What is AMBISOME?

AMBISOME 50 MG contains AMPHOTERICIN B : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02241630, held by ASTELLAS PHARMA CANADA INC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 24-Jul-2012. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is AMBISOME used for?

AmBisome (liposomal amphotericin B for injection) is indicated for empirical therapy for presumed fungal infection in febrile, neutropenic patients and for treatment of cryptococcal meningitis in HIV-infected patients. AmBisome is also indicated for the treatment of systemic or disseminated infections due to Candida, Aspergillus or Cryptococcus in patients who are refractory to or intolerant to conventional amphotericin B therapy or renally impaired patients.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

AmBisome (liposomal amphotericin B for injection) should be administered by intravenous infusion over a period of approximately 120 minutes. Infusion time may be reduced to approximately 60 minutes in patients in whom the treatment is well tolerated. If the patient experiences discomfort during infusion, the duration of infusion may be increased. The recommended concentration for intravenous infusion is 0.5 mg/mL to 2.0 mg/mL of AmBisome. The daily dose and duration of therapy of AmBisome should be based on the infecting organism, the patient's condition and the response to therapy. Treatment should be continued until clinical parameters and laboratory tests indicate that an active fungal infection has been cured or subsided. An inadequate period of treatment may lead to recurrence of active infection. Dose, rate of infusion and duration of treatment may have to be individualized for the needs of specific patients. The recommended initial dosage of AmBisome for each indication for adult, pediatric and special population groups is outlined below and reported in the “Pharmacology” section. Systemic Mycoses: Patients with a proven systemic infection with Aspergillus, Candida and/or Cryptococcus species who are refractory to or intolerant to conventional amphotericin B therapy or are renally impaired usually have therapy instituted at 3.0 mg/kg/day, which is increased up to 5.0 mg/kg/day, as required. Cryptococcal Meningitis in HIV-Infected Patients: HIV-infected patients with cryptococcal meningitis were treated with a dose of 3.0 mg/kg/day or 6.0 mg/kg/day for an average of 14 days. Due to an increased incidence of adverse events with the 6.0 mg/kg/day dose, it is recommended patients be started with a dose of 3.0 mg/kg/day and increase to 6.0 mg/kg/day as required. Because of the high frequency of relapses, chronic suppressive therapy with another agent may be necessary after completion of a treatment course with AmBisome. Empirical Treatment: For empirical therapy, AmBisome was administered at an initial dose of 3.0 mg/kg/day, and increased or decreased as needed (dose range of 1.5-6.0 mg/kg/day) for 1-53 days at a cumulative dose of 33.4 ± 30.8 mg/kg.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Unopened vials of lyophilized material are to be stored between temperatures of 2 to 25°C (36 - 77°F). The reconstituted product concentrate may be stored for up to 24 hours at 2-8°C (36-46°F) following reconstitution with Sterile Water for Injection, USP. Do not freeze. Do not freeze. Injection of AmBisome should commence within 6 hours of dilution with 5% Dextrose. CAUTION: DISCARD partially-used vials.

How is it supplied?

AmBisome is supplied as a lyophilized powder in either 20 mL or 30 mL vials. Each vial of AmBisome contains 50 mg of amphotericin B. AmBisome is available as single unit vials in a pack of ten vials in individual cartons. Each carton contains one pre-packaged, disposable sterile 5 micron filter.

Contraindications

AmBisome (liposomal amphotericin B for injection) is contraindicated in those patients who have demonstrated or have known hypersensitivity to conventional amphotericin B or any other constituents of AmBisome unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk.

Warnings and precautions

Anaphylaxis has been reported with conventional amphotericin B and other amphotericin B-containing drugs. Anaphylactoid-type reactions have been reported with AmBisome (liposomal amphotericin B for injection). If a severe reaction occurs, the infusion should be immediately discontinued. The patient should not receive further infusions of AmBisome. AmBisome should be administered primarily to patients with progressive, potentially fatal infections. This drug should not be used to treat the common apparent forms of fungal diseases, which show only positive skin or serologic tests.

What can be used instead?

Other Canadian products sharing ATC code J02AA01 AMPHOTERICIN B. 2 of 7 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies AMPHOTERICIN B worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. AMPHOTERICIN B appears in 24 registered pack listings across 10 markets, published on 8 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.