Genentech takes the health and safety of our patients, customers, employees and local communities very seriously, and we are actively responding to the global COVID-19 pandemic. For more, please visit our COVID-19 response page or call 1-877-436-3683.

Update on Actemra® (tocilizumab) Supply in the U.S.

Updated September 3, 2021

We have begun receiving scheduled replenishments of Actemra in the U.S., and anticipate additional replenishments of all SKUs of Actemra IV and subcutaneous (SC) formulations (ACTPen ® and prefilled syringe) in the coming weeks and months. During this time, availability of Actemra will vary. We expect additional intermittent periods of stockouts in the months ahead, especially if the pandemic continues at the current pace.

We recognize the urgency around the situation and understand the frustration that patients, their families and healthcare providers are experiencing due to these supply constraints.

Genentech and Roche are working as quickly as possible to expedite replenishments and increase manufacturing capacity and supply, including through active collaboration with external partners. Genentech has implemented new distribution strategies for hospital and clinic customers to enable access for the greatest number of patients, as supply permits.

For the most up-to-date information on product availability for Actemra IV and/or SC formulations, hospitals and practices should contact their authorized distributors.

Updated August 20, 2021

Our thoughts are with the healthcare workers, patients and families who are facing the impact of this current wave of the COVID-19 pandemic. The unprecedented surge in worldwide demand and supply constraints driven by Delta variant spikes in much of the rest of the world that preceded the current situation in the U.S., has led to a global shortage of Actemra® (tocilizumab) supply for at least the next several weeks.

The dramatic emergence of the COVID-19 Delta variant, as well as the unexpected slowing of vaccination rates in the U.S., has led to an overwhelmingly high incidence of COVID-19 hospitalizations in certain areas of the country. This new wave of the pandemic has led to Genentech experiencing an unprecedented demand for Actemra IV-- well-over 400% of pre-COVID levels over the last two weeks alone and it continues to increase.

Genentech is committed to providing Actemra IV to patients in most critical need and our teams have been working as urgently as possible to fulfill the large volume of orders. We have recently taken several actions, including allocating all Actemra IV formulations (80, 200 and 400mg vials), drop shipping medicine direct to hospitals and clinics in COVID-19 hotspots, and collaborating with distributors and shipping carriers to find logistics solutions.

In 2020, ahead of data on Actemra in COVID-19 becoming available, Roche and Genentech ramped up our own manufacturing network and contracted with all available large-scale manufacturers around the world to transfer our technologies and maximize production.

Despite these efforts, we are experiencing a temporary stockout of Actemra IV in the U.S. as of Monday, August 16th, and have notified our customers. The most up-to-date information on Actemra supply can be found here.

We expect to receive scheduled replenishments by the end of August. However, if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead.

Currently, we have a supply of subcutaneous Actemra available, which is indicated to treat rheumatoid arthritis and several other inflammatory-related conditions -- though the supply situation continues to evolve. Subcutaneous Actemra is not authorized for the treatment of COVID-19 patients under the Emergency Use Authorization.

We are committed to proactive and timely communication with hospitals, practices, distributors and pharmacy customers as the situation evolves, and Actemra supply becomes more readily available.

For questions regarding fulfillment of Actemra IV order requests, hospitals and practices should contact their Distributor.

For more information on the global Actemra supply situation, please see the Roche media statement here.


About Actemra

Actemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. Actemra subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis (GCA), for the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA), and for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). In addition, Actemra is also approved in the IV formulation for patients two years of age and older with active PJIA, SJIA or CAR T cell-induced cytokine release syndrome (CRS). Actemra is not approved for subcutaneous use in people with CRS. It is not known if Actemra is safe and effective in children with PJIA, SJIA or CRS under two years of age or in children with conditions other than PJIA, SJIA or CRS.

Actemra is intended for use under the guidance of a healthcare practitioner.


IMPORTANT INFORMATION ABOUT ACTEMRA FOR COVID-19

AUTHORIZED USE

ACTEMRA is authorized for emergency use under an Emergency Use Authorization (EUA) for the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving corticosteroids and who require supplemental oxygen, or a machine that helps with their breathing (ventilator) or a machine that adds oxygen to the blood outside the body (extracorporeal membrane oxygenation or ECMO). ACTEMRA is not FDA-approved for this use. There is limited information known about the safety or effectiveness of using ACTEMRA to treat people in the hospital with COVID-19. The safety and effectiveness of ACTEMRA have not been studied in pediatric patients hospitalized with COVID-19.

The EUA for ACTEMRA is in effect for the duration of the COVID-19 declaration justifying emergency use of this product, unless terminated or revoked (after which the products may no longer be used under the EUA).

IMPORTANT SAFETY INFORMATION ABOUT ACTEMRA FOR COVID-19

Actemra can cause serious side effects. The most important side effects include:

  • Serious infections
  • Tears (perforation) of the stomach or intestines
  • Liver problems (hepatotoxicity)
  • Changes in certain laboratory test results including low neutrophil (white blood cells that help the body fight off bacterial infections) or platelet (blood cells that help with blood clotting and stop bleeding) counts or high liver function tests
  • Allergic reactions: If a patient has symptoms such as rash, swelling of their lips, tongue, or throat, or hives (raised red patches of skin that are often very itchy) they should tell their doctor or nurse. This may mean the patient is having an allergic reaction.
  • Nervous system problems

The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

Patients should not receive ACTEMRA if they are allergic to tocilizumab or if they have had a bad reaction to ACTEMRA previously.

ACTEMRA & pregnancy:

There is limited experience giving ACTEMRA to pregnant women or breastfeeding mothers. ACTEMRA may harm the patient’s unborn baby. It is unknown if ACTEMRA passes into a patient’s breast milk. If a patient is pregnant or breastfeeding, they can discuss their options and specific situation with their doctor.

If a patient is pregnant or becomes pregnant while taking ACTEMRA, they should join the pregnancy registry. To learn more, patients can call the registry at 1-877-311-8972 or talk to their doctor to enroll.

Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. Report side effects to Genentech at 1-888-835- 2555.

Please see additional information in Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers, and FDA Letter of Authorization.

For more Important Safety Information please see the full Prescribing Information and Medication Guide, including SERIOUS SIDE EFFECTS.

Important Safety Information for FDA-Approved Indications

Actemra can cause serious side effects. Actemra changes the way a patient’s immune system works. This can make a patient more likely to get infections or make any current infection worse. Some people taking Actemra have died from these infections.

Actemra can cause other serious side effects. These include:

  • Tears of the stomach or intestines
  • Liver problems (hepatotoxicity)
  • Changes in blood test results, including low neutrophil (white blood cells) and platelet (platelets help the blood to clot) counts, and increases in certain liver function test levels and blood cholesterol levels
  • An increased risk of certain cancers by changing the way a patient’s immune system works
  • Hepatitis B infection
  • Serious allergic reactions, including death. These may happen with Actemra infusions or injections, even if they did not occur with an earlier infusion or injection. If a patient has had hives, a rash, or experienced flushing after injecting, the patient should tell their doctor or nurse before their next injection
  • Nervous system problems

Patients should not receive Actemra if they are allergic to Actemra or if they have had a bad reaction to Actemra previously.

Most common side effects in patients treated with Actemra:

Patients should tell their doctor if they have these or any other side effect that bothers them or does not go away:

  • Upper respiratory tract infections (like common cold and sinus infections)
  • Headache
  • Increased blood pressure (also called hypertension)
  • Injection site reactions

Actemra & pregnancy:

Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. The patient and their doctor should decide if the patient will take Actemra or breastfeed. Patients should not do both. If a patient is pregnant and taking Actemra, they should join the pregnancy registry. To learn more, patients should call 1-877-311-8972 or talk to their doctor to register.

Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. Report side effects to Genentech at 1-888-835- 2555.

Please visit http://www.actemra.com for the full Prescribing Information, including Boxed Warning and Medication Guide, for additional Important Safety Information or call 1-800-ACTEMRA (228-3672).


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.