50 mg powder for infusion , dispersion
Amphotericin B
1. What AmBisome liposomal is and what it is used for
The active substance in AmBisome liposomal is amphotericin B which is encapsulated in small fat particles ( liposomes ). AmBisome liposomal is an antibiotic used to treat serious infections caused by fungi. You will receive the medicine as an infusion into a blood vessel.
AmBisome liposomal is also used to treat visceral leishmaniasis, a disease caused by a parasite
AmBisome liposomal can also be used to treat patients who are suspected of having fungal infections and fever and are deficient in a type of white blood cell called neutrophils. Neutrophils are a type of white blood cell that helps fight infection.
2. What you need to know before using AmBisome liposomal
Do not use AmBisome liposomal:
- if you are allergic (hypersensitive) to amphotericin B or any of the other ingredients of AmBisome liposomal.
Warnings and cautions
- if you get a severe anaphylactic reaction: the doctor will discontinue the infusion. An anaphylactic reaction is an acute, life-threatening allergic reaction with such symptoms as redness, itching, nausea, swelling of the face, mouth, tongue, and airways, often so severe that it becomes difficult to breathe.
- if you get other reactions that are thought to be due to the infusion: your doctor may slow down the infusion rate so that you get AmBisome liposomal for a longer period of time (about 2 hours). Your doctor may also give you medicines that prevent reactions to infusion one. See section 4 Possible Side Effects below.
- if you are taking other medicines that may cause kidney damage.AmBisome liposomal can damage the kidneys. Your doctor or nurse will take regular blood tests to test for creatinine (a chemical substance in the blood that shows kidney function) and electrolyte levels (especially potassium and magnesium ) which may be abnormal due to impaired kidney function. This is especially important if you are taking other medicines that could damage your kidneys. The blood samples will also be tested for changes in your liver function and the body’s ability to produce new blood cells.
- if the results of the blood tests show that you have a low level of potassium in your blood: your doctor may prescribe a potassium supplement to take while you are receiving AmBisome liposomal.
- if the results of your blood tests show a change in kidney function or other important changes: your doctor may give you a lower dose of AmBisome liposomal or discontinue treatment.
- if you are receiving or have just had a transfusion of white blood cells ( leukocytes ). Acute and severe lung problems can occur if you receive an AmBisome liposomal infusion during or shortly after a white blood cell transfusion, and therefore your doctor will recommend that the infusions be given as long as possible to reduce the risk of lung problems. In addition, your lung function will be monitored.
- if you have diabetes. Each vial of AmBisome liposomal contains approximately 900 milligrams of sucrose (sugar).
Other medicines and AmBisome liposomal
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription
It is known that the following medicines may affect or be affected by the concomitant use of AmBisome liposomal.
• Medicines that can cause kidney damage, including:
- Immunosuppressive drugs (drugs that reduce the activity of the body’s natural defenses) e.g. cyclosporine.
- Drugs in the antibiotic group called aminoglycosides.
- Pentamidine, a drug used to treat pneumonia in patients with AIDS and leishmaniasis.
These medicines can cause kidney damage and AmBisome liposomal can aggravate kidney damage. If you are taking medicines that can cause kidney damage, your doctor or nurse will take regular blood tests to see if there have been any changes in your kidney function.
• Medicines that can lower potassium levels, including:
- Corticosteroid s (cortisone: an anti-inflammatory drug that acts by reducing the immune system’s reaction) and corticotropin (ACTH), used to control the speed of the natural production of corticosteroid s.
- Diuretics ( diuretics ), e.g. furosemide .
- Digitalis glycosides used to treat heart failure. AmBisome liposomal can lower the level of potassium in the blood which can aggravate the side effects of digitalis(changes in heart rhythm).
- Muscle relaxants (eg tubocurarine ). AmBisome liposomal can increase the muscle relaxing effect.
• Other medicines
- Medicines against fungi, e.g. flucytosine. AmBisome liposomal can aggravate the side effects of flucytosine (changes in the body’s ability to produce new blood cells as seen in blood tests).
- Cancer drugs (antineoplastic drugs) such as methotrexate, doxorubicin, carmustine, and cyclophosphamide. Taking this type of medicine at the same time as you receive AmBisome liposomal infusion may cause kidney damage, wheezing or difficulty breathing, and low blood pressure.
- The transfusion is of white blood cells ( leukocytes ). Acute and severe lung problems have occurred in patients receiving amphotericin B during or shortly after transfusion of white blood cells. The infusions should be given at as long intervals as possible and lung function should be monitored.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The safety of AmBisome liposomal in pregnant women is unknown. If you are pregnant, your doctor will prescribe AmBisome liposomal only if he/she considers the benefits of the treatment to outweigh the potential risks to you and your unborn baby.
It is not known if AmBisome liposomal passes into breast milk. A decision to breastfeed or not while receiving AmBisome liposomal should be based on the potential risk to the baby, the benefit of breast-feeding to the baby, and the benefit of AmBisome liposomal therapy to the mother.
Driving and using machines
Some of the side effects of AmBisome liposomal may affect your ability to drive or use machines safely (see section 4 on Possible side effects ).
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use AmBisome liposomal
You will always receive AmBisome liposomal from a doctor or nurse.
Adults
The dose of an AmBisome liposomal depends on body weight and is adjusted according to the needs of each individual patient.
For the treatment of systemic fungal infections, the treatment can usually last up to 21 days.
You will receive the appropriate dose of an AmBisome liposomal as an infusion into a vein.
Normally it takes infusion, 30 to 60 minutes, but the larger the dose you can infusion takes up to 2 hours.
4. Possible side effects
Like all medicines, AmBisome liposomal can cause side effects, although not everybody gets them.
Fever, chills, and chills are the most common reactions associated with infusion one.
Uncommon reactions to infusion may include tightness in the chest, chest pain, shortness of breath, difficulty breathing (possibly with wheezing), redness, a faster-than-normal heart rate, low blood pressure, and pain in the joints, back, or skeleton (musculoskeletal pain). These pass quickly when the infusion is stopped. These reactions do not need to occur during future infusions of AmBisome liposomal or when a slower infusion rate (2 hours) is used.
Your doctor may give you other medicines to prevent infusion reactions or to treat the symptoms should they occur. For example, you can get medicines for pain, hypersensitivity, or medicines that work by reducing the reaction of the immune system.
If you get a severe reaction to infusion one, your doctor will discontinue AmBisome liposomal infusion one and you should not receive this treatment in the future.
The following side effects have occurred during treatment with AmBisome liposomal:
Very common
(may affect more than 1 in 10 people)
- Feeling tired or confused or muscle weakness or cramps caused by low potassium levels in the blood
- Nausea, vomiting
- Fever, chills, or chills
Usual
(may affect up to 1 in 10 people)
- Fatigue or confusion or muscle weakness or cramps caused by low levels of magnesium, calcium, or sodium in the blood
- High blood sugar levels
- Headache
- Faster heart rate than usual
- Dilation of blood vessels, low blood pressure, and redness
- Shortness of breath
- Diarrhea, abdominal pain
- Abnormal results regarding liver or kidney function seen in blood or urine tests
- Rash
- Chest or back pain
Less common
(may affect up to 1 in 100 people)
- Bleeding in the skin, bruising for no apparent reason, and bleeding for a long time after an injury
- Allergy-like (anaphylactoid) reaction [(see section 2 of this leaflet for information on severe hypersensitivity reactions (anaphylactic reactions)].
- Seizures (attacks or seizures)
- Breathing difficulties, possibly with wheezing
Has been reported
(occurs in an unknown number of users)
- Anemia ( anemia – a decrease in the number of red blood cells in the blood, with symptoms in the form of pronounced fatigue, shortness of breath after light activity, and pallor)
- Anaphylactic reactions and hypersensitivity reactions (see section 2 of this leaflet for information on anaphylactic reactions)
- Heart attacks and a change in the normal heart rhythm
- Renal failure and renal impairment
- Severe swelling of the skin around the lips and eyes or of the tongue
- Muscle breakdown
- Skeletal pain and joint pain
Impact on phosphorus blood test results. False results that show increased levels of phosphates in your blood can occur during analysis with a special analysis method called the PHOSm method.
If your test shows high levels of phosphates, another test with another method may be necessary to confirm the results.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store AmBisome liposomal
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after {EXP}. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance in each vial is amphotericin B 50 mg, encapsulated in liposomes (small fat particles).
- The other ingredients are hydrogenated soy phosphatidylcholine, cholesterol, di-stearoyl phosphatidylglycerol, sucrose (sugar), disodium succinate hexahydrate, alpha-tocopherol, sodium hydroxide, and hydrochloric acid.
What the medicine looks like and the contents of the pack
AmBisome liposomal is a lyophilized powder for infusion, dispersion. It is a sterile, light yellow powder that is supplied in a 15, 20,112 or 30-milliliter glass vial. Each vial contains 50 milligrams of the active substance, amphotericin B. The closure consists of a rubber stopper and a sealing aluminum ring with a removable plastic cap. Ten vials are packed in a carton along with 10 filters.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Gilead Sciences Ireland UC
Carrigtohill,
County Cork, T45 DP77
Ireland
Manufacturer
Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland