Drug Name:
TRACLEER Rx

Generic Name and Formulations:
Bosentan 62.5mg, 125mg; tabs.
Company:
Actelion Pharmaceuticals
Therapeutic Use:
Indications for TRACLEER:
Pulmonary arterial hypertension (PAH) (WHO Group I) in adults with WHO Class II–IV symptoms to improve exercise ability and decrease clinical worsening. Idiopathic or congenital PAH to improve pulmonary vascular resistance (expected to improve exercise ability) in pediatrics ≥3yrs.
Adults and Children:
Must register patient in the Tracleer REMS Program (see full labeling). Take in the AM and PM. ≤12yrs (≥4–8kg): 16mg twice daily; (>8–16kg): 32mg twice daily; (>16–24kg): 48mg twice daily; (>24–40kg): 64mg twice daily. >12yrs (<40kg): 62.5mg twice daily; (>40kg): initially 62.5mg twice daily for 4 weeks, then 125mg twice daily. Concomitant ritonavir (for at least 10 days): start bosentan at the recommended initial dose once daily or every other day based on tolerability; discontinue bosentan at least 36 hours before starting ritonavir. Dose adjustments for ALT/AST elevations (confirm with another test): see full labeling.
Contraindications:
Pregnancy. Concomitant cyclosporine A, glyburide.
Boxed Warning:
Risk of hepatotoxicity. Embryo-fetal toxicity.
Boxed Warning:
Risk of hepatotoxicity. Embryo-fetal toxicity.
Warnings/Precautions:
Moderate or severe hepatic impairment or baseline ALT/AST >3xULN: not recommended. Monitor ALT/AST levels prior to initiating therapy and then monthly; discontinue if elevations are accompanied by clinical symptoms of hepatotoxicity or increases in bilirubin ≥2xULN. Reduce dose or interrupt treatment, and monitor if ALT/AST >3xULN (see full labeling); permanently discontinue if ALT/AST >8xULN. Embryo-fetal toxicity. Obtain (–) pregnancy test and use 2 effective methods of contraception prior to initiation, monthly during treatment, and for 1 month after last dose (see full labeling). Monitor hemoglobin and hematocrit at 1 and 3 months, then every 3 months thereafter. Monitor for significant fluid retention and pulmonary edema; discontinue if pulmonary veno-occlusive disease develops. Avoid abrupt cessation. Nursing mothers: not recommended.
See Also:
Pharmacological Class:
Endothelin receptor antagonist.
Interactions:
See Contraindications. Potentiated by CYP2C9 (eg, fluconazole, amiodarone) or strong or moderate CYP3A inhibitors (eg, ketoconazole, itraconazole, amprenavir, erythromycin, diltiazem); concomitant CYP2C9 inhibitor plus moderate/strong CYP3A inhibitor: not recommended. Potentiated by ritonavir. Rifampin alters bosentan levels (monitor hepatic function weekly for 4 weeks, followed by normal monitoring). Antagonizes CYP2C9 or CYP3A substrates (eg, simvastatin). May interfere with hormonal contraceptives; use additional forms of contraception.
Adverse Reactions:
Respiratory tract infection, headache, edema, chest pain, syncope, flushing, hypotension, sinusitis, arthralgia, elevated liver enzymes, palpitations, anemia, pyrexia; hepatotoxicity, fluid retention, decreased sperm counts.
Note:
Only prescribers and pharmacies registered with Tracleer REMS Program may prescribe Tracleer. Patients must be enrolled and meet all conditions of Tracleer REMS Program. To register call (866) 228-3546.
REMS:
How Supplied:
Tabs—30, 60; Tabs for oral susp—14, 56
Sign Up for Free e-newsletters
ONA Articles
- FDA: Number of U.S. Women With Breast Implant-Caused Cancer Has Increased
- Takeda to Collaborate With MSKCC on CAR-T Therapies for Multiple Myeloma
- Sequential Immunotherapy, Targeted Therapy Linked to Cutaneous Adverse Events in Advanced Melanoma
- Immunotherapy for HER2-positive Breast Cancer: Recent Advances and Combination Therapeutic Approaches
- NIH Establishes Educational Program on Genomics, Genetics for Oncology Nurses
- Oncology Nurse Navigation Facilitates Timely Treatment of Pancreatic Cancer
- Helping Patients Face the Challenge of Eating Healthy During Cancer Treatment
- Oncology Nurses Weigh In on Their Patient-Centered Communication Practices, Needs
- Substitute for Lidocaine
- CART cell therapy for prostate cancer: status and promise
- Immunotherapy for HER2-positive Breast Cancer: Recent Advances and Combination Therapeutic Approaches
- Survey Demonstrates Relationship Between Symptom Burden, Medical Disability Leave Among Myeloproliferative Neoplasms
- A Review of Clinical Outcomes in Patients With Early-Stage Burkitt Lymphoma
- FDA: Number of U.S. Women With Breast Implant-Caused Cancer Has Increased
- USPSTF Still Recommends Against Pancreatic Cancer Screening
Regimen and Drug Listings
GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION
Bone Cancer | Regimens | Drugs |
Brain Cancer | Regimens | Drugs |
Breast Cancer | Regimens | Drugs |
Endocrine Cancer | Regimens | Drugs |
Gastrointestinal Cancer | Regimens | Drugs |
Genitourinary Cancer | Regimens | Drugs |
Gynecologic Cancer | Regimens | Drugs |
Head and Neck Cancer | Regimens | Drugs |
Hematologic Cancer | Regimens | Drugs |
Lung Cancer | Regimens | Drugs |
Other Cancers | Regimens | |
Rare Cancers | Regimens | |
Skin Cancer | Regimens | Drugs |