Sign Out
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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Trial Experience in Adult Patients: Clinical trials enrolled 1,864 adult patients treated with CUBICIN and 1,416 treated with comparator.
Complicated Skin and Skin Structure Infection Trials in Adults: In Phase 3 complicated skin and skin structure infection (cSSSI) trials in adult patients, CUBICIN was discontinued in 15/534 (2.8%) patients due to an adverse reaction, while comparator was discontinued in 17/558 (3.0%) patients.
The rates of the most common adverse reactions, organized by body system, observed in adult patients with cSSSI (receiving 4 mg/kg CUBICIN) are displayed in Table 15. (See Table 15.)
Click on icon to see table/diagram/imageDrug-related adverse reactions (possibly or probably drug-related) that occurred in <1% of adult patients receiving CUBICIN in the cSSSI trials are as follows: Body as a Whole: fatigue, weakness, rigors, flushing, hypersensitivity.
Blood/Lymphatic System: leukocytosis, thrombocytopenia, thrombocytosis, eosinophilia, increased International Normalized Ratio (INR).
Cardiovascular System: supraventricular arrhythmia.
Dermatologic System: eczema.
Digestive System: abdominal distension, stomatitis, jaundice, increased serum lactate dehydrogenase.
Metabolic/Nutritional System: hypomagnesemia, increased serum bicarbonate, electrolyte disturbance.
Musculoskeletal System: myalgia, muscle cramps, muscle weakness, arthralgia.
Nervous System: vertigo, mental status change, paresthesia.
Special Senses: taste disturbance, eye irritation.
S. aureus Bacteremia/Endocarditis Trial in Adults: In the S. aureus bacteremia/endocarditis trial involving adult patients, CUBICIN was discontinued in 20/120 (16.7%) patients due to an adverse reaction, while comparator was discontinued in 21/116 (18.1%) patients.
Serious Gram-negative infections (including bloodstream infections) were reported in 10/120 (8.3%) CUBICIN-treated patients and 0/115 comparator-treated patients. Comparator-treated patients received dual therapy that included initial gentamicin for 4 days. Infections were reported during treatment and during early and late follow-up. Gram-negative infections included cholangitis, alcoholic pancreatitis, sternal osteomyelitis/mediastinitis, bowel infarction, recurrent Crohn's disease, recurrent line sepsis, and recurrent urosepsis caused by a number of different Gram-negative bacteria.
The rates of the most common adverse reactions, organized by System Organ Class (SOC), observed in adult patients with S. aureus bacteremia/endocarditis (receiving 6 mg/kg CUBICIN) are displayed in Table 16. (See Table 16.)
Click on icon to see table/diagram/imageThe following reactions, not previously included, were reported as possibly or probably drug-related in the CUBICIN-treated group: Blood and Lymphatic System Disorders: eosinophilia, lymphadenopathy, thrombocythemia, thrombocytopenia.
Cardiac Disorders: atrial fibrillation, atrial flutter, cardiac arrest.
Ear and Labyrinth Disorders: tinnitus.
Eye Disorders: vision blurred.
Gastrointestinal Disorders: dry mouth, epigastric discomfort, gingival pain, hypoesthesia oral.
Infections and Infestations: candidal infection NOS, vaginal candidiasis, fungemia, oral candidiasis, urinary tract infection fungal.
Investigations: blood phosphorous increased, blood alkaline phosphatase increased, INR increased, liver function test abnormal, alanine aminotransferase increased, aspartate aminotransferase increased, prothrombin time prolonged.
Metabolism and Nutrition Disorders: appetite decreased NOS.
Musculoskeletal and Connective Tissue Disorders: myalgia.
Nervous System Disorders: dyskinesia, paresthesia.
Psychiatric Disorders: hallucination NOS.
Renal and Urinary Disorders: proteinuria, renal impairment NOS.
Skin and Subcutaneous Tissue Disorders: pruritus generalized, rash vesicular.
Other Trials in Adults: In Phase 3 trials of community-acquired pneumonia (CAP) in adult patients, the death rate and rates of serious cardiorespiratory adverse events were higher in CUBICIN-treated patients than in comparator-treated patients. These differences were due to lack of therapeutic effectiveness of CUBICIN in the treatment of CAP in patients experiencing these adverse events [see Limitations of Use under Indications/Uses].
Laboratory Changes in Adults: Complicated Skin and Skin Structure Infection Trials in Adults: In Phase 3 cSSSI trials of adult patients receiving CUBICIN at a dose of 4 mg/kg, elevations in CPK were reported as clinical adverse events in 15/534 (2.8%) CUBICIN-treated patients, compared with 10/558 (1.8%) comparator-treated patients. Of the 534 patients treated with CUBICIN, 1 (0.2%) had symptoms of muscle pain or weakness associated with CPK elevations to greater than 4 times the upper limit of normal (ULN). The symptoms resolved within 3 days and CPK returned to normal within 7 to 10 days after treatment was discontinued [see Myopathy and Rhabdomyolysis under Precautions]. Table 17 summarizes the CPK shifts from Baseline through End of Therapy in the cSSSI adult trials. (See Table 17.)
Click on icon to see table/diagram/imageS. aureus Bacteremia/Endocarditis Trial in Adults: In the S. aureus bacteremia/endocarditis trial in adult patients, at a dose of 6 mg/kg, 11/120 (9.2%) CUBICIN-treated patients, including two patients with baseline CPK levels >500 U/L, had CPK elevations to levels >500 U/L, compared with 1/116 (0.9%) comparator-treated patients. Of the 11 CUBICIN-treated patients, 4 had prior or concomitant treatment with an HMG-CoA reductase inhibitor. Three of these 11 CUBICIN-treated patients discontinued therapy due to CPK elevation, while the one comparator-treated patient did not discontinue therapy [see Myopathy and Rhabdomyolysis under Precautions].
Clinical Trial Experience in Pediatric Patients: Complicated Skin and Skin Structure Infection Trial in Pediatric Patients: The safety of CUBICIN was evaluated in one clinical trial (in cSSSI), which included 256 pediatric patients (1 to 17 years of age) treated with intravenous CUBICIN and 133 patients treated with comparator agents. Patients were given age-dependent doses once daily for a treatment period of up to 14 days (median treatment period was 3 days). The doses given by age group were as follows: 10 mg/kg for 1 to < 2 years, 9 mg/kg for 2 to 6 years, 7 mg/kg for 7 to 11 years and 5 mg/kg for 12 to 17 years of age [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions]. Patients treated with CUBICIN were (51%) male, (49%) female and (46%) Caucasian and (32%) Asian.
Adverse Reactions Leading to Discontinuation: In the cSSSI study, CUBICIN was discontinued in 7/256 (2.7%) patients due to an adverse reaction, while comparator was discontinued in 7/133 (5.3%) patients.
Most Common Adverse Reactions: The rates of the most common adverse reactions, organized by body system, observed in these pediatric patients with cSSSI are displayed in Table 18. (See Table 18.)
Click on icon to see table/diagram/imageThe safety profile in the clinical trial of cSSSI pediatric patients was similar to that observed in the cSSSI adult patients.
S. aureus Bacteremia Trial in Pediatric Patients: The safety of CUBICIN was evaluated in one clinical trial (in S. aureus bacteremia), which treated 55 pediatric patients with intravenous CUBICIN and 26 patients with comparator agents. Patients were given age-dependent doses once daily for a treatment period of up to 42 days (mean duration of IV treatment was 12 days). The doses by age group were as follows: 12 mg/kg for 1 to <6 years, 9 mg/kg for 7 to 11 years and 7 mg/kg for 12 to 17 years of age [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions]. Patients treated with CUBICIN were (69%) male and (31%) female. No patients 1 to <2 years of age were enrolled.
Adverse Reactions Leading to Discontinuation: In the bacteremia study, CUBICIN was discontinued in 3/55 (5.5%) patients due to an adverse reaction, while comparator was discontinued in 2/26 (7.7%) patients.
Most Common Adverse Reactions: The rates of the most common adverse reactions, organized by body system, observed in these pediatric patients with bacteremia are displayed in Table 19. (See Table 19.)
Click on icon to see table/diagram/imagePost-Marketing Experience: The following adverse reactions have been identified during post-approval use of CUBICIN. 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.
Blood and lymphatic system disorders: anemia, thrombocytopenia.
General and administration site conditions: pyrexia.
Immune System Disorders: anaphylaxis; hypersensitivity reactions, including angioedema, pruritus, hives, shortness of breath, difficulty swallowing, truncal erythema, and pulmonary eosinophilia [see Contraindications; Anaphylaxis/Hypersensitivity Reactions under Precautions].
Infections and Infestations: Clostridioides difficile-associated diarrhea [see Clostridioides difficile-Associated Diarrhea under Precautions].
Laboratory Investigations: platelet count decreased.
Musculoskeletal Disorders: myoglobin increased; rhabdomyolysis (some reports involved patients treated concurrently with CUBICIN and HMG-CoA reductase inhibitors) [see Myopathy and Rhabdomyolysis under Precautions; HMG-CoA Reductase Inhibitors under Interactions; Pharmacology: Pharmacokinetics under Actions].
Respiratory, Thoracic, and Mediastinal Disorders: cough, eosinophilic pneumonia, organizing pneumonia [see Eosinophilic Pneumonia under Precautions].
Nervous System Disorders: peripheral neuropathy [see Peripheral Neuropathy under Precautions].
Skin and Subcutaneous Tissue Disorders: serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome and vesiculobullous rash (with or without mucous membrane involvement), acute generalized exanthematous pustulosis [see Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) under Precautions].
Gastrointestinal Disorders: nausea, vomiting.
Renal and urinary disorders: acute kidney injury, renal insufficiency, renal failure, and tubulointerstitial nephritis (TIN) [see Tubulointerstitial Nephritis (TIN) under Precautions].
Special Senses: visual disturbances.
View ADR Reporting Link
