Last Reviewed by C. H. Weaver M.D., Medical Editor 3/2019
For which conditions is this drug approved? Neulasta® has been FDA approved to decrease the risk of infection associated with treatment for cancer. Specifically, Neulasta® is approved for patients being treated for non-hematologic cancers with agents that are associated with causing low white blood cell levels, a condition that leaves patients susceptible to potential life-threatening infections. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Neulasta® belongs to a group of drugs called colony stimulating factors. Neulasta® stimulates the growth of neutrophils, a type of white blood cell, which are important immune cells that fight infection caused by bacteria, viruses or fungus. Neutrophils can be damaged by chemotherapy and leave patients susceptible to severe infection. Neulasta® works by binding to areas on immature blood cells, which stimulates the blood cells to grow, reproduce and mature into neutrophils. Neulasta® is a long-acting form of another commonly used colony stimulating factor, Neupogen® (filgrastim), meaning it stays active in the body for a longer time than Neupogen®.
How is Neulasta® typically given (administered)? Neulasta® is given as a subcutaneous (under the skin) injection and comes in prefilled syringes. The recommended dose of Neulasta® is a prefilled syringe (6 mg) once per chemotherapy cycle. Neulasta® should not be given to infants, children, or adolescents weighing less than 45 kilograms.
OnPro: The on-body injector is a small, lightweight delivery system applied to the skin during your chemo appointment. It's designed to automatically administer the dose of Neulasta® as an under-the-skin (subcutaneous) injection the next day, so you do not have to return to the doctor just for a Neulasta® injection.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Neulasta®. Typically, blood will be drawn to check levels of white blood cells. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.
What are the common (occur in 30% or more of patients) side effects of treatment with Neulasta®?
There are no known common side effects attributable to Neulasta®.
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Neulasta®?
• Bone pain
• Changes in some laboratory tests, which tend to normalize following treatment
• Soreness or tenderness at the injection site
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to alleviate bone pain associated with Neulasta injection?
Several medications can alleviate Neulasta associated bone pain.
Claritin (loratadine) taken prior to Neulasta injection can help prevent bone pain by blocking histamine release.(2)
What can patients do to help alleviate or prevent discomfort and side effects?
Since Neulasta® is typically given with chemotherapy agents that are associated with causing low neutrophil levels, much of the following pertains to precautions that should be taken to minimize the risk of infection. However, all chemotherapy agents are associated with individual risks.
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• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• If possible, avoid large crowds or people who are sick or not feeling well, as chemotherapy drugs may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Eat small meals frequently to help alleviate nausea.
• If patients have been prescribed an anti-nausea medication, they should be sure to take the prescribed doses.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• If Neulasta® is being administered at home, patients should make sure that they know how to safely store the drug and dispose of needles.
• Patients should not skip getting their blood drawn – important information, including responses to Neulasta® as well as to therapy, is obtained from these blood tests.
Are there special precautions patients should be aware of before treatment with Neulasta®?
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• Patients should tell their physician if they had any reactions to prior therapy with Neupogen®.
When should patients notify their physician?
• Pain in the left side of the abdomen
• Pain in the left shoulder tip
• Difficulty breathing
• Signs of allergic reaction (hives, skin rash, difficulty breathing, wheezing, facial swelling, fast pulse, sweating, low blood pressure)
• Signs of infection (fever, chills, cough, sore throat, redness, swelling)
What Do The Studies Show?
Naproxen May Relieve Bone Pain Associated with Neulasta
Twice-daily naproxen is effective in reducing the incidence and severity of bone pain associated with the use of Neulasta® (pegfilgrastim), according to the results of a study published in the Journal of Clinical Oncology.
Naproxen is a prescription pain reliever in a class of drugs called non-steroidal anti-inflammatory drugs or NSAIDs. It works by stopping the body’s production of a substance that causes pain, fever, and inflammation.
To evaluate the effects of naproxen on Neulasta-induced bone pain, researchers randomly assigned 510 patients to receive naproxen (500 mg, twice a day) or placebo on the day of Neulasta injection and continuing for five to eight days afterward. Patients recorded pain severity and duration on a daily basis.
The results indicated that pain reached its peak on day three for both groups, but was higher in the placebo group. Overall, the incidence and severity of pain was higher in the placebo group. The researchers concluded that naproxen reduced the incidence, duration, and severity of Neulasta-induced pain; however, even with the preventive treatment, more than 60 percent of patients experienced some pain. More strategies are needed to address bone pain associated with Neulasta, but naproxen appears to be one viable strategy.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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- Kirshner JJ, Heckler CE, Janelsins MC, et al. Prevention of pegfilgrastim-induced bone pain: A phase III double-blind placebo-controlled randomized clinical trial of the University of Rochester Cancer Center Clinical Community Oncology Program Research Base. Journal of Clinical Oncology. 2012; 16: 1974-1979.