Consumer medicine information

1. Why am I using GLATIRA?

GLATIRA 20 mg/1 mL and GLATIRA 40 mg/1 mL (GLATIRA) contains the active ingredient glatiramer acetate. GLATIRA is used for the management of relapsing forms of Multiple Sclerosis (MS).
For more information, see Section 1. Why am I using GLATIRA? in the full CMI.

2. What should I know before I use GLATIRA?

Do not use if you have ever had an allergic reaction to glatiramer acetate or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use GLATIRA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with GLATIRA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use GLATIRA?

• The recommended dose of one Glatira 20 mg/1 mL pre-filled syringe is to be injected once a day.

• The recommended dose of one Glatira 40 mg/1 mL pre-filled syringe is to be injected three times a week and at least 48 hours apart.

• GLATIRA is given by an injection into the fatty layer under the skin (subcutaneous injection).

5. What should I know while using GLATIRA?

6. Are there any side effects?

Common side effects: Immediate Post Injection Reaction which includes the following symptoms - reddening of the face and/or neck, chest pain or tightness, feeling your heart beat quickly (heart palpitations), anxiety and difficulty in breathing.
Serious side effects: Symptoms of an allergic reaction that include - swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, hives, chest pain, trouble breathing and severe pain, redness or swelling at the injection site that does not go away.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Glatiramer acetate.

2 Qualitative and Quantitative Composition

Glatira 20 mg/1 mL contains 20 mg of glatiramer acetate.
Glatira 40 mg/1 mL contains 40 mg of glatiramer acetate.
Glatiramer acetate, the active ingredient in both Glatira 20 mg/1 mL and Glatira 40 mg/1 mL, is the acetate salt of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine and L-lysine with an average molar fraction 0.141, 0.427, 0.095 and 0.338, respectively.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Glatira 20 mg/1 mL is a clear, colourless solution for injection, in a 1 mL pre-filled syringe.
Glatira 40 mg/1 mL is a clear, colourless solution for injection, in a 1 mL pre-filled syringe.
The pH of a 0.5% solution in water is in the range of 5.5 to 7.0 and an osmolarity of about 265 mOsmol/L and 300 mOsmol/L for the 20 mg/mL and 40 mg/mL, respectively.

4 Clinical Particulars

4.9 Overdose

There are 13 reports to date of overdose with glatiramer acetate which were confirmed by health care professionals. Most cases concern 2 or 3 injections given on the same day. The largest dose of glatiramer acetate that has been administered is 300 mg on a single occasion. No adverse reactions occurred and the patient continued treatment.
There is no specific antidote. Treatment of overdose consists of discontinuation of glatiramer acetate, along with monitoring the patient for at least 10 hours and the institution of appropriate symptomatic and supportive therapy.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Animal toxicology. In a 2-year carcinogenicity study in mice, subcutaneous administration of glatiramer acetate at doses ≥ 3 mg/kg/day (approximately half the daily human therapeutic dose on a mg/m² basis) was associated with increased mortality in the first 8 weeks of the study. The cause of these deaths was not established, but limited data suggest that they may have been associated with type 1 hypersensitivity reactions.
Genotoxicity. Glatiramer acetate was not mutagenic in vitro, but a clastogenic effect was observed in two separate in vitro assays in human lymphocytes. There was no evidence of clastogenicity in a mouse bone marrow micronucleus assay in vivo.
Carcinogenicity. In a 2-year carcinogenicity study, repeated subcutaneous administration of glatiramer acetate to male mice at doses 12 times the daily human therapeutic dose on a mg/m² basis was associated with the development of skin and subcutis sarcomas. This effect may have been associated with persistent tissue damage at injection sites, which tended to be more common and was of greater severity in males. The incidence of skin sarcoma was not increased in female mice at doses up to 12 times the daily human therapeutic dose on a mg/m² basis. In a 2-year carcinogenicity study in rats, subcutaneous administration of glatiramer acetate at 12 times the daily therapeutic human dose on a mg/m² basis was associated with an increased incidence of benign adrenal pheochromocytomas in males only; this effect was not seen at 6 times the daily human dose and was within the historical control values for the testing laboratory. The possible relevance of these findings to humans is not known.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Glatiramer acetate is a white to slightly yellowish lyophilised material which is sparingly soluble in water and insoluble in acetone. The pH of a 0.5% solution in water is in the range of 5.5 to 7.0.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSGLAACE.gif Structural Formula: Poly [ L-Glu^13-15, L-Ala^39-46, L-Tyr^8.6-10, L-Lys^30-37].n(CH₃CO₂H).
n = 15 to 24 units per 100 amino acid residues.
The superscripts in the formula above represent the molar fraction percent range of the amino acid residues comprising the various polypeptide species in glatiramer acetate where the sequence of the amino acid residues varies among the individual species.
CAS number. 147245-92-9.
CAS Registry Number of the free base: 28704-27-0.
Average Molecular weight: 5000-9000 daltons.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes

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