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Taking ABSORICA

Before taking ABSORICA

Tell your Dermatology Healthcare Specialist if you or a family member has any of the following health conditions:

  • Mental problems, asthma, liver disease, diabetes, heart disease, bone loss (osteoporosis) or weak bones, an eating problem called anorexia nervosa (where people eat too little), and food or medicine allergies

Tell your Dermatology Healthcare Specialist if you are pregnant or breastfeeding. ABSORICA isotretinoin capsules must not be used by women who are pregnant or breastfeeding.

Tell your Dermatology Healthcare Specialist about all of the medications you take, including prescription and non-prescription medications, vitamins, and herbal supplements. ABSORICA isotretinoin capsules and certain other medications can interact with each other, sometimes causing serious side effects. Especially tell your prescriber if you take:

  • Vitamin A supplements
  • Tetracycline antibiotics
  • Progestin-only birth control pills (mini-pills)
  • Dilantin (phenytoin)
  • Corticosteroid medicines
  • St. John's wort

These medications should not be used with ABSORICA isotretinoin capsules, unless your prescriber tells you it is okay. Know the medications you take. Keep a list of them to show to your prescriber and pharmacist. Do not take any new medication without talking with your prescriber.

There are also some important things you need to avoid while taking ABSORICA that you should be aware of:

  • Do not get pregnant while taking ABSORICA and for 1 month after stopping treatment.
  • Do not breastfeed while taking ABSORICA and for 1 month after stopping treatment.
    • It is not known if ABSORICA can pass through breast milk and harm a baby.
  • Do not donate blood while taking ABSORICA and for 1 month after stopping treatment.
    • If a pregnant woman gets your donated blood, her baby may be exposed to ABSORICA and may be born with birth defects.
  • Do not take other medications or herbal supplements while taking ABSORICA, unless allowed to by your prescriber.
  • Do not drive at night until you know if ABSORICA has affected your vision.
    • ABSORICA may decrease your ability to see in the dark.
  • Avoid sunlight and ultraviolet light as much as possible.
    • Tanning machines use ultraviolet light. ABSORICA may make your skin more sensitive to light.
  • Do not share ABSORICA with other people.
    • It can cause birth defects and other serious health problems.
    • Each treatment is individualized for each patient, as determined by a licensed prescriber.

Starting on ABSORICA

You will receive no more than a 30-day supply of ABSORICA isotretinoin capsules at a time. This is to make sure you are following the iPLEDGE™ Program requirements. The dose of ABSORICA that you will take has been specifically chosen for you by your prescriber. The amount of medicine you need is based on your weight and other factors. It is recommended that ABSORICA be taken twice a day, but only your prescriber can decide the right dosing for you. To help you stay on track, the PARTNERx SHIP® Program will deliver your ABSORICA medication free of charge. Get details >

ABSORICA is recommended in two divided doses. The capsules should be swallowed whole with a full glass of liquid. Do not chew or suck on the capsules. ABSORICA can hurt the tube that connects your mouth to your stomach (esophagus) if it is not swallowed whole. IF YOU MISS A DOSE, JUST SKIP THAT DOSE. Do not take 2 doses at the same time. If you take too much ABSORICA, or overdose, call your prescriber or the poison control center right away. The usual length of treatment is 15 to 20 weeks.

With ABSORICA, you don't have to change your usual eating style. While taking ABSORICA, you can eat healthy foods, such as foods with little added fat. You also don't have to time your meals with your medication, since ABSORICA can be taken with or without food. How is ABSORICA different? >

Important instructions while taking ABSORICA

During treatment with ABSORICA isotretinoin capsules and for at least 6 months after treatment:

  • Do not have cosmetic procedures to smooth your skin.
    • This includes waxing, dermabrasion and laser procedures.
    • ABSORICA can increase your chance of scarring from these procedures. Check with your Dermatology Healthcare Specialist for advice about when you can have cosmetic procedures.

Before prescribing you ABSORICA, your Dermatology Healthcare Specialist will explain the requirements of the iPLEDGE Program to you and have you sign the Patient Information/Informed Consent form. Female patients who can get pregnant, must also sign another consent form. You will not be prescribed ABSORICA if you cannot agree to follow all the requirements of the iPLEDGE Program. Be sure to ask your Dermatology Healthcare Specialist any questions you may have. Get a 101 on the iPLEDGE Program >

Pregnancy prevention

This information applies to patients who are able to get pregnant. This includes:

  • Women who have menstrual periods.
  • Young women who have not started having menstrual periods.
  • Women who have had a tubal sterilization (women who have had their tubes tied can still get pregnant).

This information does not apply to the following patients:

  • Males.
  • Women who have stopped having periods for 12 months in a row (menopause) and are confirmed by a prescriber as being in menopause.
  • Women who have had their ovaries or uterus removed by surgery

Because ABSORICA isotretinoin capsules can cause birth defects.

It is critical for female patients not to get pregnant while taking ABSORICA. Abstinence means that you will not have sex or sexual contact with any male for 24 hours a day, 7 days a week. This may be difficult to do, especially if you are used to having sex. If you cannot commit to continuous abstinence from sex with a male, you should use 2 forms of effective birth control while you are taking ABSORICA and for 1 month after finishing your therapy.

Each month of your therapy with ABSORICA isotretinoin capsules:

  • Continue using 2 forms of effective birth control together.
  • Get a pregnancy test performed at a CLIA-certified laboratory. The test results must be negative.
  • Get a prescription from your prescriber for your next 30-day supply of ABSORICA.
  • Answer questions to show that you understand the iPLEDGE Program and pregnancy prevention.
  • Begin your next 30-day prescription of ABSORICA and make sure to schedule your next appointment. Take ABSORICA exactly as prescribed. IF YOU MISS A DOSE, SKIP IT. DO NOT TAKE 2 DOSES TOGETHER.

After your final prescription is finished:

  • Get a pregnancy test administered by your prescriber.
  • Answer questions to show that you understand the iPLEDGE Program and pregnancy prevention.
  • Continue using 2 forms of effective birth control together for 30 more days.
  • Get a final pregnancy test administered by your prescriber 30 days after your last dose of ABSORICA.
  • DO NOT donate blood for 1 month after your last dose of ABSORICA.

Staying on ABSORICA

To have the best chance for treatment success, it's important to take your ABSORICA exactly as prescribed for as long as your Dermatology Healthcare Specialist instructs you to. It's also important to follow the requirements of the iPLEDGE Program. Contact the PARTNERx SHIP Program > for ongoing support during your treatment and for a dedicated Case Manager to answer your questions and help you stay on track with your prescription.

There is a lot to remember when taking your treatment. Try your best to be patient, organized, and committed to your ABSORICA treatment plan. Lean on your family and friends to help you stick with it. Think of it as a commitment to yourself: taking acne control into your own hands and managing your overall health.

Start the conversation

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

See Real Results

View Before & Afters to see the real difference ABSORICA can make.

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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.

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.