Cubicin 500mg Inj (refrigerate)
It is used to treat bacterial infections.
Drug Class
Lipopeptide antibiotic
Pharmacologic Class
Cyclic lipopeptide antibacterial
Pregnancy Category
Category B
FDA Approved
Sep 2003
DEA Schedule
Not Controlled
Overview
What is this medicine?
Daptomycin is an antibiotic used to treat serious bacterial infections, especially those affecting the skin or bloodstream. It works by attacking the bacteria's outer layer, causing them to die. It is given as an injection into a vein.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Adhere to the dosage instructions provided by your healthcare team. This medication is administered intravenously over a specified period.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Report any muscle pain, tenderness, or weakness immediately to your doctor.
- Stay well-hydrated unless otherwise advised by your doctor.
- Inform your healthcare provider about all medications you are taking, including over-the-counter drugs, supplements, and herbal products, especially cholesterol-lowering medications (statins).
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
4 mg/kg IV once every 24 hours for cSSSI; 6 mg/kg IV once every 24 hours for S. aureus bloodstream infections (SAB) including right-sided infective endocarditis (RIE)
Dose Range:
4 - 6 mg
Condition-Specific Dosing:
complicatedSkinAndSkinStructureInfections:
4 mg/kg IV once every 24 hours for 7-14 days
staphylococcusAureusBloodstreamInfections:
6 mg/kg IV once every 24 hours for 2-6 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for all indications; for cSSSI in 1 to <2 years: 10 mg/kg IV once every 24 hours
Child:
For cSSSI in 2 to 6 years: 9 mg/kg IV once every 24 hours; 7 to 11 years: 7 mg/kg IV once every 24 hours; 12 to 17 years: 5 mg/kg IV once every 24 hours. For SAB in 1 to <7 years: 12 mg/kg IV once every 24 hours; 7 to 11 years: 10 mg/kg IV once every 24 hours; 12 to 17 years: 7 mg/kg IV once every 24 hours.
Adolescent:
For cSSSI: 5 mg/kg IV once every 24 hours. For SAB: 7 mg/kg IV once every 24 hours.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl >50 mL/min)
Moderate:
No adjustment needed (CrCl 30-50 mL/min)
Severe:
Administer 4 mg/kg (cSSSI) or 6 mg/kg (SAB) once every 48 hours (CrCl <30 mL/min)
Dialysis:
Administer 4 mg/kg (cSSSI) or 6 mg/kg (SAB) once every 48 hours. If possible, administer dose after hemodialysis (HD) on HD days.
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
No adjustment
Pharmacology
Mechanism of Action
Daptomycin is a cyclic lipopeptide antibacterial that binds to bacterial cell membranes and causes rapid depolarization of the membrane potential. This leads to inhibition of protein, DNA, and RNA synthesis, resulting in bacterial cell death. It exhibits concentration-dependent killing.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
0.7-1.3 hours (end of infusion)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
0.09-0.13 L/kg
ProteinBinding:
92% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
7.7-8.1 hours (healthy volunteers); prolonged in renal impairment
Clearance:
Not available
ExcretionRoute:
Renal (primarily), fecal (minor)
Unchanged:
78% (renal)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of exposure to susceptible bacteria)
PeakEffect:
Within 1 hour of infusion completion
DurationOfAction:
Concentration-dependent killing, sustained post-antibiotic effect
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Feeling extremely tired or weak
Abnormal burning, numbness, or tingling sensations
Fever
Cough
Shortness of breath
Chest pain or pressure
Swelling
Muscle aches or weakness (in rare cases, a severe muscle problem with or without kidney problems may occur)
Diarrhea, especially if it is severe, bloody, or watery (a condition called C. diff-associated diarrhea, or CDAD, may occur, which can lead to a life-threatening bowel problem)
If you experience any of the following, contact your doctor right away:
Muscle pain or weakness
Dark urine
Trouble passing urine
Stomach pain, cramps, or severe diarrhea
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:
Headache
Stomach pain or diarrhea
Trouble sleeping
Excessive sweating
Sore throat
Vomiting
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Feeling extremely tired or weak
Abnormal burning, numbness, or tingling sensations
Fever
Cough
Shortness of breath
Chest pain or pressure
Swelling
Muscle aches or weakness (in rare cases, a severe muscle problem with or without kidney problems may occur)
Diarrhea, especially if it is severe, bloody, or watery (a condition called C. diff-associated diarrhea, or CDAD, may occur, which can lead to a life-threatening bowel problem)
If you experience any of the following, contact your doctor right away:
Muscle pain or weakness
Dark urine
Trouble passing urine
Stomach pain, cramps, or severe diarrhea
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:
Headache
Stomach pain or diarrhea
Trouble sleeping
Excessive sweating
Sore throat
Vomiting
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Unexplained muscle pain, tenderness, or weakness
- Dark urine
- Numbness or tingling in hands or feet
- Fever, chills, or other signs of worsening infection
- Severe diarrhea (especially if bloody or watery)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have kidney disease, as this may affect how your body processes the medication.
If you have a condition that prevents you from breaking down fructose, a type of sugar. Some formulations of this medication contain sorbitol, which can cause severe and potentially life-threatening health issues in individuals with fructose intolerance.
If you are currently taking any of the following medications:
+ Atorvastatin
+ Fluvastatin
+ Lovastatin
+ Pitavastatin
+ Pravastatin
+ Rosuvastatin
+ Simvastatin
Please note that this is not an exhaustive list of potential interactions. It is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist to ensure safe use.
To guarantee your safety, always check with your doctor before starting, stopping, or changing the dose of any medication. This will help prevent potential interactions and ensure that you can take this medication safely with your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have kidney disease, as this may affect how your body processes the medication.
If you have a condition that prevents you from breaking down fructose, a type of sugar. Some formulations of this medication contain sorbitol, which can cause severe and potentially life-threatening health issues in individuals with fructose intolerance.
If you are currently taking any of the following medications:
+ Atorvastatin
+ Fluvastatin
+ Lovastatin
+ Pitavastatin
+ Pravastatin
+ Rosuvastatin
+ Simvastatin
Please note that this is not an exhaustive list of potential interactions. It is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist to ensure safe use.
To guarantee your safety, always check with your doctor before starting, stopping, or changing the dose of any medication. This will help prevent potential interactions and ensure that you can take this medication safely with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug may interfere with certain laboratory tests, so be sure to notify your healthcare providers and lab personnel that you are taking it.
Regular blood tests will be necessary to monitor your condition, as directed by your doctor. Discuss any concerns or questions you have with your doctor. Do not take this medication for longer than prescribed, as this may increase the risk of a second infection.
A severe and potentially life-threatening reaction can occur, characterized by symptoms such as fever, rash, or swollen glands, along with problems in organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have any questions or concerns, consult your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. This medication is not recommended for children under 12 months, as it may increase the risk of muscle and nerve problems. However, your child's doctor may determine that the benefits of taking this medication outweigh the risks. If your child has been prescribed this medication, ask their doctor to discuss the benefits and risks, and consult with them if you have any questions.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks to you and your baby.
Regular blood tests will be necessary to monitor your condition, as directed by your doctor. Discuss any concerns or questions you have with your doctor. Do not take this medication for longer than prescribed, as this may increase the risk of a second infection.
A severe and potentially life-threatening reaction can occur, characterized by symptoms such as fever, rash, or swollen glands, along with problems in organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have any questions or concerns, consult your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. This medication is not recommended for children under 12 months, as it may increase the risk of muscle and nerve problems. However, your child's doctor may determine that the benefits of taking this medication outweigh the risks. If your child has been prescribed this medication, ask their doctor to discuss the benefits and risks, and consult with them if you have any questions.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Increased CPK levels
- Muscle pain or weakness
- Peripheral neuropathy
What to Do:
There is no specific antidote. Treatment is supportive. Daptomycin is slowly cleared by hemodialysis (approximately 15% of dose removed in 4 hours). Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention.
Drug Interactions
Major Interactions
- Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy/rhabdomyolysis. Consider temporary discontinuation of statin during daptomycin therapy.
- Warfarin: Potential for altered INR, though clinical significance is variable. Monitor INR closely.
Moderate Interactions
- Tobramycin: Potential for increased daptomycin levels in patients with renal impairment.
- Other nephrotoxic drugs (e.g., NSAIDs, aminoglycosides): Increased risk of renal toxicity.
Monitoring
Baseline Monitoring
Creatine Phosphokinase (CPK/CK)
Rationale: To establish baseline and monitor for myopathy/rhabdomyolysis, a known adverse effect.
Timing: Prior to initiation of therapy
Renal function (SCr, BUN, CrCl)
Rationale: Daptomycin is renally eliminated; dose adjustment is required in severe renal impairment.
Timing: Prior to initiation of therapy
Routine Monitoring
Creatine Phosphokinase (CPK/CK)
Frequency: At least weekly, or more frequently if clinically indicated (e.g., muscle pain, weakness)
Target: Within normal limits
Action Threshold: Discontinue daptomycin if CPK levels are âĨ5 times the upper limit of normal (ULN) or if CPK levels are âĨ1000 U/L in asymptomatic patients, or if CPK levels are associated with muscle symptoms.
Renal function (SCr, BUN)
Frequency: Weekly, or more frequently if clinically indicated
Target: Stable, within patient's baseline
Action Threshold: Adjust dose for significant decline in renal function (CrCl <30 mL/min).
INR (if co-administered with warfarin)
Frequency: Daily or as per standard warfarin monitoring protocol, with increased vigilance
Target: Therapeutic range for indication
Action Threshold: Adjust warfarin dose as needed to maintain INR within target range.
Symptom Monitoring
- Muscle pain
- Muscle tenderness
- Muscle weakness
- Numbness or tingling (paresthesia)
- Signs of peripheral neuropathy
- Fever
- Rash
- Signs of kidney injury (e.g., decreased urine output, swelling)
Special Patient Groups
Pregnancy
Daptomycin is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified in animal studies.
Second Trimester:
No specific increased risk identified in animal studies.
Third Trimester:
No specific increased risk identified in animal studies.
Lactation
Daptomycin is excreted in human milk in low concentrations. The amount ingested by a breastfed infant is likely low. Caution should be exercised when daptomycin is administered to a nursing woman. Monitor infant for gastrointestinal disturbances (e.g., diarrhea, candidiasis).
Infant Risk:
Low risk, but potential for gastrointestinal upset or alteration of gut flora.
Pediatric Use
Approved for complicated skin and skin structure infections (cSSSI) in pediatric patients 1 to 17 years of age and for Staphylococcus aureus bloodstream infections (SAB) including right-sided infective endocarditis (RIE) in pediatric patients 1 to 17 years of age. Dosing varies by age and indication. Safety and efficacy in neonates (<1 year) have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment is primarily based on renal function, which may be diminished in elderly patients.
Clinical Information
Clinical Pearls
- Daptomycin is NOT indicated for the treatment of pneumonia, as it is inactivated by pulmonary surfactant.
- Monitor CPK levels weekly due to the risk of myopathy and rhabdomyolysis. More frequent monitoring is needed if muscle pain or weakness develops, or if co-administered with statins.
- Consider temporary discontinuation of statins during daptomycin therapy to reduce the risk of muscle toxicity.
- Daptomycin is effective against Gram-positive bacteria, including MRSA and VRE.
- Administer once daily. For patients on hemodialysis, administer after dialysis on dialysis days.
- Refrigeration is required for the powder for injection. Reconstituted solution is stable for 12 hours at room temperature or 48 hours if refrigerated.
Alternative Therapies
- Vancomycin (for MRSA, VRE)
- Linezolid (for MRSA, VRE)
- Teicoplanin (outside US, for MRSA, VRE)
- Ceftaroline (for MRSA cSSSI)
- Dalbavancin (for cSSSI)
- Oritavancin (for cSSSI)
- Tigecycline (for cSSSI)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500 per 500mg vial per 500mg vial
Generic Available:
Yes
Insurance Coverage:
Tier 3 (Non-preferred brand) or Tier 2 (Preferred generic) on most formularies, often requires prior authorization due to cost and specific indications.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.