Neupro transdermal

You should not use rotigotine if you are allergic to it.

To make sure rotigotine is safe for you, tell your doctor if you have:

• asthma or sulfite allergy;

• high or low blood pressure;

• heart disease, congestive heart failure, or heart rhythm disorder;

• kidney disease;

• a history of mental illness or psychosis;

• narcolepsy or other sleep disorder; or

• tremors (dyskinesia) or uncontrolled muscle movements.

People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether rotigotine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether rotigotine passes into breast milk or if it could harm a nursing baby. Rotigotine may also slow breast milk production. Tell your doctor if you are breast-feeding a baby.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To use the patch, open the sealed pouch and remove the protective liner. Apply the patch to clean, dry, hairless, and healthy skin on your stomach, thigh, hip, side, shoulder, or upper arm. Your medication instructions will show you the best places on your body to wear the patch. Avoid placing the patch on a skin area that will be rubbed by a waistband or tight clothing.

Press the patch firmly into place for at least 30 seconds to make sure it sticks. You may leave the patch on while bathing, showering, or swimming.

Leave the patch in place and wear it for 24 hours. Remove the skin patch after 24 hours and replace it with a new one. Try to apply a new patch at the same time each day.

Choose a different place on your body to wear the patch each time you put on a new one. Do not use the same skin area twice within 14 days.

If a patch falls off, put a new patch on a different place on your body and wear it the rest of the day. Then replace the patch the next day at your regular time.

After removing a patch, fold it in half so it sticks together and throw it away in a place where children or pets cannot get to it.

Use baby oil or mild soap and water to remove any adhesive residue that stays on your skin. Avoid using harsh soaps, alcohol, nail polish remover, or other solvents that could irritate your skin.

Wash your hands with soap and water after applying or removing the patch.

Do not wear more than one rotigotine patch at a time. Using extra skin patches will not make the medication more effective. Never cut a skin patch.

If you are using this medication for RLS, call your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using rotigotine.

The rotigotine patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

Do not stop using rotigotine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using rotigotine.

Keep the rotigotine transdermal patch in its sealed pouch until you are ready to use it. Store the pouches at room temperature away from heat and moisture.

Common side effects of Neupro include: application site reaction, insomnia, nausea, and vomiting. Other side effects include: dizziness, dyspepsia, increased blood pressure, increased heart rate, orthostatic hypotension, and orthostatic dizziness. See below for a comprehensive list of adverse effects.

Animal studies have revealed evidence of embryotoxicity or teratogenicity. In mice, rats, and rabbits, an adverse effect on embryo-fetal development at doses similar to or lower than those used clinically was observed. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use should be avoided. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: Use of adequate methods of contraception should be encouraged.

Summary of Use during Lactation

No information is available on the use of rotigotine during breastfeeding, but it suppresses serum prolactin and may interfere with breastfeeding. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information in nursing mothers was not found as of the revision date. Rotigotine lowers serum prolactin.[1][2] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

References

1. Mastrangelo M, Giannini MT, Carducci CL et al. Safety and efficacy of rotigotine in 7 patients with monoaminergic neurotransmitter deficiency. J Inherit Metab Dis. 2016;39 (Suppl 1):S228. Abstract. DOI: doi:10.1007/s10545-016-9969-2

2. Daniel JS, Govindan JP, Kamath C et al. Newer dopaminergic agents cause minimal endocrine effects in idiopathic Parkinson's disease. Clin Med Insights Endocrinol Diabetes. 2014;7:13-7. PMID: 24855402