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Privacy Policy

Privacy policy

Clinigen respects your privacy and is committed to protecting your personal data. This privacy policy will tell you how we look after your personal data when you visit our websites and tell you about your privacy rights and how the law protects you.

WHO WE ARE

This privacy policy is issued on behalf of Clinigen, Inc., a subsidiary of Clinigen Group plc, (“Clinigen”). Clinigen is the controller and is responsible for this website (http://www.proleukin.com). This website is intended for use by residents of the United States (“US”) and its territories who are 18 years of age or older. This website is not intended for children and we do not knowingly collect information related to children.

Clinigen respects your privacy and is committed to protecting your personal information in the event we receive it.

This privacy policy should be read in conjunction with the terms of use for this website. If you have any questions about this privacy policy, including any requests to exercise your legal rights, please contact us at LegalandContracts@clinigengroup.com.

HOW THIS WEBSITE WORKS

Clinigen does not collect any personal information through you visiting this website. This website is designed not to access, collect, or process any personal information including technical information, such as cookies or your IP address.

You may choose to interact with this website in 2 ways:

  • Search the location of a Treatment Center. There is a Treatment Center finder on both the patient and the healthcare professional portions of the website. The full list of Treatment Centers is part of the website. When you enter a city, state, or zip code, the list is narrowed to provide you with Treatment Centers in the area. We do not collect the information you enter when you search
  • Request a mentor. On the patient portion of the website, you have the option to contact us if you would like to speak to a mentor to discuss his or her experience with Proleukin. If you choose to contact us, the information you provide will be processed according to the policy below

THE INFORMATION WE MAY COLLECT ABOUT YOU

If you contact Clinigen in connection with requesting a mentor or exercising your legal rights, we may collect your personal information. The remainder of this privacy policy will tell you about how we look after your personal information, in the event we receive it, and tell you about your privacy rights and how the law protects you.

Personal information means any information about an individual from which that person can be identified. It includes personal information that identifies, relates to, describes, is reasonably capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular consumer or household. It does not include data where the identifiers have been removed (deidentified or anonymized data).

We may collect, use, store, and transfer different kinds of personal information about you which we have grouped together as follows:

  • Identity information including first name, maiden name, last name, username or similar identifier, social security number, driver’s license number, passport number, marital status, title, date of birth, and gender
  • Contact information including billing address, delivery address, email address, and telephone numbers

We do not collect any other information about you in connection with this website.

It is important that the personal information we hold about you is accurate and current. Please keep us informed if your personal information changes during your relationship with us.

HOW YOUR PERSONAL INFORMATION IS COLLECTED

We may collect information from and about you through:

  • Direct interactions. You may give us your identity and contact information by corresponding with us by phone or email
  • Third parties or publicly available sources. We may receive identity and contact data from publicly available sources in order to verify your identity, if necessary

HOW WE USE YOUR PERSONAL INFORMATION

We will only use (process) your personal information when the law allows us to. We have described below how we plan to use your personal information, and which of the legal bases we rely on to do so.

Purpose/Activity Type of Information Lawful Basis for Processing
To connect you with a mentor (a) Identity
(b) Contact		 Consent
To manage our relationship with you which will include:
(a) Notifying you about changes to our terms or privacy policy
(b) Confirming your identity in connection with exercising your legal rights 		(a) Identity
(b) Contact		 Necessary to comply with a legal obligation

CHANGE OF PURPOSE

We will only use your personal information for the purposes for which we collected it, unless we reasonably consider that we need to use it for another reason that is compatible with the original purpose. If we need to use your personal information for an unrelated purpose, we will notify you and will explain the legal basis which allows us to do so.

Please note that we may process your personal information without your knowledge or consent where this is required or permitted by law.

DISCLOSURES OF YOUR PERSONAL INFORMATION

We do not share your personal information with any third parties. If you choose to be put in touch with a mentor, we will send you the mentor’s contact information (with his or her consent). It will be up to you to reach out to your mentor and communicate as you see fit. Clinigen will not have access to your communications.

We do not sell your personal information.

HOW SECURE IS MY INFORMATION?

We have put in place appropriate security measures to prevent your personal information from being accidentally lost, used, or accessed in an unauthorized way, altered, or disclosed. In addition, we limit access to your personal information to those individuals within Clinigen who have a business need to know. They will only process your personal information on our instructions and they are subject to a duty of confidentiality.

We have put in place procedures to deal with any suspected personal information breach and will notify you and any applicable regulator of a breach where we are legally required to do so.

HOW LONG WILL YOU USE MY PERSONAL INFORMATION?

We will only retain your personal information for as long as necessary to fulfill the purposes we collected it for, including for the purposes of satisfying any legal requirements.

To determine the appropriate retention period for personal information, we consider the amount, nature, and sensitivity of the personal information; the potential risk of harm from unauthorized use or disclosure of your personal information; the purposes for which we process your personal information and whether we can achieve those purposes through other means; and the applicable legal requirements.

In some circumstances we may anonymize your personal data (so that it can no longer be associated with you) for research or statistical purposes in which case we may use this information indefinitely without further notice to you.

YOUR LEGAL RIGHTS

You have rights under certain privacy and data protection laws, including the California Consumer Privacy Act of 2018 (“CCPA”), as applicable, in relation to your personal information:

  • Request disclosure. You have the right to know the categories of personal information we have collected about you; the categories of sources from which the personal information is collected; our purpose for collecting personal information; and the specific pieces of personal information we have collected about you

Please note that we are not required to retain any personal information about you that was collected for a single, one-time transaction, or to reidentify information that is not maintained in a manner that would be considered personal information in the ordinary course of business.

  • Request deletion. Subject to certain exceptions set out below, on receipt of a verifiable request from you, we will delete your personal information from our records

Please note that we may not delete your personal information in certain circumstances, including if it is necessary to complete the transaction for which the personal information was collected or provide a service requested by you; comply with an existing legal obligation; or otherwise use your personal information, internally, in a lawful manner that is compatible with the context in which you provided the information.

  • Protection against discrimination. You have the right to not be discriminated against by us because you exercised any of your rights under the CCPA. This means we cannot, among other things, deny services to you if you request disclosure or deletion of your personal information
  • Request correction. This enables you to have any incomplete or inaccurate information we hold about you corrected, though we may need to verify the accuracy of the new data you provide to us

HOW TO EXERCISE YOUR RIGHTS

If you wish to exercise any of your rights as described in this privacy policy, please:

  • Call us toll-free at 833-888-0255
  • Contact us:
    Clinigen, Inc.
    Attention: Legal and Compliance
    790 Township Line Road, Suite 120
    Yardley, PA 19067
  • Email us at LegalandContracts@clinigengroup.com

You will not have to pay a fee to access your personal information or to exercise any of your other rights. However, we may charge a reasonable fee if your request is clearly unfounded, repetitive, or excessive. Alternatively, we may refuse to comply with your request under these circumstances. Please note that you may only make a CCPA-related request twice within a 12-month period.

WHAT WE MAY NEED FROM YOU

If you choose to contact us directly, you will need to provide the following:

  • Enough information to identify you (eg, your full name and address)
  • Proof of your identity and address (eg, a copy of your driver’s license or passport and a recent utility or credit card bill)
  • A description of what right you want to exercise and the information to which your request relates

We are not obligated to make a disclosure if we cannot verify that the person making the request is the person about whom we collected information, or is someone authorized to act on such person’s behalf.

Any personal information we collect from you to verify your identity in connection with your request will be used solely for the purposes of verification.

We may also contact you to ask you for further information in relation to your request to speed up our response.

TIME LIMIT TO RESPOND

We try to respond to all legitimate requests within one month. Occasionally, it may take us longer than a month if your request is particularly complex or you have made a number of requests. In this case, we will notify you and keep you updated.

WHERE TO SEEK FURTHER ADVICE

If you have any questions regarding this privacy policy or any related issue, you should contact LegalandContracts@clinigengroup.com.

Effective date: 8 April 2020

EXPAND +

Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic melanoma (mM) and metastatic renal cell carcinoma (mRCC).

Summary of Important Safety Information for Proleukin® (aldesleukin) for injection, for intravenous infusion.

Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (mRCC) and metastatic melanoma (mM).

Summary of Important Safety Information for Proleukin® (aldesleukin) for injection, for intravenous infusion.

WARNINGS

Therapy with Proleukin® (aldesleukin) should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and formal pulmonary function testing. Extreme caution should be used in patients with a normal thallium stress test and a normal pulmonary function test who have a history of cardiac or pulmonary disease.

Proleukin should be administered in a hospital setting under the supervision of a qualified physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.

Proleukin administration has been associated with capillary leak syndrome (CLS) which is characterized by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space. CLS results in hypotension and reduced organ perfusion which may be severe and can result in death. CLS may be associated with cardiac arrhythmias (supraventricular and ventricular), angina, myocardial infarction, respiratory insufficiency requiring intubation, gastrointestinal bleeding or infarction, renal insufficiency, edema, and mental status changes.

Proleukin treatment is associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Consequently, preexisting bacterial infections should be adequately treated prior to initiation of Proleukin therapy. Patients with indwelling central lines are particularly at risk for infection with gram positive microorganisms. Antibiotic prophylaxis with oxacillin, nafcillin, ciprofloxacin, or vancomycin has been associated with a reduced incidence of staphylococcal infections.

Proleukin administration should be withheld in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma.

 

INDICATION AND USAGE

Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC).

Proleukin is indicated for the treatment of adults with metastatic melanoma.

Careful patient selection is mandatory prior to the administration of Proleukin.

Evaluation of clinical studies to date reveals that patients with more favorable ECOG performance status (ECOG PS 0) at treatment initiation respond better to Proleukin, with a higher response rate and lower toxicity. Therefore, selection of patients for treatment should include assessment of performance status.

Experience in patients with ECOG PS > 1 is extremely limited.

 

CONTRAINDICATIONS

Proleukin® (aldesleukin) is contraindicated in patients with a known history of hypersensitivity to interleukin-2 or any component of the Proleukin formulation.

Proleukin is contraindicated in patients with an abnormal thallium stress test or abnormal pulmonary function tests and those with organ allografts. Retreatment with Proleukin is contraindicated in patients who have experienced the following drug-related toxicities while receiving an earlier course of therapy: sustained ventricular tachycardia (≥ 5 beats), cardiac arrhythmias not controlled or unresponsive to management, chest pain with ECG changes, consistent with angina or myocardial infarction, cardiac tamponade, intubation for > 72 hours, renal failure requiring dialysis > 72 hours, coma or toxic psychosis lasting > 48 hours, repetitive or difficult to control seizures, bowel ischemia/perforation, GI bleeding requiring surgery.

 

WARNINGS

Because of the severe adverse events which generally accompany Proleukin® (aldesleukin) therapy at the recommended dosages, thorough clinical evaluation should be performed to identify patients with significant cardiac, pulmonary, renal, hepatic, or CNS impairment in whom Proleukin is contraindicated. Patients with normal cardiovascular, pulmonary, hepatic, and CNS function may experience serious, life-threatening or fatal adverse events. Adverse events are frequent, often serious, and sometimes fatal.

Should adverse events, requiring dose modification occur, dosage should be withheld rather than reduced.

Proleukin has been associated with exacerbation of preexisting autoimmune disease and inflammatory disorders. In some cases, the onset of new autoimmune diseases, such as vitiligo, may occur. Symptomatic hyperglycemia and/or diabetes mellitus have been reported during Proleukin therapy.

All patients should have thorough evaluation and treatment of CNS metastases and have a negative scan prior to receiving Proleukin therapy. New neurologic signs, symptoms, and anatomic lesions following Proleukin therapy have been reported in patients without evidence of CNS metastases. Neurologic signs and symptoms associated with Proleukin therapy usually improve after discontinuation of Proleukin therapy; however, there are reports of permanent neurologic defects. In patients with known seizure disorders, extreme caution should be exercised as Proleukin may cause seizures.

 

PRECAUTIONS

Patients should have normal cardiac, pulmonary, hepatic, and CNS function at the start of therapy. Capillary leak syndrome (CLS) begins immediately after Proleukin® (aldesleukin) treatment starts and is marked by increased capillary permeability to protein and fluids and reduced vascular tone.

Proleukin® (aldesleukin) treatment should be withheld for failure to maintain organ perfusion as demonstrated by altered mental status, reduced urine output, a fall in the systolic blood pressure below 90 mm Hg or onset of cardiac arrhythmias.

Recovery from CLS begins soon after cessation of Proleukin therapy. Usually, within a few hours, the blood pressure rises, organ perfusion is restored and reabsorption of extravasated fluid and protein begins.

Kidney and liver function are impaired during Proleukin treatment. Use of concomitant nephrotoxic or hepatotoxic medications may further increase toxicity to the kidney or liver.

Mental status changes including irritability, confusion, or depression which occur while receiving Proleukin may be due to bacteremia or early bacterial sepsis, hypoperfusion, occult CNS malignancy, or direct Proleukin-induced CNS toxicity. Patients should be evaluated for these and other causes of mental status changes. Alterations in mental status due solely to Proleukin therapy may progress for several days before recovery begins. Rarely, patients have sustained permanent neurologic deficits.

Proleukin enhancement of cellular immune function may increase the risk of allograft rejection in transplant patients.

Serious manifestations of eosinophilia involving eosinophilic infiltration of cardiac and pulmonary tissues can occur following Proleukin.

 

ADVERSE REACTIONS

The rate of drug-related deaths in the 255 metastatic RCC patients who received single-agent Proleukin® (aldesleukin) was 4% (11/255); the rate of drug-related deaths in the 270 metastatic melanoma patients who received single-agent Proleukin was 2% (6/270).

In clinical trials, the following life-threatening (Grade 4) adverse events were seen in > 1% of 525 patients (255 with metastatic renal cell cancer and 270 with metastatic melanoma) treated with Proleukin: oliguria (6%), anuria (5%), hypotension (3%), respiratory disorder (3%), bilirubinemia (2%), coma (2%), diarrhea (2%), acidosis (1%), acute kidney failure (1%), apnea (1%), cardiovascular disorder (1%), coagulation disorders (1%), confusion (1%), creatinine increase (1%), dyspnea (1%), fever (1%), heart arrest (1%), infection (1%), myocardial infarction (1%), psychosis (1%), sepsis (1%), SGOT increase (1%), stupor (1%), supraventricular tachycardia (1%), thrombocytopenia (1%), ventricular tachycardia (1%), and vomiting (1%). From the same trials, the following adverse events (Grades 1-4) were seen in ≥ 30% of 525 patients (255 with metastatic renal cell cancer and 270 with metastatic melanoma) treated with Proleukin: hypotension (71%), diarrhea (67%), oliguria (63%), chills (52%), vomiting (50%), dyspnea (43%), rash (42%), bilirubinemia (40%), thrombocytopenia (37%), nausea (35%), confusion (34%), and creatinine increase (33%).

Please see the full Prescribing Information, including Boxed Warning, for Proleukin® (aldesleukin) for injection, for intravenous infusion.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The content contained in this website is not intended to be a substitute for professional medical advice related to any topic discussed. Patients are urged to consult with their treating physicians or other professionals. Never disregard professional, medical, or legal advice or delay seeking such advice because of something you have read on this website.