The FINANCIAL — Teva Pharmaceutical Industries Ltd., on September 15 announced the launch of an authorized generic of Cubicin®1 (daptomycin for injection) 500 mg per vial in the United States.
Daptomycin for injection is an antibacterial drug indicated in adults for the treatment of 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).
Daptomycin for injection is indicated in adults for the treatment of Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates, according to Teva.
Daptomycin for injection is not indicated for the treatment of pneumonia. Daptomycin for injection is not indicated for the treatment of left-sided infective endocarditis (LIE) due to S. aureus. Daptomycin for injection has not been studied in patients with prosthetic valve endocarditis.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of daptomycin for injection and other antibacterial drugs, daptomycin for injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. 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.
Teva remains committed to strengthening its generic injectable business globally with continued investment in newer, higher-value generic injectable products. Teva currently has 338 product registrations pending FDA approval and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, 1-in-5 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
Daptomycin for injection had annual sales of approximately $1.2 billion in the United States, according to IMS data as of July 2016.
Selected Important Safety Information
Anaphylaxis/hypersensitivity reactions, which may be life-threatening, have been reported with daptomycin for injection use. If an allergic reaction occurs, discontinue daptomycin for injection and treat appropriately.
Myopathy and rhabdomyolysis have been reported with daptomycin for injection use. Monitor for muscle pain or weakness, particularly of the distal extremities. Monitor creatine phosphokinase (CPK) levels weekly and more frequently in patients with CPK elevations while on daptomycin for injection treatment and in those who received recent prior or concomitant HMG-CoA reductase inhibitors. In patients with renal impairment, monitor renal function and CPK levels more than once weekly. Discontinue daptomycin for injection in patients with unexplained signs and symptoms of myopathy with CPK levels >1,000 U/L (~5× ULN), and in patients without symptoms and CPK levels >2,000 U/L (≥10× ULN). In addition, consider temporarily suspending agents associated with rhabdomyolysis, such as HMG-CoA reductase inhibitors.
Eosinophilic pneumonia has been reported with daptomycin for injection use. Promptly evaluate patients who develop fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates and discontinue daptomycin for injection immediately. Treatment with systemic steroids is recommended. Recurrence of eosinophilic pneumonia upon re-exposure has been reported.
Peripheral neuropathy has been reported with daptomycin for injection use. Monitor for signs and symptoms of peripheral neuropathy.
Potential nervous and/or muscular system effects in patients younger than 12 months: Avoid use of daptomycin for injection in patients younger than 12 months due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs.
Clostridium difficile-associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis, has been reported with nearly all systemic antibacterial agents, including daptomycin for injection. Evaluate all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterial use not directed against C. difficile should be discontinued, if possible.
Patients with persisting or relapsing S. aureus bacteremia/endocarditis, possibly due to reduced daptomycin susceptibility, or poor clinical response should have repeat blood cultures. Appropriate surgical intervention and/or change in antibacterial regimen may be required. Failure of treatment due to persisting or relapsing S. aureus bacteremia/endocarditis may be due to reduced daptomycin susceptibility.
In the cSSSI and S. aureus bacteremia/endocarditis trials, decreased efficacy was observed in daptomycin for injection-treated patients with moderate baseline renal impairment (CrCL <50 mL/min).
Adverse Reactions: The most clinically significant adverse reactions observed with daptomycin for injection 4 mg/kg (cSSSI trials) and 6 mg/kg (S. aureus bacteremia/endocarditis trial) were abnormal liver function tests, elevated CPK, and dyspnea.
CrCL=creatinine clearance; HMG-CoA=3-hydroxy-3-methylglutaryl-coenzyme A; ULN=upper limit of normal.
Discussion about this post