Abraxan - Instructions For Use, Price, Reviews, Drug Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Abraxan

Abraxan: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Abraxane

ATX code: L01CD01

Active ingredient: paclitaxel (Paclitaxel), albumin (Albumin)

Producer: Fresenius Kabi LLC (USA), Abraxis BioScience LLC (USA)

Description and photo update: 2019-10-07

Abraxan is an anticancer drug, an alkaloid.

Release form and composition

The drug is available in the form of a lyophilisate for preparing a suspension for infusion: a porous powdery mass of white or white with a yellow tint, after dissolving the lyophilisate, a translucent suspension of white with a yellow tint or white with a homogeneous structure is formed (100 mg each in transparent glass bottles, in a cardboard box 1 bottle and instructions for the use of Abraxan).

In 1 bottle the content of active ingredients is:

• paclitaxel - 100 mg;
• human albumin - 900 mg.

Pharmacological properties

Pharmacodynamics

Abraxan is an alkaloid, anticancer drug. It contains nanosized paclitaxel, which is stabilized with albumin. Paclitaxel in nanoparticles is in an amorphous (non-crystalline) state, their size is approximately 130 nm.

The mechanism of action of the drug is due to the ability of paclitaxel to stimulate the assembly of microtubules of the mitotic spindle from dimeric tubulin molecules, and then, by suppressing the depolymerization of microtubules, to stabilize them. As a result, the normal dynamic reorganization of the microtubular network is suppressed in the interphase of mitosis, the formation of an abnormal accumulation of microtubules throughout the entire cell cycle is potentiated and the appearance of multiple star-shaped clusters (asters) in the mitosis phase.

After intravenous (iv) administration, the nanoparticles rapidly dissociate and form soluble complexes of paclitaxel bound to albumin. Their approximate size is 10 nm. It is known that albumin is capable of regulating the processes of transendothelial transfer of plasma components; its presence in Abraxan stimulates the transport of paclitaxel through the endothelial cell layer, which is confirmed by the results of in vitro studies. There is a scientific hypothesis that transendothelial transport is indirectly related to the albumin transporter gp-60, and that an increase in paclitaxel accumulation in the tumor is due to the presence of albumin-binding protein, an acidic secreted protein rich in cysteine (SPARC).

Pharmacokinetics

Clinical studies to study the pharmacokinetics of paclitaxel in Abraxan were carried out at doses ranging from 80 to 375 mg per 1 m ² (mg / m ²) with infusion durations of 0.5 and 3 hours. In the dose range 80–300 mg / m ², the AUC values (total plasma concentration) increased linearly from 2653 to 16 736 ng / h / ml.

The pharmacokinetic parameters of the drug were evaluated in comparison with the parameters of the pharmacokinetics of paclitaxel based on the solvent when it was administered at a dose of 175 mg / m ² for 3 hours. The study was conducted involving patients with advanced solid tumors, which in / Abraxane was administered at a dose of 260 mg / m ² for 0.5 hours. Excluding compartments analysis results showed that after administration of Abraxane clearance of paclitaxel was higher by 43%, and V _d (volume of distribution) - by 53% compared to paclitaxel-based solvent.

The terminal half-life (T _1/2) was the same. With repeated intravenous administration of the drug at a dose of 260 mg / m ², it was found that in different patients the variability in the values of systemic exposure of paclitaxel (AUC) can be 19%. After several courses of therapy, there were no signs of accumulation of paclitaxel.

Plasma protein binding of paclitaxel is 94%.

In patients with solid tumors, paclitaxel was evenly distributed in blood cells and plasma.

It was found that the connection of paclitaxel with blood plasma proteins against the background of the simultaneous use of ranitidine, cimetidine, diphenhydramine or dexamethasone is not violated.

The total _{Vd is} approximately 1741 L, indicating intense binding of paclitaxel to tissue proteins and / or extravascular distribution.

Paclitaxel is metabolized mainly in the liver under the influence of isoenzymes of the cytochrome P _{450 system} CYP2C8 and CYP3A4 with the formation of hydroxylated metabolites: 6-alpha-hydroxypaclitaxel, 3'-n-hydroxypaclitaxel and 6-alpha-3'-n-dihydroxypaclitaxel.

The drug is characterized by significant extrarenal clearance. After the introduction of paclitaxel at a dose of 80-300 mg / m ^2, its average plasma clearance can be from 13 to 30 l / h / m ², and the average terminal T _1/2 - from 13 to 27 hours. The drug is excreted mainly with bile.

With mild hepatic failure, when total bilirubin exceeds the upper limit of normal (UHN) by no more than 1.5 times, there is no clinically significant change in paclitaxel pharmacokinetics parameters.

In moderate and severe hepatic impairment (total bilirubin is 1.5–5 times higher than ULN), there is a 22–26% decrease in the maximum rate of elimination, and the average paclitaxel AUC increases by about 20%. In this case, the average value of the maximum concentration (C _max) of paclitaxel does not change.

In patients with hepatic impairment, the elimination of paclitaxel is directly proportional to the parameters of the concentration of albumin in the blood plasma and inversely proportional to the indicators of total bilirubin.

There is no correlation between liver function (in terms of the initial concentration of total bilirubin or albumin) and neutropenia, taking into account the exposure of the drug Abraxan.

In patients with metastatic adenocarcinoma of the pancreas and total bilirubin exceeding VGN by more than 5 times, the effect of liver function on the pharmacokinetics of paclitaxel has not been established.

In mild to moderate renal failure with creatinine clearance (CC) from 30 to 90 ml / min, the maximum elimination rate and systemic exposure (C _max and AUC) of paclitaxel do not undergo clinically significant changes. In patients with severe and end-stage renal disease, the pharmacokinetics of paclitaxel has not been established.

The maximum rate of elimination and systemic exposure (AUC and C _max) of paclitaxel did not differ significantly in patients aged 24 to 85 years. In patients with advanced solid tumors over the age of 65, the plasma exposure of paclitaxel does not change, but during the first cycle of therapy they are more prone to developing neutropenia.

Gender, race or type of solid tumors do not have a clinically significant effect on systemic exposure (AUC and C _max) of Abraxan. In patients with a body weight of 50 kg, the AUC of paclitaxel is approximately 25% lower than in patients with a body weight of 75 kg. The clinical significance of this information has not been established.

Indications for use

• second and subsequent lines of therapy for metastatic breast cancer, refractory (or, if patients have contraindications) to standard combination chemotherapy containing anthracyclines, or if the disease recurs within 6 months after completion of adjuvant chemotherapy;
• the first line of therapy for metastatic adenocarcinoma of the pancreas in combination with gemcitabine.

Contraindications

Absolute:

• severe liver dysfunction [total bilirubin exceeds ULN by more than 5 times and the ACT (aspartate aminotransferase) indicator is more than 10 times higher than ULN];
• liver failure of moderate and severe degree in patients with metastatic adenocarcinoma of the pancreas;
• severe and end-stage renal failure;
• simultaneous use of drugs that are inducers of isoenzymes CYP2C8 and CYP3A4;
• neutropenia (the number of neutrophils in the blood is less than 1500 / μl);
• period of pregnancy;
• breast-feeding;
• age up to 18 years;
• hypersensitivity to drug components.

It is recommended to prescribe Abraxan with caution in case of suppression of bone marrow hematopoiesis (including the period after radiation or chemotherapy), impaired liver function of mild or moderate severity, heart disease, pulmonary pathologies, neuropathy, acute infectious diseases, patients with previous anthracyclines therapy, concurrent therapy with drugs, which are inhibitors of isoenzymes CYP2C8 and CYP3A4.

Abraxan, instructions for use: method and dosage

Abraxan should be used only in specialized departments, under the supervision of an oncologist with experience in treatment with cytotoxic drugs.

The pharmacological properties of paclitaxel in Abraxan may differ significantly from those of paclitaxel in other drugs. In this regard, it is contraindicated during therapy to replace it with other dosage forms of paclitaxel or combine with them.

The reconstituted suspension is intended for intravenous drip administration.

The infusion system should have a built-in filter with a pore diameter of 15 microns. The filter prevents the protein filaments formed from the silicone oil used in the manufacture of syringes and infusion bags from entering the bloodstream. Removing these particles does not change the physical and chemical characteristics of the reconstituted suspension.

A suspension for infusion should be prepared with strict adherence to aseptic requirements, in a specially equipped room. The personnel are advised to use protective clothing, gloves, glasses. Do not allow the drug to come into contact with the skin. If the drug gets on the skin, wash it immediately with soap and water, if it gets on the mucous membranes, they are also thoroughly washed with water.

Having removed the protective cap from the bottle, the cork must be wiped with an alcohol solution. Using a sterile syringe, slowly (for at least 1 minute), directing a stream along the inner wall of the vial, 20 ml of 0.9% sodium chloride solution for injection is injected into the vial. To avoid foaming, avoid spilling the solvent directly onto the lyophilisate. After the introduction of a dose of sodium chloride solution, the vial is left for 5 minutes to uniformly soak the lyophilisate with the solution. Then, for a complete and even distribution of the lyophilisate in the solution and the formation of a homogeneous suspension, the bottle with the contents is carefully rotated and / or inverted for at least 2 minutes, avoiding foaming. If it was not possible to avoid the formation of foam or agglomerates, then the bottle is left for 15 minutes. After the foam settles with light rotational movements of the bottle, the complete disappearance of agglomerates in its contents should be achieved.

The finished suspension should have a homogeneous translucent structure, white or white with a yellow tint, without any mechanical impurities. After the suspension is restored, its slight sedimentation is possible, in this case, before administration, the drug should be brought back to a homogeneous structure.

Before the introduction, it is necessary to make sure by visual inspection that there are no visible mechanical particles in the suspension. In the presence of foreign particles, the introduction of the suspension is not allowed.

1 ml of the resulting suspension contains 5 mg of albumin-stabilized nanodispersed paclitaxel; additional dilution is not required before administration. To determine the total volume of the drug for infusion, the prescribed dose (mg) must be divided by 5 mg / ml.

The required volume of the finished Abraxan suspension is transferred into a sterile empty infusion bag. The optimal infusion time is no more than 30 minutes; a longer period increases the risk of developing adverse reactions at the injection site. The preparation ready for administration should be used immediately after dilution.

Due to the use of a filter with pores less than 15 microns, it may become clogged and blocked. Therefore, it is necessary to carefully monitor the introduction of Abraxan for the timely detection of symptoms of infiltration at the injection site.

The suspension should be reconstituted immediately before infusion. If necessary, the finished suspension in vials can be stored for no more than 8 hours at a temperature of 2–8 ° C in a refrigerator, protected from bright light.

In an infusion bag, the finished suspension can be stored at room temperature (no more than 25 ° C) and normal light for 8 hours after reconstitution.

The recommended dosage for the treatment of breast cancer: the rate of 260 mg per 1 m ² body surface area (mg / m ²) 1 patient once a day with an interval between infusions of 21 days. If during treatment with Abraxan the patient develops severe neutropenia (the number of neutrophils is less than 500 / μl for 7 days or more) or severe sensory neuropathy during all subsequent courses of therapy, the dose of the drug should be 220 mg / m ²… The use of the drug should be resumed only after the neutrophil count is restored to a level above 1500 / μl and when the platelet count is above 100,000 / μl. Treatment should be suspended for grade III sensory neuropathy until its severity subsides to grade I or II. In case of repeated development of these complications, a single dose must be reduced to 180 mg / m ².

In the combined treatment of adenocarcinoma of the pancreas, the drug and gemcitabine are administered sequentially iv on the first, eighth and fifteenth days of each 28-day cycle in the following doses: Abraxan - 125 mg / m ², gemcitabine - 1000 mg / m ² for 30 minutes immediately after completion of the paclitaxel infusion.

Recommended dose reduction of drugs for combined therapy of pancreatic adenocarcinoma:

• full dose: paclitaxel - 125 mg / m ², gemcitabine - 1000 mg / m ²;
• first dose reduction: paclitaxel - 100 mg / m ², gemcitabine - 800 mg / m ²;
• second dose reduction: paclitaxel - 75 mg / m ², gemcitabine - 600 mg / m ²;
• need for additional dose reduction: the use of two drugs should be discontinued.

If neutropenia and / or thrombocytopenia occurs early or mid-cycle in patients with pancreatic adenocarcinoma, the dose of each drug should be changed. The correction is made depending on the indices of the absolute number of neutrophil cells and the number of platelet cells in 1 mm ³, as well as on which day of the cycle their change was detected.

It is recommended to observe the following dose adjustment scheme for Abraxan and gemcitabine for neutropenia and / or thrombocytopenia in patients with pancreatic adenocarcinoma:

• the first day of the cycle: if the absolute number of neutrophils (ANC) is less than 1500 cells in mm ³ or the number of platelets is less than 100 cells in mm ³, the therapy is suspended until the indicators are restored;
• the eighth day of the cycle: if the ANC is 500–1000 cells / mm ³ or the number of platelets is 50–75 cells / mm ³, the doses of drugs are reduced by one level. If the ANC is less than 500 cells / mm ³ or the number of platelets is less than 50 cells / mm ³ - treatment should be suspended;
• the fifteenth day of the cycle (in patients who did not change the dose of drugs intended for the eighth day of the cycle): if the ANC is 500–1000 cells / mm ³ or the platelet count is 50–75 cells / mm ³ - the drugs are administered at a dose intended for the eighth day with the subsequent introduction of a colony-stimulating factor. Alternatively, reduce the dose of drugs one level from the dose on the eighth day. If the ANC is less than 500 cells / mm ³ or the number of platelets is less than 50 cells / mm ³, the therapy is stopped;
• the fifteenth day of the cycle (in patients who have been reduced the doses of drugs intended for use on the eighth day of the cycle): if the ANC is 1000 cells / mm ³ or more or the number of platelets is 75 cells / mm ³ or more, the drugs are again administered at doses of the first day, followed by the introduction of a colony-stimulating factor. Alternatively, the use of doses that were administered on the eighth day of the cycle. If the ANC is 500–1000 cells / mm ³ or the number of platelets is 50–75 cells / mm ³, the drugs are administered in a dose intended for the eighth day of the cycle, followed by the introduction of a colony-stimulating factor. Alternatively, reduce the dose of drugs one level from the dose on the eighth day. If ANC is less than 500 cells / mm ³or the number of platelets is less than 50 cells / mm ³ - the therapy is stopped;
• the fifteenth day of the cycle (if the therapy on the eighth day was suspended): if the ANC is 1000 cells / mm ³ or more or the number of platelets is 75 cells / mm ³ or more, the infusion is carried out using the doses of the first day of the cycle, then a colony-stimulating factor is introduced. Alternatively, the use of doses reduced by one level from the doses of the first day. If the ANC is 500–1000 cells / mm ³ or the number of platelets is 50–75 cells / mm ³ - reduce the dose of drugs by one level followed by the introduction of a colony-stimulating factor or reduce the dose of drugs by 2 levels from the doses of the first day of the cycle. If the ANC is less than 500 cells / mm ³ or the number of platelets is less than 50 cells / mm ³, therapy is stopped.

In addition, in the treatment of pancreatic adenocarcinoma, a dose adjustment of Abraxan and gemcitabine is required when patients develop the following adverse drug reactions:

• peripheral neuropathy (III-IV degree): the Abraxan infusion is postponed until the severity of neuropathy decreases to I degree and below, when therapy is resumed, the dose is reduced using the dose of the next level. Gemcitabine continues to be administered at the same dose;
• febrile neutropenia (III-IV degree): the administration of drugs is suspended for the period necessary for the disappearance of fever and restoration of the number of neutrophils to 1500 cells / mm ³ and above. When resuming therapy, the dose of drugs should be reduced by one level, according to the recommendations for lowering doses;
• toxicity from the skin and subcutaneous tissues (II – III degree): the dose of each drug should be reduced by 1 level. If the severity of adverse reactions persists, therapy should be discontinued;
• toxicity from the gastrointestinal tract (mucositis, III degree of severity of diarrhea): the administration of drugs is canceled until the severity of toxicity is reduced to I degree, when the procedures are resumed, doses of the next, lower level are used.

With mild hepatic failure (the total bilirubin index exceeds the ULN by no more than 1.5 times, AST exceeds the ULN by no more than 10 times), dose adjustment is not required, regardless of the clinical indication.

In the treatment of metastatic breast cancer in patients with moderate to severe hepatic insufficiency (total bilirubin exceeds the ULN by more than 1.5 times, but less than 5 times, and AST exceeds the ULN by no more than 10 times), it is recommended to reduce the dose of the drug by 20%. For patients who tolerated the first 2 cycles of therapy well, the reduced dose can be increased to the total therapeutic dose in the next cycle.

Regardless of the indications, there are no recommendations on the dosing regimen for patients with total bilirubin exceeding the ULN by more than 5 times and the ACT indicator exceeding the ULN by more than 10 times.

Patients with mild or moderate renal failure (CC 30–90 ml / min) do not need to adjust the starting dose of Abraxan.

When treating patients aged 65 and over, an additional dose reduction of Abraxan is not provided.

When working with the drug, the rules for the destruction of cytotoxic substances should be observed.

Side effects

The undesirable disorders described below are classified as follows: very common - ≥ 1/10; often - ≥ 1/100 and <1/10; infrequently - ≥ 1/1000 and <1/100; rarely - ≥ 1/10 000 and <1/1000; very rarely - <1/10 000, including isolated cases.

Side effects of Abraxan, established in the treatment of breast cancer:

• on the part of the lymphatic system and blood: very often - anemia, leukopenia, neutropenia, thrombocytopenia, suppression of bone marrow hematopoiesis, lymphopenia; often - febrile neutropenia; rarely - pancytopenia;
• from the immune system: infrequently - hypersensitivity reactions; rarely - severe hypersensitivity reactions;
• from the side of metabolism and nutrition: very often - anorexia; often - decreased appetite, dehydration, hypokalemia; infrequently - fluid retention, polydipsia, hypoalbuminemia, hyperglycemia, hypokalemia, hyponatremia, hypocalcemia, hypoglycemia, hypophosphatemia;
• on the part of the organ of vision: often - blurred vision, increased lacrimation, dry eye syndrome, madarosis, dry keratoconjunctivitis; infrequently - itching and / or pain in the eyes, blurred vision, impaired visual perception, conjunctivitis, eye irritation, decreased visual acuity, keratitis; rarely, cystic macular edema;
• on the part of the organ of hearing and labyrinthine disorders: often - vertigo; infrequently - tinnitus, ear pain;
• from the heart: often - supraventricular tachycardia, tachycardia, arrhythmia; rarely - left ventricular dysfunction, bradycardia, atrioventricular block, congestive heart failure, cardiac arrest;
• on the part of the vessels: often - increased blood pressure (BP), lymphatic edema, hot flushes; infrequently - coldness of the extremities, lowering blood pressure, orthostatic hypotension; very rarely - thrombosis;
• from the respiratory system, chest and mediastinal organs: often - epistaxis, shortness of breath, cough, pharyngolaryngeal pain, rhinitis, rhinorrhea, interstitial pneumonitis; infrequently - allergic rhinitis, dryness or nasal congestion, swelling of the paranasal sinuses, wheezing, hoarseness, cough with phlegm, shortness of breath during exertion, poor breathing, thromboembolism or pulmonary embolism, pleural effusion;
• from the gastrointestinal tract: very often - stomatitis, nausea, vomiting, constipation, diarrhea; often - hypesthesia of the oral mucosa, pain in the epigastric region, bloating, dyspepsia, abdominal pain, gastroesophageal reflux; infrequently - pain in the gums, ulcerative lesions of the oral mucosa, dry mouth, pain in the mouth, dysphagia, flatulence, esophagitis, lower abdominal pain, loose stools, rectal bleeding, glossalgia;
• from the hepatobiliary system: infrequently - hepatomegaly;
• from the musculoskeletal system: very often - myalgia, arthralgia; often - bone pain, pain in the limbs, back pain, pain in the distal extremities, muscle cramps; infrequently - muscle weakness, muscle spasms, neck pain, chest pain, groin pain, discomfort in the limbs, pain in the side, musculoskeletal pain;
• from the urinary system: infrequently - hematuria, dysuria, pollakiuria, nocturia, urinary incontinence, polyuria;
• on the part of the genitals and mammary gland: infrequently - pain in the mammary gland;
• from the nervous system: very often - hypesthesia, paresthesia, peripheral neuropathy, neuropathy; often - headache, dizziness, dysgeusia, ataxia, increased drowsiness, peripheral motor neuropathy, peripheral sensory neuropathy, sensory disturbances; infrequently - postural dizziness, loss of sensitivity, decreased reflexes or areflexia, polyneuropathy, neurogenic pain, tremor, dyskinesia, neuralgia, fainting;
• mental disorders: often - anxiety, insomnia, depression; infrequently - anxiety;
• unspecified, benign and malignant neoplasms (including cysts and polyps): infrequently - tumor necrosis, metastatic pain;
• parasitic and infectious pathologies: often - infections, folliculitis, candidiasis, sinusitis, upper respiratory tract infections, urinary tract infections; infrequently - nasopharyngitis, oral candidiasis, herpes simplex, herpes zoster, fungal infections, cellulitis, pneumonia, viral infections, neutropenic sepsis, infectious complications at the injection site, sepsis, infections associated with the use of a catheter;
• dermatological reactions: very often - skin rash, alopecia; often - itching, erythema, dry skin, damage to the nail plates (discoloration of the nail bed, changes in pigmentation), damage to the nails, onycholysis (exfoliation of nails), nail changes, hyperpigmentation of the skin; infrequently - itchy rash, erythematous rash, rashes, generalized rash, dermatitis, maculopapular rash, excessive sweating, night sweats, photosensitivity reactions, pain in the skin, skin pigmentation abnormalities, soreness of the nail bed, onychomadiasis (complete) in the nails, generalized itching, vitiligo, skin damage, hypotrichosis, facial edema, skin diseases; very rarely - toxic epidermal necrolysis, Stevens-Johnson syndrome;
• general disorders and disorders at the injection site: very often - fever, asthenia, fatigue; often - drowsiness, weakness, inflammation of the mucous membrane, malaise, flu-like syndrome, chills, peripheral edema, pain, decreased performance, edema, hyperthermia, chest pain; infrequently - reactions at the injection site, swelling, chest discomfort, gait disturbance; rarely - extravasation;
• laboratory indicators: often - an increase in body temperature, a decrease in body weight, an increase in the activity of ACT, ALT (alanine aminotransferase), alkaline phosphatase and / or GTT (gamma-glutamyl transferase), a decrease in the number of erythrocytes, a decrease in hematocrit; infrequently - increased blood pressure, increased body weight, hyperglycemia, hyponatremia, hyperbilirubinemia, increased serum creatinine concentration, LDH activity (lactate dehydrogenase), hyperphosphatemia;
• complications of manipulations, trauma and intoxication: infrequently - bruises; rarely - radiation pneumonitis, anamnestic radiation phenomenon.

Adverse reactions of Abraxan, established in the treatment of pancreatic adenocarcinoma in combination with gemcitabine:

• from the lymphatic system and blood: very often - anemia, thrombocytopenia, neutropenia; often pancytopenia; infrequently - thrombotic thrombocytopenic purpura;
• on the part of metabolism and nutrition: very often - decreased appetite, hypokalemia, dehydration;
• on the part of the organ of vision: often - increased lacrimation; infrequently - cystic macular edema;
• from the side of the vessels: often - increase / decrease in blood pressure;
• from the side of the heart: often - tachycardia, congestive heart failure;
• from the respiratory system, chest and mediastinal organs: very often - cough, nosebleeds, shortness of breath; often - nasal congestion, pneumonitis; infrequently - dryness of the nose or throat;
• from the gastrointestinal tract: very often - constipation, diarrhea, pain in the epigastric region, abdominal pain, nausea, vomiting; often - dryness of the oral mucosa, stomatitis, colitis, intestinal obstruction;
• from the hepatobiliary system: often - cholangitis;
• from the musculoskeletal system: very often - arthralgia, myalgia, pain in the limbs; often - muscle weakness, bone pain;
• from the urinary system: often - acute renal failure; infrequently - hemolytic uremic syndrome;
• from the nervous system: very often - headache, dysgeusia, dizziness, peripheral neuropathy; infrequently - paralysis of the facial nerve;
• mental disorders: very often - depression, insomnia; infrequently - anxiety;
• infectious and parasitic pathologies: often - oral candidiasis, sepsis, pneumonia;
• dermatological reactions: very often - skin rash, alopecia; often - dry skin, itching, hot flashes, nail diseases;
• laboratory indicators: very often - a decrease in body weight, an increase in ALT activity; often - an increase in the concentration of creatinine in the blood plasma, ACT activity, hyperbilirubinemia;
• general disorders and disorders at the injection site: very often - fever, chills, fatigue, asthenia, peripheral edema; often - reactions at the injection site.

Overdose

Symptoms: the main predictable complications include myelosuppression, mucositis, and peripheral neuropathy.

Treatment: there is no specific antidote, therefore, in case of an overdose of Abraxan, the patient's condition should be carefully monitored, including the necessary laboratory tests. Symptomatic treatment is prescribed as needed.

special instructions

If symptoms of hypersensitivity appear, the infusion should be stopped immediately. Due to the existing risk of developing severe hypersensitivity reactions, including fatal ones, it is impossible to resume treatment with the drug in this category of patients.

The hematological toxicity of Abraxan is mainly manifested by the development of neutropenia, which is dose-dependent.

The main risk factors for the development of sepsis in the treatment of pancreatic cancer are various complications, including the presence of a biliary stent and obstruction of the biliary tract. Therefore, regardless of the number of neutrophils, broad-spectrum antibiotics should be prescribed for any increase in body temperature in a patient.

Confirmation of the diagnosis of pneumonitis is the basis for the immediate termination (without the possibility of renewal) treatment with Abraxan.

Patients with impaired liver function are at a higher risk of developing toxic reactions, therefore, in this category of patients, it is necessary to regularly monitor the blood picture. This will promptly identify the symptoms of severe myelosuppression.

The efficacy and safety of the use of Abraxan in cancer metastases in the central nervous system have not been established.

For the relief of nausea, vomiting or diarrhea, antiemetic and antidiarrheal drugs are indicated.

In adenocarcinoma of the pancreas with normal values of the pancreatic cancer antigen (CA 19-9) before the start of treatment, there was no obvious advantage in the form of prolongation of overall survival from the use of Abraxan.

When treating patients who limit sodium intake, it should be borne in mind that after reconstitution, 1 ml of the suspension contains 4.2 mg of sodium.

Inhalation of paclitaxel can cause shortness of breath, nausea, sore throat or chest pain, and burning sensation in the eyes.

It is impossible to work with Abraxan during pregnancy.

Influence on the ability to drive vehicles and complex mechanisms

With the development of dizziness and increased fatigue during treatment with Abraxan, patients should not engage in potentially hazardous activities, including driving or driving complex mechanisms.

Application during pregnancy and lactation

The use of Abraxan is contraindicated during the period of gestation and breastfeeding.

Patients should avoid conception during the entire treatment period. In addition, men need to use condoms for 6 months after completing therapy.

Women of childbearing age need to use reliable contraceptive methods for the entire period of therapy and one month after its completion.

If it is necessary to use Abraxan during lactation, breastfeeding should be discontinued.

The results of in vivo studies indicate the genotoxic, teratogenic, fetotoxic and embryotoxic effects of paclitaxel. In addition, reproductive function decreases, in men it can manifest itself in the form of atrophy or degeneration of the testicles, in women - a decrease in the incidence of conception and an increase in the risk of embryo death.

In connection with the existing risk of developing irreversible infertility, men should be advised to preserve their own sperm samples before starting treatment.

Pediatric use

There is no reliable information about the efficacy and safety of Abraxan's use in children, therefore, the drug is contraindicated in patients under 18 years of age.

With impaired renal function

The appointment of Abraxan is contraindicated for the treatment of patients with severe and end-stage renal failure.

For violations of liver function

The appointment of Abraxan is contraindicated for the treatment of patients with severe hepatic impairment, moderate and severe hepatic insufficiency in patients with metastatic adenocarcinoma of the pancreas.

Abraxan should be used with caution in case of mild or moderate hepatic dysfunction.

Use in the elderly

There is no evidence of the benefit of combination therapy with Abraxane and gemcitabine compared with gemcitabine monotherapy in patients aged 75 years and older. At this age, in patients with a combination of the drug with gemcitabine, there is an increase in the incidence of serious adverse reactions, including peripheral neuropathy, hematological toxicity, decreased appetite, dehydration, often requiring early discontinuation of treatment. When prescribing Abraxan to patients with pancreatic adenocarcinoma aged 75 years and older, special attention should be paid to their general condition, concomitant diseases, and the increased risk of infections should be taken into account. Patients should be closely monitored.

Drug interactions

It is recommended to use Abraxan with caution in combination with antifungal agents (including ketoconazole, imidazole derivatives, erythromycin, gemfibrozil, ritonavir, cimetidine, fluoxetine, saquinavir, nelfinavir, indinavir) and other inhibitors of CYP2CYP3A4 isoenzyme isoenzyme inhibitors due to the age of CYP3A4 and CYP3A4 toxel and CYP3A4 toxel age increase due to age

The simultaneous use of the drug with phenytoin, efavirenz, rifampicin, carbamazepine, nevirapine is not recommended. These and other drugs, which induce CYP3A4 and CYP2C8 isoenzymes, reduce paclitaxel exposure and efficacy.

The pharmacokinetic interaction of Abraxane and gemcitabine has not been established.

It is impossible to combine Abraxan with other antineoplastic agents (not including gemcitabine).

Analogs

Abraxan analogs are: Abitaxel, Mitotax, Paxen, Paklikal, Paclitaxel, Paclitaxel-Ebeve, Paclitaxel-Kelun-Kazpharm, Paclitaxel-Teva, Paclitaxel-LENS, Paclitaxel-Phylaxis, Paklitera, Sindaxel, Taksol, Kanataxel.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C in a dark place.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Abraksan

Reviews about Abraxan are mostly positive.

The price of Abraxan in pharmacies

The price of Abraxan for a package containing 1 bottle of lyophilisate can range from 41,000 rubles.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!