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ABSORICA- isotretinoin capsule


  1. Patient Information
  2. What Is The Most Important Information I Should Know About Absorica?
  3. Females Must Not Get Pregnant:
  4. Who Should Not Take Absorica?
  5. Tell Your Doctor If You Or A Family Member Has Any Of The Following Health Conditions:
  6. You Must Take Absorica Exactly As Prescribed. You Must Also Follow All The Instructions Of The Ipledge Program. Before Prescribing Absorica, Your Doctor Will:
  7. What Should I Avoid While Taking Absorica?
  8. Active Ingredient:
  9. Inactive Ingredients:

Patient Information 

See FDA-Approved Patient Labeling (Medication Guide)

Advise the patient that ABSORICA is only available through a restricted program called iPLEDGE.

As a component of the iPLEDGE Program, prescribers must instruct patients to read the Medication Guide, the iPLEDGE Program patient educational booklets, theiPLEDGE Program Birth Control Information Sheetand watch the video with the following videos Be Prepared, Be Protected and Be Aware: The Risk of Pregnancy While on Isotretinoin . The video includes information about contraception, the most common reasons that contraception fails, the importance of using 2 methods of effective contraception when taking teratogenic drugs, and comprehensive information about types of potential birth defects which could occur if a female patient who is pregnant takes ABSORICA at any time during pregnancy.
Male patients and females of non-reproductive potential must understand the risks and benefits of ABSORICA, comply with the REMS requirements described in the booklet entitledGuide to Isotretinoin for Male Patients and Female Patients Who Cannot Get Pregnant, and sign a Patient Information/Informed Consent form.
Females of reproductive potential must be instructed that they must not be pregnant when ABSORICA therapy is initiated or plan to become pregnant while receiving ABSORICA therapy. Additionally, they must use 2 methods of effective contraception simultaneously for 1 month before starting ABSORICA, while taking ABSORICA, and for 1 month after ABSORICA has been stopped, unless they commit to continuous abstinence from heterosexual intercourse. They should also sign a Patient Information/Informed Consent form and Patient Information/Informed Consent About Birth Defects (for female patients who can get pregnant) form prior to beginning ABSORICA therapy. Female patients should be seen by their prescribers monthly and have a urine or serum pregnancy test, in a CLIA-certified laboratory, performed each month during treatment to confirm negative pregnancy status before another ABSORICA prescription is written. Additionally, a pregnancy test must be completed at the end of the entire course of ABSORICA therapy and 1 month after discontinuation of therapy.
Advise the patient that isotretinoin is found in the semen of male patients taking isotretinoin, but the amount delivered to a female partner would be about one million times lower than an oral dose of 40 mg. While the no-effect limit for isotretinoin induced embryopathy is unknown, 20 years of postmarketing reports include four with isolated defects compatible with features of retinoid exposed fetuses; however two of these reports were incomplete and two had other possible explanations for the defects observed.
Advise the patient that ABSORICA is available only from pharmacies that are certified in the iPLEDGE Program, and provide them with the telephone number (1-866-495-0654) and website (www.ipledgeprogram.com) for information on how to obtain.
Advise patients that they may be requested to participate in a survey to evaluate the effectiveness of the iPLEDGE Program.
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 treatment, patients and family members should be asked about any history of psychiatric disorder, and at each visit during treatment patients should be assessed for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation may be necessary. Inform patients thatsymptoms of depression include sad mood, hopelessness, feelings of guilt, worthlessness or helplessness, loss of pleasure or interest in activities, fatigue, difficulty concentrating, change in sleep pattern, change in weight or appetite, suicidal thoughts or attempts, restlessness, irritability, acting on dangerous impulses, and persistent physical symptoms unresponsive to treatment. Patients should stop treatment and the patient or a family member should promptly contact their prescriber if the patient develops depression, mood disturbance, psychosis, or aggression, without waiting until the next visit. Discontinuation of ABSORICA treatment may be insufficient; further evaluation may be necessary. While such monitoring may be helpful, it may not detect all patients at risk. Patients may report mental health problems or family history of psychiatric disorders. These reports should be discussed with the patient and/or the patient's family. A referral to a mental health professional may be necessary. The physician should consider whether ABSORICA therapy is appropriate in this setting; for some patients the risks may outweigh the benefits of ABSORICA therapy.
Patients must be informed that some patients, while taking isotretinoin or soon after stopping isotretinoin, have become depressed or developed other serious mental problems. Symptoms of depression include sad, anxious or empty mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. Some patients taking isotretinoin have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts), some have tried to end their own lives, and some have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on isotretinoin becoming aggressive or violent. There have also been reports of psychotic symptoms, which indicate a loss of contact with reality. Psychotic symptoms include feelings of suspiciousness toward others, strange beliefs, hearing voices or other noises without an obvious source, and seeing unusual objects or people with no explanation. No one knows if isotretinoin caused these behaviors and symptoms or if they would have happened even if the person did not take isotretinoin. If any of these behaviors or symptoms occur, the patient should stop treatment and the patient or family member should contact the prescriber promptly without waiting until the next visit[see Warnings and Precautions (5.4)]. Some people have had other signs of depression while taking isotretinoin.
Patients must be informed that they must not share ABSORICA with anyone else because of the risk of birth defects and other serious adverse reactions.
Patients must be informed not to donate blood during therapy and for 1 month following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to ABSORICA.
ABSORICA may be taken without regard to meals[see Dosage and Administration (2.1)].To decrease the risk of esophageal irritation, patients should swallow the capsules with a full glass of liquid.
Patients should be informed that inflammatory bowel disease (including regional ileitis) may occur without a prior history of intestinal disorders. In rare instances, symptoms have been reported to persist after treatment has stopped. Patients should be informed that if they experience abdominal pain, rectal bleeding or severe diarrhea, they should discontinue ABSORICA immediately.
Patients should be informed that transient exacerbation (flare) of acne has been seen, generally during the initial period of therapy.
Wax epilation and skin resurfacing procedures (such as dermabrasion, laser) should be avoided during ABSORICA therapy and for at least 6 months thereafter due to the possibility of scarring.
Patients should be advised to avoid prolonged exposure to UV rays or sunlight.
Patients should be informed that they may experience dry eye, corneal opacities, and decreased night vision. Contact lens wearers may experience decreased tolerance to contact lenses during and after therapy.
Patients should be informed that 16% of patients treated with isotretinoin in a clinical trial developed musculoskeletal symptoms (including arthralgia) during treatment. In general, these symptoms were mild to moderate, but occasionally required discontinuation of the drug. Transient pain in the chest has been reported less frequently. In the clinical trial, these symptoms generally cleared rapidly after discontinuation of therapy, but in some cases persisted.
There have been rare postmarketing reports of rhabdomyolysis, some associated with strenuous physical activity.
Pediatric patients and their caregivers should be informed that approximately 17% to 29% of pediatric patients treated with isotretinoin developed back pain. In a clinical trial, back pain was severe in 13.5% of the cases and occurred at a higher frequency in female patients than male patients. Arthralgias were experienced in 22% (79/358) of pediatric patients. Arthralgias were severe in 7.6% (6/79) of patients. Appropriate evaluation of the musculoskeletal system should be done in patients who present with these symptoms during or after a course of treatment. Consideration should be given to discontinuation of isotretinoin if any significant abnormality is found.
Neutropenia and rare cases of agranulocytosis have been reported in patients treated with isotretinoin. ABSORICA should be discontinued if clinically significant decreases in white cell counts occur.
Patients should be advised that severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported in postmarketing data in patients treated with isotretinoin. Treatment with ABSORICA should be discontinued if clinically significant skin reactions occur.
Adolescent patients who participate in sports with repetitive impact should be informed that isotretinoin use may increase their risk of spondylolisthesis or hip growth plate injuries. There are spontaneous reports of fractures and/or delayed healing in patients while on therapy with isotretinoin or following cessation of therapy with isotretinoin while involved in these activities[see Warnings and Precautions (5.12)].

ABSORICA is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

Manufactured by:
Galephar Pharmaceutical Research, Inc.
Humacao, PR 00792

Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

GK-067

Revised: May 2018

What Is The Most Important Information I Should Know About Absorica? 

ABSORICA is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
Because ABSORICA can cause birth defects, ABSORICA is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE Program.
ABSORICA may cause serious mental health problems.

1. Birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births.Females who are pregnant or who plan to become pregnant must not take ABSORICA.

Females Must Not Get Pregnant: 

for 1 month before starting ABSORICA
while taking ABSORICA
for 1 month after stopping ABSORICA

If you get pregnant while taking ABSORICA, stop taking it right away and call your doctor.Doctors and patients should report all cases of pregnancy to:

FDA MedWatch at 1-800-FDA-1088, and
The iPLEDGE Pregnancy Registry at 1-866-495-0654

2. Serious mental health problems.ABSORICA may cause:

depression
psychosis(

ABSORICA is a medicine taken by mouth to treat the most severe form of acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. ABSORICA can cause serious side effects (

Severe nodular acne is when many red, swollen, tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars.

Who Should Not Take Absorica? 

Do not take ABSORICA if you are pregnant, plan to become pregnant, or become pregnant during ABSORICA treatment.ABSORICA causes severe birth defects.

Tell Your Doctor 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)
food or medicine allergies

Tell your doctor if you are pregnant or breastfeeding. ABSORICA must not be used by females who are pregnant or breastfeeding.

Tell your doctor about all of the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements.ABSORICA and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:

Vitamin A supplements. Vitamin A in high doses has many of the same side effects as ABSORICA. Taking both together may increase your chance of getting side effects.
Tetracycline antibiotics. Tetracycline antibiotics taken with ABSORICA can increase the chances of getting increased pressure in the brain.
Progestin-only birth control pills (mini-pills). They may not work while you take ABSORICA. Ask your doctor or pharmacist if you are not sure what type you are using.
Dilantin (phenytoin). This medicine taken with ABSORICA may weaken your bones.
Corticosteroid medicines. These medicines taken with ABSORICA may weaken your bones.
St. John s Wort. This herbal supplement may make birth control pills work less effectively.

These medicines should not be used with ABSORICA unless your doctor tells you it is okay.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.

You Must Take Absorica Exactly As Prescribed. You Must Also Follow All The Instructions Of The Ipledge Program. Before Prescribing Absorica, Your Doctor Will: 

explain the iPLEDGE Program to you
have you sign the Patient Information/Informed Consent form (for all patients). Females who can get pregnant must also sign another consent form.

You will not be prescribed ABSORICA if you cannot agree to or follow all the instructions of the iPLEDGE Program.

You will get no more than a 30-day supply of ABSORICA at a time. This is to make sure you are following the ABSORICA iPLEDGE Program. You should talk with your doctor each month about side effects.
The amount of ABSORICA you take has been specially chosen for you. It is based on your body weight, and may change during treatment.
Take ABSORICA 2 times a day without regard to meals, unless your doctor tells you otherwise.Swallow your ABSORICA capsules whole with a full glass of liquid. Do not chew or suck on the capsule.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. Donottake two doses at the same time.
If you take too much ABSORICA or overdose, call your doctor or poison control center right away.
Your acne may get worse when you first start taking ABSORICA. This should last only a short while. Talk with your doctor if this is a problem for you.
You must return to your doctor as directed to make sure you don t have signs of serious side effects. Your doctor may do blood tests to check for serious side effects from ABSORICA. Females who can get pregnant will get a pregnancy test each month.
Females who can get pregnant must agree to use two separate forms of effective birth control at the same time one month before, while taking, and for one month after taking ABSORICA.You must access the iPLEDGE Program system to answer questions about the program requirements and to enter your two chosen forms of birth control.To access the iPLEDGE Program system, go towww.ipledgeprogram.comor call 1-866-495-0654.

You must talk about effective birth control forms with your doctor or go for a free visit to talk about birth control with another doctor or family planning expert. Your doctor can arrange thisfreevisit, which will be paid for by the company that makes ABSORICA.

If you have sex at any time without using two forms of effective birth control, get pregnant, or miss your expected period, stop using ABSORICA and call your doctor right away.

What Should I Avoid While Taking Absorica? 

Do not get pregnantwhile taking ABSORICA and for one month after stopping ABSORICA.

ABSORICA can cause birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births.

Store ABSORICA at room temperature, 68 F to 77 F (20 C to 25 C). Protect from light.
Keep ABSORICA and all medicines out of the reach of children.

General Information about ABSORICA

Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use ABSORICA for a condition for which it was not prescribed. Do not give ABSORICA to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about ABSORICA. If you would like more information, talk with your doctor.

You can ask your doctor or pharmacist for information about ABSORICA that is written for health care professionals. You can also call iPLEDGE Program at 1-866-495-0654 or visitwww.ipledgeprogram.com.

Active Ingredient: 

Isotretinoin, USP

Inactive Ingredients: 

Propyl gallate, sorbitan monooleate, soybean oil and stearoyl polyoxylglycerides. Gelatin capsules contain the following dye systems: 10 mg iron oxide (yellow) and titanium dioxide; 20 mg iron oxide (red) and titanium dioxide; 25 mg FD&C Blue #1, FD&C Yellow #5(tartrazine), FD&C Yellow #6 and titanium dioxide; 30 mg iron oxide (black, red and yellow) and titanium dioxide; 35 mg FD&C Blue #2, iron oxide (black, red and yellow) and titanium dioxide; and 40 mg iron oxide (black, red and yellow) and titanium dioxide.

ABSORICA is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

Manufactured by:
Galephar Pharmaceutical Research, Inc.
Humacao, PR 00792

Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

GK-244

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: May 2018



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