Hospital Pharmacists Concerned About Actemra Shortage

The shortage of Genentech’s Actemra (tocilizumab) due to its dual use to treat COVID-19 and autoimmune diseases such as rheumatoid arthritis is the most concerning to American Society of Health-System Pharmacists’ members, an executive told FormularyWatch®.

In June, the FDA issued a issued an emergency use authorization (EUA) allowing Actemra to be used for hospitalized adults and pediatric patients 2 years of age and older who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

“In clinical trials of hospitalized patients with COVID-19, Actemra in addition to the routine care patients receive for treatment of COVID-19, which included corticosteroid therapy, was shown to reduce the risk of death through 28 days of follow-up and decrease the amount of time patients remained hospitalized,” FDA said in a press release.

The risk of patients being placed on ventilators or death through 28 days of follow-up was also decreased.

However, Actemra is also used to treat rheumatoid arthritis and other forms of arthritis in both pediatric and adult patients.

Michael Ganio, Pharm.D.

After the EUA, Genentech temporarily stopped filing orders of the medication, Michael Ganio, Pharm.D., senior director of pharmacy practice and quality for ASHP, told FormularyWatch®.

Genentech said in a notice on its website that it anticipates “additional intermittent periods of stockouts in the months ahead if the pandemic continues at the current pace.”

“We realize that all eligible Actemra patients’ needs may not be met during this time. We are working to expedite replenishments and increase manufacturing capacity and supply wherever possible,” Genentech said.

The company is allocating orders through some wholesalers, and “filling orders as they can” as they also try to increase production, according to Ganio. “This is a biologic, so ramping up production is not as simple as it sounds,” he said.

In addition, Actemra’s subcutaneous formulations (ACTPen and pre-filled syringe) continue to be available for patients, Genentech. However, those will also be in limited supply through the authorized distributors.

Hospital pharmacists are reporting short supply of Actemra but are trying to continue to treat patients. In some cases, they are referring patients elsewhere or prolonging the interval between patient visits as the drug is also used to alleviate reactions after chemotherapy for certain types of cancer, Ganio said.

In some cases, the pharmacists are converting patients who were using the IV form to the subcutaneous injection.

The shortage of tocilizumab in hospitals may be aided by a recent decision by the National Institutes of Health’s COVID-19 Treatment Guidelines Panel recommendation of using IV Kevzara (sarilumab) from Sanofi and Regeneron as an alternative to IV tocilizumab “only when IV tocilizumab is not available or not feasible to use.”

“That should take some pressure off tocilizumab, but if hospitals are reaching for both, possibly there could be a shortage of sarilumab in the coming weeks,” Ganio said.