Drugs List

Therapeutic Indications

Uses

Reversal of neuromuscular blockade induced by rocuronium or vecuronium

Routine reversal of rocuronium induced blockade in children and adolescents

Administration

To be administered intravenously as a single bolus injection. It should be given rapidly within 10 seconds directly into a vein or existing IV line.

If sugammadex is administrated via the same infusion line as used for other medical products then the line should be adequately flushed (e.g. with sodium chloride 0.9%) between administration of sugammadex and any incompatible products - see Administration: Incompatibilities.

When used in paediatric patients, sugammadex may be diluted in order to increase the accuracy of dosing - see Administration: Reconstitution.

Reconstitution

Paediatric use: Sugammadex may be diluted in sodium chloride 0.9% to a final concentration of 10mg/ml.

After first opening and dilution, chemical and physical in-use stability has been demonstrated for 48 hours at 2 to 25 degrees C.
From a microbiological viewpoint, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally be no longer than 24 hours at 2 to 8 degrees C, unless dilution has taken place under aseptic conditions.

Compatibilities

Sodium chloride 0.9%
Glucose 5%
Sodium chloride 0.45% and glucose 2.5%
Ringers lactate solution
Ringers solution
Glucose 5% in sodium chloride 0.9%

Incompatibilities

Physical incompatibility has been reported with:
Verapamil
Ondansetron
Ranitidine

Contraindications

Children under 2 years
Severe renal impairment (creatinine clearance less than 30ml/minute).

Precautions and Warnings

Sugammadex should only be administered by, or under the supervision of an anaesthetist.

Ventilatory support is required until spontaneous respiration is restored.

Further ventilatory support may be required in the peri- and post operative period if respiratory function is compromised by other medical products or if there is a re-occurrence of neuromuscular blockade. Re-occurrence of blockade may occur when medicinal products which potentiate neuromuscular blockade are used in the post-operative period or during the administration of certain medical products after sugammadex use which could theoretically cause displacement of rocuronium or vecuronium from sugammadex. See Dosage: Additional Dosage.

History of pulmonary complications: bronchospasm may occur.

Severe hepatic impairment - see Dosage: Hepatic impairment.

Obesity - dosage should be based on actual body weight.

Clinicians should be prepared for the possibility of hypersensitivity reactions (including anaphylactic reactions).

Pregnancy - see Pregnancy.

Breastfeeding - see Lactation.

Conditions associated with prolonged circulation time such as cardiovascular disease, old age or oedema may be associated with longer recovery times.

Sugammadex has been reported to prolong the activated partial thromboplastin time or the prothrombin time. The effect is of short duration (less than 30 minutes). Use with caution when considering the use of sugammadex in patients receiving therapeutic anticoagulants for a pre-existing or co-morbid condition.

An increased risk of bleeding can not be excluded in patients:
- with hereditary vitamin K dependent clotting factor
- with pre-existing coagulopathies
- on coumarin derivates and at an INR above 3.5
- using anticoagulants who receive a dose of 16mg/kg sugammadex.
If there is a medical need to give sugammadex to these patients the anaesthesiologist needs to decide if the benefits of treatment out weight the possible risks of bleeding complications considering the patients history of bleeding episodes and the type of surgery scheduled. Monitoring of haemostasis and coagulation parameters is recommended.

If re-administration of either rocuronium or vecuronium is required the following intervals should elapse before they are given again.
Re-administration of rocuronium or vecuronium after routine reversal ( up to 4mg/kg sugammadex):
Minimum waiting time 5 minutes - use 1.2mg/kg rocuronium
Minimum waiting time 4 hours - use 0.6mg/kg rocuronium or 0.1mg/kg vecuronium.

The onset of neuromuscular blockade may be prolonged up to approximately 4 minutes, and the duration of neuromuscular blockade may be shortened by up to approximately 15 minutes after re-administration of rocuronium.

The recommended waiting time for patients with mild or moderate renal impairment for re-use of 0.6mg/kg rocuronium or 0.1mg/kg vecuronium after routine reversal with sugammadex should be 24 hours. If a shorter waiting time is required, the rocuronium dose for a new neuromuscular blockade should be 1.2mg/kg.

Re-administration of rocuronium or vecuronium after immediate reversal ( 16mg/kg sugammadex):
For very rare cases where this may be required, a waiting time of 24hours is suggested.

If neuromuscular blockade is required before the recommended waiting time has passed, a nonsteroidal neuromuscular blocking agent should be used.

When neuromuscular blockade is reversed while anaesthesia is continued, signs of light anaesthesia have occasionally been observed. Therefore additional doses of anaesthetic and/or opioid should be given as clinically indicated.

Not to be used to reverse nerve block from other steroidal neuromuscular blockers or any non-steroidal neuromuscular blockers.

Each ml of sugammadex solution contains 9.7mg sodium. A dose of 23mg sodium is considered essentially sodium-free so if a dose of more than 2.4ml solution needs to be given, this should be taken into account by patients on a low sodium intake.

Patients should be advised that a single dose of sugammadex may reduce the contraceptive effect of oral contraceptives (both combined oral contraceptives and progesterone-only contraceptives) which is equivalent to one missed daily dose of oral contraceptive. Patients should follow the missed dose advice in the product information if sugammadex is administered on the same day as an oral contraceptive is taken. For non-oral hormonal contraceptives, the patient should be advised to use an additional non-hormonal contraceptive method for 7 days following sugammadex administration.

Sugammadex may affect some laboratory test - see Effects on Laboratory Tests .

Pregnancy and Lactation

Pregnancy

To date, safety in human pregnancy has not been established (no data on exposed pregnancies is available to date). However the manufacturers state caution should be used when administering sugammadex to pregnant women.

Animal studies do not indicate any harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.

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 14-17 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 ).

Licensed in pregnancy? - No

Recommended for use in pregnancy? - No

Animal data - No harmful effects were observed in animal studies.

Lactation

Use with caution.

The manufacturers recommend that sugammadex can be used during breastfeeding. However, it is unknown whether sugammadex is excreted in human breast milk, animal studies have shown excretion into breast milk. Oral absorption of cyclodextrins is low so no effects on the nursing infant are anticipated following a single dose of sugammadex to the breastfeeding woman.

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

Considered suitable by manufacturer? - Yes

Drug substance licensed in infants? - No. Contraindicated in children under 2 years.

Side Effects

Dysgeusia
Flushing
Erythematous rash
Bronchospasm
Skin reactions
Anaphylaxis
Urticaria
Hypotension
Tachycardia
Tongue swelling
Oropharyngeal swelling
Spontaneous movements
Cough
Prothrombin time increased
Anaphylactic shock
Anaesthetic complications
Hypersensitivity reactions
Nausea
Facial grimacing

Presentation

Solution for injection containing sugammadex 200mg per 2ml

Solution for injection containing sugammadex 500mg per 5ml

Drugs List

Therapeutic Indications

Uses

Reversal of neuromuscular blockade induced by rocuronium or vecuronium

Routine reversal of rocuronium induced blockade in children and adolescents

Dosage

Sugammadex should only be administered by, or under the supervision of an anaesthetist.

The dose of sugammadex depends on the level of neuromuscular blockade to be reversed. The recommended dose does not depend on the anaesthetic regimen.

Adults

Elderly

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Administration

To be administered intravenously as a single bolus injection. It should be given rapidly within 10 seconds directly into a vein or existing IV line.

If sugammadex is administrated via the same infusion line as used for other medical products then the line should be adequately flushed (e.g. with sodium chloride 0.9%) between administration of sugammadex and any incompatible products - see Administration: Incompatibilities.

When used in paediatric patients, sugammadex may be diluted in order to increase the accuracy of dosing - see Administration: Reconstitution.

Reconstitution

Paediatric use: Sugammadex may be diluted in sodium chloride 0.9% to a final concentration of 10mg/ml.

After first opening and dilution, chemical and physical in-use stability has been demonstrated for 48 hours at 2 to 25 degrees C.
From a microbiological viewpoint, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally be no longer than 24 hours at 2 to 8 degrees C, unless dilution has taken place under aseptic conditions.

Compatibilities

Sodium chloride 0.9%
Glucose 5%
Sodium chloride 0.45% and glucose 2.5%
Ringers lactate solution
Ringers solution
Glucose 5% in sodium chloride 0.9%

Incompatibilities

Physical incompatibility has been reported with:
Verapamil
Ondansetron
Ranitidine

Contraindications

Children under 2 years
Severe renal impairment (creatinine clearance less than 30ml/minute).

Precautions and Warnings

Sugammadex should only be administered by, or under the supervision of an anaesthetist.

Ventilatory support is required until spontaneous respiration is restored.

Further ventilatory support may be required in the peri- and post operative period if respiratory function is compromised by other medical products or if there is a re-occurrence of neuromuscular blockade. Re-occurrence of blockade may occur when medicinal products which potentiate neuromuscular blockade are used in the post-operative period or during the administration of certain medical products after sugammadex use which could theoretically cause displacement of rocuronium or vecuronium from sugammadex. See Dosage: Additional Dosage.

History of pulmonary complications: bronchospasm may occur.

Severe hepatic impairment - see Dosage: Hepatic impairment.

Obesity - dosage should be based on actual body weight.

Clinicians should be prepared for the possibility of hypersensitivity reactions (including anaphylactic reactions).

Pregnancy - see Pregnancy.

Breastfeeding - see Lactation.

Conditions associated with prolonged circulation time such as cardiovascular disease, old age or oedema may be associated with longer recovery times.

Sugammadex has been reported to prolong the activated partial thromboplastin time or the prothrombin time. The effect is of short duration (less than 30 minutes). Use with caution when considering the use of sugammadex in patients receiving therapeutic anticoagulants for a pre-existing or co-morbid condition.

An increased risk of bleeding can not be excluded in patients:
- with hereditary vitamin K dependent clotting factor
- with pre-existing coagulopathies
- on coumarin derivates and at an INR above 3.5
- using anticoagulants who receive a dose of 16mg/kg sugammadex.
If there is a medical need to give sugammadex to these patients the anaesthesiologist needs to decide if the benefits of treatment out weight the possible risks of bleeding complications considering the patients history of bleeding episodes and the type of surgery scheduled. Monitoring of haemostasis and coagulation parameters is recommended.

If re-administration of either rocuronium or vecuronium is required the following intervals should elapse before they are given again.
Re-administration of rocuronium or vecuronium after routine reversal ( up to 4mg/kg sugammadex):
Minimum waiting time 5 minutes - use 1.2mg/kg rocuronium
Minimum waiting time 4 hours - use 0.6mg/kg rocuronium or 0.1mg/kg vecuronium.

The onset of neuromuscular blockade may be prolonged up to approximately 4 minutes, and the duration of neuromuscular blockade may be shortened by up to approximately 15 minutes after re-administration of rocuronium.

The recommended waiting time for patients with mild or moderate renal impairment for re-use of 0.6mg/kg rocuronium or 0.1mg/kg vecuronium after routine reversal with sugammadex should be 24 hours. If a shorter waiting time is required, the rocuronium dose for a new neuromuscular blockade should be 1.2mg/kg.

Re-administration of rocuronium or vecuronium after immediate reversal ( 16mg/kg sugammadex):
For very rare cases where this may be required, a waiting time of 24hours is suggested.

If neuromuscular blockade is required before the recommended waiting time has passed, a nonsteroidal neuromuscular blocking agent should be used.

When neuromuscular blockade is reversed while anaesthesia is continued, signs of light anaesthesia have occasionally been observed. Therefore additional doses of anaesthetic and/or opioid should be given as clinically indicated.

Not to be used to reverse nerve block from other steroidal neuromuscular blockers or any non-steroidal neuromuscular blockers.

Each ml of sugammadex solution contains 9.7mg sodium. A dose of 23mg sodium is considered essentially sodium-free so if a dose of more than 2.4ml solution needs to be given, this should be taken into account by patients on a low sodium intake.

Patients should be advised that a single dose of sugammadex may reduce the contraceptive effect of oral contraceptives (both combined oral contraceptives and progesterone-only contraceptives) which is equivalent to one missed daily dose of oral contraceptive. Patients should follow the missed dose advice in the product information if sugammadex is administered on the same day as an oral contraceptive is taken. For non-oral hormonal contraceptives, the patient should be advised to use an additional non-hormonal contraceptive method for 7 days following sugammadex administration.

Sugammadex may affect some laboratory test - see Effects on Laboratory Tests .

Pregnancy and Lactation

Pregnancy

To date, safety in human pregnancy has not been established (no data on exposed pregnancies is available to date). However the manufacturers state caution should be used when administering sugammadex to pregnant women.

Animal studies do not indicate any harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.

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 14-17 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 ).

Licensed in pregnancy? - No

Recommended for use in pregnancy? - No

Animal data - No harmful effects were observed in animal studies.

Lactation

Use with caution.

The manufacturers recommend that sugammadex can be used during breastfeeding. However, it is unknown whether sugammadex is excreted in human breast milk, animal studies have shown excretion into breast milk. Oral absorption of cyclodextrins is low so no effects on the nursing infant are anticipated following a single dose of sugammadex to the breastfeeding woman.

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

Considered suitable by manufacturer? - Yes

Drug substance licensed in infants? - No. Contraindicated in children under 2 years.

Effects on Ability to Drive and Operate Machinery

None known: No studies on the effects of sugammadex on driving or operating machinery have been performed.

Counselling

Patients should be advised that a single dose of sugammadex may reduce the contraceptive effect of oral contraceptives (both combined oral contraceptives and progesterone-only contraceptives) which is equivalent to one missed daily dose of oral contraceptive. Patients should follow the missed dose advice in the product information if sugammadex is administered on the same day as an oral contraceptive is taken. For non-oral hormonal contraceptives, the patient should be advised to use an additional non-hormonal contraceptive method for 7 days following sugammadex administration.

Side Effects

Dysgeusia
Flushing
Erythematous rash
Bronchospasm
Skin reactions
Anaphylaxis
Urticaria
Hypotension
Tachycardia
Tongue swelling
Oropharyngeal swelling
Spontaneous movements
Cough
Prothrombin time increased
Anaphylactic shock
Anaesthetic complications
Hypersensitivity reactions
Nausea
Facial grimacing

Effects on Laboratory Tests

Sugammadex has been reported to prolong the activated partial thromboplastin time or the prothrombin time.

A plasma concentration of 100micrograms/ml sugammadex (peak plasma level following a 8mg/kg bolus injection dose) may interfere with the serum progesterone assay.

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 ).

Shelf Life and Storage

Store below 30 degrees C
Do not freeze
Keep vial in outer carton in order to protect from light.

Further Information

Last Full Review Date: December 2012

Reference Sources

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

Summary of Product Characteristics: Bridion 100mg/ml solution for injection. Organon Laboratories Ltd. Revised January 2021.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 05 September 2017