omadacycline (Rx)

Brand and Other Names:Nuzyra
  • Print

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 150mg (equivalent to 196mg omadacycline tosylate)

injectable, lyophilized powder for reconstitution

  • 100mg/single-dose vial (equivalent to 131mg omadacycline tosylate)

Community-Acquired Bacterial Pneumonia

Indicated for treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms

Loading dose (Day 1): 200 mg IV once OR 100 mg IV x 2 doses

Maintenance dose: 100 mg IV qDay OR 300 mg PO qDay

Treatment duration: 7-14 days

Bacterial Skin and Skin Structure Infections

Indicated for treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible microorganisms

Treatment duration: 7-14 days

Loading dose

  • IV (Day 1): 200 mg IV once OR 100 mg IV x 2 doses OR
  • PO (Days 1 and 2): 450 mg PO qDay x 2 days

Maintenance dose

  • IV: 100 mg IV qDay OR
  • PO: 300 mg PO qDay

Dosage Modifications

Renal or hepatic impairment

  • No dosage adjustment required with any severity of renal or hepatic impairment, including patients with ESRD or those receiving dialysis

Dosing Considerations

Bacterial-resistance

  • To reduce development of drug-resistant bacteria and maintain effectiveness of omadacycline and other antibacterial drugs, use only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria
  • In absence of susceptibility data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy

Susceptible microorganisms

  • CABP
    • Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae
  • ABSSSI
    • Staphylococcus aureus (methicillin-susceptible and methacillin-resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp (includes Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae

<18 years: Safety and efficacy not established

Mortality imbalance observed in the CABP clinical trial, with 8 deaths (2%) occurring in patients treated with omadacycline compared with 4 deaths (1%) in patients treated with moxifloxacin

The cause of the mortality imbalance has not been established

All deaths, in both treatment arms, occurred in patients aged >65 yr; most patients had multiple comorbidities

Next:

Interactions

Interaction Checker

and omadacycline

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            >10% (ABSSSI)

            Nausea (21.9%)

            Vomiting (11.4%)

            1-10% (ABSSI)

            Infusion site reactions (5.2%)

            Increased ALT (4.1%)

            Increased AST (3.6%)

            Headache (3.3%)

            Diarrhea (3.2%)

            1-10% (CABP)

            Increased ALT (3.7%)

            Hypertension (3.4%)

            Increased GGT (2.6%)

            Insomnia (2.6%)

            Vomiting (2.6%)

            Constipation (2.4%)

            Nausea (2.4%)

            Increased AST (2.1%)

            Headache (2.1%)

            Previous
            Next:

            Warnings

            Contraindications

            Hypersensitivity to any tetracyclines

            Cautions

            Mortality imbalance observed in the CABP clinical trial, with 8 deaths (2%) occurring in patients treated with omadacycline compared with 4 deaths (1%) in patients treated with moxifloxacin; cause not established; all deaths, in both treatment arms, occurred in patients aged >65 years and most patients had multiple comorbidities

            Clostridium difficile-associated diarrhea (CDAD) reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis; if CDAD is suspected or confirmed, consider discontinuing ongoing antibacterial drug use not directed against C difficile and initiating treatment-appropriate measures

            Bacterial resistance to tetracyclines may develop; because of this, use only as indicated

            As with other antibiotics, use may result in overgrowth of nonsusceptible organisms, including fungi

            Hypersensitivity reactions reported; life-threatening hypersensitivity (anaphylactic) reactions reported with other tetracyclines (see Contraindications)

            Tetracycline class effects

            • Intracranial hypertension, pseudotumor cerebri, antianabolic action reported in adults and adolescents associated with tetracycline use; clinical manifestations include headache, blurred vision, and papilledema
            • Photosensitivity manifested by an exaggerated sunburn reaction observed with tetracyclines; instruct patients to minimize or avoid exposure to natural or artificial sunlight
            • Increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests may occur
            • Discontinue if these adverse effects suspected

            Teratogenic effects

            • Can cause fetal harm if used during pregnancy
            • Use during tooth and bone development
              • Use during tooth development (last half of pregnancy, infancy, and childhood to age 8 years) may cause permanent discoloration of the teeth (yellow-grey-brown); enamel hypoplasia reported with tetracyclines; advise patient of potential risk
              • May cause reversible inhibition of bone growth during pregnancy, infancy, and early childhood
              • All tetracyclines form a stable calcium complex in any bone-forming tissue
              • Decreased fibula growth rate observed in premature infants given PO tetracycline in doses of 25 mg/kg q6hr; reversible when drug discontinued
              • Also see Pregnancy

            Drug interaction overview

            • Avoid coadministration with oral retinoids; may have additive effects on increasing intracranial pressure
            • Coadministration with antacids containing aluminum, calcium, or magnesium; bismuth subsalicylate; and iron-containing preparations decrease tetracycline absorption, which may decrease efficacy; separate doses
            • May interfere with bacteriocidal action of penicillin; avoid coadministration
            • May depress plasma prothrombin activity, which may increase bleeding risk in patients who are on anticoagulant therapy
            Previous
            Next:

            Pregnancy

            Pregnancy

            Like other tetracycline-class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during second and third trimesters of pregnancy

            Pregnant women should discontinue omadacycline as soon as pregnancy is recognized

            Animal data

            • Administration during organogenesis resulted in fetal loss and/or congenital malformations in pregnant rats and rabbits at 7 times and 3 times the mean AUC exposure, respectively, of the clinical IV dose of 100 mg and the oral dose of 300 mg; reductions in fetal weight occurred in rats at all administered doses

            Infertility

            • Males: Based on animal studies, can lead to impaired spermiation and sperm maturation, resulting in abnormal sperm morphology and poor motility
            • Females: Based on animal studies, omadacycline affected fertility parameters, resulting in reduced ovulation and increased embryonic loss at intended human exposures

            Contraception

            • Advise women of reproductive potential to use highly effective form of contraception

            Lactation

            Tetracyclines are excreted in human milk

            Because of the potential for serious adverse reactions on bone and tooth development in nursing infants, omadacycline is not recommended in breastfeeding women

            Advise women not to breastfeed during treatment and for 4 days after last dose

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Aminomethylcycline antibacterial within the tetracycline drug class

            Binds to the 30S ribosomal subunit and blocks protein synthesis

            Active in vitro against gram-positive bacteria expressing tetracycline resistance active efflux pumps (tetK and tet L) and ribosomal protection proteins (tet M)

            In general, considered bacteriostatic; however, has demonstrated bactericidal activity against some isolates of S pneumoniae and H influenzae

            Absorption

            Bioavailability: 34.5% (single 300-mg dose)

            Peak plasma time, steady-state: 0.5 hr (IV); 2.5 hr (PO)

            Peak plasma concentration, steady-state: 2120 ng/mL (IV); 952-1077 ng/mL (PO)

            AUC, steady-state: 12,140 hr·ng/mL (IV); 11,156-13,367 hr·ng/mL (PO)

            Distribution

            Protein bound: 20%

            Vd, steady-state: 190 L (IV)

            Metabolism

            Not metabolized

            Elimination

            Half-life, steady-state: 16 hr (IV); 15.5-16.8 hr (PO)

            Systemic clearance, steady-state: 8.8 L/hr (IV)

            Renal clearance: 2.4-3.3 L/hr

            Excretion

            • Urine
              • IV: 27%
              • PO: 14.4%
            • Feces
              • PO: 81.1%
            Previous
            Next:

            Administration

            Oral Administration

            Instruct patients not to eat or drink (other than water) 4 hr before or 2 hr after taking omadacycline tablets

            Do not to consume dairy products, antacids, or multivitamins for 4 hr after taking tablets

            IV Compatibilities

            0.9% NaCl

            D5W

            IV Preparation

            Lyophilized powder must be reconstituted and then further diluted

            Reconstitution

            • Calculate dose and number of vials needed
            • Reconstitute each 100-mg vial with 5 mL of sterile water for injection
            • Do not shake; gently swirl vial contents and let stand until the lyophilized cake has completely dissolved and any foam disperses
            • Reconstituted solution should appear yellow to dark orange; if not, discard solution
            • Visually inspect for particulate matter and discoloration before further dilution and administration; if needed, invert vial to dissolve any remaining powder and swirl gently to prevent foaming

            Dilution

            • Within 1 hr of reconstitution, withdraw solution from vial(s) and further dilute by adding to 100-mL bag of 0.9% NaCl or D5W
            • If diluted infusion bag is refrigerated, remove from refrigeration, place in upright vertical position, and allow bag to come to room temperature 60 minutes before use

            IV Administration

            Infuse through dedicated IV line or Y-site

            If same IV line is used for sequential infusion of several drugs, flush with 0.9% NaCl or D5W before and after omadacycline

            100-mg dose: Infuse over 30 minutes

            200-mg dose: infuse over 60 minutes

            Storage

            Vials of lyophilized power or tablets

            • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
            • Do not freeze

            Diluted IV solution

            • Room temperature: Use within 24 hr when stored at ≤77°F (≤25°C)
            • Refrigerated: Use within 48 hr when refrigerated 36-46°F (2-8°C); do not freeze
            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.