Cobimetinib Fumarate and Ertapenem Sodium

• Generic Name: cobimetinib
• Dosage Forms: n.a.
• Other Brand Names: Cotellic

In combination with vemurafenib for treatment of unresectable or metastatic melanoma with b-Raf serine-threonine kinase (BRAF) V600E or V600K mutation (designated an orphan drug by FDA for this use).

FDA-approved in vitro diagnostic test (e.g., cobas 4800 BRAF V600 mutation test) required to confirm presence of BRAF V600E or V600K mutation prior to initiation of therapy.

Limited data suggest greater efficacy (longer progression-free and overall survival, higher objective response rates) in patients with BRAF inhibitor-naive disease versus those with disease progression during prior BRAF inhibitor therapy.

• Generic Name: ertapenem
• Dosage Forms: n.a.
• Other Brand Names: Invanz, INVanz ADD-Vantage

Treatment of moderate to severe acute pelvic infections (including postpartum endomyometritis, septic abortion, postsurgical infections) caused by susceptible Streptococcus agalactiae (group B streptococci), Escherichia coli, Bacteroides fragilis, Porphyromonas asaccharolytica, Peptostreptococcus, or Prevotella bivia.

Treatment of complicated intra-abdominal infections caused by susceptible E. coli, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus, B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, or B. uniformis.

Treatment of moderate to severe community-acquired pneumonia (CAP) caused by susceptible Streptococcus pneumoniae (penicillin-susceptible strains only), including cases with concurrent bacteremia.

Treatment of moderate to severe CAP caused by susceptible Haemophilus influenzae (non-β-lactamase-producing strains only) or Moraxella catarrhalis.

Treatment of complicated skin and skin structure infections, including diabetic foot infections without concurrent osteomyelitis, caused by susceptible Staphylococcus aureus (oxacillin-susceptible [methicillin-susceptible] strains only), Streptococcus agalactiae, S. pyogenes (group A β-hemolytic streptococci), E. coli, Klebsiella pneumoniae, Proteus mirabilis, Bacteroides fragilis, Peptostreptococcus species, Porphyromonas asaccharolytica, or Prevotella bivia.

Treatment of complicated UTIs (including pyelonephritis) caused by susceptible E. coli (including cases with concurrent bacteremia) or Klebsiella pneumoniae.