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At PAH Pathways® our goal is to provide a streamlined process for your patients taking Tracleer. Because getting your patients on therapy is our highest priority, PAH Pathways will help your patients get Tracleer in a timely manner and provide them with answers regarding their shipment status.
Because of the risks of liver injury and birth defects associated with treatment, the use of Tracleer requires participation in the Tracleer Access Program (T.A.P.)®, a restricted distribution program. In order to receive Tracleer, prescribers and patients must enroll in T.A.P. and agree to comply with the requirements of this program. Enrollment in T.A.P. is accomplished by completing and submitting the Tracleer Enrollment for Patients and Prescribers form to PAH Pathways, which administers T.A.P. You can reach PAH Pathways by calling toll-free at 1-866-ACTELION (1-866-228-3546).
Here's how it all comes together:
1. Enroll your patient in the Tracleer Access Program (T.A.P.): In order to receive Tracleer, prescribers and patients must enroll in T.A.P. and agree to comply with the requirements of this program. Enrollment in T.A.P. is accomplished by completing and submitting the Tracleer Enrollment for Patients and Prescribers form. Call 1-866-ACTELION (1-866-228-3546) or click here to download the Tracleer Access Program prescribing materials and fax to 1-866-279-0669.
2. PAH Pathways contacts your patient: Once we receive the Tracleer Enrollment for Patients and Prescribers form, PAH Pathways will:
3. The specialty pharmacy calls your patients to confirm tests and delivers Tracleer: Tracleer is not dispensed through retail pharmacies; rather, it is dispensed through a restricted network of specialty pharmacies that are certified by Actelion to dispense Tracleer. Specialty pharmacies arrange for Tracleer to be delivered conveniently and directly to patients each month.
Specialty pharmacies help to ensure that required monthly liver function and pregnancy testing has occurred. If a patient does not confirm having the monthly tests or becomes pregnant, the pharmacy will contact you.
4. Renew Tracleer Enrollment annually: In order to continue your patients on Tracleer, you must renew their T.A.P. enrollment each year by completing the Tracleer Renewal form, indicating whether you have counseled your patients on the risks of Tracleer and reviewed their liver function tests and pregnancy tests (if applicable). The Prescriber Essentials Guide will serve as your guide for the essential steps to enrollment and renewal in T.A.P.
Call 1-866-ACTELION (1-866-228-3546) or click here to download the Tracleer Access Program prescribing materials and fax to 1-866-279-0669.
Tracleer® (bosentan) is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%). Considerations for use: Patients with WHO class II symptoms showed reduction in the rate of clinical deterioration and a trend for improvement in walk distance. Physicians should consider whether these benefits are sufficient to offset the risk of hepatotoxicity in WHO class II patients, which may preclude future use as their disease progresses.
Because of the risks of hepatotoxicity and birth defects, Tracleer is available only through a restricted program called the Tracleer Access Program (T.A.P.), which is a component of the Tracleer Risk Evaluation and Mitigation Strategy (REMS). Under the Tracleer REMS, prescribers, patients, and pharmacies must enroll in the program, by calling T.A.P at 1-866-228-3546.
Elevations of liver aminotransferases (ALT, AST) and liver failure have been reported with Tracleer. In a setting of close monitoring, rare cases of liver failure and unexplained hepatic cirrhosis were observed after prolonged (>12 months) treatment. In general, avoid using Tracleer in patients with elevated aminotransferases (>3 x ULN) at baseline. Measure liver aminotransferases prior to initiation of treatment and then monthly. Discontinue Tracleer if aminotransferase elevations are accompanied by signs or symptoms of liver dysfunction or injury or increases in bilirubin ≥2 x ULN.
Based on animal data, Tracleer is likely to cause major birth defects if used during pregnancy. Exclude pregnancy before and during treatment. To prevent pregnancy, females of childbearing potential must use 2 reliable forms of contraception during treatment and for 1 month after stopping Tracleer unless the patient has a tubal sterilization or Copper T 380A IUD or LNg-20 IUS inserted, in which case no other contraception is needed. Obtain monthly pregnancy tests.
Tracleer is contraindicated:
In clinical trials, ALT/AST elevations (>3 x ULN) were observed in 11% of patients treated with Tracleer, accompanied by elevated bilirubin in a few cases. The combination of hepatocellular injury (increases in aminotransferases of >3 x ULN) and increases in total bilirubin (≥2 x ULN) is a marker for potential serious hepatotoxicity. Liver aminotransferase levels must be measured prior to initiation of treatment and then monthly. Avoid using Tracleer in patients with moderate or severe liver impairment or elevated ALT/AST >3 x ULN prior to drug initiation.
If clinically significant fluid retention develops, with or without associated weight gain, the cause, such as Tracleer or underlying heart failure, must be determined. Patients may require treatment or Tracleer therapy may need to be discontinued.
Should signs of pulmonary edema occur, consider the possibility of associated pulmonary veno-occlusive disease and consider whether Tracleer should be discontinued.
Decreased sperm counts have been observed in patients receiving Tracleer. Preclinical data also suggest that Tracleer, like other endothelin receptor antagonists, may have an adverse effect on spermatogenesis.
Treatment with Tracleer can cause a dose-related decrease in hemoglobin (Hgb) and hematocrit. Hgb should be checked after 1 and 3 months, and then every 3 months. Upon marked decrease in Hgb, determine the cause and need for specific treatment.
It is important to adhere strictly to the monthly monitoring schedule for LFTs and, if applicable, pregnancy for the duration of treatment.
Please see full Prescribing Information, including BOXED WARNING about hepatotoxicity and teratogencity and Warnings and Precautions.
Ventavis® (iloprost) Inhalation Solution is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (65%) or PAH associated with connective tissue disease (23%).
Please see full Prescribing Information for Ventavis.