Adempas ® (Riociguat)

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What is Adempas?

Adempas is the first and only medicine approved by the FDA to treat adults with:

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.

How far might Adempas take you?

Adempas can help increase your ability to walk farther and improve some of your symptoms. Patients with PAH and CTEPH taking Adempas were able to walk farther in a 6-minute walk distance (6MWD) test than patients taking a placebo (no Adempas) in the following studies:

As you begin your treatment journey, it’s important to remember that there are others who are on similar paths.

Lauren’s journey is now here:

How is Adempas administered?

Here are the basics:

  • Adempas will be provided to you by a certified pharmacy. Your doctor will give you complete details.
  • Always take Adempas exactly as your doctor tells you.
  • Adempas is taken 3 times each day, about 6 to 8 hours apart, with or without food.
  • If you can’t swallow whole tablets, you can crush and mix Adempas with water or soft foods, such as applesauce, immediately before administration.
  • If you miss a dose, take your next dose at the regular time.
  • If you take a heartburn medicine (antacid) that contains aluminum hydroxide or magnesium hydroxide, do not take it within 1 hour of taking Adempas.
  • Do not take Adempas within 24 hours of sildenafil. Do not take Adempas 24 hours before or within 48 hours after tadalafil.
  • Do not take more than a total of 7.5 mg of Adempas in one day unless your doctor tells you to.

View the Adempas Dosing Guide.

Your doctor might adjust your dose.

The Adempas starting dose is 0.5 mg or 1 mg. During the first weeks, your doctor may change your dose. When you begin treatment, your blood pressure should be monitored about every 2 weeks to help your doctor decide the correct dose of medicine for you. It is important to tell your doctor if you have any symptoms of low blood pressure during this time, such as dizziness, lightheadedness, or fainting.

Available Doses:

Starting dose options

Adempas comes in tablets that are taken 3 times a day

When to contact your doctor

Call your doctor if you:

  • Have symptoms of low blood pressure such as dizziness, lightheadedness, or fainting
  • Ever experience any adverse side effects
  • Take too much Adempas
  • Miss 3 or more days of Adempas
  • Stop or start smoking
  • Are a female patient and miss a menstrual period, think you may be pregnant, or have questions about feeding your baby (it is not known if Adempas passes into your breast milk).

Always take Adempas exactly as your doctor tells you. Don’t stop taking it or change your dose without talking to your doctor.

Can’t swallow whole tablets?

If you are unable to swallow whole tablets, Adempas may be crushed and mixed with water or soft foods (such as applesauce) immediately before administration.

Medication Guide for Patients

Adempas Side Effect Management

  Side Effect Severity

Mild

Moderate

Severe

Likely (>10%)

Headache (27%)
Dyspepsia and Gastritis (21%)

Nausea (14%)
Dizziness (20%)
Diarrhea

Less Likely (1-10%)

Anemia (7%)
Constipation (5%)
Gastroesophageal Reflux Disease (5%)

Hypotension (10%)
Vomiting (10%)

Bleeding (2%)
Hemoptysis (2%)

Rare (<1%)

 

The most common side effects of Adempas and some simple solutions include:

  • Headache: Consider taking Acetaminophen (Tylenol ®)
  • Dizziness: Discuss with your health care provider, you may be dehydrated, taking too many blood pressure medications, or you may need to decrease Adempas dose
  • Indigestion: Consider taking with food and water, if not, consider taking over the counter heartburn medications such as H2 Blockers (cimetidine -Zantac ®, ranitidine (Pepcid ®) or proton pump inhibitors (omeprazole-Prilosec ®)
  • Nausea/Vomiting: Start with suggestions for indigestion and ask your health care provider for anti-Nausea medications.
  • Diarrhea: Consider a change in diet.Take loperamide (Imodium ®) as directed and if not enough, ask for stronger daily anti-diarrheal from your health care provider.
  • Swelling of your hands, legs, feet, and ankles (peripheral edema);
  • Tell your doctor if you have any side effect that bothers you or that does not go away.

Hypotension is a possible adverse effect. It could happen during up-titration phase. This could possibly be treated with reverting to lower dose, decreasing or removing hypertensive medications, gentle hydration. Please report this to your health care provider and explore other causes.

Starting a New Medication

A new medication for you today. Specialty medications are different from regular prescriptions, as you may not pick them up from your local pharmacy. Specialty medications acquisition require more steps than a regular prescription. The process is as follows:

  • The prescription is filled out on a form called a Referral. The physician will sign the form and it gets faxed to the manufacturers’ “Hub”. You may be asked to sign the form, as well.
  • Once the Hub receives the referral, they will verify your benefits with your current insurance. This helps them know which Specialty Pharmacy is in network with your insurance. The Hub will fax our office a Prior Authorization for the medication. Every Specialty Medication requires a Prior Authorization.
  • Prior Authorization is submitted to your insurance and they will review to see if it meets their criteria for approval. The process can take up to a couple of weeks depending on your insurance. If for some reason the insurance decides not to approve your medication, we will look to see why they made this decision and try to appeal this decision.
  • It is possible that your insurance will require a copay. In the case the copay is significant and you cannot afford the amount, you can ask special foundations for copay assistance. Non-Medicare patients can directly apply for assistance from the drug company manufacturing the drug. You will find more information in the Financial Assistance tab of this web page. Your physician’s office can also guide you in this matter. In spite of sometimes a hefty copay, through a variety of channels, patients usually are able to afford these specialty drugs- it does take some work by you to apply. You may receive phone calls during this time from the hub, the pharmacy, the drug company or assistance foundations to verify your income and assets. Please cooperate with them, they just want to help!
  • Once the medication is approved, the Specialty Pharmacy will be ready to ship it to you. You will receive a phone call from the Hub and/or from the Specialty Pharmacy. These will likely be 1-800 numbers. You have to answer the phone in order for them to be able to ship your medication to you. Please call them back. The medication will be mailed to your home address. Some medications require that a nurse from the Specialty Pharmacy visit you while you are taking the medication, your clinician will discuss this in detail if it applies to you.
  • You should work with all members of your Care Team during this process. This includes your physician, office nurse, Specialty Pharmacy staff (Pharmacist and Nurse).
Financial Support

Aim Patient Support Program

Your health care provider will help enroll you by the forms you sign during initiation.

Your health care provider will help enroll you by the forms you sign during initiation.

The Aim Patient Support Program is here to help you learn more and provide you with support, including financial assistance. For more information, call toll-free: 1-855-4ADEMPAS (1-855-423-3672) or learn about what resources are available to you below.

 

Co-pay Assistance Program
  • Reduce out-of-pocket costs: up to 100% of co-pays or coinsurance paid 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 program has an annual cap per patient year.

 

Patient Assistance Program (PAP)
  • If you are uninsured or underinsured (when criteria are met and alternative funding cannot be identified), you will receive your medicine free of cost for 1 year from the date of acceptance (Medicare Part D patients will be enrolled based on calendar year if eligible for the PAP)

Your health care provider will help enroll you by the forms you sign during initiation.

 

Non-profit charitable assistance funds:

We maintain an updated list and verify if funding is available on a weekly basis.

For Medicare and Medicaid patients, the following foundations may be able to assist with copay support. It may take some work by you to apply. Your physician’s office, the Hub or specialty pharmacy contacts may help you through this. (See Starting a New Medication Tab)

Click here to see foundations.

 

 

Patient Support

As you start taking Adempas, you can rely on the resources and support of the Aim Patient Support Program, brought to you by Bayer.
Before you can start taking Adempas, you will need to first read, sign, and date the enrollment forms your doctor has completed.

Aim Patient Support Program

The Aim Patient Support Program is here to help you learn more and provide you with support. For more information, call toll-free: 1-855-4ADEMPAS (1-855-423-3672) or learn about what resources are available to you in the link bellow:
Aim Patient Support Program

Patient Support Groups

Through Pulmonary Hypertension Association, find a support group close to you.

Expectations

Pulmonary Arterial Hypertension is a serious condition. The medications designed to fight the disease typically show benefit slowly, over months, with most needing 4 to 6 months for maximum effect. The adverse effects (Side-effects) of these medications, however happen upfront. Your body typically will get used to them either with time, or with additional natural remedy or drugs. This may also take 2 to 3 months. It is necessary that you have patience, and talk to your doctor or nurses about dealing with them. Sometimes slowing the planned increase or cutting down on medication for a while will allow your body to adjust. Discuss matters with your doctors’ office before taking action of your own. Patience is a virtue!

Resources
Resources from Bayer

Aim Patient Support Program

The Aim Patient Support Program is here to help you learn more and provide you with support. For more information, call toll-free: 1-855-4ADEMPAS (1-855-423-3672) or learn more online here.

Pulmonary Hypertension Association

Learn about new treatments and ways to cope with pulmonary hypertension and connect with other patients and caregivers.

American Heart Association

The American Heart Association is the nation’s oldest and largest voluntary organization devoted to fighting cardiovascular diseases.

The National Heart, Lung, and Blood Institute (NHLBI)

Global leadership for research, training, and education for the prevention and treatment of heart, lung, and blood diseases.

Disability

Important resource for information on disability, linking to over 14,000 resources from government, academic, and nonprofit institutions.

Medicaid

Resource for state-administered healthcare programs.

Medicare

The official US government site for Medicare.

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