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Zanamivir: Drug information

Zanamivir: Drug information
(For additional information see "Zanamivir: Patient drug information" and see "Zanamivir: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Relenza Diskhaler
Brand Names: Canada
  • Relenza Diskhaler
Pharmacologic Category
  • Antiviral Agent;
  • Neuraminidase Inhibitor
Dosing: Adult
Influenza, seasonal, prophylaxis

Influenza, seasonal, prophylaxis:

Postexposure prophylaxis (household exposure): Oral inhalation: Two inhalations (10 mg) once daily for 7 days after last known exposure (CDC 2020a).

Postexposure prophylaxis (institutional outbreak): Note: Recommended for all residents regardless of vaccination status. Consider prophylaxis in employees, depending on vaccination status (CDC 2020a; IDSA [Uyeki 2019]).

Oral inhalation: Two inhalations (10 mg) once daily; continue for ≥2 weeks and until ~7 days after identification of illness onset in the last patient (CDC 2020a; IDSA [Uyeki 2019]).

Preexposure prophylaxis (community outbreak): Note: Consider use in patients at very high risk of developing complications from influenza infection (eg, severely immunocompromised patients) who are not protected by immunization (IDSA [Uyeki 2019]).

Oral inhalation: Two inhalations (10 mg) once daily; continue until influenza activity in community subsides or immunity obtained from immunization (CDC 2020a; IDSA [Uyeki 2019]; manufacturer's labeling).

Influenza, seasonal, treatment

Influenza, seasonal, treatment:

Note: Therapy should begin within 48 hours from onset of signs or symptoms. Not recommended for treatment of severe or progressive influenza or patients with disease severe enough to warrant hospitalization, due to lack of data (CDC 2020a).

Oral inhalation: Two inhalations (10 mg) twice daily for 5 days. Doses on first day should be separated by at least 2 hours; on subsequent days, doses should be spaced by ~12 hours (CDC 2020a).

Missed dose: If a dose is missed, administer as soon as possible unless it is ≤2 hours before the next scheduled dose. Then, continue administration at the previous schedule; do not administer a double dose.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary; however, the potential for drug accumulation should be considered.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Zanamivir: Pediatric drug information")

Note: 10 mg dose is provided by 2 inhalations (one 5 mg blister per inhalation):

Influenza, seasonal, prophylaxis

Influenza, seasonal, prophylaxis: Note: Recommendations for patient selection for prophylaxis are variable (see guidelines for details); not recommended in patients with underlying respiratory disease.

Children ≥5 years and Adolescents: Oral inhalation: Two inhalations (10 mg) once daily.

Duration of chemoprophylaxis varies with exposure or outbreak type, influenza vaccination status, presence of immunosuppression, and risk of severe complications from infection; in general, duration is as follows; see guidelines for additional details (AAP 2021; CDC 2021b; HHS [OI pediatric 2021]; IDSA [Uyeki 2019]).

Household/nonoutbreak exposure: 7 days from last known exposure.

Institutional outbreak: A minimum of 2 weeks and at least 1 week after the last identified case.

Influenza, seasonal, treatment

Influenza, seasonal, treatment: Note: Therapy should begin within 2 days from onset of signs or symptoms. Not recommended for treatment of severe influenza, including in patients with disease severe enough to warrant hospitalization, due to lack of data (CDC 2021b). Not recommended in patients with underlying respiratory disease.

Children ≥7 years and Adolescents: Oral inhalation: Two inhalations (10 mg) twice daily for 5 days; doses on first day should be separated by at least 2 hours; on subsequent days, doses should be spaced by ~12 hours.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

No dosage adjustment necessary due to minimal absorption; however, has not been studied in severe renal insufficiency; the potential for drug accumulation should be considered.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Gastrointestinal: Sore throat (or discomfort; prophylaxis, children: 11%)

Respiratory: Cough (prophylaxis, children: 16%), nasal signs and symptoms (prophylaxis, children: 20%), tonsil disease (discomfort or pain; prophylaxis, children: 11%)

1% to 10%:

Dermatologic: Urticaria (treatment, adolescents and adults: <2%)

Gastrointestinal: Abdominal pain (treatment, adolescents and adults: <2%)

Nervous system: Dizziness (treatment, adolescents and adults: 2%)

Neuromuscular & skeletal: Arthralgia (≤2%), rheumatism (prophylaxis: 2%)

Respiratory: Sinusitis (treatment, adolescents and adults: 3%)

Postmarketing:

Cardiovascular: Cardiac arrhythmia, syncope

Dermatologic: Erythema multiforme, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis

Hypersensitivity: Anaphylaxis, facial edema, hypersensitivity reaction (or hypersensitivity-like reaction), oropharyngeal edema

Nervous system: Abnormal behavior, agitation, anxiety, confusion, delirium, delusions, hallucination, impaired consciousness, nightmares, seizure

Respiratory: Bronchospasm, dyspnea

Contraindications

Hypersensitivity to zanamivir or any component of the formulation (contains milk proteins)

Warnings/Precautions

Concerns related to adverse effects:

• Allergic reactions: Allergic-like reactions, including anaphylaxis, oropharyngeal edema, and serious skin rashes have been reported. Discontinue use and institute appropriate treatment if an allergic reaction occurs.

• Neuropsychiatric events: Rare occurrences of neuropsychiatric events (including confusion, delirium, hallucinations, seizure, and/or self-injury) have been reported, primarily in pediatric patients; may be abrupt in onset. Direct causation is difficult to establish; influenza infection may also be associated with behavioral and neurologic changes.

• Respiratory effects: Bronchospasm, including serious cases and some with fatal outcomes, and decreased lung function have been reported in patients with and without airway disease; discontinue with bronchospasm or decreased lung function. For a patient with an underlying airway disease where a medical decision has been made to use zanamivir, a fast-acting bronchodilator should be made available.

Disease-related concerns:

• Respiratory disease: Not recommended for use in patients with underlying respiratory disease, such as asthma or COPD, due to lack of efficacy in influenza treatment and risk of serious bronchospasm. If zanamivir is prescribed in such patients, closely monitor respiratory function.

Special populations:

• Nursing home patients: Effectiveness has not been established for prophylaxis of influenza in nursing home patients (per manufacturer); however, the CDC recommends zanamivir as an option to be used to control institutional outbreaks of influenza (refer to current guidelines) (CDC 2020a).

Dosage form specific issues:

• Lactose: Powder for oral inhalation contains lactose; use contraindicated in patients allergic to milk proteins.

Other warnings/precautions:

• Administration: Relenza inhalation powder should only be administered via inhalation using the provided Diskhaler delivery device. The commercially available formulation is a lactose containing powder and is not intended to be solubilized or administered via any nebulizer/mechanical ventilator; inappropriate administration has resulted in death.

• Appropriate use: Antiviral treatment should begin within 48 hours of symptom onset; however, the CDC recommends that treatment may still be beneficial and should be started in patients with severe, complicated or progressive illness, and in hospitalized patients if >48 hours. Treatment should not be delayed while awaiting results of laboratory tests for influenza. Outpatients who are not at high risk for developing severe or complicated illness are not likely to benefit if treatment is started >48 hours after symptom onset (CDC 2020a). Safety and efficacy have not been established in patients with significant underlying medical conditions. Not a substitute for annual flu vaccination; has not been shown to reduce risk of transmission of influenza to others. Patients must be instructed in the use of the delivery system. Consider primary or concomitant bacterial infections. Safety and efficacy of repeated courses have not been established.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Powder Breath Activated, Inhalation:

Relenza Diskhaler: 5 mg/actuation (20 ea) [contains lactose]

Generic Equivalent Available: US

No

Pricing: US

Aerosol powder (Relenza Diskhaler Inhalation)

5 mg/ACT (per each): $3.54

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Powder Breath Activated, Inhalation:

Relenza Diskhaler: 5 mg/actuation (1 ea) [contains lactose]

Administration: Adult

Oral inhalation: Must be used with Diskhaler delivery device. The foil blister disk containing zanamivir inhalation powder should not be manipulated, solubilized, or administered via a nebulizer. Patients scheduled to use an inhaled bronchodilator at the same time as zanamivir should use their bronchodilator prior to zanamivir. With the exception of the initial dose when used for treatment, administer at approximately the same time each day.

Administration: Pediatric

Oral Inhalation: Must be used with the provided breath-actuated Diskhaler delivery device. The foil blister disk containing zanamivir inhalation powder should not be manipulated, solubilized, or administered via a nebulizer. The foil blister disk (contains 4 x 5 mg doses) should be loaded into the Diskhaler; ensure that the silver foil is not broken and ensure the mouthpiece is clear prior to use. After loading the Rotadisk into the Diskhaler, activate to pierce blister; see product labeling for detailed instructions. Keep the Diskhaler in a level position and exhale fully prior to placing mouthpiece in mouth. Close lips around mouthpiece and inhale (steadily and deeply). Hold breath for a few seconds. Activate second blister to administer full dose (10 mg) and repeat steps. See product labeling for detailed instructions for loading, activating, and administering medication. Patients scheduled to use an inhaled bronchodilator at the same time as zanamivir should be advised to use their bronchodilator prior to zanamivir.

Use: Labeled Indications

Influenza, seasonal, prophylaxis: Prophylaxis of influenza (A or B) in patients ≥5 years of age.

Influenza, seasonal, treatment: Treatment of uncomplicated acute illness caused by influenza (A or B) infection in patients ≥7 years of age who have been symptomatic for no more than 48 hours.

Limitations of use: Not a substitute for annual influenza vaccination. Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use zanamivir.

Medication Safety Issues
Sound-alike/look-alike issues:

Relenza may be confused with Albenza, Aplenzin

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Influenza Virus Vaccine (Live/Attenuated): Antiviral Agents (Influenza A and B) may diminish the therapeutic effect of Influenza Virus Vaccine (Live/Attenuated). Management: Avoid administration of live influenza virus vaccine (LAIV) within 2 weeks before or 48 hours after administration of antiviral agents. Consider avoiding LAIV if peramivir was given within the last 5 days or baloxavir was given within the last 17 days. Risk D: Consider therapy modification

Pregnancy Considerations

Based on multiple studies, the maternal use of zanamivir has not been shown to increase the risk of adverse pregnancy outcomes (CDC 2020a; CDC 2020b). However, pregnant and postpartum patients (≤2 weeks after delivery) have a higher risk for complications from influenza, including preterm delivery, pneumonia, admission to a hospital or ICU, and maternal and fetal death. Underlying maternal medical conditions increase these risks (ACOG 2018; CDC 2020a).

Zanamivir is not the preferred neuraminidase inhibitor for the treatment and prophylaxis of influenza during pregnancy, however it may be used as an alternative agent when otherwise appropriate (ACOG 2018; CDC 2020a; CDC 2020b); zanamivir may be preferred for prophylaxis use during pregnancy due to its limited systemic absorption (IDSA [Uyeki 2019]). Pregnant patients with known or suspected influenza can be treated with antiviral medications, regardless of trimester, vaccination status, or laboratory test results. Postexposure antiviral prophylaxis may be considered for pregnant and postpartum patients (including following pregnancy loss) (ACOG 2018; CDC 2020a; CDC 2020b).

An algorithm is available for the treatment of pregnant patients with known or suspected influenza (ACOG 2018). Refer to the Centers for Disease Control and Prevention recommendations for treatment updates based on resistance patterns (ACOG 2018; CDC 2020a).

Breastfeeding Considerations

It is not known if zanamivir is present in breast milk.

Adverse events have not been reported in breastfed infants. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Until additional information becomes available, zanamivir is not the preferred neuraminidase inhibitor for the treatment of influenza in patients who are breastfeeding (CDC 2021a). However, breastfeeding does not need to be discontinued during zanamivir treatment (IDSA [Uyeki 2019]). Infectious patients should take precautions to avoid influenza transmission to the breastfed infant. If the mother is too ill to breastfeed, expressed breast milk can be given to the infant by a healthy caregiver who does not have influenza (CDC 2021a).

Mechanism of Action

Zanamivir inhibits influenza virus neuraminidase enzymes, potentially altering virus particle aggregation and release.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Inhalation: Systemic: ~4% to 17%

Distribution: Vd: ~16 L

Protein binding, plasma: <10%

Metabolism: None

Half-life elimination, serum: 2.5 to 5.1 hours

Time to peak, plasma: 1 to 2 hours

Excretion: Urine (as unchanged drug); feces (unabsorbed drug)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Systemic exposure is increased after an IV dose.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (PL) Poland: Relenza;
  • (QA) Qatar: Relenza Rotadisk
  1. American Academy of Pediatrics (AAP) Committee on Infectious Diseases. Recommendations for prevention and control of influenza in children, 2021-2022 . Pediatrics. Published online September 7, 2021. doi:10.1542/peds.2021-053745 [PubMed 34493538]
  2. American College of Obstetricians and Gynecologists (ACOG). ACOG committee opinion no. 753: Assessment and treatment of pregnant women with suspected or confirmed influenza. Obstet Gynecol. 2018;132(4):e169-e173. [PubMed 30247362]
  3. Centers for Disease Control and Prevention (CDC). Breastfeeding. Influenza (Flu). https://www.cdc.gov/breastfeeding/breastfeeding-special-circumstances/maternal-or-infant-illnesses/influenza.html. Published January 12, 2021a. Accessed on January 19, 2021.
  4. Centers for Disease Control and Prevention (CDC). Influenza antiviral medications: summary for clinicians. Available at http://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm. Last updated September 22, 2021b. Accessed October 8, 2021.
  5. Centers for Disease Control and Prevention (CDC). Influenza antiviral medications: summary for clinicians. http://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm. Published November 30, 2020a. Accessed December 4, 2020.
  6. Centers for Disease Control and Prevention, (CDC). Recommendations for obstetric health care providers related to use of antiviral medications in the treatment and prevention of influenza. https://www.cdc.gov/flu/professionals/antivirals/avrec_ob.htm. Published November 30, 2020b. Accessed December 16, 2020.
  7. Dreitlein WB, Maratos J, and Brocavich J. Zanamivir and Oseltamivir: Two New Options for the Treatment and Prevention of Influenza. Clin Ther. 2001;23(3):327-355. [PubMed 11318072]
  8. Louie JK, Jamieson DJ, Rasmussen SA, et al. 2009 Pandemic Influenza A (H1N1) Virus Infection in Postpartum Women in California. Am J Obstet Gynecol. 2011;204(2):144.e1-6. [PubMed 21074132]
  9. Metlay JP, Waterer GW, Long AC, et al. Diagnosis and treatment of adults with community-acquired pneumonia. An official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Resp Crit Care Med. 2019;200(7):e45-e67. doi:10.1164/rccm.201908-1581ST. [PubMed 31573350]
  10. Relenza (zanamivir) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; October 2021.
  11. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Guidelines for prevention and treatment of opportunistic infections in HIV-exposed and HIV-infected children. https://clinicalinfo.hiv.gov/en/guidelines/pediatric-opportunistic-infection/whats-new. Updated March 19, 2021. Accessed May 20, 2021.
  12. Uyeki TM, Bernstein HH, Bradley JS, et al. Clinical practice guidelines by the Infectious Diseases Society of America: 2018 update on diagnosis, treatment, chemoprophylaxis, and institutional outbreak management of seasonal influenza. Clin Infect Dis. 2019;68(6):895-902. doi:10.1093/cid/ciy874 [PubMed 30834445]
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