Genus Pharmaceuticals

Apomorphine is associated with local subcutaneous effects.  These can sometimes be reduced by the rotation of injection sites or possibly by the use of ultrasound (if available) to areas of nodularity and induration.

The effect of apomorphine on reproduction has been investigated in rats. Apomorphine was not teratogenic in this species, but it was noted that doses which are toxic to the mother can cause loss of maternal care and failure to breathe in the newborn.

Please note 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             Interaction with other medicinal products and other forms of interaction

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.

Changes to Section 4.8 Interaction with other medicinal products and other forms of interaction

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.”

Section 6.3: The shelf life has changed from 2 to 3 years.

Section 4.5 (interactions): Theoretical interaction with antihypertensive and cardiac active medicinal products has been removed.

Section 4.6 (pregnancy and lactation): Caution should be exercised if prescribing apomorphine to pregnant women and women of childbearing potential.

Section 4.8 (undesirable effects): Breathing difficulties has been added.