Precautions
SPRAVATOTM is a prescription medicine, used along with an antidepressant taken by mouth, for treatment-resistant depression (TRD) in adults.
What is spravatotm?
Spravato is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if Spravato is safe or effective as an anesthetic medicine. It is not known if this medicine is safe and effective in children.
Is Spravato safe to use as anesthetic medicine?
Spravato isn’t approved to treat obsessive-compulsive disorder (OCD). No clinical studies have been done that would show whether Spravato is effective for treating OCD. Ketamine (a drug similar to Spravato) has been looked at in several clinical studies as a treatment for OCD. Results in these studies were conflicting.
How effective is Spravato for obsessive-compulsive disorder?
After 4 weeks of treatment with SPRAVATO®, evidence of therapeutic benefit should be evaluated to determine need for continued treatment.* It’s a good idea to set up these appointments at the outset to help ensure the proper timing is followed. Patient REMS enrollment will differ in an inpatient vs outpatient setting.
When is evidence of therapeutic benefit evaluated for Spravato® treatment?
What happens when you take Spravato?
The most common side effects that can occur during and after taking SPRAVATO® include: Feeling disconnected from yourself, your thoughts, feelings and things around you (dissociation) Dizziness. Nausea.
How does Spravato treatment work?
Esketamine works in a similar way, but unlike other antidepressant medications, Spravato increases glutamate, the most abundant neurotransmitter in the brain. Glutamate is a powerful excitatory neurotransmitter that regulates learning and memory.
How long does Spravato treatment last?
80% of panelists agreed that the minimum total treatment duration with SPRAVATO plus an oral antidepressant should be 6 months in patients with TRD.
Is Spravato a narcotic?
Yes. Spravato (esketamine) is a Schedule III Controlled Substance in the United States. Spravato is rapid acting nasal spray used conjunction with an oral antidepressant, for use in adults with treatment-resistant depression.
How does SPRAVATO make you feel?
Spravato may cause feelings of sedation (extreme sleepiness), anxiousness, or dissociation (feeling disconnected from yourself or your thoughts). Dissociation was the most common side effect, and sedation was among the most common side effects in Spravato's studies.
How do you feel after a SPRAVATO treatment?
The most common side effects that can occur during and after taking SPRAVATO® include:Feeling disconnected from yourself, your thoughts, feelings and things around you (dissociation)Dizziness.Nausea.Feeling sleepy (sedation)Spinning sensation.Decreased feeling of sensitivity (numbness)Feeling anxious.Lack of energy.More items...
What is the success rate of SPRAVATO?
Studies show an efficacy of 40-60% depending on the duration of treatment.
Does SPRAVATO cause weight gain?
Weight gain is not a side effect of Spravato. Weight gain was not reported in clinical trials of the drug. Weight gain is a side effect of some other medications that are used to treat depression, such as Abilify (aripiprazole) and Symbyax (fluoxetine/olanzapine).
Can SPRAVATO worsen depression?
Spravato may cause worsening of depression and suicidal thoughts and behaviors, especially during the first few months of treatment and when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions.
Who is a candidate for Spravato?
Who is a candidate for Spravato? Spravato is for adults with treatment-resistant depression and those who have suicidal thoughts or actions related to severe major depressive disorder. Treatment-resistant depression is when you don't achieve adequate symptoms relief after trying two or more antidepressant medications.
Can Spravato be used for bipolar?
Summary. SPRAVATO nasal spray has not been studied, and is not indicated, for patients with bipolar disorder. A case report describes the improvement of depressive symptoms in an adult patient with treatmentresistant bipolar depression prescribed SPRAVATO.
Is Spravato an antidepressant?
The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression).
What is Spravato approved for?
The Food and Drug Administration (FDA) approves prescription drugs such as Spravato to treat certain conditions. Spravato may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.
How long does it take for Spravato to work?
This is unlike many other depression medications, which can take weeks to start working. Side effects. Possible side effects of Spravato include dissociation (feeling “out of body”) and sedation (sleepiness, trouble thinking clearly, inability to drive or use heavy machinery).
How much Spravato should I take?
The first dose of Spravato is 56 mg. Each dose after that is either 56 mg or 84 mg. Your doctor will prescribe your dose based on how well your body tolerates the drug. At the end of the induction phase, you and your doctor will discuss whether you should continue to the maintenance phase.
How many sprays of Spravato are there?
It’s given through a special device that sprays the drug into your nose. Each device delivers two sprays of the medication. Each spray contains 14 mg of Spravato.
What is dissociation in Spravato?
Dissociation was one of the most common side effects seen during clinical trials of Spravato. This condition is a change in your mental state. It’s often described as having an “out-of-body” experience. People can feel disconnected from time, space, or their own body or mind.
How long do you have to watch for Spravato?
Your healthcare provider will monitor you while you’re taking Spravato. They’ll continue to watch you for at least two hours after your dose. This monitoring is done to make sure that you have no serious side effects after your treatment. Your doctor will advise when you can safely leave the clinic.
Is Spravato FDA approved?
Spravato was approved by the Food and Drug Administration (FDA) in March 2019. Its approval is considered controversial by some people for a few reasons: Similarity to ketamin e. Spravato is similar to ketamine (an anesthetic drug), which is sometimes used as a party drug.
What is the first nasal spray?
SPRAVATO® is the first prescription nasal spray, taken with an oral antidepressant, for: Adults with treatment-resistant depression. X In the SPRAVATO® clinical trials, treatment-resistant depression was diagnosed in adults who were struggling with major depressive disorder and had not responded adequately to at least two different antidepressants ...
Can you take spravato nasal spray?
You will take SPRAVATO ® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO ® nasal spray device. Your healthcare provider will tell you how much SPRAVATO ® you will take and when you will take it.
Can you drive on a treatment day?
So you’ll need to plan for rides on treatment days.
Can you take spravato if you have aneurysm?
Do not take SPRAVATO® if you have a blood vessel disease (aneurysm), an abnormal connection between your blood vessels (arteriovenous malformation), a history of bleeding in the brain or if you are allergic to esketamine, ketamine or any of the ingredients in SPRAVATO®.
Can you administer spravato nasal spray?
On treatment days, you will administer SPRAVATO® nasal spray yourself under the supervision of a healthcare provider. Your health care provider will assess your blood pressure before and after you administer SPRAVATO® nasal spray. Watch Instructional Video.
Treating Patients
Before starting patients on SPRAVATO®, you must provide a thorough consultation to discuss the potential benefits, risks and side effects, and process of SPRAVATO® treatment.
Patient Support
Before starting a patient on SPRAVATO®, you will need to investigate his or her insurance benefits and obtain prior authorization, if needed.
Treat, Monitor, and Assess Patients
Reach out to the referring HCP before the first SPRAVATO® treatment session.
Manage Used and Unused Product
Once the SPRAVATO® device has been used by the patient, it should be disposed of as medical waste according to local, state, and federal regulations for controlled substances.
What are the side effects of Spravato?
The most common side effects experienced by patients treated with Spravato in the clinical trials were disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.
Who approved Spravato?
The FDA granted the approval of Spravato to Janssen Pharmaceuticals, Inc. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
When will Spravato be released?
For Immediate Release: March 05, 2019. Español. The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression).
Is Spravato a treatment resistant drug?
Patients with major depressive disorder who, despite trying at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode, have not responded to treatment are considered to have treatment- resistant depression. The Spravato labeling contains a Boxed Warning that cautions that patients are at risk ...
Can you take Spravato at home?
The patient self-administers Spravato nasal spray under the supervision of a health care provider in a certified doctor’s office or clinic, and the spray cannot be taken home. The health care provider will instruct the patient on how to operate the nasal spray device.
Does the FDA approve nasal spray?
FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic | FDA.
Is Spravato a placebo?
In the three short-term studies, patients were randomized to receive Spravato or a placebo nasal spray. In light of the serious nature of treatment-resistant depression and the need for patients to receive some form of treatment, all patients in these studies started a new oral antidepressant at the time of randomization and ...
For more information and support for patients and their caregivers
Once you and your healthcare provider have decided that SPRAVATO® is right for you, Janssen CarePath will help you find the resources you may need to get started and stay on track.
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