Glatiramer
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: ANAPHYLACTIC REACTIONS Cases of life-threatening and fatal anaphylaxis have been reported with COPAXONE. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy. Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction; instruct them to seek immediate medical care should these symptoms occur. Prompt identification of anaphylaxis is important to avoid a delay in treatment [see Warnings and Precautions ( 5.1 )] .
COPAXONE is contraindicated in patients with a history of hypersensitivity reactions to COPAXONE, including anaphylaxis. If an anaphylactic reaction occurs, treatment with COPAXONE must be immediately discontinued. Unless a clear alternative etiology is identified, COPAXONE must be permanently discontinued [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . WARNING: ANAPHYLACTIC REACTIONS See full prescribing information for complete boxed warning.
Life-threatening and fatal anaphylaxis, which can occur at any time following initiation of therapy (from as early as after the first dose, up to years after initiation of treatment), has been reported in patients receiving COPAXONE. Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction. Prompt identification of anaphylaxis is important to avoid a delay in treatment ( 5.1 ). COPAXONE is contraindicated in patients with a history of hypersensitivity reactions to COPAXONE, including anaphylaxis ( 4 ).
Dosing in kidney impairment
Although COPAXONE is intended to minimize the autoimmune response to myelin, there is the possibility that continued alteration of cellular immunity due to chronic treatment with COPAXONE may result in untoward effects. Glatiramer acetate-reactive antibodies are formed in most patients receiving glatiramer acetate. Studies in both the rat and monkey have suggested that immune complexes are deposited in the renal glomeruli.
Preparation and administration
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Recommended Dose COPAXONE is for subcutaneous use only [see Dosage and Administration] . Do not administer intravenously. The dosing schedule depends on the product strength that is selected. The recommended doses are: COPAXONE 20 mg per mL: administer once per day or COPAXONE 40 mg per mL: administer three times per week and at least 48 hours apart COPAXONE 20 mg per mL and COPAXONE 40 mg per mL are not interchangeable.
Contraindications
4 CONTRAINDICATIONS COPAXONE is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.1 )]. Known hypersensitivity to glatiramer acetate or mannitol ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
BLikelihood score B: Likely cause of clinically apparent liver injury.
Glatiramer acetate is a mixture of synthetic polypeptides that has unique antiinflammatory and immunomodulatory activities and that is used to treat relapsing-remitting multiple sclerosis. Glatiramer therapy is associated with a low rate of transient serum enzyme elevations during therapy and has been linked to rare instances of clinically apparent liver injury with jaundice.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Available data from pharmacovigilance and published observational studies over decades of use with glatiramer acetate during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes (see Data) . Administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryofetal or offspring development ( see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other outcomes.
In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Data from pharmacovigilance and published observational studies have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes when glatiramer acetate was used during pregnancy. However, the published comparative observational studies have methodological limitations, such as short exposure duration during pregnancy, confounding, selection bias, and exposure misclassification.
Animal Data In rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryofetal development were observed at doses up to 37.5 mg/kg/day (18 and 36 times, respectively, the therapeutic human dose of 20 mg/day on a mg/m 2 basis). In rats receiving subcutaneous glatiramer acetate at doses of up to 36 mg/kg from day 15 of pregnancy throughout lactation, no significant effects on delivery or on offspring growth and development were observed.
Breastfeeding (LactMed)
Glatiramer is the active portion of the drug, glatiramer acetate. Breastfeeding is not expected to result in clinically relevant exposure of the infant to the drug. Follow-up of infants indicates that maternal use of glatiramer acetate does not appear to cause any adverse effects in breastfed infants. Glatiramer acetate is generally considered safe by most experts and is one of the preferred disease-modifying agents for treating multiple sclerosis during breastfeeding. No special precautions appear to be required during breastfeeding while using glatiramer and breastfeeding can resume immediately after injection.
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Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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