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 * DOSING
 * ACCESS
 * LD DIFFERENCE
   * LONG-LASTING CLEARANCE
   * NO MEAL REQUIREMENTS
   * 2X ABSORPTION
   * REAL RESULTS

 * Important Safety Information
 * Prescribing Information
 * Medication Guide
 * iPLEDGE®
 * Contact
 * Patient Site




PHARMACY FINDER





IMPORTANT SAFETY INFORMATION

WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY

ABSORICA LD can cause severe life-threatening birth defects and is
contraindicated in pregnancy. There is an extremely high risk that severe birth
defects will result if pregnancy occurs while taking any amount of ABSORICA LD
even for short periods of time. Potentially any fetus exposed during pregnancy
can be affected. There are no accurate means of determining prenatally whether
an exposed fetus has been affected. If pregnancy occurs, discontinue ABSORICA LD
immediately and refer the patient to an Obstetrician-Gynecologist experienced in
reproductive toxicity for further evaluation and counseling.

Because of the risk of embryo-fetal toxicity, ABSORICA LD is available only
through a restricted program under a Risk Evaluation and Mitigation Strategy
(REMS) called the iPLEDGE® REMS.

INDICATIONS AND USAGE

ABSORICA LD (isotretinoin) capsules is indicated for the treatment of severe
recalcitrant nodular acne in non-pregnant patients 12 years of age and older
with multiple inflammatory nodules with a diameter of 5 mm or greater. Because
of significant adverse reactions associated with its use, ABSORICA LD is
reserved for patients with severe nodular acne who are unresponsive to
conventional therapy, including systemic antibiotics.

Limitations of Use:

If a second course of ABSORICA LD therapy is needed, it is not recommended
before a two-month waiting period because the patient’s acne may continue to
improve following a 15 to 20-week course of therapy.

CONTRAINDICATIONS

Pregnancy: ABSORICA LD is contraindicated in pregnancy.

Hypersensitivity: ABSORICA LD is contraindicated in patients with
hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to
isotretinoin) or to any of its components (anaphylaxis and other allergic
reactions have occurred).

WARNINGS AND PRECAUTIONS

ABSORICA and ABSORICA LD are Not Substitutable: The bioavailability and the
recommended dosage of ABSORICA and ABSORICA LD are different. For example, while
ABSORICA and ABSORICA LD both have a 20 mg strength, these strengths have
different bioavailability and are not substitutable.

Psychiatric Disorders: ABSORICA LD may cause depression, psychosis and, rarely,
suicidal ideation, suicide attempts, suicide, and aggressive and/or violent
behaviors. Prior to and during therapy, assess for these conditions.

Patients should immediately stop ABSORICA LD and promptly contact their
prescriber if they develop depression, mood disturbance, psychosis, or
aggression. Discontinuation of ABSORICA LD may be insufficient; further
evaluation may be necessary such as a referral to a mental healthcare
professional.

Intracranial Hypertension (Pseudotumor Cerebri): Isotretinoin use has been
associated with cases of intracranial hypertension (pseudotumor cerebri), some
of which involved concomitant use of tetracyclines. Concomitant treatment with
tetracyclines should therefore be avoided with ABSORICA LD use.

Serious Skin Reactions: There have been postmarketing 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, life-threatening events,
hospitalization, or disability. Patients should be monitored closely for severe
skin reactions, and ABSORICA LD should be discontinued if they occur.

Acute Pancreatitis: Acute pancreatitis has been reported with isotretinoin use
in patients with either elevated or normal serum triglyceride levels. In rare
instances, fatal hemorrhagic pancreatitis has been reported. If symptoms of
pancreatitis occur, the patient should discontinue ABSORICA LD and seek medical
attention.

Lipid Abnormalities: Elevations of serum triglycerides above 800 mg/dL have been
reported with isotretinoin use. These lipid changes were reversible upon
isotretinoin capsule cessation. Some patients have been able to reverse
triglyceride elevation by reduction in weight and restriction of dietary fat and
alcohol while continuing isotretinoin or through dosage reduction. The
cardiovascular consequences of hypertriglyceridemia associated with isotretinoin
are unknown.

Hearing Impairment: Impaired hearing has been reported in patients taking
isotretinoin; in some cases, the impairment has been reported to persist after
therapy has been discontinued. Mechanism(s) and causality for this reaction have
not been established. Patients who experience tinnitus or hearing impairment
should discontinue ABSORICA LD treatment and be referred for specialized care
for further evaluation.

Hepatotoxicity: Clinical hepatitis has been reported with isotretinoin use.
Additionally, mild to moderate elevations of liver enzymes have been observed in
approximately 15% of individuals treated during clinical trials with
isotretinoin capsules, some of which normalized with dosage reduction or
continued administration of the drug. If normalization does not readily occur or
if hepatitis is suspected during treatment, ABSORICA LD should be 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. Patients experiencing
abdominal pain, rectal bleeding or severe diarrhea should discontinue ABSORICA
LD immediately.

Musculoskeletal Abnormalities: Effects of multiple courses of isotretinoin on
the developing musculoskeletal system are unknown. There is some evidence that
long-term, high-dose, or multiple courses of therapy with isotretinoin have more
of an effect than a single course of therapy on the musculoskeletal system. It
is important that ABSORICA LD be given at the recommended dose for no longer
than the recommended duration.

Ocular Abnormalities: Visual problems should be carefully monitored. If visual
difficulties occur, the patient should discontinue ABSORICA LD treatment and
obtain an ophthalmological examination.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥ 5%) are: dry lips, dry skin, back
pain, dry eye, arthralgia, epistaxis, headache, nasopharyngitis, chapped lips,
dermatitis, increased creatine kinase, cheilitis, musculoskeletal discomfort,
upper respiratory tract infection, reduced visual acuity.

DRUG INTERACTIONS

Vitamin A: ABSORICA LD is closely related to vitamin A. Therefore, the use of
both vitamin A and ABSORICA LD at the same time may lead to vitamin A related
adverse reactions. Patients treated with ABSORICA LD should be advised against
taking supplements containing Vitamin A to avoid additive toxic effects.

Tetracyclines: Concomitant treatment with ABSORICA LD and tetracyclines should
be avoided because isotretinoin use has been associated with a number of cases
of intracranial hypertension (pseudotumor cerebri), some of which involved
concomitant use of tetracyclines.

USE IN SPECIFIC POPULATIONS

There are no data on the presence of isotretinoin in either animal or human
milk, the effects on the breastfed infant, or the effects on milk production.
Because of the potential for serious adverse reactions in nursing infants from
isotretinoin, advise patients that breastfeeding is not recommended during
treatment with ABSORICA LD, and for at least 8 days after the last dose of
ABSORICA LD.

These are not all of the possible side effects of ABSORICA LD. Call your doctor
for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088 or Sun Pharmaceutical Industries, Inc. at 1-800-818-4555.

Please see full Prescribing Information for Boxed Warning, Contraindications,
and other important Warnings and Precautions.

References:


 1. ABSORICA/ABSORICA LD [prescribing Information]. Cranbury, NJ: Sun
    Pharmaceutical Industries, Inc.; November 2019.




This site is intended for US residents only.
ABSORICA and ABSORICA LD are trademarks of Sun Pharmaceutical Industries, Inc.
All other trademarks are property of their respective owners.
©2023 Sun Dermatology, a division of Sun Pharmaceutical Industries, Inc.
All rights reserved. PM-US-ABD-0483 04/23

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