throbber
12/28/2015
`
`Adempas (riociguat) ­ Aim Patient Support Program Overview
`
`Important Safety Information
`Adempas can cause serious birth defects if taken during pregnancy. Females must not be pregnant when they start
`taking Adempas (riociguat) tablets or become pregnant during treatment with Adempas. Females who are able to get
`pregnant must have a negative pregnancy test before beginning treatment with Adempas, each month during treatment,
`and 1 month after you stop treatment with Adempas. Females can only receive Adempas through a restricted program
`called the Adempas REMS Program...Continue reading below.
`
`This site is for US Audiences Only
`For Non US Residents
`Medication Guide
`Important Safety Information
`
`Full Prescribing Information, including BOXED WARNING
`For Healthcare Professionals
`Adempas REMS
`
`Menu
`
`
`
`Support Every Step Of
`The Way
`
`As you start taking Adempas,
`you can rely on the resources
`and support of the Aim
`Patient Support Program,
`brought to you by Bayer.
`
`The Aim Patient Support
`Program:
`
`Bayer is committed to providing resources
`that can help adults with pulmonary
`arterial hypertension (PAH) (WHO group
`
`1) or chronic thromboembolic pulmonary
`http://www.adempas­us.com/support­every­step­of­the­way/
`
`1/10
`
`Page 1
`
`

`
`12/28/2015
`
`Adempas (riociguat) ­ Aim Patient Support Program Overview
`1) or chronic thromboembolic pulmonary
`hypertension (CTEPH) (WHO Group 4)
`that is inoperable or recurrent/persistent
`after surgery. The Aim Patient Support
`Program is comprised of the following 3
`components to help with the many
`different aspects of your Adempas
`treatment. Please read more about each
`piece below.
`
`The Adempas clinical studies included
`mostly patients with WHO functional
`class II-III symptoms. It is not known if
`Adempas is safe and effective in children.
`
`myAim Education and
`Encouragement
`
`With this Aim resource, you will
`receive helpful resources and
`personalized communications to
`provide you with information to
`support you during the very
`beginning, as well as throughout
`your Adempas treatment. This
`information may include:
`
`• Educational support through some of
`the key stages of Adempas treatment
`and what to expect along the way
`• Personalized treatment resources
`provided how and when you want
`them
`• Tips on what to talk to your doctor
`about
`• Information about other online
`resources and support
`
`Sign Up
`
`
`
`Aim Nursing Services
`
`http://www.adempas­us.com/support­every­step­of­the­way/
`
`2/10
`
`Page 2
`
`

`
`12/28/2015
`
`Adempas (riociguat) ­ Aim Patient Support Program Overview
`With this Aim resource, you have
`access to nurse advice and visits by
`telephone 24/7 as well as in your
`home.
`
`Toll-free assistance, 24/7
`
`• Representatives on-call to address your
`questions
`• Provided by your specialty pharmacy
`
`At-home nurse visits (as directed by
`your physician)
`
`• Administer a clinical assessment
`• Follow-up on your specific needs
`• Provide Adempas information
`
`Learn More
`
`
`
`Aim Financial Assistance
`
`With this Aim resource, you have
`access to financial support for
`treatment payment and
`coordination of lab visits.
`
`Co-pay Assistance Program*
`
`• Up to 100% coverage of co-pays or
`coinsurance directly to the insurer
`
`*Patients must have private commercial
`insurance with a percentage coinsurance or
`co-pay requirement. Medicare or Medicaid
`patients are ineligible. Assistance is for one
`year, after which, patients must re-apply.
`Patients must notify the program of any
`change in their insurance status. Patients in
`certain states may be ineligible. The co-pay
`assistance program has an annual cap per
`patient year.
`
`Temporary Patient Assistance
`http://www.adempas­us.com/support­every­step­of­the­way/
`
`3/10
`
`Page 3
`
`

`
`12/28/2015
`
`Adempas (riociguat) ­ Aim Patient Support Program Overview
`Temporary Patient Assistance
`Program (TPAP)
`
`• For temporary situations and
`uninsured or underinsured patients
`
`Patient Assistance Program (PAP)
`
`• Uninsured or underinsured patients
`can apply to receive medicine free of
`cost
`
`Learn More
`
`
`
`Additional resources
`• Lab coordination services (for females
`of reproductive potential only) to
`assist with scheduling and reminders
`
`For more information, call toll-free:
`1-855-4ADEMPAS
`(1-855-423-3672)
`
`Important Safety Information
`
`Adempas can cause serious birth
`defects if taken during pregnancy.
`
`• Females must not be pregnant when
`they start taking Adempas
`(riociguat) tablets or become
`pregnant during treatment with
`Adempas.
`
`• Females who are able to get pregnant
`must have a negative pregnancy test
`before beginning treatment with
`Adempas, each month during
`treatment, and 1 month after you stop
`treatment with Adempas. Talk to your
`doctor about your menstrual cycle.
`Your doctor will decide when to do the
`test.
`
`• Females who are able to get
`pregnant are females who:
`• Have entered puberty, even if
`http://www.adempas­us.com/support­every­step­of­the­way/
`
`4/10
`
`Page 4
`
`

`
`12/28/2015
`
`Adempas (riociguat) ­ Aim Patient Support Program Overview
`• Have entered puberty, even if
`they have not started their
`period, have a uterus, and have
`not gone through menopause
`(have not had a period for at
`least 12 months for natural
`reasons, or have had their
`ovaries removed).
`
`• Females who are not able to get
`pregnant are females who:
`
`• Have not yet entered puberty, do
`not have a uterus, or have gone
`through menopause.
`
`Females who are able to get pregnant
`must use two acceptable forms of birth
`control, during Adempas treatment and
`for one month after stopping Adempas.
`
`• If you have had a tubal sterilization,
`have a progesterone implant, or have
`an IUD (intrauterine device), these
`methods can be used alone and no
`other form of birth control is needed.
`
`• Talk with your doctor or gynecologist
`(a doctor who specializes in female
`reproduction) to find out how to
`prevent pregnancy during treatment
`with Adempas.
`
`• Do not have unprotected sex. Talk
`to your doctor or pharmacist right
`away if you have unprotected sex
`or if you think your birth control
`has failed. Your doctor may tell
`you to use emergency birth
`control.
`
`• Tell your doctor right away if you
`miss a menstrual period or think
`you may be pregnant for any
`reason.
`
`If you are the parent or caregiver of a
`female child who started taking Adempas
`before reaching puberty, you should
`check your child regularly to see if she is
`http://www.adempas­us.com/support­every­step­of­the­way/
`
`5/10
`
`Page 5
`
`

`
`12/28/2015
`
`Adempas (riociguat) ­ Aim Patient Support Program Overview
`check your child regularly to see if she is
`developing signs of puberty. Tell your
`doctor right away if you notice that she is
`developing breast buds or any pubic hair.
`Your doctor should decide if your child
`has reached puberty. Your child may
`reach puberty before having her first
`menstrual period.
`
`Females can only receive Adempas
`through a restricted program called the
`Adempas Risk Evaluation and Mitigation
`Strategies (REMS) program. If you are a
`female who can become pregnant, you
`must talk to your doctor, understand the
`benefits and risks of Adempas, and agree
`to all of the instructions in the Adempas
`REMS program. Males can receive
`Adempas without taking part in the
`Adempas REMS program.
`
`Do not take Adempas if:
`
`• you are pregnant, plan to become
`pregnant, or become pregnant
`during treatment with Adempas.
`Adempas can cause serious birth
`defects.
`
`• you take:
`
`• a nitrate medicine to treat high
`blood pressure or heart disease,
`such as nitroglycerin, or a medicine
`called a nitric oxide donor, such as
`amyl nitrite
`
`• certain other medicines that
`contain sildenafil (Revatio or
`Viagra), tadalafil (Adcirca or Cialis),
`vardenafil (Levitra or Staxyn),
`dipyridamole, or theophylline.
`Revatio and Adcirca are also used
`to treat PAH
`
`Ask your doctor or pharmacist if you are
`not sure if you take any of the
`medicines listed above.
`
`Before you take Adempas, tell your
`http://www.adempas­us.com/support­every­step­of­the­way/
`
`6/10
`
`Page 6
`
`

`
`12/28/2015
`
`Adempas (riociguat) ­ Aim Patient Support Program Overview
`Before you take Adempas, tell your
`doctor if you:
`
`• smoke; have recently had serious
`bleeding from your lungs, or if you
`have had a medical procedure called
`bronchial arterial embolization to stop
`you from coughing up blood; have
`problems with your heart or blood
`circulation; have low blood pressure;
`have liver problems; have kidney
`problems or are on dialysis; have
`narrowing of the pulmonary veins, a
`condition called pulmonary veno-
`occlusive disease or PVOD; have any
`other medical conditions.
`
`Tell your doctor about all the medicines
`you take, including prescription and
`non-prescription medicines, vitamins,
`and herbal supplements. Adempas and
`other medicines may affect each other
`causing side effects. Do not start any new
`medicine until you check with your doctor.
`
`What should I avoid while taking
`Adempas?
`
`• Do not get pregnant while taking
`Adempas. If you miss a menstrual
`period, or think you might be
`pregnant, call your doctor right away.
`
`• It is not known if Adempas passes into
`your breast milk. You should not
`breastfeed if you take Adempas. Talk
`to your doctor about the best way to
`feed your baby if you take Adempas.
`
`• Adempas may make you feel dizzy. Do
`not drive, operate machinery, or do
`other activities that require mental
`alertness or coordination until you
`know how Adempas affects you. Talk
`with your doctor if you are concerned
`about when it is safe for you to do
`these activities.
`
`• Smoking. Adempas may not work as
`
`well if you smoke during treatment.
`http://www.adempas­us.com/support­every­step­of­the­way/
`
`7/10
`
`Page 7
`
`

`
`12/28/2015
`
`Adempas (riociguat) ­ Aim Patient Support Program Overview
`well if you smoke during treatment.
`Tell your doctor if you stop smoking or
`start smoking during treatment with
`Adempas, because your dose of
`Adempas may need to be changed.
`
`Adempas can cause serious side effects
`including:
`
`• Serious birth defects.
`
`• Reduced blood pressure. This may
`cause symptoms of low blood pressure,
`such as lightheadedness, chest pain,
`and dizziness especially in people who
`are dehydrated, have a severe
`blockage of blood flow out of the
`heart, or have certain other medical
`problems. Your doctor will check you
`for any of these problems.
`
`• Increased risk of bleeding, including
`bleeding from the respiratory tract.
`Tell your doctor right away if you
`cough up blood during treatment with
`Adempas.
`
`• Worsening of symptoms in people
`with Pulmonary Veno-Occlusive
`Disease (PVOD). If you have PVOD,
`treatment with Adempas may cause a
`build-up of fluid in your lungs
`(pulmonary edema) which may result
`in shortness of breath. Your doctor
`may tell you to stop taking Adempas
`and switch you to a different medicine.
`
`The most common side effects of
`Adempas are:
`
`• Headache; dizziness; indigestion;
`swelling of your hands, legs, feet, and
`ankles (peripheral edema); nausea;
`diarrhea; and vomiting
`
`Tell your doctor if you have any side
`effect that bothers you or that does not
`go away. These are not all the possible
`side effects of Adempas.
`Indication
`http://www.adempas­us.com/support­every­step­of­the­way/
`
`8/10
`
`Page 8
`
`

`
`12/28/2015
`
`Adempas (riociguat) ­ Aim Patient Support Program Overview
`Indication
`
`Adempas is a prescription medicine
`used to treat adults with:
`
`• chronic thromboembolic pulmonary
`hypertension (CTEPH) (WHO Group 4)
`treated with surgery but who continue
`to have high pulmonary blood pressure
`(persistent) or it comes back after
`surgery (recurrent), or that cannot be
`treated with surgery.
`
`• CTEPH is a type of high blood
`pressure in the arteries of your
`lungs caused by blood clots that
`narrow or block blood flow.
`Adempas can improve your ability
`to exercise (measured by 6-minute
`walk distance) and can help to
`improve some of your symptoms.
`
`• pulmonary arterial hypertension (PAH)
`(WHO Group 1)
`
`• PAH is a type of high blood pressure
`in the arteries of your lungs.
`Adempas can improve your ability
`to exercise (measured by 6-minute
`walk distance), improve some of
`your symptoms, and help slow down
`the worsening of your physical
`condition [this includes death,
`heart/lung transplant, a surgery to
`reduce pressure in your lung,
`hospitalization for worsening of
`pulmonary hypertension, start of a
`new PAH-specific treatment,
`continued decline in your ability to
`exercise (measured by 6-minute
`walk distance) and some of your
`symptoms].
`
`The Adempas clinical studies included
`mostly patients with WHO functional
`class II-III symptoms. It is unknown if
`Adempas is safe and effective in children.
`
`For important risk and use information
`http://www.adempas­us.com/support­every­step­of­the­way/
`
`9/10
`
`Page 9
`
`

`
`12/28/2015
`
`Adempas (riociguat) ­ Aim Patient Support Program Overview
`For important risk and use information
`please see the full Prescribing
`Information, including Boxed Warning
`and Medication Guide.
`
`You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit
`www.fda.gov/medwatch or call 1-800-FDA-1088.
`
`BAYER, the Bayer Cross and Adempas are registered trademarks of Bayer. All other trademarks are property of their
`respective owners. These trademark owners are not affiliated with Bayer and do not sponsor or endorse Bayer or this
`product.
`
`Frequently Asked Questions
`Privacy Policy
`Terms of Use
`Contact Us
`Resources
`Prescribing Information
`Información de Prescripción
`Guia del Medicamento
`
`Site Last Modified: 9/2015
`©2015 Bayer HealthCare Pharmaceuticals. All rights reserved.
`
`http://www.adempas­us.com/support­every­step­of­the­way/
`
`10/10
`
`Page 10

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket