Hypersensitivity: In clinical studies, approximately 4% of subjects receiving ASPEN ABACAVIR developed a hypersensitivity reaction which in rare cases proved fatal.
Description: This is characterised by the appearance of symptoms indicating multiorgan/body-system involvement. The majority of patients have fever and/or rash as part of the syndrome. The symptoms of this hypersensitivity reaction can occur at any time during treatment with ASPEN ABACAVIR, but usually appear within the first 6 weeks of initiation of treatment with ASPEN ABACAVIR (median time to onset 11 days), and most often include fever, gastrointestinal symptoms (nausea, vomiting, diarrhoea and abdominal pain), rash and fatigue or malaise. Other symptoms may include myalgia, arthralgia, oedema, paraesthesia and respiratory symptoms such as dyspnoea, sore throat or cough.
The symptoms worsen with continued therapy and can be life-threatening. These symptoms usually resolve upon discontinuation of ASPEN ABACAVIR.
Management: To avoid a delay in diagnosis and minimize the risk of a life threatening hypersensitivity reaction, ASPEN ABACAVIR should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible (respiratory diseases, flu-like illness, gastroenteritis or reactions to other medications).
ASPEN ABACAVIR should not be re-started even if a recurrence of symptoms occurs following re-challenge with alternative medication(s).
An Alert Card with information for the patient about the hypersensitivity reaction is included in the ASPEN ABACAVIR pack.
Special considerations following an interruption of ASPEN ABACAVIR therapy:
If therapy with ASPEN ABACAVIR has been discontinued and restarting therapy is under consideration, the reason for discontinuation should be evaluated to ensure that the patient did not have symptoms of a hypersensitivity reaction. Patients who have stopped ASPEN ABACAVIR due to possible adverse reactions or illness should be advised to contact their doctor before restarting. If hypersensitivity cannot be ruled out ASPEN ABACAVIR should not be restarted.
There have been infrequent reports of hypersensitivity reaction following reintroduction of ASPEN ABACAVIR, where the interruption was preceded by a single key symptom (e.g. rash, fever or gastrointestinal symptoms). When patients who have discontinued ASPEN ABACAVIR present with an indeterminate diagnosis of hypersensitivity (single symptom), the doctor should:
Assess the probability that hypersensitivity preceded the interruption
Assess the risk: benefit of reinitiating ASPEN ABACAVIR
Select the appropriate medical setting in which to re-introduce ASPEN ABACAVIR, if such a decision is made.
On very rare occasions hypersensitivity reactions have been reported in patients who have re-started therapy, and who had no apparent preceding symptoms of a hypersensitivity reaction. Some of these cases were poorly documented. The clinical significance of these reports is unclear. If a decision is made to re-start ASPEN ABACAVIR, this must be done only if medical care can be accessed readily by the patient or others.
Essential patient information:
Prescribers must ensure that patients are fully informed regarding the following hypersensitivity reaction:
Patients must be made aware of the possibility of a hypersensitivity reaction to
abacavir that may result in a life-threatening reaction or death.
Patients developing signs or symptoms possibly linked with a hypersensitivity reaction MUST CONTACT their doctor IMMEDIATELY.
In order to avoid restarting ASPEN ABACAVIR, patients who have experienced a hypersensitivity reaction should be asked to return the remaining ASPEN ABACAVIR Oral Solution to the pharmacy.
Patients who have stopped ASPEN ABACAVIR for any reason, and particularly due to adverse reactions or illness, must be advised to contact their doctor before restarting.
Each patient should be reminded to read the package insert and the PIL included in the ASPEN ABACAVIR pack. They should be reminded of the importance of removing the Alert Card included in the pack and keeping it with them at all times.
|Preservatives:||methylparaben 0,15% m/v|
|propylparaben 0,018% m/v.|
|-||in patients with known hypersensitivity to abacavir or any ingredient of the formulations (see WARNINGS)|
|-||in patients with a hereditary fructose intolerance|
|-||in patients with liver function impairment|
|-||in pregnancy and lactation (see PREGNANCY AND LACTATION)|
|-||in infants under 3 months of age.|
|Hypersensitivity: In clinical studies, approximately 4% of subjects receiving ASPEN ABACAVIR developed a hypersensitivity reaction which in rare cases proved fatal. This is characterised by the appearance of symptoms indicating multi-organ/ body-system involvement.|
Almost all patients developing hypersensitivity reactions will have fever and/or rash (usually maculopapular or urticarial) as part of the syndrome, however reactions have occurred without rash or fever.
Symptoms can occur at any time while being treated with ASPEN ABACAVIR, but usually appear within the first 6 weeks of initiation of treatment with ASPEN ABACAVIR (median time to onset 11 days).(see WARNINGS)
|PATIENT INFORMATION LEAFLET|
Read all of this leaflet carefully before you start taking ASPEN ABACAVIR.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or pharmacist.
ASPEN ABACAVIR has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.
|||If you are hypersensitive (allergic) to abacavir or any of the other ingredients of ASPEN ABACAVIR.|
|||If you have stopped taking ASPEN ABACAVIR due to an allergic reaction you MUST NOT start taking it again as you may have a life-threatening drop in blood pressure or death.|
|||If you have a hereditary fructose intolerance as ASPEN ABACAVIR contains sorbitol which is converted into fructose.|
|||If you have problems with your liver.|
|||If you are pregnant or breastfeeding your baby.|
|1.||Remove the bottle cap.|
|2.||Push the plastic adapter into the neck of the bottle, while holding the bottle firmly.|
|3.||Insert the syringe firmly into the adapter.|
|4.||Turn the bottle upside down.|
|5.||Pull out syringe plunger until the correct amount is withdrawn.|
|6.||Turn the bottle the correct way up and remove the syringe from the adapter.|
|7.||Replace and tighten the bottle cap.|
|8.||Administer the dose into the mouth by placing the tip of the syringe against the inside of the cheek. Slowly depress the plunger, allowing time to swallow. Forceful squirting to the back of the throat may cause choking.|
|A serious allergic reaction has been reported in about 4 in every 100 patients who have been treated with ASPEN ABACAVIR. The most common symptoms of this reaction are high temperature and a skin rash. Other frequently observed signs or symptoms include nausea, vomiting, diarrhoea, stomach pain, shortness of breath, cough, headache and tiredness. Other symptoms may include joint or muscle pain, swelling of the neck and sore throat. Occasionally inflammation of the eye, ulcers in the mouth or low blood pressure may occur. The symptoms of this allergic reaction can occur at any time during treatment with ASPEN ABACAVIR. However they usually occur in the first 6 weeks of treatment and get worse with continued treatment. The hypersensitivity reaction can be life-threatening or fatal if treatment with ASPEN ABACAVIR is continued. You should contact your doctor immediately for advice on whether you should stop taking ASPEN ABACAVIR if:|
You get a skin rash or
You get one or more symptoms from at least TWO of the following groups
- shortness of breath, sore throat or cough
- nausea or vomiting or diarrhoea or stomach pain
- severe tiredness or achiness or generally feeling ill
|IMPORTANT ALERT CARD|
ASPEN ABACAVIR 20 mg/mlORAL SOLUTION
Carry this card with you at all times
Patients taking ASPEN ABACAVIR may develop a hypersensitivity reaction (serious
allergic reaction) that can be life-threatening if treatment with ASPEN ABACAVIR is
continued. CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you
should stop taking ASPEN ABACAVIR if:
1) you get a skin rash OR
2) you get one or more symptoms from at least TWO of the following groups:
shortness of breath, cough or sore throat
nausea, vomiting, diarrhoea or stomach ache
severe tiredness or aches or general ill feeling
If you have discontinued ASPEN ABACAVIR due to this reaction, YOU MUST NEVER take ASPEN ABACAVIR again as within hours you may experience a life-threatening lowering of your blood pressure or death.
You should immediately contact your Doctor if you think you are having a hypersensitivity reaction to ASPEN ABACAVIR. Write your Doctors details below:
If your doctor is not available, you must urgently seek alternative medical advice (e.g. the emergency unit of the nearest hospital).