Generic drug: daptomycin
Brand name: Cubicin
What is Cubicin (daptomycin), and how does it work?
Cubicin RF (daptomycin) for injection is a lipopeptide antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age); and Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis in adult patients.
What are the side effects of Cubicin?
Cubicin RF is available in generic form. Common side effects of Cubicin RF include:
- abnormal liver function tests,
- elevated creatinine phosphokinase (CPK),
- urinary tract infections,
- low blood pressure (hypotension),
- shortness of breath,
- abdominal pain,
- chest pain,
- sore throat,
- increased sweating,
- insomnia, and
- high blood pressure (hypertension).
What is the dosage for Cubicin?
Important Administration Duration Instructions
Administer the appropriate volume of the reconstituted Cubicin RF (concentration of 50 mg/mL) to adult patients intravenously either by injection over a two (2) minute period or by intravenous infusion over a thirty (30) minute period [see sections below].
Pediatric Patients (1 to 17 Years of Age)
Unlike in adults, do NOT administer Cubicin RF by injection over a two (2) minute period to pediatric patients.
- Pediatric Patients 7 to 17 years of Age: Administer Cubicin RF intravenously by infusion over a 30-minute period [see sections below].
- Pediatric Patients 1 to 6 years of Age: Administer Cubicin RF intravenously by infusion over a 60-minute period [see sections below].
Dosage In Adults For cSSSI
Administer Cubicin RF 4 mg/kg to adult patients intravenously once every 24 hours for 7 to 14 days.
Dosage In Pediatric Patients (1 to 17 Years of Age) for cSSSI
The recommended dosage regimens based on age for pediatric patients with cSSSI are shown in Table 1. Administer Cubicin RF intravenously once every 24 hours for up to 14 days.
Table 1: Recommended Dosage of Cubicin RF in Pediatric
Patients (1 to 17 Years of Age) with cSSSI, Based on Age
|Age Range||Dosage Regimen*||Duration of therapy|
|12 to 17 years||5 mg/kg once every 24 hours infused over 30 minutes||Up to 14 days|
|7 to 11 years||7 mg/kg once every 24 hours infused over 30 minutes|
|2 to 6 years||9 mg/kg once every 24 hours infused over 60 minutes|
|1 to less than 2 years||10 mg/kg once every 24 hours infused over 60 minutes|
|*Recommended dosage regimen is for pediatric patients (1 to 17 years of age) with normal renal function. Dosage adjustment for pediatric patients with renal impairment has not been established.|
Dosage In Adult Patients With Staphylococcus Aureus Bloodstream Infections (Bacteremia), Including Those With Right-Sided Infective Endocarditis, Caused By Methicillin-Susceptible And Methicillin-Resistant Isolates
Administer Cubicin RF 6 mg/kg to adult patients intravenously once every 24 hours for 2 to 6 weeks. There are limited safety data for the use of Cubicin for more than 28 days of therapy. In the Phase 3 trial, there were a total of 14 adult patients who were treated with Cubicin for more than 28 days.
Dosage In Pediatric Patients (1 to 17 Years of Age) With Staphylococcus aureus Bloodstream Infections (Bacteremia)
The recommended dosage regimens based on age for pediatric patients with S. aureus bloodstream infections (bacteremia) are shown in Table 2. Administer Cubicin RF intravenously in 0.9% sodium chloride injection once every 24 hours for up to 42 days.
Table 2: Recommended Dosage of Cubicin RF in Pediatric
Patients (1 to 17 Years of Age) with S. aureus Bacteremia, Based on Age
|Age group||Dosage*||Duration of therapy|
|12 to 17 years||7 mg/kg once every 24 hours infused over 30 minutes||Up to 42 days|
|7 to 11 years||9 mg/kg once every 24 hours infused over 30 minutes|
|1 to 6 years||12 mg/kg once every 24 hours infused over 60 minutes|
|*Recommended dosage is for pediatric patients (1 to 17 years of age) with normal renal function. Dosage adjustment for pediatric patients with renal impairment has not been established.|
Dosage In Patients With Renal Impairment
No dosage adjustment is required in adult patients with creatinine clearance (CLCR) greater than or equal to 30 mL/min. The recommended dosage regimen for Cubicin RF in adult patients with CLCR less than 30 mL/min, including adult patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), is 4 mg/kg (cSSSI) or 6 mg/kg (S. aureus bloodstream infections) once every 48 hours (Table 3). When possible, Cubicin RF should be administered following the completion of hemodialysis on hemodialysis days.
Table 3: Recommended Dosage of Cubicin RF in Adult Patients
|Creatinine Clearance (CLcr)||Dosage Regimen in Adults|
|cSSSI||S. aureus Bloodstream Infections|
|Greater than or equal to 30 mL/min||4 mg/kg once every 24 hours||6 mg/kg once every 24 hours|
|Less than 30 mL/min, including hemodialysis and CAPD||4 mg/kg once every 48 hours*||6 mg/kg once every 48 hours*|
|*When possible, administer Cubicin RF following the completion of hemodialysis on hemodialysis days.|
The dosage regimen for Cubicin RF in pediatric patients with renal impairment has not been established.
What drugs interact with Cubicin?
HMG-CoA Reductase Inhibitors
- In healthy adult subjects, concomitant administration of Cubicin and simvastatin had no effect on plasma trough concentrations of simvastatin, and there were no reports of skeletal myopathy.
- However, inhibitors of HMG-CoA reductase may cause myopathy, which is manifested as muscle pain or weakness associated with elevated levels of creatine phosphokinase (CPK). In the adult Phase 3 S. aureus bacteremia/endocarditis trial, some patients who received prior or concomitant treatment with an HMG-CoA reductase inhibitor developed elevated CPK.
- Experience with the coadministration of HMG-CoA reductase inhibitors and Cubicin in patients is limited; therefore, consideration should be given to suspending use of HMG-CoA reductase inhibitors temporarily in patients receiving Cubicin RF.
Drug-Laboratory Test Interactions
- Clinically relevant plasma concentrations of daptomycin have been observed to cause a significant concentration-dependent false prolongation of prothrombin time (PT) and elevation of International Normalized Ratio (INR) when certain recombinant thromboplastin reagents are utilized for the assay.
- The possibility of an erroneously elevated PT/INR result due to interaction with a recombinant thromboplastin reagent may be minimized by drawing specimens for PT or INR testing near the time of trough plasma concentrations of daptomycin. However, sufficient daptomycin concentrations may be present at trough to cause interaction.
- If confronted with an abnormally high PT/INR result in a patient being treated with Cubicin RF, it is recommended that clinicians:
- Repeat the assessment of PT/INR, requesting that the specimen be drawn just prior to the next Cubicin RF dose (i.e., at trough concentration). If the PT/INR value obtained at trough remains substantially elevated above what would otherwise be expected, consider evaluating PT/INR utilizing an alternative method.
- Evaluate for other causes of abnormally elevated PT/INR results.
Is Cubicin safe to use while pregnant or breastfeeding?
- Limited published data on use of Cubicin RF in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage.
- Limited published data report that daptomycin is present in human milk at infant doses of 0.1% of the maternal dose.
- There is no information on the effects of daptomycin on the breastfed infant or the effects of daptomycin on milk production.
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Cubicin and any potential adverse effects on the breastfed infant from Cubicin RF or from the underlying maternal condition.
Latest Medications News
Daily Health News
Cubicin RF (daptomycin) for injection is a lipopeptide antibacterial used to treat complicated skin and skin structure infections (cSSSI) in adults and children (1 to 17 years of age); and Staphylococcus aureus bloodstream infections (bacteremia). Common side effects of Cubicin RF include diarrhea, headache, dizziness, rash, abnormal liver function tests, elevated creatinine phosphokinase (CPK), urinary tract infections, low blood pressure (hypotension), shortness of breath, and others.
Multimedia: Slideshows, Images & Quizzes
Bacterial Infections 101: Types, Symptoms, and Treatments
Get more information on bacterial skin infections, which bacteria cause food poisoning, sexually transmitted bacteria, and more....
Skin Infections: Types, Causes, and Symptoms
Viruses, bacteria, and fungi can all cause skin infections. What is scabies? Learn about golden staph infections, cellulitis,...
Fungal Skin Infections: Types, Symptoms, and Treatment
Fungal skin infections and fungal nail infections produce symptoms like red, itchy, circular rashes and thick, discolored, flaky...
What Is a Staph Infection? Causes, Symptoms, Treatments
Do you know what a staph infection is? What about golden staph? Learn about the causes, symptoms, and treatments of staph...
MRSA Infection: Causes, Symptoms, and Treatment
MRSA and staph infections are caused by a 'super bug' resistant to antibiotics. Learn causes, symptoms, and treatment options of...
MRSA Quiz: Infection Symptoms & Treatment
It's the MRSA Quiz! For the carriers among us, you'd be surprised that the infectious superbug is lurking on this body part! Take...
Strep (Streptococcal) Throat Infection Quiz: Test Your Infectious Disease IQ
Take the Strep (Streptococcal) Throat Infection Quiz to learn about causes, symptoms, treatments, prevention methods, diagnosis,...
Picture of Fungal Nail Infection
Nails that are infected with a fungus may become discolored (yellowish-brown or opaque), thick and brittle, and may separate from...
Related Disease Conditions
Staph (Staphylococcus) Infection
Staphylococcus or staph is a group of bacteria that can cause a multitude of diseases. Staph infections can cause illness directly by infection or indirectly by the toxins they produce. Symptoms and signs of a staph infection include redness, swelling, pain, and drainage of pus. Minor skin infections are treated with an antibiotic ointment, while more serious infections are treated with intravenous antibiotics.
Is a Staph Infection Contagious?
A staph infection is caused by the bacteria Staphylococcus aureus. Staph can cause boils, food poisoning, cellulitis, toxic shock syndrome, MRSA, and various other illnesses and infections. Most staph infections are transmitted from person to person.
E. coli (0157:H7) Infection
There are many types of E. coli (Escherichia coli). E. coli can cause urinary tract and bladder infections, or lead to sepsis. E coli O157:H7 (EHEC) causes bloody diarrhea and colitis. Complications of E. coli infection include hemorrhagic diarrhea, hemolytic-uremic syndrome, and thrombotic thrombocytopenic purpura. Symptoms include severe abdominal pain and bloody diarrhea. E coli O157:H7 commonly is due to eating raw or undercooked hamburger or raw milk or dairy products.
CRE Bacteria Infection
Carbapenem-resistant Enterobacteriaceae (CRE) is a type of bacteria that is highly resistant to antibiotics. Escherichia coli (E. coli) and Klebsiella are common types of Enterobacteriaceae that can be found in the human intestines. However, these bacteria can cause infections if they escape the intestines. Carbapenems are broad-spectrum antibiotics that treat infections caused by bacteria that are highly resistant to other types of antibiotics.
What Are Some Common Eye Infections?
An eye infection is a condition in which viruses, bacteria or other microbial agents may attack the eye. This can cause itching around the eyes or the eyes may turn pink. The infection can affect the eyelid, cornea or conjuctiva (inside lining of the eyelid).
How Serious Is a Staph Infection?
A Staphylococcus or staph infection is caused by a germ that may be found in 30% of healthy people’s noses. Most of the time, these bacteria do not cause any health problems. However, in some people, it may cause skin and other organ infections. Most often, staph causes minor skin infections such as a boil. However, if it enters into your bloodstream and other organs, it may turn out to be deadly.
Staph Infection Causes
Staph or Staphylococcus is a group of bacteria that is found over the skin of most individuals. Staph bacteria usually live inside the nose, but they do not cause an infection. Staph infections may turn deadly if the bacteria invade deeper into the body, entering the bloodstream, joints, bones, lungs, or heart.
Treatment & Diagnosis
Medications & Supplements
Health Solutions From Our Sponsors
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.