Anidula IV Infusion
Anidulafungin
100 mg/vial
Healthcare Pharmaceuticals Ltd.
| Pack size | 100 mg vial |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 7500.00 AED |
Indications
Anidula IV Infusion is used for:
Oesophageal candidiasis, Invasive candidiasis, Candidaemia, Candida infections (intra-abdominal abscess, pertonitis)
Adult Dose
Intravenous
Oesophageal candidiasis
Adult: Loading dose of 100 mg on day 1, then 50 mg once daily thereafter. Continue treatment for at least 14 days and for at least 7 days following resolution of symptoms. To be given by IV infusion. Max infusion rate: 1.1 mg/min.
Invasive candidiasis, Candidaemia, Candida infections (intra-abdominal abscess, pertonitis)
Adult: Loading dose of 200 mg on day 1, then 100 mg once daily thereafter. Continue treatment for at least 14 days after the last positive culture. To be given by IV infusion. Max infusion rate: 1.1 mg/min.
Child Dose
Child
Intravenous
1 Month of Age and Older
Indicated for treatment of candidemia and intra-abdominal abscess and peritonitis caused by Candida infections in pediatric patients aged ?1 month
Day 1: 3 mg/kg (not to exceed 200 mg/dose) IV infusion, THEN
Day 2 and thereafter: 1.5 mg/kg (not to exceed 100 mg/dose) IV
Generally continue 14 days after last positive culture
Renal Dose
Dosage adjustments are not required for patients with any degree of renal insufficiency including those on hemodialysis. Anidulafungin has negligible (<1%) renal clearance.
Administration
IV Preparation
Reconstitute lyophilized powder
Reconstitute vial with sterile water for injection (SWI)
50-mg vial: Add 15 mL SWI to provide concentration of 3.33 mg/mL
100-mg vial: Add 30 mL SWI to provide concentration of 3.33 mg/mL
Further dilution required
Adults: Aseptically transfer contents from reconstituted vial(s) to appropriately sized IV bag/bottle of D5W or 0.9% NaCl
Pediatric patients
Infusion solution volume required is dependent on child’s weight
Reconstituted solution must be further diluted to 0.77 mg/mL for final infusion solution
IV Administration
Visually inspect solution for particulate matter and discoloration; if identified, discard solution
IV infusion rate: Not to exceed 1.1 mg/min
Do not give as IV bolus
Contra Indications
Hypersensitivity to anidulafungin or other echinocandins.
Known or suspected hereditary fructose intolerance.
Precautions
Hepatic Effects: Risk of abnormal liver tests, hepatitis, hepatic failure;
Hypersensitivity: Anaphylaxis, including shock has been reported. Risk of infusion-related adverse reactions, possibly histamine-mediated, including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension; to reduce the occurrence, do not exceed a rate of infusion of 1.1 mg/minute.
Risk of Neonatal Toxicity Associated with Polysorbates: Anidulafungin contains polysorbate 80, an inactive ingredient. Thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis have been reported in low-birth-weight infants receiving high doses of polysorbate.
Anidulafungin is not approved in pediatric patients younger than 1 month of age.
Hereditary Fructose Intolerance (HFI): Anidulafungin contains fructose. Risk of metabolic crisis with life-threatening hypoglycemia, hypophosphatemia, lactic acidosis, and hepatic failure. Obtain a history of HFI symptoms in pediatric patients before Anidulafungin administration.
Monitoring Parameters
Monitor hepatic function during therapy.
Pregnancy-Lactation
Pregnancy
Based on findings from animal studies, therapy can cause fetal harm when administered to pregnant females; there are no available human data on use in pregnant females to inform a drug-associated risk of adverse developmental outcomes
Animal studies
Fetal toxicity was observed in animal reproduction studies in the presence of maternal toxicity when anidulafungin was administered to pregnant rabbits during organogenesis at 4 times the proposed therapeutic maintenance dose of 100 mg/day (dose based on relative body surface area)
Lactation
There are no data on presence of drugs in human milk, effects on breastfed infant or on milk production
Drug found in milk of lactating rats; when a drug is present in animal milk, it is likely that the drug will be present in human milk
Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition
Interactions
Cyclosporine
Administration of multiple doses of anidulafungin and cyclosporine to healthy subjects resulted in no significant alteration in the steady-state pharmacokinetics of either drug. No dosage adjustment of cyclosporine or anidulafungin is needed when the two drugs are co-administered.
Voriconazole
Administration of multiple doses of anidulafungin and voriconazole to healthy subjects resulted in no significant alteration in the steady-state pharmacokinetics of either drug. No dosage adjustment of voriconazole or anidulafungin is needed when the two drugs are co-administered.
Tacrolimus
Administration of multiple doses of anidulafungin and a single dose of tacrolimus to healthy subjects resulted in no significant alteration in the steady-state pharmacokinetics of either drug. No dosage adjustment of tacrolimus or anidulafungin is needed when the two drugs are co-administered.
Rifampin
Administration of multiple doses of anidulafungin and rifampin to patients resulted in no significant alteration in the steady-state pharmacokinetics of anidulafungin. No dosage adjustment of anidulafungin is needed when it is co-administered with rifampin.
Amphotericin B Liposome for Injection
Administration of multiple doses of anidulafungin and liposomal amphotericin B to patients resulted in no significant alteration in the steady-state pharmacokinetics of anidulafungin. No dosage adjustment of anidulafungin is needed when it is co-administered with liposomal amphotericin B.
Contraindicated (0)
Serious - Use Alternative (1)
Saccharomyces boulardii
Adverse Effects
Side effects of Anidulafungin :
Adults
Candidemia and other forms of Candida infections: The most common adverse reactions (>15%) are
hypokalemia, nausea, diarrhea, vomiting, pyrexia, insomnia, hypotension.
Esophageal candidiasis: Most common adverse reactions (>5%) are
diarrhea, pyrexia, anemia, headache, vomiting, nausea, dyspepsia, oral candidiasis, and hypokalemia.
Pediatric Patients (1 month and older)
Candidemia and other forms of Candida infections: Most common adverse reactions (> 5%): diarrhea, vomiting, pyrexia, abdominal pain, anemia,
thrombocytopenia, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) increased, hypoglycemia, epistaxis, and rash.
Mechanism of Action
Anidulafungin is a semi-synthetic echinocandin antifungal. It inhibits 1, 3-beta-D-glucan synthesis, an essential component of the fungal cell walls. It has been shown to have in vitro activity against many Aspergillus spp and Candida spp.
Note
Anidula 100 mg/vial IV Infusion manufactured by Healthcare Pharmaceuticals Ltd.. Its generic name is Anidulafungin. Anidula is availble in Bangladesh.
Farmaco BD drug index information on Anidula IV Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.