Common questions about SAPHRIS for bipolar I disorder in children
and teens ages 10 to 17
Q: What is SAPHRIS?
A: SAPHRIS (asenapine) is an FDA-approved prescription medicine for children and teens ages 10 to 17. It can be used alone for the acute treatment of manic or mixed episodes associated with bipolar I disorder.
Q: Who should not take SAPHRIS?
A: People who should NOT take SAPHRIS include:
- People who are allergic to any ingredients in SAPHRIS. Get emergency medical help if you are having an allergic reaction (eg, difficulty breathing; itching; swelling of the face, tongue, or throat; or lightheadedness)
- People with severe liver problems
Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking antipsychotic drugs are at an increased risk of death. SAPHRIS is not approved for treating people with dementia-related psychosis.
Q: Will SAPHRIS cause sleepiness?
A: In the 3-week clinical study, about 50% of children and teens (10-17 years of age) taking SAPHRIS complained at least once of feeling sleepy, compared with 12% who were on a sugar pill (placebo). Among those who felt sleepy while on SAPHRIS, the vast majority described it as either mild or moderate. Do not let your child or teen drive or use dangerous machinery until you know how SAPHRIS affects him or her. SAPHRIS may make them drowsy.
Q: I’ve heard some medicines for bipolar l disorder can cause weight gain. Is the same true for SAPHRIS?
A: SAPHRIS has been associated with weight gain. On average, children and teens taking SAPHRIS gained about 3 to 4 pounds compared with those on placebo who gained about a pound during the 3-week clinical study. During treatment with SAPHRIS, their healthcare provider should check their weight regularly.
Q: Is SAPHRIS associated with restlessness or muscle stiffness?
A: In the 3-week clinical study of children and teens, ages 10 to 17, up to 5% of those taking SAPHRIS and 3% of those taking placebo showed signs of restlessness or muscle stiffness. If these symptoms occur, contact your child’s or teen’s healthcare provider. In some cases, muscle stiffness may become permanent.
Q: How does SAPHRIS affect blood sugar?
Q: How does SAPHRIS affect cholesterol or triglycerides?
A: Increases in cholesterol and triglycerides were reported with SAPHRIS in the clinical study. Your child’s or teen’s healthcare provider may decide to check his or her cholesterol and triglyceride levels during treatment.
Q: What are possible side effects of SAPHRIS?
- In clinical trials, the most common side effects in children (ages 10-17): sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain
- Since FDA approval, patients taking SAPHRIS have reported reactions under the tongue (where you place SAPHRIS), such as sores, oral blisters, peeling/sloughing, or inflammation. Choking has also been reported
Tell your child's or teen's healthcare provider if they experience any side effect that bothers them or that does not go away. These are not all of the possible side effects of SAPHRIS.
Learn more and see risks and side effects of SAPHRIS.
Q: Which symptoms of my child’s or teen’s bipolar I disorder does SAPHRIS help with?
A: SAPHRIS is for the acute treatment of manic or mixed episodes associated with bipolar I disorder in children and teens (ages 10-17). Talk to your child’s or teen’s doctor about their specific symptoms and treatment.
Q: If my child or teen is currently taking another medicine, or if
they were taking another medicine to treat the
symptoms of bipolar I disorder, how should my child or teen start taking SAPHRIS?
Q: How should my child or teen take SAPHRIS?
A: Click here for instructions on how to take SAPHRIS.
Q: How quickly does SAPHRIS dissolve?
A:. The whole tablet should be placed under the tongue to allow to dissolve completely. Your child or teen should not chew or swallow the tablet. SAPHRIS dissolves in saliva within seconds, helping your child or teen get the medicine his or her healthcare provider prescribed.
It is important that the SAPHRIS tablet is not removed from the tablet pack until your child or teen is ready to take it. Use dry hands when handling the tablet, and do not split, cut, or crush it. Also, it is important that your child or teen does not eat or drink for at least 10 minutes after taking SAPHRIS, and that they take it exactly as prescribed by their healthcare provider.
Q: Can I put SAPHRIS in a weekly pillbox?
A: No. Keep SAPHRIS in the tablet pack that it comes in. The packaging was designed to help the tablets stay dry, which is important because if the tablets get wet, they may dissolve. If you want to be sure your child or teen has remembered to take SAPHRIS, you might want to use a calendar and have them put a check mark on it every time they take a tablet.
Q: What doses is SAPHRIS available in?
A: For patients ages 10 to 17, SAPHRIS is available in 2.5 mg, 5 mg, and 10 mg tablets. The healthcare provider will decide which dose is right for your child or teen.
Q: What if I’m having trouble paying for SAPHRIS?
A: Allergan, Inc., may be able to help. Call 1-800-851-0758 or visit www.Allergan.com/pap for more information.