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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
- amenorrhea
- anaphylactoid reactions
- anemia
- angina
- angioedema
- anxiety
- aphasia
- appetite stimulation
- arrhythmia exacerbation
- arthralgia
- asthenia
- ataxia
- atrial fibrillation
- back pain
- bleeding
- bone pain
- bradycardia
- breast enlargement
- bullous rash
- candidiasis
- cardiomyopathy
- cataracts
- cerebral edema
- chest pain (unspecified)
- chills
- cholecystitis
- cholelithiasis
- cirrhosis
- colitis
- coma
- contact dermatitis
- cough
- Cushing’s syndrome
- cyanosis
- depression
- diplopia
- dysphagia
- dyspnea
- edema
- emotional lability
- eosinophilia
- epistaxis
- eructation
- erythema
- erythema nodosum
- esophageal ulceration
- esophagitis
- fecal urgency
- fever
- flank pain
- flushing
- furunculosis
- goiter
- gout
- hallucinations
- heart failure
- hematemesis
- hematoma
- hematuria
- hepatitis
- hepatomegaly
- hostility
- hypercholesterolemia
- hyperhidrosis
- hypertension
- hyperthyroidism
- hyperventilation
- hypotension
- hypothyroidism
- hypoventilation
- impaired wound healing
- impotence (erectile dysfunction)
- increased urinary frequency
- infection
- influenza
- injection site reaction
- laryngospasm
- leukopenia
- libido decrease
- lipodystrophy
- lymphadenopathy
- maculopapular rash
- melena
- memory impairment
- meningitis
- menorrhagia
- migraine
- mydriasis
- myelitis
- myocardial infarction
- myoclonia
- myopathy
- nausea
- new primary malignancy
- nocturia
- optic neuritis
- oral ulceration
- palpitations
- pancreatitis
- pancytopenia
- paranoia
- paresthesias
- pericardial effusion
- peripheral edema
- peripheral vasodilation
- pharyngitis
- phlebitis
- photophobia
- photosensitivity
- pleural effusion
- priapism
- pruritus
- psoriasis
- ptosis
- pulmonary embolism
- rash
- renal failure (unspecified)
- rhinitis
- seizures
- serum sickness
- sinus tachycardia
- skin atrophy
- skin necrosis
- splenomegaly
- spontaneous fetal abortion
- stomatitis
- striae
- syncope
- tenesmus
- thrombocytopenia
- thrombosis
- tongue discoloration
- tremor
- urinary urgency
- urticaria
- vaginal bleeding
- vaginitis
- vesicular rash
- visual impairment
- vomiting
- weight gain
- weight loss
- xerophthalmia
- xerosis
- xerostomia
Monitoring Parameters
- laboratory monitoring not necessary
Contraindications
- breast-feeding
- immunosuppression
- infection
- intravenous administration
- mannitol hypersensitivity
- pregnancy
- vaccination
Interactions
- Ocrelizumab
- Ozanimod
