Abraxane

Name: Abraxane

What should I discuss with my healthcare provider before receiving paclitaxel protein-bound?

You should not receive paclitaxel protein-bound if you are allergic to it, or if you have:

  • a low white blood cell count; or

  • severe liver disease.

To make sure paclitaxel protein-bound is safe for you, tell your doctor if you have:

  • liver disease;

  • kidney disease;

  • heart disease, heart rhythm disorder; or

  • bone marrow suppression.

Do not use paclitaxel protein-bound if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy during treatment.

Use birth control to prevent pregnancy while you are receiving this medicine, whether you are a man or a woman. Paclitaxel protein-bound use by either parent may cause birth defects. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving paclitaxel protein-bound.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Commonly used brand name(s)

In the U.S.

  • Abraxane

Available Dosage Forms:

  • Powder for Suspension

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

Precautions While Using Abraxane

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Men who are receiving this medicine should not father a child. This medicine can harm the unborn baby of your partner.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

Paclitaxel can temporarily lower the number of white blood cells in your blood, which will increase the chance of getting an infection. It can also lower the number of platelets in your blood, which are necessary for proper blood clotting. If this occurs, these are the precautions you can take to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection, or if you get a fever or chills, cough or hoarseness, lower back or side pain, or have painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in your urine or stools, or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects, such as a safety razor, fingernail clippers, or toenail clippers.
  • Avoid contact sports or other situations where bruising or injury could occur.

This medicine is made from donated human blood. Although the risk is low, some people have received viruses from human blood products. Human donors and donated blood are both tested for viruses before the medicine is prepared. Talk with your doctor if this concerns you.

Check with your doctor right away if you have burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called sensory neuropathy.

Lung or breathing problems may occur if you are receiving this medicine together with gemcitabine. Tell your doctor right away if you have shortness of breath, trouble breathing, or a persistent dry cough.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What do I need to tell my doctor BEFORE I take Abraxane?

  • If you have an allergy to paclitaxel or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have liver disease.
  • If you are breast-feeding or plan to breast-feed.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Abraxane with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Very bad dizziness or passing out.
  • Chest pain or pressure or a fast heartbeat.
  • Flushing.
  • A heartbeat that does not feel normal.
  • Slow heartbeat.
  • Very bad headache.
  • Very bad belly pain.
  • Very upset stomach or throwing up.
  • Very loose stools (diarrhea).
  • A burning, numbness, or tingling feeling that is not normal.
  • Any unexplained bruising or bleeding.
  • Nosebleed.
  • Feeling very tired or weak.
  • Very bad muscle or joint pain.
  • Change in eyesight.
  • Irritation where the shot is given.
  • This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.
  • Very bad and sometimes deadly lung problems have happened with Abraxane. Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.

Drug Interactions

The metabolism of paclitaxel is catalyzed by CYP2C8 and CYP3A4. Caution should be exercised when administering Abraxane concomitantly with medicines known to inhibit (e.g., ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) or induce (e.g., rifampicin, carbamazepine, phenytoin, efavirenz, and nevirapine) either CYP2C8 or CYP3A4.

Abraxane Description

Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non-crystalline, amorphous state. Abraxane is supplied as a white to yellow, sterile, lyophilized powder for reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP prior to intravenous infusion. Each single-use vial contains 100 mg of paclitaxel (bound to human albumin) and approximately 900 mg of human albumin (containing sodium caprylate and sodium acetyltryptophanate). Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel formulated as albumin-bound particles. Abraxane is free of solvents.

The active agent in Abraxane is paclitaxel, a microtubule inhibitor. The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine.

Paclitaxel has the following structural formula:

Paclitaxel is a white to off-white crystalline powder with the empirical formula C47H51NO14 and a molecular weight of 853.91. It is highly lipophilic, insoluble in water, and melts at approximately 216°C to 217°C.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of Abraxane has not been studied.

Paclitaxel was clastogenic in vitro (chromosome aberrations in human lymphocytes) and in vivo (micronucleus test in mice). Abraxane was not mutagenic in the Ames test or the CHO/HGPRT gene mutation assay.

Administration of paclitaxel formulated as albumin-bound particles to male rats at 42 mg/m2 on a weekly basis (approximately 16% of the daily maximum recommended human exposure on a body surface area basis) for 11 weeks prior to mating with untreated female rats resulted in significantly reduced fertility accompanied by decreased pregnancy rates and increased loss of embryos in mated females. A low incidence of skeletal and soft tissue fetal anomalies was also observed at doses of 3 and 12 mg/m2/week in this study (approximately 1 to 5% of the daily maximum recommended human exposure on a mg/m2 basis). Testicular atrophy/degeneration was observed in single-dose toxicology studies in rodents administered paclitaxel formulated as albumin-bound particles at doses lower than the recommended human dose; doses were 54 mg/m2 in rodents and 175 mg/m2 in dogs.

Clinical Studies

Metastatic Breast Cancer

Data from 106 patients accrued in two single arm open label studies and from 460 patients enrolled in a randomized comparative study were available to support the use of Abraxane in metastatic breast cancer.

Single Arm Open Label Studies
In one study, Abraxane was administered as a 30-minute infusion at a dose of 175 mg/m2 to 43 patients with metastatic breast cancer. The second trial utilized a dose of 300 mg/m2 as a 30-minute infusion in 63 patients with metastatic breast cancer. Cycles were administered at 3-week intervals. Objective responses were observed in both studies.

Randomized Comparative Study
This multicenter trial was conducted in 460 patients with metastatic breast cancer. Patients were randomized to receive Abraxane at a dose of 260 mg/m2 given as a 30-minute infusion, or paclitaxel injection at 175 mg/m2 given as a 3-hour infusion. Sixty-four percent of patients had impaired performance status (ECOG 1 or 2) at study entry; 79% had visceral metastases; and 76% had > 3 sites of metastases. Fourteen percent of the patients had not received prior chemotherapy; 27% had received chemotherapy in the adjuvant setting, 40% in the metastatic setting and 19% in both metastatic and adjuvant settings. Fifty-nine percent received study drug as second or greater than second-line therapy. Seventy-seven percent of the patients had been previously exposed to anthracyclines.

In this trial, patients in the Abraxane treatment arm had a statistically significantly higher reconciled target lesion response rate (the trial primary endpoint) of 21.5% (95% CI: 16.2% to 26.7%), compared to 11.1% (95% CI: 6.9% to 15.1%) for patients in the paclitaxel injection treatment arm. See Table 11. There was no statistically significant difference in overall survival between the two study arms.

Table 11: Efficacy Results from Randomized Metastatic Breast Cancer Trial
a Reconciled Target Lesion Response Rate (TLRR) was the prospectively defined protocol specific endpoint, based on independent radiologic assessment of tumor responses reconciled with investigator responses (which also included clinical information) for the first 6 cycles of therapy. The reconciled TLRR was lower than the investigator Reported Response Rates, which are based on all cycles of therapy.
b From Cochran-Mantel-Haenszel test stratified by 1st line vs. > 1st line therapy.
c Prior therapy included an anthracycline unless clinically contraindicated.
  Abraxane
260 mg/m2
Paclitaxel Injection
175 mg/m2
Reconciled Target Lesion Response Rate (primary endpoint)a
All randomized patients Response Rate
[95% CI]
50/233 (21.5%)
[16.19% – 26.73%]
25/227 (11.1%)
[6.94% – 15.09%]
p-valueb 0.003
Patients who had failed combination chemotherapy or relapsed within 6 months of adjuvant chemotherapyc Response Rate
[95% CI]
20/129 (15.5%)
[9.26% – 21.75%]
12/143 (8.4%)
[3.85% – 12.94%]

Non-Small Cell Lung Cancer

A multicenter, randomized, open-label study was conducted in 1052 chemonaive patients with Stage IIIb/IV non-small cell lung cancer to compare Abraxane in combination with carboplatin to paclitaxel injection in combination with carboplatin as first-line treatment in patients with advanced non-small cell lung cancer. Abraxane was administered as an intravenous infusion over 30 minutes at a dose of 100 mg/m2 on Days 1, 8, and 15 of each 21-day cycle. Paclitaxel injection was administered as an intravenous infusion over 3 hours at a dose of 200 mg/m2, following premedication. In both treatment arms carboplatin at a dose of AUC = 6 mg•min/mL was administered intravenously on Day 1 of each 21-day cycle after completion of Abraxane/paclitaxel infusion. Treatment was administered until disease progression or development of an unacceptable toxicity. The major efficacy outcome measure was overall response rate as determined by a central independent review committee using RECIST guidelines (Version 1.0).

In the intent-to-treat (all-randomized) population, the median age was 60 years, 75% were men, 81% were White, 49% had adenocarcinoma, 43% had squamous cell lung cancer, 76% were ECOG PS 1, and 73% were current or former smokers. Patients received a median of 6 cycles of treatment in both study arms.

Patients in the Abraxane/carboplatin arm had a statistically significantly higher overall response rate compared to patients in the paclitaxel injection/carboplatin arm [(33% versus 25%) see Table 12]. There was no statistically significant difference in overall survival between the two study arms.

Table 12: Efficacy Results from Randomized Non-Small Cell Lung Cancer Trial (Intent-to-Treat Population)
CI = confidence interval; DoR= Duration of response
Abraxane (100 mg/m2
weekly)
+ carboplatin
(N=521)
Paclitaxel Injection
(200 mg/m2 every 3 weeks)
+ carboplatin
(N=531)
Overall Response Rate (ORR)
Confirmed complete or partial overall response, n (%) 170 (33%) 132 (25%)
      95% CI 28.6, 36.7 21.2, 28.5
      P-value (Chi-Square test) 0.005
           
Median DoR in months (95% CI) 6.9 (5.6, 8.0) 6.0 (5.6, 7.1)
           
Overall Response Rate by Histology
Carcinoma/Adenocarcinoma 66/254 (26%) 71/264 (27%)
Squamous Cell Carcinoma 94/229 (41%) 54/221 (24%)
Large Cell Carcinoma 3/9 (33%) 2/13 (15%)
Other 7/29 (24%) 5/33 (15%)

Adenocarcinoma of the Pancreas

A multicenter, multinational, randomized, open-label study was conducted in 861 patients comparing Abraxane plus gemcitabine versus gemcitabine monotherapy as first-line treatment of metastatic adenocarcinoma of the pancreas. Key eligibility criteria were Karnofsky Performance Status (KPS) ≥70, normal bilirubin level, transaminase levels ≤ 2.5 times the upper limit of normal (ULN) or ≤ 5 times the ULN for patients with liver metastasis, no prior cytotoxic chemotherapy in the adjuvant setting or for metastatic disease, no ongoing active infection requiring systemic therapy, and no history of interstitial lung disease. Patients with rapid decline in KPS (≥10%) or serum albumin (≥20%) during the 14 day screening period prior to study randomization were ineligible.

A total of 861 patients were randomized (1:1) to the Abraxane/gemcitabine arm (N=431) or to the gemcitabine arm (N=430). Randomization was stratified by geographic region (Australia, Western Europe, Eastern Europe, or North America), KPS (70 to 80 versus 90 to 100), and presence of liver metastasis (yes versus no). Patients randomized to Abraxane/gemcitabine received Abraxane 125 mg/m2 as an intravenous infusion over 30-40 minutes followed by gemcitabine 1000 mg/m2 as an intravenous infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle. Patients randomized to gemcitabine received 1000 mg/m2 as an intravenous infusion over 30-40 minutes weekly for 7 weeks followed by a 1-week rest period in Cycle 1 then as 1000 mg/m2 on Days 1, 8 and 15 of each subsequent 28-day cycle. Patients in both arms received treatment until disease progression or unacceptable toxicity. The major efficacy outcome measure was overall survival (OS). Additional outcome measures were progression-free survival (PFS) and overall response rate (ORR), both assessed by independent, central, blinded radiological review using RECIST (version 1.0).

In the intent to treat (all randomized) population, the median age was 63 years (range 27-88 years) with 42% ≥ 65 years of age; 58% were men; 93% were White and KPS was 90-100 in 60%. Disease characteristics included 46% of patients with 3 or more metastatic sites; 84% of patients had liver metastasis; and the location of the primary pancreatic lesion was in the head of pancreas (43%), body (31%), or tail (25%).

Results for overall survival, progression-free survival, and overall response rate are shown in Table 13.

Table 13: Efficacy Results from Randomized Study in Patients with Adenocarcinoma of the Pancreas (ITT Population)
CI = confidence interval, HR = hazard ratio of Abraxane plus gemcitabine / gemcitabine, ITT = intent-to-treat population.
a Stratified Cox proportional hazard model.
b Stratified log-rank test stratified by geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis (yes versus no).
c Based on Independent Radiological Reviewer Assessment.
d Chi-square test.
Abraxane (125 mg/m2)
and gemcitabine
(N = 431)
Gemcitabine
(N = 430)
Overall Survival
Number of deaths, n (%) 333 (77) 359 (83)
      Median Overall Survival (months) 8.5 6.7
      95% CI 7.9, 9.5 6.0, 7.2
      HR (95% CI) a 0.72 (0.62, 0.83)
      P-valueb <0.0001
Progression-free Survivalc
Death or progression, n (%) 277 (64) 265 (62)
      Median Progression-free Survival (months) 5.5 3.7
      95% CI 4.5, 5.9 3.6, 4.0
      HR (95% CI) a 0.69 (0.58, 0.82)
      P-valueb <0.0001
Overall Response Ratec
Confirmed complete or partial overall response, n (%) 99 (23) 31 (7)
      95% CI 19.1, 27.2 5.0, 10.1
      P-value d <0.0001

In exploratory analyses conducted in clinically relevant subgroups with a sufficient number of subjects, the treatment effects on overall survival were similar to that observed in the overall study population.

Figure 1: Kaplan-Meier Curve of Overall Survival (Intent-to-treat Population)

Abraxane and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. No well-controlled studies have been done in humans. Based on its mechanism of action and findings in animals, Abraxane can harm your unborn baby. You should not become pregnant while receiving Abraxane. Women who may become pregnant should use effective birth control (contraception). Talk to your doctor about the best way to prevent pregnancy while receiving Abraxane.

Warnings

Black Box Warnings

Should not be administered if baseline neutrophil counts <1,500 cells/mm³; frequent monitoring of peripheral blood cell counts for all patients recommended to avoid bone marrow suppression

An albumin form of paclitaxel may substantially affect a drug’s functional properties relative to those of drug in solution; do not substitute for or with other paclitaxel formulations

Contraindications

Neutrophils <1500 cells/mm³

Severe and sometimes fatal hypersensitivity reactions, including anaphylactic reactions reported; do not rechallenge in patients who experience severe hypersensitivity

Cautions

Causes myelosuppression; monitor CBC and withhold and/or reduce the dose as needed (see Dosage Modifications)

Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption (see Dosage Modifications)

Sepsis occurred in 5% of patients with or without neutropenia; biliary obstruction or presence of biliary stent were risk factors for severe or fatal sepsis

Pneumonitis, including fatalities, occurred in 4% of patients

Exposure and toxicity increased with hepatic impairment; particularly from myelosuppression; closely monitor for development of profound myelosuppression; monitor AST and bilirubin and adjust dose if needed (see Dosage Modifications)

Contains albumin derived from human blood which has a theoretical risk of viral transmission

Fetal harm may occur when administered to a pregnant woman; women of childbearing potential should avoid becoming pregnant

Men should not father a child while taking paclitaxel

CYP3A4 and CYP2C8 substrate; inducers or inhibitors of these isoenzymes may alter metabolism; if coadministered, monitor closely

Patient Handout

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Before taking this medicine

You should not receive Abraxane if you are allergic to paclitaxel, or if you have:

  • a low white blood cell count; or

  • severe liver disease.

To make sure Abraxane is safe for you, tell your doctor if you have:

  • liver disease;

  • kidney disease;

  • heart disease, heart rhythm disorder; or

  • bone marrow suppression.

Do not use Abraxane if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy during treatment.

Use birth control to prevent pregnancy while you are receiving this medicine, whether you are a man or a woman. Abraxane use by either parent may cause birth defects. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

It is not known whether paclitaxel protein-bound passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving Abraxane.

Abraxane dosing information

Usual Adult Dose of Abraxane for Breast Cancer:

260 mg/m2 administered intravenously over 30 minutes every 3 weeks

Usual Adult Dose of Abraxane for Non-Small Cell Lung Cancer:

100 mg/m2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. The recommended dose of carboplatin is target AUC of 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of paclitaxel protein-bound administration.

The Calvert Formula for calculating carboplatin dosing is: Total carboplatin dose (mg) = (target AUC) x (GFR + 25) with GFR capped at 125 mL/min. For carboplatin target AUC of 6 mg*min/mL the resulting maximum carboplatin dose is 900 mg.

Usual Adult Dose of Abraxane for Pancreatic Cancer:

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 paclitaxel protein-bound on Days 1, 8 and 15 of each 28-day cycle.

Approved indication: Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

For the Consumer

Applies to paclitaxel protein-bound: intravenous powder for suspension

Along with its needed effects, paclitaxel protein-bound (the active ingredient contained in Abraxane) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking paclitaxel protein-bound:

More common
  • Black, tarry stools
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred or double vision
  • chest pain
  • chills
  • cough
  • fever
  • loss of taste
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • rapid weight gain
  • sneezing
  • sore mouth, tongue, or throat
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual weight gain or loss
  • unusual tiredness or weakness
Less common
  • Anxiety
  • bleeding
  • blood in the urine or stools
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • confusion
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, slow, or irregular heartbeat or pulse
  • general feeling of discomfort or illness
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • pain in the chest, groin, or legs, especially the calves
  • pinpoint red spots on the skin
  • rapid, shallow breathing
  • sensation of pins and needles
  • severe, sudden headache
  • skin itching, rash, or redness
  • slurred or slow speech
  • stabbing pain
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arms or legs
  • sudden, unexplained shortness of breath
  • sweating
  • swelling of the face, throat, or tongue
  • thickening of bronchial secretions
  • trouble thinking or walking

Some side effects of paclitaxel protein-bound may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Cracked lips
  • decreased appetite
  • diarrhea
  • difficulty with moving
  • headache
  • lack or loss of strength
  • loss of hair
  • muscle pain or stiffness
  • nausea
  • pain in the joints
  • swelling
  • vomiting
Less common
  • Bleeding, blistering, burning, coldness, discoloration of the skin, a feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Rare
  • Nail changes

Usual Adult Dose for Pancreatic Cancer

125 mg/m2 IV over 30 to 40 minutes on Days 1, 8, and 15 of each 28-day cycle; administer gemcitabine immediately after paclitaxel protein-bound on Days 1, 8 and 15 of each 28-day cycle

Use: For metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine

Other Comments

Administration advice:
-This drug should only be administered under the supervision of a qualified oncologist in facilities specialized in the administration of cytotoxic agents.
-This drug should not be substituted for or with other paclitaxel formulations.
-For IV administration only

Storage requirements:
-Store in original container to protect from light.
-Consult the manufacturer product information.

Reconstitution/preparation techniques:
-Consult the manufacturer product information.

IV compatibility:
Consult the manufacturer product information

Usual Adult Dose for Breast Cancer - Adjuvant

For adjuvant treatment of node-positive breast cancer:
175 mg/m2 IV over 3 hours every 3 weeks for 4 courses administered sequentially to doxorubicin-containing chemotherapy

Comment:
-All patients should be premedicated prior to receiving this drug to prevent severe hypersensitivity reactions. Consult the manufacturer product information or local protocol for premedication guidelines.

Use: For the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy

Precautions

US BOXED WARNINGS:
-This drug should only be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents in facilities appropriately equipped for management of complications.
-Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving this drug in clinical trials. Fatal reactions can occur despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H2 antagonists. Patients who experience severe hypersensitivity reactions should not be rechallenged with the drug.
-This drug should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm3 and should not be given to patients with AIDS-related Kaposi's sarcoma if the baseline neutrophil count is less than 1000 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving this drug.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

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