Key Considerations for Taking Stimate

Stimate Nasal Spray may not work if used too often

If Stimate Nasal Spray is used too often over a short period of time, your body may stop responding to it. If this happens, it might not work when you really need it.

  • Be sure to follow your healthcare provider’s precise instructions for taking Stimate Nasal Spray
  • Inform your healthcare provider immediately if your treatment is no longer controlling your bleeding symptoms. You may be placed on an alternative treatment that’s right for you
  • Humate-P—If Stimate Nasal Spray isn’t right for your VWD, learn about an important treatment option, Humate-P

Please see important safety information for Humate-P below.

Use during pregnancy

If you know you are pregnant or may become pregnant, or if you are nursing a child, notify your healthcare provider right away.

Use in children

As with all prescription medicines, the use of Stimate Nasal Spray in children will need to be closely watched by your HCP or HTC.

  • The dose for children is usually different from that for adults, and the amount of fluid they drink (fluid intake) must be more carefully restricted.
  • This product should not be used in infants younger than 11 months. As with all medicines, keep Stimate Nasal Spray out of the reach of children.

Use with other medicines

Before using Stimate Nasal Spray, be sure to tell your HCP or HTC about any other medicines you or your child are taking, whether prescription or over-the-counter. 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.

Who should not use Stimate Nasal Spray

There are some patients that should not use Stimate Nasal Spray. Tell your HCP if you are someone who has ever had:

  • An allergic reaction to desmopressin acetate (the active chemical in Stimate Nasal Spray)
  • A problem with high blood pressure (hypertension) or blood clots (thrombosis)
  • A history of heart disease, kidney disease, or cystic fibrosis
  • A condition that causes you to be very thirsty
  • Have any nasal problems (such as a stuffy nose), or have had trouble breathing through or surgery on your nose

If you have one of these issues in your medical history, your HCP may need to use other therapies to treat your bleeding episodes.

  • Stimate Nasal Spray may be cautiously considered for patients who have Type 2B VWD1

    — The decrease in platelets it may cause is temporary and often not associated with bleeding or thrombosis (clotting inside a blood vessel)

Never let other people use your Stimate Nasal Spray

This medicine is for your use only. As with all medical conditions, each person needs individual treatment as prescribed by his or her own HCP.

Side effects associated with the use of Stimate Nasal Spray

Fluid Retention/Hyponatremia — While using this treatment, your body will hold excess fluid. In some cases, too much fluid could "dilute" the salts in your body. This could cause your body’s salt level to become very low, a condition called hyponatremia. Very rarely, cases of hyponatremia have been reported from worldwide experience in patients treated with Stimate Nasal Spray. Children and the elderly are most at risk for this side effect.

Other Possible Side Effects—Common side effects that have been reported include:

  • Facial flushing (your face may feel warm and turn slightly red)
  • Nasal congestion
  • Runny nose
  • Nosebleed
  • Sore throat
  • Cough
  • Upper respiratory infections

As with any medicine, it is important that you report any unusual or uncomfortable symptoms to your HCP right away.

References:

  1. National Heart, Lung, and Blood Institute. The Diagnosis, Evaluation, and Management of von Willebrand Disease. Bethesda, MD: National Institutes of Health; 2007. NIH Publication No. 08-5832.

Important Safety Information for Stimate

Stimate® (desmopressin acetate) Nasal Spray, 1.5 mg/mL, is indicated for patients with hemophilia A and Factor VIII coagulant activity levels over 5%. Desmopressin acetate is not indicated to treat hemophilia A patients with Factor VIII coagulant activity levels equal to or less than 5%, or for the treatment of hemophilia B, or in patients with Factor VIII antibodies.

Stimate Nasal Spray is indicated for patients with mild to moderate classic type 1 von Willebrand disease (VWD) and Factor VIII levels greater than 5%. Stimate Nasal Spray is not indicated for the treatment of severe classic VWD (Type I) nor when there is evidence of an abnormal molecular form of Factor VIII antigen.

Stimate Nasal Spray should not be used in patients with type 2B VWD, since platelet aggregation may be induced. Stimate Nasal Spray is for intranasal use only.

Stimate Nasal Spray is a potent antidiuretic that can lead to water intoxication and/or hyponatremia; hyponatremia can be fatal if not properly diagnosed and treated. Very rare cases of hyponatremia have been reported in worldwide marketing experience.

Fluid intake should be adjusted downward to decrease the potential for water intoxication and/or hyponatremia, especially in patients at increased risk for these conditions, including pediatric and geriatric patients, and those with habitual or psychogenic polydipsia, who may be more likely to drink excessive amounts. All patients receiving Stimate therapy should be observed for signs or symptoms associated with hyponatremia, including: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status, such as hallucinations, decreased consciousness and confusion. Severe symptoms can include one or a combination of the following: seizure, coma and/or respiratory arrest. Particular attention should be paid to the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures that could lead to coma.

Other adverse reactions reported with use of injectable and/or intranasal desmopressin acetate include headache, nausea, somnolence, dizziness, chest pain, palpitations and tachycardia, and severe allergic reactions, including anaphylaxis. See full prescribing information for a complete list of adverse reactions.

Please see full prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


Important Safety Information for Humate-P

Humate-P is indicated for treatment and prevention of bleeding in adult patients with hemophilia A (classical hemophilia). Humate-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of spontaneous and trauma-induced bleeding episodes, and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD, and patients with mild and moderate VWD for whom use of desmopressin is known or suspected to be inadequate. Humate-P is not indicated for the prophylaxis of spontaneous bleeding episodes.

Humate-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. Also monitor VWF:RCo and FVIII levels in VWD patients, especially those undergoing surgery.

Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement. Caution should be exercised and antithrombotic measures considered, particularly in patients with known risk factors for thrombosis.

Humate-P is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

The most commonly reported adverse reactions in patients receiving Humate-P are allergic-anaphylactic reactions, including urticaria (hives), chest tightness, rash, pruritus (itching), and edema (swelling). For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding, or nosebleed.

Please see full prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.