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Privacy Policy

Effective Date: February 2017

This privacy policy (the “Privacy Policy”) describes how Sun Pharmaceutical Industries, Inc. (“Sun Pharma,” “we” or “us”) collects, uses, and shares personal information gathered through the LEVULAN Access Support website located at http://www.levulanaccesssupport.com (the “Website”).

This Privacy Policy is incorporated into, and is subject to, the Terms of Use. By visiting the Website, you accept and consent to the practices described in the Privacy Policy and Terms of Use. If you do not agree to the Terms of Use or this Privacy Policy, please do not use the Website.

1. What Types of Information Do We Collect?

Personal Information. We obtain certain personal information only when you provide it to us. For example, if you contact us using the form on our Website, you may provide certain personal information, including your email, phone, and organization. Some of that information can be used by Sun Pharma to identify or contact you directly and is sometimes referred to as personally identifiable information.

Non-Personal Information. Sun Pharma also gathers non-personal information from users. Non-personal information is information that usually cannot by itself be used to identify a particular person or entity, and may include: the Internet Protocol (IP) address, unique device identifiers, anonymous IDs for advertising, operating system, mobile network information, browser type, existing applications, and browsing activity.

2. How Do We Use Information?

We use the personal information that you provide to respond to your contact inquiries, provide you with services you have requested and/or customer support, and communicate with you about products or services that may be of interest to you.

We analyze non-personal information to help us determine how users access parts of the Website and who our users are. We may use non-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 products 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.

3. How Do We Share Information?

We will only share your personal information as described in this Privacy Policy. We do not sell your personal information to third parties. We may, however, share the personal information we collect from you in limited circumstances, including:

  • We may disclose to our suppliers, contractors 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 contractors 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.
  • We may disclose to any law enforcement agency, court, regulator, government authority or other third party where we believe this is necessary to comply with a legal or regulatory obligation, in order to enforce our Terms of Use, or otherwise to protect our rights/property or the rights/property of any third party.
  • We may disclose to any third party that purchases, or to which we transfer, all or substantially all of our assets and business. Should such a sale or transfer occur, we will use reasonable efforts to try to ensure that the entity to which we transfer your personal information uses it in a manner that is consistent with this Privacy Policy.

We may share non-personal information with third parties, including but not limited to advisors, advertisers, analytics providers, and investors, for the purpose of conducting our business. Sun Pharma uses Google Analytics to track aggregated visitor data, which does not include any personal information. We reserve the right to disclose to third parties non-personal information collected for any lawful purpose.

4. Security

Sun Pharma cares about the security and confidentiality of your information. We maintain commercially reasonable administrative, technical and physical security measures to protect the security of the information you submit to us. However, no website is completely secure or “hacker proof.” You are also responsible for taking reasonable steps to protect your personal information against unauthorized disclosure or misuse. We are not responsible for third party circumvention of any privacy settings or security measures.

5. Children

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 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.

6. Cookies and Do Not Track

Sun Pharma uses cookies and similar technologies to collect non-personal information for the purposes outlined in this Privacy Policy. A cookie is a small data file that our server sends to your browser when you visit the Website. The use of cookies helps us to assist your use of certain aspects of the Website. Most Internet browsers allow you to disable, turn the cookie feature off, or reject cookies entirely by changing the settings. Changing these settings, however, may affect your ability to use certain features and functions of the Website. Please note that by visiting the Website you are consenting to the use of cookies. For more information about third party cookies, including information about how to opt out of these technologies, click here.

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.

7. Privacy Policy Changes

We may, in our sole discretion, change this Privacy Policy from time to time. Any and all changes to this Privacy Policy will be reflected here and the date new versions are posted will be stated at the top of this Privacy Policy. If you do not agree with this Privacy Policy, please do not use or access the Website, and if you do not agree to any changes we make in the future, you must end your use of the Website.

8. Links to Third Party Websites

Our Website may contain links to other third party websites. This Privacy Policy does not apply to the practices of other websites, and Sun Pharma is not responsible for the actions and privacy policies of third parties. We encourage you to be aware of when you leave our Website and to read the privacy policies of each website that you visit.

9. How Does This Policy Apply Outside Of The U.S.?

The information collected by Sun Pharma is hosted in the United States of America and is subject to U.S. state and federal law. If you are accessing the Website from other jurisdictions, please be advised that you are transferring your personal information to us in the United States where data protection and privacy laws may be less stringent than the laws of your country. BY USING OUR WEBSITE, YOU CONSENT TO THE TRANSFER AND USE OF YOUR PERSONAL INFORMATION IN ACCORDANCE WITH THIS PRIVACY POLICY.

10. Contact Us

If you have any questions or comments regarding our Privacy Policy, please contact us at us.privacypolicy@sunpharma.com.

WEB-1511 Rev A

IMPORTANT SAFETY INFORMATION

LEVULAN® KERASTICK® (aminolevulinic acid HCl) for topical solution, 20%, plus blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp, or actinic keratosis of the upper extremities.

Contraindicated in patients with cutaneous photosensitivity at wavelengths of 400–450 nm, porphyria, or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the LEVULAN KERASTICK topical solution.

Application of LEVULAN KERASTICK topical solution should involve lesions on the face or scalp, or upper extremities. Multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously.

Do not apply to the eyes or to mucus membranes. Irritation may be experienced if LEVULAN KERASTICK topical solution is applied to eyes or mucous membranes. Treatment of upper extremities is approved after an incubation time of 3 hours under occlusion. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours.

Transient amnestic episodes have been reported during postmarketing use of LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Inform patients and their caregivers that LEVULAN KERASTICK in combination with PDT may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.

After LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. To avoid unintended photosensitivity, LEVULAN KERASTICK topical solution should be applied by a qualified health professional to no more than 5 mm of perilesional skin surrounding each target actinic keratosis lesion.

Advise patients to wear a wide-brimmed hat or similar head covering of light-opaque material or a long-sleeved shirt and/or gloves to shade the treated actinic keratoses from sunlight or other bright light sources until at least 40 hours after the application of LEVULAN KERASTICK topical solution. Sunscreens will not protect against photosensitivity reactions caused by visible light. The patient should be advised to reduce light exposure if the sensations of stinging and/or burning are experienced.

LEVULAN KERASTICK topical solution has not been tested on patients with inherited or acquired coagulation defects.

It is possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction of actinic keratoses treated with the LEVULAN KERASTICK topical solution.

During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear as specified in the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions.

The most common local adverse reactions (incidence ≥ 10%) were erythema, edema, stinging/burning, scaling/crusting, itching, erosion, hypo/hyperpigmentation, oozing/vesiculation/crusting, scaling and dryness.

In clinical trials, severe stinging and/or burning was reported by at least 50% of face and scalp patients and 9% of upper extremity patients at some time during treatment. However, less than 3% of subjects receiving treatment for face or scalp lesions discontinued light treatment because of stinging/burning. No subjects discontinued light treatment in the trial for upper extremity lesions.

Please refer to the full Prescribing Information for complete discussion of the risks associated with LEVULAN KERASTICK (aminolevulinic acid HCl) for topical solution, 20%.

IMPORTANT SAFETY INFORMATION

LEVULAN® KERASTICK® (aminolevulinic acid HCl) for topical solution, 20%, plus blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp, or actinic keratosis of the upper extremities.

Contraindicated in patients with cutaneous photosensitivity at wavelengths of 400–450 nm, porphyria, or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the LEVULAN KERASTICK topical solution.

Application of LEVULAN KERASTICK topical solution should involve lesions on the face or scalp, or upper extremities. Multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously.

Do not apply to the eyes or to mucus membranes. Irritation may be experienced if LEVULAN KERASTICK topical solution is applied to eyes or mucous membranes. Treatment of upper extremities is approved after an incubation time of 3 hours under occlusion. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours.

Transient amnestic episodes have been reported during postmarketing use of LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Inform patients and their caregivers that LEVULAN KERASTICK in combination with PDT may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.

After LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. To avoid unintended photosensitivity, LEVULAN KERASTICK topical solution should be applied by a qualified health professional to no more than 5 mm of perilesional skin surrounding each target actinic keratosis lesion.

Advise patients to wear a wide-brimmed hat or similar head covering of light-opaque material or a long-sleeved shirt and/or gloves to shade the treated actinic keratoses from sunlight or other bright light sources until at least 40 hours after the application of LEVULAN KERASTICK topical solution. Sunscreens will not protect against photosensitivity reactions caused by visible light. The patient should be advised to reduce light exposure if the sensations of stinging and/or burning are experienced.

LEVULAN KERASTICK topical solution has not been tested on patients with inherited or acquired coagulation defects.

It is possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction of actinic keratoses treated with the LEVULAN KERASTICK topical solution.

During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear as specified in the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions.

The most common local adverse reactions (incidence ≥ 10%) were erythema, edema, stinging/burning, scaling/crusting, itching, erosion, hypo/hyperpigmentation, oozing/vesiculation/crusting, scaling and dryness.

In clinical trials, severe stinging and/or burning was reported by at least 50% of face and scalp patients and 9% of upper extremity patients at some time during treatment. However, less than 3% of subjects receiving treatment for face or scalp lesions discontinued light treatment because of stinging/burning. No subjects discontinued light treatment in the trial for upper extremity lesions.

Please refer to the full Prescribing Information for complete discussion of the risks associated with LEVULAN KERASTICK (aminolevulinic acid HCl) for topical solution, 20%.

References:
  1. Symphony Health. Actinic Keratosis Total Patient Share. June 2018.
  2. Data on file, Sun Pharma.
  3. LEVULAN KERASTICK full Prescribing Information, April 2018.
  4. Shergill B, Zokaie S, Carr AJ. Non-adherence to topical treatments for actinic keratosis. Patient Prefer Adherence. 2014;17(8):35-41.
  5. Taub AF. Photodynamic therapy in dermatology: history and horizons. J Drugs Dermatol. 2004;3(suppl 1):S8-S25.
  6. BLU-U Blue Light Photodynamic Therapy llluminator Model 4170 Operating manual.
  7. AMELUZ® Prescribing Information, BioFrontera Pharma GmbH. Wakefield, MA. 2016