Drugs List

Therapeutic Indications

Uses

Treatment of relapsing-remitting multiple sclerosis

Administration

For subcutaneous injection only.

Instruct patient on appropriate self-injection technique. The first time a patient self-administers, ensure they are supervised by an appropriate healthcare professional during administration and for 30 minutes afterwards.

A different site for injection should be chosen every day to reduce the chances of any irritation or pain at the site of the injection. Sites for self injection include the abdomen, arms, hips and thighs.

Contraindications

Children under 12 years

Precautions and Warnings

Children aged 12 to 18 years
Elderly
Breastfeeding
Cardiac disorder
Pregnancy
Renal impairment

Not all available products are licensed for all age groups
Treatment to be initiated and supervised by a specialist
Rotate injection sites to minimise the risk of lipoatrophy
Monitor patient for 30 minutes after first administration
Monitor patients with cardiac disorders
Review self injection technique periodically, especially if reactions occur
Consider discontinuing treatment if severe hepatic injury occurs
Discontinue if severe hypersensitivity reactions occur
Advise patient to seek medical advice if adverse reactions occur

Patients should be made aware that reactions such as vasodilation, chest pain, dyspnoea, palpitations or tachycardia may occur within minutes of administration of glatiramer injection. The majority of these symptoms are short lived and resolve spontaneously without any sequelae.

Convulsions and severe hypersensitivity reactions (including bronchospasm, urticaria and anaphylaxis) have been reported rarely. Should a severe adverse reaction or hypersensitivity reaction occur, the patient must immediately stop using glatiramer treatment and seek medical advice. Symptomatic treatment should be considered and treatment should be discontinued if severe hypersensitivity reactions occur.

Cases of severe liver injury including hepatitis with jaundice, liver failure and isolated liver transplantation cases have been reported following glatiramer acetate treatment. Concomitant conditions reported in these cases include excessive alcohol consumption, existing or history of liver injury and use of other potentially hepatotoxic medication.

Pregnancy and Lactation

Pregnancy

Use glatiramer acetate with caution in pregnancy. Reproductive toxicity has not been found in animal studies. It is not known if glatiramer acetate crosses the human placenta. The average molecular weight of glatiramer acetate is 5000 to 9000 suggesting that it does not cross the human placenta to the foetus by simple diffusion.
Sources suggest that the drug does not appear to present significant risk to the foetus and the benefits of the drug outweigh the risk to the foetus. Schaefer states that glatiramer does not need to be stopped when planning a pregnancy. A detailed ultrasound examination should be offered to confirm the normal development of the foetus.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use glatiramer acetate with caution in breastfeeding.

At the time of writing it is unknown whether glatiramer is excreted in human breast milk. Due to the high molecular weight it is doubtful that the unmetabolised agent is excreted in breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abnormal liver function tests
Abortion
Abscess
Alcohol intolerance
Angioedema
Anorexia
Anxiety
Arthralgia
Asthenia
Benign skin neoplasms
Breast enlargement
Bronchitis
Cellulitis
Chest pain
Chills
Cholelithiasis
Cognitive impairment
Confusion
Constipation
Convulsions
Cysts
Depression
Dizziness
Dream abnormalities
Dysgeusia
Dyspnoea
Ear disorder
Ecchymosis
Epistaxis
Erectile dysfunction
Extrasystoles
Eye disorder
Facial oedema
Faecal incontinence
Gastro-enteritis
Gastro-intestinal symptoms
Goitre
Gout
Haematuria
Hallucinations
Hangover effects
Headache
Hepatomegaly
Herpes infections
Hyperhidrosis
Hyperlipidaemia
Hypersensitivity reactions
Hyperthyroidism
Hypertonia
Hypothermia
Infection
Influenza-like syndrome
Injection site reactions
Laryngospasm
Leukocytosis
Leukopenia
Liver damage
Lymphadenopathy
Micturition disorders
Migraine
Mucous membrane disorder
Muscular atrophy
Neoplasms
Nephrolithiasis
Nervousness
Osteoarthritis
Pain
Palpitations
Paralysis
Peripheral oedema
Personality disorder
Priapism
Prostate abnormalities
Pruritus
Pyrexia
Rectal disorders
Respiratory disorders
Rhinitis
Sinus bradycardia
Skin carcinoma
Skin reactions
Splenomegaly
Suicidal tendencies
Syncope
Tachycardia
Testicular disorders
Thrombocytopenia
Tooth disorder
Toxic hepatitis
Tremor
Urinary tract disorders
Urticaria
Vaginal candidiasis
Varicose veins
Vasodilatation
Visual disturbances
Vulvovaginal disorders
Weight gain

Presentation

Injections of glatiramer acetate.

Drugs List

Therapeutic Indications

Uses

Treatment of relapsing-remitting multiple sclerosis

Dosage

Adults

Children

Administration

For subcutaneous injection only.

Instruct patient on appropriate self-injection technique. The first time a patient self-administers, ensure they are supervised by an appropriate healthcare professional during administration and for 30 minutes afterwards.

A different site for injection should be chosen every day to reduce the chances of any irritation or pain at the site of the injection. Sites for self injection include the abdomen, arms, hips and thighs.

Contraindications

Children under 12 years

Precautions and Warnings

Children aged 12 to 18 years
Elderly
Breastfeeding
Cardiac disorder
Pregnancy
Renal impairment

Not all available products are licensed for all age groups
Treatment to be initiated and supervised by a specialist
Rotate injection sites to minimise the risk of lipoatrophy
Monitor patient for 30 minutes after first administration
Monitor patients with cardiac disorders
Review self injection technique periodically, especially if reactions occur
Consider discontinuing treatment if severe hepatic injury occurs
Discontinue if severe hypersensitivity reactions occur
Advise patient to seek medical advice if adverse reactions occur

Patients should be made aware that reactions such as vasodilation, chest pain, dyspnoea, palpitations or tachycardia may occur within minutes of administration of glatiramer injection. The majority of these symptoms are short lived and resolve spontaneously without any sequelae.

Convulsions and severe hypersensitivity reactions (including bronchospasm, urticaria and anaphylaxis) have been reported rarely. Should a severe adverse reaction or hypersensitivity reaction occur, the patient must immediately stop using glatiramer treatment and seek medical advice. Symptomatic treatment should be considered and treatment should be discontinued if severe hypersensitivity reactions occur.

Cases of severe liver injury including hepatitis with jaundice, liver failure and isolated liver transplantation cases have been reported following glatiramer acetate treatment. Concomitant conditions reported in these cases include excessive alcohol consumption, existing or history of liver injury and use of other potentially hepatotoxic medication.

Pregnancy and Lactation

Pregnancy

Use glatiramer acetate with caution in pregnancy. Reproductive toxicity has not been found in animal studies. It is not known if glatiramer acetate crosses the human placenta. The average molecular weight of glatiramer acetate is 5000 to 9000 suggesting that it does not cross the human placenta to the foetus by simple diffusion.
Sources suggest that the drug does not appear to present significant risk to the foetus and the benefits of the drug outweigh the risk to the foetus. Schaefer states that glatiramer does not need to be stopped when planning a pregnancy. A detailed ultrasound examination should be offered to confirm the normal development of the foetus.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use glatiramer acetate with caution in breastfeeding.

At the time of writing it is unknown whether glatiramer is excreted in human breast milk. Due to the high molecular weight it is doubtful that the unmetabolised agent is excreted in breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abnormal liver function tests
Abortion
Abscess
Alcohol intolerance
Angioedema
Anorexia
Anxiety
Arthralgia
Asthenia
Benign skin neoplasms
Breast enlargement
Bronchitis
Cellulitis
Chest pain
Chills
Cholelithiasis
Cognitive impairment
Confusion
Constipation
Convulsions
Cysts
Depression
Dizziness
Dream abnormalities
Dysgeusia
Dyspnoea
Ear disorder
Ecchymosis
Epistaxis
Erectile dysfunction
Extrasystoles
Eye disorder
Facial oedema
Faecal incontinence
Gastro-enteritis
Gastro-intestinal symptoms
Goitre
Gout
Haematuria
Hallucinations
Hangover effects
Headache
Hepatomegaly
Herpes infections
Hyperhidrosis
Hyperlipidaemia
Hypersensitivity reactions
Hyperthyroidism
Hypertonia
Hypothermia
Infection
Influenza-like syndrome
Injection site reactions
Laryngospasm
Leukocytosis
Leukopenia
Liver damage
Lymphadenopathy
Micturition disorders
Migraine
Mucous membrane disorder
Muscular atrophy
Neoplasms
Nephrolithiasis
Nervousness
Osteoarthritis
Pain
Palpitations
Paralysis
Peripheral oedema
Personality disorder
Priapism
Prostate abnormalities
Pruritus
Pyrexia
Rectal disorders
Respiratory disorders
Rhinitis
Sinus bradycardia
Skin carcinoma
Skin reactions
Splenomegaly
Suicidal tendencies
Syncope
Tachycardia
Testicular disorders
Thrombocytopenia
Tooth disorder
Toxic hepatitis
Tremor
Urinary tract disorders
Urticaria
Vaginal candidiasis
Varicose veins
Vasodilatation
Visual disturbances
Vulvovaginal disorders
Weight gain

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: February 2018

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Copaxone 20mg/ml, Solution for Injection, Pre-Filled Syringe. Teva Pharmaceuticals Ltd. Revised September 2020.

Summary of Product Characteristics: Copaxone 40mg/ml Solution for Injection, Pre-filled Syringe. Teva Pharmaceuticals Ltd. Revised September 2020.

Summary of Product Characteristics: Brabio 20mg/ml Solution for injection, Pre-filled Syringe. Generics UK T/A Mylan. Revised March 2017.

Summary of Product Characteristics: Brabio 40mg/ml Solution for injection, Pre-filled Syringe. Generics UK T/A Mylan. Revised November 2017.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 19 February 2018.