Alerta

Each vial contains Ertapenem sodium 1.046 g equivalent to Alerta 1 g. The sodium content is approximately 137 mg (approximately 6 mEq).

Alerta is [4R-[3(3S*,5S*),4α,5β,6β(R*)]]-3-[[5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monosodium salt.

Its empirical formula is C₂₂H₂₄N₃O₇SNa.

Alerta sodium is a white to off-white hygroscopic, weakly crystalline powder, with a molecular weight of 497.5. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol and insoluble in isopropyl acetate and tetrahydrofuran.

Alerta is supplied as sterile lyophilized powder for IV infusion after reconstitution with appropriate diluent and transfer to 50 mL of 0.9% sodium chloride injection or for IM injection following reconstitution with 1% lidocaine HCl.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Alerta® and other antibacterial drugs, Alerta should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they 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.

Treatment

Alerta is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with the following moderate to severe infections caused by susceptible isolates of the designated microorganisms.

Complicated Intra-Abdominal Infections

Alerta is indicated for the treatment of complicated intra-abdominal infections due to Escherichia coli, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus species, Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, or Bacteroides uniformis.

Complicated Skin and Skin Structure Infections, Including Diabetic Foot Infections without Osteomyelitis

Alerta is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis due to Staphylococcus aureus (methicillin susceptible isolates only), Streptococcus agalactiae, Streptococcus pyogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Bacteroides fragilis, Peptostreptococcus species, Porphyromonas asaccharolytica, or Prevotella bivia. Alerta has not been studied in diabetic foot infections with concomitant osteomyelitis.

Community Acquired Pneumonia

Alerta is indicated for the treatment of community acquired pneumonia due to Streptococcus pneumoniae (penicillin susceptible isolates only) including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates only), or Moraxella catarrhalis.

Complicated Urinary Tract Infections Including Pyelonephritis

Alerta is indicated for the treatment of complicated urinary tract infections including pyelonephritis due to Escherichia coli, including cases with concurrent bacteremia, or Klebsiella pneumoniae.

Acute Pelvic Infections Including Postpartum Endomyometritis, Septic Abortion and Post Surgical Gynecologic Infections

Alerta is indicated for the treatment of acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecological infections due to Streptococcus agalactiae, Escherichia coli, Bacteroides fragilis, Porphyromonas asaccharolytica, Peptostreptococcus species, or Prevotella bivia.

Prevention

Alerta is indicated in adults for:

Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery

Alerta is indicated for the prevention of surgical site infection following elective colorectal surgery.

Alerta is used alone or in combination with other antibiotics to treat infections caused by bacteria in many different parts of the body. It works by killing bacteria or preventing their growth. Alerta will not work for colds, flu, or other virus infections. Alerta is also used to prevent infections after having surgery of the colon and rectum.

Alerta is available only with your doctor's prescription.

Instructions For Use In All Patients

For

Intravenous or

Intramuscular Use

DO NOT MIX OR CO-INFUSE Alerta WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).

Alerta may be administered by intravenous infusion for up to 14 days or intramuscular injection for up to 7 days. W hen administered intravenously, Alerta should be infused over a period of 30 minutes.

Intramuscular administration of Alerta may be used as an alternative to intravenous administration in the treatment of those infections for which intramuscular therapy is appropriate.

Treatment Regimen

13 Years Of Age And Older

The dose of Alerta in patients 13 years of age and older is 1 gram (g) given once a day.

3 Months To 12 years Of Age

The dose of Alerta in patients 3 months to 12 years of age is 15 mg/kg twice daily (not to exceed 1 g/day).

Table 1 presents treatment guidelines for Alerta.

Table 1 : Treatment Guidelines for Adults and Pediatric Patients With Normal Renal Function* and Body Weight

Figure 2

To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover.

Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately ½ turn (180°) after the first audible click. The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove.

Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.

Label appropriately.

Figure 3

Figure 4

To Prepare Admixture:

Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.

With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container.

Pull the inner cap from the drug vial. Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.

Mix container contents thoroughly and use within the specified time.

Figure 5

Figure 6

Preparation for Administration: (Use Aseptic Technique)

Confirm the activation and admixture of vial contents.

Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. Close flow control clamp of administration set.

Remove cover from outlet port at bottom of container.

Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.

NOTE: See full directions on administration set carton.

Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger.

Squeeze and release drip chamber to establish proper fluid level in chamber.

Open flow control clamp and clear air from set. Close clamp.

Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.

Regulate rate of administration with flow control clamp.

WARNING: Do not use flexible container in series connections.

Storage

Alerta (Alerta for Injection) 1 g single dose ADD-Vantage® vials should be prepared with ADD-Vantage® diluent containers containing 50 mL or 100 mL of 0.9% Sodium Chloride Injection. W hen prepared with this diluent, Alerta (Alerta for Injection) maintains satisfactory potency for 6 hours at room temperature (25°C) or for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of Alerta should not be frozen.

Before administering, see accompanying package circular for Alerta (Alerta for Injection).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit. Solutions of Alerta range from colorless to pale yellow. Variations of color within this range do not affect the potency of the product.

How supplied

Dosage Forms And Strengths

Vials

Alerta is a sterile lyophilized powder in a vial containing 1.046 g Alerta sodium equivalent to 1 g Alerta for intravenous infusion or for intramuscular injection.

ADD-Vantage® Vials

Alerta is a lyophilized powder in an ADD-Vantage® vial containing 1.046 g Alerta sodium equivalent to 1 g Alerta for intravenous infusion.

Alerta is supplied as a sterile lyophilized powder in single dose vials containing Alerta for intravenous infusion or for intramuscular injection as follows:

No. 3843 - 1 g Alerta equivalent

NDC 0006-3843-71 in trays of 10 vials.

Alerta is supplied as a sterile lyophilized powder in single dose ADD-Vantage® vials containing Alerta for intravenous infusion as follows:

No. 3845 - 1 g Alerta equivalent

NDC 0006-3845-71 in trays of 10 ADD-Vantage® vials.

Storage And Handling

Before reconstitution

Do not store lyophilized powder above 25°C (77°F).

Reconstituted And Infusion Solutions

The reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection, may be stored at room temperature (25°C) and used within 6 hours or stored for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of Alerta should not be frozen.

REFERENCES

Refer to the prescribing information for lidocaine HCl.

Manuf for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. By: Laboratoires Merck Sharp & Dohme-Chibret. Revised: Sep 2014

See also:
What is the most important information I should know about Alerta?

You should not use this medication if you are allergic to Alerta or to any other antibiotic.

Before using Alerta, tell your doctor if you have kidney disease, a seizure disorder such as epilepsy, a history of head injury or brain tumor, or if you are allergic to numbing medicine such as lidocaine or Novocain.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop using Alerta and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Alerta will not treat a viral infection such as the common cold or flu.

Use Alerta as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Alerta is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Alerta at home, a health care provider will teach you how to use it. Be sure you understand how to use Alerta. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Alerta if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• To clear up your infection completely, use Alerta for the full course of treatment. Keep using it even if you feel better in a few days.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Alerta, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Alerta.

Use: Labeled Indications

Intra-abdominal infection, complicated: For the treatment of complicated intra-abdominal infections caused by Clostridium clostridioforme, Escherichia coli, Eubacterium lentum, Peptostreptococcus spp, Bacteroides distasonis, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, or Bacteroides uniformis.

Pelvic infection: For the treatment of acute pelvic infections, including postpartum endomyometritis, septic abortion, and postsurgical gynecologic infections caused by Streptococcus agalactiae, E. coli, B. fragilis, Porphyromonas asaccharolytica, Peptostreptococcus spp, or Prevotella bivia.

Pneumonia, community acquired: For the treatment of community-acquired pneumonia (CAP) caused by Streptococcus pneumoniae (penicillin-susceptible isolates only), including cases with concurrent bacteremia; Haemophilus influenzae (beta-lactamase-negative isolates only); or Moraxella catarrhalis.

Skin and skin structure infection, complicated: For the treatment of complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis caused by Staphylococcus aureus (methicillin-susceptible isolates only), S. agalactiae, Streptococcus pyogenes, E. coli, Klebsiella pneumoniae, Proteus mirabilis, B. fragilis, Peptostreptococcus spp, P. asaccharolytica, or P. bivia. Alerta has not been studied in diabetic foot infections with concomitant osteomyelitis.

Surgical prophylaxis: For the prophylaxis of surgical site infection in adults following elective colorectal surgery.

Urinary tract infection, complicated: For the treatment of complicated urinary tract infections (UTIs), including pyelonephritis caused by E. coli, including cases with concurrent bacteremia or K. pneumoniae.

Note: Methicillin-resistant Staphylococcus aureus, Enterococcus spp, Acinetobacter, Pseudomonas aeruginosa, and penicillin-resistant strains of Streptococcus pneumoniae are resistant to Alerta while most extended-spectrum beta-lactamase (ESBL)-producing bacteria remain sensitive to Alerta.

Off Label Uses

Bite wound, treatment (animal or human bite)

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections, Alerta is an effective and recommended treatment for animal or human bite wounds.

Bloodstream infection

Data from retrospective studies suggest that Alerta may be beneficial for the treatment of bloodstream infections caused by extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae.

Prosthetic joint infection

Based on the IDSA guidelines for the diagnosis and management of prosthetic joint infection, Alerta is an effective and recommended agent for the treatment of prosthetic joint infection.

See also:
What other drugs will affect Alerta?

When Alerta is administered with probenecid, probenecid competes for active tubular secretion and thus inhibits the renal excretion of Alerta. This leads to small but statistically significant increases in the elimination t_½ (19%) and in the extent of systemic exposure (25%). No dosage adjustment is necessary when Alerta is given with probenecid. Because of the small effect on t_½, the co-administration with probenecid to extend the t_½ of Alerta is not recommended.

In vitro studies indicate that Alerta does not inhibit P-glycoprotein-mediated transport of digoxin or vinblastine and that Alerta is not a substrate for P-glycoprotein-mediated transport. In vitro studies in human liver microsomes indicate Alerta does not inhibit metabolism mediated by any of the 6 major cytochrome P-450 (CYP) isoforms: 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4. Drug interactions caused by inhibition of P-glycoprotein-mediated drug clearance or CYP-mediated drug clearance are unlikely.

Other than with probenecid, no specific clinical drug interaction studies have been conducted.

Case reports in the literature have shown that co-administration of carbapenems, including Alerta, to patients receiving valproic acid or divalproex sodium results in a reduction of valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore, increasing the risk of breakthrough seizures. Although the mechanism of this interaction is unknown, data from in vitro and animal studies suggest that carbapenems may inhibit the hydrolysis of valproic acid's glucuronide metabolite (VPA-g) back to valproic acid, thus decreasing the serum concentrations of valproic acid.

See also:
What are the possible side effects of Alerta?

The following are described in greater detail in the WARNINGS AND PRECAUTIONS section.

• Hypersensitivity Reactions
• Seizure Potential
• Interaction with Valproic Acid
• Clostridium difficile-Associated Diarrhea (CDAD)
• Caution with

  Intramuscular Administration

• Development of Drug-Resistant Bacteria
• Laboratory Tests

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults Receiving Alerta as a Treatment Regimen

Clinical trials enrolled 1954 patients treated with Alerta; in some of the clinical trials, parenteral therapy was followed by a switch to an appropriate oral antimicrobial. Most adverse experiences reported in these clinical trials were described as mild to moderate in severity. Alerta was discontinued due to adverse experiences in 4.7% of patients. Table 3 shows the incidence of adverse experiences reported in ≥ 2.0% of patients in these trials. The most common drug-related adverse experiences in patients treated with Alerta, including those who were switched to therapy with an oral antimicrobial, were diarrhea (5.5%), infused vein complication (3.7%), nausea (3.1%), headache (2.2%), and vaginitis in females (2.1%).

Table 3 : Incidence (%) of Adverse Experiences Reported During Study Therapy Plus 14-Day Follow-Up in ≥ 2.0% of Adult Patients Treated With Alerta in Clinical Trials

In patients treated for complicated intra-abdominal infections, death occurred in 4.7% (15/316) of patients receiving Alerta and 2.6% (8/307) of patients receiving comparator drug. These deaths occurred in patients with significant co-morbidity and/or severe baseline infections. Deaths were considered unrelated to study drugs by investigators.

In clinical trials, seizure was reported during study therapy plus 14-day follow-up period in 0.5% of patients treated with Alerta, 0.3% of patients treated with piperacillin/tazobactam and 0% of patients treated with ceftriaxone.

Additional adverse experiences that were reported with Alerta with an incidence > 0.1% within each body system are listed below

Body as a Whole: abdominal distention, pain, chills, septicemia, septic shock, dehydration, gout, malaise, asthenia/fatigue, necrosis, candidiasis, weight loss, facial edema, injection site induration, injection site pain, extravasation, phlebitis/thrombophlebitis, flank pain, syncope

Cardiovascular System: heart failure, hematoma, chest pain, hypertension, tachycardia, cardiac arrest, bradycardia, arrhythmia, atrial fibrillation, heart murmur, ventricular tachycardia, asystole, subdural hemorrhage

Digestive System: acid regurgitation, oral candidiasis, dyspepsia, gastrointestinal hemorrhage, anorexia, flatulence, C. difficile-associated diarrhea, stomatitis, dysphagia, hemorrhoids, ileus, cholelithiasis, duodenitis, esophagitis, gastritis, jaundice, mouth ulcer, pancreatitis, pyloric stenosis

Musculoskeletal System: leg pain

Nervous System & Psychiatric: anxiety, nervousness, seizure, tremor, depression, hypesthesia, spasm, paresthesia, aggressive behavior, vertigo

Respiratory System: cough, pharyngitis, rales/rhonchi, respiratory distress, pleural effusion, hypoxemia, bronchoconstriction, pharyngeal discomfort, epistaxis, pleuritic pain, asthma, hemoptysis, hiccups, voice disturbance

Skin & Skin Appendage: erythema, sweating, dermatitis, desquamation, flushing, urticaria

Special Senses: taste perversion

Urogenital System: renal impairment, oliguria/anuria, vaginal pruritus, hematuria, urinary retention, bladder dysfunction, vaginal candidiasis, vulvovaginitis.

In a clinical trial for the treatment of diabetic foot infections in which 289 adult diabetic patients were treated with Alerta, the adverse experience profile was generally similar to that seen in previous clinical trials.

Prophylaxis of Surgical Site Infection following Elective Colorectal Surgery

In a clinical trial in adults for the prophylaxis of surgical site infection following elective colorectal surgery in which 476 patients received a 1 g dose of Alerta 1 hour prior to surgery and were then followed for safety 14 days post surgery, the overall adverse experience profile was generally comparable to that observed for Alerta in previous clinical trials. Table 4 shows the incidence of adverse experiences other than those previously described above for Alerta that were reported regardless of causality in ≥ 2.0% of patients in this trial.

Table 4 : Incidence (%) of Adverse Experiences Reported During Study Therapy Plus 14-Day Follow-Up in ≥ 2.0% of Adult Patients Treated With Alerta for Prophylaxis of Surgical Site Infections Following Elective Colorectal Surgery

Additional adverse experiences that were reported in this prophylaxis trial with Alerta, regardless of causality, with an incidence > 0.5% within each body system are listed below:

Gastrointestinal Disorders: C. difficile infection or colitis, dry mouth, hematochezia

General Disorders and Administration Site Condition: crepitations

Infections and Infestations: cellulitis, abdominal abscess, fungal rash, pelvic abscess

Injury, Poisoning and Procedural Complications: incision site complication, incision site hemorrhage, intestinal stoma complication, anastomotic leak, seroma, wound dehiscence, wound secretion

Musculoskeletal and Connective Tissue Disorders: muscle spasms

Nervous System Disorders: cerebrovascular accident

Renal and Urinary Disorders: dysuria, pollakiuria

Respiratory, Thoracic and Mediastinal Disorders: crackles lung, lung infiltration, pulmonary congestion, pulmonary embolism, wheezing.

Pediatric Patients Receiving Alerta as a Treatment Regimen

Clinical trials enrolled 384 patients treated with Alerta; in some of the clinical trials, parenteral therapy was followed by a switch to an appropriate oral antimicrobial. The overall adverse experience profile in pediatric patients is comparable to that in adult patients. Table 5 shows the incidence of adverse experiences reported in ≥ 2.0% of pediatric patients in clinical trials. The most common drug-related adverse experiences in pediatric patients treated with Alerta, including those who were switched to therapy with an oral antimicrobial, were diarrhea (6.5%), infusion site pain (5.5%), infusion site erythema (2.6%), vomiting (2.1%).

Table 5 : Incidence (%) of Adverse Experiences Reported During Study Therapy Plus 14-Day Follow-Up in ≥ 2.0% of Pediatric Patients Treated With Alerta in Clinical Trials

Additional adverse experiences that were reported with Alerta with an incidence > 0.5% within each body system are listed below:

Gastrointestinal Disorders: nausea

General Disorders and Administration Site Condition: hypothermia, chest pain, upper abdominal pain; infusion site pruritus, induration, phlebitis, swelling, and warmth

Infections and Infestations: candidiasis, oral candidiasis, viral pharyngitis, herpes simplex, ear infection, abdominal abscess

Metabolism and Nutrition Disorders: decreased appetite

Musculoskeletal and Connective Tissue Disorders: arthralgia

Nervous System Disorders: dizziness, somnolence

Psychiatric Disorders: insomnia

Reproductive System and Breast Disorders: genital rash

Respiratory, Thoracic and Mediastinal Disorders: wheezing, nasopharyngitis, pleural effusion, rhinitis, rhinorrhea

Skin and Subcutaneous Tissue Disorders: dermatitis, pruritus, rash erythematous, skin lesion

Vascular Disorders: phlebitis.

Post-Marketing Experience

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

Gastrointestinal Disorders: teeth staining

Immune System Disorders: anaphylaxis including anaphylactoid reactions

Musculoskeletal and Connective Tissue Disorders: muscular weakness

Nervous System Disorders: coordination abnormal, depressed level of consciousness, dyskinesia, gait disturbance, myoclonus, tremor

Psychiatric Disorders: altered mental status (including aggression, delirium), hallucinations

Skin and Subcutaneous Tissue Disorders: Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome)

Adverse Laboratory Changes In Clinical Trials

Adults Receiving Alerta as Treatment Regimen

Laboratory adverse experiences that were reported during therapy in ≥ 2.0% of adult patients treated with Alerta in clinical trials are presented in Table 6. Drug-related laboratory adverse experiences that were reported during therapy in ≥ 2.0% of adult patients treated with Alerta, including those who were switched to therapy with an oral antimicrobial, in clinical trials were ALT increased (6.0%), AST increased (5.2%), serum alkaline phosphatase increased (3.4%), and platelet count increased (2.8%). Alerta was discontinued due to laboratory adverse experiences in 0.3% of patients.

Table 6 : Incidence* (%) of Laboratory Adverse Experiences Reported During Study Therapy Plus 14-Day Follow-Up in ≥ 2.0% of Adult Patients Treated With Alerta in Clinical Trials

Additional laboratory adverse experiences that were reported during therapy in > 0.1% of patients treated with Alerta in clinical trials include: increases in serum creatinine, serum glucose, BUN, total, direct and indirect serum bilirubin, serum sodium and potassium, PT and PTT; decreases in serum potassium, serum albumin, W BC, platelet count, and segmented neutrophils.

In a clinical trial for the treatment of diabetic foot infections in which 289 adult diabetic patients were treated with Alerta, the laboratory adverse experience profile was generally similar to that seen in previous clinical trials.

Prophylaxis of Surgical Site Infection following Elective Colorectal Surgery

In a clinical trial in adults for the prophylaxis of surgical site infection following elective colorectal surgery in which 476 patients received a 1 g dose of Alerta 1 hour prior to surgery and were then followed for safety 14 days post surgery, the overall laboratory adverse experience profile was generally comparable to that observed for Alerta in previous clinical trials.

Pediatric Patients Receiving Alerta as a Treatment Regimen

Laboratory adverse experiences that were reported during therapy in ≥ 2.0% of pediatric patients treated with Alerta in clinical trials are presented in Table 7. Drug-related laboratory adverse experiences that were reported during therapy in ≥ 2.0% of pediatric patients treated with Alerta, including those who were switched to therapy with an oral antimicrobial, in clinical trials were neutrophil count decreased (3.0%), ALT increased (2.2%), and AST increased (2.1%).

Table 7 : Incidence* (%) of Specific Laboratory Adverse Experiences Reported During Study Therapy Plus 14-Day Follow-Up in ≥ 2.0% of Pediatric Patients Treated With Alerta in Clinical Trials

Additional laboratory adverse experiences that were reported during therapy in > 0.5% of patients treated with Alerta in clinical trials include: alkaline phosphatase increased, eosinophil count increased, platelet count increased, white blood cell count decreased and urine protein present.