Albumin 5%

Albumin 5%

Human Albumin

Traumatic and surgical shock, burns accompanied by dehydration, hypoproteinemia and hypoalbuminemia, cirrhosis of the liver, gastrointestinal lesions (peptic ulcer disease, tumors, impaired patency of gastrointestinal anastomosis), acute pancreatitis, brain edema, prolonged suppurative processes, dystrophy, nephropathic syndrome.

Thrombosis, hypertension, internal bleeding.

WARNINGS

Infusion of protein-containing solutions such as Albuminar®-25 (albumin (human)) that have been excessively or inappropriately diluted with hypotonic solutions such as sterile water for injection may result in severe hemolysis and acute renal failure. Please refer to the DOSAGE AND ADMINISTRATION section for information about the recommended diluents for Albuminar®-25 (albumin (human)) , which are normal saline and 5% dextrose.

Do not use if the solution is turbid. Since this product contains no antimicrobial preservative, do not begin administration more than 4 hours after the container has been entered.

Albumin (Human) 25%, Albuminar®-25 is made from human plasma. Products made from human plasma may contain infectious agents such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses during manufacture. The manufacturing procedure for Albumin (Human) 25%, Albuminar®-25 (albumin (human)) includes processing steps designed to reduce further the risk of viral transmission. Stringent procedures utilized at plasma collection centers, plasma testing laboratories, and fractionation facilities are designed to reduce the risk of viral transmission. Albuminar®-25 (albumin (human)) is pasteurized in the final container at 60.0 +/- 0.5°C for 10-11 hours. Virus elimination/inactivation is also achieved by the cold alcohol fractionation process. (See DESCRIPTION section for further information on viral reduction measures.) Despite these measures, such products may still potentially contain human pathogenic agents, including those not yet known or identified. Thus the risk of transmission of infectious agents cannot be totally eliminated. Any infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to ZLB Behring at 800-504-5434. The physician should discuss the risks and benefits of this product with the patient.

Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.

PRECAUTIONS

General

If dehydration is present additional fluids must accompany or follow the administration of albumin. Administration of large quantities of albumin should be supplemented with or replaced by packed red blood cells to combat the relative anemia which would follow such use. The quick response of blood pressure which may follow the rapid administration of concentrated albumin necessitates careful observation of the injured patient to detect bleeding points which failed to bleed at lower blood pressure. Albumin (Human) 25%, Albuminar®-25 (albumin (human)) should be administered with caution to patients with low cardiac reserve or with no albumin deficiency because a rapid increase in plasma volume may cause circulatory compromise (e.g. hypertension, hypotension, or pulmonary edema). In cases of hypertension, a slower rate of administration is desired - 200 mL of albumin solution may be mixed with 300 mL of 10% dextrose solution and administered at a rate of 10 grams of albumin (100 mL) per hour.

If anaphylactic or severe anaphylactoid reactions occur, discontinue infusion immediately. Infusion rates and the patient's clinical state should be monitored closely during infusion.

Pregnancy Category C- Animal reproduction studies have not been conducted with Albumin (Human) 25%, Albuminar®-25 (albumin (human)). It is also not known whether Albuminar®-25 (albumin (human)) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Albuminar®-25 (albumin (human)) should be given to a pregnant woman only if clearly needed.

Pediatric Use - No clinical studies using Albumin (Human) 25%, Albuminar®-25 (albumin (human)) have been conducted in pediatric patients. Safety and effectiveness in pediatric patients have not been established. However, extensive experience in patients suggests that children respond to Albumin (Human) 25%, Albuminar (albumin (human)) ®-25 in the same manner as adults.

SIDE EFFECTS

Allergic or pyrogenic reactions are characterized primarily by fever and chills; rash, nausea, vomiting, tachycardia and hypotension have also been reported. Should an adverse reaction occur, slow or stop the infusion for a period of time which may result in the disappearance of the symptoms. If administration has been stopped and the patient requires additional ALBUMIN (HUMAN) USP, ALBUTEIN^® ,material from a different lot should be used.

ALBUTEIN^® , particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema.

DRUG INTERACTIONS

No information provided.

The most frequent and clinically significant adverse drug reactions (NLR) that develop against the background of the use of the drug Abraxan were neutropenia, peripheral neuropathy, arthralgia/myalgia and gastrointestinal disorders. The following are the NLRs registered during treatment with Abraxane - as monotherapy and in combination with gemcitabine — for all possible indications.

The following terms are used in this description to assess the incidence of NLR of the drug: very often (≥1/10), often (<1/10–≥1/100), infrequently (<1/100–≥1/1000), rarely (<1/1000–≥1/10000), very rarely (<1/10000).

Breast cancer (monotherapy with Abraxane)

Infectious and parasitic diseases: common-infections, urinary tract infections, folliculitis, upper respiratory tract infections, candidiasis, sinusitis, infrequently-oral candidiasis, nasopharyngitis, phlegmon, herpes simplex, viral infections, pneumonia, catheter-associated infections, fungal infections, shingles infectious complications at the injection site, sepsis², neutropenic sepsis².

Benign, malignant, and unspecified neoplasms (including cysts and polyps): rarely, metastatic pain, necrosis of the tumor.

From the blood and lymphatic system: very often — neutropenia, anemia, leukopenia, thrombocytopenia, lymphopenia, suppression of bone marrow hematopoiesis, often-febrile neutropenia, rarely-pancytopenia.

On the part of the immune system: infrequently¹ - hypersensitivity reactions, rarely-severe hypersensitivity reactions.

From the side of metabolism and nutrition: very often-anorexia, often-dehydration, decreased appetite, hypokalemia, infrequently-hypophosphatemia, fluid retention, hypoalbuminemia, polydipsia, hyperglycemia, hypokalemia, hypocalcemia, hypoglycemia, hyponatremia.

Mental disorders: often-insomnia, depression, anxiety, infrequently-anxiety.

From the nervous system: very often-peripheral neuropathy, neuropathy, hypesthesia, paresthesia, often-peripheral sensory neuropathy, headache, dysgeusia, dizziness, peripheral motor neuropathy, ataxia, sensory disorders, increased drowsiness, infrequently-polyneuropathy, decreased reflexes/areflexia, dyskinesia, neuralgia, loss of sensitivity, fainting, postural dizziness, neurogenic pain, tremor.

On the part of the visual organ: often-increased lacrimation, blurred vision, dry eye syndrome, dry keratoconjunctivitis, madarosis, infrequently-eye irritation, eye pain, visual impairment, decreased visual acuity, conjunctivitis, visual perception disorders, itching in the eyes, keratitis, rarely - cystic macular edema².

On the part of the organ of hearing and labyrinth disorders: often, vertigo, rarely — pain in the ears, tinnitus.

From the heart: often-tachycardia, arrhythmia, supraventricular tachycardia, rarely-bradycardia, cardiac arrest, left ventricular dysfunction, congestive heart failure, AV block².

From the side of the vessels: often-hot flushes, increased blood pressure, lymphatic edema, infrequently decreased blood pressure, cold extremities, orthostatic hypotension, very rarely — thrombosis.

From the respiratory system, chest and mediastinal organs: often-interstitial pneumonitis³, shortness of breath, nasal bleeding, pharyngolaryngeal pain, cough, rhinitis, rhinorrhea, infrequently — cough with sputum, shortness of breath during exercise, swelling of the sinus mucosa, weakened breathing, pleural effusion, allergic rhinitis, hoarseness, dry/stuffy nose, wheezing, thromboembolism/embolism of the pulmonary artery.

From the gastrointestinal tract: very often — nausea, diarrhea, vomiting, constipation, stomatitis, often — abdominal pain, bloating, epigastric pain, dyspepsia, gastroesophageal reflux, hypesthesia of the oral mucosa, infrequently — dysphagia, flatulence, glossalgia, dry mouth, gum pain, loose stools, esophagitis, lower abdominal pain, ulcerative lesions of the oral mucosa, mouth pain, rectal bleeding.

From the liver and biliary tract: infrequently — hepatomegaly.

From the skin and subcutaneous tissues:², toxic epidermal necrolysis³.

Musculoskeletal and connective tissue disorders: very often — arthralgia, myalgia, often-pain in the extremities, bone pain, back pain, muscle cramps, pain in the distal extremities, infrequently-chest pain, muscle weakness, neck pain, groin pain, muscle spasms, musculoskeletal pain, side pain, feeling of discomfort in the extremities.

From the kidneys and urinary tract: rarely — dysuria, pollakiuria, hematuria, nocturia, polyuria, urinary incontinence.

From the genitals and breast: infrequently-pain in the mammary gland.

General disorders and disorders at the injection site: very often-fatigue, asthenia, fever, often-peripheral edema, inflammation of the mucous membrane, pain, chills, swelling, weakness, decreased performance, chest pain, flu-like syndrome, malaise, drowsiness, hyperthermia, infrequently-a feeling of discomfort in the chest, gait disorders, swelling, reactions at the injection site, rarely-extravasation.

Laboratory and instrumental data: often-weight loss, increased activity of ALT, ACT, ALP, GTT, decreased red blood cell count, decreased hematocrit, increased body temperature, infrequently-increased blood pressure, increased body weight, hyperbilirubinemia, increased serum creatinine concentration, hyperphosphatemia, hyperglycemia, hyponatremia, increased LDH activity.

Injuries, intoxication, and complications of manipulation: infrequently-bruises, rarely-anamnestic radiation phenomenon, radiation pneumonitis³

¹ The frequency of hypersensitivity reactions was determined on the basis of one definitely associated with the drug Abraxane case in a population of 789 patients.

² According to the post-registration report on the drug Abraxane.

³ The frequency of pneumonitis was calculated based on the generalized data of 1310 patients who participated in clinical trials of the drug Abraxane, which was prescribed as monotherapy for breast cancer and other indications (see "Special instructions").

Pancreatic adenocarcinoma (drug Abraxane in combination with gemcitabine)

Infectious and parasitic diseases: often-sepsis, pneumonia, candidiasis of the oral cavity.

From the blood and lymphatic system: very often-neutropenia, anemia, thrombocytopenia, often-pancytopenia, infrequently-thrombotic thrombocytopenic purpura.

From the side of metabolism and nutrition: very often — dehydration, decreased appetite, hypokalemia.

Mental disorders: very often — insomnia, depression, infrequently-anxiety.

From the nervous system: very often — peripheral neuropathy, dysgeusia, headache, dizziness, infrequently-facial nerve paralysis.

On the part of the visual organ: often-increased lacrimation, infrequently - cystic edema of the macula.

From the heart: often-congestive heart failure, tachycardia.

From the side of the vessels: often-a decrease and increase in blood pressure.

From the respiratory system, chest and mediastinal organs: very often-shortness of breath, nosebleeds, cough, often-pneumonitis, nasal congestion, infrequently - dry throat/nose.

From the gastrointestinal tract: very often-nausea, diarrhea, vomiting, constipation, abdominal pain, pain in the epigastric region, often — stomatitis, intestinal obstruction, colitis, dryness of the oral mucosa.

From the liver and biliary tract: often-cholangitis.

From the skin and subcutaneous tissues: very often-alopecia, skin rash, often-itching, dry skin, nail diseases, hot flashes.

Musculoskeletal and connective tissue disorders: very often-pain in the extremities, arthralgia, myalgia, often-muscle weakness, pain in the bones.

From the kidneys and urinary tract: often-acute renal failure, infrequently-hemolytic-uremic syndrome.

General disorders and disorders at the injection site: very often — fatigue, peripheral edema, fever, asthenia, chills, often-reactions at the injection site.

Laboratory and instrumental data: very often-weight loss, increased ALT activity, often-increased ACT activity, hyperbilirubinemia, increased creatinine concentration in blood plasma.

Description of individual adverse reactions

From the blood and lymphatic system: Table 4 provides information on the frequency and severity of changes in the indicators of hematological tests in patients receiving the drug Abraxan in combination with gemcitabine or gemcitabine alone.

Table 4

Pathological changes in the parameters of hematological tests in patients with pancreatic adenocarcinoma

¹ The data of 405 patients treated with the combination of Abraxane/gemcitabine were evaluated.

² The data of 388 patients treated with gemcitabine were evaluated.

³ The data of 404 patients treated with the combination of Abraxane/gemcitabine were evaluated.

Post-marketing experience with the use

During the post-registration study of the drug Abraxan, cases of cranial nerve paralysis, paresis of the vocal cords, and rare cases of severe hypersensitivity reactions were described.

Rare cases of decreased visual acuity due to cystic retinal macular edema have also been reported during therapy with Abraxan. It is necessary to cancel Abraxan when making a diagnosis of cystic edema of the retinal macula. In some patients who received pre-capecitabine, cases of palmar-plantar erythrodysesthesia were noted. Due to the fact that such complications were reported spontaneously during clinical use of the drug, their true frequency and causal relationship cannot be determined.

The specific antidote of paclitaxel is unknown. In the case of an overdose of the drug Abraxane, symptomatic treatment and careful monitoring of the patient are carried out. Treatment should be directed to the main predicted complications (myelosuppression, mucositis, and peripheral neuropathy).

• Substitutes for plasma and other blood components