"The U.S. Food and Drug Administration today approved Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare, autosomal recessive lysosomal storage disease "...
The following adverse reactions are described, or described in greater detail, in other sections:
- Anaphylaxis [see WARNINGS AND PRECAUTIONS]
- Residual paralysis [see WARNINGS AND PRECAUTIONS]
- Myopathy [see WARNINGS AND PRECAUTIONS]
- Increased pulmonary vascular resistance [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical studies in the US (n=1137) and Europe (n=1394) totaled 2531 patients. The patients exposed in the US clinical studies provide the basis for calculation of adverse reaction rates. The following adverse reactions were reported in patients administered ZEMURON (all events judged by investigators during the clinical trials to have a possible causal relationship):
Adverse reactions in greater than 1% of patients: None
Adverse reactions in less than 1% of patients (probably related or relationship unknown):
Digestive: nausea, vomiting
Skin and Appendages: rash, injection site edema, pruritus
In the European studies, the most commonly reported reactions were transient hypotension (2%) and hypertension (2%); these are in greater frequency than the US studies (0.1% and 0.1%). Changes in heart rate and blood pressure were defined differently from in the US studies in which changes in cardiovascular parameters were not considered as adverse events unless judged by the investigator as unexpected, clinically significant, or thought to be histamine related.
In a clinical study in patients with clinically significant cardiovascular disease undergoing coronary artery bypass graft, hypertension and tachycardia were reported in some patients, but these occurrences were less frequent in patients receiving beta or calcium channel-blocking drugs. In some patients, ZEMURON was associated with transient increases (30% or greater) in pulmonary vascular resistance. In another clinical study of patients undergoing abdominal aortic surgery, transient increases (30% or greater) in pulmonary vascular resistance were observed in about 24% of patients receiving ZEMURON 0.6 or 0.9 mg/kg.
In pediatric patient studies worldwide (n=704), tachycardia occurred at an incidence of 5.3% (n=37), and it was judged by the investigator as related in 10 cases (1.4%).
The following adverse reactions have been identified during post-approval use of ZEMURON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders
In clinical practice, there have been reports of severe allergic reactions (anaphylactic and anaphylactoid reactions and shock) with ZEMURON, including some that have been life-threatening and fatal [see WARNINGS AND PRECAUTIONS].
General Disorders And Administration Site Conditions
Read the Zemuron (rocuronium bromide injection) Side Effects Center for a complete guide to possible side effects
Drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as ZEMURON include certain antibiotics (e.g., aminoglycosides; vancomycin; tetracyclines; bacitracin; polymyxins; colistin; and sodium colistimethate). If these antibiotics are used in conjunction with ZEMURON, prolongation of neuromuscular block may occur.
In 2 of 4 patients receiving chronic anticonvulsant therapy, apparent resistance to the effects of ZEMURON was observed in the form of diminished magnitude of neuromuscular block, or shortened clinical duration. As with other nondepolarizing neuromuscular blocking drugs, if ZEMURON is administered to patients chronically receiving anticonvulsant agents such as carbamazepine or phenytoin, shorter durations of neuromuscular block may occur and infusion rates may be higher due to the development of resistance to nondepolarizing muscle relaxants. While the mechanism for development of this resistance is not known, receptor up-regulation may be a contributing factor [see WARNINGS AND PRECAUTIONS].
Use of inhalation anesthetics has been shown to enhance the activity of other neuromuscular blocking agents (enflurane > isoflurane > halothane).
Isoflurane and enflurane may also prolong the duration of action of initial and maintenance doses of ZEMURON and decrease the average infusion requirement of ZEMURON by 40% compared to opioid/nitrous oxide/oxygen anesthesia. No definite interaction between ZEMURON and halothane has been demonstrated. In one study, use of enflurane in 10 patients resulted in a 20% increase in mean clinical duration of the initial intubating dose, and a 37% increase in the duration of subsequent maintenance doses, when compared in the same study to 10 patients under opioid/nitrous oxide/oxygen anesthesia. The clinical duration of initial doses of ZEMURON of 0.57 to 0.85 mg/kg under enflurane or isoflurane anesthesia, as used clinically, was increased by 11% and 23%, respectively. The duration of maintenance doses was affected to a greater extent, increasing by 30% to 50% under either enflurane or isoflurane anesthesia.
Potentiation by these agents is also observed with respect to the infusion rates of ZEMURON required to maintain approximately 95% neuromuscular block. Under isoflurane and enflurane anesthesia, the infusion rates are decreased by approximately 40% compared to opioid/nitrous oxide/oxygen anesthesia. The median spontaneous recovery time (from 25% to 75% of control T1) is not affected by halothane, but is prolonged by enflurane (15% longer) and isoflurane (62% longer). Reversal-induced recovery of ZEMURON neuromuscular block is minimally affected by anesthetic technique [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
Local anesthetics have been shown to increase the duration of neuromuscular block and decrease infusion requirements of neuromuscular blocking agents [see WARNINGS AND PRECAUTIONS].
Nondepolarizing Muscle Relaxants
There are no controlled studies documenting the use of ZEMURON before or after other nondepolarizing muscle relaxants. Interactions have been observed when other nondepolarizing muscle relaxants have been administered in succession.
Procainamide has been shown to increase the duration of neuromuscular block and decrease infusion requirements of neuromuscular blocking agents [see WARNINGS AND PRECAUTIONS].
The use of propofol for induction and maintenance of anesthesia does not alter the clinical duration or recovery characteristics following recommended doses of ZEMURON.
Injection of quinidine during recovery from use of muscle relaxants is associated with recurrent paralysis. This possibility must also be considered for ZEMURON [see WARNINGS AND PRECAUTIONS].
The use of ZEMURON before succinylcholine, for the purpose of attenuating some of the side effects of succinylcholine, has not been studied.
If ZEMURON is administered following administration of succinylcholine, it should not be given until recovery from succinylcholine has been observed. The median duration of action of ZEMURON 0.6 mg/kg administered after a 1 mg/kg dose of succinylcholine when T1 returned to 75% of control was 36 minutes (range: 14-57, n=12) vs. 28 minutes (range: 17-51, n=12) without succinylcholine.
Read the Zemuron Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 2/26/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Zemuron Information
Report Problems to the Food and Drug Administration
Find out what women really need.