ENROLL A PATIENT

Updates to the Letairis patient enrollment process

What has changed?

Due to changes in the FDA-mandated REMS enrollment process, there are now two separate patient enrollment forms. To simplify the process, we also now offer paperless online enrollment, complete with digital signatures. To start the online patient enrollment process now, click here. Or, if you prefer to download the forms, follow the 3-step process below to complete a Letairis patient enrollment.

Step 1: Complete the Letairis REMS Patient Enrollment and Consent Form for ALL female patients
All female patients MUST complete the Letairis Patient Enrollment and Consent Form to enroll in the Letairis REMS Program prior to receiving treatment with Letairis.

Step 2: Complete the optional Letairis Prescription and LEAP Patient Support Enrollment Form
Both male and female patients should complete the Letairis Prescription and Letairis Education and Access Support Program (LEAP) enrollment form if they plan to participate in the support programs provided by LEAP. LEAP helps support both males and females with access to Letairis including: health insurance coverage, prior authorization support, financial support programs, insurance claim appeal support, and Certified Pharmacy coordination.

Step 3: Complete the enrollment process for male and female patients
Ensure all applicable forms are SIGNED and FAX them along with all patient insurance information, including drug benefit cards (front and back), to LEAP at 1-888-882-4035. Writable PDFs are available on this website that can be filled out electronically or printed, signed, and faxed to LEAP.

Also available: Online Patient Enrollment

  • Streamlined entry of information
  • Electronic signatures of both patients and prescribers
  • Electronic submission of forms directly to LEAP

Letairis REMS Program

Because of the risk of embryo-fetal toxicity, Letairis is only available to females under a restricted program under an FDA-required REMS. Males do not need to enroll in the Letairis REMS Program.

Overview of the Letairis REMS Program

  • Prescribers must enroll in the Letairis REMS Program and comply with the Letairis REMS Program requirements to prescribe Letairis
  • All female patients must enroll in the Letairis REMS Program to receive 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
  • Prescribers must order and review pregnancy tests for Females of Reproductive Potential prior to initiation of treatment, monthly during treatment, and for 1 month after stopping treatment

For more information, go to www.letairisREMS.com or call 1-866-664-5327.

Download the REMS enrollment form Close

Letairis Patient Support

LEAP helps support both males and females with access to Letairis including: health insurance coverage, prior authorization support, financial support programs, insurance claim appeal support, and Certified Pharmacy coordination.

By enrolling in LEAP, your patients are eligible for the following support programs:

Health insurance coverage determination

LEAP Case Specialists research each patient’s insurance coverage for Letairis and provide your patients with their coverage requirements.

Prior authorization support

If a patient’s insurance requires a prior authorization, LEAP Case Specialists can provide that information.

Financial support programs

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.

Insurance claim appeal support

If prescription coverage for Letairis is denied, LEAP Case Specialists can provide information about the appeals process.

Certified Pharmacy coordination

LEAP Case Specialists work with each Certified Pharmacy to help patients receive their Letairis as soon as possible.

Download the LEAP enrollment form Close
See other support programs offered for help with accessing Letairis

Important Safety Information & Indication

BOXED WARNING: EMBRYO-FETAL TOXICITY

  • 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
  • Exclude pregnancy before the initiation of treatment with Letairis. Females of reproductive potential must use acceptable methods of contraception during treatment with Letairis and for one month after treatment. Obtain monthly pregnancy tests during treatment and 1 month after discontinuation of treatment
  • Because of the risk of embryo-fetal toxicity, females can only receive Letairis through a restricted program called the Letairis REMS program

Contraindications

  • Pregnancy: Letairis can cause fetal harm
  • Idiopathic Pulmonary Fibrosis (IPF), including IPF patients with pulmonary hypertension (WHO Group 3)

Warnings and Precautions

  • Embryo-fetal toxicity and Letairis REMS Program requirements:
    • Prescribers must be certified with the program by enrolling in and completing training
    • All female patients, regardless of reproductive potential, must enroll in the Letairis REMS Program
    • Male patients are not enrolled in the program
    • Pharmacies must be certified with the program and must dispense to female patients who are authorized to receive Letairis

    Further information is available at www.letairisrems.com or 1-866-664-5327.

  • Peripheral edema: Peripheral edema is a known class effect of endothelin receptor antagonists, and is also a clinical consequence of PAH and worsening PAH. Further evaluate patients who develop clinically significant fluid retention to determine the cause and possible need for edema treatment or to discontinue Letairis. In clinical studies, peripheral edema was more common with Letairis than with placebo (most edema was mild to moderate in severity); and with Letairis plus tadalafil than with either drug alone. There have also been postmarketing reports of fluid retention occurring within weeks after starting Letairis that required a diuretic, fluid management, or hospitalization for decompensating heart failure
  • Pulmonary edema with pulmonary veno-occlusive disease (PVOD): Consider PVOD in patients who develop acute pulmonary edema during Letairis initiation and discontinue Letairis if PVOD is confirmed
  • Decreased sperm counts have been observed in patients taking endothelin receptor antagonists and in animal fertility studies with ambrisentan. Counsel patients about potential effects on fertility
  • Hematologic changes: Measure hemoglobin prior to initiation of Letairis, at 1 month, and periodically thereafter. Letairis initiation is not recommended for patients with clinically significant anemia. Consider discontinuing Letairis if clinically significant decreases in hemoglobin occur and other causes have been excluded. Decreases in hemoglobin and hematocrit have been observed within the first few weeks of Letairis treatment, which may persist during treatment. There have also been postmarketing reports of anemia requiring transfusion

Adverse Reactions

  • Most common adverse reactions when used as monotherapy compared to placebo were peripheral edema (17% vs 11%), nasal congestion (6% vs 2%), sinusitis (3% vs 0%) and flushing (4% vs 1%)
  • 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%)

Drug Interactions

  • Cyclosporine increases ambrisentan exposure by 2-fold, limit Letairis to 5 mg once daily

Use in Specific Populations

  • Breastfeeding: Choose Letairis or breastfeeding
  • Hepatic impairment: Letairis is not recommended in patients with moderate or severe hepatic impairment. Fully investigate cause of liver injury in patients who develop hepatic impairment; discontinue Letairis if liver aminotransferases are >5x ULN or if elevations are accompanied by bilirubin >2x ULN, or by signs or symptoms of liver dysfunction and other causes are excluded

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, or chew tablets
  • Pregnancy testing: Initiate Letairis in females of reproductive potential only after a negative pregnancy test. Obtain monthly pregnancy tests during treatment

Indication

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. Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).

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. The study establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (58%) or PAH associated with connective tissue diseases (36%).1

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%).

Please click to view full Prescribing Information, including BOXED WARNING.


Important Safety Information & Indication