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What you should know before using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatrics

Studies on this medicine have been done only in adult patients and there is no specific information comparing use of pegfilgrastim in children with use in other age groups. The 6-mg syringe should not be used in infants, children, and smaller adolescents weighing less than 45 kilograms (99 lbs) of body weight.

Geriatric

This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bone marrow cancer or other bone marrow problems—Pegfilgrastim may make cancer or other problems worse.
  • Liver problems—Safety of this medicine in patients with liver problems has not been studied.
  • Peripheral blood progenitor cell (PBPC) mobilization—Use of pegfilgrastim is not recommended for PBPC mobilization.
  • Sepsis (serious infection)—There have been reports of adult respiratory distress syndrome (ARDS) in patients who had a serious infection and were receiving a similar medicine called filgrastim.
  • Sickle cell disease—Pegfilgrastim may increase the risk of unwanted effects.

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