Glatiramer

Glatiramer Brand Names

Copaxone | Copaxone Patient Pack | Glatopa

What is Glatiramer

Glatiramer acetate (formerly known as copolymer-1) is a synthetic random peptide created by polymerizing L-alanine, L-glutamic acid, L-lysine, and L-tyrosine and is similar in structure to myelin basic protein.

Glatiramer is given subcutaneously and is used to reduce the frequency of attacks in adult patients with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Glatiramer is often one of the medications used off-label in children and adolescents with MS.

In a phase III study with a 2-year follow-up, glatiramer 20 mg daily produced a 29% reduction in relapse rate, prolonged the time to relapse, and increased the number of patients who were relapse-free.

In a randomized, double-blind, placebo-controlled trial, use of 40 mg 3 times weekly significantly reduced relapses compared to placebo, with a relative risk reduction of 34% over 1 year.

Glatiramer has been associated with significant reductions of cumulative numbers of MS-related lesions on MRI scans.

The use of glatiramer delays the time to clinically definite multiple sclerosis (CDMS) among patients who have experienced a first clinical episode and have MRI results consistent with multiple sclerosis.

A clinical trial (the PROMiSE trial) of glatiramer in adults with primary progressive multiple sclerosis was terminated after an interim evaluation suggested the drug was unlikely to demonstrate a significant benefit. Development of an oral form of glatiramer was suspended after initial clinical studies did not show efficacy versus placebo at the doses tested.

Glatiramer subcutaneous injection may result in an immediate post-injection reactions (flushing, chest pain, dyspnea, and urticaria) have been reported and may be serious, and often present several months after treatment initiation.

Indications

  • multiple sclerosis

For the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

NOTE: Glatiramer has been designated an orphan drug by the FDA for this indication.

Side Effects

  1. amenorrhea
  2. anaphylactoid reactions
  3. anemia
  4. angina
  5. angioedema
  6. anxiety
  7. aphasia
  8. appetite stimulation
  9. arrhythmia exacerbation
  10. arthralgia
  11. asthenia
  12. ataxia
  13. atrial fibrillation
  14. back pain
  15. bleeding
  16. bone pain
  17. bradycardia
  18. breast enlargement
  19. bullous rash
  20. candidiasis
  21. cardiomyopathy
  22. cataracts
  23. cerebral edema
  24. chest pain (unspecified)
  25. chills
  26. cholecystitis
  27. cholelithiasis
  28. cirrhosis
  29. colitis
  30. coma
  31. contact dermatitis
  32. cough
  33. Cushing’s syndrome
  34. cyanosis
  35. depression
  36. diplopia
  37. dysphagia
  38. dyspnea
  39. edema
  40. emotional lability
  41. eosinophilia
  42. epistaxis
  43. eructation
  44. erythema
  45. erythema nodosum
  46. esophageal ulceration
  47. esophagitis
  48. fecal urgency
  49. fever
  50. flank pain
  51. flushing
  52. furunculosis
  53. goiter
  54. gout
  55. hallucinations
  56. heart failure
  57. hematemesis
  58. hematoma
  59. hematuria
  60. hepatitis
  61. hepatomegaly
  62. hostility
  63. hypercholesterolemia
  64. hyperhidrosis
  65. hypertension
  66. hyperthyroidism
  67. hyperventilation
  68. hypotension
  69. hypothyroidism
  70. hypoventilation
  71. impaired wound healing
  72. impotence (erectile dysfunction)
  73. increased urinary frequency
  74. infection
  75. influenza
  76. injection site reaction
  77. laryngospasm
  78. leukopenia
  79. libido decrease
  80. lipodystrophy
  81. lymphadenopathy
  82. maculopapular rash
  83. melena
  84. memory impairment
  85. meningitis
  86. menorrhagia
  87. migraine
  88. mydriasis
  89. myelitis
  90. myocardial infarction
  91. myoclonia
  92. myopathy
  93. nausea
  94. new primary malignancy
  95. nocturia
  96. optic neuritis
  97. oral ulceration
  98. palpitations
  99. pancreatitis
  100. pancytopenia
  101. paranoia
  102. paresthesias
  103. pericardial effusion
  104. peripheral edema
  105. peripheral vasodilation
  106. pharyngitis
  107. phlebitis
  108. photophobia
  109. photosensitivity
  110. pleural effusion
  111. priapism
  112. pruritus
  113. psoriasis
  114. ptosis
  115. pulmonary embolism
  116. rash
  117. renal failure (unspecified)
  118. rhinitis
  119. seizures
  120. serum sickness
  121. sinus tachycardia
  122. skin atrophy
  123. skin necrosis
  124. splenomegaly
  125. spontaneous fetal abortion
  126. stomatitis
  127. striae
  128. syncope
  129. tenesmus
  130. thrombocytopenia
  131. thrombosis
  132. tongue discoloration
  133. tremor
  134. urinary urgency
  135. urticaria
  136. vaginal bleeding
  137. vaginitis
  138. vesicular rash
  139. visual impairment
  140. vomiting
  141. weight gain
  142. weight loss
  143. xerophthalmia
  144. xerosis
  145. xerostomia

Monitoring Parameters

  • laboratory monitoring not necessary

Contraindications

  • breast-feeding
  • immunosuppression
  • infection
  • intravenous administration
  • mannitol hypersensitivity
  • pregnancy
  • vaccination

Interactions

  • Ocrelizumab
  • Ozanimod
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