Genentech Confirms Sufficient Nationwide Supply Available of Xofluza and Tamiflu for Pharmacies to Order

South San Francisco, CA — December 7th, 2022 —

Genentech’s flu antiviral medicines, Xofluza^® (baloxavir marboxil) and branded Tamiflu^® (oseltamivir), remain available nationwide for pharmacies to order. We have sufficient supply to meet the demand and are continuously evaluating the need to increase production. In anticipation of the current flu season, we have been shipping Xofluza to distributors across the U.S. since September and have been shipping branded Tamiflu since October. 

The flu is a very common, contagious and potentially serious illness. The Centers for Disease Control and Prevention (CDC) recommends that all eligible people six months of age and older get the flu vaccine annually; however, even if vaccinated, people can still contract the flu. 

There are multiple treatment options for the flu. According to the CDC, flu antiviral medications, like Xofluza and Tamiflu, work to treat flu when started within two days of symptoms appearing, or to help keep people protected if in close contact with someone who has the flu. Xofluza is indicated in otherwise healthy patients 5 years of age and older, and Tamiflu is indicated for people 2 weeks old and above. Genentech does not manufacture the generic version of Tamiflu.

We encourage all pharmacies to contact and work directly with their distributors to ensure uninterrupted patient access across the U.S. Online-only portals and dashboards pharmacies use for order placement may not accurately reflect actual availability, which can be resolved by contacting distributors for the most current information. 

Patients experiencing flu symptoms or in close contact with others diagnosed with the flu should speak with their healthcare provider immediately.

Xofluza U.S. Important Safety Information & Indication

What is XOFLUZA?

XOFLUZA is a prescription medicine used to:

• treat the flu (influenza) in people who have flu symptoms for no more than 48 hours and who are:
  • otherwise healthy adults and children 5 years of age and older, or
  • adults and children 12 years of age and older who are at high risk of developing problems from the flu.
• prevent the flu in people 5 years of age and older following contact with a person who has the flu (post-exposure prophylaxis).

XOFLUZA does not treat or prevent illness that is caused by infections other than the influenza virus.

XOFLUZA does not prevent bacterial infections that may happen with the flu.

It is not known if XOFLUZA is safe and effective for the treatment and prevention of the flu in children less than 5 years of age. XOFLUZA is not for use in children less than 5 years of age.

Important Safety Information

Who should not take XOFLUZA?

• Do not take XOFLUZA if you are allergic to baloxavir marboxil or any of the ingredients in XOFLUZA.

What should I tell my healthcare provider before using XOFLUZA?

• Tell your healthcare provider about all of your medical conditions, including if you are:
  • Pregnant or plan to become pregnant. It is not known if XOFLUZA can harm your unborn baby.
  • Breastfeeding or plan to breastfeed. It is not known if XOFLUZA passes into your breast milk.
• Talk to your healthcare provider before you receive a live flu vaccine after taking XOFLUZA.
• Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, antacids, laxatives, vitamins, and herbal supplements.

What are the possible side effects of XOFLUZA?

Serious side effects may include

• Allergic reaction. Get emergency medical help right away if you develop any of the following signs or symptoms of an allergic reaction:
  • trouble breathing
  • skin rash, hives or blisters
  • swelling of your face, throat or mouth
  • dizziness or lightheadedness

The most common side effects of XOFLUZA for treatment of the flu in adults and adolescents (12 years of age and older) were diarrhea, bronchitis, nausea, sinusitis, and headache.

The most common side effects of XOFLUZA for treatment of the flu in children (5 years of age to less than 12 years of age) were diarrhea and vomiting.

These are not all the possible side effects of XOFLUZA. Call your healthcare provider for medical advice about side effects.

XOFLUZA is not effective in treating or preventing infections other than influenza. Other kinds of infections can have symptoms like those of the 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.

You are encouraged to report side effects to Genentech by calling 1-888-835-2555 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Please see full Prescribing Information, including Patient Product Information.

Tamiflu U.S. Important Safety Information & Indication

INDICATIONS

TAMIFLU is a prescription medicine used to treat the flu (influenza) in people 2 weeks of age and older who have had flu symptoms for no more than 2 days. TAMIFLU can also reduce the chance of getting the flu in people 1 year and older.

TAMIFLU does not prevent bacterial infections that may happen with the flu.

TAMIFLU is not a substitute for an annual flu vaccination.

TAMIFLU is not recommended if you have severe kidney disease and are not on dialysis.

Do not take TAMIFLU if you are allergic to oseltamivir phosphate or any of the ingredients in TAMIFLU.

IMPORTANT SAFETY INFORMATION

• If you have an allergic reaction or a severe rash with TAMIFLU, stop taking it and contact your doctor right away. This may be very serious
• People with the flu, particularly children and adolescents, may be at an increased risk of seizure, confusion, or abnormal behavior early during their illness
• Let your doctor know if you are pregnant, nursing, have heart problems, breathing problems, a weakened immune system (immunocompromised), kidney problems or other medical conditions as TAMIFLU may not be right for you
• Also tell your doctor about any medications you are taking or if you’ve received a nasal- spray flu vaccine in the past two weeks
• The most common side effects when treating the flu include nausea, vomiting, and headache. The most common side effects when preventing the flu include nausea, vomiting, headache, and pain

Please see the TAMIFLU full Prescribing Information for complete important safety information.

You are encouraged to report side effects to Genentech by calling 1-888-835-2555 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

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About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.