Cubicin 500mg Rf (no Refrigeration
It is used to treat bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Lipopeptide antibiotic
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 caused by resistant bacteria like MRSA. It works by disrupting the outer layer of the bacteria, causing them to die. It is given as an intravenous (IV) infusion, usually once a day.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This drug 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.
- Inform your doctor about all medications you are taking, especially cholesterol-lowering drugs (statins).
- Maintain good hydration as advised by your healthcare provider.
- Complete the full course of treatment, even if you start feeling better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Complicated Skin and Skin Structure Infections (cSSSI): 4 mg/kg IV once every 24 hours. Staphylococcus aureus Bloodstream Infections (Bacteremia), including Right-Sided Infective Endocarditis: 6 mg/kg IV once every 24 hours.
Dose Range:
4 - 6 mg
Condition-Specific Dosing:
cSSSI:
4 mg/kg IV once every 24 hours for 7-14 days or until cure.
S. aureus Bacteremia/Right-Sided Infective Endocarditis:
6 mg/kg IV once every 24 hours for 2-6 weeks, depending on infection site and resolution.
Pediatric Dosing
Neonatal:
Not established (limited data, generally not recommended).
Infant:
Not established (limited data, generally not recommended).
Child:
1 to <7 years: 9 mg/kg IV once every 24 hours for cSSSI; 12 mg/kg IV once every 24 hours for S. aureus bacteremia. 7 to <12 years: 7 mg/kg IV once every 24 hours for cSSSI; 10 mg/kg IV once every 24 hours for S. aureus bacteremia.
Adolescent:
12 to 17 years: 5 mg/kg IV once every 24 hours for cSSSI; 7 mg/kg IV once every 24 hours for S. aureus bacteremia.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 50 mL/min).
Moderate:
No adjustment needed (CrCl 30-50 mL/min).
Severe:
CrCl < 30 mL/min: Administer once every 48 hours.
Dialysis:
Hemodialysis (HD) or Peritoneal Dialysis (PD): Administer once every 48 hours. If possible, administer after completion of HD.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed (pharmacokinetics not significantly altered).
Pharmacology
Mechanism of Action
Daptomycin is a cyclic lipopeptide antibiotic. It inserts into the bacterial cell membrane in a calcium-dependent manner, leading to rapid depolarization of the membrane potential. This disruption of membrane function inhibits protein, DNA, and RNA synthesis, ultimately leading to bacterial cell death without causing cell lysis.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV administration)
Tmax:
Not applicable (IV administration, peak concentration reached at end of infusion)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.1 L/kg (similar to extracellular fluid volume)
ProteinBinding:
Approximately 92% (primarily to albumin)
CnssPenetration:
Limited (does not readily cross the blood-brain barrier)
Elimination:
HalfLife:
Approximately 8-10 hours (in subjects with normal renal function)
Clearance:
Approximately 7-9 mL/min/kg
ExcretionRoute:
Primarily renal (78% of dose excreted in urine, 52% as unchanged drug; 6% in feces)
Unchanged:
Approximately 52%
Pharmacodynamics
OnsetOfAction:
Rapid (bactericidal activity observed within hours)
PeakEffect:
Not applicable (concentration-dependent killing)
DurationOfAction:
24 hours (due to once-daily dosing regimen)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while 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
+ Fainting
+ Changes in vision
Signs of kidney problems, such as:
+ Inability to urinate
+ 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), as this can be a sign of a potentially life-threatening condition called C. diff-associated diarrhea (CDAD)
If you experience any of the following symptoms, contact your doctor right away:
Muscle pain or weakness
Dark urine
Trouble urinating
Stomach pain
Cramps
Severe diarrhea (especially if it is bloody or watery)
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. 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 an exhaustive list of 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.
Although rare, some people may experience severe and potentially life-threatening side effects while 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
+ Fainting
+ Changes in vision
Signs of kidney problems, such as:
+ Inability to urinate
+ 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), as this can be a sign of a potentially life-threatening condition called C. diff-associated diarrhea (CDAD)
If you experience any of the following symptoms, contact your doctor right away:
Muscle pain or weakness
Dark urine
Trouble urinating
Stomach pain
Cramps
Severe diarrhea (especially if it is bloody or watery)
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. 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 an exhaustive list of 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:
- Severe muscle pain, tenderness, or weakness (especially with dark urine)
- Numbness, tingling, or burning sensation in hands or feet (peripheral neuropathy)
- Persistent cough, shortness of breath, or new onset of fever (possible eosinophilic pneumonia)
- Signs of an allergic reaction: rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble breathing.
- Severe diarrhea (possibly C. difficile infection)
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 this condition.
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 all potential interactions.
To ensure your safety, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist will help you verify that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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 this condition.
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 all potential interactions.
To ensure your safety, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist will help you verify that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of 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 all of your healthcare providers and laboratory personnel that you are taking this medication.
Regular blood tests will be necessary to monitor your condition, as directed by your doctor. Be sure to 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 secondary infection.
A rare but potentially life-threatening reaction can occur with this medication, characterized by symptoms such as fever, rash, or swollen glands, along with problems in various organs, including 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 of age, 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 potential benefits and risks, and consult with them if you have any questions or concerns.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of taking this medication with you, considering both your health and the health of your baby.
Regular blood tests will be necessary to monitor your condition, as directed by your doctor. Be sure to 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 secondary infection.
A rare but potentially life-threatening reaction can occur with this medication, characterized by symptoms such as fever, rash, or swollen glands, along with problems in various organs, including 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 of age, 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 potential benefits and risks, and consult with them if you have any questions or concerns.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of taking this medication with you, considering both your health and the health of your baby.
Overdose Information
Overdose Symptoms:
- Increased CPK levels
- Muscle weakness
- Peripheral neuropathy
- Renal impairment
What to Do:
There is no specific antidote. Treatment is supportive. Hemodialysis removes approximately 15% of the dose in 4 hours. Contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Major Interactions
- HMG-CoA reductase inhibitors (statins)
Moderate Interactions
- Warfarin
- Tobramycin (and other aminoglycosides)
Monitoring
Baseline Monitoring
Creatine Phosphokinase (CPK)
Rationale: To establish a baseline before initiating therapy due to the risk of myopathy/rhabdomyolysis.
Timing: Prior to initiation of therapy.
Renal Function (CrCl, BUN, Creatinine)
Rationale: Daptomycin is primarily renally eliminated, and dose adjustments are required in renal impairment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Creatine Phosphokinase (CPK)
Frequency: At least weekly, or more frequently if CPK levels are elevated at baseline or if symptoms of myopathy develop.
Target: Normal range (typically < 200 U/L or < 3x ULN)
Action Threshold: Discontinue daptomycin if CPK levels are âĨ 5 times the upper limit of normal (ULN) or if CPK levels are âĨ 3 times ULN and associated with muscle symptoms.
Renal Function (CrCl, BUN, Creatinine)
Frequency: Periodically, especially in patients with pre-existing renal impairment or those receiving concomitant nephrotoxic agents.
Target: Stable renal function
Action Threshold: Adjust dose frequency if CrCl falls below 30 mL/min.
INR (if on warfarin)
Frequency: Monitor frequently during co-administration.
Target: Therapeutic range for indication
Action Threshold: Adjust warfarin dose as needed to maintain target INR.
Symptom Monitoring
- Muscle pain
- Muscle tenderness
- Muscle weakness
- Fever
- Rash
- Shortness of breath
- Cough
- Peripheral neuropathy symptoms (e.g., numbness, tingling)
Special Patient Groups
Pregnancy
Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data, but human data limited.
Second Trimester:
Low risk based on animal data, but human data limited.
Third Trimester:
Low risk based on animal data, but human data limited.
Lactation
L3 (Moderately Safe). Daptomycin is excreted in human milk in low concentrations. The amount ingested by an infant is likely small. Monitor breastfed infants for gastrointestinal disturbances (e.g., diarrhea, candidiasis) and potential effects on gut flora. Weigh the benefits of breastfeeding against the potential risks.
Infant Risk:
Low to moderate risk. Potential for altered gut flora, diarrhea, or candidiasis in the infant. No serious adverse effects reported in limited human data.
Pediatric Use
Dosing varies significantly by age group and indication. Safety and efficacy have been established in pediatric patients (1 to 17 years of age) for cSSSI and S. aureus bacteremia. Not recommended for children under 1 year due to potential for muscle, nerve, and kidney effects.
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 based on renal function is important in this population.
Clinical Information
Clinical Pearls
- Daptomycin is bactericidal against Gram-positive bacteria, including MRSA and VRE.
- It is NOT effective for the treatment of pneumonia because it is inactivated by pulmonary surfactant.
- Monitor CPK levels at baseline and at least weekly during therapy due to the risk of myopathy/rhabdomyolysis. More frequent monitoring is needed if CPK is elevated or if muscle symptoms occur.
- Avoid co-administration with HMG-CoA reductase inhibitors (statins) due to increased risk of myopathy. If co-administration is necessary, consider temporary discontinuation of the statin or very close CPK monitoring.
- Eosinophilic pneumonia has been reported with daptomycin; monitor for new or worsening fever, cough, and shortness of breath.
- Peripheral neuropathy has been reported; monitor for numbness, tingling, or weakness.
- Cubicin RF (no refrigeration) formulation offers convenience for storage and preparation compared to the original Cubicin formulation.
Alternative Therapies
- Vancomycin (for MRSA, VRE)
- Linezolid (for MRSA, VRE)
- Tedizolid (for MRSA)
- Ceftaroline (for MRSA)
- Dalbavancin (for MRSA)
- Oritavancin (for MRSA)
- Tigecycline (for cSSSI, not for bacteremia)
Cost & Coverage
Average Cost:
$1,000 - $2,000+ per 500mg vial
Generic Available:
Yes
Insurance Coverage:
Tier 3 (Non-preferred Brand) or Tier 2 (Preferred Generic) depending on plan
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. 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. Additionally, some medications may come with a separate 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 of ingestion.