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INDICATION
PRIALT is a prescription medicine used to treat severe chronic pain in adults who cannot take other treatments or when other treatments do not work, stop working, or cause bothersome side effects. PRIALT can only be delivered by or under the direction of a doctor who injects the medicine into your spinal fluid through a special device (a procedure called intrathecal infusion) and should only be used in patients who are appropriate for the procedure.
Patient spotlight
INDICATION
PRIALT is a prescription medicine used to treat severe chronic pain in adults who cannot take other treatments or when other treatments do not work, stop working, or cause bothersome side effects. PRIALT can only be delivered by or under the direction of a doctor who injects the medicine into your spinal fluid through a special device (a procedure called intrathecal infusion) and should only be used in patients who are appropriate for the procedure.
Patient spotlight
Hear from real PRIALT patients
David and Nicole both suffer from severe chronic pain. Listen to their experiences with PRIALT and how it worked for them.
David – Severe chronic pain due to cancer
[Intro music fades in, then fades softly into background]
[Onscreen: David standing by a bookshelf]
[Onscreen text: TerSera Therapeutics logo | David Garrett, PhD Speech-Language Pathology, Texas]
DAVID:
I am Dr. David Garrett. I'm a retired professor of medical speech pathology
[Onscreen text: David Garrett, PhD | Texas]
[Onscreen: David standing with a man and a woman]
[Onscreen text: What type of severe chronic pain do you suffer from?]
DAVID:
Three years ago, I started having some very severe pains in the upper abdomen, which is just right underneath the rib cage here, but also in the back, as if I had some kind of a back muscle problem or something like that, and those pains would alternate, and they were getting worse and worse. And so, I went into my regular physician, and he ran a bunch of tests and everything, and we were trying to figure out what was wrong. And so he was ruling out things left and right and up and down, up and down, and then we did some hardcore scanning. He called me back that evening and he said, "I'm sorry." He said, "We have found a mass on your pancreas." And I said, "So are we talking about potentially cancer?" And he said, "Yes."
[Onscreen: David standing in front of a fountain with a woman]
[Onscreen text: How long have you lived with severe chronic pain?]
DAVID:
I've been here three years, and I've been doing really well with that, the chemotherapy and radiation, and I had a clinical trial where they were injecting little capsules into my tumor. All of those things were taking care of the cancer component. The component that really wasn't getting taken care of was the pain.
[Onscreen: David riding a horse]
[Onscreen text: How has severe chronic pain impacted your life?]
DAVID:
It has impacted me a lot. What ends up happening oftentimes is that pain seems to, at least for me, it tended to kind of overcome things, and it kind of pushed my energy down, my energy level down, and my feelings about things down. There were points along this journey where the pain itself was becoming the thing for me. In other words, the doctors were take...with chemo and all these other things, were taking care of the medical stuff. And so I knew that stuff is being taken care of, but the main thing that wasn't being fixed was that severe chronic pain, and having it just hurt all the time.
[Onscreen text: David Garrett, PhD | Texas]
DAVID:
And so, it makes it difficult when most of the night you're hurting, and then you wake up in the morning and you're still hurting, and then maybe you'll have a couple hours that are good, and then you go back to hurting again. Then one of the things that happens is that the pain, as the pain level goes up, then you have a choice of, "I'm going to take more pain medication and help put that pain level down," or, "I'm just going to hurt worse."
[Onscreen: David walking with his horse]
[Onscreen text: What treatments have you used to manage your severe chronic pain?]
DAVID:
I was able to go to a pain clinic, and they were able to take me through most common things, and common medications that are used to reduce pain. They took me through a series of different pain medications, and what ends up happening is that they will give you a particular pain medication, they try it for a while, and see what effects it has. You go back to them, let them know what's happened, and then they make adjustments based on that.
DAVID:
We did go through that process in a number of ways, tried a whole bunch of different medications, and everything. Finally found something that was working, but as the tumor got bigger, and the pain got stronger, the chronic pain got worse, and worse, and worse. I was either increasing the amount of the pain medications, or I was just suffering more, and I just had to choose day by day, "Do I want to suffer more today, or do I want to go ahead and take medications?" And so, I talked to them about, "Is there anything else?" And they said, "Well, we do have a thing that's called a pain pump."
[Onscreen text: David Garrett, PhD | Texas]
[Music fades out.]
End of transcript.
[Intro music fades in, then fades softly into background]
[Onscreen: Nicole standing in front of a body of water]
[Onscreen text: TerSera Therapeutics logo | Nicole Chiarella, New York | What type of severe chronic pain do you suffer from?]
NICOLE:
In 2001, I was involved in a motor vehicle accident in the course of my duties as a police officer. And as a result of that, I sustained a neck and shoulder injury. The chronic pain became severe where I was having full body nerve pain. It started with pain in my neck and right shoulder, and then the pain became more severe on my right arm and my right leg, and the nerve pain mirrored on the left side. And because of that, it impacted my life, whereas I was unable to do the regular activities that I was normally able to do prior to the injury.
[Onscreen: Nicole in police uniform]
[Onscreen text: How long have you lived with severe chronic pain?]
NICOLE:
The initial injury was in 2001, and I have been diagnosed with complex regional pain syndrome in 2010, but I've suffered since 2001. In 2009, I had to have shoulder surgery, and as a result of that, the pain became a lot worse. It was full body nerve pain. It started on my right side, my right arm into my right leg, and then it mirrored onto the left side of my body. I had to see several doctors, tried conventional methods of pain relief with absolutely no positive results. The doctors really could not figure out what was wrong with me. It was more of where is this pain coming from and why is she having it? And, as a result of that, it took several years for me to find the appropriate doctors to diagnose me with complex regional pain syndrome.
[Onscreen text: Nicole Chiarella | New York]
[Onscreen: Nicole in a hospital gown holding a walker]
[Onscreen text: How has severe chronic pain impacted your life?]
NICOLE:
Because of the chronic pain, my life basically went from being an active police officer, being able to take my children places to do things with them and be an avid person to exercise, it got to the point where I couldn't even do household chores. I was unable to assist my children.
[Onscreen: Nicole sitting in a wheelchair | Nicole asleep in hospital bed]
NICOLE:
So basically, my life as I knew it completely came to a standstill, and it was because the pain was so severe. The basic things that I used to take for granted became very difficult for me to even function, and I was unable to cook. I was unable to clean. I had difficulty bathing myself. It got to the point where it was so excruciating that I felt as though I did not know what to do with my life because something that was a basic thing that I would do every day turned into something I couldn't do.
[On screen: Nicole awake in hospital bed]
[Onscreen text: What treatments have you used to manage your severe chronic pain?]
NICOLE:
Some of the treatments that I used were narcotics prescribed by a pain management doctor, injections in my spine along with physical therapy and chiropractor treatment. When those were not effective for me, I went and had a spinal cord stimulator implanted.
[Onscreen text: Nicole Chiarella | New York]
[Soft music fades out]
End of transcript.
[Intro music fades in, then fades softly into background]
[Onscreen: David standing by a bookshelf] [Onscreen text: TerSera Therapeutics logo | PRIALT logo]
[Onscreen VO text: INDICATION: PRIALT is a prescription medicine used to treat severe chronic pain in adults who cannot take other treatments or when other treatments do not work, stop working, or cause bothersome side effects. PRIALT can only be delivered by or under the direction of a doctor who injects the medicine into your spinal fluid through a special device (a procedure called intrathecal infusion) and should only be used in patients who are appropriate for the procedure.
IMPORTANT SAFETY INFORMATION
PRIALT may cause serious side effects including psychiatric (mental) symptoms and problems thinking (confusion, memory problems, speech difficulties). The doctor should be called immediately if, while taking PRIALT, you are confused or disoriented, are less alert, see or hear things that are not real (hallucinations), have changes in mood or consciousness. Your doctor may stop your treatment with PRIALT, give you other medicines, or require you to be hospitalized if you experience any of these symptoms.]
[Onscreen text: David Garrett, PhD Speech-Language Pathology, Texas]
DAVID:
I'm Dr. David Garrett. I'm a retired professor of medical speech pathology.
[Onscreen: David standing with a man and a woman]
[Onscreen text: What led you and your healthcare provider to decide to start PRIALT?]
DAVID:
We spent a lot of time talking about the PRIALT that it's a good option and they said, but recognize, it's possible it could not work, but if you can compare what do you have now to what is it likely if the PRIALT actually works? And so we talked a fair amount about that. I really liked that there was no narcotic that was in the pump or me having to take all the narcotics and stuff.
I loved the idea of taking the PRIALT and having that part be my pain medication. I want to encourage you to spend fair amount of time with your physician talking over those issues because they can go through and talk about, well, this is how it would work and here's how it may not work. And they can go through all those specifics from a medical standpoint so that you have the real true picture. And so that may be step one if you haven't already done it, is really get with a physician who knows these things and is able to talk you through them and give you really good advice.
[Onscreen text: David Garrett, PhD | Texas]
[Onscreen: David and his wife]
[Onscreen VO text: You should not be given PRIALT if you: are allergic to PRIALT or any of its ingredients; have a condition or are receiving a treatment that would cause an injection in your spinal fluid to be unsafe; have or had a mental illness called psychosis (a loss of contact with reality, usually including delusions (false beliefs about what is taking place or who one is) or hallucinations (seeing or hearing things that aren't real))]
[Onscreen: David in a kayak]
[Onscreen VO text: PRIALT may cause or worsen depression, which increases the risk of suicide. People 65 years of age and older have a higher risk for confusion with PRIALT. Taking certain other medicines along with PRIALT may raise the risk of having problems with thinking or alertness. Tell your doctor about all the medicines you are taking.]
[Onscreen text: Describe your experience starting PRIALT]
DAVID:
When we got the pump implanted, my physician told me that pain isn't like a pill that you can pop and it's all done and everything's good. So what you have to do is you have to figure it out over a particular time period. So what they did is they started with a small amount of dosage and they put that in the system. We would go a few days and then they would check with me and we would talk about how is that affecting it, is it improving it? And they would ask me all these medical questions and then they would make decisions on what the next stage was. And by doing that, what they did is that they were able to slowly increase so that we had the minimum amount of medication needed to actually get what we needed, which is the reduction of the pain.
DAVID:
It may take several weeks for you to go through that process of being able to say, okay, we're going to increase at this level. We're going to increase at this level. We're going to increase it and to get to exactly where you need to be. And they may go up and down and that kind of thing, but they will walk you through the process. Any advice I have, it's talk to your doctor. Tell them what's happening, make sure and be verbal with them. So it hurts worse, tell them. It hurts better, tell them.
[Onscreen: David and his horse]
[Onscreen VO text: PRIALT is a non-opioid and non-NSAID analgesic agent used for the management of severe and chronic pain. Administer PRIALT intrathecally by or under the direction of a physician experienced in the technique of intrathecal administration and who is familiar with the drug and device labeling. PRIALT is not for intravenous administration. PRIALT is delivered using a programmable implanted variable rate microinfusion device or an external microinfusion device and catheter. PRIALT 25 mcg/mL is used undiluted, the 100 mcg/mL formulation must be used diluted until an appropriate dose has been established. Saline solutions containing preservatives must not be used.]
[Onscreen: David and his wife]
[Onscreen VO text: Refrigerate but do not freeze all PRIALT solutions after preparation. Begin infusion within 24 hours. Initiate PRIALT at no more than 2.4 mcg/day (0.1 mcg/hr) and titrated to patient response. Doses may be titrated upward by up to 2.4 mcg/day (0.1 mcg/hr) at intervals of no more than two to three times per week, up to a recommended maximum of 19.2 mcg/day (0.8 mcg/hr) by day 21.]
[Onscreen: David in a cowboy hat]
[Onscreen VO text: Meningitis (inflammation of the protective membranes covering the brain and spinal cord) or other infections can happen if the infusion device becomes contaminated. Tell your doctor right away if you have fever, headache, stiff neck, changes in mental status (feeling tired, confused, disoriented), nausea, vomiting, and/or seizures as these may be symptoms of developing meningitis.]
[Onscreen text: How is PRIALT working to manage your severe chronic pain?]
DAVID:
For me, it's been a very positive experience that even in the early titration phase, when they added just a little bit of medication, my pain level went down. As they went through the titration phase, they got closer and closer to what my body needs. Having that pain reduction was probably one of the biggest struggles that we were having. So we had the medical struggle, but we felt like, okay, the doctors are taking care of that with the chemo and this and that and all that stuff. But the biggest struggle we were having was dealing with that pain. What we found was that the PRIALT has really been a very positive experience for us in reducing that amount of pain.
[Onscreen text: David Garrett, PhD | Texas]
[Onscreen: David and his wife]
[Onscreen VO text: PRIALT may cause unconsciousness or reduced mental alertness. Avoid activities where you need to be alert, awake, and have full control of your body (activities like operating machinery or driving a car) during treatment with PRIALT.]
[Onscreen text: How has the relief from severe chronic pain that PRIALT provides impacted you?]
DAVID:
It has really helped things and it feels better when that pain goes down to be able to say, okay, now I can get up and I can think about those things, or I can do those things. So even just simple things of getting out of bed, of doing light stuff around the house, I'm going to do the dishes or things like that. Even small tasks like that change and make it much easier when the pain level seems to go down. For me, it has had a very positive effect.
[Onscreen text: PRIALT may not work for everyone. Ask your doctor if PRIALT is right for you.]
[Onscreen: David and his horse]
[Onscreen VO text: Tell the doctor if you experience new or worsening muscle pain, soreness, weakness or if your urine is dark in color as this could be a sign of rare but serious muscle side effects. You should also tell the doctor if you are pregnant, plan to become pregnant or if you are breastfeeding.]
[Onscreen: David and his wife]
[Onscreen text: What advice would you give to somebody starting on PRIALT?]
DAVID:
Probably the biggest advice I can give you is to learn as much as you can from the means that you can. So from looking at this website, listening to these testimonials, but then most important is to find a physician who's a specialist in this area and to talk with them. They can go through all the pros and cons and how it would affect you and whether you'd be a good candidate or not. You can ask them the questions. And so in a very short order, you can find out many of the things that you weren't sure about and can really work through, is this a good decision for me?
[Onscreen text: David Garrett, PhD | Texas]
[Onscreen: David standing in front of a bookshelf]
[Onscreen VO text: The most common side effects of PRIALT include dizziness, nausea, confusion, and uncontrolled eye movements. These are not all the possible side effects of PRIALT. Talk to your doctor about any side effects you may be experiencing.]
[Onscreen: PRIALT logo]
[Music fades out.]
End of transcript.
[Intro music fades in, then fades softly into background]
[Onscreen: Nicole standing in front of a body of water]
[Onscreen text: TerSera Therapeutics logo | PRIALT logo | Nicole Chiarella, New York | What led you and your healthcare provider to decide to start PRIALT?]
NICOLE:
What led to my healthcare provider and myself to decide to use PRIALT was that all the other methods were not effective for my pain, the severity that I was having in my pain. So we found a physician out of state that specifically dealt with PRIALT and intrathecal pain pumps, so I flew down to visit with that doctor. I spent a week there, went through a battery of tests, and we determined that PRIALT may be best suited for the condition and the pain that I was having. And at that point we found a neurosurgeon that would be able to continue that in New York and also with my neurologist to handle the pain management portion of the aftereffects of the surgery along with the PRIALT medication.
[Onscreen text: Nicole Chiarella, New York]
[Onscreen: Nicole in police uniform]
[Onscreen VO text: Indication. PRIALT is a prescription medicine used to treat severe chronic pain in adults who cannot take other treatments or when other treatments do not work, stop working, or cause bothersome side effects. PRIALT can only be delivered by or under the direction of a doctor who injects the medicine into your spinal fluid through a special device (a procedure called intrathecal infusion) and should only be used in patients who are appropriate for the procedure.
IMPORTANT SAFETY INFORMATION. PRIALT may cause serious side effects including psychiatric (mental) symptoms and problems thinking (confusion, memory problems, speech difficulties). The doctor should be called immediately if, while taking PRIALT, you are confused or disoriented, are less alert, see or hear things that are not real (hallucinations), have changes in mood or consciousness. Your doctor may stop your treatment with PRIALT, give you other medicines, or require you to be hospitalized if you experience any of these symptoms.]
[Onscreen: Nicole in police uniform]
[Onscreen VO text: You should not be given PRIALT if you: are allergic to PRIALT or any of its ingredients; have a condition or are receiving a treatment that would cause an injection in your spinal fluid to be unsafe; have or had a mental illness called psychosis (a loss of contact with reality, usually including delusions (false beliefs about what is taking place or who one is) or hallucinations (seeing or hearing things that aren't real))
PRIALT may cause or worsen depression, which increases the risk of suicide. People 65 years of age and older have a higher risk for confusion with PRIALT. Taking certain other medicines along with PRIALT may raise the risk of having problems with thinking or alertness. Tell your doctor about all the medicines you are taking.]
[Onscreen text: Describe your experience during the dosing and titration process of PRIALT]
NICOLE:
The expectations for the intrathecal pain pump and the medication, PRIALT, was that I was going to have an improvement on my condition from the pain that I was experiencing.
[Onscreen: Nicole smiling in a hospital bed]
[Onscreen text: Describe your experience during the dosing and titration process of PRIALT]
NICOLE:
My doctor and I discussed the dosage and we decided to use a higher dosage because of the severity of my pain. I was using the PRIALT and also other medications along with it, and I experienced side effects. Once I removed those other medications from my system along with lowering the dosage of PRIALT, the side effects subsided.
[Onscreen text: Nicole Chiarella | New York]
[Onscreen: Nicole standing on a dock]
[Onscreen VO text: Meningitis (inflammation of the protective membranes covering the brain and spinal cord) or other infections can happen if the infusion device becomes contaminated. Tell your doctor right away if you have fever, headache, stiff neck, changes in mental status (feeling tired, confused, disoriented), nausea, vomiting, and/or seizures as these may be symptoms of developing meningitis.]
[Onscreen text: How has the relief from severe chronic pain that PRIALT provides impacted your life?]
NICOLE:
The relief that PRIALT has provided me once I had the correct dosage and I removed all the other medications from my system, I noticed a significant improvement. I spoke with my physician about starting to be able to do some light exercises and he agreed that that would be okay.
[Onscreen: Nicole standing in a boot store]
[Onscreen VO text: PRIALT may cause unconsciousness or reduced mental alertness. Avoid activities where you need to be alert, awake, and have full control of your body (activities like operating machinery or driving a car) during treatment with PRIALT.]
[Onscreen text: What advice would you give to somebody starting on PRIALT?]
NICOLE:
My advice for anyone that is considering PRIALT is first to discuss with your physician.
[Onscreen: Nicole standing at a formal event]
[Onscreen VO text: Tell the doctor if you experience new or worsening muscle pain, soreness, weakness or if your urine is dark in color as this could be a sign of rare but serious muscle side effects. You should also tell the doctor if you are pregnant, plan to become pregnant or if you are breastfeeding.]
NICOLE:
Give the medication a chance to work. For me, I did give the medication a chance and I did discuss with my doctor how my body was responding to it. And once I did that, I noticed a significant change in my pain.
[Onscreen text: Nicole Chiarella | New York]
[Onscreen: Nicole standing in front of a body of water]
[Onscreen VO text: The most common side effects of PRIALT include dizziness, nausea, confusion, and uncontrolled eye movements. These are not all the possible side effects of PRIALT. Talk to your doctor about any side effects you may be experiencing.]
[Onscreen text: PRIALT logo]
[Soft music fades out]
End of transcript.
