Stimate

What is Stimate used for?

Stimate is used to treat hemophilia A, and von Willebrand disease.

Stimate may be given to you for other reasons. Talk to your doctor.

Description

Stimate® (desmopressin acetate) is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. Stimate® Nasal Spray contains 1.5 mg/mL desmopressin acetate in an aqueous solution at a pH of approximately 5. Stimate® Nasal Spray’s compression pump delivers 0.1 mL (150 mcg) of solution per spray. It is chemically defined as follows:

Mol. Wt. 1183.34 Empirical formula: C46H64N14O12S2 ∙C2H4O2∙3H2O

1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.

Stimate® Nasal Spray is provided as an aqueous solution for intranasal use.

Each mL contains:

Before taking Stimate, tell your doctor:

• If you are allergic to Stimate; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Kidney disease or if you have ever had low sodium levels.
• If you have any of these health problems: Heart failure (weak heart), high blood pressure, or a health problem called syndrome of inappropriate antidiuretic hormone (SIADH) secretion.
• If you have type IIB von Willebrand disease.
• If you have a health problem that leads to sodium loss like adrenal gland problems, diarrhea, eating disorders like anorexia or bulimia, nausea, or vomiting that will not stop.
• If you are drinking more water than normal.
• If you are pregnant or plan to get pregnant.
• If you have a stuffy nose, scarring on the inside of your nose, trouble breathing through your nose, or other nose problems.
• If you have had any recent nose surgery, injury, ulcers, or sores, talk with your doctor.
• If you are using another drug in the nose.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Stimate with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Stimate?

• Tell all of your health care providers that you take Stimate. This includes your doctors, nurses, pharmacists, and dentists.
• Very bad allergic reactions have rarely happened. Sometimes, allergic reactions have been deadly with the shot form of Stimate. Talk with the doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
• Use with care in children. Talk with the doctor.
• This medicine can cause low sodium levels. Very low sodium levels can be life-threatening, leading to seizures, passing out, trouble breathing, or death.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor if you have an infection, a fever, diarrhea, or are throwing up. Talk with your doctor if you will be out in very hot weather, will be active, or will be changing how much water you drink for any reason.
• Talk with your doctor if you are taking any drugs that can raise the chance of low sodium levels. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you are 65 or older, use Stimate with care. You could have more side effects.

How is Stimate best taken?

Use Stimate as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• You may need to watch how much fluid you drink while taking Stimate. Follow what your doctor has told you about how much fluid you can drink and how much physical activity you can have. If you have questions, talk with your doctor.
• Do not take Stimate by mouth. Use in your nose only. Keep out of your mouth and eyes (may burn).
• Blow your nose before use.
• Some products may have different ways to prime the pump. Some pumps may also need to be primed if not used for different periods of time. Follow how and when to prime as you have been told.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Stimate that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Upset stomach or throwing up.
• Hallucinations (seeing or hearing things that are not there).
• Feeling tired or weak.
• Restlessness.
• Muscle weakness.
• Muscle spasm.
• Not hungry.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Chest pain or pressure or a fast heartbeat.
• Coughing up blood.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• A heartbeat that does not feel normal.

What are some other side effects of Stimate?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing.
• Runny nose.
• Stuffy nose.
• Stomach cramps.
• Cough.
• Nosebleed.
• Sore throat.
• Signs of a common cold.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Stimate?

• Store upright at room temperature. Do not freeze.
• After opening, throw away any part not used after 6 months.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Instruction for use

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

Using your Stimate

1. Remove the protective cap.

2. When using Stimate® Nasal Spray for 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 Spray pump delivers one dose of medicine each time it is pressed. For the right dose, tilt your Stimate® Nasal Spray pump 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 has 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 sprays with each bottle of Stimate. 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 Spray or 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 sprays.

Label

• NDC 0053-6871-002.5 mL
• STIMATE ® (desmopressin acetate)
• Nasal Spray,
  1.5 mg/mL
• 2.5 mL (25 Sprays of 150 mcg)
• Delivers 0.1 mL (150 mcg)
  per spray.
• See package insert for
  detailed dosage instructions.
• ATTENTION PHARMACIST–
  Dispense the patient’s
  instructions with the
  spray pump.
• KEEP OUT OF REACH
  OF CHILDREN
• Rx only
• CSL Behring

 

What are the other ingredients in Stimate

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