Caspogin IV Infusion

Caspogin IV Infusion is used for: Candidemia, and other Candida infections including intra-abdominal abscesses, peritonitis, and pleural space infections, Esophageal Candidiasis, Invasive Aspergillosis, Febrile Neutropenia

Intravenous Candida Infections Includes candidemia and other Candida infections including intra-abdominal abscesses, peritonitis, and pleural space infections Day 1 loading dose: 70 mg IV infused over 1 hr (as a single dose) Maintenance: 50 mg IV once daily infused over 1 hr Continue antifungal therapy for at least 14 days after last positive culture; patients who remain persistently neutropenic may warrant longer course of therapy pending resolution of neutropenia Esophageal Candidiasis Indicated for treatment of esophageal candidiasis 50 mg IV once daily infused over 1 hr, continue for 7-14 days after symptom resolution Loading dose not necessary has not been studied with this indication May consider suppressive oral therapy in patients with HIV infection because of the risk of oropharyngeal candidiasis relapse Invasive Aspergillosis Indicated for invasive aspergillosis in patients refractory to or intolerant of other therapies (eg, amphotericin B, itraconazole) Day 1 loading dose: 70 mg IV infused over 1 hr (as a single dose) Maintenance: 50 mg IV once daily infused over 1 hr Duration of treatment should be based upon the severity of the underlying disease, recovery from immunosuppression, and clinical response. Febrile Neutropenia Empirical therapy for presumed fungal infections in febrile, neutropenic patients Day 1 loading dose: 70 mg IV infused over 1 hr Maintenance: 50 mg IV once daily infused over 1 hour; if well tolerated but not achieving adequate response, may increase to 70 mg IV once daily Duration of treatment should be based on clinical response; continue empirical therapy until resolution of neutropenia If fungal infection is confirmed, continue therapy for a minimum of 14 days; treatment should continue for at least 7 days after both neutropenia and clinical symptoms are resolved

Candida Infections Includes candidemia and other Candida infections including intra-abdominal abscesses, peritonitis, and pleural space infections Dosing based on patient’s body surface area <3 months: Safety and efficacy not established; limited data suggest an off-label dose of 25 mg/m²/dose IV once daily >3 months Day 1 loading dose: 70 mg/m² IV infused over 1 hr Maintenance: 50 mg/m² IV qDay infused over 1 hr If well tolerated but not achieving adequate response, may increase to 70 mg/m² IV once daily Not to exceed 70 mg once daily Continue antifungal therapy for at least 14 days after last positive culture; patients who remain persistently neutropenic may warrant longer course of therapy pending resolution of neutropenia Esophageal Candidiasis Dosing based on patient’s body surface area <3 months: Safety and efficacy not established >3 months Day 1 loading dose: 70 mg/m² IV infused over 1 hr Maintenance: 50 mg/m² IV qDay infused over 1 hr If well tolerated but not achieving adequate response, may increase to 70 mg/m² IV once daily Not to exceed 70 mg once daily Continue antifungal therapy for 7-14 days after symptoms resolution Invasive Aspergillosis Dosing based on patient’s body surface area <3 months: Safety and efficacy not established >3 months Day 1 loading dose: 70 mg/m² IV infused over 1 hr Maintenance: 50 mg/m² IV qDay infused over 1 hr If well tolerated but not achieving adequate response, may increase to 70 mg/m² IV once daily Not to exceed 70 mg once daily Duration of treatment should be based upon the severity of the underlying disease, recovery from immunosuppression, and clinical response Febrile Neutropenia Empirical therapy for presumed fungal infections in febrile, neutropenic patients Dosing based on patient’s body surface area <3 months: safety and efficacy not established >3 months Day 1 loading dose: 70 mg/m² IV infused over 1 hr Maintenance: 50 mg/m² IV once daily infused over 1 hr If well tolerated but not achieving adequate response, may increase to 70 mg/m² IVonce daily Not to exceed 70 mg once daily Duration of treatment should be based on clinical response; continue empirical therapy until resolution of neutropenia If fungal infection is confirmed, continue therapy for a minimum of 14 days; treatment should continue for at least 7 days after both neutropenia and clinical symptoms are resolved

IV Preparation Reconstitute vial (70 mg for loading dose or 50 mg for daily dose) with 10.5 mL NS, SWI or BWI-may be stored for up to 1 hr at 25°C (or less) Mix gently to obtain clear soln-discard if particulate or discolored Transfer 10 mL of reconstituted solution to 250 mL NS, 1/2NS 1/4NS or LR Use infusion soln within 24 hr if stored at room temp or within 48 hr if refrigerated at 2-8°C If 70 mg vials are not available for preparation of the loading dose, reconstitute two 50 mg vials & transfer 14 mL to 250 mL NS, 1/2NS, 1/4NS or LR For 35 mg, reconstitute a 50 mg vial w/ 10 mL & transfer 7 mL to 250 mL (or 100 mL if medically necessary) infusion soln IV Administration Infuse IV slowly over 1 hr

Hypersensitivity.

Hypersensitivity: Anaphylaxis, possible histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth or bronchospasm, and cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with use of caspofungin acetate for injection. Discontinue Caspofungin acetate for Injection at the first sign or symptom of a hypersensitivity reaction and administer appropriate treatment. Hepatic Effects: Can cause abnormalities in liver enzymes. Isolated cases of hepatic dysfunction, hepatitis, or hepatic failure have been reported. Monitor patients who develop abnormal liver enzymes for evidence of worsening hepatic function and evaluate risk/benefit of continuing Caspofungin acetate for Injection. Elevated Liver Enzymes during Concomitant use with Cyclosporine: Limit use to patients for whom potential benefit outweighs potential risk. Monitoring Parameters Monitor hepatic function. Monitor patients who develop abnormal liver function tests (LFTs) during concomitant use with Caspofungin acetate for Injection.

Pregnancy There are insufficient human data to establish whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes in pregnant women Animal data In animal studies, drug caused embryofetal toxicity, including increased resorptions, increased peri-implantation loss, and incomplete ossification at multiple fetal sites when administered intravenously to pregnant rats and rabbits during organogenesis at doses up to 0.8 and 2 times the clinical dose, respectively; advise patients of potential risk to fetus; estimated background risk of major birth defects and miscarriage for indicated population is unknown; all pregnancies have a background risk of birth defect, loss, or other adverse outcomes Lactation There are no data on presence of drug in human milk, effects on breast-fed child, or on milk production Drug was found in milk of lactating, drug-treated rats; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition

Reduced plasma concentration w/ rifampicin and other CYP enzyme inducers. May increase hepatic enzymes w/ cyclosporin. May decrease blood concentration of tacrolimus. Contraindicated (0) Serious (6) ceftobiprole medocaril sodium cyclosporine eluxadoline leniolisib Saccharomyces boulardii trofinetide

Side effects of Caspofungin : >10% Infused vein complications/ phlebitis (20-35%) Fever (6-30%) Diarrhea (6-27%) Shivering (9-23%) Rash (4-23%) Incr serum alk phos (9-22%) Hypotension (3-20%) Respiratory failure (2-20%) Incr transaminases (2-18%) Septic shock (11% to 14% ) 1-10% (selected) Pleural effusion (9%) Respiratory distress (up to 8%) Abdominal pain Nausea Vomiting Anemia Decreased Hgb Neutropenia Chills Hypokalemia Dizziness Erythema Facial edema, flushing Hematuria Hyperbilirubinemia Increased serum creatinine Induration Myalgia Pain Paresthesia Pruritus Sepsis Tachycardia <1% Erythema multiforme Stevens-Johnson syndrome Pancreatitis Hepatic necrosis Liver failure Anaphylaxis Nephrotoxicity Renal impairment

Caspofungin, a semisynthetic echinocandin antifungal, shows activity against Aspergillus and Candida species. It inhibits the synthesis of β-1,3-D-glucan, an essential component of the fungal cell wall that is not present in mammalian cells.

Caspogin 50 mg/vial IV Infusion manufactured by Healthcare Pharmaceuticals Ltd.. Its generic name is Caspofungin. Caspogin is availble in Bangladesh. Farmaco BD drug index information on Caspogin IV Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.