Bosentan

Bosentan Brand Name– Tracleer

What is Bosentan

Bosentan is a cardiovascular agent that belongs to a group of compounds known as endothelin-receptor antagonists and is indicated for use in pulmonary arterial hypertension in patients with WHO Class II to IV symptoms. It is a specific and competitive antagonist at both type A and B endothelin-1 receptors.

Bosentan is associated with a high frequency of elevated hepatic enzymes, a potential for teratogenic effects, and many drug interactions. Bosentan is extensively metabolized by, and a significant inducer of, CYP2C9 and CYP3A4 isoenzymes.

Due to the risk for fetal harm and the potential hepatotoxicity of the drug, registration in the Bosentan REMS program is required for prescribers, pharmacies, and patients. Information may be obtained by visiting www.BosentanREMSProgram.com.

Indications

  • persistent pulmonary hypertension of the newborn
  • pulmonary hypertension

For the treatment of pulmonary hypertension (pulmonary arterial hypertension WHO Group 1)

NOTE: Studies establishing effectiveness in adult patients were comprised predominately of patients with NYHA Functional Class II to IV symptoms and etiologies of idiopathic or heritable pulmonary arterial hypertension (PAH) (60%), PAH associated with connective tissue diseases (21%) and PAH associated with congenital heart disease with left-to-right shunts (18%).

Side Effects

  1. anaphylactoid reactions
  2. anemia
  3. angioedema
  4. arthralgia
  5. blurred vision
  6. chest pain (unspecified)
  7. cirrhosis
  8. diaphoresis
  9. dizziness
  10. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
  11. edema
  12. elevated hepatic enzymes
  13. fluid retention
  14. flushing
  15. headache
  16. hepatic failure
  17. hepatotoxicity
  18. hyperbilirubinemia
  19. hypotension
  20. infection
  21. jaundice
  22. leukopenia
  23. nasal congestion
  24. nausea
  25. neutropenia
  26. oligospermia
  27. palpitations
  28. peripheral edema
  29. pharyngitis
  30. rash
  31. sinusitis
  32. syncope
  33. teratogenesis
  34. thrombocytopenia
  35. vomiting
  36. weight gain

Monitoring Parameters

  • hemoglobin/hematocrit
  • LFTs
  • pregnancy testing
  • serum bilirubin (total and direct)

Contraindications

  • anemia
  • breast-feeding
  • contraception requirements
  • edema
  • geriatric
  • heart failure
  • hepatic disease
  • hepatitis
  • hepatotoxicity
  • infertility
  • jaundice
  • peripheral edema
  • phenylketonuria
  • pregnancy
  • pregnancy testing
  • pulmonary edema
  • reproductive risk
  • veno-occlusive disease (VOD)
  • ventricular dysfunction

Interactions

  • Abacavir; Dolutegravir; Lamivudine
  • Abemaciclib
  • Acetaminophen; Butalbital; Caffeine; Codeine
  • Acetaminophen; Caffeine; Dihydrocodeine
  • Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
  • Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine
  • Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine
  • Acetaminophen; Codeine
  • Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine
  • Acetaminophen; Dextromethorphan; Phenylephrine
  • Acetaminophen; Dextromethorphan; Pseudoephedrine
  • Acetaminophen; Dichloralphenazone; Isometheptene
  • Acetaminophen; Guaifenesin; Phenylephrine
  • Acetaminophen; Hydrocodone
  • Acetaminophen; Oxycodone
  • Acetaminophen; Pseudoephedrine
  • Acrivastine; Pseudoephedrine
  • Alfentanil
  • Aliskiren; Amlodipine
  • Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
  • Aliskiren; Hydrochlorothiazide, HCTZ
  • Aliskiren; Valsartan
  • Alpha-blockers
  • Alprazolam
  • Ambrisentan
  • Amiloride; Hydrochlorothiazide, HCTZ
  • Amiodarone
  • Amitriptyline; Chlordiazepoxide
  • Amlodipine
  • Amlodipine; Atorvastatin
  • Amlodipine; Benazepril
  • Amlodipine; Celecoxib
  • Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan
  • Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
  • Amlodipine; Olmesartan
  • Amlodipine; Telmisartan
  • Amlodipine; Valsartan
  • Amobarbital
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  • Amoxicillin; Clarithromycin; Omeprazole
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  • Chlorpheniramine; Hydrocodone
  • Chlorpheniramine; Hydrocodone; Phenylephrine
  • Chlorpheniramine; Hydrocodone; Pseudoephedrine
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  • Chlorpheniramine; Pseudoephedrine
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  • food
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  • Guanfacine
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  • Hydrochlorothiazide, HCTZ; Triamterene
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  • Hydrocodone
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