Read PLR Content Marketing Mississippi: Copaxone

Generic Name: Glatiramer Acetate
Class: Biologic Response Modifiers
Chemical Name: l-Glutamic acid polymer with l-alanine, l-lysine, and l-tyrosine, acetate
Molecular Formula: (C₅H₉NO₄ • C₃H_7-5H₉NO₄ • C₃H₇NO₂ • C₆H₁₄N₂O₂ • C₉H₁₁NO₃)_x • x(C₂H₄O₂)
CAS Number: 147245-92-9

Introduction

Immunomodulatory agent; synthetic polypeptide mixture consisting of 4 naturally occurring amino acids.¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸

Uses for Copaxone

Multiple Sclerosis (MS)

Treatment to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis (RRMS).¹ ⁶ ⁷ ⁸ ⁹ ¹⁶ ¹⁸

The Medical Advisory Board of the National Multiple Sclerosis Society recommends therapy with an immunomodulator (e.g., glatiramer acetate, interferon-β) should be considered as soon as possible following a definite diagnosis of MS with a relapsing course and for selected patients with an initial attack who are at high risk for MS.¹⁴ ¹⁵ ¹⁸

May be useful in patients who do not respond adequately to or who do not tolerate interferon-β.¹⁵

Copaxone Dosage and Administration

Administration

Administer only by sub-Q injection; do not administer IV.¹

Administer initial self-administered dose under the supervision of qualified clinicians.¹

Sub-Q Administration

Commercially available prefilled syringes intended for single use only; discard unused portion.¹

Warm prefilled syringes to room temperature by removing from refrigerator about 20 minutes prior to use.¹ ¹⁸

Inject sub-Q into the arm, abdomen, hip, or thigh.¹ ⁶ ¹⁸

To minimize risk of serious injection site reactions (e.g., lipoatrophy, necrosis), rotate injection sites daily; follow a planned rotation of sites within an area so that any one area is not injected more than once every week.¹ ⁶ ¹⁸ (See Acute Injection Reactions under Cautions.)

Dosage

Available as glatiramer acetate; dosage expressed in terms of the salt.^a

Adults

Multiple Sclerosis

Sub-Q

20 mg once daily.¹ ⁶

Therapy should be continued indefinitely except when there is a clear lack of benefit, intolerable adverse effects, or availability of better treatments.¹⁴

Special Populations

No special population dosage recommendations at this time.¹ ⁶

Cautions for Copaxone

Contraindications

Known hypersensitivity to glatiramer, mannitol, or any other ingredient in the formulation.

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis accompanied by anti-glatiramer IgE antibodies reported rarely.¹⁰ ¹⁸

General Precautions

Effects on Immune Response

Possible modification of immune response and interference with useful immune function.¹

Possible interference with the recognition of foreign antigens, which may undermine the body’s tumor surveillance ability and defenses against infection.¹

Possibility of adverse effects resulting from continued alteration of cellular immunity associated with chronic administration of the drug.¹

Antibody Formation

Development of IgG antibodies to glatiramer reported in most patients;¹ ¹⁰ however, data to date indicate that antibodies do not neutralize therapeutic effects.³ ¹⁸ ²⁰

Animal studies suggest that immune complexes are deposited in renal glomeruli.¹

Acute Injection Reactions

Acute injection reactions reported in approximately 10% of patients, generally within minutes after sub-Q injection.^a Symptoms are transient and generally self-limited and include flushing,¹ ² ⁶ ⁷ ⁸ chest pain¹ ² ⁶ or tightness,⁶ ⁷ ⁸ palpitations,¹ ² ⁵ ⁶ ⁷ ⁸ anxiety,¹ ² ⁵ ⁶ ⁷ ⁸ dyspnea,¹ ² ⁵ ⁶ ⁷ ⁸ constriction of the throat,¹ and urticaria.¹

Reactions generally occur several months after initiation of therapy and generally are isolated events.⁷

Not currently known whether reactions have an immunologic or nonimmunologic mechanism.¹ ⁶

Chest Pain

Transient chest pain reported, generally >1 month after initiation of therapy.¹ Episodes generally last only a few minutes, often are unassociated with other symptoms, and do not appear to produce clinically important sequelae.¹

Injection Site Reactions

Injection site reactions, including lipoatrophy and, rarely, skin necrosis reported; injection site rotation and proper administration techniques may prevent these effects.^a

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether glatiramer is distributed into milk.¹ Use with caution in nursing women.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.¹

Common Adverse Effects

Injection site reactions,¹ ² ⁵ vasodilation,¹ chest pain,¹ asthenia,¹ infection,¹ pain,¹ nausea,¹ arthralgia,¹ anxiety,¹ hypertonia.¹

Interactions for Copaxone

Interactions with other drugs not fully evaluated to date.¹

No clinically important interactions reported in clinical trials between glatiramer and drugs commonly used in multiple sclerosis, including concurrent corticosteroid therapy for up to 28 days.¹ Not formally evaluated in combination with interferon-β.¹ ⁶

Copaxone Pharmacokinetics

Distribution

Following sub-Q injection, some portion of the dose may enter the lymphatic circulation and some may enter systemic circulation.¹ Does not appear to cross the blood-brain barrier.⁶

Elimination

Metabolism

Hydrolyzed locally at injection site to small oligopeptides and free amino acids.¹ ⁶

Stability

Storage

Parenteral

Injection

2–8°C; protect from light.^a May be stored at room temperature (15–30°C) for up to one week.¹

ActionsActions

Mechanism of action not fully elucidated;¹ appears to modify immune processes responsible for the pathogenesis of MS.¹ ⁶ ⁸ ¹⁵

Induces and activates drug-specific suppressor T-cells that migrate into the CNS and down-regulate immune response (e.g., inflammation) to myelin antigens in the periphery.¹ ⁶ ⁸ ¹⁵

Advice to Patients

Importance of reading and understanding manufacturer’s patient information before beginning therapy.¹

Importance of clinicians instructing patient and/or caregivers in proper injection techniques and about avoiding reuse of syringes and needles and proper disposal of such equipment in a puncture-resistant container after use.¹

Importance of clinicians advising patient about adverse effects, including instructions to contact clinician immediately and withhold further administration of the drug if hives, skin rash with irritation, dizziness, sweating, chest pain, breathing difficulty, or severe pain at the injection site occurs.¹

Importance of not changing dosage or discontinuing therapy without consulting clinician.¹

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

Importance of patient informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Glatiramer Acetate
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for subcutaneous use	20 mg/1 mL	Copaxone (available as 1-mL prefilled syringe)	TEVA Neuroscience

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

References

1. TEVA Neuroscience. Copaxone (glatiramer acetate injection) prescribing information. Kansas City, MO; 2004 Feb.

2. Johnson KP, Brooks BR, Cohen JA et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind, placebo-controlled trial. Neurology. 1995; 45:1268-76. [IDIS 350103] [PubMed 7617181]

3. Johnson KP, Brooks BR, Cohen JA et al. Extended use of glatiramer acetate (Copaxone) is well tolerated and maintains its clinical effect on multiple sclerosis relapse rate and degree of disability. Neurology. 1998; 50:701-8. [IDIS 403141] [PubMed 9521260]

4. Bornstein MB, Miller A, Slagle S et al. A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis. N Engl J Med. 1987; 317:408-14. [IDIS 232708] [PubMed 3302705]

5. Comi G, Filippi M, Wolinsky JS et al. European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging-measured disease activity and burden in patients with relapsing multiple sclerosis. Ann Neurol. 2001; 49:290-7. [IDIS 461166] [PubMed 11261502]

6. Simpson D, Noble S, Perry C. Glatiramer acetate: a review of its use in relapsing-remitting multiple sclerosis. CNS Drugs. 2002; 16:825-50. [PubMed 12421116]

7. Calabresi PA. Considerations in the treatment of relapsing-remitting multiple sclerosis. Neurology. 2002; 58(Suppl 4):S10-S22.

8. Miller AE. Glatiramer acetate in the treatment of multiple sclerosis. Neurol Clin. 2005; 23:215-31. [PubMed 15661095]

9. Goodin DS, Frohman EM, Garmany GP Jr et al. Disease modifying therapies in multiple sclerosis: report of the therapeutics and technology assessment subcommittee of the American Academy of Neurology and the MS council for clinical practice guidelines. Neurology. 2002; 58: 169-178. [IDIS 475332] [PubMed 11805241]

10. Rauschka H, Farina C, Sator P et al. Severe anaphylactic reaction to glatiramer acetate with specific IgE. Neurology. 2005; 64:1481. [IDIS 534043] [PubMed 15851756]

11. Ge Y, Grossman RI, Udupa JK et al. Glatiramer acetate (Copaxone) treatment in relapsing-remitting MS. Neurology. 2000; 54:813-7. [IDIS 443731] [PubMed 10690968]

12. Johnson KP, Ford CC, LIsak RP et al. Neurologic consequence of delaying glatiramer acetate therapy for multiple sclerosis: 8-year data. Acta Neurol Scand. 2005; 111:42-7. [PubMed 15595937]

13. Rizvi SA, Agius MA. Current approved options for treating patients with multiple sclerosis. Neurology. 2004; 63(Suppl 6):S8-S14. [IDIS 528071] [PubMed 15623672]

14. Disease management consensus statement from the Medical Advisory Board of the National Multiple Sclerosis Society. Available at: http://www.nationalmssociety.org/pdf/forpros/Exp_Consensus.pdf. Accessed September 6, 2005.

15. Mezzapesa DM, Rovaris M, Filippi M. Glatiramer acetate in multiple sclerosis. Expert Rev Neurotherapeutics. 2005; 5:451-8.

16. Boneschi FM, Rovaris M, Johnson KP et al. Effects of glatiramer acetate on relapse rate and accumulated disability in multiple sclerosis: meta-analysis of three double-blind, randomized, placebo-controlled clinical trials. Multiple Sclerosis. 2003; 9:349-55. [PubMed 12926839]

17. Johnson KP, Brooks BR, Ford CC et al. Glatiramer acetate (Copaxone): comparison of continuous versus delayed therapy in a six-year organized multiple sclerosis trial. Multiple Sclerosis. 2003; 9:585-91. [PubMed 14664471]

18. Teva Neuroscience, Overland Park, KS. Personal communication.

19. Johnson KP, Panitch HS, Ford CC et al. Long-term slowing of disability progression in patients receiving continuous glatiramer acetate compared with those withdrawing from therapy: 10 year results from an ongoing trial. Neurology. 2004; 62(7 Suppl 5):A180.

20. Teitelbaum D, Brenner T, Abramsky O et al. Antibodies to glatiramer acetate do not interfere with its biological functions and therapeutic efficacy. Mult Scler. 2003; 9:592-9. [PubMed 14664472]

a. TEVA Neuroscience. Copaxone (glatiramer acetate injection) prescribing information. Kansas City, MO; 2006 May.

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Multiple Sclerosis

Friday, 17 August 2012

Copaxone