How to Get LETAIRIS
The LETAIRIS Education and Access Program (LEAP) is a program to help prescribers and patients learn about the risks of LETAIRIS, including the serious risks of liver injury and birth defects. Because of the risk of liver injury, and in an effort to make the chance of fetal exposure to LETAIRIS as small as possible, LETAIRIS may be prescribed only through LEAP by calling 1-866-664-LEAP (5327).
LEAP works by:
- Providing information to prescribers on the risks of LETAIRIS
- Providing comprehensive education to patients and assistance with obtaining LETAIRIS
- Requiring enrollment of both prescriber and patient in LEAP
- Controlling dispensing through a specialized distribution network (specialty pharmacies)
LEAP Overview
The Prescriber:
- Completes a Prescriber Enrollment and Agreement Form and faxes it to LEAP
- Counsels each patient on the risks of LETAIRIS treatment
- Reviews the patient Medication Guide and patient education brochure with the patient
- Orders and reviews liver function tests (including aminotransferases and bilirubin) and pregnancy tests prior to initiating treatment with LETAIRIS and monthly during treatment
- Orders and reviews hemoglobin concentrations and hematocrit prior to initiating treatment with LETAIRIS, at 1 month, and periodically thereafter
- Assists patient with choosing a specialty pharmacy
- Completes a Patient Enrollment and Consent Form for each patient and faxes it to LEAP
- Re-enrolls appropriate patients after the first 12 months of treatment and annually thereafter
LEAP:
- Enters every LETAIRIS prescriber and patient in the LEAP database
- Along with the specialty pharmacy, LEAP confirms insurance coverage or investigates alternative sources of reimbursement or assistance
- Sends patient information to the chosen specialty pharmacy
The Specialty Pharmacy:
- Files the insurance claim
- Contacts patients each month to obtain confirmation that they completed the required testing
- Answers questions and provides information about LETAIRIS
- Ships LETAIRIS to the patient
The following is a list of participating specialty pharmacies:
INDICATION: LETAIRIS is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO Class II or III symptoms to improve exercise capacity and delay clinical worsening.
Clinical worsening was defined as the first occurrence of death, lung transplantation,
hospitalization for PAH, atrial septostomy, study withdrawal due to the addition of other
PAH therapeutic agents, or study withdrawal due to early escape1
Early escape criteria were two or more of the following after a minimum treatment
period of 4 weeks: ≥20% decrease in 6MWD; worsening WHO functional class;
worsening right ventricular failure; rapidly progressing cardiac, hepatic, or renal failure;
and refractory systolic hypotension <85 mm Hg1,2
WARNING: POTENTIAL LIVER INJURY
LETAIRIS (ambrisentan) can cause elevation of liver aminotransferases (ALT and AST) to at least 3 times the upper limit of normal (ULN). LETAIRIS treatment was associated with aminotransferase elevations >3 x ULN in 0.8% of patients in 12-week trials and 2.8% of patients including long-term open-label trials out to one year. One case of aminotransferase elevations >3 x ULN has been accompanied by bilirubin elevations >2 x ULN. Because these changes are a marker for potentially serious liver injury, serum aminotransferase levels (and bilirubin if aminotransferase levels are elevated) must be measured prior to initiation of treatment and then monthly.
In the post-marketing period with another endothelin receptor antagonist (ERA), bosentan, rare cases of unexplained hepatic cirrhosis were reported after prolonged (>12 months) therapy. In at least one case with bosentan, a late presentation (after >20 months of treatment) included pronounced elevations in aminotransferases and bilirubin levels accompanied by non-specific symptoms, all of which resolved slowly over time after discontinuation of the suspect drug. This case reinforces the importance of strict adherence to the monthly monitoring schedule for the duration of treatment.
Elevations in aminotransferases require close attention. LETAIRIS should generally be avoided in patients with elevated aminotransferases (>3 x ULN) at baseline because monitoring liver injury may be more difficult. If liver aminotransferase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, fever, abdominal pain, jaundice, or unusual lethargy or fatigue) or increases in bilirubin >2 x ULN, treatment should be stopped. There is no experience with the re-introduction of LETAIRIS in these circumstances.
CONTRAINDICATION: PREGNANCY
LETAIRIS is very likely to produce serious birth defects if used by pregnant women, as this effect has been seen consistently when it is administered to animals [see Contraindications (4.1)]. Pregnancy must therefore be excluded before the initiation of treatment with LETAIRIS and prevented during treatment and for one month after stopping treatment by the use of two acceptable methods of contraception unless the patient has had a tubal sterilization or chooses to use a Copper T 380A IUD or LNg 20 IUS, in which case no additional contraception is needed. Obtain monthly pregnancy tests.
Because of the risks of liver injury and birth defects, LETAIRIS is available only through a special restricted distribution program called the LETAIRIS Education and Access Program (LEAP), by calling 1-866-664-LEAP (5327). Only prescribers and pharmacies registered with LEAP may prescribe and distribute LETAIRIS. In addition, LETAIRIS may be dispensed only to patients who are enrolled in and meet all conditions of LEAP [see Warnings and Precautions (5.5)].
Please see full prescribing information, for important safety information, including boxed WARNINGS on the possible risk of liver injury and the risk of serious birth defects.
Prescriber Enrollment Materials
