How do I enroll a patient on Letairis?
The Letairis patient enrollment process To start a patient on Letairis, there are two separate patient enrollment forms. Follow the 3-step process below to complete a Letairis patient enrollment. Step 1: Complete the REMS Patient Enrollment and Consent Form for ALL female patients
How do I sign up for REMS for Letairis?
To complete the REMS enrollment for female patients, SIGN and FAX the REMS Patient Enrollment and Consent Form to 1-866-750-9802. Because of the risk of embryo-fetal toxicity, Letairis is only available to females through a restricted program under an FDA-required REMS.
What should I do if my Prescription for Letairis is denied?
If prescription coverage for Letairis is denied, LEAP Case Specialists can provide information about the appeals process. LEAP Case Specialists work with each Certified Pharmacy to help patients receive their Letairis as soon as possible. Do not administer Letairis to a pregnant female because it may cause fetal harm.
Can Letairis be used to treat pulmonary hypertension?
Obtain monthly pregnancy tests during treatment Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening; and in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.
How do you get Letairis?
Ready to get started on Letairis?Letairis is only available through a Certified Pharmacy and will be shipped directly to you. ... Your Certified Pharmacy will call you to coordinate your prescription. ... Sign for delivery when Letairis is shipped to your home.
How much does Letairis cost per month?
Letairis Coupon & Prices - Cost $49 per month.
How long does it take for Letairis to work?
How Long Does Letairis Take to Work? Letairis starts working soon after you take your first dose. It typically takes at least four weeks for people to notice an improvement in their ability to exercise.
What is Letairis used for?
Letairis (ambrisentan) is a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of the lungs.
Is Letairis covered by Medicare?
Part D covers most oral pulmonary hypertension (PH) medications, including Adcirca, Adempas, Letairis, Opsumit, Orenitram, Revatio, Tracleer and Veletri. *Flolan, Ventavis, Remodulin and Tyvaso are generally covered under Medicare Part B because of the use of durable medical equipment when administered.
Is there a generic for Letairis?
On April 11, 2019, Sun launched an AB-rated generic version of Gilead Sciences' Letairis (ambrisentan) tablets. — Mylan, Teva, Zydus, Par, and Sigmapharm received FDA approval of AB-rated generic versions of Letairis.
What drug class is Letairis?
Ambrisentan is in a class of medications called endothelin receptor antagonists. It works by stopping the action of endothelin, a natural substance that causes blood vessels to narrow and prevents normal blood flow in people who have PAH.
What type of drug is Letairis?
Ambrisentan (Letairis) is an endothelin receptor antagonist. It works on proteins in your body that control the bloodflow going to your lungs. This medication relaxes the arteries in your lungs and allows more blood to flow through.
What are side effects of ambrisentan?
Common side effects of Letairis include:stuffy nose,runny nose,sinus pain,headache,abdominal or stomach pain,vomiting,constipation,sore throat, or.More items...
Who makes Letairis?
It is likely that more than one manufacturer will produce generic forms of ambrisentan, the active ingredient in Letairis. Gilead Sciences, the manufacturer of Letairis, does not produce or sell a generic version of ambrisentan.
What is another name for ambrisentan?
Ambrisentan (U.S. trade name Letairis; E.U. trade name Volibris; India trade name Pulmonext by MSN labs) is a drug indicated for use in the treatment of pulmonary hypertension. The peptide endothelin constricts muscles in blood vessels, increasing blood pressure.
Does ambrisentan cause anemia?
Low red blood cell levels (anemia) can happen during the first weeks after starting Letairis. If this happens, you may need a blood transfusion.
What are the side effects of tadalafil?
Side EffectsArm, back, or jaw pain.chest pain, discomfort, tightness, or heaviness.cold sweats.faintness or lightheadedness when getting up suddenly from a lying or sitting position.fast or irregular heartbeat.increased erection.pain or discomfort in the arms, jaw, back, or neck.pounding in the ears.More items...•
Does Opsumit lower blood pressure?
Macitentan lowers blood pressure in your lungs, helping your heart pump blood more efficiently. Macitentan is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.
Is there a generic for Opsumit?
Is there a generic for Opsumit (macitentan)? Opsumit (macitentan) currently does not come in a generic form. There are two other drugs in the same medication class, bosentan (Tracleer) and ambrisentan (Letairis), that are used to treat PAH and available as generics.
What are the risks of Letairis?
Prescribers must educate and counsel Females of Reproductive Potential and Pre-Pubertal Females on the risks of Letairis, including the risk of serious birth defects. The parent/guardian of the Pre-Pubertal Female must also be educated and counseled on the risks of Letairis.
How to enroll in Leap?
To complete enrollment in LEAP for male and female patients, SIGN and FAX the Letairis Prescription and LEAP Patient Support Enrollment Form, along with all patient insurance information, including drug benefit cards (front and back), to LEAP at 1-888-882-4035.
What are the adverse reactions to tadalafil?
Most common adverse reactions in combination with tadalafil compared to Letairis or tadalafil monotherapy were peripheral edema (45% vs 38% or 28%), headache (41% vs 34% or 35%), nasal congestion (19% vs 16% or 11%), cough (18% vs 13% or 16%), anemia (15% vs 7% or 11%), dyspepsia (11% vs 3% or 12%), and bronchitis (10% vs 4% or 9%)
Is Letairis available to females?
Because of the risk of embryo-fetal toxicity, Letairis is only available to females through a restricted program under an FDA-required REMS. Males do not need to enroll in the REMS Program.
What does a LEAP case specialist do?
If a patient is uninsured, underinsured, or cannot afford the co-pay or co-insurance for Letairis, LEAP Case Specialists can identify and explain to the patient the potential support programs that may be available to help.
Can females receive Letairis?
Because of the risk of embryo-fetal toxicity, females can only receive Letairis through a restricted program called the Letairis REMS program
Can you get Letairis after a negative pregnancy test?
Pregnancy testing: Initiate Letairis in females of reproductive potential only after a negative pregnancy test. Obtain monthly pregnancy tests during treatment
What is Letairis used for?
Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.
What is the purpose of Letairis?
Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (64%) or PAH associated with connective tissue diseases (32%).
What are the adverse reactions to tadalafil?
Most common adverse reactions in combination with tadalafil compared to Letairis or tadalafil monotherapy were peripheral edema (45% vs 38% or 28%), headache (41% vs 34% or 35%), nasal congestion (19% vs 16% or 11%), cough (18% vs 13% or 16%), anemia (15% vs 7% or 11%), dyspepsia (11% vs 3% or 12%), and bronchitis (10% vs 4% or 9%)
What is the phone number for LEAP?
For questions about LEAP, call 1‐866‐664‐5327. Learn about financial support. Start a patient on Letairis. Review clinical results.
Can females receive Letairis?
Because of the risk of embryo-fetal toxicity, females can only receive Letairis through a restricted program called the Letairis REMS program
Can you get Letairis after a negative pregnancy test?
Pregnancy testing: Initiate Letairis in females of reproductive potential only after a negative pregnancy test. Obtain monthly pregnancy tests during treatment
Can you give Letairis to a pregnant woman?
Do not administer Letairis to a pregnant female because it may cause fetal harm. Letairis is very likely to produce serious birth defects if used by pregnant females, as this effect has been seen consistently when it is administered to animals
How many patients have been prescribed Letairis?from letairis.com
Did you know? More than 40,000 patients have been prescribed Letairis since FDA approval in 2007. Get the details here.
Who should not take Letairis?from letairis.com
You are pregnant, plan to become pregnant, or become pregnant while taking Letairis. Letairis can cause serious birth defects. (See "What is the most important information I should know about Letairis?")
What are the other possible side effects of Letairis?from letairis.com
Tell your doctor right away if you have any unusual weight gain, tiredness, or trouble breathing while taking Letairis. These may be symptoms of a serious health problem. You may need to be treated with medicine or need to go to the hospital
How to enroll in Leap?from letairis.com
To complete enrollment in LEAP for male and female patients, SIGN and FAX the Letairis Prescription and LEAP Patient Support Enrollment Form, along with all patient insurance information, including drug benefit cards (front and back), to LEAP at 1-888-882-4035.
How to report side effects of prescription drugs?from letairis.com
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
What does a certified pharmacy call you?from letairis.com
Your Certified Pharmacy will call you to coordinate your prescription. It is very important that you answer any calls from the Certified Pharmacy to avoid any potential delays in receiving your Letairis.
What does Leap do for Letairis?from letairis.com
LEAP can help you understand your insurance benefits for Leta iris, coordinate your monthly shipment with your certified pharmacy, and refer you to applicable financial support programs. You will need to provide the following: Your insurance information. Your signature on the form.
What is Accredo checklist?
Accredo has developed a checklist to assist you in completing the required clinical documentation for insurance approval for your PAH patients. This checklist is a tool to help remind you everything you need to submit along with the therapy referral form. Our experience has shown that patients get approved quicker when all of the required documentation is submitted along with the referral form. In certain instances we may require additional supporting documentation when there is a presence of other disease comorbidities for example.
Do you need to submit a checklist with a referral?
Please note: the checklist is only a tool and is not required to be submitted along with the referral form and the clinical documentation.
What is the drug class of Letairis?
Letairis (ambrisentan) is a member of the agents for pulmonary hypertension drug class and is commonly used for Pulmonary Hypertension.
What is REMS in Letairis?
All Females must enroll in the Letairis Risk Evaluation and Mitigation Strategy (REMS) Program prior to receiving treatment with Letairis. Co-payment assistance, patient support, and patient assistance programs are available for eligible patients. Applicable drugs:
Is Letairis a generic?
Prices are for cash paying customers only and are not valid with insurance plans. A generic version of Letairis is available, see ambrisentan prices. This Letairis price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies.
Boxed Warning: Embryo-Fetal Toxicity
Contraindications
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
Dosage and Administration
- Adult dosage:Initiate Letairis 5 mg once daily, with or without tadalafil 20 mg once daily. At 4-week intervals, consider either increasing to Letairis 10 mg or tadalafil 40 mg. Do not split, crush...
- Pregnancy testing:Initiate Letairis in females of reproductive potential only after a negative pregnancy test. Obtain monthly pregnancy tests during treatment