Abraxane

Name: Abraxane

What is the most important information I should know about paclitaxel protein-bound?

You should not receive paclitaxel protein-bound if you have a very low white blood cell count.

Uses of Abraxane

  • It is used to treat cancer.

What are some things I need to know or do while I take Abraxane?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Abraxane affects you.
  • Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
  • Other drugs may be given before this medicine to help avoid side effects.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
  • This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
  • Talk with your doctor before getting any vaccines. Use with Abraxane may either raise the chance of an infection or make the vaccine not work as well.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Do not father a child while taking Abraxane.
  • If you are a man and have sex with a female who could get pregnant, protect her from pregnancy. Use birth control that you can trust.
  • Use birth control that you can trust to prevent pregnancy while taking this medicine.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Abraxane, call your doctor right away.

Abraxane Dosage and Administration

Metastatic Breast Cancer

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.

Non-Small Cell Lung Cancer

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 [see Clinical Studies (14.2)].

Adenocarcinoma of the Pancreas

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 [see Clinical Studies (14.3)].

Dosage in Patients with Hepatic Impairment

For patients with mild hepatic impairment (total bilirubin greater than ULN and less than or equal to 1.5 x ULN and aspartate aminotransferase [AST] less than or equal to 10 x ULN), no dose adjustments are required, regardless of indication.

Do not administer Abraxane to patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment.

Do not administer Abraxane to patients with total bilirubin greater than 5 x ULN or AST greater than 10 x ULN regardless of indication as these patients have not been studied.

Recommendations for dosage adjustment for the first course of therapy are shown in Table 1.

Table 1: Recommendations for Starting Dose in Patients with Hepatic Impairment
MBC = Metastatic Breast Cancer; NSCLC = Non-Small Cell Lung Cancer.
a Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance.
b A dose increase to 260 mg/m2 for patients with metastatic breast cancer or 100 mg/m2 for patients with non-small cell lung cancer in subsequent courses should be considered if the patient tolerates the reduced dose for two cycles.
c Patients with bilirubin levels above the upper limit of normal were excluded from clinical trials for pancreatic or lung cancer.
SGOT (AST) Levels Bilirubin Levels Abraxane Dosea
MBC NSCLC c Pancreatic c
Adenocarcinoma
Mild < 10 x ULN AND > ULN to ≤ 1.5 x ULN 260 mg/m2 100 mg/m2 125 mg/m2
Moderate < 10 x ULN AND >1.5 to ≤ 3 x ULN 200 mg/m2 b 80 mg/m2 b not recommended
Severe < 10 x ULN AND > 3 to ≤ 5 x ULN 200 mg/m2 b 80 mg/m2 b not recommended
> 10 x ULN OR > 5 x ULN not recommended not recommended not recommended

Dose Reduction/Discontinuation Recommendations

Metastatic Breast Cancer
Patients who experience severe neutropenia (neutrophils less than 500 cells/mm3 for a week or longer) or severe sensory neuropathy during Abraxane therapy should have dosage reduced to 220 mg/m2 for subsequent courses of Abraxane. For recurrence of severe neutropenia or severe sensory neuropathy, additional dose reduction should be made to 180 mg/m2. For Grade 3 sensory neuropathy hold treatment until resolution to Grade 1 or 2, followed by a dose reduction for all subsequent courses of Abraxane [see Contraindications (4), Warnings and Precautions (5.1, 5.2) and Adverse Reactions (6.1)].

Non-Small Cell Lung Cancer

  • Do not administer Abraxane on Day 1 of a cycle until absolute neutrophil count (ANC) is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3 [see Contraindications (4),Warnings and Precautions (5.1) and Adverse Reactions (6.2)].
  • In patients who develop severe neutropenia or thrombocytopenia withhold treatment until counts recover to an absolute neutrophil count of at least 1500 cells/mm3 and platelet count of at least 100,000 cells/mm3 on Day 1 or to an absolute neutrophil count of at least 500 cells/mm3 and platelet count of at least 50,000 cells/mm3 on Days 8 or 15 of the cycle. Upon resumption of dosing, permanently reduce Abraxane and carboplatin doses as outlined in Table 2.
  • Withhold Abraxane for Grade 3-4 peripheral neuropathy. Resume Abraxane and carboplatin at reduced doses (see Table 2) when peripheral neuropathy improves to Grade 1 or completely resolves [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)].
Table 2: Permanent Dose Reductions for Hematologic and Neurologic Adverse Drug Reactions in NSCLC
Adverse Drug Reaction Occurrence Weekly
Abraxane Dose
(mg/m2)
Every 3-Week
Carboplatin Dose
(AUC mg•min/mL)
Neutropenic Fever (ANC less than 500/mm3 with fever >38°C)
                                                      OR
Delay of next cycle by more than 7 days for ANC less than 1500/mm3
                                                      OR
ANC less than 500/mm3 for more than 7 days
First 75 4.5
Second 50 3
Third Discontinue Treatment
Platelet count less than 50,000/mm3 First 75 4.5
Second Discontinue Treatment
Severe sensory Neuropathy – Grade 3 or 4 First 75 4.5
Second 50 3
Third Discontinue Treatment

Adenocarcinoma of the Pancreas
Dose level reductions for patients with adenocarcinoma of the pancreas, as referenced in Tables 4 and 5, are provided in Table 3.

Table 3: Dose Level Reductions for Patients with Adenocarcinoma of the Pancreas
  Dose Level Abraxane (mg/m2) Gemcitabine (mg/m2)
   Full dose 125 1000
   1st dose reduction 100 800
   2nd dose reduction 75 600
   If additional dose reduction required Discontinue Discontinue

Recommended dose modifications for neutropenia and thrombocytopenia for patients with adenocarcinoma of the pancreas are provided in Table 4.

Table 4: Dose Recommendation and Modifications for Neutropenia and/or Thrombocytopenia at the Start of a Cycle or within a Cycle for Patients with Adenocarcinoma of the Pancreas
ANC = Absolute Neutrophil Count
Cycle
Day
ANC (cells/mm3)     Platelet count (cells/mm3) Abraxane / Gemcitabine
Day 1   < 1500   OR      < 100,000 Delay doses until recovery
Day 8   500 to < 1000   OR      50,000 to < 75,000 Reduce 1 dose level
      < 500   OR      < 50,000 Withhold doses
Day 15: If Day 8 doses were reduced or given without modification:
      500 to < 1000   OR      50,000 to < 75,000 Reduce 1 dose level from Day 8
      < 500   OR      < 50,000 Withhold doses
Day 15: If Day 8 doses were withheld:
      ≥ 1000   OR      ≥ 75,000 Reduce 1 dose level from Day 1
      500 to < 1000   OR      50,000 to < 75,000 Reduce 2 dose levels from Day 1
      < 500   OR      < 50,000 Withhold doses

Recommended dose modifications for other adverse drug reactions in patients with adenocarcinoma of the pancreas are provided in Table 5.

Table 5: Dose Modifications for Other Adverse Drug Reactions in Patients with Adenocarcinoma of the Pancreas
Adverse Drug Reaction Abraxane Gemcitabine
Febrile Neutropenia:
   Grade 3 or 4
Withhold until fever resolves and ANC ≥ 1500; resume at next lower dose level
Peripheral Neuropathy:
   Grade 3 or 4
Withhold until improves to ≤ Grade 1;
resume at next lower dose level
No dose reduction
Cutaneous Toxicity:
   Grade 2 or 3
Reduce to next lower dose level; discontinue treatment if toxicity persists
Gastrointestinal Toxicity:
   Grade 3 mucositis or diarrhea
Withhold until improves to ≤ Grade 1;
resume at next lower dose level

Preparation and Administration Precautions

Abraxane is a cytotoxic drug and, as with other potentially toxic paclitaxel compounds, caution should be exercised in handling Abraxane. The use of gloves is recommended. If Abraxane (lyophilized cake or reconstituted suspension) contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure to paclitaxel, events may include tingling, burning and redness. If Abraxane contacts mucous membranes, the membranes should be flushed thoroughly with water.

Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration. Limiting the infusion of Abraxane to 30 minutes, as directed, reduces the likelihood of infusion-related reactions [see Adverse Reactions (6.4)].

Premedication to prevent hypersensitivity reactions is generally not needed prior to the administration of Abraxane. Premedication may be needed in patients who have had prior hypersensitivity reactions to Abraxane. Patients who experience a severe hypersensitivity reaction to Abraxane should not be re-challenged with this drug [see Warnings and Precautions (5.5)].

Preparation for Intravenous Administration

Abraxane is supplied as a sterile lyophilized powder for reconstitution before use. AVOID ERRORS, READ ENTIRE PREPARATION INSTRUCTIONS PRIOR TO RECONSTITUTION.

  1. Aseptically, reconstitute each vial by injecting 20 mL of 0.9% Sodium Chloride Injection, USP.
  2. Slowly inject the 20 mL of 0.9% Sodium Chloride Injection, USP, over a minimum of 1 minute, using the
    sterile syringe to direct the solution flow onto the INSIDE WALL OF THE VIAL.
  3. DO NOT INJECT the 0.9% Sodium Chloride Injection, USP, directly onto the lyophilized cake as this
    will result in foaming.
  4. Once the injection is complete, allow the vial to sit for a minimum of 5 minutes to ensure proper wetting of
    the lyophilized cake/powder.
  5. Gently swirl and/or invert the vial slowly for at least 2 minutes until complete dissolution of any cake/powder
    occurs. Avoid generation of foam.
  6. If foaming or clumping occurs, stand solution for at least 15 minutes until foam subsides.

Each mL of the reconstituted formulation will contain 5 mg/mL paclitaxel.

The reconstituted suspension should be milky and homogenous without visible particulates. If particulates or settling are visible, the vial should be gently inverted again to ensure complete resuspension prior to use. Discard the reconstituted suspension if precipitates are observed. Discard any unused portion.

Calculate the exact total dosing volume of 5 mg/mL suspension required for the patient and slowly withdraw the dosing volume of the reconstituted suspension from the vial(s) into a syringe: Dosing volume (mL)=Total dose (mg)/5 (mg/mL).

Inject the appropriate amount of reconstituted Abraxane into an empty, sterile intravenous bag [plasticized polyvinyl chloride (PVC) containers, PVC or non-PVC type intravenous bag]. The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions. The use of medical devices containing silicone oil as a lubricant (ie, syringes and intravenous bags) to reconstitute and administer Abraxane may result in the formation of proteinaceous strands.

Visually inspect the reconstituted Abraxane suspension in the intravenous bag prior to administration. Discard the reconstituted suspension if proteinaceous strands, particulate matter or discoloration are observed.

Stability

Unopened vials of Abraxane are stable until the date indicated on the package when stored between 20°C to 25°C (68°F to 77°F) in the original package. Neither freezing nor refrigeration adversely affects the stability of the product.

Stability of Reconstituted Suspension in the Vial
Reconstituted Abraxane in the vial should be used immediately, but may be refrigerated at 2°C to 8°C (36°F to 46°F) for a maximum of 24 hours if necessary. If not used immediately, each vial of reconstituted suspension should be replaced in the original carton to protect it from bright light. Discard any unused portion.

Stability of Reconstituted Suspension in the Infusion Bag
The suspension for infusion when prepared as recommended in an infusion bag should be used immediately, but may be refrigerated at 2°C to 8°C (36°F to 46°F) and protected from bright light for a maximum of 24 hours.

The total combined refrigerated storage time of reconstituted Abraxane in the vial and in the infusion bag is 24 hours. This may be followed by storage in the infusion bag at ambient temperature (approximately 25°C) and lighting conditions for a maximum of 4 hours.

Discard any unused portion.

Abraxane - Clinical Pharmacology

Mechanism of Action

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.

Pharmacokinetics

Absorption
The pharmacokinetics of total paclitaxel following 30 and 180-minute infusions of Abraxane at dose levels of 80 to 375 mg/m2 were determined in clinical studies. Dose levels of mg/m2 refer to mg of paclitaxel in Abraxane. Following intravenous administration of Abraxane, paclitaxel plasma concentrations declined in a biphasic manner, the initial rapid decline representing distribution to the peripheral compartment and the slower second phase representing drug elimination.

The drug exposure (AUCs) was dose proportional over 80 to 300 mg/m2 and the pharmacokinetics of paclitaxel for Abraxane were independent of the duration of intravenous administration.

The pharmacokinetic data of 260 mg/m2 Abraxane administered over a 30-minute infusion was compared to the pharmacokinetics of 175 mg/m2 paclitaxel injection over a 3-hour infusion. Clearance was larger (43%) and the volume of distribution was higher (53%) for Abraxane than for paclitaxel injection. There were no differences in terminal half-lives.

Distribution
Following Abraxane administration to patients with solid tumors, paclitaxel is evenly distributed into blood cells and plasma and is highly bound to plasma proteins (94%). In a within-patient comparison study, the fraction of unbound paclitaxel in plasma was significantly higher with Abraxane (6.2%) than with solvent-based paclitaxel (2.3%). This contributes to significantly higher exposure to unbound paclitaxel with Abraxane compared with solvent-based paclitaxel, when the total exposure is comparable. In vitro studies of binding to human serum proteins, using paclitaxel concentrations ranging from 0.1 to 50 µg/mL, indicated that the presence of cimetidine, ranitidine, dexamethasone, or diphenhydramine did not affect protein binding of paclitaxel. The total volume of distribution is approximately 1741 L; the large volume of distribution indicates extensive extravascular distribution and/or tissue binding of paclitaxel.

Metabolism
In vitro studies with human liver microsomes and tissue slices showed that paclitaxel was metabolized primarily to 6α-hydroxypaclitaxel by CYP2C8; and to two minor metabolites, 3’-p-hydroxypaclitaxel and 6α, 3’-p-dihydroxypaclitaxel, by CYP3A4. In vitro, the metabolism of paclitaxel to 6α-hydroxypaclitaxel was inhibited by a number of agents (ketoconazole, verapamil, diazepam, quinidine, dexamethasone, cyclosporin, teniposide, etoposide, and vincristine), but the concentrations used exceeded those found in vivo following normal therapeutic doses. Testosterone, 17α-ethinyl estradiol, retinoic acid, and quercetin, a specific inhibitor of CYP2C8, also inhibited the formation of 6α-hydroxypaclitaxel in vitro. The pharmacokinetics of paclitaxel may also be altered in vivo as a result of interactions with compounds that are substrates, inducers, or inhibitors of CYP2C8 and/or CYP3A4 [see Drug Interactions (7)].

Elimination
At the clinical dose range of 80 to 300 mg/m2, the mean total clearance of paclitaxel ranges from 13 to 30 L/h/m2, and the mean terminal half-life ranges from 13 to 27 hours.

After a 30-minute infusion of 260 mg/m2 doses of Abraxane, the mean values for cumulative urinary recovery of unchanged drug (4%) indicated extensive non-renal clearance. Less than 1% of the total administered dose was excreted in urine as the metabolites 6α-hydroxypaclitaxel and 3’-p-hydroxypaclitaxel.

Fecal excretion was approximately 20% of the total dose administered.

Specific Populations

Pharmacokinetics in Hepatic Impairment
The effect of hepatic impairment on the pharmacokinetics of paclitaxel following Abraxane administration was studied in patients with advanced solid tumors. The results showed that mild hepatic impairment (total bilirubin >1 to ≤1.5 x ULN, AST ≤10 x ULN, n=8) had no clinically important effect on pharmacokinetics of paclitaxel. Patients with moderate (total bilirubin >1.5 to ≤ 3 x ULN, AST ≤10 x ULN, n=7) or severe (total bilirubin >3 to ≤5 x ULN, n=5) hepatic impairment had a 22% to 26% decrease in the maximum elimination rate of paclitaxel and approximately 20% increase in mean paclitaxel AUC compared with patients with normal hepatic function (total bilirubin ≤ULN, AST ≤ULN, n=130). [see Dosage and Administration (2.4) and Use in Specific Populations (8.6)].

Elimination of paclitaxel shows an inverse correlation with total bilirubin and a positive correlation with serum albumin. Pharmacokinetic/pharmacodynamic modeling indicates that there is no correlation between hepatic function (as indicated by the baseline albumin or total bilirubin level) and neutropenia after adjusting for Abraxane exposure. Pharmacokinetic data are not available for patients with total bilirubin >5 x ULN or for patients with metastatic adenocarcinoma of the pancreas [see Dosage and Administration (2.4) and Use in Specific Populations (8.6)].

Pharmacokinetics in Renal Impairment
The effect of pre-existing mild (creatinine clearance ≥60 to <90 mL/min, n=61) or moderate (creatinine clearance ≥30 to <60 mL/min, n=23) renal impairment on the pharmacokinetics of paclitaxel following Abraxane administration was studied in patients with advanced solid tumors. Mild to moderate renal impairment had no clinically important effect on the maximum elimination rate and systemic exposure (AUC and Cmax) of paclitaxel [see Use in Specific Populations (8.7)].

Other Intrinsic Factors
Population pharmacokinetic analyses for Abraxane show that body weight (40 to 143 kg), body surface area (1.3 to 2.4 m2), gender, race (Asian vs. White), age (24 to 85 years) and type of solid tumors do not have a clinically important effect on the maximum elimination rate and systemic exposure (AUC and Cmax) of paclitaxel.

Pharmacokinetic Interactions between Abraxane and Carboplatin
Administration of carboplatin immediately after the completion of the Abraxane infusion to patients with NSCLC did not cause clinically meaningful changes in paclitaxel exposure. The observed mean AUCinf of free carboplatin was approximately 23% higher than the targeted value (6 min*mg/mL), but its mean half-life and clearance were consistent with those reported in the absence of paclitaxel.

Pharmacokinetic Interactions between Abraxane and Gemcitabine
Pharmacokinetic interactions between Abraxane and gemcitabine have not been studied in humans.

How Supplied/Storage and Handling

How Supplied

Product No.: 103450
NDC No.: 68817-134-50        100 mg of paclitaxel in a single-use vial, individually packaged in a carton.

Storage

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.

Handling and Disposal

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published [see References (15)]. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

Patient information

ABRAXANE®
(ah-BRAKS-ane)
(paclitaxel) Protein-bound Particles for Injectable Suspension

Read this Patient Information before you start receiving ABRAXANE and before each infusion. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is ABRAXANE?

ABRAXANE is a prescription medicine used to treat:

  • advanced breast cancer in people who have already received certain other medicines for their cancer.
  • advanced non-small cell lung cancer, in combination with carboplatin in people who cannot be treated with surgery or radiation.
  • and advanced pancreatic cancer, when used in combination with gemcitabine as the first medicine for advanced pancreatic cancer.

It is not known if ABRAXANE is safe or effective in children.

Who should not receive ABRAXANE?

Do not receive ABRAXANE if:

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

What should I tell my doctor before receiving ABRAXANE?

Before you receive ABRAXANE, tell your doctor if you:

  • have liver or kidney problems.
  • have any other medical conditions.
  • are a man planning to father a child. You should not father a child during your treatment with ABRAXANE. ABRAXANE can harm the unborn baby of your partner. Talk to your doctor if this is a concern to you.
  • are pregnant or plan to become pregnant. 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.
  • are breastfeeding or plan to breastfeed. It is not known if ABRAXANE passes into your breast milk. You and your doctor should decide if you will receive ABRAXANE or breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list to show your doctor and pharmacist when you get a new medicine.

How will I receive ABRAXANE?

  • Your doctor will prescribe ABRAXANE in an amount that is right for you.
  • Premedication to prevent allergic reactions is generally not needed to receive ABRAXANE. Premedication may be needed if you have had an allergic reaction to ABRAXANE. In case of severe allergic reaction, ABRAXANE should not be used again.
  • ABRAXANE will be given to you by intravenous infusion into your vein.
  • Your doctor should do regular blood tests while you receive ABRAXANE.

What are the possible side effects of ABRAXANE?

ABRAXANE may cause serious side effects, including:

  • decreased blood cell counts. ABRAXANE can cause a severe decrease in neutrophils (a type of white blood cells important in fighting against bacterial infections) and platelets (important for clotting and to control bleeding). Your doctor will check your blood cell count during your treatment with ABRAXANE and after you have stopped your treatment.
  • numbness, tingling, pain, or weakness in your hands or feet (neuropathy).
  • severe infection (sepsis). If you receive ABRAXANE in combination with gemcitabine, infections can be severe and lead to death. Tell your doctor right away if you have a fever (temperature of greater than 100.4° F) or develop signs of infection.
  • lung or breathing problems. If you receive ABRAXANE in combination with gemcitabine, lung or breathing problems may be severe and can lead to death. Tell your doctor right away if you have a sudden onset of persistent dry cough or shortness of breath.
  • allergic reactions. Allergic reactions to ABRAXANE may be severe and can lead to death.

The most common side effects of ABRAXANE include:

  • hair loss
  • numbness, tingling, pain, or weakness in the hands or feet
  • abnormal heart beat
  • tiredness
  • joint and muscle pain
  • changes in your liver function tests
  • rash
  • low red blood cell count (anemia). Red blood cells carry oxygen to your body tissues. Tell your doctor if you feel weak, tired or short of breath.
  • nausea and vomiting
  • infections. If you have a fever (temperature of greater than 100.4° F) or other signs of infection, tell your doctor right away.
  • Diarrhea
  • Loss of body fluid (dehydration)
  • Swelling in the hands or feet

These are not all the possible side effects of ABRAXANE. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of ABRAXANE.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

This Patient Information leaflet summarizes the important information about ABRAXANE. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about ABRAXANE that is written for health professionals.

For more information, call 1-888-423-5436.

What are the ingredients in ABRAXANE?

Active ingredient: paclitaxel (bound to human albumin).

Other ingredient: human albumin (containing sodium caprylate and sodium acetyltryptophanate).

Abraxane Dosage

The following Abraxane regimens are recommended:

  • Breast cancer: Abraxane (paclitaxel) is typically given every 3 weeks. The actual dose and total length of therapy will be determined by your doctor, but the recommended dose is Abraxane is 260 mg/m2 administered in a vein (IV) over 30 minutes every 3 weeks.
  • Non-small cell lung cancer: Abraxane (paclitaxel) is typically given on days 1, 8, and 15 of each 21-day cycle. The actual dose and total length of therapy will be determined by your doctor, but the recommended dose is Abraxane is 100 mg/m2 administered in a vein (IV) over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin should be administered on Day 1 of each 21 day cycle immediately after Abraxane.
  • Advanced pancreatic cancer: Abraxane (paclitaxel) is typically given on days 1, 8, and 15 of each 28 day cycle. The actual dose and total length of therapy will be determined by your doctor, but the recommended dose is Abraxane 125 mg/m2 administered in a vein (IV) over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle. Gemcitabine should be administered immediately after Abraxane on Days 1, 8 and 15 of each 28-day cycle.

What happens if i miss a dose (abraxane)?

Call your doctor for instructions if you miss an appointment for your paclitaxel protein-bound injection.

Abraxane side effects

Get emergency medical help if you have any signs of an allergic reaction to Abraxane: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • numbness, tingling, pain, or weakness in your hands or feet;

  • sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;

  • low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed;

  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;

  • dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Abraxane side effects may include:

  • dehydration, low blood cell counts, signs of infection;

  • pale skin, weakness, feeling tired;

  • irregular heartbeats;

  • swelling in your hands or feet;

  • muscle and joint pain;

  • abnormal liver function tests;

  • nausea, vomiting, diarrhea; or

  • hair loss, mild rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Breast Cancer

260 mg/m2 IV over 30 minutes every 3 weeks

Use: For metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy; prior therapy should have included an anthracycline unless clinically contraindicated

Usual Adult Dose for Non-Small Cell Lung Cancer

100 mg/m2 IV 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 paclitaxel protein-bound

Use: For locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy

Paclitaxel protein-bound Pregnancy Warnings

Animal studies have revealed evidence of embryofetal toxicities (e.g., intrauterine mortality, increased resorptions, and fetal anomalies). Fetal anomalies in animals included soft tissue and skeletal malformations, such as eye bulge, folded retina, microphthalmia, and dilation of brain ventricles. There are no controlled data in human pregnancy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

AU: Use is contraindicated. UK, US: Use should be avoided. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: -This drug can have genotoxic effects and can cause serious birth defects when administered to a pregnant woman. -If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. -Women of childbearing potential should be advised to avoid becoming pregnant while receiving this drug. -Male patients should seek advice on conservation of sperm prior to treatment due to the risk of irreversible infertility. -Males treated with this drug should not father a child during and up to 6 months after treatment.

Paclitaxel protein-bound Breastfeeding Warnings

AU, UK: Use is contraindicated. US: A decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes

Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. Based on limited data, this drug appears to be excreted into milk in relatively large amounts. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.

Liver Dose Adjustments

Dose adjustments for liver impairment:

24-hour infusion:
-Transaminase levels less than 2 x ULN and bilirubin levels less than or equal to 1.5 mg/dL: 135 mg/m2 IV
-Transaminase levels 2 to less than 10 x ULN and bilirubin levels less than or equal to 1.5 mg/dL: 100 mg/m2 IV
-Transaminase levels less than 10 x ULN and bilirubin levels 1.6 to 7.5 mg/dL: 50 mg/m2 IV
-Transaminase levels greater than or equal to 10 x ULN or bilirubin levels greater than 7.5 mg/dL: Use is not recommended

3-hour infusion:
-Transaminase levels less than 10 x ULN and bilirubin levels less than or equal to 1.25 x ULN: 175 mg/m2 IV
-Transaminase levels less than 10 x ULN and bilirubin levels 1.26 to 2 x ULN: 135 mg/m2 IV
-Transaminase levels less than 10 x ULN and bilirubin levels 2.01 to 5 x ULN: 90 mg/m2 IV
-Transaminase levels greater than or equal to 10 x ULN or bilirubin levels greater than 5 x ULN: Use is not recommended

Dose Adjustments

Data not available

Dialysis

Data not available

(web3)