Absorica

Name: Absorica

Proper Use of isotretinoin

This section provides information on the proper use of a number of products that contain isotretinoin. It may not be specific to Absorica. Please read with care.

Isotretinoin comes with a patient information form and Medication Guide. It is very important that you read and understand this information. Be sure to carefully follow these instructions and ask your doctor if you have any questions.

Women of reproductive age must sign up for a pregnancy risk program called iPLEDGE™ in order to receive their isotretinoin prescription each month. You can sign up on the internet (www.ipledge.com) or by telephone (1-866-495-0654). Be sure to ask your doctor if you have any questions about this program. It is very important that you understand and follow all of the requirements. You will not get another prescription unless you follow the instructions for the program.

Swallow the capsule whole with a full glass (8 ounces) of water or other liquid. Accutane® and its generic products should be taken with food. Absorica® may be taken with or without food. Do not crush, break, chew, or suck the capsule.

It is very important that you take isotretinoin only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

It is very important that you not share this medicine with anyone else because of the risk of birth defects and other serious side effects.

Absorica® oral capsules should not be substituted with other forms of isotretinoin (eg, Accutane®). Different brands may not work the same way. If you refill your medicine and it looks different, check with your pharmacist.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For acne:
      • Adults and children 12 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.5 to 1 milligram (mg) per kilogram (kg) of body weight per day, divided and given in 2 doses. Your doctor may adjust your dose as needed.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

How do I store and/or throw out Absorica?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Dosage Forms and Strengths

Absorica is available in 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg capsules.

• 10 mg: Dark yellow, opaque, capsule imprinted with black ink “G 240” on cap and “10” on the body • 20 mg: Red, opaque, capsule imprinted with black ink “G 241” on cap and “20” on the body • 25 mg: Green, opaque, capsule imprinted with white ink “G 342” on cap and “25” on the body • 30 mg: Brown, opaque, capsule imprinted with white ink “G 242” on cap and “30” on the body • 35 mg: Dark blue, opaque, capsule imprinted with white ink “G 343” on cap and “35” on the body • 40 mg: Brown and red, capsule imprinted with white ink “G 325” on cap and “40” on the body

How Supplied/Storage and Handling

Absorica (isotretinoin) Capsules are supplied as follows:

• 10 mg: Dark yellow, opaque, capsule imprinted with black ink “G 240” on cap and “10” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-115-31 • 20 mg: Red, opaque, capsule imprinted with black ink “G 241” on cap and “20” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-116-31 • 25 mg: Green, opaque, capsule imprinted with white ink “G 342” on cap and “25” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-133-31 • 30 mg: Brown, opaque, capsule imprinted with white ink “G 242” on cap and “30” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-117-31 • 35 mg: Dark blue, opaque, capsule imprinted with white ink “G 343” on cap and “35” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-134-31 • 40 mg: Brown and red, capsule imprinted with white ink “G 325” on cap and “40” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-118-31

Storage and Handling

Store at 20° C - 25° C (68° F - 77° F), excursion permitted between 15° C - 30° C (59° F - 86° F) [see USP controlled room temperature]. Protect from light.

Patient Counseling 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, and 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, and the importance of using 2 forms 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 entitled The iPLEDGE Program Guide 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 forms 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 post-marketing 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 that symptoms 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 post marketing 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)].

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Warnings

Included as part of the PRECAUTIONS section.

Manufacturer

  • Ranbaxy Laboratories Ltd.

Side Effects of Absorica

Serious side effects have been reported with Absorica. See “Absorica Precautions” section.

Common side effects of Absorica may include the following:

  • dry skin
  • chapped lips
  • dry eyes
  • back pain
  • dry nose that may lead to nosebleeds

Call your doctor if you get any side effect that bothers you or that does not go away.

Absorica Precautions

  • 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.

Absorica can cause serious side effects:

1) Birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby and early (premature) births. Female patients who are pregnant or who plan to become pregnant must not take Absorica. Female patients 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 (seeing or hearing things that are not real)
  • 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 and call your doctor 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

Other serious side effects:

  • Serious brain problems: Absorica 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 doctor right away if you get any of these signs of increased brain pressure:
    • bad headache
    • blurred vision
    • dizziness
    • nausea or vomiting
    • seizures (convulsions)
    • stroke
  • Skin problems: Skin rash can occur in patients taking Absorica. In some patients a rash can be serious. Stop using Absorica and call your doctor right away if you develop conjunctivitis (red or inflamed eyes, like “pink eye”), a rash with a fever, blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes, or if your skin begins to peel.
  • 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 doctor if you get:
    • severe stomach, chest or bowel pain.
    • trouble swallowing or painful swallowing.
    • new or worsening heartburn.
    • diarrhea.
    • rectal bleeding.
    • 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 doctor if you plan hard physical activity during treatment with Absorica. Tell your doctor if you get:
    • back pain.
    • joint pain.
    • broken bone. Tell all healthcare providers that you take Absorica if you break a bone.

    Stop Absorica and call your doctor 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 using Absorica and call your doctor 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. This condition usually clears up after you stop taking Absorica, but it may be permanent. Other serious eye effects can occur. Stop taking Absorica and call your doctor 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 while taking Absorica and after treatment.
  • 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 doctor for blood tests to check your lipids and to get any needed treatment. These problems usually go away when Absorica treatment is finished.
  • Serious allergic reactions: Stop taking Absorica and get emergency care right away if you develop hives, a swollen face or mouth or have trouble breathing. Stop taking Absorica and call your doctor if you get a fever, rash or red patches or bruises on your legs.
  • Blood sugar problems: Absorica may cause blood sugar problems including diabetes. Tell your doctor if you are very thirsty or urinate a lot.
  • Decreased red and white blood cells: Call your doctor if you have trouble breathing, faint or feel weak.

After stopping Absorica, you may also need follow-up mental health care if you had any of these symptoms.

  • Do not take Absorica if you are pregnant, plan to become pregnant or become pregnant during Absorica treatment. Absorica causes severe birth defects.
  • Do not take Absorica if you are allergic to anything in it.

Absorica Overdose

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Absorica FDA Warning

CONTRAINDICATIONS AND WARNINGS

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.
  • Acne (Pimples)
  • Microdermabrasion

Isotretinoin Identification

Substance Name

Isotretinoin

CAS Registry Number

4759-48-2

Drug Class

Dermatologic Agents

Keratolytic Agents

Retinoids

Administrative Information

LactMed Record Number

735

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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