Medicinal Products

AMBISOME 50 mg

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Amphotericin B
laboratory: Gilead Sciences

Powder for suspension of liposomes for IV infusion
Box of 10 vials (+ filter) of 50 mg
All forms

Indication

AMBISOME is an anti-fungal medicine indicated in adults and children as follows:

· Treatment of Aspergillus invasive fungal infections as a therapeutic alternative in case of voriconazole failure or intolerance.

· Treatment of Candida invasive fungal infections and neuromeningocritic cryptococcosis in HIV-infected individuals:

o Having developed renal insufficiency under amphotericin B defined by:

Elevation of serum creatinine above 220 micromol / l

or

§ Lower creatinine clearance below 25 ml / min.

o In case of pre-existing and persistent alteration of renal function defined by:

§ Creatinine greater than 220 micromol / l

or

§ Creatinine clearance less than 25 ml / min.

Empirical treatment of suspected fungal infections in febrile neutropenic patients. The maximum benefit was observed in allogeneic bone marrow transplant patients, adult patients with neutropenia greater than or equal to 7 days from the introduction of the antifungal, receiving at the same time nephrotoxic agents.

Treatment of visceral leishmaniasis in case of proven or probable resistance to antimonials.

Dosage AMBISOME 50 mg Powder for suspension of liposomes for infusion IV Box of 10 vials (+ filter) of 50 mg

Dosage

· Treatment of invasive fungal infections with Aspergillus and Candida . The recommended dose is 3 mg / kg / day.

· Treatment of neuro-meningeal cryptococcosis in HIV-infected individuals. The recommended dose is 3 mg / kg / day.

· Empirical treatment of suspected fungal infections in febrile neutropenic patients. The recommended dose is 3 mg / kg / day.

· Treatment of visceral leishmaniasis: the recommended cumulative dose is 18-24 mg / kg in 6 infusions: one infusion per day for 5 consecutive days and a sixth infusion on the 10th day in the child and the immunocompetent subject.

· In immunocompromised individuals, data are limited. Doses up to 40 mg / kg over 10 to 20 consecutive days have been administered.

In case of aggravation of the renal function under AMBISOME, the continuation of the treatment must be discussed according to the estimated benefit / risk ratio. In the absence of a validated dose adjustment regimen, it is proposed to lower the doses of AMBISOME to 1.5 mg / kg / day transiently, or to temporarily space the infusions.

children

Clinical studies show that pediatric doses are identical to those used in adults, reported per kilogram of body weight.

Elderly

No data in the elderly (≥ 65 years) can recommend a different dosing regimen than the adult.

Administration mode

Precautions to be taken before handling or administering the drug

For instructions on reconstitution and dilution of the drug before administration, see section Instructions for use, handling and disposal .

AMBISOME should be administered as a strict intravenous infusion for 30 to 60 minutes. If the patient feels discomfort during this infusion, the duration of the infusion can be prolonged. The recommended concentration for intravenous infusion is between 0.20 mg / ml and 2 mg / ml of AMBISOME.

Against indications

AMBISOME is contraindicated in patients with known hypersensitivity to amphotericin B or any other component.

Ambisome side effects

The following adverse reactions have been attributed to AMBISOME based on clinical trial data and post-marketing experience. The indicated frequency is based on the analysis of pooled clinical trial data. The frequencies are defined as follows:

Very common (≥ 1/10)

Frequent (≥ 1/100 and <1/10)

Uncommon (≥ 1/1000 and <1/100)

Rare (≥ 1/10000 and <1/1000)

Very rare (<1 / 10, 000)

Not known frequency

Reactions occurring during the infusion:

· Very common: fever, chills

· Common: headache, backache, chest pain, dyspnea, hypotension, vasodilation, flushing, tachycardia, rash, angioedema

· Uncommon: Bronchospasm

· Not known: anaphylactic shock, musculoskeletal pain (described as arthralgia or bone pain)

Adverse reactions other than reactions occurring during infusion are listed below by organ class according to the MedDRA classification.

Blood and lymphatic system disorders

Uncommon: thrombocytopenia

Not known: anemia

Metabolism and nutrition disorders

Very common: hypokalemia

Common: hyponatremia, hypocalcemia, hypomagnesemia, hyperglycemia

Nervous system disorders

Common: headache

Not known: convulsions

Heart conditions

Common: tachycardia

Not known: cardiac arrest, arrhythmia

Gastrointestinal disorders

Very common: nausea, vomiting

Common: diarrhea, abdominal pain

Hepatobiliary disorders

Common: liver test abnormalities, hyperbilirubinemia, elevated alkaline phosphatase

Musculoskeletal and systemic disorders:

· Common: back pain

· Not known: rhabdomyolysis (associated with hypokalemia), musculoskeletal pain (described as arthralgia or bone pain)

Renal and urinary disorders

Frequent: increased creatinine, increased blood urea

Not known: renal dysfunction, renal failure

Investigations:

Pseudohyperphosphatémie *

* This is an analytical interference when the inorganic phosphorus assay is performed by the PHOSm method on Beckman Coulter analyzers equipped with the LX20 system.

In addition, the following effects have been reported during the use of amphotericin B but may possibly occur with AMBISOME:

· General: discomfort, weight loss.

· Renal: distal tubular acidosis.

· Gastrointestinal: anorexia, dyspepsia.

· Pulmonary: non-cardiogenic pulmonary edema.

· Neurological: loss of hearing, ringing of ears, visual disturbances or diplopia, vertigo, peripheral neuropathy.

· Locomotors: muscle and joint pains.

· Cardiovascular: hypertension.

· Hematologic: agranulocytosis, leukopenia, eosinophilia.

· Local: injection site pain with or without phlebitis or thrombophlebitis.

· Dermatological: pruritus.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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