Generic Name: paclitaxel (pack-li-TACKS-ahl) protein-bound particles for injectable suspension
Trade Name: Abraxane®
How is this drug used? Paclitaxel protein-bound particles for injectable suspension is FDA-approved for the treatment of metastastic breast cancer that has recurred following previous combination chemotherapy or for the treatment of adjuvant breast cancer that has recurred within 6 months of receiving previous combination chemotherapy. Prior therapy for breast cancer patients treated with paclitaxel protein-bound particles for injectable suspension should have included a class of chemotherapy agents referred to as anthracyclines, unless the patient is medically ineligible for treatment with anthracyclines. Aditionally, paclitaxel protein-bound particles for injectable suspension is approved for first-line treatment in combination with carboplatin for advanced non-small cell lung cancer (NSCLC) who are not candidates for surgery or radiation, and in first-line treatment for advanced adenocarcinoma of the pancreas in combination with gemcitabine.
What is the mechanism of action? Paclitaxel protein-bound particles for injectable suspension belongs to a group of drugs referred to as taxanes, which are anti-microtubule agents. Paclitaxel protein-bound particles for injectable suspension produces its anti-cancer effects by causing abnormalities in microtubule formation in cells. Microtubules are components of cells that provide structural framework that enables cells to divide and grow. The abnormal microtubule formation caused by paclitaxel protein-bound particles for injectable suspension inhibits cellular replication and ultimately causes cellular death. Paclitaxel protein-bound particles for injectable suspension is unique in that the active form of the drug is bound with albumin, which is a type of protein normally found in the human body. This form of paclitaxel delivers high concentrations of the active ingredient into the cancer cells and reduces the incidence of side effects compared to the original form of the drug.
How is paclitaxel protein-bound particles for injectable suspension given (administered)? Paclitaxel protein-bound particles for injectable suspension is administered intravenously (into a vein) and the dose depends on several factors, including the size of the patient, the particular regimen being used, and the overall health of the patient.
Allergic-type reactions, although rare, may occur following treatment with paclitaxel protein-bound particles for injectable suspension. These reactions are characterized by difficulty breathing, low blood pressure, lightheadedness or dizziness. Patients will be monitored for these reactions.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with paclitaxel protein-bound particles for injectable suspension. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. A neurologic exam that includes reflex testing will be performed, as paclitaxel protein-bound particles for injectable suspension may cause numbness to the feet, hands or extremities. Patients may also have their heart function monitored, as paclitaxel protein-bound particles for injectable suspension has caused abnormalities to the heart, although this is uncommon.
What are the common (occur in 30% or more of patients) side effects of treatment with paclitaxel protein-bound particles for injectable suspension?
- Low levels of white blood cells – increases risk of infection
- Low levels of red blood cells – increases risk of anemia
- Abnormalities on heart rhythm tests
- Abnormalities or numbness in sensation to the feet, hands or extremities
- Muscle aches or pain
- Joint aches or pain
- Hair loss
- Changes in liver function tests
What are the less common (occur in 10% to 29% of patients) side effects of treatment with paclitaxel protein-bound particles for injectable suspension?
- Shortness of breath
- Fluid retention
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
- Pay careful attention to the physician’s instructions and inform the physician of any side effects.
- Maintain adequate rest and nutrition.
- If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
- Wash hands often to reduce the risk of infection.
- Eat small, frequent meals in an attempt to relieve nausea.
Are there any special precautions patients should be aware of before starting treatment?
- Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
- It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
- Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
- Patients should check with their physician before starting any new drug or nutritional supplement.
- Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
- Patients with advanced adenocarcinoma of the pancreas with moderate to severe hepatic impairment should not be administered this line of treatment.
When should patients notify their physician?
- Sore throat
- Flu or cold-like symptoms
- Excessive or prolonged fatigue or weakness
- Yellowing of skin or eyes
- Changes in heart rate or rhythm
- Difficulty in breathing
- Chest pain
- Excessive or prolonged nausea or vomiting
- Severe or prolonged diarrhea
- Numbness or changes in sensation in extremities
- Severe pain
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy, or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition, or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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