Copaxone


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glatiramer acetate

Copaxone

Pharmacologic class: Immunomodulator

Therapeutic class: Multiple sclerosis agent

Pregnancy risk category B

Action

Unknown. Thought to alter immune processes believed to be responsible for pathogenesis of multiple sclerosis.

Availability

Injection: 20 mg lyophilized glatiramer acetate and 40 mg mannitol in single-use 2-ml vial (1-ml vial of sterile water for injection included for reconstitution)

Indications and dosages

To reduce frequency of relapses in relapsing-remitting multiple sclerosis

Adults: 20 mg/day subcutaneously

Contraindications

• Hypersensitivity to drug

Precautions

Use cautiously in:
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Give only by subcutaneous injection into arms, abdomen, hips, or thighs.
• Administer immediately after preparing. Discard unused portion.

Adverse reactions

CNS: abnormal dreams, agitation, anxiety, confusion, emotional lability, migraine, nervousness, speech disorder, stupor, tremor, weakness, vertigo

CV: chest pain, hypertension, palpitations, tachycardia, peripheral edema

EENT: eye disorder, nystagmus, ear pain, rhinitis

GI: nausea, vomiting, diarrhea, anorexia, gastroenteritis, other GI disorder, oral candidiasis, salivary gland enlargement, ulcerative stomatitis

GU: urinary urgency, hematuria, erectile dysfunction, amenorrhea, dysmenorrhea, menorrhagia, abnormal Papanicolaou smear, vaginal candidiasis, vaginal hemorrhage

Hematologic: ecchymosis, lymphadenopathy

Musculoskeletal: joint, back, or neck pain; foot drop; hypertonia

Respiratory: bronchitis, dyspnea, hyperventilation

Skin: eczema, erythema, diaphoresis, pruritus, rash, skin atrophy, skin nodules, urticaria, warts

Other: dental caries, facial edema, weight gain, herpes simplex, herpes zoster, cysts, chills, flulike symptoms, pain at injection site

Interactions

None reported

Patient monitoring

Assess for immediate postinjection reaction, including flushing, chest pain, anxiety, breathing problems, and hives.
• Watch for transient chest pain, but be aware that this problem doesn't seem to be clinically significant.
• Check for vaginal bleeding.
• Watch for signs and symptoms of infection.

Patient teaching

• Teach patient how to prepare and self-administer drug. Supervise him the first time he does so.

Teach patient to recognize and immediately report signs and symptoms of postinjection reaction. Tell him this reaction may occur right away or up to several months after first dose.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

Instruct patient to report signs or symptoms of infection or vaginal hemorrhage.
• Provide dietary counseling. Refer patient to dietitian if adverse GI effects significantly affect food intake.
• As appropriate, review all other significant and life-threatening adverse reactions.

glatiramer

(gla-ti-ra-mer) ,

Copaxone

(trade name)

Classification

Therapeutic: anti multiple sclerosis agents
Pharmacologic: immune response modifiers
Pregnancy Category: B

Indications

Reduction of frequency of relapses in relapsing-remitting multiple sclerosis (MS), including patients who have experienced a first clinical episode and MRI features consistent with MS.

Action

Appears to modify the immune process thought to be responsible for MS.

Therapeutic effects

Decreased incidence of relapses in relapsing-remitting MS.

Pharmacokinetics

Absorption: Some absorption follows subcutaneous administration.
Distribution: Some enters the lymphatic system.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile

ROUTEONSETPEAKDURATION
Subcutunknownunknownunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity to glatiramer or mannitol.
Use Cautiously in: Obstetric / Lactation / Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • anxiety (most frequent)
  • weakness (most frequent)
  • confusion
  • migraine
  • vertigo

Cardiovascular

  • chest pain (most frequent)
  • palpitations (most frequent)
  • edema
  • syncope
  • tachycardia
  • vasodilation

Dermatologic

  • pruritis (most frequent)
  • rashes (most frequent)
  • sweating (most frequent)
  • erythema

Ear, Eye, Nose, Throat

  • rhinitis (most frequent)
  • nystagmus

Gastrointestinal

  • diarrhea (most frequent)
  • nausea (most frequent)
  • anorexia
  • vomiting

Genitourinary

  • urgency (most frequent)

Local

  • injection site reactions (most frequent)

Musculoskeletal

  • arthralgia (most frequent)
  • back pain (most frequent)
  • hypertonia (most frequent)

Neurologic

  • tremor

Respiratory

  • dyspnea (most frequent)

Miscellaneous

  • flu-like symptoms (most frequent)
  • lymphadenopathy (most frequent)
  • fever
  • immediate postinjection reaction
  • infection
  • pain
  • weight gain

Interactions

Drug-Drug interaction

Unknown.

Route/Dosage

Subcutaneous (Adults) 20 mg/day.

Availability

Injection: 20 mg/mL in prefilled syringes

Nursing implications

Nursing assessment

  • Assess patient for side effects immediately after injection. Symptoms may include flushing, chest pain, palpitations, anxiety, dyspnea, constriction of throat, and urticaria. Symptoms are usually transient and self-limited without requiring treatment. May occur at the beginning of or following several months of therapy, and patients may experience one or several episodes of symptoms.

Potential Nursing Diagnoses

Impaired physical mobility (Indications)
Deficient knowledge (Patient/Family Teaching)

Implementation

  • Subcutaneous: Allow prefilled syringes to warm to room temperature for 20 min before injection. Solution is clear, colorless to slightly yellow; do not administer solutions that are discolored or contain particulate matter. Sites for injection include arms, abdomen, hips, or thighs. Pinch skin and inject at a 90° angle. Discard unused solution. Unused syringes should be stored in refrigerator. Rotate injection sites to minimize risk of lipoatrophy.
    • First injection should be performed under the supervision of a health care professional.

Patient/Family Teaching

  • Instruct patient to administer medication exactly as directed. Missed doses should be taken as soon as remembered but omitted if not remembered until next day; do not double doses.
  • Advise patient not to discontinue medication or change dose or dosing schedule without consulting health care professional.
  • Inform patient of potential post-injection reactions. Advise patient to contact health care professional if chest pain is unusally severe.
  • Home Care Issues: Instruct patient in the correct technique for self-injection, storage, and proper disposal of equipment. Provide and discuss patient package insert. Caution patient not to reuse syringe. Provide patient with a puncture-proof container for needle and syringe disposal.

Evaluation/Desired Outcomes

  • Decreased incidence of relapses in relapsing-remitting MS.

Copaxone®

Glatiramer acetate, copolymer-1 Therapeutics A noninterferon, nonsteroidal agent that ↓ relapses in Pts with multiple sclerosis. See Multiple sclerosis.

Copaxone

A brand name for GLATIRAMER.
References in periodicals archive ?
The US Food and Drug Administration (FDA) approved a new drug application that would inject Copaxone at a higher dose, but fewer times per week for patients with relapsing forms of multiple sclerosis.
The approval of the drug given orally to treat multiple sclerosis and may bite Copaxone s market share, stock market analysis mention that the radical drop of TEVA stock is not because of the FDA approval of the generic drug, it is more because of the investors concern and panic, hearing such news.
said a study assessing a new formulation of Copaxone injection to treat multiple sclerosis (MS) reported significantly less pain and fewer injection site reactions.
s Copaxone drug can cut the likelihood of patients progressing to full-blown multiple sclerosis almost in half, researchers said.
The FDA has extended the labeling of Copaxone (glatiramer acetate) to include people with MS who have experienced a first clinical episode and have MRI features consistent with MS.
A short course of Novantrone before beginning regular Copaxone therapy proved to be both safe and notably more effective than Copaxone alone, in a trial involving 40 people over 15 months.
Without mitoxantrone and Copaxone treatment, I simply don't think it would have been possible - it is not an exaggeration to say that I feel as though the treatment has given me my life back.
Copaxone, which is now being tested in Britain for primary progressive MS, has already proved highly effective in the treatment of relapsing MS.
The drug now being tested for primary progressive MS, Copaxone (glatiramer acetate), has already proved highly effective in the treatment of relapsing MS.
In this Phase II study, women receiving oral Trimesta plus injectable Copaxone demonstrated a statistically significant 47 percent decrease in annualized MS relapse rate in the first 12 months of treatment compared to women receiving placebo plus Copaxone (p=0.
the world's biggest maker of generic drugs, saw its shares fall the most in two years in Nasdaq trading on test results that may make it easier for rivals to sell copies of its top-selling Copaxone medicine.
After preliminary pilot trials showed that taking Avonex plus Copaxone is safe, the National Institutes of Health (NIH) began a multi-million dollar trial last year to get solid answers about effectiveness.