Pegfilgrastim 

(Subcutaneous Route)

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1. Description and Brand Names
2. Before Using
3. Proper Use
4. Precautions
5. Side Effects

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Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

1. Neulasta

Descriptions

Pegfilgrastim is a synthetic (man-made) version of a substance that is naturally produced in your body called a colony stimulating factor. It helps the bone marrow to make new white blood cells.

When certain cancer medicines are used to fight cancer cells, they also affect the white blood cells that fight infections. Pegfilgrastim is used to reduce the risk of infection while you are being treated with cancer medicines.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, pegfilgrastim is used in certain patients with the following medical conditions:

• Harvesting of peripheral blood stem cells, prior to autologous stem-cell transplantation.

This product is available in the following dosage forms:

• Solution

• Before Using

  Drug information provided by: Micromedex
  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.
  

  Pediatric

  Appropriate studies have not been performed on the relationship of age to the effects of pegfilgrastim in the pediatric population. Safety and efficacy have not been established.
  

  Geriatric

  Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pegfilgrastim in the elderly.
  

  Pregnancy

  Information about this pegfilgrastim-subcutaneous-route

  	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.

  Breastfeeding

  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.

• Lung disease or breathing problems—Use with caution. May make these conditions worse.

• Peripheral blood progenitor cell (PBPC) mobilization—Use of pegfilgrastim is not recommended for PBPC mobilization.

• Sepsis (serious infection)—There have been reports of acute 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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  Proper Use

  Drug information provided by: Micromedex
  This medicine is given as a shot under your skin. You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
  This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions about:
  
• How to prepare the injection.
• The proper use of disposable syringes.
• How to give the injection.
• How long the injection can be stored at home.

If you have any questions about any of this, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injectable dosage form:
  • To increase white blood cell count:
    • Adults—6 milligrams (mg) as a single injection one time every chemotherapy cycle.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

• Precautions

  Drug information provided by: Micromedex
  It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
  The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause an allergic reaction in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.
  If you have left upper stomach pain or shoulder tip pain, contact your doctor right away. This could be a symptom of a serious side effect with the spleen.
  Check with your doctor right away at the first sign of any infection such as fever; chills; cough; diarrhea; sore throat; or redness, swelling, or pain around a cut or sore.
  Stop using this medicine and check with your doctor right away if you develop fever, shortness of breath, chest pain or tightness, fast breathing, or wheezing. These could be symptoms of a serious lung condition called acute respiratory distress syndrome (ARDS).
  This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; swelling of the face, tongue, or throat; trouble with breathing; or chest pain after you receive the medicine.
  You should not use this medicine for 14 days before and up to 24 hours after you receive cancer medicines.
  

  Side Effects

  Drug information provided by: Micromedex
  Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
  Check with your doctor immediately if any of the following side effects occur:
  

  More common

• Chills
• cough
• fever
• sore throat
• ulcers; sores, or white spots in the mouth

Rare

1. Bluish lips or skin
2. pain, left upper abdomen or shoulder
3. shortness of breath
4. tightness in the chest
5. troubled breathing
6. wheezing

Incidence not known

1. Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
2. difficulty with swallowing
3. dizziness
4. fast heartbeat
5. flushing or redness of the skin
6. hives or welts
7. itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
8. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
9. skin rash
10. sores on the skin
11. unusual tiredness or weakness
12. unusually warm skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

1. Abdominal or stomach pain
2. acid or sour stomach
3. belching
4. bone pain
5. change in sense of taste
6. constipation
7. cracked lips
8. diarrhea
9. hair loss or thinning of hair
10. headache
11. heartburn
12. indigestion
13. joint pain
14. lack or loss of strength
15. loss of appetite
16. muscle soreness
17. nausea
18. stomach discomfort, upset, or pain
19. swelling of the hands, ankles, feet, or lower legs
20. swelling or inflammation of the mouth
21. trouble sleeping
22. vomiting
23. weakness, generalized
24. weight loss

Incidence not known

1. Body produces substance that can bind to drug making it less effective or cause side effects

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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