Neulasta

DRUG DESCRIPTION

Neulasta® (pegfilgrastim) is a covalent conjugate of recombinant methionyl human G-CSF (Filgrastim) and monomethoxypolyethylene glycol. Filgrastim is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Filgrastim is obtained from the bacterial fermentation of a strain of Escherichia coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of Filgrastim. The average molecular weight of pegfilgrastim is approximately 39 kD.

Neulasta® (pegfilgrastim) is supplied in 0.6 mL prefilled syringes for subcutaneous injection. Each syringe contains 6 mg pegfilgrastim (based on protein weight), in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), sorbitol (30.0 mg), polysorbate 20 (0.02 mg), and sodium (0.02 mg) in water for injection, USP.

What are the possible side effects of pegfilgrastim (Neulasta)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; dizziness, fast pulse; sweating; swelling of your face, lips, tongue, or throat.

Stop using pegfilgrastim and call your doctor at once if you have any of these serious side effects:

  • sudden or severe pain in your left upper stomach spreading up to your shoulder;
  • rapid breathing or feeling short of breath;
  • any sign of infection such as fever, chills, body aches, flu symptoms,...

Read All Potential Side Effects and See Pictures of Neulasta »

What are the precautions when taking pegfilgrastim (Neulasta)?

Before using pegfilgrastim, tell your doctor or pharmacist if you are allergic to it or to filgrastim; or to other medications made in a similar way (biotechnology-produced proteins using E. coli); or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex in the needle cover on the prefilled syringe), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: sickle cell disease, spleen problems.

If you are scheduled to have radiation therapy, tell your doctor you are taking pegfilgrastim. This medication should not be given during the time you are receiving radiation...

Read All Potential Precautions of Neulasta »


Neulasta Consumer (continued)

SIDE EFFECTS: Bone pain may occur. Taking a non-aspirin pain reliever such as acetaminophen may help with this pain. Ask your doctor or pharmacist for more details. Injection site reactions such as redness, swelling, itching, lumps, or bruising may also occur. If any of these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if any of these rare but very serious side effects occur: breathing problems (e.g., trouble breathing, shortness of breath, fast breathing).

Rarely, possibly fatal damage to the spleen may occur. Get medical help right away if you experience the following side effects: stomach/abdominal pain and/or shoulder pain.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, fast heartbeat, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using pegfilgrastim, tell your doctor or pharmacist if you are allergic to it or to filgrastim; or to other medications made in a similar way (biotechnology-produced proteins using E. coli); or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex in the needle cover on the prefilled syringe), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: sickle cell disease, spleen problems.

If you are scheduled to have radiation therapy, tell your doctor you are taking pegfilgrastim. This medication should not be given during the time you are receiving radiation therapy.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Neulasta Patient Information Including Side Effects

Brand Names: Neulasta

Generic Name: pegfilgrastim (Pronunciation: PEG fil GRAS tim)

  • What is pegfilgrastim (Neulasta)?
  • What are the possible side effects of pegfilgrastim (Neulasta)?
  • What is the most important information I should know about pegfilgrastim (Neulasta)?
  • What should I discuss with my healthcare provider before using pegfilgrastim (Neulasta)?
  • How should I use pegfilgrastim (Neulasta)?
  • What happens if I miss a dose (Neulasta)?
  • What happens if I overdose (Neulasta)?
  • What should I avoid while using pegfilgrastim (Neulasta)?
  • What other drugs will affect pegfilgrastim (Neulasta)?
  • Where can I get more information?

What is pegfilgrastim (Neulasta)?

Pegfilgrastim is a colony stimulating factor. It is a man-made form of a protein that stimulates the growth of white blood cells called neutrophils in your body. White blood cells help your body fight against infection.

Pegfilgrastim is used to treat neutropenia, a lack of certain white blood cells caused by receiving cancer chemotherapy. It is used in people with cancers other than bone marrow cancer.

Pegfilgrastim may also be used for other purposes not listed in this medication guide.

What are the possible side effects of pegfilgrastim (Neulasta)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; dizziness, fast pulse; sweating; swelling of your face, lips, tongue, or throat.

Stop using pegfilgrastim and call your doctor at once if you have any of these serious side effects:

  • sudden or severe pain in your left upper stomach spreading up to your shoulder;
  • rapid breathing or feeling short of breath;
  • any sign of infection such as fever, chills, body aches, flu symptoms, diarrhea, skin rash, or redness or swelling of a skin wound;
  • swelling in your hands, ankles, or feet;
  • white patches or sores inside your mouth or on your lips; or
  • redness, swelling, bruising, itching, or a hard lump where the medicine was injected.

Less serious side effects may include:

  • muscle, joint, or bone pain;
  • temporary hair loss;
  • nausea, vomiting, constipation, loss of appetite;
  • changes in your sense of taste;
  • weakness, dizziness;
  • headache; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about pegfilgrastim (Neulasta)?

You should not use this medication if you are allergic to pegfilgrastim, filgrastim (Neupogen), or to other medicines made with the E. coli bacteria.

Before using pegfilgrastim, tell your doctor if you are allergic to any drugs, or if you have sickle cell disorder or are taking lithium (Eskalith, Lithobid).

Pegfilgrastim is usually given 24 hours after you receive a chemotherapy treatment. Pegfilgrastim should not be given within the 14 days leading up to your chemotherapy treatment, or within the 24 hours immediately following chemotherapy. Follow your doctor's instructions.

Call your doctor at once if you have a serious side effect such as sudden or severe pain in your left upper stomach spreading up to your shoulder, rapid breathing or feeling short of breath, or any sign of infection such as fever, chills, body aches, flu symptoms, diarrhea, skin rash, redness or swelling of a skin wound, or white patches or sores inside your mouth or on your lips.

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