FOR PATIENTS

Important Safety Information 

Getting Started

Sandoz Treprostinil Injection is provided by a specialty pharmacy (SP) that is staffed by nurses and pharmacists with specific training for pulmonary arterial hypertension (PAH). Your SP has years of experience supporting people with PAH and medicines like Treprostinil Injection.

Your SP can provide

•  Specialized education from pharmacists and nurses
•  Support for understanding options to help address side effects*
•  In-home or office visits to help you learn how to use Treprostinil Injection
•  Help understanding your insurance and financial assistance options
•  Answers to your questions 24/7
* Contact your healthcare provider for medical advice about managing side effects.

The SP may call from a phone number that you don’t recognize. Be sure to answer the phone and return phone calls.

Delays can occur if the SP has trouble reaching you.

Treprostinil Injection is currently available at

Accredo Health Group, Inc.

Phone 1-866-344-4874

Financial support for Treprostinil Injection

Treprostinil Injection co-payment assistance may be available for people who qualify. If you are eligible, you may pay as little as $0 per prescription filled for Treprostinil Injection, with up to $8000 annually in assistance available.

For information about how to receive co-payment assistance, call the Sandoz Treprostinil Injection Savings Program toll-free at 1-877-251-4947 or .

Sandoz Treprostinil Injection Savings Program Eligibility

The Sandoz Treprostinil Injection Savings Program provides up to $8,000 in annual support for patient cost-sharing for prescriptions filled with Sandoz Treprostinil Injection. For commercially insured patients, you may pay a co-pay as low as $0 out-of-pocket per Treprostinil Injection prescription filled. You pay the first co-pay for your Treprostinil Injection and Sandoz will pay the balance of your cost-sharing up to $8,000 per year. This program is not health insurance. This program is for commercially-insured patients only; uninsured cash-paying patients are not eligible. Patients are not eligible if prescriptions are paid, in whole or in part, by any state or federally funded programs, including but not limited to Medicare (including Part D, even in the coverage gap) or Medicaid, Medigap, VA, DOD, or TriCare, or private indemnity, or HMO insurance plans that reimburse you for the entire cost of your prescription drugs, or where prohibited by law. Card may not be combined with any other rebate, coupon, or offer. Card has no cash value. Sandoz reserves the right to rescind, revoke, or amend this offer without further notice.

Learn more about pulmonary arterial hypertension

The (PHA) is an organization for people who are affected by PAH. You’ll find information about PAH, education, support groups, resources for people with PAH and their families, and more.

The (AHA) is an organization dedicated to fighting heart disease and stroke. The AHA provides information about your heart and lungs and about PAH.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

•  Treprostinil Injection can be delivered using a tube placed in a big blood vessel (vein) within the chest. This type of delivery is associated with the risk of bloodstream infections and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion delivered just beneath the skin is the preferred method of delivery.
•  You should not stop or change your Treprostinil Injection dose without consulting your doctor first, as this may cause your PAH symptoms to worsen.
•  Treprostinil Injection acts by lowering your blood pressure. In some cases, your blood pressure may become too low and cause other side effects. If you also take other drugs that lower your blood pressure, the risk is increased. You should discuss all of your symptoms with your doctor, including those associated with low blood pressure.
•  If you have liver problems, your ability to tolerate Treprostinil Injection may be affected.
•  Because Treprostinil Injection can reduce the blood's ability to clot, it may increase your risk of bleeding, especially if you are taking anticoagulants (blood thinners).
•  Other medical conditions and medicines may affect your use of Treprostinil Injection by increasing the risk of side effects or decreasing the drug's effectiveness. It is important to tell your doctor about your medical conditions and any medicines you may be taking.

ADVERSE REACTIONS

During clinical trials with SC infusion of treprostinil, infusion site pain and infusion site reaction (e.g., redness of the skin, hardness of the skin, or rash) were the most common adverse events and occurred in the majority of those treated with treprostinil. Infusion site reactions were sometimes severe and led to discontinuation of treatment. Rash and low blood pressure (14% and 4%, respectively) were also commonly reported with SC infusion of treprostinil. Other common adverse events (≥3% more than placebo) with either SC or IV treprostinil included headache, diarrhea, jaw pain, edema (swelling), vasodilatation (widening of the blood vessels), and nausea. The adverse reactions with treprostinil IV included bloodstream infections, arm swelling, tingling or prickling sensation, bruising, and pain.

DRUG INTERACTIONS

If you are taking gemfibrozil (for high cholesterol), rifampin (for infection), or other drugs that affect liver enzymes, your doctor may need to adjust your Treprostinil Injection dosage.

USE IN SPECIFIC POPULATIONS

If you are pregnant, planning to become pregnant, or breast-feeding, talk with your doctor about whether you should use Treprostinil Injection.

Please see full for Treprostinil Injection.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit or call 1-800-FDA-1088 or contact Sandoz Inc. at 1-800-525-8747.

INDICATION

Treprostinil Injection is a prescription medication used in adults with pulmonary arterial hypertension (PAH), World Health Organization (WHO) Group 1, to reduce symptoms associated with exercise. PAH is high blood pressure in the arteries of your lungs. Treprostinil was studied mainly in patients with New York Heart Association (NYHA) Functional Class II-IV symptoms.

In people with PAH who need to switch from epoprostenol sodium, Treprostinil Injection is approved to slow the worsening of symptoms. The risks and benefits of each drug should be carefully considered before switching.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

•  Treprostinil Injection can be delivered using a tube placed in a big blood vessel (vein) within the chest. This type of delivery is associated with the risk of bloodstream infections and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion delivered just beneath the skin is the preferred method of delivery.
•  You should not stop or change your Treprostinil Injection dose without consulting your doctor first, as this may cause your PAH symptoms to worsen.
•  Treprostinil Injection acts by lowering your blood pressure. In some cases, your blood pressure may become too low and cause other side effects. If you also take other drugs that lower your blood pressure, the risk is increased. You should discuss all of your symptoms with your doctor, including those associated with low blood pressure.
•  If you have liver problems, your ability to tolerate Treprostinil Injection may be affected.
•  Because Treprostinil Injection can reduce the blood's ability to clot, it may increase your risk of bleeding, especially if you are taking anticoagulants (blood thinners).
•  Other medical conditions and medicines may affect your use of Treprostinil Injection by increasing the risk of side effects or decreasing the drug's effectiveness. It is important to tell your doctor about your medical conditions and any medicines you may be taking.

ADVERSE REACTIONS

During clinical trials with SC infusion of treprostinil, infusion site pain and infusion site reaction (e.g., redness of the skin, hardness of the skin, or rash) were the most common adverse events and occurred in the majority of those treated with treprostinil. Infusion site reactions were sometimes severe and led to discontinuation of treatment. Rash and low blood pressure (14% and 4%, respectively) were also commonly reported with SC infusion of treprostinil. Other common adverse events (≥3% more than placebo) with either SC or IV treprostinil included headache, diarrhea, jaw pain, edema (swelling), vasodilatation (widening of the blood vessels), and nausea. The adverse reactions with treprostinil IV included bloodstream infections, arm swelling, tingling or prickling sensation, bruising, and pain.

DRUG INTERACTIONS

If you are taking gemfibrozil (for high cholesterol), rifampin (for infection), or other drugs that affect liver enzymes, your doctor may need to adjust your Treprostinil Injection dosage.

USE IN SPECIFIC POPULATIONS

If you are pregnant, planning to become pregnant, or breast-feeding, talk with your doctor about whether you should use Treprostinil Injection.

Please see full for Treprostinil Injection.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit or call 1-800-FDA-1088 or contact Sandoz Inc. at 1-800-525-8747.