Sugammadex Dr. Reddy's 100 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sugammadex Dr. Reddys 100 mg/ml solution for injection EFG

Read the entire leaflet carefully before you are given this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your anaesthetist (anaesthesiologist) or your doctor.
• If you experience any adverse effects, consult your anaesthetist or another doctor, even if these adverse effects are not listed in this leaflet. See section 4.

Package leaflet contents

1. What Sugammadex Dr. Reddy's is and what it is used for
2. What you need to know before administration of Sugammadex Dr. Reddy's
3. How Sugammadex Dr. Reddy's is administered
4. Possible side effects
5. Storage of Sugammadex Dr. Reddy's
6. Contents of the pack and other information

1. What Sugammadex Dr. Reddy's is and what it is used for

Sugammadex Dr. Reddy's is a medicine used to reverse the effects of certain muscle relaxants (neuromuscular blocking agents) used during surgery. Specifically, it reverses the muscle relaxation caused by rocuronium or vecuronium, which are aminosteroid neuromuscular blocking agents. Sugammadex Dr. Reddy's works by encapsulating these agents, thereby rapidly restoring muscle function after surgery. This allows patients to regain the ability to breathe and move independently following general anesthesia.

What is Sugammadex Dr. Reddys

This medicine contains the active substance sugammadex. Sugammadex is considered a Selective Binding Agent because it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.

What Sugammadex Dr. Reddys is used for

When you undergo surgery, your muscles must be completely relaxed, which makes it easier for the surgeon to perform the procedure. For this reason, during general anesthesia, you will be given medications to relax your muscles. These are called muscle relaxants, such as rocuronium bromide and vecuronium bromide. Since these medications also block the muscles used for breathing, you will need assistance with breathing (mechanical ventilation) during and after your surgery until you can breathe on your own again.

Sugammadex is used to speed up muscle recovery after surgery so that you can breathe independently again sooner. It works by binding to rocuronium bromide or vecuronium bromide in your body.

It can be used in newborns, infants, young children, children, and adolescents (from birth up to 17 years of age) when rocuronium bromide is used.

2. What you need to know before receiving Sugammadex Dr. Reddys

Do not receive Sugammadex Dr. Reddys

• if you are allergic to sugammadex or to any of the other ingredients of this medicine (listed in section 6).

→ Inform your anaesthetist if this applies to you.

Warnings and precautions

Talk to your anaesthetist before receiving Sugammadex Dr. Reddys

• if you have kidney disease or have had it in the past. This is important because sugammadex is eliminated from your body through the kidneys.
• if you have liver disease or have had it previously.
• if you have fluid retention (oedema).
• if you have a condition that increases your risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant medication.

Other medicines and Sugammadex Dr. Reddys

→ Inform your anaesthetist if you are taking, have recently taken, or might need to take any other medicines.

Sugammadex may affect other medicines or may be affected by them.

Some medicines reduce the effect of Sugammadex Dr. Reddys

→ It is especially important that you inform your anaesthetist if you have recently taken:

• toremifene (used to treat breast cancer).
• fusidic acid (an antibiotic).

Sugammadex Dr. Reddys may affect hormonal contraceptives

• Sugammadex may make hormonal contraceptives—such as the “Pill”, vaginal ring, implants, or a hormonal intrauterine device (IUD-h)—less effective because it reduces the amount of progestogen hormone available. The amount of progestogen lost due to sugammadex use is approximately equivalent to missing one oral contraceptive pill.

→ If you are taking the Pill on the same day that sugammadex is administered, follow the missed dose instructions provided in the Pill’s package leaflet.

→ If you are using other hormonal contraceptives (e.g., vaginal ring, implant, or IUD-h), you should use a non-hormonal contraceptive method (such as a condom) for the following 7 days and follow the recommendations in the product leaflet.

Effects on blood tests

In general, sugammadex has no effect on laboratory tests. However, it may affect the results of a blood test measuring levels of the hormone progesterone. Consult your doctor if your progesterone levels need to be tested on the same day you receive sugammadex.

Pregnancy and breastfeeding

→ Inform your anaesthetist if you are pregnant, think you might be pregnant, or if you are breastfeeding.

You may still be given sugammadex, but this should be discussed in advance.

It is not known whether sugammadex passes into breast milk. Your anaesthetist will help you decide whether to interrupt breastfeeding or to avoid treatment with sugammadex, taking into account the benefits of breastfeeding for the baby and the benefits of sugammadex for the mother.

Driving and using machines

Sugammadex has no known influence on the ability to drive or operate machinery.

Sugammadex Dr. Reddys contains sodium

This medicine contains up to 9.7 mg of sodium (the main component of table/cooking salt) per ml. This corresponds to 0.5% of the maximum daily recommended sodium intake for an adult.

3. How Sugammadex Dr. Reddy's is administered

Sugammadex will be administered to you by your anaesthetist, or under your anaesthetist's supervision.

Dosage

Your anaesthetist will calculate the dose of sugammadex you need based on:

• your body weight
• the amount of residual muscle relaxant effect still present.

The usual dose is 2–4 mg per kg of body weight for patients of any age. A dose of 16 mg/kg may be used in adults when urgent reversal of muscle relaxation is required.

How Sugammadex Dr. Reddy's is administered

Sugammadex will be administered to you by your anesthesiologist. It is injected as a single intravenous dose.

If you are given more Sugammadex Dr. Reddy's than recommended

Since your anesthetist will be carefully monitoring your condition, it is unlikely that you will be given too much sugammadex. However, even if this were to happen, it is unlikely to cause any problems.

If you have any further questions about the use of this medicine, ask your anesthetist or another doctor.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

If these adverse effects occur while you are under the effects of anesthesia, your anesthetist will detect and treat them.

Frequent (may affect up to 1 in 10 people)

• Cough
• Airway difficulties which may include coughing or movements as if awake or gasping for breath
• Light anesthesia – you may start to wake up, so you will need more anesthetic. This may cause you to move or cough at the end of the operation
• Complications during the procedure, such as changes in heart rate, coughing, or movement
• Decreased blood pressure due to the surgical procedure

Uncommon (may affect up to 1 in 100 people)

• Breathing difficulty due to muscle spasms in the airways (bronchospasm), occurring in patients with a history of lung problems
• Allergic reactions (drug hypersensitivity) – such as rash, skin redness, swelling of the tongue and/or pharynx, difficulty breathing, changes in blood pressure or heart rate, sometimes resulting in a severe drop in blood pressure. Allergic-type reactions or severe allergic reactions may be life-threatening

Allergic reactions were reported more frequently in healthy, conscious volunteers

• Recurrence of muscle relaxation after surgery

Frequency not known

• When Sugammadex Dr. Reddys is administered, a significant slowing of the heart may occur, which can even lead to cardiac arrest

Reporting of Adverse Reactions

If you experience any type of adverse reaction, consult your anaesthetist, another doctor, or your pharmacist, even if these are possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Dr. Reddy's

Storage shall be the responsibility of healthcare professionals.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and label after "CAD". The expiry date is the last day of the month indicated.

Do not freeze. Store the vial in the outer packaging to protect it from light.

After opening and dilution, store at 2-8°C and use within 24 hours.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. These measures will help protect the environment.

6. Contents of the container and other information

Composition of Sugammadex Dr. Reddy's

• The active substance is sugammadex.

1 ml of injectable solution contains sodium sugammadex equivalent to 100 mg of sugammadex.

Each 2 ml vial contains sodium sugammadex equivalent to 200 mg of sugammadex.

Each 5 ml vial contains sodium sugammadex equivalent to 500 mg of sugammadex.

The other components are water for injections and for pH adjustment: sodium hydroxide 0.04% and hydrochloric acid 0.3%.

Appearance of the product and contents of the container

Sugammadex Dr. Reddy's is a clear, colourless to slightly yellow, injectable solution.

Container sizes:

1 vial of 2 ml
10 vials of 2 ml
1 vial of 5 ml
10 vials of 5 ml

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona (Spain)

Telephone: 93.355.49.16

Fax: 93.355.49.61

Manufacturer

betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg,
Germany

or

Dr. Reddy’s Laboratories România S.R.L.
Str. Daniel Danielopolu, no. 30 - 32, Space 2
5th Floor, Sector 1
Bucharest, postal code 014134,
Romania

or

SC Rual Laboratories SRL
313, Splaiul Unirii, Building H, 1st floor, sector 3
030138 Bucharest,
Romania

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany	Sugammadex beta 100 mg/ml concentrate for solution for injection
Austria	Sugammadex Reddy 100 mg/ml solution for injection
Czech Republic	Sugammadex Reddy
Denmark	Sugammadex Reddy
Spain	Sugammadex Dr. Reddys 100 mg/ml solution for injection EFG
Finland	Sugammadex Reddy 100 mg/ml injection solution, solution
France	SUGAMMADEX REDDY PHARMA 100 mg/ml, solution for injection
Ireland	Sugammadex 100 mg/ml solution for injection
Italy	Sugammadex Dr. Reddy’s
Netherlands	Sugammadex Reddy 100 mg/ml solution for injection
Norway	Sugammadex Reddy
Poland	Sugammadex Reddy
Portugal	Sugammadex Reddy 100 mg/ml solution for injection
Romania	Sugammadex Dr. Reddy’s 100 mg/ml solution for injection
Slovakia	Sugammadex Reddy 100 mg/ml concentrate for solution for injection
Sweden	Sugammadex Reddy 100 mg/ml concentrate for solution for injection

Date of the most recent review of this summary: March 2026.

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

For detailed information, consult the Summary of Product Characteristics (SmPC) for Sugammadex Dr. Reddys.

Therapeutic indications and dosage

Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.

For the paediatric population: sugammadex is recommended only in paediatric patients from birth to 17 years of age for routine reversal of rocuronium-induced blockade.

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

Appropriate neuromuscular monitoring techniques are recommended to monitor recovery from neuromuscular blockade (see SmPC, section 4.4).

Adults

Routine reversal:

A dose of 4 mg/kg sugammadex is recommended when recovery has reached at least 1–2 post-tetanic counts (PTC) following rocuronium- or vecuronium-induced blockade. The mean time to recover the T4/T1 ratio to 0.9 is approximately 3 minutes (see SmPC, section 5.1).

A dose of 2 mg/kg sugammadex is recommended when spontaneous recovery has occurred to at least the reappearance of T2 following rocuronium- or vecuronium-induced blockade. The mean time to recover the T4/T1 ratio to 0.9 is approximately 2 minutes (see SmPC, section 5.1).

When the recommended doses for routine reversal are used, the mean time to recover the T4/T1 ratio to 0.9 will be slightly faster with rocuronium compared to neuromuscular blockade induced by vecuronium (see SmPC, section 5.1).

Immediate reversal of rocuronium-induced neuromuscular blockade:

When there is a clinical need for immediate reversal after administration of rocuronium, a dose of 16 mg/kg sugammadex is recommended. If 16 mg/kg sugammadex is administered 3 minutes after a bolus dose of 1.2 mg/kg rocuronium bromide, recovery of the T4/T1 ratio to 0.9 can be expected in a mean time of approximately 1.5 minutes (see SmPC, section 5.1).

There are no available data to recommend the use of sugammadex for immediate reversal following vecuronium-induced blockade.

Repeat dosing of sugammadex:

In the exceptional case where postoperative recurrence of neuromuscular blockade occurs (see SmPC, section 4.4) after an initial dose of 2 mg/kg or 4 mg/kg sugammadex, administration of a further dose of 4 mg/kg sugammadex is recommended. After the second dose of sugammadex, the patient should be closely monitored to confirm sustained recovery of neuromuscular function.

Renal impairment:

Sugammadex is not recommended in patients with severe renal impairment (including patients requiring dialysis (CrCl < 30 ml/min)) (see SmPC, section 4.4).

Obese patients:

In obese patients, including those with morbid obesity (body mass index ≥ 40 kg/m²), the dose of sugammadex should be based on actual body weight. The same dosing recommendations as those for adults should be followed.

Paediatric population (from birth to 17 years of age)

Sugammadex Dr. Reddys 100 mg/ml injectable solution may be diluted to 10 mg/ml to improve dosing accuracy in the paediatric population (see SmPC, section 6.6).

Routine reversal:

A dose of 4 mg/kg sugammadex is recommended for reversal of rocuronium-induced blockade when recovery has reached at least 1–2 PTC.

A dose of 2 mg/kg is recommended for reversal of rocuronium-induced blockade when T2 reappears (see SmPC, section 5.1).

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC.

Special warnings and precautions for use

As is customary in post-anaesthesia practice following neuromuscular blockade, patients should be monitored in the immediate postoperative period for unexpected effects such as recurrence of neuromuscular blockade.

Monitoring of respiratory function during recovery:

Mechanical ventilation must be maintained until adequate spontaneous respiration is restored after reversal of neuromuscular blockade. Even if neuromuscular blockade is fully reversed, other medications used in the peri- and postoperative periods may depress respiratory function, so mechanical ventilation may still be required.

If neuromuscular blockade recurs after extubation, adequate ventilation should be provided.

Recurrence of neuromuscular blockade:

In clinical trials involving patients treated with rocuronium or vecuronium, where sugammadex was administered at doses appropriate for the depth of neuromuscular blockade, an incidence of 0.20% for recurrence of neuromuscular blockade was observed, based on neuromuscular monitoring or clinical evidence. Using doses lower than those recommended may increase the risk of recurrence of neuromuscular blockade after initial reversal, and is therefore not recommended (see SmPC, sections 4.2 and 4.8).

Effect on haemostasis:

In a study in healthy volunteers, doses of 4 mg/kg and 16 mg/kg sugammadex resulted in mean maximum prolongations of activated partial thromboplastin time (aPTT) by 17% and 22%, respectively, and international normalized ratio of prothrombin time [PT(INR)] by 11% and 22%, respectively. These mean prolongations in aPTT and PT(INR) were of short duration (≤ 30 minutes). Based on the clinical database (N=3,519), and a specific study in 1,184 patients undergoing hip fracture surgery/major joint replacement surgery, there was no clinically relevant effect on the incidence of peri- and postoperative bleeding complications with sugammadex 4 mg/kg alone or in combination with anticoagulants.

In vitro experiments showed a pharmacodynamic interaction (prolongation of activated partial thromboplastin time [aPTT] and prothrombin time [PT]) with vitamin K antagonists, unfractionated heparin, low molecular weight heparinoids, rivaroxaban, and dabigatran. In patients receiving standard postoperative prophylactic anticoagulation, this pharmacodynamic interaction is not clinically relevant. Caution should be exercised when considering the use of sugammadex in patients receiving anticoagulant therapy for a pre-existing or concomitant condition.

An increased risk of bleeding cannot be excluded in patients:

• with hereditary deficiencies of vitamin K-dependent coagulation factors;
• with pre-existing coagulopathies;
• treated with coumarin derivatives and with an INR factor above 3.5;
• using anticoagulants and receiving a dose of 16 mg/kg sugammadex.

If there is a medical need to administer sugammadex to these patients, the anaesthetist should decide whether the benefits outweigh the potential risk of bleeding complications, taking into account the patient's history of bleeding episodes and the type of surgery planned. Monitoring of haemostasis and coagulation parameters is recommended if sugammadex is administered to these patients.

Recommended waiting times before re-administering neuromuscular blocking agents after reversal with sugammadex:

Table 1: Re-administration of rocuronium or vecuronium after routine reversal (up to 4 mg/kg sugammadex):

Minimum waiting time	NMB and dose to be administered
5 minutes	1.2 mg/kg rocuronium
4 hours	0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium

After re-administration of 1.2 mg/kg rocuronium within 30 minutes following sugammadex administration, the onset of neuromuscular blockade may be prolonged by approximately 4 minutes, and the duration of neuromuscular blockade may be reduced by approximately 15 minutes.

Based on the pharmacokinetic (PK) model, the recommended waiting time in patients with mild or moderate renal impairment for re-administration of 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium after routine reversal with sugammadex is 24 hours. If a shorter waiting time is required, the rocuronium dose for a new neuromuscular blockade should be 1.2 mg/kg.

Re-administration of rocuronium or vecuronium after immediate reversal (16 mg/kg sugammadex):

In very rare cases where this may be required, a waiting time of 24 hours is recommended.

If neuromuscular blockade needs to be administered before the recommended waiting time, a non-steroidal neuromuscular blocker should be used. The onset of a depolarizing neuromuscular blocker may be slower than expected, as a substantial fraction of postsynaptic nicotinic receptors may still be occupied by the neuromuscular blocker.

Renal impairment:

The use of sugammadex is not recommended in patients with severe renal impairment, including those requiring dialysis (see FT, section 5.1).

Light anesthesia:

In clinical trials, when neuromuscular blockade was intentionally reversed during anesthesia, signs of light anesthesia (movements, coughing, facial twitching, and endotracheal tube biting) were occasionally observed.

If neuromuscular blockade is reversed while anesthesia continues, additional doses of anesthetic and/or opioid should be administered as clinically indicated.

Pronounced bradycardia:

In rare cases, pronounced bradycardia has been observed a few minutes after sugammadex administration for reversal of neuromuscular blockade. Occasionally, bradycardia may lead to cardiac arrest (see FT, section 4.8). Patients should be closely monitored to prevent hemodynamic changes during and after reversal of neuromuscular blockade. If clinically significant bradycardia occurs, treatment with anticholinergics such as atropine should be administered.

Hepatic impairment:

Sugammadex is not metabolized or eliminated by the liver; therefore, no specific studies have been conducted in patients with hepatic impairment. Patients with severe hepatic impairment should be treated with great caution. If hepatic impairment is accompanied by coagulopathy, refer to information on effects on hemostasis.

Use in Intensive Care Units (ICU):

Sugammadex has not been investigated in patients who have received rocuronium or vecuronium in the ICU.

Reversal of neuromuscular blockade caused by drugs other than rocuronium or vecuronio:

Sugammadex treatment should not be used to reverse blockade induced by non-steroidal neuromuscular blockers such as succinylcholine or benzylisoquinolinium derivatives.

Sugammadex treatment should not be used for reversal of neuromuscular blockade induced by steroidal neuromuscular blockers other than rocuronium or vecuronium, as efficacy and safety data are not available in these cases. Limited data are available regarding reversal of pancuronium-induced blockade, but sugammadex is not recommended for use in this situation.

Delayed recovery:

Conditions associated with prolonged circulation time, such as cardiac disease, advanced age (see FT, section 4.2 regarding recovery time in elderly patients), or edematous states (e.g., severe hepatic impairment), may be associated with prolonged recovery times.

Hypersensitivity reactions to the drug:

Physicians should be prepared for the possibility of hypersensitivity reactions (including anaphylactic reactions) and should take necessary precautions (see FT, section 4.8).

Sodium:

This medicinal product contains up to 9.7 mg of sodium per ml, equivalent to 0.5% of the maximum daily intake of 2 g of sodium recommended by the WHO for an adult.

Interaction with other medicinal products and other forms of interaction

The information in this section is based on the binding affinity between sugammadex and other drugs, non-clinical experiments, clinical trials, and simulations using a model that accounts for the pharmacodynamic effect of neuromuscular blockers and the pharmacokinetic interaction between neuromuscular blockers and sugammadex. Based on these data, clinically significant pharmacodynamic interactions with other drugs are not expected, except for the following:

Toremifene and fusidic acid: displacement interactions cannot be excluded (capture interactions of clinical relevance are not expected).

Hormonal contraceptives: capture interactions of clinical relevance cannot be excluded (displacement interactions are not expected).

Interactions potentially affecting the efficacy of sugammadex (displacement interactions):

Theoretically, administration of certain drugs after sugammadex treatment may displace rocuronium or vecuronium from the sugammadex complex, leading to reappearance of neuromuscular blockade. In such cases, mechanical ventilation should be provided to the patient. Administration of the displacing drug should be discontinued if given by infusion. In situations where potential displacement interactions may be anticipated due to parenteral administration of another drug within 7.5 hours after sugammadex administration, patients should be carefully monitored for signs of recurrence of neuromuscular blockade (for approximately 15 minutes).

Toremifene:

With concomitant administration of toremifene, which has relatively high binding affinity for sugammadex and may be present at relatively high plasma concentrations, some displacement of rocuronium or vecuronium from the sugammadex complex may occur.

Physicians should be aware that recovery of the T4/T1 ratio to 0.9 may therefore be delayed in patients who have received toremifene on the day of surgery.

Intravenous administration of fusidic acid:

Preoperative use of fusidic acid may cause some delay in recovery of the T4/T1 ratio to 0.9. Recurrence of neuromuscular blockade is not expected in the postoperative phase, as fusidic acid infusion lasts several hours and blood levels accumulate over 2–3 days. See FT section 4.2 for re-administration of sugammadex.

Interactions potentially affecting the efficacy of other drugs (capture interactions):

Sugammadex administration may reduce plasma (free) concentrations of certain drugs, potentially decreasing their efficacy. If this occurs, the physician should consider re-administering the same drug, administering a therapeutically equivalent drug (preferably from a different chemical class), and/or applying necessary non-pharmacological interventions.

Hormonal contraceptives:

The interaction between sugammadex 4 mg/kg and progestogen is expected to reduce progestogen exposure (34% of AUC), similar to the reduction observed when a daily oral contraceptive dose is taken with a 12-hour delay, which may lead to reduced effectiveness. For estrogens, a lesser effect is expected. Therefore, administration of a bolus dose of sugammadex is considered equivalent to missing one daily dose of an oral steroidal contraceptive (either combined or progestogen-only). If sugammadex is administered on the same day as an oral contraceptive, refer to the recommendations for missed dose provided in the oral contraceptive’s package leaflet. For non-oral hormonal contraceptives, the patient should use a non-hormonal complementary contraceptive method for the next 7 days and follow the product leaflet recommendations.

Interactions due to prolonged effect of rocuronium or vecuronium:

If drugs that potentiate neuromuscular blockade are used in the postoperative period, special attention should be paid to the possibility of recurrence of neuromuscular blockade. Refer to the rocuronium or vecuronium package leaflets for a list of specific drugs that potentiate neuromuscular blockade. In case of recurrence of neuromuscular blockade, the patient may require mechanical ventilation and repeat dosing of sugammadex (see FT, section 4.2).

Fertility, pregnancy and lactation

Pregnancy

There are no clinical data on exposure of pregnant women to sugammadex.

Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryofetal development, parturition, or postnatal development.

Sugammadex should be used with caution in pregnant women.

Lactation

It is unknown whether sugammadex is excreted in human breast milk. Animal studies have shown that sugammadex is excreted in milk. Oral absorption of cyclodextrins is generally low, and no effect on the infant is expected after a single dose administered to a woman during lactation.

A decision must be made whether to discontinue breastfeeding or discontinue treatment, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Fertility

The effects of sugammadex on human fertility have not been studied. Animal studies evaluating fertility showed no harmful effects.

Adverse reactions

Summary of safety profile

Sugammadex Dr. Reddy's was administered concomitantly with neuromuscular blockers and anesthetics in surgical patients. Therefore, causality of adverse effects is difficult to assess.

The most frequently reported adverse reactions in surgical patients were cough, anesthesia-related respiratory complications, anesthesia complications, hypotension due to therapeutic procedure, and surgical complications (Frequent (? 1/100 to < 1/10)).

Table 2: Table of adverse reactions

The safety of sugammadex has been evaluated in 3,519 individual patients through a combined phase I–III safety database. The following adverse reactions were reported in placebo-controlled trials in which patients received anesthesia and/or neuromuscular blockers (1,078 patients exposed to sugammadex vs. 544 exposed to placebo):

[Very common (?1/10), common (?1/100 to <1/10), uncommon (?1/1,000 to <1/100), rare (?1/10,000 to <1/1,000), very rare (<1/10,000)]

Organ system classification	Frequencies	Adverse reactions (Preferred terms)
Immune system disorders	Uncommon	Hypersensitivity reactions (see FT, section 4.4)
Respiratory, thoracic and mediastinal disorders	Common	Cough
Injury, poisoning and procedural complications	Common	Respiratory complication due to anaesthesia Anaesthesia complications (see FT, section 4.4) Hypotension due to therapeutic procedure Surgical complication

Description of selected adverse reactions

Hypersensitivity reactions:

Hypersensitivity reactions, including anaphylaxis, have occurred in some patients and volunteers (for information on volunteers, see below, Information on healthy volunteers). In surgical clinical trials, these reactions were reported infrequently, and in post-marketing reports, the frequency is unknown.

These reactions ranged from isolated skin reactions to severe systemic reactions (i.e., anaphylaxis, anaphylactic shock) and have occurred in patients without prior exposure to sugammadex.

Symptoms associated with these reactions may include: flushing, urticaria, erythematous rash, hypotension (severe), tachycardia, tongue swelling, pharyngeal swelling, bronchospasm, and obstructive pulmonary events. Severe hypersensitivity reactions may be fatal.

In post-marketing reports, hypersensitivity has been observed with both sugammadex and the sugammadex-rocuronium complex.

Anesthesia-related airway complications:

Anesthesia-related airway complications included spasms related to the end of anesthesia or to extubation against the endotracheal tube, coughing, mild spasms related to the end of anesthesia or to extubation, emergence reaction during surgery, coughing during the anesthetic procedure or during surgery, or patient's spontaneous breathing related to the anesthetic procedure.

Anesthesia complications:

Anesthesia complications, indicating recovery of neuromuscular function, include movement of a limb or body, coughing during anesthesia administration or during surgery, facial spasms, or suctioning of the endotracheal tube. See FT, section 4.4, for superficial anesthesia.

Procedure-related complications:

Procedure-related complications included coughing, movements, tachycardia, bradycardia, and increased heart rate.

Marked bradycardia:

Post-marketing, isolated cases of marked bradycardia and bradycardia with cardiac arrest have been observed a few minutes after sugammadex administration (see FT, section 4.4).

Reappearance of neuromuscular blockade:

In clinical trials with patients treated with rocuronium or vecuronium, where sugammadex was administered using a dose established for the depth of neuromuscular blockade (N=2,022), an incidence of 0.20% for reappearance of neuromuscular blockade was observed, based on neuromuscular monitoring or clinical evidence (see FT, section 4.4).

Information on healthy volunteers:

A randomized, double-blind study evaluated the incidence of drug hypersensitivity reactions in healthy volunteers who received up to 3 doses of placebo (N=76), sugammadex 4 mg/kg (N=151), or sugammadex 16 mg/kg (N=148). Suspected hypersensitivity reactions were adjudicated by an independent committee. The established incidence of hypersensitivity was 1.3%, 6.6%, and 9.5% in the placebo, sugammadex 4 mg/kg, and sugammadex 16 mg/kg groups, respectively. There were no reports of anaphylaxis after administration of placebo or sugammadex 4 mg/kg. Only one confirmed case of anaphylaxis occurred after administration of the first dose of sugammadex 16 mg/kg (incidence of 0.7%). Upon repeat dosing of sugammadex, there was no indication of increased frequency or severity of hypersensitivity.

In a previous study with a similar design, there were three confirmed cases of anaphylaxis, all after administration of sugammadex 16 mg/kg (incidence of 2.0%).

In the pooled Phase I clinical trial database, the common (≥ 1/100 to < 1/10), or very common (≥ 1/10) adverse reactions occurring more frequently in patients treated with sugammadex than in the placebo group include dysgeusia (10.1%), headache (6.7%), nausea (5.6%), urticaria (1.7%), pruritus (1.7%), dizziness (1.6%), vomiting (1.2%), and abdominal pain (1.0%).

Additional information for special populations

Pulmonary complications:

In post-marketing data and in a specific clinical trial, bronchospasm was reported as an adverse reaction possibly related to treatment in patients with a history of pulmonary complications. As with all patients with a history of pulmonary complications, physicians should remain vigilant for the possible occurrence of bronchospasm.

Paediatric population

In studies of paediatric patients from birth to 17 years of age, the safety profile of sugammadex (up to 4 mg/kg) was generally similar to that observed in adults.

Patients with morbid obesity

In a specific clinical trial in patients with morbid obesity, the safety profile was generally similar to that in adult patients in combined Phase 1 to 3 trials (see Table 2).

Patients with severe systemic disease

In a trial in patients classified as ASA Class 3 or 4 (i.e., patients with severe systemic disease or patients with severe systemic disease that is a constant threat to life), the adverse reaction profile in these ASA Class 3 and 4 patients was generally similar to that in adult patients in combined Phase 1 to 3 trials (see Table 2). See FT, section 5.1.

Overdose

During clinical trials, one case of accidental overdose with 40 mg/kg was reported without any significant adverse reactions. In human tolerance studies, sugammadex was administered at doses up to 96 mg/kg. No dose-related adverse reactions or serious adverse reactions were reported.

Sugammadex can be removed by hemodialysis using a high-flux filter, but not with a low-flux filter. Clinical trials indicate that plasma concentrations of sugammadex are reduced by up to 70% after a 3- to 6-hour dialysis session.

List of excipients

Hydrochloric acid 3.7% (for pH adjustment) and/or sodium hydroxide (for pH adjustment)

Water for injections.

Shelf life

3 years

After first opening and dilution, chemical and physical in-use stability has been demonstrated for 48 hours between 2°C and 25°C. From a microbiological standpoint, 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 generally should not exceed 24 hours between 2°C and 8°C, unless dilution has been carried out under controlled and validated aseptic conditions.

Special precautions for storage

Store below 30°C.

Do not freeze.

Keep the vial in the outer packaging to protect from light.

For storage conditions after dilution of the medicinal product, see FT, section 6.3.

Special precautions for disposal and other handling

Sugammadex may be administered via the same intravenous line already in use for infusion with the following intravenous solutions: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%), sodium chloride 4.5 mg/ml (0.45%), glucose 25 mg/ml (2.5%), Ringer's lactate solution, and Ringer's solution with glucose 50 mg/ml (5%) in sodium chloride 9 mg/ml (0.9%).

The infusion line should be adequately flushed (e.g., with 0.9% sodium chloride solution) between administration of Sugammadex Dr. Reddys and other medications.

Use in the paediatric population

For paediatric patients, sugammadex may be diluted using sodium chloride 9 mg/ml (0.9%) to a concentration of 10 mg/ml (see FT, section 6.3).