ABELCET ® is a sterile, pyrogen-free suspension for intravenous infusion. ABELCET ® consists of amphotericin B complexed with two phospholipids in a 1:1 drug-to-lipid molar ratio. The two phospholipids, l-α-dimyristoylphosphatidylcholine (DMPC) and l-α-dimyristoylphosphatidylglycerol (DMPG), are present in a 7:3 molar ratio. ABELCET ® is yellow and opaque in appearance, with a pH of 5 - 7.
NOTE: Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products.
Amphotericin B is a polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as [1R-(1R*, 3S*, 5R*, 6R*, 9R*, 11R*, 15S*, 16R*, 17R*, 18S*, 19E, 21E, 23E, 25E, 27E, 29E, 31E, 33R*, 35S*, 36R*, 37S*)]-33-[(3-Amino-3, 6-dideoxy- β-D-mannopyranosyl) oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1] nonatriaconta-19, 21, 23, 25, 27, 29, 31-heptaene-36-carboxylic acid.
It has a molecular weight of 924.09 and a molecular formula of C 47H 73NO 17. The structural formula is:
ABELCET ® is provided as a sterile, opaque suspension in 20 mL glass, single-use vials. Each 20 mL vial contains 100 mg of amphotericin B in 20 mL of suspension (see DOSAGE AND ADMINISTRATION), and each mL of ABELCET ® contains:
Amphotericin B USP 5.0 mg
l-α-dimyristoylphosphatidylcholine (DMPC) 3.4 mg
l-α-dimyristoylphosphatidylglycerol (DMPG) 1.5 mg
Sodium Chloride USP 9.0 mg
Water for Injection USP, q.s. 1.0 mL
MICROBIOLOGY
Mechanism of Action
The active component of ABELCET ®, amphotericin B, acts by binding to sterols in the cell membrane of susceptible fungi, with a resultant change in the permeability of the membrane. Mammalian cell membranes also contain sterols, and damage to human cells is believed to occur through the same mechanism of action.
Activity in vitro and in vivo
ABELCET ® shows in vitro activity against Aspergillus sp. (n=3) and Candida sp. (n=10), with MICs generally <1 μg/mL. Depending upon the species and strain of Aspergillus and Candida tested, significant in vitro differences in susceptibility to amphotericin B have been reported (MICs ranging from 0.1 to >10 μg/mL).
ABELCET ® is active in animal models against Aspergillus fumigatus, Candida albicans, C. guillermondii, C. stellatoideae, and C. tropicalis, Cryptococcus sp., Coccidioidomyces sp., Histoplasma sp., and Blastomyces sp. in which end-points were clearance of microorganisms from target organ(s) and/or prolonged survival of infected animals.
Drug Resistance
Fungal species with decreased susceptibility to amphotericin B have been isolated after serial passage in culture media containing the drug, and from some patients receiving prolonged therapy. Although the relevance of drug resistance to clinical outcome has not been established, fungal species which are resistant to amphotericin B may also be resistant to ABELCET ®.
Susceptibility Testing
For specific information regarding susceptibility test interpretive criteria, and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.
Pharmacokinetics
The assay used to measure amphotericin B in the blood after the administration of ABELCET ® does not distinguish amphotericin B that is complexed with the phospholipids of ABELCET ® from amphotericin B that is uncomplexed.
The pharmacokinetics of amphotericin B after the administration of ABELCET ® are nonlinear. Volume of distribution and clearance from blood increase with increasing dose of ABELCET ®, resulting in less than proportional increases in blood concentrations of amphotericin B over a dose range of 0.6-5 mg/kg/day. The pharmacokinetics of amphotericin B in whole blood after the administration of ABELCET ® and amphotericin B desoxycholate are:
Pharmacokinetic Parameters of Amphotericin B in Whole Blood in Patients Administered Multiple Doses of ABELCET ® or Amphotericin B Desoxycholate | ||
Pharmacokinetic Parameter | ABELCET ® 5 mg/kg/day for 5-7 days Mean ± SD | Amphotericin B |
Peak Concentration ( μg/mL) | 1.7 ± 0.8 (n=10) b | 1.1 ± 0.2 (n=5) |
Concentration at End of Dosing Interval (μg/mL) | 0.6 ± 0.3 (n=10 b | 0.4 ± 0.2 (n=5) |
Area Under Blood Concentration-Time Curve |
|
|
Clearance (mL/h*kg) | 436.0.± 188.5 (n=14) b,c | 38.0 ± 15 (n=5) |
Apparent Volume of Distribution (Vd area) (L/kg) | 131.0.± 57.7 (n=8) c | 5.0.± 2.8 (n=5) |
Terminal Elimination Half-Life (h) | 173.4 ± 78.0 (n=8) c | 91.1 ± 40.9 (n=5) |
Amount Excreted in Urine Over 24 h After Last Dose (% of dose) d |
|
|
a Data from patients with mucocutaneous leishmaniasis. Infusion rate was 0.25 mg/kg/h.
b Data from studies in patients with cytologically proven cancer being treated with chemotherapy or neutropenic patients with
presumed or proven fungal infection. Infusion rate was 2.5 mg/kg/h.
c Data from patients with mucocutaneous leishmaniasis. Infusion rate was 4 mg/kg/h.
d Percentage of dose excreted in 24 hours after last dose.
The large volume of distribution and high clearance from blood of amphotericin B after the admistration of ABELCET ® probably reflect uptake by tissues. The long terminal elimination half-life probably reflects a slow redistribution from tissues. Although amphotericin B is excreted slowly, there is little accumulation in the blood after repeated dosing. AUC of amphotericin B increased approximately 34% from day 1 after the administration of ABELCET ® 5 mg/kg/day for 7 days. The effect of gender or ethnicity on the pharmacokinetics of ABELCET ® has not been studied.
Tissue concentrations of amphotericin B have been obtained at autopsy from one heart transplant patient who received three doses of ABELCET ® at 5.3 mg/kg/day:
Concentration in Human Tissues | |
| Amphotericin B Tissue Concentration (µg/g) |
Spleen | 290.0 |
Lung | 222.0 |
Liver | 196.0 |
Lymph Node | 7.6 |
Kidney | 6.9 |
Heart 0 | 5. |
Brain | 1.6 |
This pattern of distribution is consistent with that observed in preclinical studies in dogs in which greatest concentrations of amphotericin B after ABELCET ® administration were observed in the liver, spleen, and lung; however, the relationship of tissue concentrations of amphotericin B to its biological activity when administered as ABELCET ® is unknown.
Special Populations
Hepatic Impairment: The effect of hepatic impairment on the disposition of ABELCET ® is not known.
Renal Impairment: The effect of renal impairment on the disposition of ABELCET ® is not known. The effect of dialysis on the elimination of ABELCET ® has not been studied; however, amphotericin B is not removed by hemodialysis when administered as amphotericin B desoxycholate.
Pediatric and Elderly Patients: The pharmacokinetics and pharmacodynamics of pediatric patients (≤16 years of age) and elderly patients (≥65 years of age) have not been studied.
ABELCET ® is indicated for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy. This is based on open-label treatment of patients judged by their physicians to be intolerant to or failing conventional amphotericin B therapy (See DESCRIPTION OF CLINICAL STUDIES).
DESCRIPTION OF CLINICAL STUDIES
Fungal Infections
Data from 473 patients were pooled from three open-label studies in which ABELCET ® was provided for the treatment of patients with invasive fungal infections who were judged by their physicians to be refractory to or intolerant of conventional amphotericin B, or who had preexisting nephrotoxicity. Results of these studies demonstrated effectiveness of ABELCET ® in the treatment of invasive fungal infections as a second line therapy.
Patients were defined by their individual physician as being refractory to or failing conventional amphotericin B therapy based on overall clinical judgement after receiving a minimum total dose of 500 mg of amphotericin B. Nephrotoxicity was defined as a serum creatinine that had increased to >2.5 mg/dL in adults and >1.5 mg/dL in pediatric patients, or a creatinine clearance of <25 mL/min while receiving conventional amphotericin B therapy.
Of the 473 patients, four were enrolled more than once; each enrollment contributed separately to the denominator. The median age was 39 years (range of <1 to 93 years); 307 patients were male and 166 female. Patients were Caucasian (381, 81%), African-American (41, 9%), Hispanic (27, 6%), Asian (10, 2%), and various other races (14, 3%). The median baseline neutrophil count was 4,000 PMN/mm3; of these, 101 (21%) had a baseline neutrophil count <500/mm 3.
Two-hundred eighty-two patients of the 473 patients were considered evaluable for response to therapy; the other 191 patients were excluded on the basis of unconfirmed diagnosis, confounding factors, concomitant systemic antifungal therapy, or receiving 4 doses or less of ABELCET ®. For evaluable patients, the following fungal infections were treated (n=282): aspergillosis (n=111), candidiasis (n=87), zygomycosis (n=25), cryptococcosis (n=16), and fusariosis (n=11). There were fewer than 10 evaluable patients for each of several other fungal species treated.
For each type of fungal infection listed above there were some patients successfully treated. However, in the absence of controlled studies it is unknown how response would have compared to either continuing conventional amphotericin B therapy or the use of alternative antifungal agents.
Renal Function: Patients with aspergillosis who initiated treatment with ABELCET ® when serum creatinine was above 2.5 mg/dL experienced a decline in serum creatinine during treatment (Figure 1). Serum creatinine levels were also lower during treatment with ABELCET ® when compared to the serum creatinine levels of patients treated with conventional amphotericin B in a retrospective historical control study. Meaningful statistical testing of the differences between these two groups is precluded since these data were obtained from two separate studies.
[ ]= Number of patients at each time point.
Note: These curves do not represent the clinical course of a given patient, but that of an open-label cohort of patients.
[ ]= Number of patients at each time point.
Note: These curves do not represent the clinical course of a given patient, but that of an open-label cohort of patients.
In a randomized study of ABELCET ® for the treatment of invasive candidiasis in patients with normal baseline renal function, the incidence of nephrotoxicity was significantly less for ABELCET ® at a dose of 5 mg/kg/day than for conventional amphotericin B at a dose of 0.7 mg/kg/day.
Despite generally less nephrotoxicity of ABELCET ® observed at a dose of 5 mg/kg/day compared with conventional amphotericin B therapy at a dose range of 0.6-1 mg/kg/day, dose-limiting renal toxicity may still be observed with ABELCET ®. Renal toxicity of doses greater than 5 mg/kg/day of ABELCET ® has not been formally studied.
ABELCET ® is contraindicated in patients who have shown hypersensitivity to amphotericin B or any other component in the formulation.
Anaphylaxis has been reported with amphotericin B desoxycholate and other amphotericin B-containing drugs. Anaphylaxis has been reported with ABELCET ® with an incidence rate of <0.1%. If severe respiratory distress occurs, the infusion should be immediately discontinued. The patient should not receive further infusions of ABELCET ®.
General:
As with any amphotericin B-containing product, during the initial dosing of ABELCET ®, the drug should be administered under close clinical observation by medically trained personnel.
Acute reactions including fever and chills may occur 1 to 2 hours after starting an intravenous infusion of ABELCET ®. These reactions are usually more common with the first few doses of ABELCET ® and generally diminish with subsequent doses. Infusion has been rarely associated with hypotension, bronchospasm, arrhythmias, and shock.
Laboratory Tests:
Serum creatinine should be monitored frequently during ABELCET ® therapy (see ADVERSE REACTIONS). It is also advisable to regularly monitor liver function, serum electrolytes (particularly magnesium and potassium), and complete blood counts.
Drug Interactions:
No formal clinical studies of drug interactions have been conducted with ABELCET ®. However, when administered concomitantly, the following drugs are known to interact with amphotericin B; therefore, the following drugs may interact with ABELCET ®:
Antineoplastic agents: Concurrent use of antineoplastic agents and amphotericin B may enhance the potential for renal toxicity, bronchospasm, and hypotension. Antineoplastic agents should be given concomitantly with ABELCET ® with great caution.
Corticosteroids and corticotropin (ACTH): Concurrent use of corticosteroids and corticotropin (ACTH) with amphotericin B may potentiate hypokalemia which could predispose the patient to cardiac dysfunction. If used concomitantly with ABELCET ®, serum electrolytes and cardiac function should be closely monitored.
Cyclosporin A: Data from a prospective study of prophylactic ABELCET ® in 22 patients undergoing bone marrow transplantation suggested that concurrent initiation of cyclosporin A and ABELCET ® within several days of bone marrow ablation may be associated with increased nephrotoxicity.
Digitalis glycosides: Concurrent use of amphotericin B may induce hypokalemia and may potentiate digitalis toxicity. When administered concomitantly with ABELCET ®, serum potassium levels should be closely monitored.
Flucytosine: Concurrent use of flucytosine with amphotericin B-containing preparations may increase the toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion. Flucytosine should be given concomitantly with ABELCET ® with caution.
Imidazoles (e.g., ketoconazole, miconazole, clotrimazole, fluconazole, etc.): Antagonism between amphotericin B and imidazole derivatives such as miconazole and ketoconazole, which inhibit ergosterol synthesis, has been reported in both in vitro and in vivo animal studies. The clinical significance of these findings has not been determined.
Leukocyte transfusions: Acute pulmonary toxicity has been reported in patients receiving intravenous amphotericin B and leukocyte transfusions. Leukocyte transfusions and ABELCET ® should not be given concurrently.
Other nephrotoxic medications: Concurrent use of amphotericin B and agents such as aminoglcosides and pentamidine may enhance the potential for drug-induced renal toxicity. Aminoglycosides and pentamidine should be used concomitantly with ABELCET ® only with great caution. Intensive monitoring of renal function is recommended in patients requiring any combination of nephrotoxic medications.
Skeletal muscle relaxants: Amphotericin B-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants (e.g., tubocurarine) due to hypokalemia. When administered concomitantly with ABELCET ®, serum potassium levels should be closely monitored.
Zidovudine: Increased myelotoxicity and nephrotoxicity were observed in dogs when either ABELCET ® (at doses 0.16 or 0.5 times the recommended human dose) or amphotericin B desoxycholate (at 0.5 times the recommended human dose) were administered concomitantly with zidovudine for 30 days. If zidovudine is used concomitantly with ABELCET ®, renal and hematologic function should be closely monitored.
Carcinogenesis, Mutagenesis, and Impairment of Fertility:
No long-term studies in animals have been performed to evaluate the carcinogenic potential of ABELCET ®. The following in vitro (with and without metabolic activation) and in vivo studies to assess ABELCET ® for mutagenic potential were conducted: bacterial reverse mutation assay, mouse lymphoma forward mutation assay, chromosomal aberration assay in CHO cells, and in vivo mouse micronucleus assay. ABELCET ® was found to be without mutagenic effects in all assay systems. Studies demonstrated that ABELCET ® had no impact on fertility in male and female rats at doses up to 0.32 times the recommended human dose (based on body surface area considerations).
Pregnancy:
There are no reports of pregnant women having been treated with ABELCET ®. Teratogenic Effects. Reproductive studies in rats and rabbits at doses of ABELCET ® up to 0.64 times the human dose revealed no harm to the fetus. Because animal reproductive studies are not always predictive of human response, and adequate and well-controlled studies have not been conducted in pregnant women, ABELCET ® should be used during pregnancy only after taking into account the importance of the drug to the mother.
Nursing Mothers:
It is not known whether ABELCET ® is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in breast-fed infants from ABELCET ®, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use:
One hundred eleven children (2 were enrolled twice and counted as separate patients), age 16 years and under, of whom 11 were less than 1 year, have been treated with ABELCET ® at 5 mg/kg/day in two open-label studies and one small, prospective, single-arm study. In one single-center study, 5 children with hepatosplenic candidiasis were effectively treated with 2.5 mg/kg/day of ABELCET ®. No serious unexpected adverse events have been reported.
Geriatric Use:
Forty-nine elderly patients, age 65 years or over, have been treated with ABELCET ® at 5 mg/kg/day in two open-label studies and one small, prospective, single-arm study. No serious unexpected adverse events have been reported.
The total safety data base is composed of 921 patients treated with ABELCET ® (5 patients were enrolled twice and counted as separate patients), of whom 775 were treated with 5 mg/kg/day. Of these 775 patients, 194 patients were treated in four comparative studies; 25 were treated in open-label, non-comparative studies; and 556 patients were treated in an open-label, emergency-use program. Most had underlying hematologic neoplasms, and many were receiving multiple concomitant medications. Of the 556 patients treated with ABELCET ®, 9% discontinued treatment due to adverse events regardless of presumed relationship to study drug.
In general, the adverse events most commonly reported with ABELCET ® were transient chills and/or fever during infusion of the drug.
Adverse Events a with an Incidence of ≥3% (N=556) | |
Adverse Event | Percentage (%) of Patients |
Chills | 18 |
Fever | 14 |
Increased Serum Creatinine | 11 |
Multiple Organ Failure | 11 |
Nausea | 9 |
Hypotension | 8 |
Respiratory Failure | 8 |
Vomiting | 8 |
Dyspnea | 7 |
Sepsis | 7 |
Diarrhea | 6 |
Headache | 6 |
Cardiac Arrest | 6 |
Hypertension | 5 |
Hypokalemia | 5 |
Infection | 5 |
Kidney Failure | 5 |
Pain | 5 |
Thrombocytopenia | 5 |
Anemia | 4 |
Hyperbilirubinemia | 4 |
Gastrointestinal Hemorrhage | 4 |
Leukopenia | 4 |
Rash | 4 |
Respiratory Disorder | 4 |
Chest Pain | 3 |
Nausea and Vomiting | 3 |
aThe causal association between these adverse events and ABELCET ® is uncertain.
The following adverse events have also been reported in patients using ABELCET ® in open-label, uncontrolled clinical studies. The causal association between these adverse events and ABELCET ® is uncertain.
Body as a whole: malaise, weight loss, deafness, injection site reaction including inflammation
Allergic: bronchospasm, wheezing, asthma, anaphylactoid and other allergic reactions
Cardiopulmonary: cardiac failure, pulmonary edema, shock, myocardial infarction, hemoptysis, tachypnea, thrombophlebitis, pulmonary embolus, cardiomyopathy, pleural effusion, arrhythmias including ventricular fibrillation.
Dermatological: maculopapular rash, pruritus, exfoliative dermatitis, erythema multiforme
Gastrointestinal: acute liver failure, hepatitis, jaundice, melena, anorexia, dyspepsia, cramping, epigastric pain, veno-occlusive liver disease, diarrhea, hepatomegaly, cholangitis, cholecystitis
Hematologic: coagulation defects, leukocytosis, blood dyscrasias including eosinophilia
Musculoskeletal: myasthenia, including bone, muscle, and joint pains
Neurologic: convulsions, tinnitus, visual impairment, hearing loss, peripheral neuropathy, transient vertigo, diplopia, encephalopathy, cerebral vascular accident, extrapyramidal syndrome and other neurologic symptoms
Urogenital: oliguria, decreased renal function, anuria, renal tubular acidosis, impotence, dysuria
Serum electrolyte abnormalities: hypomagnesemia, hyperkalemia, hypocalcemia, hypercalcemia
Liver function test abnormalities: increased AST, ALT, alkaline phosphatase, LDH
Renal function test abnormalities: increased BUN
Other test abnormalities: acidosis, hyperamylasemia, hypoglycemia, hyperglycemia, hyperuricemia, hypophosphatemia
To report SUSPECTED ADVERSE REACTIONS, contact Leadiant Biosciences, Inc. at 1-888-393-4584 or by email at drugsafety@leadiant.com or contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.
Amphotericin B desoxycholate overdose has been reported to result in cardio-respiratory arrest. Fifteen patients have been reported to have received one or more doses of ABELCET ® between 7-13 mg/kg. None of these patients had a serious acute reaction to ABELCET ®. If an overdose is suspected, discontinue therapy, monitor the patient’s clinical status, and administer supportive therapy as required. ABELCET ® is not hemodialyzable.
The recommended daily dosage for adults and children is 5 mg/kg given as a single infusion. ABELCET ® should be administered by intravenous infusion at a rate of 2.5 mg/kg/h. If the infusion time exceeds 2 hours, mix the contents by shaking the infusion bag every 2 hours.
Renal toxicity of ABELCET ®, as measured by serum creatinine levels, has been shown to be dose dependent. Decisions about dose adjustments should be made only after taking into account the overall clinical condition of the patient.
Preparation of Admixture for Infusion: Shake the vial gently until there is no evidence of any yellow sediment at the bottom. Withdraw the appropriate dose of ABELCET ® from the required number of vials into one or more sterile syringes using an 18-gauge needle. Remove the needle from each syringe filled with ABELCET ® and replace with the 5-micron filter needle supplied with each vial. Each filter needle may be used to filter the contents of up to four 100 mg vials. Insert the filter needle of the syringe into an IV bag containing 5% Dextrose Injection USP, and empty the contents of the syringe into the bag. The final infusion concentration should be 1 mg/mL. For pediatric patients and patients with cardiovascular disease the drug may be diluted with 5% Dextrose Injection to a final infusion concentration of 2 mg/mL. Before infusion, shake the bag until the contents are thoroughly mixed. Do not use the admixture after dilution with 5% Dextrose Injection if there is any evidence of foreign matter. Vials are for single use. Unused material should be discarded. Aseptic technique must be strictly observed throughout handling of ABELCET ®, since no bacteriostatic agent or preservative is present.
DO NOT DILUTE WITH SALINE SOLUTIONS OR MIX WITH OTHER DRUGS OR ELECTROLYTES as the compatibility of ABELCET ® with these materials has not been established. An existing intravenous line should be flushed with 5% Dextrose Injection before infusion of ABELCET ®, or a separate infusion line should be used. DO NOT USE AN IN-LINE FILTER.
The diluted ready-for-use admixture is stable for up to 48 hours at 2° to 8°C (36° to 46°F) and an additional 6 hours at room temperature.
Single-use vials along with 5-micron filter needles are individually packaged.
100 mg of ABELCET ® in 20 mL of suspension NDC 57665-101-41
Storage
Prior to admixture, ABELCET ® should be stored at 2° to 8°C (36° to 46°F) and protected from exposure to light. Do not freeze. ABELCET ® should be retained in the carton until time of use.
The admixed ABELCET ® and 5% Dextrose Injection may be stored for up to 48 hours at 2° to 8°C (36° to 46°F) and an additional 6 hours at room temperature. Do not freeze. Any unused material should be discarded.
U.S. Patent Nos. 4,973,465
5,616,334
6,406,713
I-101-41-US-Q
Manufactured by Exelead, Inc., Indianapolis, IN 46268
Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878
Revised 11/2018
NDC 57665-101-41
100 mg
ABELCET®
(Amphotericin B Lipid Complex Injection)
Lipid
Formulation
For Intravenous Use Only
5 mg/mL
Contents:
One 100 mg vial
One filter needle
Manufactured by:
Exelead, Inc.
Indianapolis, IN 46268
Distributed by: Leadiant
Biosciences, Inc.
Gaithersburg, MD 20878
U.S. PATENT NOS. 4,973,465 5,616,334 6,406,713
C-101-41-US-M
NDC 57665-101-41
100 mg
ABELCET®
(Amphotericin B Lipid Complex Injection)
For Intravenous Use Only
Each mL of ABELCET contains:
Amphotericin B USP 5 mg
L-α-dimyristoylphosphatidylcholine (DMPC) 3.4 mg
L-α-dimyristoylphosphatidylglycerol (DMPG) 1.5 mg
Sodium Chloride USP 9 mg
Water for Injection USP, q.s. 1 mL
Preparation
ABELCET must be added to 5% Dextrose Injection USP
before intravenous infusion.
See package insert for complete directions.
Dosage
See package insert for dosage and administration information.
Storage
Store between 2° and 8°C (36° to 46°F).
Do not freeze. Protect from light. Single-use vial.
Rx Only.
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Labeler -Leadiant Biosciences, Inc.(068301431)
FAQs
What are the side effects of ABELCET? ›
Fever, shaking, chills, flushing, loss of appetite, dizziness, nausea, vomiting, headache, shortness of breath, or fast breathing may occur 1 to 2 hours after the infusion is started.
What is ABELCET used for? ›Amphotericin B lipid complex is an antifungal medicine that is used to treat serious, life-threatening fungal infections that cannot be treated with other antifungal medications.
How long does ABELCET infusion take? ›It should be injected slowly over 2 hours. Dosage is based on your medical condition, weight, and response to therapy.
How is ABELCET different from amphotericin B? ›Abelcet has a comparable cost to Amphotec but is generally better tolerated with fewer infusion-related reactions. Abelcet has a comparable cost to AmBisome but results in a higher incidence of nephrotoxicity and infusion-related side effects.
What are the side effects of lipid based amphotericin B gel? ›A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
What are the side effects of disartan? ›-Side effects due to valsartan: Dizziness, increased blood urea nitrogen, hypotension, orthostatic hypotension, syncope, hyperkalemia, abdominal pain, diarrhea, nausea, upper abdominal pain, neutropenia, viral infection, fatigue, headache, orthostatic dizziness, vertigo, arthralgia, back pain, blurred vision, increased ...
What serious adverse effect is most associated with amphotericin B? ›The most common side effects of amphotericin B include: Loss of potassium. Loss of magnesium. Anaphylaxis.
How much does amphotericin B injection cost in the US? ›The cost for amphotericin b intravenous powder for injection 50 mg is around $56 for a supply of 1 powder for injection, depending on the pharmacy you visit.
What are the side effects of amphotericin B bladder irrigation? ›Additional therapy may not benefit all patients unresponsive to 2-day regimens [1]. Adverse effects associated with amphotericin B bladder irrigation have not been frequent but may include hematuria, cramping, bladder discomfort, dysuria, and burning during irrigation [29, 31, 34, 35].
What class of drug is Abelcet? ›Abelcet belongs to a class of drugs called Antifungals, Systemic.
What is the dosing for Abelcet? ›
DOSAGE AND ADMINISTRATION
The recommended daily dosage for adults and children is 5 mg/kg given as a single infusion. ABELCET ® should be administered by intravenous infusion at a rate of 2.5 mg/kg/h. If the infusion time exceeds 2 hours, mix the contents by shaking the infusion bag every 2 hours.
It is recommended that amphotericin B is infused slowly over two to six hours, based on the assumption that the severity and frequency of toxic reactions increase during more rapid infusions. Incorporation of amphotericin B into liposomal formulations reduces its toxicity, but the reasons for this are unclear.
Why is liposomal amphotericin B better than amphotericin B? ›Current evidence suggests that liposomal amphotericin B is less nephrotoxic than conventional amphotericin B (when the effect on kidney function is measured as an increase in serum creatinine level equal to or greater than two‐fold from the baseline level).
What are the side effects of amphotericin B? ›- stomach pain or cramping.
- heartburn.
- diarrhea.
- weight loss.
- bone, muscle, or joint pain.
- lack of energy.
- redness or swelling at the injection site.
- pale skin.
Amphotericin is available for injection to treat progressive and potentially life-threatening fungal infections. Nystatin is used orally and topically for superficial fungal infections, oral candidiasis, and vaginal candidiasis.
What is the major downside to long term treatment with amphotericin B? ›The major drawback of the conventional amphotericin B is its nephrotoxicity.
Is amphotericin B toxic to kidney? ›Amphotericin B Nephrotoxicity
It binds not only to ergosterol in fungal cell walls but also to cholesterol in human cell membranes; this is what accounts for its nephrotoxicity. Characteristic electrolyte abnormalities include wasting of potassium and magnesium secondary to increased permeability of the cell membranes.
An elimination half-life of approximately 15 days follows an initial plasma half-life of about 24 hours. Amphotericin B circulating in plasma is highly bound ( > 90%) to plasma proteins and is poorly dialyzable.
Does Mounjaro have long term side effects? ›Mounjaro has a boxed warning about the risk of thyroid cancer. A boxed warning is a serious warning from the Food and Drug Administration (FDA). Using Mounjaro could raise the risk of developing thyroid cancer. Animal studies show an increased risk of thyroid cancer in animals taking the drug.
Which blood pressure medicine is the best? ›- the ACE inhibitor lisinopril (Prinivil, Zestril) tops the list,
- followed by amlodipine besylate (Norvasc),
- a calcium channel blocker, and.
- generic hydrochlorothiazide (HCTZ).
How bad are the side effects of Mounjaro? ›
Mounjaro can cause side effects. The most common side effects reported by patients were nausea, diarrhea, decreased appetite, indigestion, vomiting, constipation, and stomach pain.
Is amphotericin B toxic to the heart? ›Amphotericin-B may cause important side effects such as rigors, fever, myalgias, headache, renal dysfunction, and cardiac abnormalities such as bradycardia and other cardiac arrhythmias [1].
What drugs should not be taken with amphotericin? ›Some products that may interact with this drug include: anti-cancer drugs (such as mechlorethamine, nitrogen mustard), azole antifungals (such as ketoconazole, itraconazole), cidofovir, digoxin, flucytosine, medications that affect the kidneys (including pentamidine, tacrolimus, aminoglycosides such as gentamicin), ...
How to prevent kidney damage in amphotericin B? ›In animals exposed to amphotericin B, sodium loading interferes with this response. Mounting clinical evidence also supports the usefulness of sodium supplementation to prevent as well as to reverse amphotericin B-induced nephrotoxicity.
What is the mortality rate of amphotericin B? ›The most common underlying risk factor was diabetes mellitus (84.3%). The used dose of liposomal amphotericin B ranged between 2–3 mg/kg per day. The overall 3-month mortality rate was 35.7%.
What is the success rate of amphotericin B? ›Patients were treated with either amphotericin B deoxycholate or liposomal amphotericin B, depending on renal function. The pre-emptive approach was non-inferior to empirical treatment for survival; 95.1% of patients were alive at 14 days in the pre-emptive group compared with 97.3% in the empirical group.
What is the cost of amphotericin B 50 mg injection? ›Abhope 50mg Injection Amphotericin B 50mg, Box, Prescription at Rs 2000/piece in Delhi.
Does amphotericin B cause liver damage? ›The severity of the liver injury due to amphotericin is usually mild, most patients being asymptomatic and anicteric. Recovery is rapid with stopping amphotericin but can recur with rechallenge.
What is amphotericin B the most effective drug against? ›Amphotericin B is a polyene substance that is one of the most effective drugs for the treatment of fungal and parasite infections.
How much amphotericin B for bladder irrigation? ›The dose of amphotericin B bladder irrigation varied, depending on continuous (10 to 50mg/L) or intermittent (1mg/200mL to 30mg/100mL) treatment.
What is the active ingredient in ABELCET? ›
ABELCET is a yellow, opaque sterile suspension for infusion in glass vials containing 20 mL. Each vial comes with a filter needle and is individually packed. Active ingredient: Each 20 mL vial contains 100 mg amphotericin B.
What is the brand name of amphotericin B? ›Amphotericin B Deoxycholate is a prescription medication used to treat the symptoms of Systemic Fungal Infections. Amphotericin B Deoxycholate is available under the following different brand names: Amphotericin B (conventional), AmBisome.
What is the brand name of ABELCET? ›BRAND NAME(S): Abelcet, Ambisome, Amphotec. USES: This medication is used to treat a variety of serious fungal infections.
What is the use of amphotericin B tablet? ›Amphotericin B is an antifungal used to treat fungal infections in neutropenic patients, cryptococcal meningitis in HIV infection, fungal infections, and leishmaniasis. Amphotericin B shows a high order of in vitro activity against many species of fungi.
What is the dosing for Dhivy? ›The recommended starting dosage of DHIVY is one 25 mg / 100 mg tablet taken orally three times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by up to one whole tablet every day or every other day, as needed to a maximum daily dosage of eight whole tablets.
What is the dosing schedule for iloperidone? ›The recommended starting dose for FANAPT tablets is 1 mg twice daily. Dose increases to reach the target range of 6-12 mg twice daily (12_24 mg/day) may be made with daily dosage adjustments not to exceed 2 mg twice daily (4 mg/day). The maximum recommended dose is 12 mg twice daily (24 mg/day).
What is the black box warning for amphotericin? ›Black Box Warnings:
Exercise CAUTION to prevent overdosage, which can result in potentially fatal cardiac or cardiopulmonary arrest.
The principal acute toxicity of AmB deoxycholate includes nausea, vomiting, rigors, fever, hypertension or hypotension, and hypoxia. Its principal chronic adverse effect is nephrotoxicity.
Can amphotericin cross blood brain barrier? ›Amphotericin B penetrates into the central nervous system through focal disruption of the blood-brain barrier in experimental hematogenous Candida meningoencephalitis.
Why is liposomal amphotericin B toxic? ›Renal toxicity is probably due to interaction of subcompartments of the kidney with free (diffusible) amphotericin B. The drug component of liposomal amphotericin B is enclosed in the liposome and not accessible for interaction with renal distal tubules.
Is liposomal amphotericin B safe? ›
No patients developed nephrotoxicity. Our finding indicates that liposomal amphotericin B at 10 mg/kg body weight is safe and effective in children. Results of our study support the use of single dose liposomal amphotericin B in all age group populations for elimination of kala-azar from the Indian subcontinent.
What is an alternative to liposomal amphotericin B injection? ›These studies suggest fluconazole, posaconazole or voriconazole may be useful alternatives to amphotericin B in therapy of C.
Is amphotericin B toxic to cells? ›Amphotericin B can be toxic to some cell lines, especially at higher dosages. For this reason, the lowest possible dose should be used to achieve the desired result. Amphotericin B is supplied as a 250 μg/mL stock solution in deionized water.
What does amphotericin B treat other than fungi? ›Amphotericin B is used for life-threatening protozoan infections such as visceral leishmaniasis and primary amoebic meningoencephalitis.
Does amphotericin B affect blood pressure? ›The mechanism of amphotericin B-associated hypertension is unclear but could include vasoconstricting properties of the drug or the administration of intravenous NaCl 0.9% prior to amphotericin B infusion.
What are the three types of amphotericin B? ›Three lipid formulations of amphotericin B are commercially available: a liposomal preparation, a lipid complex and a colloidal dispersion. They differ in their lipid composition, shape, pharmacokinetic behaviour and clinical effects.
Is amphotericin B liposomal better than conventional? ›Liposomal amphotericin B is as effective as conventional amphotericin B for empirical antifungal therapy in patients with fever and neutropenia, and it is associated with fewer breakthrough fungal infections, less infusion-related toxicity, and less nephrotoxicity.
Does amphotericin B cover Candida? ›The efficacy and renal safety of amphotericin B lipid complex (ABLC) were assessed in >900 patients with candidiasis. Overall, a favorable clinical response (cured or improved) was observed in 61% of patients infected with Candida species only, in 62% of patients infected with C.
What is the active ingredient in Abelcet? ›ABELCET is a yellow, opaque sterile suspension for infusion in glass vials containing 20 mL. Each vial comes with a filter needle and is individually packed. Active ingredient: Each 20 mL vial contains 100 mg amphotericin B.
What is the brand name of Abelcet? ›BRAND NAME(S): Abelcet, Ambisome, Amphotec. USES: This medication is used to treat a variety of serious fungal infections.
What is the generic for Abelcet? ›
Abelcet Generic Name & Formulations
Amphotericin B lipid complex 5mg/mL; susp for IV infusion after dilution; preservative-free.
Drug Label Information. If you are a consumer or patient please visit this version. DEMADEX® (torsemide) is a diuretic of the - pyridine-sulfonylurea class. Its chemical name is 1-isopropyl-3-[(4-m-toluidino-3-pyridyl) sulfonyl]urea and its structural - formula is: Its empirical ...
What type of drug is mebaral? ›Mebaral belongs to a class of drugs called Barbiturates, Barbiturate Anticonvulsants.
Who manufactures Abelcet? ›Abelcet® B lipid complex injection - United States | Leadiant Biosciences.
What is the active ingredient in Eraxis? ›In addition to the active ingredient, anidulafungin, ERAXIS for Injection contains the following inactive ingredients: fructose (50 mg), mannitol (250 mg), polysorbate 80 (125 mg), tartaric acid (5.6 mg), and sodium hydroxide and/or hydrochloric acid for pH adjustment.
Is Abelcet a liposome? ›Three lipid formulations are available in most countries: AmBisome, the only true liposome; Abelcet, with a ribbon-like structure; and Amphocil/Amphotec, composed of disc-like structures.
What is the generic name of Eraxis? ›Anidulafungin is a prescription medication used to treat Candidemia, and Esophageal Candidiasis. Anidulafungin is available under the following different brand names: Eraxis.
What is avidoxy generic name? ›Doxycycline is sometimes sold under the brand name Avidoxy. In this article, I'll describe how Avidoxy works, when it's prescribed, and outline its common side effects, dosage, and risks. I'll also explain how to take Avidoxy, what to avoid when doing so, and when to talk to your doctor or another healthcare provider.
What is another name for iloperidone? ›Iloperidone, commonly known as Fanapt and previously known as Zomaril, is an atypical antipsychotic for the treatment of schizophrenia.
What is another name for doxycycline mono? ›Brand names: Vibramycin-D, Efracea, Periostat.
What kind of medicine is doxycycline mono? ›
Doxycycline monohydrate is a tetracycline antibiotic. It prevents bacteria from making certain proteins, which stops them from multiplying and spreading in your body. The way it works to treat rosacea isn't fully known, but it's thought to help lower inflammation.