This website is intended for U.S. residents only

Ipsen Journeys logo

This website is intended for U.S. residents only

Enroll Here

IPSEN CARES® PATIENT AUTHORIZATION FORM

STEP 1: Patient Authorization And Signature – IPSEN CARES Program

I authorize my/the patient’s doctor(s) and their staff (including those pharmacies that may receive my/the patient’s prescription for SohonosTM) to disclose my/the patient’s protected health information (“PHI”), including health information about insurance, prescription, care management, and medical condition to Ipsen Biopharmaceuticals, Inc., and/or its affiliates, and/or its agents or third-party vendors that have been hired to administer the Ipsen Coverage, Access, Reimbursement & Education Support (IPSEN CARES) program (collectively, “Ipsen”) in order for Ipsen to (1) enroll me/the patient in IPSEN CARES; (2) establish my/the patient’s benefit eligibility and potential out of pocket costs for Sohonos; (3) communicate with my/the patient’s doctors and health plans about my/the patient’s treatment plan; (4) provide support services, including patient education and financial assistance for Sohonos; (5) help get Sohonos shipped to me/the patient or my healthcare provider; and (6) facilitate my/the patient’s participation in Sohonos patient programs as I have requested or may request, including the IPSEN CARES Patient Assistance Program (the “PAP”) if applicable. I agree that, using the contact information I provide, Ipsen may contact me/the patient by phone, mail, and/or email for reasons related to the IPSEN CARES program and support services, including (1) determining if I/the patient am/is eligible for assistance and related support services, (2) leaving messages for me that disclose that I/the patient am/is on Sohonos therapy and/or applied for IPSEN CARES support services and am/is or am not/is not eligible for assistance; (3) operating Ipsen Cares patient programs that might help me pay for or access my/the patient’s medicines; and (4) confirming receipt of medications. I consent to being contacted by an IPSEN CARES program representative in order for the program to obtain further information or clarification regarding any adverse event I/the patient may experience. I also give Ipsen permission to share my/the patient’s PHI and other information with people and companies that work with IPSEN CARES, including; government agencies, including insurance providers; my/the patient’s doctor(s) and other people, or institutions who are involved in my/the patient’s healthcare, such as pharmacies and hospitals; and/or other organizations that might help me pay for my/the patient’s medication. All information that I provide may be used by Ipsen or any third party working on behalf of Ipsen in connection with IPSEN CARES. I understand that my/the patient’s healthcare providers may receive remuneration from Ipsen in connection with my/the patient’s PHI and/or for any therapy support services provided to me/the patient.

I understand that once my/the patient’s PHI has been disclosed to Ipsen, it is no longer protected by federal privacy laws, and Ipsen may re-disclose it; however, Ipsen has agreed to make reasonable efforts to protect my/the patient’s PHI by using and disclosing it only for the purposes described above or as required by law. I can withdraw this authorization by contacting IPSEN CARES at 1-866-435-5677 or mailing a letter requesting such revocation to IPSEN CARES, 2250 Perimeter Park Dr. Suite 300 Morrisville, NC 27560, but it will not change any actions taken before I withdraw this authorization. Withdrawal of this authorization will end further uses and disclosures of PHI by the parties identified in this form except to the extent those uses and disclosures have been made in reliance upon this authorization.

I understand that I may refuse to sign this form and, if I do so, I/the patient will not be able to participate in IPSEN CARES, but it will not affect my/the patient’s eligibility to obtain medical treatment, my/the patient’s ability to seek payment for this treatment, or affect my/the patient’s insurance enrollment or eligibility for insurance coverage. This authorization expires three years from the date signed unless a shorter time is required by law or unless I revoke my authorization before that time. I understand that I will receive a copy of the signed authorization.

I confirm that any information, including financial and insurance information, that I provide to IPSEN CARES is complete and true, and unless I have said something different in this application, I have no insurance coverage for this product, which includes Medicaid, Medicare, or any public or private assistance programs or any other form of insurance. If my income or health insurance coverage changes, I will immediately notify IPSEN CARES at 1-866-435-5677. I confirm that I/the patient am/is a resident of the United States (including its territories). I understand that Ipsen may revise, change, or terminate this program at any time without notice.

Text Communications

To the extent that I have opted in by checking the box below this paragraph, I agree to be contacted by autodialed text messages (“texts”) at the mobile phone number I have provided for the purpose of helping me/the patient stay on therapy, which may promote or advertise the Ipsen products included in the therapy plan, and/or which may include provision of educational materials and information about programs that support patients. I certify that the number I am providing belongs to me and not a family member or third party. I understand that I may opt out of individual communications or all text communications entirely at any time by calling 1-866-435-5677 or replying “STOP” by text to any text from Ipsen. Ipsen will not sell or rent this information and will use it only in accordance with this authorization and consent. Consent to being contacted by text messages is not a condition of participation in the IPSEN CARES programs or the purchase of any products or services. I understand that my cellular service carrier’s data and text messaging rates may apply. This authorization expires three years from the date signed unless a shorter time is required by law or unless I revoke my authorization before that time. If I am providing this consent on behalf of another person, I certify that I am authorized to agree to every element of this consent on behalf of such other person, and I agree that I will be liable and will hold Ipsen harmless in the event that such other person alleges that they did not give consent.

market

Marketing Information

To the extent that I have opted in by checking the box below this paragraph, I would like to receive information from Ipsen via mail, email, phone or text message, all of which may include marketing content, advertisements, disease state awareness materials and educational material about SohonosTM, and programs that support patients. These text messages and voice calls may be made via the use of automatic telephone dialing systems. I certify that the number I am providing belongs to me and not to a family member or other third party. I understand that I do not have to sign this section of the form in order to participate in the IPSEN CARES program and that I may revoke this authorization to receive additional product information at any time. I agree that Ipsen and its agents may use and disclose my personal information (including name, address, phone number, and/or email) to provide this information and Ipsen may also contact me to solicit my opinions regarding Sohonos and Ipsen’s products and services. I understand and agree that any information I provide may be used by Ipsen to conduct data analysis and market research, and to develop new programs and resources. I understand that my cell phone carrier’s standard rates may apply for calls and texts to my cell phone. This authorization expires three years from the date signed unless a shorter time is required by law or unless I revoke my authorization before that time. I may revoke this authorization, by calling 1-866-435-5677 or sending a request in writing to: IPSEN CARES, 2250 Perimeter Park Dr. Suite 300 Morrisville, NC 27560. If I am providing this consent on behalf of another person, I certify that I am authorized to agree to every element of this consent on behalf of such other person, and I agree that I will be liable and will hold Ipsen harmless in the event that such other person alleges that they did not give consent.

market
Required if patient is under 18 years of age.

We are collecting personal information in order to fulfill your request. Please see Ipsen’s privacy policy at https://www.ipsen.com/us/privacy-policy/. Residents of certain states have additional rights regarding the collection, use, and disclosure of their personal information. For more information, please see Ipsen’s Supplemental State Privacy Notice at https://www.ipsen.com/us/Supplement-Website-Privacy-Notice/.

IMPORTANT SAFETY INFORMATION & INDICATION for SOHONOSTM (palovarotene) Capsules

What is the most important information I should know about SOHONOS?

 

SOHONOS can cause birth defects (deformed babies) if taken during pregnancy. Females who are pregnant or who plan to become pregnant must not take SOHONOS.

  • Your healthcare provider will ask you to take a pregnancy test 1 week before starting treatment with SOHONOS, periodically during treatment, and 1 month after you stop treatment.
  • You must use effective birth control (contraception) starting at least 1 month before starting treatment with SOHONOS, during treatment, and for 1 month after the last dose. Talk to your healthcare provider about birth control methods that may be right for you.
  • If you become pregnant or think you may be pregnant during treatment with SOHONOS, stop taking SOHONOS and call your healthcare provider right away.

Because SOHONOS can cause birth defects, SOHONOS is only for people who can understand and agree to carry out all instructions for pregnancy prevention.

SOHONOS can cause bone growth changes. Children may stop growing while taking SOHONOS. Bone growth changes such as permanent early closure of the growth plate in growing children have happened with SOHONOS. Your healthcare provider will closely monitor your child’s bone growth and height during treatment with SOHONOS.

Who should not take SOHONOS?

Do not take SOHONOS if you are pregnant, or allergic to medicines known as retinoids or any of the ingredients in SOHONOS.

What should I tell my healthcare provider before taking SOHONOS?

Before taking SOHONOS, tell your healthcare provider about all your medical conditions, including:

  • have bone loss (osteoporosis), weak bones or any other bone problems
  • have or had mental health problems
  • have or have had kidney problems
  • have or have had liver problems
  • are breastfeeding or plan to breastfeed. It is not known if SOHONOS passes into your breastmilk. Breastfeeding is not recommended during treatment with SOHONOS and for at least 1 month after the last dose of SOHONOS. Talk to your healthcare provider about the best way to feed your baby if you take SOHONOS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOHONOS and certain other medicines can interact with each other, sometimes causing serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist when you get a new medicine.

What should I avoid while taking SOHONOS?

  • Do not get pregnant while taking SOHONOS.
  • Avoid excessive exposure to sunlight and ultraviolet lights (tanning machines). SOHONOS may make your skin more sensitive to the exposure and you may burn more easily. Apply sunscreen and wear protective clothing and sunglasses when in sunlight.
  • Avoid driving at night until you know if SOHONOS has affected your vision. SOHONOS may decrease your ability to see in the dark.
  • Do not donate blood while taking SOHONOS and for 1 week after stopping SOHONOS.

What are the possible side effects of SOHONOS?

SOHONOS can cause serious side effects, including:

  • skin-related events such as dry skin, lip and eye, hair loss, itching, redness, rash, and skin peeling. You may be at increased risk of developing skin and soft tissue infections while taking SOHONOS. If you develop these symptoms, your healthcare provider may tell you to use moisturizer, sunscreen, or artificial tears.
  • bone mineral density problems (bone thinning) which can increase the risk of fractures in adults and children. Your healthcare provider should check you for this during treatment with SOHONOS.
  • new or worsening mental health problems that may include depression, anxiety, mood changes, and suicidal thoughts and behaviors. If you have a history of mental health problems, you may be at a higher risk of developing these side effects. Call your healthcare provider if you develop new or worsening mental health symptoms during treatment with SOHONOS. Your healthcare provider should monitor you for signs of depression and refer you for appropriate treatment, if necessary.
  • vision problems (night blindness) which may cause difficulty seeing at night or in low lit areas. Your healthcare provider should send you to see an eye specialist if you experience vision problems.

The most common side effects of SOHONOS include:

  • dry skin
  • dry lips
  • hair loss
  • itching
  • redness
  • rash
  • skin peeling
  • drug eruption
  • skin irritation
  • swelling and small cracks in corner of the mouth
  • nausea
  • muscle and joint pain
  • dry eyes
  • headache
  • fatigue

These are not all the possible side effects of SOHONOS. Call your doctor for medical advice about side effects. 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.

WHAT IS SOHONOS?

SOHONOS is a prescription medicine used to reduce the amount of new heterotopic ossification in adults and children 8 years of age and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP). SOHONOS is not recommended for females younger than 8 years of age or males younger than 10 years of age.

Please see full Prescribing Information, including Medication Guide with IMPORTANT WARNING.