glatiramer (Rx)

Brand and Other Names:Copaxone, Glatopa
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

subcutaneous solution for injection

  • 20mg/mL (once daily dosing); Copaxone, Glatopa
  • 40mg/mL (3 times/week dosing); Copaxone
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Multiple Sclerosis

Indicated for the treatment of relapsing forms of multiple sclerosis

20 mg/mL syringe: 20 mg SC qDay, OR

40 mg/mL syringe: 40 mg SC 3 times/week (administer at least 48 hr apart)

Dosing Considerations

Monitor: Hgb, WBC, Platelet, LFTs

ALS (Orphan)

Treatment of amyothrophic lateral sclerosis

Orphan indication sponsor

  • Teva Neurosciences, Inc; P. O. Box 1005; Horsham, PA 19044-8005

Primary Progressive Multiple Sclerosis (Orphan)

Orphan indication sponsor

  • Teva Neurosciences, Inc; P. O. Box 1005; Horsham, PA 19044-8005

Administration

For SC use only; do not administer IV

The dosing schedule depends on the product strength that is selected; 20 mg/mL and 40 mg/mL are not interchangeable

Let the prefilled syringe stand at room temperature for 20 minutes to allow the solution to warm to room temperature

Visually inspect for particulate matter and discoloration prior to administration; solution should appear clear, colorless to slightly yellow

If particulate matter or discoloration is observed, discard the syringe

Areas for SC self-injection include arms, abdomen, hips, and thigh

The prefilled syringe is for single use only; discard unused portions

Areas for SC self-injection include arms, abdomen, hips, and thigh

Safety and efficacy not established

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Interactions

Interaction Checker

and glatiramer

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Injection site pain (73%)

            Injection site erythema (66%)

            Injection site inflammation (49%)

            Weakness (41%)

            Injection site pruritus (40%)

            Injection site mass (27%)

            Vasodilation (27%)

            Pain (28%)

            Arthralgia (24%)

            Anxiety (23%)

            Hypertonia (22%)

            Nausea (22%)

            Flu syndrome (19%)

            Dyspnea (19%)

            Pruritus (18%)

            Rash (18%)

            Palpitations (17%)

            Chest pain (13-16% 20 mg/day; 2-4% 40 mg 3x/wk)

            Injection site induration (13%)

            Diarrhea (12%)

            Lymphadenopathy (12%)

            Injection site welt (11%)

            1-10%

            Injection site pain/inflammation (10%)

            Anorexia (8%)

            Frequency Not Defined

            Anxiety

            Arthralgia

            Asthenia

            Hypertonia

            Infection

            Pain

            Postmarketing Reports

            Cardiovascular system: Thrombosis; peripheral vascular disease; pericardial effusion; myocardial infarct; deep thrombophlebitis; coronary occlusion; congestive heart failure; cardiomyopathy; cardiomegaly; arrhythmia; angina pectoris

            Digestive system: tongue edema; stomach ulcer; hemorrhage; liver function abnormality; liver damage; hepatitis; eructation; cirrhosis of the liver; cholelithiasis

            Hemic and lymphatic system: Thrombocytopenia; lymphoma-like reaction; acute leukemia

            Metabolic and nutritional disorders: Hypercholesterolemia

            Musculoskeletal system: Rheumatoid arthritis; generalized spasm

            Nervous system: Myelitis; meningitis; CNS neoplasm; cerebrovascular accident; brain edema; abnormal dreams; aphasia; convulsion; neuralgia

            Respiratory system: Pulmonary embolus; pleural effusion; carcinoma of lung

            Special Senses: Glaucoma; blindness

            Urogenital system: Urogenital neoplasm; urine abnormality; ovarian carcinoma; nephrosis; kidney failure; breast carcinoma; bladder carcinoma; urinary frequency

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            Warnings

            Contraindications

            Hypersensitivity to glatiramer, mannitol

            Cautions

            Risk of immediate post-injection reactions (in general, symptoms appear several months following treatment initiation), including transient chest pain (seek prompt medical attention if prolonged or unusually intense chest pain); other symptoms include flushing, palpitations, anxiety, dyspnea, constriction of the throat, and urticaria

            Lipoatrophy and skin necrosis may occur at injection site (patient must follow injection technique and rotate sties daily

            May impair body's ability to fight infection by interfering with immune function

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            Pregnancy & Lactation

            Pregnancy Category: B

            Lactation: not known if excreted in breast milk, use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Synthetic amino acid copolymer; precise mechanism unknown but possibly through immune modulation; may interfere with antigen presenting function of some immune cells opposing pathogenic T-cell function; may also activate T-lymphocyte suppressor cells specific for myelin antigen

            Pharmacokinetics

            Metabolism: Drug may be hydrolyzed locally

            Distribution: Intact of partially hydrolyzed drug may enter lymphatic circulation and some may enter systemic circulation

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            • View the formulary and any restrictions for each plan.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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