Stimate® Nasal Spray
(Pronounced Stim-ate)
(desmopressin acetate)

Read this patient information leaflet before you start taking Stimate® Nasal Sprayand each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Stimate® Nasal Spray?

All patients using Stimate® Nasal Spray are at risk for water intoxication, fluid overload and low sodium levels in the blood. You must follow your healthcare provider's instructions on limiting the amount of fluid you can drink when taking Stimate® Nasal Spray.

• Do not drink more than you need to satisfy your thirst.
• You can have serious side effects such as seizures, coma, and death from drinking too much fluid.
• Children and elderly patients are at higher risk for these conditions and must follow their healthcare provider's restrictions on drinking fluids.

Call your healthcare provider right away if you have any of the following symptoms while using Stimate® Nasal Spray. They may mean that your blood sodium level is low:

Using Stimate® Nasal Spray the wrong way may cause it not to work to control bleeding.

• Call your healthcare provider right away if you have any uncontrolled bleeding.

What is Stimate® Nasal Spray?

Stimate® Nasal Sprayis a prescription medicine used to stop some types of bleeding in people with mild hemophilia A or mild to moderate von Willebrand's disease Type 1.

Stimate® Nasal Sprayshould not be used in children under 11 months of age.

What should I tell my healthcare provider before I use Stimate® Nasal Spray?

Before taking Stimate® Nasal Spray, tell your healthcare provider about all of your medical conditions, including if you:

• Have any nasal problems such as a stuffy nose, have ever had surgery on your nose, or have trouble breathing through your nose. You may need to use another form of this medicine.
• Have or have had any heart, blood circulation, or blood pressure problems.
• Have a condition that causes fluid or water imbalance problems such as:
  • Cystic fibrosis
  • Heart failure
  • Kidney problems
• Have or have had a condition that causes you to be very thirsty.
• Are pregnant or plan to become pregnant. It is not known if Stimate® Nasal Spraywill harm your unborn baby.
• Are breast-feeding or plan to breast-feed. It is not known if Stimate® Nasal Spraypasses into your breast milk. You and your healthcare provider should decide if you will take Stimate® Nasal Spray.

Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and non-prescription medicines, such as over-the-counter medicines, vitamins, supplements and herbal remedies.

Using Stimate® Nasal Spraywith certain other medicines can affect the way Stimate® Nasal Sprayworks.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

It is especially important to tell your healthcare provider if you take:

• Blood pressure or heart medicines
• Antidepressants
• Anti-anxiety medicines
• Antihistamines
• Pain relievers such as narcotics or non-steroidal anti-inflammatory medicines (NSAIDs)
• Seizure medicines
• Medicines for over-active urinary bladder

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one of these.

How should I use Stimate® Nasal Spray?

• Use Stimate® Nasal Sprayexactly as your healthcare provider told you. Do not use more Stimate® Nasal Sprayor take it more often than your healthcare provider told you.
• The Stimate® Nasal Spraypump provides the correct dose of your medicine. For detailed instructions on how to use the nasal spray pump, see the Patient Instructions for Use at the end of this leaflet.
• The nasal spray pump delivers 25 doses of Stimate® Nasal Sprayand each spray contains a measured amount of medicine. Any medicine left in the spray pump after 25 sprays should be thrown away because, at that time, the amount of medicine in each spray may be a lot less than the correct amount. Do not put any leftover medicine into another bottle.
• If your symptoms do not improve, or if they become worse, contact your healthcare provider. Do not stop taking Stimate® Nasal Spraywithout talking to your healthcare provider.
• If you use too much Stimate® Nasal Spray, call your healthcare provider or go to the nearest hospital emergency department right away.

What are the possible side effects of Stimate® Nasal Spray?

Stimate® Nasal Spraymay cause serious side effects, that come from having too much water in the body. See “What is the most important information I should know about Stimate® Nasal Spray?”.

Common side effects of Stimate Nasal Spray include:

• Occasional facial flushing
• Nasal congestion
• Runny nose
• Nosebleed
• Sore throat
• Cough
• Upper respiratory infections.

Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of Stimate® Nasal Spray. If you have questions, talk to your healthcare provider.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

How should I store Stimate® Nasal Spray?

• Store at room temperature, but not higher than 77°F (25°C).
• Throw away Stimate® Nasal Spraysix months after it is opened, or when the expiration date has passed, if this date is before the six months is up.
• Store Stimate® Nasal Spraystanding upright.

Keep Stimate® Nasal Spray and all medicines out of the reach of children.

General information about Stimate® Nasal Spray

Medicines are sometimes prescribed for conditions that are not mentioned in the patient leaflet. Do not use Stimate® Nasal Sprayfor a condition for which it was not prescribed. Do not give Stimate® Nasal Sprayto other people, even if they have the same symptoms you have. It may harm them.

This patient information leaflet summarizes the most important information about Stimate® Nasal Spray. If you would like more information about Stimate® Nasal Spray, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Stimate® Nasal Spraythat is written for health professionals. For more information, go to www.stimate.com or call CSL Behring Medical Affairs at 1-800-504-5434.

What are the ingredients in Stimate® Nasal Spray?

Active ingredients: desmopressin acetate

Inactive ingredients: sodium chloride, citric acid monohydrate, disodium phosphate dihydrate, benzalkonium chloride, purified water.

Patient Instructions for Use

Read these instructions carefully before you use your Stimate® Nasal Spraypump. The following instructions tell you how to prepare, or prime, your Stimate® Nasal Spraypump so that it is ready to use.

Using your Stimate® Nasal Spray Pump

1. Remove the protective cap.

2. When using Stimate® Nasal Sprayfor the first time, the spray pump must be primed by pressing down on the ring at the top of the pump 4 times. Hold the spray tip away from your face and eyes. See Figure A.

Figure A

3. When primed, the Stimate® Nasal Spraypump delivers one dose of medicine each time it is pressed. For the right dose, tilt your Stimate® Nasal Spraypump so that the tube inside the spray pump draws the medicine up from the deepest part of the medicine inside the container. See Figures A and B.

Figure B

4. Put the spray nozzle tip into your nostril and press the spray pump one time for one dose (150-micrograms). If two doses are prescribed, spray each nostril one time (for a dose of 300-micrograms).

5. When you finish using your Stimate® Nasal Spray, put the cap over the tip of the pump.

6. If Stimate® Nasal Sprayhas not been used for one week, you will need to prime the pump again by pressing one time, or until you see a fine mist.

Use this check-off chart to help you keep track of the number of sprays used. This will help make sure that you receive 25 doses with each bottle of Stimate® Nasal Spray. There is extra medicine in the bottle to allow for priming. When using the chart to check off sprays, do not count the priming sprays.

Stimate® Nasal Spray
25 Spray Check-off Chart

1. Keep this chart with your Stimate® Nasal Sprayor put it someplace where you can easily get it.
2. Check off number 1 on the chart with your first dose of Stimate® Nasal Spray. Check off the numbers after each use of Stimate® Nasal Spray. If your healthcare provider prescribed a 2 spray dose (300-micrograms), then two numbers should be checked off.
3. Throw away the Stimate® Nasal Spray after 25 doses.

Last reviewed on RxList: 10/3/2011
This monograph has been modified to include the generic and brand name in many instances.