Valtoco (diazepam nasal spray) is a prescription medicine for quick and effective treatment of seizure clusters, also known as acute repetitive seizures, in people with epilepsy. Seizure clusters are seizures that happen close together in time. These clusters are different from a person’s typical seizure pattern. You may also hear it called a seizure emergency. If a seizure cluster continues without treatment, it can lead to physical injury or a dangerous type of seizure called status epilepticus.
Valtoco is a seizure rescue medicine, which means you only use it during a seizure cluster, but not on a regular basis. Some seizure cluster treatments can be taken orally. But it may be difficult for a person to swallow a pill during a seizure cluster. Other forms of seizure rescue medicines include a rectal gel or a nasal spray.
Valtoco is a nasal spray designed to be easy to use outside of a medical setting. It provides a convenient alternative to rectal medicine for treating seizure emergencies.
How Does Valtoco Work for Seizure Clusters?
The active medicine in Valtoco is diazepam, which is a type of medicine called a benzodiazepine. Benzodiazepines work by boosting the effects of a natural chemical in your body called gamma-aminobutyric acid (GABA). GABA calms down the extra electrical activity in your brain that happens during a seizure.
Valtoco nasal spray is designed to make you get the right dose of medicine. When you have a seizure cluster, it is important for your seizure rescue medicine to start working right away. Getting Valtoco as a nasal spray allows the medicine to be absorbed quickly into your bloodstream through the lining in your nose.
Valtoco is an emergency medicine that should only be given as needed to treat a seizure cluster or seizure emergency. Unlike other anti-seizure medicines you take regularly, Valtoco should only be used when you need it for a seizure cluster. It is not a replacement for your other anti-seizure medicines.
How Do I Take It?
Valtoco is sprayed into one or both nostrils. It comes in different dosages: 5 milligrams, 10 milligrams, 15 milligrams, and 20 milligrams. Your health care provider will tell you the right dose of Valtoco to use based on your age and weight. The nasal spray delivers the entire dose when you activate it, so do not prime the nasal spray or attempt to reuse it.
The instructions that come with your medicine will show you or your caregiver how to use the nasal spray. It is important to use it as prescribed by your health care provider and follow these steps during a seizure emergency:
- Step 1: Prepare the nasal spray. Open the blister pack by peeling back the corner tab with the arrow. Take the nasal spray device out of the blister pack.
- Step 2: Hold the nasal spray device. Hold the nasal spray device with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle. Be careful not to press the plunger yet, because this will release the medicine too soon.
- Step 3: Place the tip of the nasal spray in the nostril. Place the tip of the nozzle into one nostril, making sure to insert it far enough that your fingers touch the bottom of the person’s nose.
- Step 4: Give the dose. Press the plunger firmly with your thumb to release the dose. The person does not need to breathe deeply when Valtoco is given. Remove the nasal spray device from the nose after giving Valtoco.
Depending on the dose the health care provider prescribed, you may need to use a second spray to get a full dose. Check the instructions carefully.
You may not be able to give yourself Valtoco, depending on your symptoms during a seizure cluster. Usually another person, such as a caregiver or family member, will give you Valtoco. It is important to plan ahead of time by making sure you and your caregivers read the instructions and understand how to use it. Make sure family members or caregivers know where you keep your Valtoco so they can give it to you during a seizure cluster if you are unable to do so. Ask your health care provider if you or your caregivers are not sure how to use Valtoco.
What Should I Do After I Give Valtoco to Someone Else?
After giving Valtoco to someone, stay with the person and watch them closely. Make a note of the time you gave them Valtoco.
Call for emergency medical help right away if any of the following happen.
- The person’s seizure behaviors are different from other episodes they have had before.
- You are alarmed by how often the seizures happen, by how severe the seizure is, or by how long the seizure lasts.
- You think the person may not be breathing normally or their color changes.
Should I Use a Second Dose?
Your health care provider may prescribe a second dose of Valtoco. If they prescribe a second dose, it will usually be given 4 hours after the first dose was given. But not everyone will be prescribed a second dose.
If you are a caregiver, do not give a person a second dose of Valtoco if any of the following happen.
- You are concerned about the person’s breathing.
- The person requires emergency medical care.
- The person becomes extremely sleepy after receiving Valtoco.
Ask a health care provider if you have any questions about using a second dose.
How Was It Studied as a Rescue Medicine for Seizures?
Valtoco was studied to see how well it works and how safe it is for treating people who had seizure clusters. Two clinical studies helped establish the efficacy of Valtoco nasal spray. The studies looked at how Valtoco compares to another form of diazepam that is given rectally. Efficacy was measured by the nature of the seizures, how often they happened, and how severe they were.
There were two studies. The people in the studies were given either diazepam rectal gel or a placebo (a dummy medicine that has no effect) when they had a seizure cluster. People in the studies did not know if they were getting diazepam or the placebo.
In the first study, 91 patients (47 children and 44 adults) were included. The group who received diazepam rectal gel after a seizure cluster had a longer average time before they had another seizure, compared to the group who got the placebo. Also, 62% of people in the study who were treated with diazepam rectal gel were seizure-free during the observation time afterward, which ranged from 12 to 24 hours, compared to 20% of the people who got the placebo.
The second study included 114 patients (53 children and 61 adults) who received medicine at the start of a seizure cluster. The people in the study were observed for 12 hours after they got a dose of diazepam rectal gel or a placebo. The group who received diazepam rectal gel had fewer seizures in the next 12 hours, compared to the group who got the placebo. The diazepam rectal gel group also had a longer average time before they had another seizure. Also, 55% of the people who received diazepam in the study were seizure-free during the 12-hour observation time afterward, compared to 34% of the people who got the placebo.
These studies showed that diazepam rectal gel makes seizures happen less often and helps prevent further seizures during an emergency. The effectiveness of Valtoco nasal spray is based on research demonstrating that the absorption of diazepam into the bloodstream is similar, whether the medicine is given as a nasal spray or rectal gel.
How Long Does It Take For It to Work?
Valtoco starts working within minutes because it is absorbed through the lining in your nose. It works more quickly than medicines you swallow. Most people will begin to see the effects soon after using it, which is important during a seizure emergency. It usually takes about an hour and a half (90 minutes) after using Valtoco before the highest level of medicine will be in your bloodstream, but you should notice improvement well before then.
What Are the Possible Side Effects, and How Can I Prevent or Manage Them?
Drowsiness is a common side effect of Valtoco caused by the way it works on the brain. After taking Valtoco, avoid activities that require you to be alert, such as driving a car. It is best to rest until the drowsiness passes.
Some side effects of Valtoco, such as drowsiness and breathing problems, can be made worse by drinking alcohol. Do not drink alcohol when you take Valtoco, and ask your health care provider before taking any new medicines.
Headaches and nasal discomfort are other common side effects of Valtoco. Tell your health care provider if you have any side effects that bother you.
While less common, Valtoco can cause serious side effects that require attention right away. Symptoms of a severe allergic reaction may include breathing problems; swelling of the face, lips, or throat; and severe itching or a rash. If you have any of these symptoms of an allergic reaction, seek medical help right away.
When some people take benzodiazepine medicines, including Valtoco, they may have new or worsening depression, unusual changes in mood, or thoughts about suicide or dying. Contact your health care provider right away if you notice these symptoms.
These are not all of the possible side effects of Valtoco. Talk with your health care provider if you are having symptoms that bother you. If you experience anything that you think may be caused by Valtoco, you can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
What Kinds of Drug Interactions May Happen?
Several medicines can interact with Valtoco, changing how well it works or increasing the risk of side effects. Your body processes and removes medicines through various enzymes and proteins. Some medicines can alter this process, either slowing down or speeding up how Valtoco is broken down or cleared from your body.
Taking Valtoco with opioid pain medicines, such as codeine, fentanyl, morphine, or oxycodone, can increase the risk of severe drowsiness, breathing problems, and other serious side effects. This happens because both opioids and Valtoco can make you feel very sleepy and slow down your breathing.
Using Valtoco with other medicines that cause dizziness and sleepiness, such as certain prescription pain medicines, sleep aids, and anxiety medicines, can make these side effects worse.
This is not a complete list of medicines that may interact with Valtoco. Always tell your health care provider about all the prescription and over-the-counter (OTC) medicines, vitamins, minerals, herbal products, and other supplements you are taking. This helps your health care provider find out if there are any interactions with Valtoco.
How Can I Get Valtoco?
Valtoco requires a prescription from a health care provider. Your neurologist or specialist who manages epilepsy and seizure disorders will usually be the health care provider who prescribes it. But your primary care provider may also prescribe it if they are managing your seizure treatment.
There is a savings card available from the drugmaker that may allow you to pay as little as $20 for your Valtoco prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at www.myNEURELIS.com or by calling 866-696-3873.
