DAPTOMYCIN PACKAGE INSERT PDF

When possible, administer Cubicin following the completion of hemodialysis on hemodialysis days. Preparation and Administration of Cubicin There are two formulations of daptomycin that have differences concerning storage and reconstitution. Carefully follow the reconstitution and storage procedures in labeling. Reconstitution of Cubicin Vial Cubicin is supplied in single-dose vials, each containing mg daptomycin as a sterile, lyophilized powder. Remove the polypropylene flip-off cap from the Cubicin vial to expose the central portion of the rubber stopper.

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When possible, administer Cubicin following the completion of hemodialysis on hemodialysis days. Preparation and Administration of Cubicin There are two formulations of daptomycin that have differences concerning storage and reconstitution.

Carefully follow the reconstitution and storage procedures in labeling. Reconstitution of Cubicin Vial Cubicin is supplied in single-dose vials, each containing mg daptomycin as a sterile, lyophilized powder. Remove the polypropylene flip-off cap from the Cubicin vial to expose the central portion of the rubber stopper.

Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface. Slowly transfer 10 mL of 0. It is recommended that a beveled sterile transfer needle that is 21 gauge or smaller in diameter, or a needleless device is used, pointing the transfer needle toward the wall of the vial.

Ensure that all of the Cubicin powder is wetted by gently rotating the vial. Allow the wetted product to stand undisturbed for 10 minutes. Gently rotate or swirl the vial contents for a few minutes, as needed, to obtain a completely reconstituted solution. Administration Instructions Parenteral drug products should be inspected visually for particulate matter prior to administration. The infusion rate should be maintained at 0. The infusion rate should be maintained at 1. No preservative or bacteriostatic agent is present in this product.

Aseptic technique must be used in the preparation of final IV solution. Do not exceed the In-Use storage conditions of the reconstituted and diluted solutions of Cubicin described below. Discard unused portions of Cubicin.

The diluted solution is stable in the infusion bag for 12 hours at room temperature and 48 hours if stored under refrigeration. The combined storage time reconstituted solution in vial and diluted solution in infusion bag should not exceed 12 hours at room temperature or 48 hours under refrigeration.

Compatible Intravenous Solutions Cubicin is compatible with 0. Incompatibilities Cubicin is not compatible with dextrose-containing diluents. Because only limited data are available on the compatibility of Cubicin with other IV substances, additives and other medications should not be added to Cubicin single-dose vials or infusion bags, or infused simultaneously with Cubicin through the same IV line.

If the same IV line is used for sequential infusion of different drugs, the line should be flushed with a compatible intravenous solution before and after infusion with Cubicin. Dosage Forms and Strengths For Injection: mg daptomycin as a sterile, pale yellow to light brown lyophilized powder for reconstitution in a single-dose vial. Contraindications Cubicin is contraindicated in patients with known hypersensitivity to daptomycin. If an allergic reaction to Cubicin occurs, discontinue the drug and institute appropriate therapy [see Adverse Reactions 6.

Myopathy and Rhabdomyolysis Myopathy, defined as muscle aching or muscle weakness in conjunction with increases in creatine phosphokinase CPK values to greater than 10 times the upper limit of normal ULN , has been reported with the use of Cubicin. Rhabdomyolysis, with or without acute renal failure, has been reported [see Adverse Reactions 6.

Patients receiving Cubicin should be monitored for the development of muscle pain or weakness, particularly of the distal extremities. In patients who receive Cubicin, CPK levels should be monitored weekly, and more frequently in patients who received recent prior or concomitant therapy with an HMG-CoA reductase inhibitor or in whom elevations in CPK occur during treatment with Cubicin.

In adult patients with renal impairment, both renal function and CPK should be monitored more frequently than once weekly [see Use in Specific Populations 8. In Phase 1 studies and Phase 2 clinical trials in adults, CPK elevations appeared to be more frequent when Cubicin was dosed more than once daily.

Therefore, Cubicin should not be dosed more frequently than once a day. In addition, consideration should be given to suspending agents associated with rhabdomyolysis, such as HMG-CoA reductase inhibitors, temporarily in patients receiving Cubicin [see Drug Interactions 7.

Eosinophilic Pneumonia Eosinophilic pneumonia has been reported in patients receiving Cubicin [see Adverse Reactions 6. In reported cases associated with Cubicin, patients developed fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organizing pneumonia. In general, patients developed eosinophilic pneumonia 2 to 4 weeks after starting Cubicin and improved when Cubicin was discontinued and steroid therapy was initiated.

Recurrence of eosinophilic pneumonia upon re-exposure has been reported. Patients who develop these signs and symptoms while receiving Cubicin should undergo prompt medical evaluation, and Cubicin should be discontinued immediately. Treatment with systemic steroids is recommended. Peripheral Neuropathy Cases of peripheral neuropathy have been reported during the Cubicin postmarketing experience [see Adverse Reactions 6. Therefore, physicians should be alert to signs and symptoms of peripheral neuropathy in patients receiving Cubicin.

Monitor for neuropathy and consider discontinuation. Clostridium difficile-Associated Diarrhea Clostridium difficile—associated diarrhea CDAD has been reported with the use of nearly all systemic antibacterial agents, including Cubicin, and may range in severity from mild diarrhea to fatal colitis [see Adverse Reactions 6. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C.

Hypertoxin-producing strains of C. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. Persisting or Relapsing S. If a blood culture is positive for S. Appropriate surgical intervention e.

Failure of treatment due to persisting or relapsing S. Table 4 shows the number of adult patients by renal function and treatment group who were clinical successes in the Phase 3 cSSSI trials.

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Daptomycin for Injection

Indications: CUBICIN and CUBICIN RF are indicated for the treatment of adult and pediatric patients 1 to 17 years of age with complicated skin and skin structure infections cSSSI caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus including methicillin-resistant isolates , Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subspecies equisimilis, and Enterococcus faecalis vancomycin-susceptible isolates only. When culture and susceptibility information is available, it should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Empiric therapy may be initiated while awaiting test results. Monitor for muscle pain or weakness, particularly of the distal extremities. In patients with renal impairment, monitor renal function and CPK levels more than once weekly. In addition, consider temporarily suspending agents associated with rhabdomyolysis, such as HMG-CoA reductase inhibitors.

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