Adempas (riociguat) | Aim Patient Support Program

ENCOURAGE YOUR PATIENTS TO STAY ON TRACK
WITH THE AIM PATIENT SUPPORT PROGRAM

As your patients start taking Adempas, they can rely on the resources and support of the Aim Patient Support Program, brought to you by Bayer.

Before your patients can start taking Adempas, they will need to first read, sign, and date the enrollment forms you have completed.

THE AIM PATIENT SUPPORT PROGRAM OVERVIEW

Bayer is committed to providing resources that can help patients with PAH (WHO Group 1) or CTEPH (WHO Group 4) that is inoperable or recurrent/persistent after surgery.

The Aim Patient Support Program is comprised of 3 components that address the different aspects of your patients’ Adempas treatment. Please read more about each part of the program below.

CTEPH=chronic thromboembolic pulmonary hypertension; PAH=pulmonary arterial hypertension; WHO=World Health Organization

AIM ACCESS AND FINANCIAL SUPPORT

Private Insurance/Commercial:

$0 Co-pay^*

Patients pay $0 regardless of income while on treatment

Quick-Start Program¹

Patients can initiate treatment while awaiting insurance approval
Patients receive Adempas at no cost for up to 90 days

Government and Uninsured/Underinsured

Patient Assistance Program²: Patients who are unable to afford their medication may be eligible to receive Adempas at no cost for 1 year
Independent Foundation Assistance: Patients requiring additional financial assistance for out-of-pocket costs will be referred to independent charitable organizations

All Patients

Adempas Hospital Program³: Patients who initiate treatment in the hospital can continue Adempas at no cost without interruption upon discharge; patients will receive treatment up to 90 days while awaiting insurance approval
Interim Assistance: Patients receive Adempas at no cost when immediate insurance coverage cannot be secured or there are gaps in coverage

AIM NURSING SUPPORT

At-home or virtual visits, as directed by you, the healthcare professional, including:

Clinical assessment
Explanation of titration
Disease information
Treatment education
24/7 hotline to address patient questions and refer them to additional resources

myAim EDUCATION + ENCOURAGEMENT

This resource includes:

Educational support through key stages of treatment and what to expect along the way
Personalized communications for patients and caregivers throughout treatment
Tips for your patients on what to talk with their doctors about
Information about other online resources and support

ENCOURAGE YOUR PATIENTS TO STAY ON TRACK WITH THE AIM PATIENT SUPPORT PROGRAM

As your patients start taking Adempas, they can rely on the resources and support of the Aim Patient Support Program, brought to you by Bayer.

Before your patients can start taking Adempas, they will need to first read, sign, and date the enrollment forms you have completed.

THE AIM PATIENT SUPPORT PROGRAM OVERVIEW

Bayer is committed to providing resources that can help patients with PAH (WHO Group 1) or CTEPH (WHO Group 4) that is inoperable or recurrent/persistent after surgery.

The Aim Patient Support Program is comprised of 3 components that address the different aspects of your patients’ Adempas treatment. Please read more about each part of the program below.

CTEPH=chronic thromboembolic pulmonary hypertension; PAH=pulmonary arterial hypertension; WHO=World Health Organization

AIM ACCESS AND FINANCIAL SUPPORT

Private Insurance/Commercial:

$0 Co-pay^*

Patients pay $0 regardless of income while on treatment

Quick-Start Program¹

Patients can initiate treatment while awaiting insurance approval
Patients receive Adempas at no cost for up to 90 days

Government and Uninsured/Underinsured

Patient Assistance Program²: Patients who are unable to afford their medication may be eligible to receive Adempas at no cost for 1 year
Independent Foundation Assistance: Patients requiring additional financial assistance for out-of-pocket costs will be referred to independent charitable organizations

All Patients

Adempas Hospital Program³: Patients who initiate treatment in the hospital can continue Adempas at no cost without interruption upon discharge; patients will receive treatment up to 90 days while awaiting insurance approval
Interim Assistance: Patients receive Adempas at no cost when immediate insurance coverage cannot be secured or there are gaps in coverage

AIM NURSING SUPPORT

At-home or virtual visits, as directed by you, the healthcare professional, including:

Clinical assessment
Explanation of titration
Disease information
Treatment education
24/7 hotline to address patient questions and refer them to additional resources

myAIM EDUCATION + ENCOURAGEMENT

This resource includes:

Educational support through key stages of treatment and what to expect along the way
Personalized communications for patients and caregivers throughout treatment
Tips for your patients on what to talk with their doctors about
Information about other online resources and support

MORE IMPORTANT SAFETY INFORMATION LESS IMPORTANT SAFETY INFORMATION

Important Safety Information and Indications

WARNING: EMBRYO-FETAL TOXICITY

Do not administer Adempas (riociguat) tablets to a pregnant female because it may cause fetal harm.

Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and one month after stopping treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment.

For all female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program.

Contraindications

Adempas is contraindicated in:

Pregnancy. Based on data from animal reproduction studies, Adempas may cause fetal harm when administered to a pregnant woman and is contraindicated in females who are pregnant. Adempas was consistently shown to have teratogenic effects when administered to animals. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form.
Concomitant administration with specific phosphodiesterase (PDE)-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE inhibitors (such as dipyridamole or theophylline) is contraindicated. Do not administer within 24 hours of sildenafil. Do not administer 24 hours before or within 48 hours after tadalafil.
Patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators.
Patients with Pulmonary Hypertension associated with Idiopathic Interstitial Pneumonias (PH-IIP).

Warnings and Precautions

Embryo-Fetal Toxicity. Based on data from animal reproduction studies, Adempas may cause embryo-fetal toxicity when administered to a pregnant female and is contraindicated in females who are pregnant. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment, monthly during treatment, and for one month after stopping treatment. Advise females of reproductive potential to use effective contraception during treatment with Adempas and for at least one month after the last dose.

For females, Adempas is only available through a restricted program under the Adempas REMS Program.

Adempas REMS Program. Females can only receive Adempas through the Adempas REMS Program, a restricted distribution program.

Important requirements of the Adempas REMS Program include the following:

Prescribers must be certified with the program by enrolling and completing training.
All females, regardless of reproductive potential, must enroll in the Adempas REMS Program prior to initiating Adempas. Male patients are not enrolled in the Adempas REMS Program.
Female patients of reproductive potential must comply with the pregnancy testing and contraception requirements.
Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive Adempas.

Further information, including a list of certified pharmacies, is available at www.AdempasREMS.com or 1-855-4ADEMPAS.

Hypotension. Adempas reduces blood pressure. Consider the potential for symptomatic hypotension or ischemia in patients with hypovolemia, severe left ventricular outflow obstruction, resting hypotension, autonomic dysfunction, or concomitant treatment with antihypertensives or strong CYP and P-gp/BCRP inhibitors. Consider a dose reduction if patient develops signs or symptoms of hypotension.

Bleeding. In the placebo-controlled clinical trials, serious bleeding occurred in 2.4% of patients taking Adempas compared to 0% of placebo patients. Serious hemoptysis occurred in 5 (1%) patients taking Adempas compared to 0 placebo patients, including one event with fatal outcome. Serious hemorrhagic events also included 2 patients with vaginal hemorrhage, 2 with catheter-site hemorrhage, and 1 each with subdural hematoma, hematemesis, and intra-abdominal hemorrhage.

Pulmonary Veno-Occlusive Disease. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Therefore, administration of Adempas to such patients is not recommended. Should signs of pulmonary edema occur, the possibility of associated PVOD should be considered and if confirmed, discontinue treatment with Adempas.

Most Common Adverse Reactions

The most common adverse reactions occurring more frequently (≥3%) on Adempas than placebo were headache (27% vs 18%), dyspepsia/gastritis (21% vs 8%), dizziness (20% vs 13%), nausea (14% vs 11%), diarrhea (12% vs 8%), hypotension (10% vs 4%), vomiting (10% vs 7%), anemia (7% vs 2%), gastroesophageal reflux disease (5% vs 2%), and constipation (5% vs 1%).

Other events that were seen more frequently in Adempas compared to placebo and potentially related to treatment were palpitations, nasal congestion, epistaxis, dysphagia, abdominal distension, and peripheral edema.

Indications

Adempas (riociguat) is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class.
Adempas is indicated for the treatment of adults with pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening.*

Efficacy was shown in patients on Adempas monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness included predominantly patients with WHO functional class II–III and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (25%).

^*Time to clinical worsening was a combined endpoint defined as death (all-cause mortality), heart/lung transplantation, atrial septostomy, hospitalization due to persistent worsening of pulmonary hypertension, start of new PAH-specific treatment, persistent decrease in 6MWD, and persistent worsening of WHO functional class.

For important risk and use information, please see the full Prescribing Information, including Boxed Warning.

SUPPORT
EVERY STEP OF THE WAY

SUPPORT
EVERY STEP OF
THE WAY

WARNING: EMBRYO-FETAL TOXICITY

SUPPORT EVERY STEP OF THE WAY

SUPPORT EVERY STEP OF THE WAY

WARNING: EMBRYO-FETAL TOXICITY

SUPPORT
EVERY STEP OF THE WAY

SUPPORT
EVERY STEP OF
THE WAY