INITIATING ADEMPAS TREATMENT

Before you can get your patients started with Adempas, you must fill out the forms found below. Within the Adempas Prescription Form, your patients may choose to enroll in the Aim Patient Support Program for support throughout their treatment journey.

Resources to help you diagnose, assess, and treat
your patients

GUIDES

Downloadable Adempas® (riociguat) dosing guidelines

ADEMPAS DOSING GUIDELINES

For any dosing questions you may have

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ADAPTED ESC/ERS GUIDELINES

Help diagnose and assess patients with PAH (WHO Group 1)

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ADEMPAS PATIENT DOSING GUIDE

A dosing guide to share with your patients

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FORMS TO GET YOUR PATIENTS STARTED

ADEMPAS PRESCRIPTION AND PATIENT SUPPORT PROGRAM ENROLLMENT FORM

All patients must sign and date the form to receive any Bayer services or communications. Patients can choose to opt in to allow information to be shared with third parties such as pharmacies, insurance companies, and Bayer. The optional patient consent allows patients to take advantage of the Aim Patient Support Program resources. They can still take Adempas if they do not opt in, but they will not receive any myAim or other communications. For Veterans Affairs (VA) patients, please complete the VA patients enrollment form.

DOWNLOAD SPANISH VA PATIENTS

ADEMPAS LETTER OF MEDICAL NECESSITY AND DIRECTIONS

This template and its accompanying directions can help you navigate barriers towards keeping your patients on branded Adempas and avoid delays in receiving treatment.

LETTER OF MEDICAL NECESSITY TEMPLATE

LETTER OF MEDICAL NECESSITY DIRECTIONS

ADEMPAS LETTER OF APPEAL AND DIRECTIONS

This template and its accompanying directions can help you navigate barriers toward keeping your patients on branded Adempas following payer denial.

LETTER OF APPEAL TEMPLATE

LETTER OF APPEAL DIRECTIONS

QUICK START GUIDE TO ENROLLMENT

ALL PATIENTS

Fill out the Adempas Prescription and Patient Support Program Enrollment Form
Make sure patients sign and date the form.
Use the prescription form to enroll in the Aim Patient Support Program, if desired.
Submit according to instructions below, and remember to include a copy of the patient’s insurance card.

HOSPITAL PATIENTS

Fill out the Adempas Hospital Program Checklist Enrollment Form.
Make sure patients sign and date the form.
To enroll, fax the completed form, along with the patient’s insurance card, to the fax number below.
A specialty pharmacy rep will contact patients to set up shipments of the medication to their home.

ENROLL ONLINE AND BEGIN TREATMENT

ENROLL ONLINE

Online enrollment is fast and secure—simply fill out the forms and sign electronically. Please note, the e-signature process requires both prescriber and patient email addresses. Start the online enrollment process below.

ENROLL ONLINE

OTHER WAYS TO ENROLL

Submit your forms to the Hub via fax (1-855-662-5200), email, or the physician portal.

For more information, call toll-free: 1-855-4ADEMPAS (1-855-423-3672).

MORE IMPORTANT SAFETY INFORMATION LESS IMPORTANT SAFETY INFORMATION

Important Safety Information and Indications

WARNING: EMBRYO-FETAL TOXICITY

Adempas is contraindicated for use during pregnancy because it may cause fetal harm based on animal data.

Exclude pregnancy prior to the start of treatment with Adempas. Advise use of effective contraception prior to initiation of treatment, during treatment, and for one month after treatment with Adempas.

If pregnancy is detected, discontinue Adempas as soon as possible.

Contraindications

Use of Adempas is contraindicated in patients who are pregnant.
Co-administration of Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated.
Concomitant administration of Adempas 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.
Adempas is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators.
Adempas in contraindicated in 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 fetal harm when administered to a pregnant patient and is contraindicated during pregnancy. The available human data for riociguat do not establish the presence or absence of major birth defects related to the use of Adempas. Counsel patients who can become pregnant on the potential risk to a fetus. Exclude pregnancy prior to initiation of treatment with Adempas. Advise females of reproductive potential to use effective contraception prior to initiation of treatment, during treatment with Adempas and for at least one month after the last dose. When pregnancy is detected, discontinue Adempas as soon as possible.

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.

RESOURCES + FORMS

INITIATING ADEMPAS TREATMENT

Resources to help you diagnose, assess, and treatyour patients

WARNING: EMBRYO-FETAL TOXICITY

Resources to help you diagnose, assess, and treat
your patients