`
`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
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`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
`
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`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
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`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
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`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
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`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
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`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.
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`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
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`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
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`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
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`Guia del Medicamento
`
`Site Last Modified: 9/2015
`©2015 Bayer HealthCare Pharmaceuticals. All rights reserved.
`
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