Is LEUKINE FDA approved?

Is LEUKINE FDA approved?

On March 29, 2018, the FDA approved use of Leukine (sargramostim) to increase survival in adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS). Myelosuppression occurs when radiation damages the bone marrow.

What type of drug is LEUKINE?

Drug type: Leukine is a biologic response modifier. Leukine is classified as a colony stimulating factor.

What are the side effects of filgrastim?

Filgrastim injection products may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, swelling, bruising, itching or a lump in the place where the medication was injected.
• bone, joint, back, arm, leg, mouth, throat, or muscle pain.
• headache.
• rash.
• constipation.
• diarrhea.
• nausea.

What is the cost of LEUKINE?

The cost for Leukine injectable powder for injection 250 mcg is around $1,447 for a supply of 5 powder for injection, depending on the pharmacy you visit….Injectable Powder For Injection.

How do you store LEUKINE?

Store LEUKINE injection for up to 20 days at 2°C-8°C once the vial has been entered. Discard any remaining solution after 20 days.

Who makes LEUKINE?

Partner Therapeutics
LEUKINE®, approved by the US FDA in 1991 and now manufactured by Partner Therapeutics, is a recombinant granulocyte macrophage colony-stimulating factor (GM-CSF) that stimulates the immune system and has been used in leukemia patients to reduce the risk of infection.

What is the therapeutic use of sargramostim LEUKINE )?

White blood cells help your body fight against infection. Leukine is used in adults and children who are at least 2 years old, to help prevent serious infection in conditions such as leukemia, bone marrow transplant, and pre-chemotherapy blood cell collection.

Why is LEUKINE used?

Leukine (sargramostim) is a protein that stimulates the production of white blood cells 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.

What is a dangerously low white blood cell count?

The definition of low white blood cell count varies from one medical practice to another. In general, for adults a count lower than 4,000 white blood cells per microliter of blood is considered a low white blood cell count.

What is the most common side effect of docetaxel?

The most common adverse reactions across all TAXOTERE indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin …

Who makes leukine?

What is leukine used for?

Are there any side effects after taking Leukine?

Edema, capillary leak syndrome, and pleural and/or pericardial effusion, have been reported in patients after Leukine administration.

What should I do if I have an allergic reaction to Leukine?

Parenteral administration of Leukine should be attended by appropriate precautions in case an allergic or untoward reaction occurs. If any serious allergic or anaphylactic reaction occurs, immediately discontinue Leukine therapy and institute medical management. Discontinue Leukine permanently for patients with serious allergic reactions.

Is it safe to take Leukine with sargramostim?

Contraindications LEUKINE is contraindicated in patients with known hypersensitivity to human granulocyte-macrophage colony stimulating factor such as sargramostim (GM-CSF), yeast-derived products, or any component of LEUKINE. Warnings and Precautions

When to take Leukine for bone marrow transplantation?

Leukine is indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed.