start acting on dangerous impulses.
  • Start seeing or hearing things that are not real. After stopping ABSORICA capsules, you may need follow-up mental health care if you had any of these symptoms.

Serious brain problems:
ABSORICA isotretinoin capsules can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking ABSORICA and call your prescriber right away if you have any of these signs of increased brain pressure:

  • Bad headache
  • Blurred vision
  • Dizziness
  • Nausea or vomiting
  • Seizures (convulsions)
  • Stroke
  • Skin problems

These are not all of the possible side effects with ABSORICA isotretinoin capsules. Your prescriber or pharmacist can give you more detailed information.

It's important to remember that all isotretinoins have the same potential safety issues. ABSORICA has no difference in safety profile and poses no additional risks than other isotretinoins.

How the iPLEDGE Program fits in

ABSORICA is only dispensed to patients enrolled in the iPLEDGE Program who can understand and agree to follow and carry out all Program requirements. This is required because of the potential safety issues with all isotretinoin medications. Your Dermatology Healthcare Specialist will explain the Program to you and support you along the way. Get tips to prepare for your discussion. >

You may also learn about the iPLEDGE Program online at www.ipledgeprogram.com.

Save on ABSORICA

The A-PLUS Savings Program can help insured patients save on ABSORICA. Learn more >

Start the conversation

Customize a Discussion Guide to help you prepare for your appointment with your Dermatologist.

The ABSORICA Difference

Unlike other isotretinoins, only ABSORICA can be taken with or without food so you can continue to eat as you choose. Learn more >

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.

ABSORICA is a registered trademark of Ranbaxy Laboratories Inc.
All other trademarks are property of their respective owners.

For more information please call 1-888-726-2299.