Gofisam® vial

Gofisam ® Amphotericin B Liposomal

For intravenous infusion only

Amphotericin B USP ………..   50 mg

(For intravenous infusion for hospitalized patients only)

This medication has been prescribed for the current condition, so do not use it for similar conditions or recommend its use to others.

General guidelines

Consult your doctor before using this medication in the following cases:

-Concurrent use of corticosteroids, ACTH, and diuretics (loop of Henle and thiazide) which may exacerbate hypokalemia.

-Hypokalemia caused by liposomal amphotericin B which may exacerbate digoxin (digitalis) toxicity.

-Hypokalemia caused by liposomal amphotericin B which may enhance the effect of skeletal muscle relaxants such as curariforms (such as tubocurarine).

-No specific interaction studies have been conducted with liposomal amphotericin B. However, the following medicinal products interact with amphotericin B and may interact with liposomal amphotericin B. Nephrotoxic drugs Concomitant use of liposomal amphotericin B with other nephrotoxic agents (e.g. cyclosporine, aminoglycosides, polymyxins, tacrolimus and pentamidine) is contraindicated due to the potential for increased drug-induced nephrotoxicity. Concomitant use of cyclosporine or aminoglycosides has been associated with less nephrotoxicity with liposomal amphotericin B than with amphotericin B. Monitoring of the patient is essential when taking liposomal amphotericin B or other nephrotoxic drugs.

-Inform your doctor if you have renal insufficiency, respiratory failure and diabetes, especially if you are taking this medicine for a long time.

– When antifungals such as flucytosine are used simultaneously with liposomal amphotericin B, an increase in the interaction of the two drugs may occur in the form of increased cellular absorption or impaired renal excretion.

– When using antineoplastic (anticancer) drugs with this drug, they should be prescribed with caution due to the possibility of increased nephrotoxicity, bronchospasm and hypotension.

– Leukocyte blood product transfusion

Acute pulmonary toxicity has been reported in patients who have received amphotericin B (with sodium deoxycholate complex salt) during or shortly after leukocyte infusion. It is recommended that infusions be spaced as far apart as possible and that pulmonary function be monitored simultaneously.

Use in pregnancy and lactation:

Fertility

Animal studies have not shown direct or indirect harmful effects on reproduction.

Pregnancy

The safety of liposomal amphotericin B in pregnant women has not been established.

Breastfeeding

It is not known whether liposomal amphotericin B is excreted in human milk, so the benefits of using the drug during breastfeeding should be determined by the attending physician.

Warnings and precautions

Contraindicated in hypersensitivity to the active substance or any of the excipients, unless in the opinion of the physician, the main treatment of a life-threatening disease that can only be treated with liposomal amphotericin B.

– Anaphylaxis and anaphylactoid reactions

Allergic reactions have been reported with liposomal amphotericin B infusion, and a trial dose is recommended before starting treatment. In the event of a severe allergic or anaphylactic reaction, the infusion should be stopped immediately and the patient should not receive further liposomal amphotericin B infusion.

-Infusion-Related Reactions

Although other serious and non-serious infusion-related reactions may occur during administration of amphotericin B-containing products, including liposomal amphotericin B, preventive measures to prevent or treat these reactions in patients to reduce infusion-related complications, such as slowing the infusion rate (to no more than 2 hours) or using usual doses of diphenhydramine, acetaminophen, pethidine, and hydrocortisone, etc., have been reported to be successful in preventing or treating these reactions.

-Nephrotoxicity

Liposomal amphotericin B has less toxicity than conventional amphotericin B, especially nephrotoxicity. However, renal adverse effects may occur.

In studies comparing 3 mg/kg liposomal amphotericin B daily with higher doses (5.6 or 10 mg/kg daily), the incidence of increased serum creatinine, hypokalemia, and hypomagnesemia was significantly higher in the high-dose groups.

Precautions for use In long-term therapy, regular laboratory evaluation of serum electrolytes, especially potassium and magnesium, as well as renal, hepatic, and hematopoietic function should be performed at least weekly, especially in patients receiving concomitant nephrotoxic drugs. Due to the risk of hypokalemia, appropriate potassium supplementation may be required during the course of amphotericin B liposomal administration. If clinically significant decline in renal function or worsening of other parameters occurs, dose reduction and discontinuation of therapy should be considered.

Pulmonary toxicity

Acute pulmonary toxicity has been reported in patients who have received amphotericin B (with sodium deoxycholate complex salt) during or shortly after leukocyte infusion. It is recommended that these infusions be separated as much as possible and that pulmonary function be monitored.

Diabetic patients

Liposomal amphotericin B contains approximately 900 mg sucrose per vial. This should be considered when treating diabetic patients.

Dosage

Treatment of mycosis (systemic fungal infection)

Treatment is usually initiated with a test dose of 1.0 mg/kg body weight daily, increased to 3.0 mg/kg once daily if necessary. Data are currently insufficient to define the total dose requirements and duration of treatment necessary to resolve mycosis. However, a cumulative dose of 1-3 g of amphotericin B as liposomal amphotericin B has been shown to be effective in treating mycosis.