TRACLEER for ORAL SUSPENSION Rx
Generic Name and Formulations:
Bosentan 32mg; dispersible tabs for oral suspension; tutti frutti flavor; contains phenylalanine.
Indications for TRACLEER for ORAL SUSPENSION:
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.
Pregnancy. Concomitant cyclosporine A, glyburide.
Risk of hepatotoxicity. Embryo-fetal toxicity.
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.
Endothelin receptor antagonist.
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.
Respiratory tract infection, headache, edema, chest pain, syncope, flushing, hypotension, sinusitis, arthralgia, elevated liver enzymes, palpitations, anemia, pyrexia; hepatotoxicity, fluid retention, decreased sperm counts.
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.
Tabs—30, 60; Tabs for oral susp—14, 56
Endocrinology Advisor Articles
- Two Phases of C-Peptide Decline Identified in Type I Diabetes
- Dulaglutide Effective for Patients With T2D, Moderate to Severe CKD
- Incidence of Diabetes Influenced by Endocrine-Disrupting Chemicals in the Environment
- Guidelines for Management of Hypothalamic-Pituitary, Growth Disorders in Childhood Cancer Survivors
- Romosozumab: Effective in Men With Osteoporosis
- Using Latent Class Trajectory Analysis to Determine Glucose Response Curve Patterns
- First CGM System With Implantable Glucose Sensor Approved
- Adjunctive Metformin for Insulin Resistance in T1D: A Clinical Perspective
- Risk for Below Knee Amputations With Canagliflozin vs Other Antihyperglycemic Agents
- Empagliflozin, Linagliptin Combination Therapy vs Linagliptin Monotherapy for Type 2 Diabetes
- NT-proBNP May Predict Cardiovascular Outcomes in Type 2 Diabetes
- Placebo Effect of Various Female Sexual Dysfunction Drug Txs Assessed
- Link Between Oral Diabetes Medications and Bullous Pemphigoid
- Calcium Channel Blocker May Benefit Patients With Type 1 Diabetes
- β-Cell Function in Youth With Impaired Glucose Tolerance, T2D