The following additions to the SmPC for APO-go® Ampoules:
4.4 Special warnings and precautions for use
“Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’s disease, including apomorphine.”
4.8 Undesirable effects
Unknown:
“Patients treated with dopamine agonists for treatment of Parkinson’s disease, including apomorphine, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.”
In addition, we have also made some further changes to the SmPC and would like to draw your attention to the points below:
Changes to Section 4.4 Special warnings and precautions for use
We have provided clarification of the association between Coombs’ positivity and haemolytic anaemia. The old wording has been removed:
“Coombs’ positive haemolytic anaemia has been reported rarely in patients treated with levodopa and the incidence in patients taking levodopa and apomorphine is unaltered. Coombs’ positive anaemia has not been reported in patients taking apomorphine in association with other therapy.”
and replaced with:
“Haemolytic anaemia has been reported in patients treated with levodopa and apomorphine. Haematology tests should be undertaken at regular intervals as with levodopa when given concomitantly with apomorphine.
Section 4.6 Pregnancy and Lactation now reads as follows:
Pregnancy
Due to the age of the treated population, the occurrence of pregnancy is improbable. Animal studies are insufficient with respect to the effects on pregnancy, embryo-fetal development, parturition and postnatal development (See section 5.3). The potential risk for humans is unknown.
Caution should be exercised if prescribing apomorphine to pregnant women and women of childbearing age.
Lactation
It is not know whether apomorphine is excreted in breast milk. However, breast-feeding should be avoided during apomorphine HCl therapy.
PLEASE NOTE: You will see that “Pregnancy and Lactation” no longer appear in contraindications Section 4.4.
Changes to Section 4.8 Undesirable effects
Common (1-10%):
We have amended the third paragraph of this section to read as follows:
“Neuropsychiatric disturbances are common in Parkinsonian patients. APO-go should be used with special caution in these patients. Neuropsychiatric disturbances (including transient mild confusion and visual hallucinations) have occurred during apomorphine HCl therapy.”
Uncommon (0.1-1%):
As above, the following text regarding Coomb’s positive haemolytic anaemia has been removed:
“Coombs’ positive haemolytic anaemia has rarely been reported in patients treated with levodopa and apomorphine.”
and the following text has been added:
Local and generalised rashes have been reported.
Haemolytic anaemia has been reported in patients treated with levodopa and apomorphine.
Positive Coombs’ tests have been reported for patients receiving apomorphine and levodopa.”
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