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What is Xofluza (baloxavir marboxil)?
Xofluza (baloxavir marboxil) is an antiviral drug used to treat acute uncomplicated influenza, or the common flu, in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use Xofluza. Xofluza is not effective in treating infections other than influenza. Other kinds of infections can appear like flu or occur along with flu and may need different kinds of treatment.
Common side effects of Xofluza include:
Serious side effects of Xofluza include:
- allergic reactions. Symptoms of allergic reactions may include trouble breathing, skin rash, hives or blisters, swelling of the face/throat/mouth, and dizziness or lightheadedness.
Drug interactions of Xofluza include polyvalent cation-containing products such as laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc), which may reduce Xofluza efficacy.
Use of Xofluza with intranasal live attenuated influenza vaccine (LAIV) has not been evaluated. Concurrent administration of antiviral drugs may inhibit viral replication of LAIV and thereby decrease the effectiveness of LAIV vaccination.
There are no available data on Xofluza use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with influenza virus infection in pregnancy.
There are no data on the presence of Xofluza in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Xofluza and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.
What are the important side effects of Xofluza (baloxavir marboxil)?
The most common side effects of Xofluza in adults and adolescents include:
Xofluza is not effective in treating infections other than influenza. Other kinds of infections can appear like flu or occur along with flu and may need different kinds of treatment. Tell your healthcare provider if you feel worse or develop new symptoms during or after treatment with Xofluza or if your flu symptoms do not start to get better.
These are not all the possible side effects of Xofluza. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800 FDA-1088.
Xofluza (baloxavir marboxil) side effects list for healthcare professionals
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.
The safety profile of Xofluza is based on data from 3 placebo-controlled trials in which a total of 1,640 subjects received Xofluza:
- 1,334 subjects (81%) were 18 to 64 years of age,
- 209 subjects (13%) were adults 65 years of age or older and
- 97 subjects (6%) were adolescents 12 to 17 years of age.
These trials included otherwise healthy adults and adolescents (N=910) and subjects at high risk of developing complications associated with influenza (N=730). Of these, 1,440 subjects received Xofluza at the recommended dose.
Table 2 displays the most common adverse events (regardless of causality assessment) reported in at least 1% of adult and adolescent subjects who received Xofluza at the recommended dose in Trials 1, 2 and 3.
Table 2: Incidence of Adverse Events Occurring in At Least 1% of Subjects Receiving Xofluza in the Acute Uncomplicated Influenza Trials 1, 2, and 3
(N = 1,440)
(N = 1,136)
The following adverse reactions have been identified during postmarketing use of Xofluza. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to Xofluza exposure.
What drugs interact with Xofluza (baloxavir marboxil)?
Effect Of Other Drugs On Xofluza
Co-administration with polyvalent cation-containing products may decrease plasma concentrations of baloxavir which may reduce Xofluza efficacy. Avoid co-administration of Xofluza with polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc).
The concurrent use of Xofluza with intranasal live attenuated influenza vaccine (LAIV) has not been evaluated. Concurrent administration of antiviral drugs may inhibit viral replication of LAIV and thereby decrease the effectiveness of LAIV vaccination. Interactions between inactivated influenza vaccines and Xofluza have not been evaluated.
Xofluza (baloxavir marboxil) is an antiviral drug used to treat acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours. Common side effects of Xofluza include diarrhea, bronchitis, common cold symptoms, headache, and nausea. Serious side effects of Xofluza include allergic reactions. There are no available data on Xofluza use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. There are no data on the presence of Xofluza in human milk, the effects on the breastfed infant, or the effects on milk production.
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Related Disease Conditions
COVID-19 vs. Flu vs. Cold
When you're feeling sick, it can be difficult to distinguish the symptoms of a COVID-19 infection from the symptoms of the common cold or the flu (influenza). While fever is common with the flu and COVID-19, sneezing is typically only associated with colds. Though sore throats are typical with colds, they are uncommon with COVID-19 infections and the flu.
Novel H1N1 influenza A virus infection (swine flu) is an infection that generally is transferred from an infected pig to a human, however there have been reported cases where infection has occured with no contact with infected pigs. Symptoms of swine flu are "flu-like" and include fever, cough, and sore throat. Treatment is generally with the antibiotics oseltamivir (Tamiflu) or zanamivir (Relenza).
Influenza (flu) is a respiratory illness caused by a virus. Flu symptoms include fever, cough, sore throat, runny nose, headache, fatigue, and muscle aches. The flu may be prevented with an annual influenza vaccination.
Bird Flu (Avian Influenza, Avian Flu)
Bird flu (avian flu, avian influenza) infection in humans may result from contact with infected poultry. There is a vaccine to prevent human infection with the H5N1 strain of the avian flu virus.
How Long Is a Cold or Flu Contagious?
Viruses cause the common cold and the flu. Early symptoms and signs for a cold and the flu are similar, however, flu symptoms are typically more severe than cold symptoms. Cold and flu viruses are transmitted typically via coughing or sneezing.
Is Swine Flu (H1N1) Contagious?
Swine flu (H1N1) is a contagious virus that spreads when an infected individual expels virus-containing droplets into the air during coughing or sneezing. Symptoms include sore throat, runny nose, fever, cough, chills, headache, fatigue, and possible vomiting and/or diarrhea. An H1N1 infection typically lasts for about a week.
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Cold, Flu, Allergy Treatments
Before treating a cold, the flu, or allergies with over-the-counter (OTC) medications, it's important to know what's causing the symptoms, which symptoms one wishes to relieve, and the active ingredients in the OTC product. Taking products that only contain the medications needed for relieving your symptoms prevents ingestion of unnecessary medications and reduces the chances of side effects.
Cold vs. Flu
Though the common cold and flu share many signs and symptoms, they are caused by different viruses. Signs and symptoms include sneezing, sore throat, runny nose, fatigue, and cough. Treatment options for the cold and flu are similar and focus on reducing symptoms. Doctors may prescribe antivirals/neuraminidase inhibitors for the flu.
Diabetes and Safe Medications for Colds and the Flu: OTC Medication Guide
If you have diabetes and catch a cold or the flu, can be more difficult to recover from infections and their complications, for example, pneumonia. Home remedies and over-the-counter (OTC) drugs used for the treatment of the signs and symptoms of colds and the flu may affect blood sugar levels in people with diabetes.Some medications are OK to take if you have diabetes get a cold or the flu include nonsteroidal anti-inflammatory drugs or NSAIDs, like acetaminophen (Tylenol) and ibuprofen (Motrin) to control symptoms of fever and pain. Most cough syrups are safe to take; however, check with your pediatrician to see what medications are safe to give your child if he or she has type 1 or 2 diabetes. If you have diabetes and are sick with a cold or flu, you need to check your blood sugar levels more frequently. Continue taking your regular medications. Eat a diabetic low-glycemic index diet rich in antioxidants. To prevent colds and the flu drink at least eight 8 ounce glasses of water a day. To replenish fluids, drink sports drinks like Gatorade and Pedialyte to replenish electrolytes. Avoid people who are sick, sneezing, coughing, or have other symptoms of a cold or flu.
Pregnancy: Swine Flu and the H1N1 Vaccine
Pregnant and women who are breastfeeding are encouraged to receive the seasonal flu shot as well as the 2009 H1N1 influenza (swine flu) vaccine. H1N1 flu is treated with the medications Tamiflu® (oseltamivir) or Relenza® (zanamivir). Pregnant women should not receive the H1N1 attenuated nasal spray vaccine. Possible side effects of the H1N1 flu vaccine include muscle aches, fever, nausea, tiredness, or headache.
Treating the Flu in People with Health Risks
Certain portions of the population are at an increased risk of suffering serious complications from the flu. Some of these indviduals at risk include: those with asthma, COPD, heart disease, liver or kidney disease, HIV, AIDs, elderly, women who are pregnant, and children under the age of two. Contact your physician if you have the flu immediately so that you receive the proper care to prevent serious complications.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.