Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Lactation (see section 4.6).
Patients who have baseline neutrophil counts <1500 cells/mm³.
Abraxane is an albumin-bound nanoparticle formulation of paclitaxel, which may have substantially different pharmacological properties compared to other formulations of paclitaxel (see sections 5.1 and 5.2). It should not be substituted for or with other paclitaxel formulations.
Rare occurrences of severe hypersensitivity reactions, including very rare events of anaphylactic reactions with fatal outcome, have been reported. If a hypersensitivity reaction occurs, the medicinal product should be discontinued immediately, symptomatic treatment should be initiated, and the patient should not be rechallenged with paclitaxel.
Bone marrow suppression (primarily neutropenia) occurs frequently with Abraxane. Neutropenia is dose-dependent and a dose-limiting toxicity. Frequent monitoring of blood cell counts should be performed during Abraxane therapy. Patients should not be retreated with subsequent cycles of Abraxane until neutrophils recover to >1500 cells/mm³ and platelets recover to >100,000 cells/mm³ (see section 4.2).
Sensory neuropathy occurs frequently with Abraxane, although development of severe symptoms is less common. The occurrence of Grade 1 or 2 sensory neuropathy does not generally require dose reduction. When Abraxane is used as monotherapy, if Grade 3 sensory neuropathy develops, treatment should be withheld until resolution to Grade 1 or 2 followed by a dose reduction for all subsequent courses of Abraxane is recommended (see section 4.2). For combination use of Abraxane and gemcitabine, if Grade 3 or higher peripheral neuropathy develops, withhold Abraxane; continue treatment with gemcitabine at the same dose. Resume Abraxane at reduced dose when peripheral neuropathy improves to Grade 0 or 1 (see section 4.2). For combination use of Abraxane and carboplatin, if Grade 3 or higher peripheral neuropathy develops, treatment should be withheld until improvement to Grade 0 or 1 followed by a dose reduction for all subsequent courses of Abraxane and carboplatin (see section 4.2).
Sepsis was reported at a rate of 5% in patients with or without neutropenia who received Abraxane in combination with gemcitabine. Complications due to the underlying pancreatic cancer, especially biliary obstruction or presence of biliary stent, were identified as significant contributing factors. If a patient becomes febrile (regardless of neutrophil count), initiate treatment with broad spectrum antibiotics. For febrile neutropenia, withhold Abraxane and gemcitabine until fever resolves and ANC ≥1500 cells/mm³, then resume treatment at reduced dose levels (see section 4.2).
Pneumonitis occurred in 1% of patients when Abraxane was used as monotherapy and in 4% of patients when Abraxane was used in combination with gemcitabine. Closely monitor all patients for signs and symptoms of pneumonitis. After ruling out infectious etiology and upon making a diagnosis of pneumonitis, permanently discontinue treatment with Abraxane and gemcitabine and promptly initiate appropriate treatment and supportive measures (see section 4.2).
Because the toxicity of paclitaxel can be increased with hepatic impairment, administration of Abraxane in patients with hepatic impairment should be performed with caution. Patients with hepatic impairment may be at increased risk of toxicity, particularly from myelosuppression; such patients should be closely monitored for development of profound myelosuppression.
Abraxane is not recommended in patients that have total bilirubin >5 x ULN or AST >10 x ULN. In addition, Abraxane is not recommended in patients with metastatic adenocarcinoma of the pancreas that have moderate to severe hepatic impairment (total bilirubin >1.5 x ULN and AST ≤10 x ULN) (see section 5.2).
Rare reports of congestive heart failure and left ventricular dysfunction have been observed among individuals receiving Abraxane. Most of the individuals were previously exposed to cardiotoxic medicinal products such as anthracyclines or had underlying cardiac history. Thus, patients receiving Abraxane should be vigilantly monitored by physicians for the occurrence of cardiac events.
The effectiveness and safety of Abraxane in patients with central nervous system (CNS) metastases has not been established. CNS metastases are generally not well controlled by systemic chemotherapy.
If patients experience nausea, vomiting and diarrhoea following the administration of Abraxane, they may be treated with commonly used anti-emetics and constipating agents.
Cystoid macular oedema (CMO) has been reported in patients treated with Abraxane. Patients with impaired vision should undergo a prompt and complete ophthalmologic examination. In case CMO is diagnosed, Abraxane treatment should be discontinued and appropriate treatment initiated (see section 4.8).
For patients of 75 years and older, no benefit for the combination treatment of Abraxane and gemcitabine in comparison to gemcitabine monotherapy has been demonstrated. In the very elderly (≥75 years) who received Abraxane and gemcitabine, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation including haematologic toxicities, peripheral neuropathy, decreased appetite and dehydration. Patients with pancreatic adenocarcinoma aged 75 years and older should be carefully assessed for their ability to tolerate Abraxane in combination with gemcitabine with special consideration to performance status, co-morbidities and increased risk of infections (see section 4.2 and 4.8).
Although limited data is available, no clear benefit in terms of prolonged overall survival has been demonstrated in pancreatic adenocarcinoma patients with normal CA 19-9 levels prior to start of treatment with Abraxane and gemcitabine (see section 5.1).
Erlotinib should not be coadministered with Abraxane plus gemcitabine (see section 4.5).
This medicine contains less than 1 mmol sodium (23 mg) per 100 mg, that is to say essentially 'sodium free'.
The metabolism of paclitaxel is catalysed, in part, by cytochrome P450 isoenzymes CYP2C8 and CYP3A4 (see section 5.2). Therefore, in the absence of a PK drug-drug interaction study, caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) because toxicity of paclitaxel may be increased due to higher paclitaxel exposure. Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 (e.g. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) is not recommended because efficacy may be compromised because of lower paclitaxel exposures.
Paclitaxel and gemcitabine do not share a common metabolic pathway. Paclitaxel clearance is primarily determined by CYP2C8 and CYP3A4 mediated metabolism followed by biliary excretion, while gemcitabine is inactivated by cytidine deaminase followed by urinary excretion. Pharmacokinetic interactions between Abraxane and gemcitabine have not been evaluated in humans.
A pharmacokinetic study was conducted with Abraxane and carboplatin in non-small cell lung cancer patients. There were no clinically relevant pharmacokinetic interactions between Abraxane and carboplatin.
Abraxane is indicated as monotherapy for breast cancer, in combination with gemcitabine for pancreatic adenocarcinoma, or in combination with carboplatin for non-small cell lung cancer (see section 4.1). Abraxane should not be used in combination with other anticancer agents.
Interaction studies have only been performed in adults.
Women of childbearing potential should use effective contraception during treatment and for at least six months after the last dose of Abraxane. Male patients with female partners of reproductive potential are advised to use effective contraception and to avoid fathering a child during treatment with Abraxane and for at least three months after the last dose of Abraxane.
There are very limited data on the use of paclitaxel in human pregnancy. Paclitaxel is suspected to cause serious birth defects when administered during pregnancy. Studies in animals have shown reproductive toxicity (see section 5.3). Women of childbearing potential should have a pregnancy test prior to starting treatment with Abraxane. Abraxane should not be used in pregnancy, and in women of childbearing potential not using effective contraception, unless the clinical condition of the mother requires treatment with paclitaxel.
Paclitaxel and/or its metabolites were excreted into the milk of lactating rats (see section 5.3). It is not known if paclitaxel is excreted in human milk. Because of potential serious adverse reactions in breast-feeding infants, Abraxane is contraindicated during lactation. Breast-feeding must be discontinued for the duration of therapy.
Abraxane induced infertility in male rats (see section 5.3). Based on findings in animals, male and female fertility may be compromised. Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Abraxane.
Abraxane has minor or moderate influence on the ability to drive and use machines. Abraxane may cause adverse reactions such as tiredness (very common) and dizziness (common) that may affect the ability to drive and use machinery. Patients should be advised not to drive and use machines if they feel tired or dizzy.
The most common clinically significant adverse reactions associated with the use of Abraxane have been neutropenia, peripheral neuropathy, arthralgia/myalgia and gastrointestinal disorders.
Table 6 lists adverse reactions associated with Abraxane monotherapy at any dose in any indication during clinical trials (N=789), Abraxane in combination with gemcitabine for pancreatic adenocarcinoma from the phase III clinical trial (N=421), Abraxane in combination with carboplatin for non-small cell lung cancer from the phase III clinical trial (N=514) and from post-marketing use.
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 6. Adverse reactions reported with Abraxane:
| Monotherapy (N=789) | Combination therapy with gemcitabine (N=421) | Combination therapy with carboplatin (N=514) | |
|---|---|---|---|
| Infections and infestations | |||
| Common: | Infection, urinary tract infection, folliculitis, upper respiratory tract infection, candidiasis, sinusitis | Sepsis, pneumonia, oral candidiasis | Pneumonia, bronchitis, upper respiratory tract infection, urinary tract infection |
| Uncommon: | Sepsis1, neutropenic sepsis1, pneumonia, oral candidiasis, nasopharyngitis, cellulitis, herpes simplex, viral infection, herpes zoster, fungal infection, catheter-related infection, injection site infection | Sepsis, oral candidiasis | |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | |||
| Uncommon: | Tumour necrosis, metastatic pain | ||
| Blood and lymphatic system disorders | |||
| Very common: | Bone marrow suppression, neutropenia, thrombocytopenia, anaemia, leukopenia, lymphopenia | Neutropenia, thrombocytopenia, anaemia | Neutropenia3, thrombocytopenia3, anaemia3, leukopenia3 |
| Common: | Febrile neutropenia | Pancytopenia | Febrile neutropenia, lymphopenia |
| Uncommon: | Thrombotic thrombocytopenic purpura | Pancytopenia | |
| Rare: | Pancytopenia | ||
| Immune system disorders | |||
| Uncommon: | Hypersensitivity | Drug hypersensitivity, hypersensitivity | |
| Rare: | Severe hypersensitivity1 | ||
| Metabolism and nutrition disorders | |||
| Very common: | Anorexia | Dehydration, decreased appetite, hypokalaemia | Decreased appetite |
| Common: | Dehydration, decreased appetite, hypokalaemia | Dehydration | |
| Uncommon: | Hypophosphataemia, fluid retention, hypoalbuminaemia, polydipsia, hyperglycaemia, hypocalcaemia, hypoglycaemia, hyponatraemia | ||
| Not known: | Tumour lysis syndrome1 | ||
| Psychiatric disorders | |||
| Very common: | Depression, insomnia | ||
| Common: | Depression, insomnia, anxiety | Anxiety | Insomnia |
| Uncommon: | Restlessness | ||
| Nervous system disorders | |||
| Very common: | Peripheral neuropathy, neuropathy, hypoaesthesia, paraesthesia | Peripheral neuropathy, dizziness, headache, dysgeusia | Peripheral neuropathy |
| Common: | Peripheral sensory neuropathy, dizziness, peripheral motor neuropathy, ataxia, headache, sensory disturbance, somnolence, dysgeusia | Dizziness, headache, dysgeusia | |
| Uncommon: | Polyneuropathy, areflexia, syncope, postural dizziness, dyskinesia, hyporeflexia, neuralgia, neuropathic pain, tremor, sensory loss | VIIth nerve paralysis | |
| Not known: | Cranial nerve palsies multiple1 | ||
| Eye disorders | |||
| Common: | Vision blurred, lacrimation increased, dry eye, keratoconjunctivitis sicca, madarosis | Lacrimation increased | Vision blurred |
| Uncommon: | Reduced visual acuity, abnormal vision, eye irritation, eye pain, conjunctivitis, visual disturbance, eye pruritus, keratitis | Cystoid macular oedema | |
| Rare: | Cystoid macular oedema1 | ||
| Ear and labyrinth disorders | |||
| Common: | Vertigo | ||
| Uncommon: | Tinnitus, ear pain | ||
| Cardiac disorders | |||
| Common: | Arrhythmia, tachycardia, supraventricular tachycardia | Cardiac failure congestive, tachycardia | |
| Rare: | Cardiac arrest, cardiac failure congestive, left ventricular dysfunction, atrioventricular block1, bradycardia | ||
| Vascular disorders | |||
| Common: | Hypertension, lymphoedema, flushing, hot flushes | Hypotension, hypertension | Hypotension, hypertension |
| Uncommon: | Hypotension, orthostatic hypotension, peripheral coldness | Flushing | Flushing |
| Rare: | Thrombosis | ||
| Respiratory, thoracic and mediastinal disorders | |||
| Very common: | Dyspnoea, epistaxis, cough | Dyspnoea | |
| Common: | Interstitial pneumonitis2, dyspnoea, epistaxis, pharyngolaryngeal pain, cough, rhinitis, rhinorrhoea | Pneumonitis, nasal congestion | Haemoptysis, epistaxis, cough |
| Uncommon: | Pulmonary emboli, pulmonary thromboembolism, pleural effusion, exertional dyspnoea, sinus congestion, decreased breath sounds, productive cough, allergic rhinitis, hoarseness, nasal congestion, nasal dryness, wheezing | Dry throat, nasal dryness | Pneumonitis |
| Not known: | Vocal cord paresis1 | ||
| Gastrointestinal disorders | |||
| Very common: | Diarrhoea, vomiting, nausea, constipation, stomatitis | Diarrhoea, vomiting, nausea, constipation, abdominal pain, abdominal pain upper | Diarrhoea, vomiting, nausea, constipation |
| Common: | Gastrooesophageal reflux disease, dyspepsia, abdominal pain, abdominal distension, abdominal pain upper, oral hypoaesthesia | Intestinal obstruction, colitis, stomatitis, dry mouth | Stomatitis, dyspepsia, dysphagia, abdominal pain |
| Uncommon: | Rectal haemorrhage, dysphagia, flatulence, glossodynia, dry mouth, gingival pain, loose stools, oesophagitis, abdominal pain lower, mouth ulceration, oral pain | ||
| Hepatobiliary disorders | |||
| Common: | Cholangitis | Hyperbilirubinaemia | |
| Uncommon: | Hepatomegaly | ||
| Skin and subcutaneous tissue disorders | |||
| Very common: | Alopecia, rash | Alopecia, rash | Alopecia, rash |
| Common: | Pruritus, dry skin, nail disorder, erythema, nail pigmentation/discolouration, skin hyperpigmentation, onycholysis, nail changes | Pruritus, dry skin, nail disorder | Pruritus, nail disorder |
| Uncommon: | Photosensitivity reaction, urticaria, skin pain, generalised pruritus, pruritic rash, skin disorder, pigmentation disorder, hyperhidrosis, onychomadesis, erythematous rash, generalised rash, dermatitis, night sweats, maculo-papular rash, vitiligo, hypotrichosis, nail bed tenderness, nail discomfort, macular rash, papular rash, skin lesion, swollen face | Skin exfoliation, dermatitis allergic, urticaria | |
| Very rare: | Stevens-Johnson syndrome1, toxic epidermal necrolysis1 | ||
| Not known: | Palmar-plantar erythrodysaesthesiae syndrome1,4, scleroderma1 | ||
| Musculoskeletal and connective tissue disorders | |||
| Very common: | Arthralgia, myalgia | Arthralgia, myalgia, pain in extremity | Arthralgia, myalgia |
| Common: | Back pain, pain in extremity, bone pain, muscle cramps, limb pain | Muscular weakness, bone pain | Back pain, pain in extremity, musculoskeletal pain |
| Uncommon: | Chest wall pain, muscular weakness, neck pain, groin pain, muscle spasms, musculoskeletal pain, flank pain, limb discomfort, muscle weakness | ||
| Renal and urinary disorders | |||
| Common: | Acute renal failure | ||
| Uncommon: | Haematuria, dysuria, pollakiuria, nocturia, polyuria, urinary incontinence | Haemolytic uraemic syndrome | |
| Reproductive system and breast disorders | |||
| Uncommon: | Breast pain | ||
| General disorders and administration site conditions | |||
| Very common: | Fatigue, asthenia, pyrexia | Fatigue, asthenia, pyrexia, oedema peripheral, chills | Fatigue, asthenia, oedema peripheral |
| Common: | Malaise, lethargy, weakness, peripheral oedema, mucosal inflammation, pain, rigors, oedema, decreased performance status, chest pain, influenza-like illness, hyperpyrexia | Infusion site reaction | Pyrexia, chest pain |
| Uncommon: | Chest discomfort, abnormal gait, swelling, injection site reaction | Mucosal inflammation, infusion site extravasation, infusion site inflammation, infusion site rash | |
| Rare: | Extravasation | ||
| Investigations | |||
| Very common: | Weight decreased, alanine aminotransferase increased | ||
| Common: | Decreased weight, increased alanine aminotransferase, increased aspartate aminotransferase, decreased haematocrit, decreased red blood cell count, increased body temperature, increased gamma-glutamyltransferase, increased blood alkaline phosphatase | Aspartate aminotransferase increased, blood bilirubin increased, blood creatinine increased | Weight decreased, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased |
| Uncommon: | Increased blood pressure, increased weight, increased blood lactate dehydrogenase, increased blood creatinine, increased blood glucose, increased blood phosphorus, decreased blood potassium, increased bilirubin | ||
| Injury, poisoning and procedural complications | |||
| Uncommon: | Contusion | ||
| Rare: | Radiation recall phenomenon, radiation pneumonitis | ||
1 As reported in the post-marketing surveillance of Abraxane.
2 The frequency of pneumonitis is calculated based on pooled data in 1310 patients in clinical trials receiving Abraxane monotherapy for breast cancer and for other indications.
3 Based on laboratory assessments: maximal degree of myelosuppression (treated population).
4 In some patients previously exposed to capecitabine.
This section contains the most common and clinically relevant adverse reactions related to Abraxane.
Adverse reactions were assessed in 229 patients with metastatic breast cancer who were treated with 260 mg/m² Abraxane once every three weeks in the pivotal phase III clinical study (Abraxane monotherapy).
Adverse reactions were assessed in 421 patients with metastatic pancreatic cancer who were treated with Abraxane in combination with gemcitabine (125 mg/m² Abraxane in combination with gemcitabine at a dose of 1000 mg/m² given on Days 1, 8 and 15 of each 28-day cycle) and 402 gemcitabine monotherapy-treated patients receiving first-line systemic treatment for metastatic adenocarcinoma of the pancreas (Abraxane/gemcitabine).
Adverse reactions were assessed in 514 patients with non-small cell lung cancer who were treated with Abraxane in combination with carboplatin (100 mg/m² Abraxane given on Days 1, 8 and 15 of each 21-day cycle in combination with carboplatin given on Day 1 of each cycle) in the phase III randomized, controlled clinical trial (Abraxane/carboplatin). Patient-reported taxane toxicity was assessed using the 4 subscales of the Functional Assessment of Cancer Therapy (FACT)-Taxane questionnaire. Using repeated measure analysis, 3 of the 4 subscales (peripheral neuropathy, pain hands/feet and hearing) favored Abraxane and carboplatin (p≤0.002). For the other subscale (oedema), there was no difference in the treatment arms.
Sepsis was reported at a rate of 5% in patients with or without neutropenia who received Abraxane in combination with gemcitabine during the conduct of a trial in pancreatic adenocarcinoma. Of the 22 cases of sepsis reported in patients treated with Abraxane in combination with gemcitabine, 5 had a fatal outcome. Complications due to the underlying pancreatic cancer, especially biliary obstruction or presence of biliary stent, were identified as significant contributing factors. If a patient becomes febrile (regardless of neutrophil count), initiate treatment with broad spectrum antibiotics. For febrile neutropenia, withhold Abraxane and gemcitabine until fever resolves and ANC ≥1500 cells/mm³, then resume treatment at reduced dose levels (see section 4.2).
In patients with metastatic breast cancer, neutropenia was the most notable important haematological toxicity (reported in 79% of patients) and was rapidly reversible and dose-dependent; leukopenia was reported in 71% of patients. Grade 4 neutropenia (<500 cells/mm³) occurred in 9% of patients treated with Abraxane. Febrile neutropenia occurred in four patients on Abraxane. Anaemia (Hb <10 g/dl) was observed in 46% of patients on Abraxane and was severe (Hb <8 g/dl) in three cases. Lymphopenia was observed in 45% of the patients.
Table 7 provides the frequency and severity of haematologic laboratory-detected abnormalities for patients treated with Abraxane in combination with gemcitabine or with gemcitabine.
Table 7. Haematologic laboratory-detected abnormalities in pancreatic adenocarcinoma trial:
| Abraxane (125 mg/m²)/ Gemcitabine | Gemcitabine | |||
| Grades 1-4 (%) | Grade 3-4 (%) | Grades 1-4 (%) | Grade 3-4 (%) | |
| Anaemiaa,b | 97 | 13 | 96 | 12 |
| Neutropeniaa,b | 73 | 38 | 58 | 27 |
| Thrombocytopeniab,c | 74 | 13 | 70 | 9 |
a 405 patients assessed in Abraxane/gemcitabine-treated group
b 388 patients assessed in gemcitabine-treated group
c 404 patients assessed in Abraxane/gemcitabine-treated group
Anaemia and thrombocytopenia were more commonly reported in the Abraxane and carboplatin arm than in the Taxol and carboplatin arm (54% versus 28% and 45% versus 27% respectively).
In general, the frequency and severity of neurotoxicity was dose-dependent in patients receiving Abraxane. Peripheral neuropathy (mostly Grade 1 or 2 sensory neuropathy) was observed in 68% of patients on Abraxane with 10% being Grade 3, and no cases of Grade 4.
For patients treated with Abraxane in combination with gemcitabine, the median time to first occurrence of Grade 3 peripheral neuropathy was 140 days. The median time to improvement by at least 1 grade was 21 days, and the median time to improvement from Grade 3 peripheral neuropathy to Grade 0 or 1 was 29 days. Of the patients with treatment interrupted due to peripheral neuropathy, 44% (31/70 patients) were able to resume Abraxane at a reduced dose. No patients treated with Abraxane in combination with gemcitabine had Grade 4 peripheral neuropathy.
For non-small cell lung cancer patients treated with Abraxane and carboplatin, the median time to first occurrence of Grade 3 treatment-related peripheral neuropathy was 121 days, and the median time to improvement from Grade 3 treatment related peripheral neuropathy to Grade 1 was 38 days. No patients treated with Abraxane and carboplatin experienced Grade 4 peripheral neuropathy.
There have been rare reports during post-marketing surveillance of reduced visual acuity due to cystoid macular oedema during treatment with Abraxane (see section 4.4).
Pneumonitis has been reported at a rate of 4% with the use of Abraxane in combination with gemcitabine. Of the 17 cases of pneumonitis reported in patients treated with Abraxane in combination with gemcitabine, 2 had a fatal outcome. Monitor patients closely for signs and symptoms of pneumonitis. After ruling out infectious etiology and upon making a diagnosis of pneumonitis, permanently discontinue treatment with Abraxane and gemcitabine and promptly initiate appropriate treatment and supportive measures (see section 4.2).
Nausea occurred in 29% of the patients and diarrhoea in 25% of the patients.
Alopecia was observed in >80% of the patients treated with Abraxane. The majority of alopecia events occurred less than one month after initiation of Abraxane. Pronounced hair loss ≥50% is expected for the majority of patients who experience alopecia.
Arthralgia occurred in 32% of patients on Abraxane and was severe in 6% of cases. Myalgia occurred in 24% of patients on Abraxane and was severe in 7% of cases. The symptoms were usually transient, typically occurred three days after Abraxane administration and resolved within a week.
Asthenia/Fatigue was reported in 40% of the patients.
The study consisted of 106 patients, 104 of whom were paediatric patients aged from 6 months to less than 18 years (see section 5.1). Every patient experienced at least 1 adverse reaction. The most frequently reported adverse reactions were neutropenia, anaemia, leukopenia and pyrexia. Serious adverse reactions reported in more than 2 patients were pyrexia, back pain, peripheral oedema and vomiting. No new safety signals were identified in the limited number of paediatric patients treated with Abraxane and the safety profile was similar to that of the adult population.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.