Protein-bound paclitaxel

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What is Protein-bound paclitaxel?

PACLITAXEL
Paclitaxel.png


What are the uses of this medicine?

This medicine is used to treat:

How does this medicine work?

  • ABRAXANE is a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization.
  • This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions.
  • Paclitaxel induces abnormal arrays or "bundles" of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

  • your white blood cell count is below 1,500 cells/ mm3.
  • you have had a severe allergic reaction to ABRAXANE.

What drug interactions can this medicine cause?

  • Use caution when concomitantly administering ABRAXANE with inhibitors or inducers of either CYP2C8 or CYP3A4.

Is this medicine FDA approved?

  • Initial U.S. Approval: 2005

How should this medicine be used?

  • Closely monitor the infusion site for extravasation or drug infiltration during administration

Recommended Dosage: Recommended Dosage for Metastatic Breast Cancerː

  • After failure of combination chemotherapy for metastatic breast cancer or relapse within 6 months of adjuvant chemotherapy, the recommended regimen for ABRAXANE is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks.

Recommended Dosage for Non-Small Cell Lung Cancerː

  • The recommended dose of ABRAXANE is 100 mg/m2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Administer carboplatin on Day 1 of each 21-day cycle immediately after ABRAXANE.

Recommended Dosage for Adenocarcinoma of the Pancreasː

  • The recommended dose of ABRAXANE is 125 mg/m2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle. Administer gemcitabine immediately after ABRAXANE on Days 1, 8, and 15 of each 28-day cycle.

Use in Patients with Hepatic Impairment:

  • ABRAXANE is not recommended for use in patients with AST > 10 × ULN; or bilirubin > 5 × ULN or with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment. For MBC or NSCLC, reduce starting dose in patients with moderate to severe hepatic impairment.

Dose Reductions for Adverse Reactions:

  • Dose reductions or discontinuation may be needed based on severe hematologic, neurologic, cutaneous, or gastrointestinal toxicities.


Administration

  • Your healthcare provider will prescribe ABRAXANE in an amount that is right for you.
  • Your healthcare provider may give you certain medicines to help prevent allergic reactions if you have had an allergic reaction to ABRAXANE in the past.
  • ABRAXANE will be given to you by intravenous (IV) infusion into your vein.
  • Your healthcare provider should do blood tests regularly during treatment with ABRAXANE.
  • Your healthcare provider may stop your treatment, delay your treatment, or change your dose of ABRAXANE if you have certain side effects.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

  • As injectable suspension: white to yellow, sterile, lyophilized powder containing 100 mg of paclitaxel formulated as albumin-bound particles in single-dose vial for reconstitution.

This medicine is available in fallowing brand namesː

  • ABRAXANE

What side effects can this medication cause?

The most common side effects of ABRAXANE in people with breast cancer include:

  • hair loss
  • numbness, tingling, pain, or weakness in the hands or feet
  • tiredness
  • changes in your liver function tests
  • nausea
  • diarrhea
  • infections
  • decreased white blood cell count
  • abnormal heartbeat
  • joint and muscle pain
  • low red blood cell count (anemia). Red blood cells carry oxygen to your body tissues. Tell your healthcare provider if you feel weak, tired, or short of breath.

The most common side effects of ABRAXANE in people with non-small cell lung cancer include:

  • low red blood cell count (anemia)
  • decreased platelet cell count
  • numbness, tingling, pain, or weakness in the hands or feet
  • tiredness
  • decreased white blood cell count
  • hair loss
  • nausea

The most common side effects of ABRAXANE in people with pancreatic cancer include:

  • decreased white blood cell count
  • numbness, tingling, pain, or weakness in the hands or feet
  • hair loss
  • diarrhea
  • vomiting
  • rash
  • tiredness
  • nausea
  • swelling in the hands or feet
  • fever
  • decreased appetite
  • signs of dehydration including thirst, dry mouth, dark yellow urine, decreased urine, headache, or muscle cramps

ABRAXANE may cause serious side effects, including:

  • severe decreased blood cell counts
  • severe nerve problems (neuropathy)
  • severe infection (sepsis)
  • lung or breathing problems
  • severe allergic reactions

What special precautions should I follow?

  • Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption.
  • Sepsis occurred in patients with or without neutropenia who received ABRAXANE in combination with gemcitabine; interrupt ABRAXANE and gemcitabine until sepsis resolves, and if neutropenia, until neutrophils are at least 1500 cells/mm3, then resume treatment at reduced dose levels.
  • Pneumonitis occurred with the use of ABRAXANE in combination with gemcitabine; permanently discontinue treatment with ABRAXANE and gemcitabine.
  • Severe hypersensitivity reactions with fatal outcome have been reported. Do not rechallenge with this drug.
  • Exposure and toxicity of paclitaxel can be increased in patients with hepatic impairment, consider dose reduction and closely monitor patients with hepatic impairment.
  • ABRAXANE contains albumin derived from human blood, which has a theoretical risk of viral transmission.
  • ABRAXANE can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

Management of overdosage:

  • There is no known antidote for ABRAXANE overdosage.

Can this medicine be used in pregnancy?

  • Based on its mechanism of action and findings in animals, ABRAXANE can cause fetal harm when administered to a pregnant woman.
  • There are no available human data on ABRAXANE use in pregnant women to inform the drug-associated risk.

Can this medicine be used in children?

  • Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

  • Active ingredient: paclitaxel (bound to human albumin).
  • Other ingredient: human albumin (containing sodium caprylate and sodium acetyltryptophanate).

Who manufactures and distributes this medicine?

  • Manufactured for: Celgene Corporation Summit, NJ

ABRAXANE® is a registered trademark of Abraxis BioScience

What should I know about storage and disposal of this medication?

  • Store the vials in original cartons at 20°C to 25°C (68°F to 77°F).
  • Retain in the original package to protect from bright light.
  • Abraxane is a cytotoxic drug.
  • Follow applicable special handling and disposal procedures.


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