FDA Approves New Way to Receive Pegfilgrastim

The U.S. Food and Drug Administration, or FDA, recently approved a new delivery system for pegfilgrastim (Neulasta). The system is called the Neulasta Delivery Kit. It includes the On-body Injector for Neulasta, a small device that can be placed on the skin at the same appointment that chemotherapy is received. The next day, the device releases a dose of pegfilgrastim, a medicine that increases white blood cell count to counteract the risk of infection that can be a side effect of chemotherapy.

Background

Chemotherapy medicines are commonly used to treat many cancers, including breast cancer. They spread throughout the body to target breast cancer cells and lower the risk of breast cancer coming back or spreading.

But chemotherapy can also have serious side effects. One of those side effects is neutropenia, or low white blood cell count, which can make it harder for the body to fight off infections. Infections can be serious health problems, and they can also cause delays in treatment.

Pegfilgrastim can be given once per cycle of chemotherapy to help the body make more white blood cells. This helps the body fight infection. Pegfilgrastim is usually given by injection, often in a doctor’s office, at least 24 hours after chemotherapy treatment. However, the On-body Injector for Neulasta is a new option for some people.

How It Works

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The device is applied to the body by a doctor or nurse on the same day as chemotherapy treatment. A small needle inserts a short, soft tube called a cannula through the skin and into fatty tissue in the body that is located directly underneath the site where the device is applied. The device is designed to release pegfilgrastim about 27 hours after it is placed on the skin, slowly injecting it over a 45-minute period.

Until it releases the medicine, a green light flashes every 5 seconds to show the device is working. It is important that the person receiving the medicine or a caregiver monitor this signal to make sure the device is still working. A fill meter on the device shows that it is full before it is released, and that it is empty once the medicine has entered the body. About 30 seconds to 2 minutes prior to the time the injection of medicine is to begin, there will be a warning beep. After that, the device’s light will flash quickly during the full 45-minute period of the injection. This indicates that the medicine is being released correctly. After the injection is complete, the green light will remain solid for 1 hour. The empty On-body Injector can be removed during or after this 1-hour period. A container is supplied for safe disposal of the On-body Injector.

Safety Information

Before using the On-body Injector, talk to your doctor about all medicines you are taking, other medical problems you may have, and if you:

• Have sickle cell trait or sickle cell disease, as the treatment can cause severe pain in people with this condition
• Have had severe skin reactions to certain types of glue
• Are allergic to latex
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

The most common side effect of pegfilgrastim is pain in the bones and in the arms and legs. Serious side effects can include

• Spleen rupture
• Lung problems
• Allergic reactions

While you are wearing the On-body Injector, avoid

• Traveling, driving or operating heavy machinery during hours 26-29 after the device was applied
• Sleeping on the device or putting pressure on it (Put the device on the side of your body that you don’t usually sleep on.)
• Bumping it or knocking it off your body
• Getting body lotions, creams, oils or other skin cleansing products near the device
• Hot tubs, whirlpools, saunas and direct sunlight. Wear a T-shirt or other garment over the device if you are at the beach or pool
• Peeling off or disturbing the device before you’ve received the full dose of pegfilgrastim
• Getting electronic devices, such as a cell phone, within 4 inches of the device
• CT scans or other radiology imaging

What This Means for You

If you receive chemotherapy to treat breast cancer and another medicine to treat the risk of infection chemotherapy can cause, scheduling an extra appointment every cycle may be a burden. It may be helpful to have this delivery method as an option for neutropenia prevention and treatment. It may also be reassuring to know that most insurance plans cover the Neulasta Delivery Kit, including Medicare. If you’re interested in this treatment option, talk to your doctor. For more information about the On-body Injector for Neulasta, visit Neualasta.com.