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Enrollment and Drug Access
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Streamlined enrollment for access to Tracleer
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:
You enroll your patients in the Tracleer Access Program by completing the enrollment form
PAH Pathways contacts your patients
The specialty pharmacy calls your patients to confirm tests and delivers Tracleer
Renew patients' Tracleer Enrollment Annually
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:
- Call your patient to discuss Tracleer insurance coverage, out-of-pocket costs, and provide information on financial assistance programs. Click here to learn more about available financial assistance.
- Forward your patient's information to a specialty pharmacy, which will then deliver Tracleer directly and conveniently either to your patient's home or to your office each month
- Mail your patient a Tracleer Getting Started Kit
- Help your patient get started in Sure Steps™, a voluntary patient education program. Patients who enroll in Sure Steps are sent a Welcome Packet along with scheduled mailings to offer continued support and encouragement on their journey.
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 INDICATION:
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.
IMPORTANT SAFETY INFORMATION
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.
HEPATOTOXICITY
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.
TERATOGENICITY
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.
CONTRAINDICATIONS
Tracleer is contraindicated:
- In females who are or may become pregnant
- With cyclosporine A
- With glyburide
- In patients who are hypersensitive to bosentan or any component of Tracleer
WARNINGS AND PRECAUTIONS
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.
ADVERSE EVENTS
In Tracleer pivotal trials, the most common adverse events occurring more often in Tracleer-treated patients than in patients taking placebo were respiratory tract infection (22% vs 17%), headache (15% vs 14%), edema (11% vs 9%), chest pain (5% vs 5%), syncope (5% vs 4%), flushing (4% vs 3%), hypotension (4% vs 2%), sinusitis (4% vs 2%), arthralgia (4% vs 2%), serum aminotransferases abnormal (4% vs 2%), palpitations (4% vs 2%), and anemia (3% vs 0%).DRUG INTERACTIONS
- Tracleer is contraindicated for use with cyclosporine A and with glyburide.
- Tracleer is metabolized by CYP2C9 and CYP3A.
- Co-administration with agents that are metabolized by these pathways may affect plasma concentrations of one or both agents.
- When initiating lopinavir/ritonavir and other ritonavir-containing HIV regimens, dosage adjustment of Tracleer is necessary.
- When co-administered with simvastatin, or other statins that are CYP3A substrates, dosage adjustment of such statins may need to be considered.
- When co-administered with rifampicin, a CYP3A inducer, liver function should be monitored weekly for the first 4 weeks before reverting to normal monitoring.
- Co-administration of tacrolimus and bosentan resulted in markedly increased plasma concentrations of bosentan in animals; caution should be exercised if they are used together.
- When co-administered with ketoconazole, a potent CYP3A inhibitor, no dose adjustment of Tracleer is necessary, but increased effects of Tracleer may need to be considered.
- There are no clinically relevant interactions between Tracleer and warfarin, digoxin, nimodipine, losartan, or sildenafil.
- Dose adjustments are not necessary when Tracleer and sildenafil are co-administered.
- Tracleer has no significant interaction with iloprost.
LIVER ENZYME ELEVATIONS
- Measure liver aminotransferases prior to initiation of treatment and then monthly.
- Use of Tracleer should generally be avoided in patients with elevated aminotransferases (>3 x ULN) at baseline because monitoring for hepatotoxicity may be more difficult.
- It is important to adhere strictly to the monthly monitoring schedule for the duration of treatment.
- Changes in aminotransferases may occur early or late in treatment.
- There have been rare postmarketing reports of liver failure and unexplained hepatic cirrhosis in a setting of close monitoring; the contribution of Tracleer could not be excluded.
- For patients whose monthly LFTs are ≤3 x ULN, no change in monitoring schedule or dosage is required.
- For patients whose monthly LFTs are >3 x ULN, close monitoring and either dose reduction or treatment cessation are necessary.
MONITORING
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 INDICATION:
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.
