Important Safety Information

Brainsway Deep TMS — Important Safety Information

What Brainsway Deep TMS Is Used For

The Brainsway Deep TMS System is FDA-cleared for the treatment of:

• Major Depressive Disorder (MDD) — for adult patients who have not achieved satisfactory improvement from previous antidepressant medication in the current episode.
• Anxious Depression — for decreasing anxiety symptoms in adult MDD patients with comorbid anxiety.
• Late-Life Depression — for older adults with depression.
• Obsessive-Compulsive Disorder (OCD) — as an adjunct treatment.
• Smoking Addiction — as a short-term aid to smoking cessation in adults.

When Brainsway Deep TMS Should Not Be Used

Deep TMS therapy delivers a magnetic field that could cause metal objects near the device to move or heat up. Deep TMS treatment should not be used if you have:

• Metal implants in or around your head (standard amalgam dental fillings are okay).
• Implanted electronic devices anywhere in your body — including pacemakers, implantable cardioverter defibrillators, vagus nerve stimulators, deep brain stimulators, cochlear implants, ocular implants, aneurysm coils, or stents.

These implants could cause serious injury or death if Deep TMS is used. Always tell your doctor about any metal devices or objects in your head or body before starting treatment.

Risk of Seizure

There is a rare risk of seizure associated with Deep TMS therapy. In Brainsway’s clinical studies, seizure incidents were extremely uncommon (approximately 4 reported across roughly 50,000 treatment sessions), and were typically associated with high alcohol consumption or high doses of antidepressant medications that are themselves known to lower the seizure threshold. None of the patients who experienced a Deep TMS-induced seizure suffered lasting physical effects.

Tell your doctor if you have ever had a seizure, a brain injury, recent medication changes, or any condition that could increase your risk of seizure. Your doctor will determine whether Deep TMS is appropriate for you.

Worsening Depression or Suicidality

Your antidepressant medications may be tapered before Deep TMS treatment begins. Tapering may cause discomfort, and depression symptoms may worsen before improvement occurs. Increased mood instability or suicidal thoughts can occur during this time. Deep TMS may require several weeks of treatment before symptom improvement is observed.

Your provider will monitor you closely throughout the course of treatment. Tell your doctor — or have a family member or caregiver tell us — immediately if you notice any of the following:

• Worsening depression
• Suicidal thoughts or attempts
• Increased aggression or irritability
• Euphoria or unusual mood elevation
• Any other significant behavioral changes

Patient Populations Where Safety Has Not Been Established

The safety and effectiveness of Brainsway Deep TMS has not been established through controlled clinical trials in the following groups. If any apply to you, discuss with your doctor before starting treatment:

• Patients who have not previously failed antidepressant medication.
• Patients who cannot tolerate withdrawal of antidepressant medications.
• Patients currently taking antidepressant medications.
• Patients with a suicide plan or recent suicide attempt.
• Patients younger than 22 or older than 68 years of age.
• Patients with a history of substance abuse, OCD (for MDD indication), or PTSD.
• Patients with psychotic disorders, including schizoaffective disorder, schizophrenia, bipolar disorder, or major depression with psychotic features.
• Patients with neurological conditions such as epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, severe or repetitive head trauma, or CNS tumors.
• Patients who have failed to respond to ECT or VNS.
• Patients who are pregnant or nursing.

Hearing Protection

The Deep TMS device emits a loud clicking sound during treatment. Patients are required to wear earplugs rated for at least 30 dB of noise reduction. With proper earplug use, no hearing loss has been reported in clinical studies.

Common Side Effects

The most commonly reported side effects with Brainsway Deep TMS are:

• Application site pain or discomfort — reported in 25–29% of treated patients in clinical studies. This usually decreases or resolves with successive treatments. The Deep TMS helmet can be slightly adjusted to relieve discomfort.
• Jaw pain — reported in approximately 10% of patients.
• Headaches — reported in 47% of patients (and 36% of sham/placebo patients), suggesting they are not always caused by the treatment itself. Headaches typically improve with successive sessions and can usually be relieved with over-the-counter pain medications such as acetaminophen.
• Other possible side effects: muscle twitching, back pain, anxiety, or insomnia.

Systemic side effects often associated with antidepressant medications — such as weight gain, dry mouth, or sexual side effects — were not observed in Deep TMS clinical trials. Tests of memory function showed no change during treatment.

Long-Term Safety

The long-term safety of Brainsway Deep TMS has been demonstrated through 16 weeks of ongoing treatment with no negative effects observed during a 3-month follow-up period. The magnetic field strength used is comparable to that of MRI scanners, which are not associated with significant short- or long-term safety concerns.

For complete prescribing information, visit brainsway.com/safety-information.

SPRAVATO^® (Esketamine) Nasal Spray — Important Safety Information

SPRAVATO^® can cause serious side effects, including:

Sedation, Dissociation, and Respiratory Depression

SPRAVATO^® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space, and time (dissociation). It may also cause breathing problems (respiratory depression and respiratory arrest).

• Tell your healthcare provider right away if you feel like you cannot stay awake or feel like you are going to pass out.
• Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO^®. Your provider will decide when you are ready to leave our office.

Abuse and Misuse

There is a risk for abuse and misuse with SPRAVATO^®, which may lead to physical and psychological dependence. Your healthcare provider will check you for signs of abuse, misuse, and dependence before and during treatment. Tell your provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

SPRAVATO^® Risk Evaluation and Mitigation Strategy (REMS)

Because of the risks for sedation, dissociation, respiratory depression, and abuse and misuse, SPRAVATO^® is only available through a restricted program called the SPRAVATO^® REMS Program. SPRAVATO^® can only be administered at certified healthcare settings. Bright Horizons Psychiatry is a SPRAVATO^® REMS-certified treatment site, and patients must be enrolled in the program to receive treatment.

Increased Risk of Suicidal Thoughts and Actions

Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. SPRAVATO^® is not for use in children. People with (or with a family history of) depression or a history of suicidal thoughts or actions may have a higher risk.

How to Watch for Suicidal Thoughts and Actions

• Pay close attention to any changes — especially sudden changes — in mood, behavior, thoughts, or feelings, or if suicidal thoughts develop.
• Tell your healthcare provider right away about any new or sudden changes.
• Keep all follow-up visits as scheduled. Call your provider between visits if you have concerns.

Tell your provider or get emergency help right away if you or a family member has any of the following symptoms — especially if they are new, worse, or worry you:

• Thoughts about suicide or dying
• New or worse depression
• Feeling very agitated or restless
• Trouble sleeping (insomnia)
• Acting aggressive, angry, or violent
• An extreme increase in activity and talking (mania)
• Suicide attempts
• New or worse anxiety
• Panic attacks
• New or worse irritability
• Acting on dangerous impulses
• Other unusual changes in behavior or mood

Do Not Take SPRAVATO^® If You:

• Have blood vessel (aneurysmal vascular) disease — including in the brain, chest, abdominal aorta, arms, and legs
• Have an abnormal connection between your veins and arteries (arteriovenous malformation)
• Have a history of bleeding in the brain
• Are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO^®

If you are not sure whether any of these conditions apply to you, talk to your healthcare provider before taking SPRAVATO^®.

Before Taking SPRAVATO^®, Tell Your Provider About:

Heart or brain conditions, including:

• High blood pressure (hypertension)
• Slow or fast heartbeats causing shortness of breath, chest pain, lightheadedness, or fainting
• History of heart attack or stroke
• Heart valve disease or heart failure
• History of brain injury or any condition with increased pressure in the brain

Other conditions:

• Liver problems
• History of psychosis (seeing, feeling, or hearing things that are not there, or believing things that are not true)
• Pregnancy: SPRAVATO^® may harm your unborn baby. You should not take SPRAVATO^® if you are pregnant. Tell your provider right away if you become pregnant during treatment. Talk to your provider about pregnancy prevention if you are able to become pregnant. There is a pregnancy registry for women exposed to SPRAVATO^® during pregnancy — call 1-844-405-6185 or visit womensmentalhealth.org.
• Breastfeeding: SPRAVATO^® passes into breast milk. You should not breastfeed during treatment.

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially mention central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs).

How You Will Take SPRAVATO^®

• You will self-administer the SPRAVATO^® nasal spray under the supervision of a healthcare provider in our office.
• Your provider will show you how to use the device and tell you how much to take and when.
• Follow your treatment schedule exactly as prescribed.
• You will be monitored during and after each dose. Your provider will decide when you are ready to leave.
• You must arrange for a caregiver or family member to drive you home after treatment — you cannot drive yourself.
• Do not eat for at least 2 hours before treatment, and do not drink liquids for at least 30 minutes before treatment, to reduce the risk of nausea and vomiting.
• If you take a nasal corticosteroid or nasal decongestant, take it at least 1 hour before SPRAVATO^®.

What to Avoid While Taking SPRAVATO^®

Do not drive, operate machinery, or do anything requiring full alertness after taking SPRAVATO^®. Wait until the next day, after a restful night’s sleep, before resuming these activities.

Other Possible Serious Side Effects

• Increased blood pressure — SPRAVATO^® can cause a temporary blood pressure increase lasting about 4 hours. Your provider will check your blood pressure before and for at least 2 hours after each dose. Tell your provider right away if you experience chest pain, shortness of breath, sudden severe headache, vision changes, or seizures.
• Problems thinking clearly — Tell your provider if you notice issues with thinking or memory.
• Bladder problems — Tell your provider if you develop frequent or urgent urination, painful urination, or frequent nighttime urination.

Most Common Side Effects of SPRAVATO^®

The most commonly reported side effects include:

• Feeling disconnected from yourself, your thoughts, feelings, or surroundings
• Dizziness
• Nausea
• Feeling sleepy
• Spinning sensation
• Decreased feeling of sensitivity (numbness)
• Feeling anxious
• Lack of energy
• Increased blood pressure
• Vomiting
• Feeling drunk
• Headache
• Feeling very happy or excited

These side effects usually occur right after taking SPRAVATO^® and resolve the same day. These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to Johnson & Johnson at 1-800-526-7736 or to the FDA at 1-800-FDA-1088.

The information on this page is for educational purposes only and does not replace medical advice from a qualified healthcare provider. Both Brainsway Deep TMS and SPRAVATO^® are available by prescription only. Individual patient results may vary. For full prescribing information, please consult your provider or visit the manufacturer’s official website.