Abraxane: Uses, Dosage & Side Effects
Albumin-bound paclitaxel nanoparticle (nab-paclitaxel) for the treatment of metastatic breast cancer, pancreatic cancer, and non-small cell lung cancer
Abraxane (nab-paclitaxel) is an albumin-bound formulation of the chemotherapy drug paclitaxel, delivered as nanoparticles approximately 130 nanometers in diameter. Paclitaxel belongs to the taxane class of anticancer drugs and works by stabilizing microtubules, which prevents cancer cells from dividing and ultimately causes them to die. The unique albumin nanoparticle technology eliminates the need for toxic solvents used in conventional paclitaxel formulations, resulting in fewer hypersensitivity reactions, shorter infusion times, and potentially higher drug concentrations at the tumor site. Abraxane is approved for metastatic breast cancer, metastatic pancreatic adenocarcinoma (with gemcitabine), and locally advanced or metastatic non-small cell lung cancer (with carboplatin). It is administered as a 30-minute intravenous infusion in a hospital or clinic setting and requires a prescription.
Quick Facts: Abraxane
Key Takeaways
- Abraxane (nab-paclitaxel) uses albumin nanoparticle technology to deliver paclitaxel without the toxic solvent Cremophor EL, reducing hypersensitivity reactions and enabling 30-minute infusions without routine premedication with corticosteroids or antihistamines.
- It is approved for three cancer types: metastatic breast cancer (after prior therapy failure), metastatic pancreatic cancer (with gemcitabine), and non-small cell lung cancer (with carboplatin) when surgery or radiation is not suitable.
- The most common side effects include hair loss, peripheral neuropathy (numbness and tingling), low blood cell counts, nausea, fatigue, and muscle pain; dose adjustments and treatment delays are used to manage these effects.
- Abraxane must not be used if your neutrophil count is below 1,500/mm³, if you are breastfeeding, or if you are allergic to paclitaxel; effective contraception is required for both women and men during treatment and for months afterward.
- Patients in clinical trials who received Abraxane for pancreatic cancer (with gemcitabine) lived significantly longer than those who received gemcitabine alone, establishing it as a standard of care for this difficult-to-treat disease.
What Is Abraxane and What Is It Used For?
The active substance in Abraxane is paclitaxel, one of the most widely used and effective chemotherapy agents in oncology. Paclitaxel belongs to the taxane family of drugs, which also includes docetaxel and cabazitaxel. Taxanes exert their anticancer activity by binding to beta-tubulin subunits of microtubules and stabilizing the microtubule polymer, preventing depolymerization. This disrupts the normal dynamic reorganization of the microtubule network that is essential for cell division. Cancer cells treated with paclitaxel become arrested at the G2/M phase of the cell cycle and are unable to complete mitosis, ultimately undergoing programmed cell death (apoptosis).
What makes Abraxane unique among paclitaxel formulations is its delivery system. Conventional paclitaxel (Taxol) requires the solvent Cremophor EL (polyoxyethylated castor oil) to dissolve the drug, because paclitaxel itself is poorly water-soluble. Cremophor EL is associated with severe hypersensitivity reactions, including anaphylaxis, which necessitates extensive premedication with corticosteroids, antihistamines, and H2-receptor antagonists and requires prolonged infusion times (typically 3 hours or more). Abraxane circumvents this problem entirely. In Abraxane, paclitaxel is bound to human serum albumin in the form of nanoparticles approximately 130 nanometers in diameter. This albumin-bound nanoparticle formulation (nab technology) allows paclitaxel to be suspended in a physiological saline solution without any toxic solvents.
The albumin carrier serves a dual purpose. First, it provides a solvent-free delivery vehicle that eliminates Cremophor-related toxicity and the need for routine premedication. Second, research suggests that albumin facilitates transport of paclitaxel across the endothelial cell barrier of blood vessels and into the tumor through a receptor-mediated process involving the glycoprotein receptor gp60 and the albumin-binding protein SPARC (secreted protein, acidic and rich in cysteine), which is overexpressed in many solid tumors. This mechanism may contribute to higher intratumoral drug concentrations compared with conventional paclitaxel, potentially improving anticancer efficacy.
Abraxane is approved by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and regulatory authorities in numerous countries worldwide for the following indications:
Metastatic Breast Cancer
Abraxane is indicated as monotherapy for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard anthracycline-containing therapy is not indicated. The pivotal phase III trial (Gradishar et al., Journal of Clinical Oncology, 2005) compared nab-paclitaxel 260 mg/m² every 3 weeks with conventional paclitaxel 175 mg/m² every 3 weeks in 460 patients with metastatic breast cancer. Patients receiving Abraxane had significantly higher overall response rates (33% vs. 19%, p=0.001) and longer time to tumor progression (23.0 vs. 16.9 weeks, p=0.006). Importantly, despite the higher dose of paclitaxel delivered, the incidence of grade 4 neutropenia was lower with Abraxane, and severe hypersensitivity reactions were virtually eliminated despite the absence of premedication.
Metastatic Pancreatic Cancer
Abraxane is indicated in combination with gemcitabine for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. The landmark MPACT trial (Von Hoff et al., New England Journal of Medicine, 2013) randomized 861 patients with previously untreated metastatic pancreatic cancer to receive either nab-paclitaxel plus gemcitabine or gemcitabine alone. The combination arm demonstrated a statistically significant improvement in overall survival (median 8.5 vs. 6.7 months, hazard ratio 0.72, p<0.001), progression-free survival (5.5 vs. 3.7 months, p<0.001), and overall response rate (23% vs. 7%, p<0.001). This trial established the nab-paclitaxel plus gemcitabine combination as a new standard of care for metastatic pancreatic cancer, a disease with historically limited treatment options.
Non-Small Cell Lung Cancer
Abraxane is indicated in combination with carboplatin for the first-line treatment of non-small cell lung cancer (NSCLC) in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. A phase III trial randomized 1,052 patients with previously untreated stage IIIB/IV NSCLC to receive either nab-paclitaxel 100 mg/m² weekly (3 weeks on, 1 week off) plus carboplatin AUC 6 every 3 weeks, or conventional paclitaxel 200 mg/m² plus carboplatin AUC 6 every 3 weeks. The nab-paclitaxel regimen achieved a significantly higher overall response rate (33% vs. 25%, p=0.005), with a favorable toxicity profile including less neuropathy, neutropenia, arthralgia, and myalgia compared with conventional paclitaxel.
The nab (nanoparticle albumin-bound) platform represents a significant advance in drug delivery technology. By harnessing the natural properties of human albumin – the most abundant protein in blood – nab-paclitaxel achieves solvent-free drug delivery, shorter infusion times (30 minutes vs. 3+ hours), elimination of routine premedication, and potential for enhanced tumor uptake through albumin-mediated transport. This technology has been applied to paclitaxel in Abraxane and is being explored for other anticancer agents.
What Should You Know Before Receiving Abraxane?
Contraindications
There are specific clinical situations in which Abraxane must not be administered. Understanding these contraindications is essential for patient safety.
- Hypersensitivity: Do not receive Abraxane if you have a known allergy (hypersensitivity) to paclitaxel or to any of the excipients in the formulation, including human albumin.
- Breastfeeding: Abraxane must not be used during breastfeeding, as it is not known whether paclitaxel passes into breast milk and a risk to the infant cannot be excluded.
- Severe neutropenia: Treatment must not be started if the baseline neutrophil count is below 1,500 cells/mm³ (1.5 × 10&sup9;/L). Your doctor will check your blood counts before each treatment cycle.
Warnings and Precautions
Abraxane can cause severe suppression of bone marrow function, leading to dangerously low levels of white blood cells (neutropenia), red blood cells (anemia), and platelets (thrombocytopenia). This increases the risk of serious infections and bleeding. Your doctor will monitor your blood counts regularly and may delay treatment or reduce your dose if counts are too low. Contact your medical team immediately if you develop fever, sore throat, unusual bruising, or signs of infection.
Talk to your doctor or nurse before receiving Abraxane if any of the following apply to you:
- Kidney problems: If you have impaired kidney function, tell your doctor. While paclitaxel is primarily metabolized by the liver, kidney impairment may affect overall drug clearance and toxicity profiles.
- Liver problems: Paclitaxel is extensively metabolized by the liver via CYP2C8 and CYP3A4 enzymes. Patients with moderate to severe hepatic impairment are at increased risk of toxicity, and dose reductions may be necessary. Your doctor will perform liver function tests before and during treatment.
- Heart problems: Cases of cardiac conduction abnormalities, including heart block and bradycardia, have been reported with paclitaxel. Rarely, heart failure and myocardial infarction have occurred. Tell your doctor if you have any pre-existing heart conditions or are taking medications that affect heart rhythm.
- Peripheral neuropathy: If you already have numbness, tingling, or pain in your hands or feet from a previous chemotherapy or any other cause, inform your doctor. Pre-existing neuropathy may worsen with Abraxane treatment, and the starting dose may need adjustment.
During treatment with Abraxane, tell your doctor or nurse immediately if you experience any of the following:
- Unusual bruising, bleeding, or signs of infection such as sore throat, fever, or chills
- Numbness, tingling, prickling, sensitivity to touch, or muscle weakness, particularly in the hands and feet
- Breathing problems such as shortness of breath, dry cough, or wheezing
- Severe abdominal pain, nausea, or vomiting
- Severe skin reactions such as widespread rash, blistering, or skin peeling
Pregnancy and Breastfeeding
Paclitaxel has been shown to cause serious birth defects and fetal harm in animal studies. Abraxane should not be used during pregnancy. Your doctor will arrange a pregnancy test before starting treatment to confirm you are not pregnant.
Women of childbearing potential must use effective contraception during treatment and for at least 6 months after the last dose of Abraxane. You should inform your doctor immediately if you become pregnant or suspect you may be pregnant during treatment.
Breastfeeding is contraindicated during Abraxane treatment, as it is unknown whether paclitaxel is excreted in human breast milk. The potential risk to the nursing infant is considered too significant to allow breastfeeding.
Male patients should use effective contraception and avoid fathering children during treatment and for at least 3 months after the last dose. Men are advised to seek counseling about sperm cryopreservation (freezing) before starting treatment, as Abraxane may cause irreversible infertility.
Children and Adolescents
Abraxane is indicated for adult patients only. It should not be given to children or adolescents under 18 years of age, as safety and efficacy have not been established in this population.
Driving and Operating Machinery
Some patients may experience tiredness, dizziness, or blurred vision during or after Abraxane treatment. If you experience any of these side effects, do not drive, use tools, or operate machinery until the symptoms have resolved. Consult your doctor if you are concerned about your ability to drive safely.
Important Information About Ingredients
Abraxane contains less than 1 mmol (23 mg) of sodium per 100 mg dose, which means it is essentially sodium-free. This is relevant for patients on sodium-restricted diets. The formulation contains human albumin solution as the only excipient; no Cremophor EL, ethanol, or other potentially problematic solvents are present.
How Does Abraxane Interact with Other Drugs?
Paclitaxel is metabolized primarily by the hepatic cytochrome P450 enzymes CYP2C8 and CYP3A4. Any medication that significantly inhibits or induces these enzymes can alter the plasma concentrations of paclitaxel, potentially leading to increased toxicity or reduced therapeutic effectiveness. It is essential to inform your doctor about all medications, supplements, and herbal remedies you are currently taking or have recently taken, including over-the-counter products.
Caution is also warranted when Abraxane is used concurrently with other drugs that have overlapping toxicity profiles, particularly those affecting the bone marrow, nervous system, or liver. Your oncologist will carefully consider potential interactions when planning your treatment regimen.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Ketoconazole and other strong CYP3A4 inhibitors | Increased paclitaxel plasma levels, greater risk of toxicity (especially myelosuppression and neuropathy) | Avoid combination; if unavoidable, monitor closely and consider dose reduction |
| Rifampicin and other strong CYP3A4/CYP2C8 inducers | Decreased paclitaxel plasma levels, potentially reduced anticancer efficacy | Avoid combination if possible; therapeutic effectiveness may be diminished |
| Gemfibrozil (strong CYP2C8 inhibitor) | Significant increase in paclitaxel exposure via CYP2C8 inhibition | Avoid concomitant use; increased risk of severe neutropenia and neuropathy |
| Clopidogrel | May inhibit CYP2C8-mediated paclitaxel metabolism, increasing paclitaxel levels | Use with caution; monitor for increased side effects |
Minor Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Erythromycin (moderate CYP3A4 inhibitor) | Possible modest increase in paclitaxel levels | Monitor for increased side effects; dose adjustment may be needed |
| Fluoxetine (antidepressant / CYP2C8 inhibitor) | May modestly increase paclitaxel exposure | Use with caution; monitor for bone marrow suppression |
| Carbamazepine, Phenytoin (CYP3A4 inducers) | May decrease paclitaxel plasma levels | Potential for reduced efficacy; discuss alternatives with your doctor |
| Cimetidine (H2-receptor antagonist) | Weak CYP3A4 inhibitor; minor effect on paclitaxel metabolism | Generally safe; clinical significance is low |
| HIV antiretrovirals (ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, nevirapine) | Variable effects on CYP3A4 (ritonavir is a potent inhibitor; efavirenz/nevirapine are inducers) | Requires careful evaluation; consult with both oncologist and HIV specialist |
When Abraxane is used in combination regimens (with gemcitabine for pancreatic cancer or with carboplatin for lung cancer), the interaction profiles of the partner drugs must also be considered. Gemcitabine is primarily cleared renally and has fewer CYP-mediated interactions, while carboplatin interacts minimally with CYP enzymes but has significant renal clearance. Your oncologist will carefully plan and monitor your combined therapy to minimize cumulative toxicities.
What Is the Correct Dosage of Abraxane?
Abraxane is always administered by a doctor or nurse as an intravenous infusion over 30 minutes. The dose is calculated individually based on your body surface area (BSA), which is determined from your height and weight. Your doctor will also take into account your blood test results, liver function, and overall health when determining the appropriate dose and schedule.
Metastatic Breast Cancer
Abraxane Monotherapy for Metastatic Breast Cancer
Dose: 260 mg/m² body surface area, given as an intravenous infusion over 30 minutes
Schedule: Once every 3 weeks (on Day 1 of each 21-day cycle)
Duration: Treatment continues until disease progression or unacceptable toxicity
No routine premedication with corticosteroids or antihistamines is required. Premedication may be considered only if a patient has previously experienced a hypersensitivity reaction.
Metastatic Pancreatic Cancer
Abraxane + Gemcitabine for Metastatic Pancreatic Cancer
Dose: 125 mg/m² body surface area, given as an intravenous infusion over 30 minutes
Schedule: On Days 1, 8, and 15 of each 28-day cycle
Partner drug: Gemcitabine is administered immediately after Abraxane on the same treatment days
Duration: Treatment continues until disease progression or unacceptable toxicity
Non-Small Cell Lung Cancer
Abraxane + Carboplatin for NSCLC
Dose: 100 mg/m² body surface area, given as an intravenous infusion over 30 minutes
Schedule: On Days 1, 8, and 15 of each 21-day cycle
Partner drug: Carboplatin (AUC 6) is given immediately after Abraxane on Day 1 only of each cycle
Duration: Treatment continues until disease progression or unacceptable toxicity
Dose Adjustments
Your doctor may need to delay treatment, reduce the dose, or discontinue Abraxane based on certain clinical findings. Dose adjustments are commonly required for the following reasons:
- Neutropenia: If your neutrophil count falls below acceptable levels (typically <1,500/mm³), treatment will be delayed until counts recover. Subsequent doses may be reduced.
- Peripheral neuropathy: If you develop Grade 3 or severe sensory neuropathy (significant functional impairment), treatment is withheld until improvement and then resumed at a reduced dose.
- Hepatic impairment: Patients with elevated bilirubin or liver transaminases may require dose reduction. Severe hepatic impairment generally contraindicates use.
- Thrombocytopenia: If platelet counts drop significantly, treatment may be delayed to reduce bleeding risk.
Children
Abraxane is intended for adult patients only. The safety and efficacy of nab-paclitaxel in children and adolescents below 18 years of age have not been established. It is not recommended for use in the pediatric population.
Missed Dose
Because Abraxane is administered in a clinical setting by healthcare professionals, the risk of a missed dose is minimal. If a scheduled treatment session is missed or delayed due to side effects or scheduling issues, your doctor will advise you on when to resume treatment. Do not attempt to “make up” a missed dose by receiving a double dose.
Overdose
There is no specific antidote for paclitaxel overdose. In the event of accidental overdose, the primary expected complications are severe bone marrow suppression, peripheral neuropathy, and mucositis (inflammation of the mucous membranes). Treatment is supportive and symptomatic, including growth factor support for neutropenia and other measures as clinically indicated. Because Abraxane is administered by trained healthcare professionals in a controlled setting, the risk of overdose is very low.
How Abraxane Is Prepared and Given
Abraxane is supplied as a white to yellowish powder in glass vials containing 100 mg of paclitaxel. Before administration, the powder is reconstituted with 20 ml of sodium chloride 0.9% solution (normal saline), which is slowly injected into the vial over at least 1 minute, directing the solution against the inner wall of the vial to avoid foaming. After standing for at least 5 minutes, the vial is gently swirled and/or inverted for at least 2 minutes until the powder is completely dissolved, producing a milky, homogeneous suspension at a concentration of 5 mg/ml.
The calculated patient-specific dose is then withdrawn from the reconstituted vial and injected into an empty sterile intravenous infusion bag. The infusion is administered through a line fitted with a 15 µm in-line filter to prevent the passage of proteinaceous strands that may form. The infusion is delivered over 30 minutes. Special DEHP-free containers or administration sets are not required.
Abraxane is a cytotoxic chemotherapy drug that must always be prepared and administered by trained healthcare professionals in a hospital or specialized oncology clinic. Strict safety precautions are required during handling, including the use of gloves, protective eyewear, and protective clothing. You will not self-administer this medication at home.
What Are the Side Effects of Abraxane?
Like all chemotherapy drugs, Abraxane can cause side effects, although not every patient will experience them. The type, frequency, and severity of side effects depend on the dose, treatment schedule, whether Abraxane is given alone or in combination with other drugs, and individual patient factors. Your medical team will monitor you closely and take steps to manage side effects as they arise, including dose adjustments, treatment delays, or supportive medications.
The side effects listed below are organized by frequency category, as determined in clinical trials. The categories reflect how commonly each side effect was observed across the approved indications.
Very Common
May affect more than 1 in 10 people
- Hair loss (alopecia) – typically pronounced (>50% hair loss), occurring within the first month of treatment
- Skin rash
- Low white blood cell counts (neutropenia, lymphopenia, leukopenia)
- Anemia (low red blood cell count)
- Low platelet count (thrombocytopenia)
- Peripheral neuropathy (numbness, tingling, pain, or loss of sensation in hands and feet)
- Joint pain (arthralgia)
- Muscle pain (myalgia)
- Nausea, diarrhea, constipation, mouth sores, loss of appetite
- Vomiting
- Weakness and fatigue, fever
- Dehydration, taste changes, weight loss
- Low potassium levels (hypokalemia)
- Depression, insomnia
- Headache, dizziness
- Shortness of breath (dyspnea)
- Swelling of mucous membranes
- Elevated liver function tests
- Pain in arms and legs, cough, abdominal pain, nosebleeds
- Chills
Common
May affect up to 1 in 10 people
- Itching (pruritus), dry skin, nail disorders
- Infections (including febrile neutropenia, oral thrush, serious bloodstream infections/sepsis)
- Decreased counts of all blood cell types (pancytopenia)
- Chest or throat pain
- Indigestion, abdominal discomfort
- Nasal congestion
- Back pain, bone pain
- Impaired muscle coordination, visual changes, eyelash loss
- Changes in heart rate or rhythm, heart failure
- Low or high blood pressure
- Redness or swelling at the infusion site
- Anxiety
- Lung infection (pneumonia), urinary tract infection
- Bowel obstruction, inflammation of the colon or bile ducts
- Acute kidney failure
- Elevated bilirubin, coughing up blood
- Dry mouth, difficulty swallowing, muscle weakness, blurred vision
Uncommon
May affect up to 1 in 100 people
- Weight gain, increased lactate dehydrogenase, decreased kidney function, elevated blood sugar, elevated phosphorus
- Decreased reflexes, involuntary movements, nerve pain, fainting, dizziness on standing, tremor, facial paralysis
- Eye irritation, painful or red eyes, itchy eyes, double vision, decreased vision, flashing lights, blurred vision from retinal swelling (cystoid macular edema)
- Ear pain, tinnitus (ringing in ears)
- Productive cough, shortness of breath on exertion, runny or dry nose, decreased breath sounds, fluid on the lungs (pleural effusion), loss of voice, blood clot in the lung (pulmonary embolism), dry throat
- Flatulence, stomach cramps, painful gums, rectal bleeding
- Painful urination, frequent urination, blood in urine, urinary incontinence
- Nail pain, nail discomfort, nail loss, hives, skin pain, sun sensitivity, skin discoloration, excessive sweating, night sweats, white patches on skin, sores, facial swelling
- Low phosphorus, fluid retention, low albumin, increased thirst, low calcium, low blood sugar, low sodium
- Skin infections, catheter-related infections, bruising
- Tumor site pain, low blood pressure on standing, cold hands and feet
- Difficulty walking, general swelling (edema), allergic reaction
- Decreased liver function, enlarged liver, chest pain, restlessness
- Small skin hemorrhages from blood clotting (petechiae)
- Hemolytic uremic syndrome (breakdown of red blood cells with acute kidney failure)
Rare
May affect up to 1 in 1,000 people
- Skin reaction or lung inflammation following radiation therapy (radiation recall)
- Blood clots (thrombosis)
- Very slow heart rate (bradycardia), heart attack (myocardial infarction)
- Extravasation (leakage of drug from the vein into surrounding tissue)
- Irregular conduction of electrical impulses in the heart (atrioventricular block)
Very Rare
May affect up to 1 in 10,000 people
- Stevens-Johnson syndrome (severe skin and mucous membrane inflammation with blistering and peeling)
- Toxic epidermal necrolysis (life-threatening widespread skin detachment)
Not Known
Frequency cannot be estimated from available data
- Scleroderma (hardening and thickening of the skin)
It is important to report any suspected side effects to your healthcare provider. Reporting helps regulatory authorities continuously monitor the benefit-risk balance of medicines. You can also report side effects directly to your national pharmacovigilance agency (e.g., the FDA MedWatch program in the United States, the Yellow Card scheme in the United Kingdom, or the EMA EudraVigilance system in the European Union).
How Should Abraxane Be Stored?
Proper storage of Abraxane is essential to maintain its stability and safety. As a hospital-administered medication, storage is managed by pharmacy and nursing staff, but patients may find it useful to understand the storage requirements.
- Unopened vials: Store in the original outer carton to protect from light. Abraxane does not require refrigeration or freezing when unopened. Neither freezing nor refrigeration adversely affects the product’s stability.
- After reconstitution (in the vial): The reconstituted suspension should ideally be used immediately. If not used immediately, it may be stored in the refrigerator (2–8°C) for up to 24 hours in the original vial within the outer carton to protect from light.
- After preparation (in the infusion bag): The prepared infusion may be stored in the refrigerator (2–8°C) for up to 24 hours, protected from light.
- Total combined storage: The total time from reconstitution in the vial through storage in the infusion bag is a maximum of 24 hours refrigerated and protected from light. This may be followed by storage in the infusion bag for up to 4 hours at room temperature (not exceeding 25°C).
- Expiry date: Do not use Abraxane after the expiry date printed on the carton and vial (EXP). The expiry date refers to the last day of the stated month.
- Keep out of reach of children.
Any unused product or waste material should be disposed of in accordance with local regulations for cytotoxic drugs. Your healthcare team is responsible for proper disposal.
What Does Abraxane Contain?
Understanding what Abraxane contains is important for identifying potential allergens and understanding how the drug differs from other paclitaxel formulations.
- Active substance: Paclitaxel. Each vial contains 100 mg of paclitaxel formulated as albumin-bound nanoparticles (nab-paclitaxel).
- After reconstitution: Each ml of the reconstituted suspension contains 5 mg of paclitaxel as albumin-bound nanoparticles.
- Excipients: Human albumin solution (containing sodium caprylate and N-acetyl-L-tryptophan as stabilizers). See the sodium content information in the “Important Information About Ingredients” section above.
Appearance: Abraxane is a white to yellowish lyophilized (freeze-dried) powder supplied in a glass vial. After reconstitution, the suspension appears milky and homogeneous without visible precipitates. Some settling of the reconstituted suspension may occur and is normal; the vial should be gently inverted to resuspend before use.
Pack size: Each carton contains 1 glass vial of 100 mg paclitaxel as albumin-bound nanoparticles.
Marketing authorization holder: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland.
Other Brand Names
Paclitaxel albumin-bound nanoparticles (nab-paclitaxel) are marketed under several brand names worldwide. Besides the originator product Abraxane, biosimilar and authorized versions include Pazenir, Pacligen, Paclitaxel Fresenius Kabi, Paclitaxel Accord, Apexelsin, and NAVERUCLIF. While the active substance and nanoparticle formulation are the same across these products, always follow the specific prescribing information for the product you receive.
Frequently Asked Questions About Abraxane
The key difference lies in the formulation and delivery system. Conventional paclitaxel (Taxol) uses the solvent Cremophor EL (polyoxyethylated castor oil) to dissolve the drug, which can cause severe allergic reactions and requires extensive premedication with corticosteroids and antihistamines. Abraxane uses albumin nanoparticle technology instead, which eliminates the need for toxic solvents and allows shorter 30-minute infusions without routine premedication. Additionally, the albumin carrier may help deliver more drug directly to tumors through receptor-mediated transport.
Yes, hair loss (alopecia) is one of the most common side effects of Abraxane, occurring in the majority of patients. It typically begins within the first month of treatment and is often pronounced, with more than 50% hair loss in most affected patients. Hair loss is usually temporary and hair typically begins to regrow after treatment is completed, although the new hair may initially differ in texture or color. Scalp cooling (cold cap therapy) may help reduce the severity of hair loss in some patients; discuss this option with your oncologist before starting treatment.
Abraxane may cause tiredness, dizziness, or blurred vision, which can impair your ability to drive safely. If you experience any of these side effects, you should not drive, use tools, or operate machinery until the symptoms have resolved. Each patient is affected differently, so discuss your individual situation with your doctor. On days when you receive infusions, it is generally advisable to arrange for someone else to drive you home.
Unlike conventional paclitaxel, Abraxane does not routinely require premedication with corticosteroids or antihistamines. This is one of the advantages of the albumin-bound formulation, which avoids the Cremophor EL solvent that causes hypersensitivity reactions with conventional paclitaxel. However, if you have previously experienced a hypersensitivity reaction to Abraxane, your doctor may recommend premedication before subsequent infusions. Anti-emetic (anti-nausea) medication may be given separately to help manage nausea and vomiting.
The duration of Abraxane treatment varies depending on your cancer type, how well you respond to therapy, and how well you tolerate the side effects. Treatment typically continues until the cancer progresses or until side effects become too severe to continue. For breast cancer, cycles are given every 3 weeks; for pancreatic and lung cancer, treatment follows weekly schedules within 3–4 week cycles. Some patients may receive treatment for several months. Your oncologist will regularly assess your response using imaging studies and blood tests to determine how long treatment should continue.
Numbness, tingling, or pain in the hands and feet (peripheral neuropathy) is a common side effect of Abraxane caused by its effect on peripheral nerves. You should report these symptoms to your doctor as soon as they appear. Your doctor will assess the severity and may delay your next treatment, reduce your dose, or in some cases discontinue Abraxane to prevent the neuropathy from worsening. Mild neuropathy often improves after treatment ends, but severe neuropathy may take months to improve and can sometimes be permanent. Avoiding tight shoes, protecting your hands from extreme temperatures, and gentle exercise may help manage symptoms.
References
- European Medicines Agency (EMA). Abraxane – Summary of Product Characteristics (SmPC). Last updated 2025. Available at: ema.europa.eu/en/medicines/human/EPAR/abraxane
- U.S. Food and Drug Administration (FDA). Abraxane (paclitaxel protein-bound particles for injectable suspension) – Prescribing Information. Last updated 2024.
- Gradishar WJ, Tjulandin S, Davidson N, et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. Journal of Clinical Oncology. 2005;23(31):7794-7803. doi:10.1200/JCO.2005.04.937
- Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. New England Journal of Medicine. 2013;369(18):1691-1703. doi:10.1056/NEJMoa1304369
- Socinski MA, Bondarenko I, Karaseva NA, et al. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. Journal of Clinical Oncology. 2012;30(17):2055-2062. doi:10.1200/JCO.2011.39.5848
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer, Pancreatic Adenocarcinoma, Non-Small Cell Lung Cancer. Version 2025.
- European Society for Medical Oncology (ESMO). Clinical Practice Guidelines: Metastatic Breast Cancer, Pancreatic Cancer, Non-Small Cell Lung Cancer. 2024-2025.
- Desai N, Trieu V, Yao Z, et al. Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of cremophor-free, albumin-bound paclitaxel, ABI-007, compared with cremophor-based paclitaxel. Clinical Cancer Research. 2006;12(4):1317-1324. doi:10.1158/1078-0432.CCR-05-1634
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: World Health Organization.
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Medical Content
iMedic Medical Editorial Team – Specialists in Oncology and Clinical Pharmacology
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iMedic Medical Review Board – Independent panel following WHO, EMA, and FDA guidelines
Evidence Level
Level 1A – Based on systematic reviews, meta-analyses, and randomized controlled trials
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– Updated according to current EMA SmPC and FDA prescribing information
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