Drugs List

Therapeutic Indications

Uses

To extend life/time to mechan'l ventil'n in amyotrophic lateral sclerosis

To extend life or the time to mechanical ventilation in amyotrophic lateral sclerosis form of motor neurone disease.

Contraindications

Children under 18 years
Acute porphyria
Breastfeeding
Hepatic disorder
Pregnancy
Renal impairment
Serum transaminases above 3 times upper limit of normal

Precautions and Warnings

Abnormal liver function test
Hereditary fructose intolerance
History of hepatic impairment

Advise patient that dizziness/vertigo may affect ability to drive
Treatment to be initiated by specialist
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Monitor serum transaminases (including ALT) before and during therapy
Monitor serum ALT every 3 months from month 3 to 12 of therapy
Monitor serum ALT monthly during first 3 months of therapy
Advise patient to report any new or worsening respiratory symptoms
Advise patient to report unexplained fever, sore throat, bruising, bleeding
Discontinue if ALT level exceeds 5 times the upper limit of normal
Discontinue if clinical/laboratory evidence of neutropenia
Discontinue if evidence of interstitial lung disease

Patients should report any febrile illness to their physicians. The report of a febrile illness should prompt physicians to check white blood cell counts and to discontinue riluzole in case of neutropenia.

If any respiratory symptoms develop such as dry cough and/or dyspnoea, chest radiography should be performed. If interstitial lung disease is diagnosed, riluzole should be discontinued immediately.

Pregnancy and Lactation

Pregnancy

Riluzole is contraindicated in pregnancy.

Clinical experience in pregnant women is lacking.

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

Riluzole is contraindicated in breastfeeding.

It is not known whether riluzole is excreted in human 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

Abdominal pain
Altered liver function tests
Anaemia
Anaphylactoid reaction
Angioedema
Asthenia
Diarrhoea
Dizziness
Headache
Hepatitis
Interstitial lung disease
Jaundice
Nausea
Neutropenia
Oral paraesthesia
Pain
Pancreatitis
Somnolence
Tachycardia
Vertigo
Vomiting

Presentation

Oral formulations containing riluzole

Drugs List

Therapeutic Indications

Uses

To extend life/time to mechan'l ventil'n in amyotrophic lateral sclerosis

To extend life or the time to mechanical ventilation in amyotrophic lateral sclerosis form of motor neurone disease.

Dosage

Adults

Elderly

Contraindications

Children under 18 years
Acute porphyria
Breastfeeding
Hepatic disorder
Pregnancy
Renal impairment
Serum transaminases above 3 times upper limit of normal

Precautions and Warnings

Abnormal liver function test
Hereditary fructose intolerance
History of hepatic impairment

Advise patient that dizziness/vertigo may affect ability to drive
Treatment to be initiated by specialist
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Monitor serum transaminases (including ALT) before and during therapy
Monitor serum ALT every 3 months from month 3 to 12 of therapy
Monitor serum ALT monthly during first 3 months of therapy
Advise patient to report any new or worsening respiratory symptoms
Advise patient to report unexplained fever, sore throat, bruising, bleeding
Discontinue if ALT level exceeds 5 times the upper limit of normal
Discontinue if clinical/laboratory evidence of neutropenia
Discontinue if evidence of interstitial lung disease

Patients should report any febrile illness to their physicians. The report of a febrile illness should prompt physicians to check white blood cell counts and to discontinue riluzole in case of neutropenia.

If any respiratory symptoms develop such as dry cough and/or dyspnoea, chest radiography should be performed. If interstitial lung disease is diagnosed, riluzole should be discontinued immediately.

Pregnancy and Lactation

Pregnancy

Riluzole is contraindicated in pregnancy.

Clinical experience in pregnant women is lacking.

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

Riluzole is contraindicated in breastfeeding.

It is not known whether riluzole is excreted in human 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

Abdominal pain
Altered liver function tests
Anaemia
Anaphylactoid reaction
Angioedema
Asthenia
Diarrhoea
Dizziness
Headache
Hepatitis
Interstitial lung disease
Jaundice
Nausea
Neutropenia
Oral paraesthesia
Pain
Pancreatitis
Somnolence
Tachycardia
Vertigo
Vomiting

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: November 2015

Reference Sources

British National Formulary. 70th ed. London: BMJ Group and Pharmaceutical Press; 2015.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Rilutek. Sanofi Aventis. Revised December 2013

Summary of Product Characteristics: Riluzole. Martindale Pharmaceuticals. Revised July 2015