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Risperdal Consta (Risperdal Long Acting Injection)

FDA ALERT [04/2005] Risperdal consta is a type of medicine called an atypical antipsychotic. FDA has found that older patients treated with atypical antipsychotics for dementia had a higher chance for death than patients who did not take the medicine. This is not an approved use.

Brand and Generic Names

Available forms…

Brand Name: Risperdal Consta® - a long-acting injection
- – 25 mg, 37.5 mg, or 50 mg for intramuscular injection
Generic name: risperidone

What is Risperdal Consta® and what does it treat?

Risperdal Consta® (Risperidone Long Acting Injection) is a new injection (“shot”) formulation of the atypical antipsychotic Risperdal®. Risperdal Consta® contains the same medication that is in the oral Risperdal® tablets and solution. The medication (risperidone) in Risperdal Consta® is enclosed in tiny beads called “microspheres”. After the microspheres are injected into the body, they slowly dissolve, releasing a constant amount of the risperidone medication. It is the only atypical antipsychotic available in a long acting or depot formulation as a shot. The FDA approved Risperdal Consta® in October of 2003 for the treatment of schizophrenia. Doctors may decide to use Risperdal Consta® for other conditions such as bipolar disorder. Just like the oral formulations, Risperdal Consta treats both the positive symptoms (hallucinations, abnormal thoughts) and negative symptoms (withdrawn, lack of motivation and emotions) of schizophrenia.

The advantage of the injection over the oral tablets and solution is that Risperdal Consta® only has to be given once every 2 weeks, so persons taking Risperdal Consta® do not have to remember to take risperidone every day.

What should I discuss with my healthcare provider before taking Risperdal Consta®?

Symptoms of schizophrenia and/or bipolar disorder that are bothersome to you.
The medications you have taken in the past for schizophrenia and/or bipolar disorder. It would be helpful for your provider to know which medications were effective and which were not.
If you had any serious side effects to other antipsychotic medications like muscle stiffness, muscle cramping, shaking, tardive dyskinesia, neuroleptic malignant syndrome, weight gain, or diabetes, tell your healthcare provider.
All other medications you are currently taking.
If you smoke cigarettes, use illegal drugs, or drink alcohol.
About any medication allergies you have.
If you are pregnant, plan to get pregnant, or are breast feeding.
What medical problems you have, especially diabetes, high cholesterol or triglycerides, increased body weight, irregular heart beats, or seizures.
Tell your doctor if you have thoughts of suicide.

How should I take Risperdal Consta®?

Prior to starting Risperdal Consta®, patients should be tried on the oral formulation of Risperdal® to determine tolerability.

The typical starting dose of Risperdal Consta® is 25 mg every 2 weeks. Depending on an individual’s response, the dose can be increased to a maximum of 50 mg every 2 weeks. Currently, Risperdal Consta® is available in strengths of 25 mg, 37.5 mg and 50 mg injections.

After the first shot of Risperdal Consta® is given, consumers should continue taking the oral risperidone (or other antipsychotic medication) for the first 3 weeks after receiving the first shot. This allows time for the injection formulation to start working in one’s body.

Risperdal Consta® is given as a shot into the muscle of one’s buttock and is usually administered by a healthcare professional. It should not be given in any other muscle.

What happens if I miss a dose?

If you miss a dose of Risperdal Consta®, schedule an appointment with your health care provider as soon as possible. Your doctor may have to restart you on the oral medication until you can receive your next shot.

What should I avoid while taking Risperdal Consta®?

Avoid smoking cigarettes, using illegal drugs, or drinking alcohol.
Avoid overexposure to the sun. Use sunscreen with at least SPF 15 and wear light colored clothing. Wear a hat to protect your head and face.
Some people get drowsy on risperidone; avoid driving a car until you are sure how the medication will affect you.

What are the possible side effects of Risperdal Consta®?

Side effects of Risperdal Consta® are similar to the oral Risperdal® medication and other atypical antipsychotics. The most common side effects individuals experience include drowsiness, dizziness, restlessness, muscle stiffness, tremors, dry mouth, and constipation. Extrapyramidal symptoms (muscle stiffness, rigidity, restlessness, and muscle spasms) are more common with higher dosages. Moderate weight gain, (5-20lbs) has also been reported in patients receiving Risperdal Consta®.

As with any injection, some pain is reported by patients receiving Risperdal Consta®. However, in clinical studies, patients report minimal or no pain.

New cases of diabetes have been reported in patients receiving oral Risperdal® and other atypical antipsychotic medications. However, the overall link between atypical antipsychotics and diabetes is not completely understood at this time. Clinicians may choose to monitor patients blood sugars periodically to determine their risk for developing diabetes.

More serious side effects include weight gain, diabetes, high cholesterol and triglycerides, or increased blood levels of prolactin which may (for example) result in females losing their period and males losing their sex drive.

Rare side effects include neuroleptic malignant syndrome (high fever, extreme muscle rigidity, altered mental status, particularly confusion), liver damage and seizures.

In some clinical trials, it was determined that elderly people , with dementia-related psychosis, treated with risperidone developed strokes at a higher rate than those on placebo medication (sugar pill). It is not known at this time if risperidone causes stroke.

Are there any risks for taking this medication for long periods of time?

Tardive dyskinesia (TD) is a side effect that develops with prolonged use of antipsychotics. Medications such as risperidone have been shown to have a much lower risk of TD compared to older antipsychotics, such as Haldol (haloperidol). Should you develop symptoms of TD, such as grimacing, sucking and smacking of lips, and other movements that you cannot control, contact your healthcare provider immediately.

Risperdal is thought to have a lower risk of weight gain than some of the other atypical antipsychotics. No one can predict how much weight a person will gain on any medicine, but an approach that includes exercise and diet and monitoring for weight gain and diabetes is recommended.

What other drugs interact with this medication?

Some antidepressants, such as Prozac (fluoxetine) and Paxil® (paroxetine) and Wellbutrin® (bupropion) may increase the blood levels of risperidone. It is possible that patients taking risperidone with either of these agents may experience a change in side effects. Tell your doctor if you begin or discontinue fluoxetine , paroxetine, or bupropion therapy.

Some medications, such as Tegretol® (carbamazepine), Dilantin® (phenytoin), phenobarbital, Rifadin® (rifampin) or Topamax® (topiramate) may decrease the blood levels of risperidone. It is possible that you may experience a decreased effect from risperidone if you also take one of these medications. Tell your doctor if you begin or discontinue any of these treatments .

How long does it take for Risperdal Consta® to work?

Risperdal Consta®, is made up of “microspheres” that suspend the medicine risperidone in the injection solution. After the microspheres are injected into the body, they slowly dissolve, releasing a constant amount of the risperidone medication. After receiving the first injection it takes 3 weeks before the medicine starts to be released, thus, requiring you to continue taking the oral risperidone for the first three weeks. When using both the combination of oral and the injection at the start of treatment, patients may notice some improvement in symptoms within a few weeks. The full benefits of risperidone may not be seen for 4-6 weeks, or longer.

How long does one have to continue taking Risperdal Consta®?

Patients with schizophrenia or other psychiatric disorders may require long-term treatment with Risperdal Consta®. Patients should never stop receiving Risperdal Consta® without first talking with their doctor.

Updated by Karen Moeller, PharmD, BCPP
(March 2007)

NAMI wishes to thank the College of Psychiatric and Neurologic Pharmacists for producing this fact sheet.

For further information please contact the pharmaceutical company listed below.

Janssen Pharmaceutica, Inc.

1125 Trenton-Harbourton Rd.

Titusville, NJ 08560

800-526-7736

(800-JANSSEN)

www.janssen.com

Free or low-cost medications provided by pharmaceutical companies

Some pharmaceutical companies offer medication assistance programs to low-income individuals and families. These programs typically require a doctor’s consent and proof of financial status. They may also require that you have either no health insurance, or no prescription drug benefit through your health insurance. Please contact the pharmaceutical company directly for specific eligibility requirements and application information.

Risperdal Rx Assitance Program: 1-800-631-1253

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