Usual Adult Dose for Skin and Structure Infection

4 mg/kg IV every 24 hours for 7 to 14 days

Use: For the treatment of complicated skin and skin structure infections (cSSSI) due to susceptible isolates of Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, S agalactiae, S dysgalactiae subspecies equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only)

Usual Adult Dose for Bacteremia

6 mg/kg IV every 24 hours for 2 to 6 weeks

Comments:

• This drug should not be used for the treatment of left-sided infective endocarditis due to S aureus; in the clinical trial, outcomes were poor.
• This drug has not been studied in patients with prosthetic valve endocarditis.
• Limited safety data regarding use of this drug beyond 28 days

Uses: For the treatment of patients with S aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, due to methicillin-susceptible and methicillin-resistant isolates

Usual Adult Dose for Endocarditis

6 mg/kg IV every 24 hours for 2 to 6 weeks

Comments:

• This drug should not be used for the treatment of left-sided infective endocarditis due to S aureus; in the clinical trial, outcomes were poor.
• This drug has not been studied in patients with prosthetic valve endocarditis.
• Limited safety data regarding use of this drug beyond 28 days

Uses: For the treatment of patients with S aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, due to methicillin-susceptible and methicillin-resistant isolates

Usual Pediatric Dose for Skin and Structure Infection

1 to less than 2 years: 10 mg/kg IV every 24 hours
2 to 6 years: 9 mg/kg IV every 24 hours
7 to 11 years: 7 mg/kg IV every 24 hours
12 to 17 years: 5 mg/kg IV every 24 hours

Duration of therapy: Up to 14 days

Use: For the treatment of cSSSI due to susceptible isolates of S aureus (including methicillin-resistant isolates), S pyogenes, S agalactiae, S dysgalactiae subspecies equisimilis, and E faecalis (vancomycin-susceptible isolates only)

Usual Pediatric Dose for Bacteremia

1 to 6 years: 12 mg/kg IV every 24 hours
7 to 11 years: 9 mg/kg IV every 24 hours
12 to 17 years: 7 mg/kg IV every 24 hours

Duration of therapy: Up to 42 days

Use: For the treatment of S aureus bloodstream infections (bacteremia)

Renal Dose Adjustments

Adult patients:
CrCl less than 30 mL/min:

• For cSSSI: 4 mg/kg IV every 48 hours
• For S aureus bloodstream infections: 6 mg/kg IV every 48 hours

Pediatric patients: Not indicated.

Comments:

• Dose has not been established in pediatric patients with renal dysfunction.

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Data not available

Precautions

CONTRAINDICATIONS:
Known hypersensitivity to the active component

Safety and efficacy have not been established in patients younger than 1 year; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

Dialysis

Adult patients:
Hemodialysis and CAPD:

• For cSSSI: 4 mg/kg IV every 48 hours
• For S aureus bloodstream infections: 6 mg/kg IV every 48 hours

Pediatric patients: Data not available

Comments:

• This drug should be administered after hemodialysis on hemodialysis days.

Other Comments

Administration advice:

• Adult patients: Administer this drug IV either by injection over 2 minutes or by infusion over 30 minutes.
• Pediatric patients: Do not administer by injection over 2 minutes.
• For patients 1 to 6 years: Administer this drug via IV infusion over 60 minutes.
• For patients 7 to 17 years: Administer this drug via IV infusion over 30 minutes.
• Cubicin(R): Administer IV in 0.9% sodium chloride injection.
• If same IV line used for sequential infusion of other drugs, flush the line before and after infusion of this drug with a compatible IV solution.

Storage requirements:

• The 2 formulations have differences regarding storage; the manufacturer product information should be consulted and followed carefully.
• The in-use storage conditions of reconstituted and diluted solutions should not be exceeded.

Cubicin(R):

• Lyophilized powder: Store original packages under refrigeration, at 2C to 8C (36F to 46F); avoid excessive heat.
• Reconstituted solution: Stable in the vial for 12 hours at room temperature and up to 48 hours when refrigerated at 2C to 8C (36F to 46F)
• Diluted solution: Stable in the infusion bag for 12 hours at room temperature and 48 hours when refrigerated
• Combined storage time (reconstituted solution in vial and diluted solution in infusion bag) should not exceed 12 hours at room temperature or 48 hours when refrigerated.

Cubicin(R) RF:

• Lyophilized powder: Store original packages at 20C to 25C (68F to 77F); excursion permitted to 15C to 30C (59F to 86F).
• In-use shelf-life with Sterile Water for Injection as diluent: 1 day (vial, syringe) or 19 hours (IV bag) at room temperature (20C to 25C [68F to 77F]) and 3 days (vial, syringe, IV bag) when refrigerated (2C to 8C [36F to 46F])
• In-use shelf-life with Bacteriostatic Water for Injection as diluent: 2 days (vial, syringe, IV bag) at room temperature and 3 days (vial) or 5 days (syringe, IV bag) when refrigerated

Reconstitution/preparation techniques:

• The 2 formulations have differences regarding reconstitution; the manufacturer product information should be consulted and followed carefully.
• Cubicin(R): Should be reconstituted with 0.9% sodium chloride injection
• Cubicin(R) RF: Should be reconstituted with Sterile Water for Injection or Bacteriostatic Water for Injection; saline-based diluents should not be used for reconstitution in the vial (resulting hyperosmotic solution may cause infusion site reactions if administered as IV injection over 2 minutes)
• Both formulations (for IV infusion): The appropriate volume of the reconstituted solution (concentration of 50 mg/mL) should be further diluted into an IV infusion bag containing the specified volume of 0.9% sodium chloride injection; the manufacturer product information should be consulted.

IV compatibility:

• Compatible IV solutions: Cubicin(R): 0.9% sodium chloride injection, lactated Ringer's injection; reconstituted Cubicin(R) RF: Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9% sodium chloride injection
• Incompatible: Dextrose-containing diluents, ReadyMED(R) elastomeric infusion pumps
• Limited data regarding compatibility with other IV products; additives and other drugs should not be added to this drug or infused concurrently through the same IV line.

General:

• Appropriate specimens for microbiological examination should be obtained before therapy to isolate and identify infecting organisms and to establish susceptibility to this drug.
• Culture and susceptibility information should be considered when selecting treatment or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy; empiric therapy may be started before test results are known.
• Combination therapy may be clinically indicated if documented or presumed pathogens include gram-negative or anaerobic organisms.
• This drug is not indicated for the treatment of pneumonia.
• This drug is not recommended for patients younger than 1 year due to risk of potential muscular, neuromuscular, and/or nervous system (peripheral and/or central) effects seen in neonatal dogs.

Monitoring:

• Infections/Infestations: Blood cultures (repeat if persisting or relapsing S aureus bacteremia/endocarditis or poor clinical response); MIC susceptibility (if blood culture positive for S aureus)
• Musculoskeletal: For muscle pain or weakness, especially of distal extremities; creatine phosphokinase (CPK) levels (weekly; more often if CPK elevations during therapy or recent prior/concurrent HMG-CoA reductase inhibitor therapy; more than once a week in adults with renal dysfunction)
• Nervous System: For neuropathy
• Renal: Renal function (more than once a week in adults with renal dysfunction)

Patient advice:

• Avoid missing doses and complete the entire course of therapy.
• Report muscle pain or weakness (especially in forearms and lower legs), tingling or numbness, and any symptoms of cough, breathlessness, or fever.
• Consult physician at once if watery and bloody stools (with or without stomach cramps and fever) develop.