Copaxone

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 ?
generics, further signs the Copaxone hole will be by new brand launches and further potential quantification around opioid liabilities emerges.
estimated quantity of purchased goods per year 672 pre-filled copaxone syringes of 20 mg / ml 23,880 pre-filled copaxone syringes of 40 mg / ml
However, the Rating Outlook remains Negative due to continued challenges in the operating profile, including headwinds to Copaxone revenues and a delay in certain new product launches.
M2 EQUITYBITES-October 30, 2017-Mylan, Synthon, receive favourable UK High Court decision regarding Teva Phamaceutical's Copaxone dispute
M2 PHARMA-October 30, 2017-Mylan, Synthon, receive favourable UK High Court decision regarding Teva Phamaceutical's Copaxone dispute
has begun shipping what it called the first generic Copaxone 40 mg/ml administered three times weekly by injection, a treatment for multiple sclerosis, and said the product may be eligible for 180-day exclusivity.
Junto a Rusia y Ucrania, Mexico se convirtio asi en plataforma para que la empresa de origen israeli colocara en el mercado--irregularmente--el medicamento Copaxone, disenado para el tratamiento de la esclerosis multiple.
Like Copaxone, Glatopa is indicated for the treatment of people with relapsing forms of MS.
Supreme Court patent ruling that will help forestall generic competition to its top-selling Copaxone multiple-sclerosis drug.
This case focuses on Teva's brand name drug Copaxone. It is used to treat patients with multiple sclerosis, and has been profitable, with Teva earning up to $4 billion a year from its sales.
The US Court of Appeals for the Federal Circuit ruled one of the four patents protecting Copaxone (glatiramer acetate injection) invalid.
product Copaxone faces a number of new competitive threats.