Leukine

DRUG DESCRIPTION

LEUKINE® (sargramostim) is a recombinant human granulocyte macrophage colony stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast (S. cerevisiae) expression system. GM-CSF is a hematopoietic growth factor which stimulates proliferation and differentiation of hematopoietic progenitor cells. LEUKINE (sargramostim) is a glycoprotein of 127 amino acids characterized by three primary molecular species having molecular masses of 19,500, 16,800 and 15,500 daltons. The amino acid sequence of LEUKINE (sargramostim) differs from the natural human GM-CSF by a substitution of leucine at position 23, and the carbohydrate moiety may be different from the native protein. Sargramostim has been selected as the proper name for yeast derived rhu GM-CSF.

The liquid LEUKINE (sargramostim) presentation is formulated as a sterile, preserved (1.1% benzyl alcohol), injectable solution (500 mcg/mL) in a vial. Lyophilized LEUKINE (sargramostim) is a sterile, white, preservative free powder (250 mcg) that requires reconstitution with 1 mL Sterile Water for Injection, USP or 1 mL Bacteriostatic Water for Injection, USP. Liquid LEUKINE (sargramostim) has a pH range of 6.7 - 7.7 and lyophilized LEUKINE (sargramostim) has a pH range of 7.1 - 7.7.

Liquid LEUKINE (sargramostim) and reconstituted lyophilized LEUKINE (sargramostim) are clear, colorless liquids suitable for subcutaneous injection (SC) or intravenous infusion (IV). Liquid LEUKINE contains 500 mcg (2.8 x 106 IU/mL) sargramostim and 1.1% benzyl alcohol in a 1 mL solution. The vial of lyophilized LEUKINE (sargramostim) contains 250 mcg (1.4 x 106 IU/vial) sargramostim. The liquid LEUKINE (sargramostim) vial and reconstituted lyophilized LEUKINE (sargramostim) vial also contain 40 mg/mL mannitol, USP; 10 mg/mL sucrose, NF; and 1.2 mg/mL tromethamine, USP, as excipients. Biological potency is expressed in International Units (IU) as tested against the WHO First International Reference Standard. The specific activity of LEUKINE (sargramostim) is approximately 5.6 x 106 IU/mg.

What are the possible side effects of sargramostim (Leukine)?

If you experience any of the following serious side effects, stop using sargramostim and seek emergency medical treatment or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • dizziness or fainting;
  • a fever (over 100.5 degrees Fahrenheit or 38 degrees Celsius);
  • signs of infection including chills, sore throat, or congestion or redness, pain, or swelling around a wound or sore;
  • swelling of...

Read All Potential Side Effects and See Pictures of Leukine »

What are the precautions when taking sargramostim (Leukine)?

Before using sargramostim, tell your doctor or pharmacist if you are allergic to it; or to other medications made in a similar manner (man-made proteins using Saccharomyces cerevisiae); or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), 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: fluid retention, lung problems, heart problems (e.g., congestive heart failure-CHF, rhythm problems), liver disease, kidney disease, other blood disorders (e.g., myeloid cancers), current chemotherapy.

If you are scheduled to have radiation therapy, tell your doctor you are taking sargramostim....

Read All Potential Precautions of Leukine »


Leukine Consumer (continued)

SIDE EFFECTS: Aching in the bones and muscles, chills, or headache may occur. Taking a non-aspirin pain reliever such as acetaminophen may help. Ask your doctor or pharmacist for more details. Nausea, vomiting, or injection-site reactions such as redness, swelling, itching, lumps, or bruising may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist 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.

Tell your doctor right away if you have any serious side effects, including: chest pain, sudden weight gain, swelling of the hands/feet, shortness of breath, black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, fast/irregular heartbeat, vision problems, a sudden reddening of the face/neck/chest, severe dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, 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 sargramostim, tell your doctor or pharmacist if you are allergic to it; or to other medications made in a similar manner (man-made proteins using Saccharomyces cerevisiae); or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), 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: fluid retention, lung problems, heart problems (e.g., congestive heart failure-CHF, rhythm problems), liver disease, kidney disease, other blood disorders (e.g., myeloid cancers), current chemotherapy.

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

During pregnancy, this medication should be used only when clearly needed. 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.


Leukine Patient Information Including Side Effects

Brand Names: Leukine

Generic Name: sargramostim (Pronunciation: sar grah MOSS tim)

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

What is sargramostim (Leukine)?

Sargramostim is a protein that stimulates the production of white blood cells. Sargramostim is similar a substance in the body called granulocyte-macrophage colony stimulating factor (GM-CSF).

Sargramostim is used to increase white blood cells and decrease the risk of infection in conditions such as cancer, bone marrow transplant, and pre-chemotherapy blood cell collection.

Sargramostim may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of sargramostim (Leukine)?

If you experience any of the following serious side effects, stop using sargramostim and seek emergency medical treatment or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • dizziness or fainting;
  • a fever (over 100.5 degrees Fahrenheit or 38 degrees Celsius);
  • signs of infection including chills, sore throat, or congestion or redness, pain, or swelling around a wound or sore;
  • swelling of the feet or lower legs;
  • sudden weight gain (5 pounds or more); or
  • chest pain, chest discomfort, or a fast, irregular pulse.

Other, less serious side effects may be more likely to occur. Continue to use sargramostim and talk to your doctor if you experience:

  • bone pain;
  • "flu-like" feeling;
  • chills;
  • muscle aching or weakness;
  • tiredness;
  • headache;
  • diarrhea;
  • nausea, upset stomach, or loss of appetite;
  • rash; or
  • swelling, redness, or pain at the injection site.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about sargramostim (Leukine)?

Do not administer an injection if you are unsure how it should be injected, how much to inject, or how often to inject the medication. Call your doctor, nurse, or pharmacist to go over the instructions with you.

Contact your doctor if you develop a fever, chills, sore throat, congestion, or other signs of infection or illness while using sargramostim.

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