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Cubicin

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Cubicin

Cubicin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cubicin (daptomycin) is used to treat bacterial infections of the skin and underlying tissues. It is an antibiotic. Common side effects include nausea, vomiting, constipation, diarrhea, headache, dizziness, trouble sleeping, anxiety, or pain/redness/swelling at the injection site.

The dose and duration of treatment with Cubicin depends upon the condition being treated. It is administered intravenously either by injection over a two (2) minute period or by infusion over a thirty (30) minute period. Cubicin may interact with blood thinners, tobramycin, or cholesterol-lowering medicines. Tell your doctor all medications you are taking. Cubicin should be used only when prescribed during pregnancy. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Cubicin (daptomycin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cubicin in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • new or worsening cough, fever, trouble breathing;
  • pain or burning when you urinate;
  • diarrhea that is watery or bloody;
  • white patches or sores in your mouth or throat;
  • vaginal itching or discharge;
  • urinating less than usual or not at all;
  • muscle pain or weakness with fever or flu symptoms and dark colored urine;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling); or
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Less serious side effects may include:

  • constipation, nausea, diarrhea, vomiting;
  • headache;
  • swelling;
  • back pain, pain in your arms or legs;
  • anxiety, sleep problems (insomnia);
  • mild itching or skin rash;
  • increased sweating; or
  • redness, discomfort, or irritation where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cubicin (Daptomycin Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Cubicin Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, constipation, diarrhea, headache, dizziness, trouble sleeping, anxiety, or pain/redness/swelling at the injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: muscle pain/cramps/weakness, numbness or tingling of hands or feet, unusual tiredness or weakness, change in amount of urine, chest pain, swelling, shakiness, sweating, increased thirst, blurred vision, unusual bleeding or bruising, irregular heartbeat, yellowing of the skin or eyes, dark urine, cough, difficult/painful breathing, new/unexplained fever.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction include: rash, itching/severe swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Cubicin (Daptomycin Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cubicin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are described, or described in greater detail, in other sections:

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 Trials Experience

Clinical trials enrolled 1,864 patients treated with CUBICIN and 1,416 treated with comparator.

Complicated Skin And Skin Structure Infection Trials

In Phase 3 complicated skin and skin structure infection (cSSSI) trials, 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 cSSSI (4 mg/kg CUBICIN) patients are displayed in Table 4.

Table 4: Incidence of Adverse Reactions that Occurred in ≥ 2% of Patients in the CUBICIN Treatment Group and ≥ the Comparator Treatment Group in Phase 3 cSSSI Trials

Adverse Reaction Patients (%)
CUBICIN 4 mg/kg
(N=534)
Comparator*
(N=558)
Gastrointestinal disorders
  Diarrhea 5.2 4.3
Nervous system disorders
  Headache 5.4 5.4
  Dizziness 2.2 2
Skin/subcutaneous disorders
  Rash 4.3 3.8
Diagnostic investigations
  Abnormal liver function tests 3 1.6
  Elevated CPK 2.8 1.8
Infections
  Urinary tract infections 2.4 0.5
Vascular disorders
  Hypotension 2.4 1.4
Respiratory disorders
  Dyspnea 2.1 1.6
* Comparator: vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g/day IV in divided doses).

Drug-related adverse reactions (possibly or probably drug-related) that occurred in < 1% of 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 the S. aureus bacteremia/endocarditis trial, 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 S. aureus bacteremia/endocarditis (6 mg/kg CUBICIN) patients are displayed in Table 5.

Table 5: Incidence of Adverse Reactions that Occurred in ≥ 5% of Patients in the CUBICIN Treatment Group and ≥ the Comparator Treatment Group in the S. aureus Bacteremia/Endocarditis Trial

Adverse Reaction* Patients n (%)
CUBICIN 6 mg/kg
(N=120)
Comparator†
(N=116)
Infections and infestations
  Sepsis NOS 6 (5%) 3 (3%)
  Bacteremia 6 (5%) 0 (0%)
Gastrointestinal disorders
  Abdominal pain NOS 7 (6%) 4 (3%)
General disorders and administration site conditions
  Chest pain 8 (7%) 7 (6%)
  Edema NOS 8 (7%) 5 (4%)
Respiratory, thoracic and mediastinal disorders
  Pharyngolaryngeal pain 10 (8%) 2 (2%)
Skin and subcutaneous tissue disorders
  Pruritus 7 (6%) 6 (5%)
  Sweating increased 6 (5%) 0 (0%)
Psychiatric disorders
  Insomnia 11 (9%) 8 (7%)
Investigations
  Blood creatine phosphokinase increased 8 (7%) 1 (1%)
Vascular disorders
  Hypertension NOS 7 (6%) 3 (3%)
* NOS, not otherwise specified.
† Comparator: vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 2 g IV q4h), each with initial low-dose gentamicin.

The following reactions, not included above, 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 Phase 3 trials of community-acquired pneumonia (CAP), 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 INDICATIONS AND USAGE].

Laboratory Changes

Complicated Skin and Skin Structure Infection Trials

In Phase 3 cSSSI trials of 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 WARNINGS AND PRECAUTIONS]. Table 6 summarizes the CPK shifts from Baseline through End of Therapy in the cSSSI trials.

Table 6: Incidence of CPK Elevations from Baseline during Therapy in Either the CUBICIN Treatment Group or the Comparator Treatment Group in Phase 3 cSSSI Trials

Change in CPK All Patients Patients with Normal CPK at Baseline
CUBICIN 4 mg/kg (N=430) Comparator* (N=459) CUBICIN 4 mg/kg (N=374) Comparator* (N=392)
% n % n % n % n
No Increase 90.7 390 91.1 418 91.2 341 91.1 357
Maximum Value > 1 ULN† 9.3 40 8.9 41 8.8 33 8.9 35
> 2 ULN 4.9 21 4.8 22 3.7 14 3.1 12
> 4 ULN 1.4 6 1.5 7 1.1 4 1.0 4
> 5 ULN 1.4 6 0.4 2 1.1 4 0.0 0
> 10 ULN 0.5 2 0.2 1 0.2 1 0.0 0
Note: Elevations in CPK observed in patients treated with CUBICIN or comparator were not clinically or statistically significantly different.
* Comparator: vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g/day IV in divided doses).
† ULN (Upper Limit of Normal) is defined as 200 U/L.

S. aureus Bacteremia/Endocarditis Trial

In the S. aureus bacteremia/endocarditis trial, 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 WARNINGS AND PRECAUTIONS].

Post-Marketing Experience

The following adverse reactions have been identified during postapproval use of CUBICIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure.

Immune System Disorders: anaphylaxis; hypersensitivity reactions, including angioedema, drug rash with eosinophilia and systemic symptoms (DRESS), pruritus, hives, shortness of breath, difficulty swallowing, truncal erythema, and pulmonary eosinophilia [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS]

Infections and Infestations: Clostridium difficile-associated diarrhea [see WARNINGS AND PRECAUTIONS]

Musculoskeletal Disorders: myoglobin increased; rhabdomyolysis (some reports involved patients treated concurrently with CUBICIN and HMG-CoA reductase inhibitors) [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY]

Respiratory, Thoracic, and Mediastinal Disorders: cough, eosinophilic pneumonia [see WARNINGS AND PRECAUTIONS]

Nervous System Disorders: peripheral neuropathy [see WARNINGS AND PRECAUTIONS]

Skin and Subcutaneous Tissue Disorders: serious skin reactions, including Stevens-Johnson syndrome and vesiculobullous rash (with or without mucous membrane involvement)

Gastrointestinal Disorders: nausea, vomiting

Read the entire FDA prescribing information for Cubicin (Daptomycin Injection) »

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Cubicin - User Reviews

Cubicin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Cubicin sorted by most helpful. Patient Discussions FAQs

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.


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