Zanamivir
Generic Name: zanamivir
Brand Names:
Relenza
11 DESCRIPTION The active component of RELENZA is zanamivir. The chemical name of zanamivir is 5-(acetylamino)-4-[(aminoiminomethyl)-amino]-2,6-anhydro-3,4,5-trideoxy-D-glycero-D-galacto-non-2-enonic acid. It has a molecular formula of C 12 H 20 N 4 O 7 and a molecular weight of 332.3. It has the following structural formula: Zanamivir is a white to off-white powder for oral inhalation with a solubility of approximately 18 mg/mL in water at 20°C.
Overview
11 DESCRIPTION The active component of RELENZA is zanamivir. The chemical name of zanamivir is 5-(acetylamino)-4-[(aminoiminomethyl)-amino]-2,6-anhydro-3,4,5-trideoxy-D-glycero-D-galacto-non-2-enonic acid. It has a molecular formula of C 12 H 20 N 4 O 7 and a molecular weight of 332.3. It has the following structural formula: Zanamivir is a white to off-white powder for oral inhalation with a solubility of approximately 18 mg/mL in water at 20°C.
Uses
1 INDICATIONS AND USAGE RELENZA, an influenza virus neuraminidase inhibitor (NAI), is indicated for: Treatment of acute, uncomplicated influenza type A and B infections in patients aged 7 years and older who have been symptomatic for no more than 2 days. ( 1.1 ) Prophylaxis of influenza in patients aged 5 years and older. ( 1.2 ) Important Limitations of Use: Not recommended for treatment or prophylaxis of influenza in: • Individuals with underlying airways disease. ( 5.1 ) Not proven effective for: • Treatment in individuals with underlying airways disease. ( 1.3 ) • Prophylaxis in nursing home residents. ( 1.3 ) Not a substitute for annual influenza vaccination.
Dosage
2 DOSAGE AND ADMINISTRATION Indication Dose Treatment of Influenza ( 2.2 ) 10 mg twice daily for 5 days Prophylaxis: ( 2.3 ) Household Setting 10 mg once daily for 10 days Community Outbreaks 10 mg once daily for 28 days Note: The 10-mg dose is provided by 2 inhalations (one 5-mg blister per inhalation). ( 2.1 ) 2.1 Dosing Considerations • RELENZA is for administration to the respiratory tract by oral inhalation only , using the DISKHALER device provided [see Warnings and Precautions ( 5.6 )] . • The 10-mg dose is provided by 2 inhalations (one 5-mg blister per inhalation). • Patients should be instructed in the use of the delivery system. Instructions should include a demonstration whenever possible.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Bronchospasm [see Warnings and Precautions ( 5.1 )] . • Safety information in patients with underlying airways disease [see Warnings and Precautions ( 5.1 )]. • Allergic-like reactions [see Warnings and Precautions ( 5.2 )] . The most common adverse events reported in greater than 1.5% of subjects treated with RELENZA and more commonly than in subjects treated with placebo are: • Treatment Trials – sinusitis, dizziness. ( 6.1 ) • Prophylaxis Trials – fever and/or chills, arthralgia, and articular rheumatism. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Interactions
7 DRUG INTERACTIONS The concurrent use of RELENZA with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of potential interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of RELENZA, unless medically indicated. The concern about possible interference arises from the potential for antiviral drugs to inhibit replication of live vaccine virus. Trivalent inactivated influenza vaccine can be administered at any time relative to use of RELENZA [see Microbiology ( 12.4 )] . Live attenuated influenza vaccine, intranasal ( 7 ): • Do not administer until 48 hours following cessation of RELENZA.
Warnings
5 WARNINGS AND PRECAUTIONS • Bronchospasm: Serious, sometimes fatal, cases have occurred. Not recommended in individuals with underlying airways disease. Discontinue RELENZA if bronchospasm or decline in respiratory function develops. ( 5.1 ) • Allergic Reactions: Discontinue RELENZA and initiate appropriate treatment if an allergic reaction occurs or is suspected. ( 5.2 ) • Neuropsychiatric Events: Patients with influenza, particularly pediatric patients, may be at an increased risk of seizures, confusion, or abnormal behavior early in their illness. Monitor for signs of abnormal behavior. ( 5.3 ) • High-Risk Underlying Medical Conditions: Safety and effectiveness have not been demonstrated in these patients. 4 CONTRAINDICATIONS RELENZA is contraindicated in patients with history of allergic reaction to any ingredient of RELENZA, including milk proteins [see Warnings and Precautions ( 5.2 ), Description ( 11 )] . Do not use in patients with history of allergic reaction to any ingredient of RELENZA, including milk proteins. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available data from published studies suggest that use of RELENZA during pregnancy is not associated with an increased risk of birth defects or adverse maternal or fetal outcomes. However, these studies are limited by their small sample sizes, which preclude a definitive assessment of the risk (see Data). There are risks to the mother and fetus associated with influenza infection in pregnancy (see Clinical Considerations) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device (NDC 0173-0681-01).
Frequently Asked Questions
What is Zanamivir used for?▼
1 INDICATIONS AND USAGE RELENZA, an influenza virus neuraminidase inhibitor (NAI), is indicated for: Treatment of acute, uncomplicated influenza type A and B infections in patients aged 7 years and older who have been symptomatic for no more than 2 days. ( 1.1 ) Prophylaxis of influenza in patients aged 5 years and older. ( 1.2 ) Important Limitations of Use: Not recommended for treatment or prophylaxis of influenza in: • Individuals with underlying airways disease. ( 5.1 ) Not proven effective for: • Treatment in individuals with underlying airways disease. ( 1.3 ) • Prophylaxis in nursing home residents. ( 1.3 ) Not a substitute for annual influenza vaccination.
What are the side effects of Zanamivir?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Bronchospasm [see Warnings and Precautions ( 5.1 )] . • Safety information in patients with underlying airways disease [see Warnings and Precautions ( 5.1 )]. • Allergic-like reactions [see Warnings and Precautions ( 5.2 )] . The most common adverse events reported in greater than 1.5% of subjects treated with RELENZA and more commonly than in subjects treated with placebo are: • Treatment Trials – sinusitis, dizziness. ( 6.1 ) • Prophylaxis Trials – fever and/or chills, arthralgia, and articular rheumatism. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Zanamivir during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from published studies suggest that use of RELENZA during pregnancy is not associated with an increased risk of birth defects or adverse maternal or fetal outcomes. However, these studies are limited by their small sample sizes, which preclude a definitive assessment of the risk (see Data). There are risks to the mother and fetus associated with influenza infection in pregnancy (see Clinical Considerations) .
What are the important warnings for Zanamivir?▼
5 WARNINGS AND PRECAUTIONS • Bronchospasm: Serious, sometimes fatal, cases have occurred. Not recommended in individuals with underlying airways disease. Discontinue RELENZA if bronchospasm or decline in respiratory function develops. ( 5.1 ) • Allergic Reactions: Discontinue RELENZA and initiate appropriate treatment if an allergic reaction occurs or is suspected. ( 5.2 ) • Neuropsychiatric Events: Patients with influenza, particularly pediatric patients, may be at an increased risk of seizures, confusion, or abnormal behavior early in their illness. Monitor for signs of abnormal behavior. ( 5.3 ) • High-Risk Underlying Medical Conditions: Safety and effectiveness have not been demonstrated in these patients. 4 CONTRAINDICATIONS RELENZA is contraindicated in patients with history of allergic reaction to any ingredient of RELENZA, including milk proteins [see Warnings and Precautions ( 5.2 ), Description ( 11 )] . Do not use in patients with history of allergic reaction to any ingredient of RELENZA, including milk proteins. ( 4 )
Related Medications
Cyanocobalamin Co-58
cyanocobalamin co-58
Manufactured by GE HEALTHCARE. Dosage form: N/A. Route: N/A. Active ingredients: CYANOCOBALAMIN (N/A); CYANOCOBALAMIN CO-57 (N/A); CYANOCOBALAMIN CO-58 (N/A). Application: NDA017406.
String Bean Mix
string bean mix
Dosage form: INJECTION, SOLUTION. Route: PERCUTANEOUS, SUBCUTANEOUS. Active ingredients: STRING BEAN (.1 g/mL). Category: BLA.
Rimantadine Hydrochloride
rimantadine hydrochloride
DESCRIPTION Rimantadine hydrochloride, USP is a synthetic antiviral drug available as a 100 mg film-coated tablet. Each film-coated tablet contains 100 mg of rimantadine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, type A and FD&C Yellow No. 6 Aluminium Lake. Film coating material, Opadry (YS-1-19025-A), contains hypromellose and polyethylene glycol.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.