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Start them off with Adempas

Adempas is the first and only treatment for adult patients with PAH (WHO Group 1)
and inoperable or persistent/recurrent CTEPH (WHO Group 4) after surgery.1*

*Studies establishing effectiveness included predominantly patients with WHO functional class II–III.1

CTEPH=chronic thromboembolic pulmonary hypertension; PAH=pulmonary arterial hypertension; WHO=World Health Organization
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    I’M LOOKING FOR

    PATIENT
    ENROLLMENT FORMS

     

    Review the patient enrollment process and download the necessary forms.

     

    TREATMENT STARTS
    WITH SETTING GOALS

     

    Get information on prognostic evaluation and risk assessment for your patients with PAH by using the 2015 ESC/ERS Guidelines for every office visit.2

    ERS=European Respiratory Society

    ESC=European Society of Cardiology

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    SUPPORT EVERY STEP OF THE WAY

     

    With the Aim Patient Support Program, your Adempas patients are covered every step of the way. Here, you can find all of the resources for your patients on their journey. The Aim Patient Support Program is comprised of 3 components: myAim Education and Encouragement, nursing support, and access and financial support.

     

    REAL PATIENTS WITH REAL STORIES

     

    Throughout treatment, it is important that your PAH and CTEPH patients know they are not alone and can connect with people who are living with their conditions. Read about different patient experiences and become more aware about the struggles of their everyday lives and how Adempas can help.

     
     
    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.

    Welcome to the Adempas® website

    Adempas® (riociguat) is a soluble guanylate cyclase (sGC) stimulator, the first member of a distinct class of compounds, discovered and developed by Bayer as an oral treatment to target a key molecular mechanism underlying pulmonary hypertension (PH).1,2

    Riociguat is approved to treat different types of PH in adults with:

    • inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

    • persistent or recurrent CTEPH after surgery to improve exercise capacity

    • pulmonary arterial hypertension (PAH with WHO functional class II to III, to improve exercise capacity), idiopathic or PAH associated with connective tissue diseases.1-3

     

    It is the first drug demonstrating robust and sustained clinical efficacy in two separate PH groups.1,2,11-14

    PH is a severe, progressive, and life-threatening disorder of the lungs and heart characterized by elevated blood pressure in the pulmonary arteries, which can lead to right heart failure and death if left untreated.6,7 There are five types of PH; each can affect the patient in a different way and every patient may have a different etiology of PH.8-10

     

    Adempas® has a dual mode of action – directly stimulating sGC independently of endogenous nitric oxide (NO) and also facilitating the binding of any remaining endogenous NO to sGC .1,2,15 Patients with CTEPH and PAH are often nitric oxide deficient; this results in sGC being under-stimulated and is associated with a poor prognosis.16-18 For patients with CTEPH and PAH, sGC stimulation is fundamental for providing treatment success and helping to regulate vascular tone, proliferation and inflammation.16-18

    Read more
    Adempas<sup>®</sup> restores NO-sGC-cGMP pathway and decreases endothelial dysfunction

     

    Starting Adempas®

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    How it works

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    Disclaimer: Please refer to your country’s specific Adempas® label and prescribing information, as they can differ from the Adempas® Expanded Company Core Data Sheet used to reference this global website.

    References

    References:
    1. Adempas Prescribing Information. Whippany, NJ. Bayer Pharmaceuticals Inc., 2021.
    2. Galiè N, Humbert M, Vachiery JL, et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Heart J. 2016;37(1):67-119.

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    Site Last Modified: 12/2022

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