Alentiva

What is it?

Alentiva is an antifungal antibiotic. The active ingredient in Alentiva is amphotericin B. Each vial of Alentiva contains 50 mg of the active ingredient amphotericin B, encapsulated within liposomes(small fat particles), intended for administration by infusion into a vein (a drip) in hospital by a doctor or nurse.

How does Alentiva work?

Alentiva Binds to ergosterol altering cell membrane permeability in susceptible fungi and causing leakage of cell components with subsequent cell death.

Indications

Alentiva is used in adults and children aged 1 month to 18 years old for:

• The treatment of severe systemic and/or deep mycoses(such as disseminated candidiasis, aspergillosis, Cryptococcosis, chronic mycetoma and mucormycosis): In patients refractory to conventional amphotericin B deoxycholate therapy or when renal impairment or unacceptable toxicity precludes the use of the deoxycholate formulation.

• Suspected fungal infections in patients with febrile neutropenia: Empiric treatment for presumed fungal infection in patients with febrile neutropenia.

• Visceral leishmaniasis, a disease caused by a parasite

• Cryptococcal meningitis in patients with HIV

You must not be given Alentiva if you:

• Are allergic (hypersensitive) to Amphotericin B or any of the other ingredients of Alentiva.However, if your condition is life-threatening you may be given Alentiva if your doctor believes that only Alentiva can help you.

• Have previously experienced a severe allergic reaction(anaphylactic or anaphylactoid) to Alentiva. Symptoms of such immediate and life-threatening allergic reactions include: flushing, itching, sickness, swelling of the face, mouth, tongue and airways, often enough to cause difficulty breathing.

Indications

Your doctor will take special care with Alentiva:

• If you have a severe allergic (anaphylactic) reaction.
• If you get other related to infusion.
• If you are taking other medicines that may cause kidney damage.
• If blood tests show a change in kidney function or other important changes.
• If you have a white blood cell transfusion.
• If you have had kidney failure and are having dialysis.
• If you have diabetes.

According to your physician’s recommendation, during treatment with Alentiva, blood tests may be required to assess kidney function and electrolyte levels (especially potassium and magnesium), as well as liver function and blood cell counts.

Use in children and adolescents:

Alentiva has been used to treat children. Alentiva is used in children and adolescents aged 1 month to 18 years old.

Diabetes

Alentiva contains approximately 900 mg of sucrose (sugar) in each vial. Tell your doctor if you have diabetes.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will only prescribe Alentiva if they think the benefits of treatment outweigh the risks to you and your unborn child or your baby.

Driving and using machines

Do not drive or operate machinery. Some of the possible side effects of Alentiva could affect your ability to drive or use machines safely.

If you receive a higher dose of Alentiva than you should:

You should tell your doctor immediately if you think you received too much Alentiva. If you have any further questions on the use of this product, ask your doctor.

What other drugs could affect Alentiva?

Tell your doctor if you are using, have recently used or might use any other medicines. This includes medicines and herbal products you bought without a prescription.

How to Use?

How to use Alentiva?

Alentiva is always given to you by a doctor or nurse. It is given intravenously (a drip). Alentiva must not be given by any other method.

Side Effects

What are the possible side effects of Alentiva?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects during the infusion

• Very common (These can affect more than 1 in every 10 people): fever, chill, and shivering.

• Less frequent infusion-related side effects include: chest tightness, chest pain, breathlessness, difficulty breathing(possibly with wheezing), flushing, a faster heart rate than normal, low blood pressure and musculoskeletal pain.

These side effects clear up quickly when the infusion is stopped.

Common side effects unrelated to infusion:

• Low blood potassium levels, leading to feeling tired,confused, having muscle weakness or cramps

• Feeling sick or being sick

• Fever, chills or shivering

For more information, please refer to the product leaflet.

Storage

How to store Alentiva?

• Keep this medicine out of the sight and reach of children.
• Do not use Alentiva after the date which is stated on the label as expiration date.
• Do not store above 25°C.
• Do not store partially used vials for future patient use.
• The ready-to-use product is semi-transparent and yellow in color. If any precipitation or foreign particles are present, do not use the product.