Oraret is used to treat severe, disfiguring nodular acne. It should be used only after other acne medicines have been tried and have failed to help the acne. Oraret may also be used to treat other skin diseases as determined by your doctor.
Oraret must not be used to treat women who are able to bear children unless other forms of treatment have been tried first and have failed. Oraret must not be taken during pregnancy because it causes birth defects in humans. If you are able to bear children, it is very important that you read, understand, and follow the pregnancy warnings for Oraret.
Oraret is available only under a registered distribution program called the iPLEDGE™ program.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Oraret is used in certain patients with the following medical conditions:
Folliculitis, gram-negative (bacterial infection of the skin on the face beginning near the nose).
Hidradenitis suppurativa (sweat gland problem).
Rosacea (red skin disorder of the face, usually of the nose and cheeks).
Thickened or patchy skin disorders, such as keratosis follicularis, palmoplantar keratoderma, lamellar ichthyosis, or pityriasis rubra pilaris.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Severe Recalcitrant Nodular Acne
Oraret (isotret (isotret (Oraret capsules) inoin capsules) inoin capsules) is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use. Oraret (isotret (isotret (Oraret capsules) inoin capsules) inoin capsules) should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Oraret (isotret (isotret (Oraret capsules) inoin capsules) inoin capsules) is indicated only for those female patients who are not pregnant, because Oraret can cause severe birth defects.
A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotret (isotret (isotret (Oraret capsules) inoin capsules) inoin capsules) inoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth.
How should I use Oraret?
Use Oraret as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Oraret comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Oraret refilled.
Some brands of Oraret should be taken with food. Some brands may be taken with or without food. Ask your pharmacist if you should take your brand of Oraret with food.
Swallow the capsule with a full glass of water or other liquid. Do not break, crush, chew, or suck on the capsule before swallowing. This will help prevent the medication inside the capsule from irritating your throat.
For best results, take Oraret regularly. Taking Oraret at the same time each day will help you remember to take it.
Oraret can only be dispensed through a special program. You must sign a consent form stating that you will follow your doctor's instructions before you can take Oraret. This will be necessary each time you refill your prescription.
You will get no more than a 30-day supply of Oraret at a time to ensure you check in with your doctor each month to discuss side effects.
If you miss a dose of Oraret, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Oraret.
Uses of Oraret in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
This medication is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (e.g., benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). It belongs to a class of drugs known as retinoids. It works by decreasing facial oil (sebum) production. High amounts of sebum can lead to severe acne. If left untreated, severe acne may cause permanent scarring.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to treat a certain type of cancer (neuroblastoma).
How to use Oraret
Read the Medication Guide provided by your pharmacist before you start using Oraret and each time you get a refill. Read and sign a Patient Information/Informed Consent form before you start taking this medication. If you have any questions about Oraret, consult your doctor or pharmacist before taking the medication.
Swallow capsules whole. Do not crush or chew them. Oraret is usually taken twice daily for 15-20 weeks, or as directed by your doctor. Directions for most generic forms of Oraret state that it should be taken with meals. However, the FDA has indicated that the Oraret brand may be taken with or without food. Food helps increase absorption of this drug into your bloodstream. Ask your doctor or pharmacist for more information. Take this drug with a full glass of water, and do not lie down for 10 minutes after taking it.
The dosage is based on your medical condition, weight, and response to treatment.
Your acne may worsen during the first few days of taking this drug, and it may take up to 1-2 months before you notice the full benefit of this medication. If severe acne returns, a second course of treatment may be started after you have stopped taking the drug for 2 months. The manufacturer does not recommend long-term use of Oraret. Do not take more than the recommended dose.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.
Oraret is a medication used for the treatment of severe acne. It is sometimes used in prevention of certain skin cancers. It is a retinoid, meaning it derives from vitamin A and is found in small quantities naturally in the body. Oraret binds to and activates nuclear retinoic acid receptors (RAR), thereby regulating cell proliferation and differentiation. This agent also exhibits immunomodulatory and anti-inflammatory responses and inhibits ornithine decarboxylase, thereby decreasing polyamine synthesis and keratinization.
Oraret (Oraret) should be administered with a meal.
The recommended dosage range for Oraret (Oraret) is 0.5 to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1.0 mg/kg/day, it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects — some of which may be dose related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2.0 mg/kg/day, as tolerated. Failure to take Oraret (Oraret) with food will significantly decrease absorption. Before upward dose adjustments are made, the patients should be questioned about their compliance with food instructions.
The safety of once daily dosing with Oraret (Oraret) has not been established. Once daily dosing is not recommended.
If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of Oraret (Oraret), even in low doses, has not been studied, and is not recommended. It is important that Oraret (Oraret) be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Oraret on bone loss is unknown.
Contraceptive measures must be followed for any subsequent course of therapy.
Table 4 : Oraret (Oraret) Dosing by Body Weight (Based on Administration With Food)
*See DOSAGE AND ADMINISTRATION: the recommended dosage range is 0.5 to 1.0 mg/kg/day.
Store at controlled room temperature (59° to 86°F, 15° to 30°C). Protect from light.
1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 13-cis-retinoic acid. N Engl J Med 300:329-333, 1979.
2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991.
3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne with 13-cis-retinoic acid: evaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980.
4. Jones H, Blanc D, Cunliffe WJ. 13-cisretinoic acid and acne. Lancet 2:1048-1049, 1980.
8. Strauss JS, Rapini RP, Shalita AR, et al. Oraret therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.
Distributed by: Roche Laboratories Inc., 340 Kingsland Street, Nutley, New Jersey 07110-1199. PI Revised: January 2010.
Vitamin A: Because of the relationship of Oraret (Oraret) to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects.
Tetracyclines: Concomitant treatment with Oraret (Oraret) and tetracyclines should be avoided because Oraret (Oraret) use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines.
Micro-dosed Progesterone Preparations: Micro-dosed progesterone preparations (“minipills” that do not contain an estrogen) may be an inadequate method of contraception during Oraret (Oraret) therapy. Although other hormonal contraceptives are highly effective, there have been reports of pregnancy from female patients who have used combined oral contraceptives, as well as transdermal patch/injectable/implantable/vaginal ring hormonal birth control products. These reports are more frequent for female patients who use only a single method of contraception. It is not known if hormonal contraceptives differ in their effectiveness when used with Oraret (Oraret). Therefore, it is critically important for female patients of childbearing potential to select and commit to use 2 forms of effective contraception simultaneously, at least 1 of which must be a primary form.
Norethindrone/ethinyl estradiol: In a study of 31 premenopausal female patients with severe recalcitrant nodular acne receiving OrthoNovum® 7/7/7 Tablets as an oral contraceptive agent, Oraret (Oraret) at the recommended dose of 1 mg/kg/day, did not induce clinically relevant changes in the pharmacokinetics of ethinyl estradiol and norethindrone and in the serum levels of progesterone, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Prescribers are advised to consult the package insert of medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products.
St. John's Wort: Oraret (Oraret) use is associated with depression in some patients. Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John's Wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John's Wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John's Wort.
Phenytoin: Oraret (Oraret) has not been shown to alter the pharmacokinetics of phenytoin in a study in seven healthy volunteers. These results are consistent with the in vitro finding that neither Oraret nor its metabolites induce or inhibit the activity of the CYP 2C9 human hepatic P450 enzyme. Phenytoin is known to cause osteomalacia. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between phenytoin and Oraret (Oraret). Therefore, caution should be exercised when using these drugs together.
Systemic Corticosteroids: Systemic corticosteroids are known to cause osteoporosis. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between systemic corticosteroids and Oraret (Oraret). Therefore, caution should be exercised when using these drugs together.
Female patients of childbearing potential must have had two negative urine or serum pregnancy tests with a sensitivity of at least 25 mIU/mL before receiving the initial Oraret (Oraret) prescription. The first test (a screening test) is obtained by the prescriber when the decision is made to pursue qualification of the patient for Oraret (Oraret). The second pregnancy test (a confirmation test) must be done in a CLIA-certified laboratory. The interval between the two tests must be at least 19 days.
For patients with regular menstrual cycles, the second pregnancy test must be done during the first 5 days of the menstrual period immediately preceding the beginning of Oraret (Oraret) therapy and after the patient has used 2 forms of contraception for 1 month.
For patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding, the second pregnancy test must be done immediately preceding the beginning of Oraret (Oraret) therapy and after the patient has used 2 forms of contraception for 1 month.
Each month of therapy, patients must have a negative result from a urine or serum pregnancy test. A pregnancy test must be repeated each month, in a CLIA-certified laboratory, prior to the female patient receiving each prescription.
Lipids: Pretreatment and follow-up blood lipids should be obtained under fasting conditions. After consumption of alcohol, at least 36 hours should elapse before these determinations are made. It is recommended that these tests be performed at weekly or biweekly intervals until the lipid response to Oraret (Oraret) is established. The incidence of hypertriglyceridemia is 1 patient in 4 on Oraret therapy.
Liver Function Tests: Since elevations of liver enzymes have been observed during clinical trials, and hepatitis has been reported, pretreatment and follow-up liver function tests should be performed at weekly or biweekly intervals until the response to Oraret has been established.
Glucose: Some patients receiving Oraret (Oraret) have experienced problems in the control of their blood sugar. In addition, new cases of diabetes have been diagnosed during Oraret (Oraret) therapy, although no causal relationship has been established.
CPK: Some patients undergoing vigorous physical activity while on Oraret (Oraret) therapy have experienced elevated CPK levels; however, the clinical significance is unknown. There have been rare postmarketing reports of rhabdomyolysis, some associated with strenuous physical activity. In a clinical trial of 217 pediatric patients (12 to 17 years) with severe recalcitrant nodular acne, transient elevations in CPK were observed in 12% of patients, including those undergoing strenuous physical activity in association with reported musculoskeletal adverse events such as back pain, arthralgia, limb injury, or muscle sprain. In these patients, approximately half of the CPK elevations returned to normal within 2 weeks and half returned to normal within 4 weeks. No cases of rhabdomyolysis were reported in this trial.
7. Dicken CH, Connolly SM. Eruptive xanthomas associated with Oraret (13-cis-retinoic acid). Arch Dermatol 116:951-952, 1980.
The following adverse reactions with Oraret or other Oraret products are described in more detail in other sections of the labeling:
Serious Skin Reactions
Inflammatory Bowel Disease
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Oraret cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.
The adverse reactions listed below reflect both clinical experience with Oraret, and consider other adverse reactions that are known from clinical trials and the post-marketing surveillance with oral Oraret. The relationship of some of these events to Oraret therapy is unknown. Many of the side effects and adverse events seen in patients receiving Oraret are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, e.g., of the lips, nasal passage, and eyes).
Cheilitis and hypertriglyceridemia are adverse reactions that are usually dose related. Most adverse reactions reported in clinical trials with Oraret were reversible when therapy was discontinued; however, some persisted after cessation of therapy.
Body as a Whole
The following adverse reactions have been reported in a clinical trial conducted with Oraret and a generic product of Oraret® (Oraret): fatigue, irritability, pain. In addition to the above adverse reactions, the following adverse reactions have been reported with Oraret: allergic reactions, including vasculitis, systemic hypersensitivity, edema, lymphadenopathy, weight loss.
The following adverse reactions have been reported with Oraret: vascular thrombotic disease, stroke, palpitation, tachycardia.
Endocrine/Metabolism and Nutritional
The following adverse reactions have been reported in a clinical trial conducted with Oraret and a generic product of Oraret® (Oraret): decreased appetite, weight fluctuation, hyperlipidaemia. In addition to the above adverse reactions, the following adverse reactions have been reported with Oraret: hypertriglyceridemia, alterations in blood sugar.
The following adverse reactions have been reported in a clinical trial conducted with Oraret and a generic product of Oraret® (Oraret): lip dry, chapped lips, cheilitis, nausea, constipation, diarrhea, abdominal pain, vomiting. In addition to the above adverse reactions, the following adverse reactions have been reported with Oraret: inflammatory bowel disease, hepatitis, pancreatitis, bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, and other nonspecific gastrointestinal symptoms.
The following adverse reactions have been reported with Oraret: allergic reactions, anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis.
Infections and infestations
The following adverse reactions have been reported in a clinical trial conducted with Oraret and a generic product of Oraret® (Oraret): nasopharyngitis, hordeolum, upper respiratory tract infection. In addition to the above adverse reactions, the following adverse reaction has been reported with Oraret: infections (including disseminated herpes simplex).
The following changes in laboratory tests have been noted in a clinical trial conducted with Oraret and a generic product of Oraret® (Oraret): blood creatine phosphokinase (CPK) increased, blood triglycerides increased, alanine aminotransferase (SGPT) increased, aspartate aminotransferase (SGOT) increased, gamma-glutamyltransferase (GGTP) increased, blood cholesterol increased, low density lipoprotein (LDL) increased, white blood cell count decreased, blood alkaline phosphatase increased, blood bilirubin increased, blood glucose increased, high density lipopoprotein (HDL) decreased, bone mineral density decreased. In addition to the above adverse reactions, the following adverse reactions have been reported with Oraret: increased LDH, elevation of fasting blood sugar, hyperuricemia, decreases in red blood cell parameters, decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis), elevated sedimentation rates, elevated platelet counts, thrombocytopenia, white cells in the urine, proteinuria, microscopic or gross hematuria.
Musculoskeletal and Connective Tissue
The following adverse reactions have been reported in a clinical trial conducted with Oraret and a generic product of Oraret® (Oraret): decreases in bone mineral density, musculoskeletal symptoms (sometimes severe) including back pain, athralgia, musculoskeletal discomfort, musculoskeletal pain, neck pain, pain in extremity, myalgia, musculoskeletal stiffness. In addition to the above adverse reactions, the following adverse reactions have been reported with Oraret: skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, tendonitis, arthritis, transient pain in the chest, and rare reports of rhabdomyolysis.
The following adverse reactions have been reported in a clinical trial conducted with Oraret and a generic product of Oraret® (Oraret): headache, syncope. In addition to the above adverse reactions, other adverse reactions reported with Oraret include: pseudotumor cerebri, dizziness, drowsiness, lethargy, malaise, nervousness, paresthesias, seizures, stroke, weakness.
The following adverse reactions have been reported in clinical trials conducted with Oraret and a generic product of Oraret® (Oraret): suicidal ideation, insomnia, anxiety, depression, irritability, panic attack, anger, euphoria, violent behaviors, emotional instability. In addition to the above adverse reactions, the following adverse reactions have been reported with Oraret: suicide attempts, suicide, aggression, psychosis and hallucination auditory. Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.
The following adverse reaction has been reported with Oraret: abnormal menses.
The following adverse reactions have been reported in a clinical trial conducted with Oraret and a generic product of Oraret® (Oraret): epistaxis, nasal dryness. In addition to the above adverse reactions, the following adverse reactions have been reported with Oraret: bronchospasms (with or without a history of asthma), respiratory infection, voice alteration.
Skin and Subcutaneous Tissue
The following adverse reactions have been reported in a clinical trial conducted with Oraret and a generic product of Oraret® (Oraret): dry skin, dermatitis, eczema, rash, dermatitis contact, alopecia, pruritus, sunburn, erythema. In addition to the above adverse reactions, the following adverse reactions have been reported with Oraret: acne fulminans, alopecia (which in some cases persists), bruising, dry nose, eruptive xanthomas, erythema multiforme, flushing, fragility of skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson syndrome, sunburn susceptibility increased, sweating, toxic epidermal necrolysis, urticaria, vasculitis (including Wegener's granulomatosis), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting).
Hearing: The following adverse reactions have been reported with Oraret: tinnitus and hearing impairment.
Ocular: The following adverse reactions have been reported in clinical trials conducted with Oraret and a generic product of Oraret® (Oraret): dry eye, visual acuity reduced, vision blurred, eye pruritis, eye irritation, asthenopia, decreased night vision, ocular hyperemia, increased lacrimation, and conjunctivitis. In addition to the above adverse reactions, the following adverse reactions have been reported with Oraret: corneal opacities, decreased night vision which may persist, cataracts, color vision disorder, conjunctivitis, eyelid inflammation, keratitis, optic neuritis, photobia, visual disturbances.
Renal and Urinary
The following adverse reactions have been reported in clinical trials conducted with Oraret: glomerulonephritis, nonspecific urogenital findings.
Hypersensitivity to Oraret or to any of the excipients of Oraret. Hepatic or renal insufficiency; hypervitaminosis A; patients with excessively elevated blood lipid values.
Use in pregnancy: Pregnancy Category X: Oraret is highly teratogenic. It is, therefore, contraindicated not only in women who are pregnant or who may become pregnant while undergoing treatment but also in all women of childbearing potential. There is an extremely high risk that a deformed infant will result if pregnancy occurs while taking Oraret in any amount even for short periods. Potentially all exposed foetuses can be affected.
Oraret is contraindicated in women of childbearing potential unless the female patient meets all of the following conditions: Severe disfiguring cystic acne resistant to standard therapies; reliability in understanding and carrying out instructions; compliance with the mandatory contraceptive measures; informed by the physician of the hazards of becoming pregnant during and 1 month after treatment with Oraret and warned of the possibility of contraceptive failure; confirms that patient has understood the warnings; negative pregnancy test within 2 weeks prior to beginning therapy, monthly repetition of pregnancy testing is recommended; use effective contraception without any interruption for at least 1 month before beginning Oraret therapy, during therapy and for 1 month following discontinuation of therapy. At least 1 and preferably 2 complementary forms of contraception including a barrier method should be used. Microdosed progesterone preparations (minipills) may be an inadequate method of contraception during Oraret therapy. If the patient starts Oraret therapy only on the 2nd or 3rd day of the next menstrual period; in the event of relapse treatments, patient must also use the same uninterrupted and effective contraceptive measures 1 month prior to, during and for 1 month after Oraret therapy; must fully understand the precautions and confirm patient understanding and willingness to comply with reliable contraceptive measures as explained.
Even female patients, who normally do not employ contraception because of a history of infertility, should be advised to do so while taking Oraret, following the previously stated guidelines.
Should pregnancy occur inspite of these precautions during treatment with Oraret or in the month following, there is a great risk of very severe malformation of the foetus (involving in particular the central nervous system, heart and large blood vessels). If pregnancy does occur, the physician and patient should discuss the advisability of continuing the pregnancy.
Major human foetal abnormalities related to Oraret administration have been documented, including hydrocephalus, microcephalus, abnormalities of the external ear (micropinna, small or absent external auditory canals), microphthalmia, cardiovascular abnormalities, facial dysmorphia, thymus gland abnormalities, parathyroid hormone deficiency and cerebellar malformation. There is also an increased risk of spontaneous abortion.
Oraret is highly teratogenic and must not be given to women who are pregnant. Oraret crosses the placental barrier in amounts that lead to congenital deformities. There is an extremely high risk that a deformed infant will result if pregnancy occurs while taking Oraret in any amount even for short periods. Potentially all exposed foetuses can be affected.
DailyMed. "ISOTRETINOIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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