Spravato 84mg Nasal Spray Dose Kit
WARNING: This drug may make you feel sleepy or dizzy, pass out, or cause anxiety. This drug may also cause a spinning feeling or an out-of-body feeling (like you are separated from your thoughts, feelings, surroundings, yourself, or time). These effects happened on the day of treatment and have gone away. Tell your doctor right away if you feel like you cannot stay awake or if you feel like passing out.This drug may cause breathing problems. Rarely, these problems were severe or life- threatening. Call your doctor right away if you have slow, shallow, or trouble breathing.You will be watched closely while you receive this drug and for some time after your dose. Talk with your doctor.Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.This drug has a risk of misuse. Use this drug only as you were told by your doctor. Tell your doctor if you have ever had alcohol or drug use disorder. @ COMMON USES: It is used to treat certain types of depression.
Drug Class
Antidepressant
Pharmacologic Class
N-methyl-D-aspartate (NMDA) receptor antagonist
Pregnancy Category
Not assigned (see Special Populations)
FDA Approved
Mar 2019
DEA Schedule
Schedule III
Overview
What is this medicine?
Spravato is a nasal spray medication used to treat severe depression that hasn't responded to other antidepressant medicines. It works differently from typical antidepressants and is given in a doctor's office or clinic because it can cause temporary side effects like feeling disconnected or sleepy. You'll need to stay at the clinic for at least 2 hours after each dose for monitoring.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all provided information carefully. This medication is for nasal use only and will be administered in a healthcare setting where you can be closely monitored.
Administration Instructions
Each nasal spray device contains 2 sprays. Your doctor will determine the number of devices you need to use for your prescribed dose. Before using the first nasal spray device, blow your nose to clear your nasal passages. If any liquid drips out after use, gently dab your nose with a tissue, but do not blow your nose.
Pre-Use Precautions
To ensure effective use, do not eat food for at least 2 hours before using this medication. Additionally, avoid drinking liquids for at least 30 minutes before use. If you are using other nasal medications on the same day, use them at least 1 hour before using this medication.
Storage and Disposal
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all provided information carefully. This medication is for nasal use only and will be administered in a healthcare setting where you can be closely monitored.
Administration Instructions
Each nasal spray device contains 2 sprays. Your doctor will determine the number of devices you need to use for your prescribed dose. Before using the first nasal spray device, blow your nose to clear your nasal passages. If any liquid drips out after use, gently dab your nose with a tissue, but do not blow your nose.
Pre-Use Precautions
To ensure effective use, do not eat food for at least 2 hours before using this medication. Additionally, avoid drinking liquids for at least 30 minutes before use. If you are using other nasal medications on the same day, use them at least 1 hour before using this medication.
Storage and Disposal
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Do not drive or operate machinery until the next day after a restful sleep, or until the effects of the medication (e.g., sedation, dissociation) have worn off completely, whichever is longer.
- Avoid alcohol and other CNS depressants (e.g., benzodiazepines, opioids) on the day of treatment and as advised by your doctor.
- Do not take Spravato at home; it must be administered by a healthcare professional in a certified clinic.
- Inform your doctor about all medications, supplements, and herbal products you are taking.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: Day 1: 84 mg. Induction (Weeks 1-4): 56 mg or 84 mg twice weekly. Maintenance (Weeks 5-8): 56 mg or 84 mg once weekly. Maintenance (Week 9 onwards): 56 mg or 84 mg every two weeks or once weekly. Administered under direct supervision in a healthcare setting.
Dose Range:
56 - 84 mg
Condition-Specific Dosing:
Treatment-Resistant Depression (TRD):
Administered in conjunction with an oral antidepressant.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No dose adjustment needed.
Dialysis:
Not studied in patients with end-stage renal disease (ESRD) on dialysis; use with caution.
Hepatic Impairment:
Mild:
No dose adjustment needed (Child-Pugh Class A).
Moderate:
Consider 56 mg dose; monitor closely for adverse reactions (Child-Pugh Class B).
Severe:
Not recommended (Child-Pugh Class C).
Pharmacology
Mechanism of Action
Esketamine is the S-enantiomer of ketamine. It is a non-competitive, N-methyl-D-aspartate (NMDA) receptor antagonist. Its antidepressant mechanism is not fully understood but is thought to involve transient increases in glutamate, leading to activation of AMPA receptors and subsequent synaptogenesis in brain regions associated with mood regulation.
Pharmacokinetics
Absorption:
Bioavailability:
48% (nasal)
Tmax:
20-40 minutes
FoodEffect:
Not applicable for nasal spray; no significant food effect.
Distribution:
Vd:
700 L
ProteinBinding:
43-53%
CnssPenetration:
Yes
Elimination:
HalfLife:
4-7 hours (esketamine); 8-12 hours (norketamine)
Clearance:
Not available
ExcretionRoute:
Urine (78%), Feces (21%)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Rapid (within hours)
PeakEffect:
Within 40 minutes of administration
DurationOfAction:
Dissociative and sedative effects typically resolve within 1.5-2 hours post-administration; antidepressant effects persist with repeated dosing.
Safety & Warnings
BLACK BOX WARNING
SPRAVATO has a Boxed Warning for sedation, dissociation, abuse and misuse, and suicidal thoughts and behaviors. SPRAVATO is only available through a restricted program called the SPRAVATO REMS. SPRAVATO must be administered in an enrolled healthcare setting under the direct supervision of a healthcare provider, and patients must be monitored for at least 2 hours after administration.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Chest pain
Shortness of breath
Seizures
Confusion or memory problems
Anxiety
Frequent or urgent need to urinate, pain while urinating, or increased nighttime urination
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Dizziness or drowsiness
Feeling sluggish, disoriented, or unwell
Excessive happiness or excitement
Upset stomach or vomiting
Changes in taste
Headache
Numbness or tingling in the mouth
Sore throat
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Chest pain
Shortness of breath
Seizures
Confusion or memory problems
Anxiety
Frequent or urgent need to urinate, pain while urinating, or increased nighttime urination
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Dizziness or drowsiness
Feeling sluggish, disoriented, or unwell
Excessive happiness or excitement
Upset stomach or vomiting
Changes in taste
Headache
Numbness or tingling in the mouth
Sore throat
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe sedation or unresponsiveness
- Feeling disconnected from your body or reality (dissociation)
- Hallucinations or delusions
- Sudden, severe increase in blood pressure or heart rate
- Difficulty breathing
- New or worsening suicidal thoughts or behaviors
- Urinary problems (e.g., frequent urination, painful urination, blood in urine) with long-term use
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Aneurysm (a type of blood vessel disease) in the brain, chest, abdomen, arms, or legs
+ Arteriovenous malformation
+ High blood pressure
+ Liver problems
If you have a history of bleeding in the brain
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
* If you are breast-feeding. You should not breast-feed while taking this medication.
Additionally, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure that it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Aneurysm (a type of blood vessel disease) in the brain, chest, abdomen, arms, or legs
+ Arteriovenous malformation
+ High blood pressure
+ Liver problems
If you have a history of bleeding in the brain
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
* If you are breast-feeding. You should not breast-feed while taking this medication.
Additionally, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure that it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
After taking a dose, avoid operating a vehicle or engaging in any activities that require alertness until the following day, after you have had sufficient sleep. It is recommended that someone else drives you home after each dose.
This medication may cause an increase in blood pressure, and your doctor will closely monitor your blood pressure levels.
Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor.
If you need to discontinue treatment with this medication, be aware of the potential for withdrawal symptoms. Report any adverse effects to your doctor, and do not hesitate to reach out if you have questions or concerns.
If you are of childbearing potential, discuss effective birth control methods with your doctor to prevent pregnancy while taking this medication. This drug may pose a risk to the unborn baby if taken during pregnancy. If you become pregnant or suspect you may be pregnant while taking this medication, contact your doctor immediately.
After taking a dose, avoid operating a vehicle or engaging in any activities that require alertness until the following day, after you have had sufficient sleep. It is recommended that someone else drives you home after each dose.
This medication may cause an increase in blood pressure, and your doctor will closely monitor your blood pressure levels.
Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor.
If you need to discontinue treatment with this medication, be aware of the potential for withdrawal symptoms. Report any adverse effects to your doctor, and do not hesitate to reach out if you have questions or concerns.
If you are of childbearing potential, discuss effective birth control methods with your doctor to prevent pregnancy while taking this medication. This drug may pose a risk to the unborn baby if taken during pregnancy. If you become pregnant or suspect you may be pregnant while taking this medication, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Severe sedation
- Profound dissociation
- Respiratory depression
- Coma
- Severe hypertension
What to Do:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Management is supportive, including maintaining a patent airway, providing oxygenation and ventilation, and monitoring cardiovascular status.
Drug Interactions
Major Interactions
Moderate Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): May increase esketamine exposure.
- CYP3A4 inducers (e.g., rifampin, carbamazepine): May decrease esketamine exposure.
Confidence Interactions
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Risk of transient increases in BP and HR.
Timing: Prior to each dose.
Mental Status Examination (MSE)
Rationale: Assess for baseline psychiatric symptoms and cognitive function.
Timing: Prior to initiation of treatment.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At 40 minutes and 1.5 hours post-dose, and as clinically indicated.
Target: Individualized, but monitor for significant elevations.
Action Threshold: Sustained clinically significant elevations (e.g., >180/120 mmHg systolic/diastolic) require immediate medical attention and potential dose modification or discontinuation.
Sedation/Dissociation (e.g., using Modified Aldrete Score, Clinician-Administered Dissociative States Scale [CADSS])
Frequency: During and for at least 2 hours post-dose.
Target: Resolution of symptoms.
Action Threshold: Persistent or severe symptoms may require extended monitoring or medical intervention.
Respiratory Status
Frequency: During and for at least 2 hours post-dose.
Target: Normal respiratory rate and effort.
Action Threshold: Respiratory depression requires immediate medical intervention.
Suicidal Ideation and Behavior
Frequency: Regularly throughout treatment, especially during initial weeks and dose changes.
Target: Reduction or absence of suicidal thoughts.
Action Threshold: Emergence or worsening of suicidal thoughts/behaviors requires immediate clinical assessment and intervention.
Symptom Monitoring
- Sedation
- Dissociation (e.g., derealization, depersonalization, perceptual changes)
- Nausea/Vomiting
- Dizziness
- Vertigo
- Anxiety
- Hypertension
- Tachycardia
- Urinary symptoms (e.g., frequency, urgency, pain, incontinence) with long-term use
- Suicidal thoughts or behaviors
Special Patient Groups
Pregnancy
Esketamine may cause fetal harm. Animal studies have shown adverse neurodevelopmental effects. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. A pregnancy exposure registry is available.
Trimester-Specific Risks:
First Trimester:
Potential for adverse developmental effects based on animal data.
Second Trimester:
Potential for adverse developmental effects based on animal data.
Third Trimester:
Potential for adverse developmental effects based on animal data; risk of neurotoxicity in developing brain.
Lactation
Esketamine is excreted in human milk. There is a potential for serious adverse reactions in the breastfed infant (e.g., sedation, respiratory depression, neurodevelopmental effects). A decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Potential for sedation, respiratory depression, and neurodevelopmental effects. Monitor infants for adverse effects.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not recommended for use in patients younger than 18 years of age.
Geriatric Use
No specific dose adjustment is required. However, elderly patients may be more sensitive to the adverse effects of esketamine, particularly sedation and dissociation. Monitor closely.
Clinical Information
Clinical Pearls
- Spravato is part of a REMS (Risk Evaluation and Mitigation Strategy) program due to risks of sedation, dissociation, and abuse/misuse. It must be administered in a certified healthcare setting.
- Patients must be monitored for at least 2 hours after administration for adverse effects, particularly sedation and dissociation, and for blood pressure changes.
- Not indicated for use as a monotherapy; must be used in conjunction with an oral antidepressant.
- Not approved for acute suicidal crisis or emergency situations.
- Patients should not drive or operate machinery until the next day after a restful sleep.
- Long-term use of ketamine (racemic mixture) has been associated with urological symptoms (e.g., interstitial cystitis); monitor for such symptoms with esketamine, especially with prolonged use.
Alternative Therapies
- Other oral antidepressants (SSRIs, SNRIs, TCAs, MAOIs)
- Electroconvulsive Therapy (ECT)
- Transcranial Magnetic Stimulation (TMS)
- Vagus Nerve Stimulation (VNS)
- Augmentation strategies with atypical antipsychotics or lithium
- Psilocybin (investigational, not FDA approved for depression)
Cost & Coverage
Average Cost:
Highly variable, typically $600-$900 per dose kit per 84mg nasal spray dose kit
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and often administered in-office, billed under medical benefit)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is important to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is important to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.