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.

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.

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ADEMPAS REMS PATIENT ENROLLMENT AND CONSENT FORM — FEMALES ONLY

The Adempas REMS is a program to tell patients and healthcare providers about the serious risks of birth defects while taking Adempas. This program is required by the Food and Drug Administration. All females must enroll in this program to receive Adempas. Obtain female patient signature and date, as the enrollment form CANNOT be processed without female patient signature.

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REMS=Risk Evaluation and Mitigation Strategy

ADEMPAS REMS PRESCRIBER AND PHARMACY ENROLLMENT FORMS

Physicians are required to enroll in the Adempas REMS program in order to prescribe Adempas and hospital pharmacies are required to enroll in the Adempas REMS program to dispense Adempas to patients admitted as inpatients.

PRESCRIBER ENROLLMENT INPATIENT ENROLLMENT

ADEMPAS HOSPITAL PROGRAM CHECKLIST

This form is only for patients who begin treatment in the hospital. Once you have enrolled them, a specialty pharmacy rep will help set up continued treatment with Adempas after discharge. If your patients want this service, they will need to sign their consent before you submit the form.

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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.

FEMALE PATIENTS

In addition to the Adempas Prescription and Patient Support Program Enrollment Form, fill out the Adempas REMS Form.
Make sure patients sign and date the forms.
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. teste
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.

QUICK START GUIDE TO ENROLLMENT

ALL PATIENTS

FEMALE PATIENTS

HOSPITAL PATIENTS

Fill out the Adempas
Prescription and Patient Support
Program Enrollment Form.

In addition to the Adempas
Prescription and Patient Support
Program Enrollment Form, fill out
the Adempas REMS Form.

Fill out the Adempas
Hospital Program Checklist
Enrollment Form.

Make sure patients sign
and date the form.

Make sure patients sign
and date the forms.

Make sure patients sign
and date the form.

Use the prescription form
to enroll in the Aim Patient
Support Program, if desired.

To enroll, fax the completed
form, along with the
patient’s insurance card,
to the fax number below.

Submit according to instructions
below, and remember to
include a copy of the
patient’s insurance card.

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

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.

PATIENT ENROLLMENT OVERVIEW AND FORMS

INITIATING ADEMPAS TREATMENT

WARNING: EMBRYO-FETAL TOXICITY

PATIENT ENROLLMENT
OVERVIEW AND FORMS