COPAXONE 40 MG

What is COPAXONE?

COPAXONE 40 MG contains GLATIRAMER ACETATE : 40 MG. It is listed in the Health Canada Drug Product Database under DIN 02456915, held by TEVA CANADA LIMITED, supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 26-Aug-2016. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is COPAXONE used for?

COPAXONE (glatiramer acetate) is indicated for: 20 mg/mL once-daily: Treatment of ambulatory patients with Relapsing Remitting Multiple Sclerosis (RRMS), including patients who have experienced a single demyelinating event and have lesions typical of multiple sclerosis on brain MRI: • To decrease the frequency of clinical exacerbations • To reduce the number and volume of active brain lesions identified on Magnetic Resonance Imaging (MRI) scans. 40 mg/mL three times-a-week: Treatment of ambulatory patients with Relapsing Remitting Multiple Sclerosis (RRMS): • To decrease the frequency of clinical exacerbations • To reduce the number and volume of active brain lesions identified on Magnetic Resonance Imaging (MRI) scans. The safety and efficacy of COPAXONE in chronic progressive MS have not been established.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

COPAXONE should only be prescribed by (or following consultation with) clinicians who are experienced in the diagnosis and management of Multiple Sclerosis. The only recommended route of administration of COPAXONE (glatiramer acetate) injection is the subcutaneous route. COPAXONE should not be administered by the intravenous or intramuscular routes. Patients should be instructed in aseptic self-injection techniques to assure the safe administration of COPAXONE (glatiramer acetate), including a careful review of the Patient Medication Information. The first injection should be performed under the supervision of an appropriately qualified health care professional. Patient understanding and use of aseptic self-injection techniques and procedures should be periodically re-evaluated. Patients should be cautioned against the re-use of needles, syringes or pens and instructed in safe disposal procedures. A puncture-resistant container for disposal of used needles, syringes and pens should be used by the patient. Patients should be instructed on the safe disposal of full containers. Recommended Dose and Dosage Adjustment The recommended dose and dosing schedule of COPAXONE (glatiramer acetate injection) for the treatment of Relapsing Remitting MS depends on the product strength selected: • COPAXONE 20 mg/mL: Administer once per day or • COPAXONE 40 mg/mL: Administer three times per week and at least 48 hours apart COPAXONE 20 mg/mL and COPAXONE 40 mg/mL are not interchangeable. Missed Dose: If a dose is missed it should be taken as soon as possible. If, however, it is closer to the time of the next dose, skip the missed dose and resume at the usual dosing schedule. For COPAXONE 20 mg/mL, avoid giving 2 injections in the same 12-hour period. For COPAXONE 40 mg/mL, ensure injections are at least 48 hours apart.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

The pre-filled syringes and pens of COPAXONE should be refrigerated immediately upon receipt (2°-8°C). DO NOT FREEZE. COPAXONE prefilled syringes and pens contain no preservative. Do not use if the solution contains any particulate matter. If you cannot have refrigerator storage, pre-filled syringes and pens of COPAXONE can be stored at room temperature (15° - 30°C) for up to 1 month. Do not store pre-filled syringes and pens at room temperature for longer than 1 month. Note: this drug is light sensitive, do not expose to light when not injecting. Each pre-filled syringe and pen is for single use only. Throw out all used syringes and pens in a hard-walled plastic container.

How is it supplied?

COPAXONE (glatiramer acetate injection) single-use 20 mg/1 mL pre-filled syringes have white plunger rods. Each pre-filled syringe contains glatiramer acetate, mannitol and sterile water for injection. Available in packs of 30 single-use 20 mg/1 mL pre-filled glass syringes. COPAXONE (glatiramer acetate injection) single use 40 mg/1 mL prefilled syringes have blue plunger rods. Each pre-filled syringe contains glatiramer acetate, mannitol and sterile water for injection. Available in packs of 12 single-use 40 mg/1 mL prefilled glass syringes. COPAXONE (glatiramer acetate injection) single-use 40 mg / 1 mL prefilled pens have blue plunger rods (blue color appears after injection). Each prefilled pen contains glatiramer acetate, mannitol and sterile water for injection. Available in packs of 12 single-use 40 mg / 1 mL prefilled pens.

Contraindications

COPAXONE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For further information on hypersensitivity, see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

Warnings and precautions

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 7 WARNINGS AND PRECAUTIONS, Immune). • 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 2 CONTRAINDICATIONS; 7 WARNINGS AND PRECAUTIONS, Immune). Immediate Post-Injection Reaction: COPAXONE has been associated with a constellation of symptoms appearing immediately after injection that included at least two of the following: flushing, chest pain, palpitations, anxiety, dyspnea, constriction of the throat and urticaria (see 8.1 Adverse Reaction Overview). Cardiovascular: Symptoms of Potentially Cardiac Origin: A number of patients exposed to either COPAXONE 20 mg/mL once per day in 4 placebo-controlled trials, or COPAXONE 40 mg/mL three times per week in a single placebo-controlled trial, experienced at least one episode of what was described as transient chest pain (see 8 ADVERSE REACTIONS). While some of these episodes occurred in the context of the Immediate Post-Injection Reaction (see 8 ADVERSE REACTIONS), many did not. The pathogenesis of this symptom is unknown. Patients in controlled clinical trials were free of significant cardiovascular problems (New York Heart Association Class I and II) and thus the risks associated with COPAXONE treatment for Multiple Sclerosis patients with comorbid cardiovascular disease are unknown. Hepatic/Biliary/Pancreatic: Very rare cases of severe liver injury, including liver failure, hepatitis with jaundice, and extremely rare cases of fulminant hepatitis leading to liver transplant, have been reported with Copaxone during postmarketing experience in patients with and without relevant risk factors in their medical history, such as history of drug induced liver events with other disease modifying therapies (DMTs) indicated for the treatment of multiple sclerosis, concomitant treatment with drugs with known Drug Induced Liver Injury (DILI) risk or medical history of liver impairment. Hepatic adverse events have occurred from days to years after initiating treatment with Copaxone and with a similar profile with both dose regimens (20 mg/mL daily and 40 mg/mL TIW), suggesting idiosyncratic drug induced liver injury in most cases. Some cases, reported in patients who previously experienced liver injury during treatment with other immunomodulatory therapies used to treat multiple sclerosis, were suggestive of autoimmune hepatitis. Most events resolved with discontinuation of treatment and a relationship to Copaxone could not be excluded (see 8.5 Post-Market Adverse Reactions).

What can be used instead?

Other Canadian products sharing ATC code L03AX13 GLATIRAMER ACETATE. 4 of 8 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies GLATIRAMER ACETATE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. GLATIRAMER ACETATE appears in 40 registered pack listings across 12 markets, published on 10 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.