Drugs List

Therapeutic Indications

Uses

Non-metastatic osteosarcoma after complete surgical resection

Treatment of patients with high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with post-operative multi-agent chemotherapy.

Administration

To be administered as an intravenous infusion over a period of 1 hour.

Contraindications

Children under 2 years
Patients over 30 years
Breastfeeding
Pregnancy

Precautions and Warnings

Females of childbearing potential
History of autoimmune disorder
Inflammatory disorder
Asthma
Chronic obstructive pulmonary disease
Collagen disorder
History of venous thromboembolism
Moderate hepatic impairment
Neutropenia
Severe renal impairment
Unstable cardiac disorder
Vasculitis

Advise ability to drive/operate machinery may be affected by side effects
Treatment to be initiated and supervised by a specialist
If fever or chills persist for more than 8 hours consider possible sepsis
Monitor clotting parameters after first dose & after several doses
Monitor for signs and symptoms of allergic reaction
Monitor for signs or symptoms of uncontrolled inflammatory reactions
Monitor hepatic function
Monitor renal function
Suspend or discontinue therapy if cardiovascular symptoms increase
Suspend treatment if patients experience worsening of respiratory symptoms
Bronchodilator therapy may be used to reduce bronchospasm
Advise patients to avoid aspirin and NSAID use
Female: Ensure adequate contraception during treatment

Pregnancy and Lactation

Pregnancy

Mifamurtide is contraindicated during pregnancy.

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

Mifamurtide is contraindicated during breastfeeding.

It is unknown whether mifamurtide is excreted in human breast milk. A decision should be made as to whether to discontinue either breastfeeding or mifamurtide treatment, taking into account the benefits of treatment for the patient and the benefits of breast feeding for the infant.

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 distension
Allergic reaction
Alopecia
Anaemia
Anorexia
Anxiety
Arthralgia
Asthenia
Blurred vision
Catheter related infection
Cellulitis
Chills
Confusion
Cough
Cyanosis
Decreased appetite
Dehydration
Depression
Dizziness
Drowsiness
Dry skin
Dysmenorrhoea
Dyspnoea
Dysuria
Epistaxis
Erythema
Fatigue
Febrile neutropenia
Fever
Flushing
Gastro-intestinal disturbances
Granulocytopenia
Haematuria
Haemoptysis
Headache
Hearing loss
Herpes simplex
Hyperhidrosis
Hypertension
Hypoaesthesia
Hypokalaemia
Hypotension
Hypothermia
Inflammatory reactions
Injection site reactions
Insomnia
Lethargy
Leukopenia
Malaise
Mucosal inflammation
Muscle spasm
Myalgia
Naso-sinus congestion
Nasopharyngitis
Nausea
Oedema
Pain
Pallor
Palpitations
Paraesthesia
Pericarditis
Peripheral oedema
Pharyngitis
Phlebitis
Pleural effusion
Pleuritis
Pollakiuria
Post-operative pain
Pruritus
Rash
Sensation of cold
Sepsis
Somnolence
Stiffness
Tachycardia
Tachypnoea
Thrombocytopenia
Tinnitus
Tremor
Upper respiratory tract infection
Urinary tract infections
Vertigo
Vomiting
Weight loss
Wheezing

Presentation

Mifamurtide powder for concentration for dispersion for infusion

Drugs List

Therapeutic Indications

Uses

Non-metastatic osteosarcoma after complete surgical resection

Treatment of patients with high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with post-operative multi-agent chemotherapy.

Dosage

Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.

Adults

Children

Administration

To be administered as an intravenous infusion over a period of 1 hour.

Contraindications

Children under 2 years
Patients over 30 years
Breastfeeding
Pregnancy

Precautions and Warnings

Females of childbearing potential
History of autoimmune disorder
Inflammatory disorder
Asthma
Chronic obstructive pulmonary disease
Collagen disorder
History of venous thromboembolism
Moderate hepatic impairment
Neutropenia
Severe renal impairment
Unstable cardiac disorder
Vasculitis

Advise ability to drive/operate machinery may be affected by side effects
Treatment to be initiated and supervised by a specialist
If fever or chills persist for more than 8 hours consider possible sepsis
Monitor clotting parameters after first dose & after several doses
Monitor for signs and symptoms of allergic reaction
Monitor for signs or symptoms of uncontrolled inflammatory reactions
Monitor hepatic function
Monitor renal function
Suspend or discontinue therapy if cardiovascular symptoms increase
Suspend treatment if patients experience worsening of respiratory symptoms
Bronchodilator therapy may be used to reduce bronchospasm
Advise patients to avoid aspirin and NSAID use
Female: Ensure adequate contraception during treatment

Pregnancy and Lactation

Pregnancy

Mifamurtide is contraindicated during pregnancy.

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

Mifamurtide is contraindicated during breastfeeding.

It is unknown whether mifamurtide is excreted in human breast milk. A decision should be made as to whether to discontinue either breastfeeding or mifamurtide treatment, taking into account the benefits of treatment for the patient and the benefits of breast feeding for the infant.

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 distension
Allergic reaction
Alopecia
Anaemia
Anorexia
Anxiety
Arthralgia
Asthenia
Blurred vision
Catheter related infection
Cellulitis
Chills
Confusion
Cough
Cyanosis
Decreased appetite
Dehydration
Depression
Dizziness
Drowsiness
Dry skin
Dysmenorrhoea
Dyspnoea
Dysuria
Epistaxis
Erythema
Fatigue
Febrile neutropenia
Fever
Flushing
Gastro-intestinal disturbances
Granulocytopenia
Haematuria
Haemoptysis
Headache
Hearing loss
Herpes simplex
Hyperhidrosis
Hypertension
Hypoaesthesia
Hypokalaemia
Hypotension
Hypothermia
Inflammatory reactions
Injection site reactions
Insomnia
Lethargy
Leukopenia
Malaise
Mucosal inflammation
Muscle spasm
Myalgia
Naso-sinus congestion
Nasopharyngitis
Nausea
Oedema
Pain
Pallor
Palpitations
Paraesthesia
Pericarditis
Peripheral oedema
Pharyngitis
Phlebitis
Pleural effusion
Pleuritis
Pollakiuria
Post-operative pain
Pruritus
Rash
Sensation of cold
Sepsis
Somnolence
Stiffness
Tachycardia
Tachypnoea
Thrombocytopenia
Tinnitus
Tremor
Upper respiratory tract infection
Urinary tract infections
Vertigo
Vomiting
Weight loss
Wheezing

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: October 2016

Reference Sources

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 27 September 2016.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications. Accessed on 27 September 2016.

Summary of Product Characteristics: Mepact 4 mg powder for suspension for infusion. Takeda UK Ltd. Revised December 2013.