EFFECTIVE DATE: JANUARY 1, 2020
“Personal Information” means information that identifies, relates to, describes, is reasonably capable of being associated with, or could reasonably be linked, directly or indirectly, with an individual or household. Aggregated or de-identified data is not considered Personal Information under the California Consumer Privacy Act of 2018 (“CCPA”).
WHAT TYPE OF PERSONAL INFORMATION DO WE COLLECT?
The Personal Information we collect falls into two categories: (1) information you voluntarily supply us when you visit our Website or otherwise interact with us; when you submit your information, such as via a contact form or as part of a transaction; when we collect your information in connection with your participation in a clinical study; and when you otherwise use our Services and (2) tracking, usage, and other information gathered as you visit our Website.
Personal Information You Provide. We obtain certain Personal Information when you provide it to us. The following Personal Information about you may be collected when you interact with us or use our Website or Services:
Identifying and contact details: Name, phone number, email, physical address, electronic signature, federal or state issued professional identification, date of birth, and demographic information (including age and gender).
Employment Information: Job title, professional experience, education, performance history, training records, income, salary, and compensation.
Household Information: Number of children and spouse.
Health Information: Physical or psychological state of health, disease state, medical history, medical treatment or diagnosis, health care provider information, prescription information, genetic information, and health insurance identification or account information.
This information may be supplied by you in response to specific questions, when you sign up for communications from us, communicate with us in person or by email, participate in our clinical studies, or use our Services. You can always refuse to supply Personal Information in response to requests, except that it may prevent you from engaging in transactions, Website-related activities or receiving responses to your inquiries or other information of interest such as our patient support programs. Information that is optional at these collection points will generally be noted and marked as such.
Passive Information. Sun Pharma may use third party analytics tools, including Google Analytics, to help us measure traffic, and usage trends by your use of our Website. These tools use various technologies, including cookies or similar technologies, to collect certain information sent by your devices to the Website, including:
Your browser name;
Demographic data about you;
The pages you visit on the Website;
Your existing applications;
Whether you have previously accessed the Website;
The IP (Internet Protocol) address for your computer;
Your mobile network information;
Navigational data, also known as log files, server logs or clickstream data; and
Anonymous IDs for advertising.
Note that these third-party service providers have their own privacy policies addressing how they use such information. To opt out of Google Analytics on the Website go to https://tools.google.com/dlpage/gaoptout.
HOW DO WE USE PERSONAL INFORMATION?
We may use your Personal Information to respond to your contact inquiries, provide you with Services you have requested and/or customer support, communicate with you about Services that may be of interest to you, and develop and improve our Services.
Additionally, we analyze Personal Information to help us determine how users access parts of the Website and who our users are. We may use Personal Information to make our Website more interesting and useful to you; for analyzing and improving the value of the material available on our Website; to increase the effectiveness of the Services we will offer to you in the future; and to help our partners and service providers, or our Website design teams, to create, serve, and track promotions our customers might like.
By using the Website or Services, or providing Personal Information to us, you agree that we may communicate with you electronically regarding security, privacy, and any administrative issues. If we learn of a security system’s breach, we may attempt to notify you electronically by posting a notice on the Website or sending an email to you. You may have a legal right to receive this notice in writing. If you have any questions or concerns, please notify us at US.Privacypolicy@sunpharma.com
HOW DO WE SHARE INFORMATION?
We may disclose to our service providers and other third parties who process your Personal Information to provide services to us or you including, without limitation, market research; fraud protection; data analysis; email management; and customer service. In some instances, these service providers and third parties may have access to Personal Information, but they are contractually obligated to maintain the confidentiality of the information and to use it only for purposes of carrying out the business of Sun Pharma. These service providers and other third parties can be classified in the following categories:
Distributors, which we use to deliver our products;
Marketing partners, which we use to send you promotional communications;
IT service providers, such as our data hosting provider and companies we employ to manage our Website and to provide Website-related services and/or to assist us in analyzing how our Website is used; and
Other service providers that we may engage to provide services to us or on our behalf.
We may disclose your Personal Information while negotiating or in relation to a change of corporate control, such as a restructuring or sale of assets.
We may share Personal Information with third parties, including but not limited to advisors, advertisers, analytics providers, and investors, for the purpose of conducting our business.
We reserve the right to disclose to third parties non-Personal Information, such as aggregated or de-identified information, for any lawful purpose.
Sun Pharma cares about the security and confidentiality of your Personal Information. We seek to maintain commercially reasonable administrative, technical, and physical security, collection, storage, and processing measures to protect against the unauthorized access, alteration, disclosure or destruction of the Personal Information you submit to us. However, no website is completely secure, error free, or “hacker proof.” You are responsible for taking reasonable steps to protect your Personal Information against unauthorized disclosure or misuse. We cannot guarantee that your use of our Website or Services will be completely safe, and we cannot ensure or warrant the security of any information you provide to us. We do not accept liability for unintentional disclosure. We are not responsible for third-party circumvention of any privacy settings or security measures.
We do not knowingly collect or store Personal Information from anyone under the age of 13 unless or except as permitted by law. ANY PERSON WHO VISITS ANY OF THE WEBSITE OR USES THE SERVICES REPRESENTS TO US THAT HE OR SHE IS 13 YEARS OF AGE OR OLDER. If we are made aware that we have received Personal Information from someone under 13, we will use reasonable efforts to remove that information from our records.
COOKIES AND DO NOT TRACK
The Website uses first party cookies (set by Sun Pharma) and third party cookies (set by web analytics partners). The cookies used on our Website may be persistent or session based. A session cookie is a piece of information that is enabled only during a particular Website session. Session cookie files are deleted after logging off the internet browser or powering off your computer. In contrast, a persistent cookie is not deleted after logging off an internet browser or powering off your computer, but “persists” between sessions. Both types of cookies provide statistical information as well as help make improvements in Website navigation.
At this time, we do not track our users’ Personal Information over time and across third-party websites. We therefore do not respond to browser Do Not Track signals. We do not knowingly permit third parties to collect Personal Information about an individual user’s online activities over time and across different websites when using our Website.
Nevada Privacy Rights
We do not sell Personal Information for monetary consideration. Nevada residents have the right to submit a verified request directing us not to sell their Personal Information. If you are a Nevada resident, and would like to submit such a request, please send your request to US.Privacypolicy@sunpharma.com
California Privacy Rights
We will provide the right to request and receive, once a year and free of charge, information about third parties to whom we have disclosed certain types of personal information (if any) about you for their direct marketing purposes in the prior calendar year, and a description of the categories of Personal Information shared. To make such a request, please send an email to US.Privacypolicy@sunpharma.com and please include the phrase "Personal Information Privacy Request" in the subject line, the domain name of the website you are inquiring about, along with your name, address and email address. At our option, we may respond to such requests by providing instructions about how our users can exercise their options to prevent our disclosure of personal information to third parties for their direct marketing purposes.
Under the CCPA, California consumers have the right to request:
the deletion of the Personal Information we have about them;
additional information about whether and how we have collected, used, disclosed, and sold Personal Information about them; and
the specific pieces of Personal Information we have about them.
California consumers also have the right not to receive discriminatory treatment if they exercise the rights list above.
You may submit a privacy rights request to us by:
Emailing us at US.Privacypolicy@sunpharma.com
When you make a request, we may require that you provide information and follow procedures so that we can verify the request and your jurisdiction before responding to it. The verification steps we take may differ depending on the request you make. We will only use the information received in a request for the purposes of responding to the request.
California law permits California consumers to use an authorized agent to make privacy rights requests. We require the authorized agent to provide us with proof of the California consumer’s written permission (for example, a power of attorney) that shows the authorized agent has the authority to submit a request for the California consumer. An authorized agent must follow the process described above to make a request. The authorized agent must also verify his/her own identity. We will confirm the agent’s authority with the California consumer about whom the request was made.
Note that certain information that is governed by the California Confidentiality of Medical Information Act (CMIA) or the Health Insurance Portability and Accountability Act of 1996, as amended and implemented (HIPAA), or is subject to the Federal Policy for the Protection of Human Subjects, also known as the Common Rule, pursuant to good clinical practice guidelines issued by the International Counsel for Harmonisation or pursuant to human subject protection requirements of the United States Food and Drug Administration, is not considered Personal Information with respect to the rights of California residents noted above. However, additional rights might be available under those laws and standards. Please contact US.Privacypolicy@sunpharma.com for more information.
Updating Your Information
To keep your Personal Information current and accurate, please contact us as specified above. If you decide to email us, please include the words “Updating Personal Information Update” in the subject line.
We will take reasonable steps to update or correct Personal Information in our possession that you have previously submitted via this Website.
Except to the extent prohibited by law, and subject to this Privacy Notice, we will retain your information for as long as needed to provide you with the Services, for Sun Pharma’s valid business purposes, and as necessary to comply with our legal obligations, resolve disputes, defend our legal rights, and enforce our agreements.
Where we process Personal Information for marketing purposes or with your consent, we process the data until you make us aware by unsubscribing to future contact. We also keep a record of the fact that you have asked us not to send you direct marketing or to process your Personal Information so that we can respect your request in the future.
Where we process Personal Information to meet legal requirements, we hold this for as long as the law requires (for example, we may hold records to help prevent fraud and other prohibited or illegal activities).
NEW USES OF PERSONAL INFORMATION
LINKS TO THIRD-PARTY WEBSITES
HOW DOES THIS POLICY APPLY OUTSIDE OF THE U.S.?
ABSORICA and 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. See additional safety information below.
ABSORICA and ABSORICA LD (isotretinoin) capsules are 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 their use, ABSORICA and ABSORICA LD are 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 or 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
IMPORTANT SAFETY INFORMATION
WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY
ABSORICA and 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 or 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 and 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 and ABSORICA LD are available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE® REMS.
Pregnancy: ABSORICA and ABSORICA LD are contraindicated in pregnancy
Hypersensitivity: ABSORICA and ABSORICA LD are 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 and 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 and ABSORICA LD and promptly contact their prescriber if they develop depression, mood disturbance, psychosis, or aggression. Discontinuation of ABSORICA and 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 and 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 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 and 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 or 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 and 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 or 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 and 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 and ABSORICA LD treatment and obtain an ophthalmological examination.
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.
Vitamin A: ABSORICA and ABSORICA LD are closely related to vitamin A. Therefore, the use of both vitamin A and ABSORICA or ABSORICA LD at the same time may lead to vitamin A related adverse reactions. Patients treated with ABSORICA and ABSORICA LD should be advised against taking supplements containing Vitamin A to avoid additive toxic effects.
Tetracyclines: Concomitant treatment with ABSORICA and 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 and ABSORICA LD, and for at least 8 days after the last dose of ABSORICA or ABSORICA LD.
These are not all of the possible side effects of ABSORICA and 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.
*ABSORICA/ABSORICA LD Clinical Statement
The effectiveness of ABSORICA/ABSORICA LD for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older has been established and is based on a double-blind, randomized, parallel-group trial in subjects with severe recalcitrant nodular acne who received ABSORICA or another isotretinoin capsule product under fed conditions. A total of 925 subjects were randomized 1:1 to receive ABSORICA or another isotretinoin capsule product. Study subjects ranged from 12 to 54 years of age (including 397 pediatric subjects aged 12 to 17 years); 60% were male, 40% were female; and the racial groups included 87% White, 4% Black, 6% Asian, and 3% Other. Enrolled subjects had a weight of 40 to 110 kg and had at least 10 nodular lesions on the face and/or trunk. Subjects were treated with an initial dose of 0.5 mg/kg/day in 2 divided doses for the first 4 weeks, followed by 1 mg/kg/day in 2 divided doses for the following 16 weeks.1 Isotretinoin with the ABSORICA formulation was the active drug in all clinical studies referenced in this piece.
1. ABSORICA/ABSORICA LD [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; October 2019. 2. Madan HK, Venkateshwaran R, Madan S, Kochar R, inventors. Low dose oral pharmaceutical composition of isotretinoin. US patent 9,750,711. September 5, 2017. 3. Madan S, Kumar S, Segal J. Comparative pharmacokinetic profiles of a novel low-dose micronized-isotretinoin 32 mg formulation and lidose-isotretinoin 40 mg in fed and fasted conditions: two open-label, randomized, crossover studies in healthy adult participants. Acta Derm Venereol. 2020;100(1-4):1-7. 4. Del Rosso JQ, Gold LS, Segal J, Zaenglein AL. An open-label, phase IV study evaluating lidose-isotretinoin administered without food in patients with severe recalcitrant nodular acne: low relapse rates observed over the 104-week post-treatment period. J Clin Aesthet Dermatol. 2019;12(11):13-18. 5. Hession MT, Graber EM. Atrophic acne scarring: a review of treatment options. J Clin Aesthet Dermatol. 2015;9(1):50-58. 6. Layton AM, Henderson CA, Cunliffe WJ. A clinical evaluation of acne scarring and its incidence. Clin Exp Dermatol. 1994;19(4):303-308. 7. Layton AM, Knaggs H, Taylor J, Cunliffe WJ. Isotretinoin for acne vulgaris—10 years later: a safe and successful treatment. Br J Dermatol. 1993;129(3):292-296. 8. Fabbrocini G, Cacciapuoti S, Monfrecola G. A qualitative investigation of the impact of acne on health-related quality of life (HRQL): development of a conceptual model. Dermatol Ther. 2018;8(1):85-99. 9. Del Rosso JQ. Face to face with oral isotretinoin: a closer look at the spectrum of therapeutic outcomes and why some patients need repeated courses. J Clin Aesthet Dermatol. 2012;5(11):17-24. 10. Claravis [prescribing information]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; April 2018. 11. Colburn WA, Gibson DM, Wiens RE, Hanigan JJ. Food increases the bioavailability of isotretinoin. J Clin Pharmacol. 1983;23(11-12):534-539. 12. Guidance for industry: Food-effect bioavailability and fed bioequivalence studies. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, December 2002. 13. Deshmukh-Taskar PR, Nicklas TA, O’Neil CE, et al. The relationship of breakfast skipping and type of breakfast consumption with nutrient intake and weight status in children and adolescents: the National Health and Nutrition Examination Survey 1999–2006. J Am Diet Assoc. 2010;110(6):869-878. 14. Deshmukh-Taskar PR, Radcliffe JD, Liu Y, Nicklas TA. Do breakfast skipping and breakfast type affect energy intake, nutrient intake, nutrient adequacy, and diet quality in young adults? NHANES 1999-2002. J Amer Col Nutr. 2010;29(4):407-418. 15. Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-973. 16. Webster GF, Leyden JJ, Gross JA. Results of a phase III, double-blind, randomized, parallel-group, non-inferiority study evaluating the safety and efficacy of isotretinoin-lidose in patients with severe recalcitrant nodular acne. J Drugs Dermatol. 2014;13(6):665-670. 17. Data on file. Sun Pharmaceutical Industries, Inc.; May 2018. 18. Webster GF, Leyden JJ, Gross JA. Comparative pharmacokinetic profiles of a novel isotretinoin formulation (isotretinoin-lidose) and the innovator isotretinoin formulation: a randomized, 4-treatment, crossover study. J Am Acad Dermatol. 2013;69(5):762-767. 19. Blagden N, deMatas M, Gavan PT, York P. Crystal engineering of active pharmaceutical ingredients to improve solubility and dissolution rates. Adv Drug Deliv Rev. 2007;59(7):617-630. 20. Choudhary S, Gupta L, Rani S, Dave K, Gupta U. Impact of dendrimers on solubility of hydrophobic drug molecules. Front Pharmacol. 2017;8:261. 21. Food and Drug Administration, Department of Health and Human Services. Determination that Accutane (isotretinoin) capsules, 10 milligrams, 20 milligrams, and 40 milligrams, were not withdrawn from sale for reasons of safety or effectiveness. https://www.federalregister.gov/documents/2010/07/07/2010-16439/determination-that-accutane-isotretinoin-capsules-10-milligrams-20-milligrams-and-40-milligrams-were. Accessed 08/24/2020. 22. Dispense as written (DAW). HMSA Provider Resource Center. https://hmsa.com/portal/provider/zav_pel.rx.DIS.400.htm. Accessed August 19, 2020.