Actemra Infusions in Short Supply
A shortage of tocilizumab (Actemra) due to increased demand to treat COVID-19 cases may affect people with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) and other diseases who use the medication.
The current shortage is for intravenous (IV) formulations, which are used to treat COVID-19 under an Emergency Use Authorization by the Food and Drug Administration, according to drug maker Genentech. In the U.S., IV supplies of 200mg and 400mg SKU are out of stock as of Aug. 16, and 80mg SKU is expected to be out of stock by the end of the week, according to an Aug. 16 alert from Genentech. A supply of the subcutaneous injectable form, which is not authorized for COVID-19 treatment, is still available, although there is a shortage and “the supply situation continues to evolve.”
The IV formulation is approved to treat polyarticular JIA and systemic JIA in children 2 years and older (as well as CAR T cell-induced cytokine release syndrome, a condition that can result from a cancer therapy). The subcutaneous form, a prefilled self-injectable, is used to treat RA, polyarticular JIA and systemic JIA in children 2 years and older, as well as giant cell arteritis and systemic sclerosis-associated interstitial lung disease.
Most people with rheumatoid or juvenile arthritis who receive tocilizumab are treated with injectable forms, which are not as severely impacted at this point, says Liana Fraenkel, MD, MPH, a rheumatology professor at Yale School of Medicine and chief of rheumatology with the VA Connecticut Healthcare System.
The shortages are driven by the significant increase in COVID-19 cases in the United States and worldwide, according to Genentech. “The dramatic emergence of the [coronavirus] 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,” the statement says.
Tocilizumab stocks are expected to be replenished by the end of August, the statement says. “However, if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead.”
These shortages may raise alarms for anyone who takes tocilizumab, but there are alternatives for some people, says Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University in Fargo. “If patients are using IV Actemra, they may be able to obtain the subcutaneous formulation instead. That would be the ideal change. It is typically given every two to four weeks, so one could space out doses a little if [they are] currently under good disease control.”
Patients who are concerned about their tocilizumab treatment should contact their rheumatologist to discuss options, says Dr. Fraenkel. “They should be reassured that there are other biologics and targeted synthetic DMARDs (disease-modifying antirheumatic drugs) that are also very effective to treat RA should they need to switch.”
For example, sarilumab (Kevzara) is in the same class — an interleukin-6 inhibitor) — that may be an appropriate substitute, Miller adds.
Know that rheumatologists are aware of the problem and working actively through the American College of Rheumatology to explore options,” Miller says. —JILL TYRER
The current shortage is for intravenous (IV) formulations, which are used to treat COVID-19 under an Emergency Use Authorization by the Food and Drug Administration, according to drug maker Genentech. In the U.S., IV supplies of 200mg and 400mg SKU are out of stock as of Aug. 16, and 80mg SKU is expected to be out of stock by the end of the week, according to an Aug. 16 alert from Genentech. A supply of the subcutaneous injectable form, which is not authorized for COVID-19 treatment, is still available, although there is a shortage and “the supply situation continues to evolve.”
The IV formulation is approved to treat polyarticular JIA and systemic JIA in children 2 years and older (as well as CAR T cell-induced cytokine release syndrome, a condition that can result from a cancer therapy). The subcutaneous form, a prefilled self-injectable, is used to treat RA, polyarticular JIA and systemic JIA in children 2 years and older, as well as giant cell arteritis and systemic sclerosis-associated interstitial lung disease.
Most people with rheumatoid or juvenile arthritis who receive tocilizumab are treated with injectable forms, which are not as severely impacted at this point, says Liana Fraenkel, MD, MPH, a rheumatology professor at Yale School of Medicine and chief of rheumatology with the VA Connecticut Healthcare System.
The shortages are driven by the significant increase in COVID-19 cases in the United States and worldwide, according to Genentech. “The dramatic emergence of the [coronavirus] 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,” the statement says.
Tocilizumab stocks are expected to be replenished by the end of August, the statement says. “However, if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead.”
These shortages may raise alarms for anyone who takes tocilizumab, but there are alternatives for some people, says Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University in Fargo. “If patients are using IV Actemra, they may be able to obtain the subcutaneous formulation instead. That would be the ideal change. It is typically given every two to four weeks, so one could space out doses a little if [they are] currently under good disease control.”
Patients who are concerned about their tocilizumab treatment should contact their rheumatologist to discuss options, says Dr. Fraenkel. “They should be reassured that there are other biologics and targeted synthetic DMARDs (disease-modifying antirheumatic drugs) that are also very effective to treat RA should they need to switch.”
For example, sarilumab (Kevzara) is in the same class — an interleukin-6 inhibitor) — that may be an appropriate substitute, Miller adds.
Know that rheumatologists are aware of the problem and working actively through the American College of Rheumatology to explore options,” Miller says. —JILL TYRER