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ENSPRYNG patient support

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Injection Training Support
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Clinical Education Managers (CEMs)* can help with supplemental injection training and more

ENSPRYNG CEMs can provide personal support to patients prescribed ENSPRYNG and their caregivers from day one—all at no cost. After receiving initial training from their healthcare provider, patients can access resources to reinforce what they’ve learned. CEMs do not perform injections.

CEMs can provide your patients:

  • In-person or virtual educational sessions 
  • Resources and information about NMOSD
  • 1:1 support from our dedicated team of experts
  • Supplemental injection training support

Encourage your patients to schedule their first session with a CEM by calling 1-844-NSPRYNG.

 

*This program is intended primarily for patients prescribed ENSPRYNG who are in their first year of treatment. CEMs are Genentech employees and do not provide medical advice.

CEMs may provide supplemental education

The video below about ENSPRYNG administration demonstrates how CEMs may help ENSPRYNG patients through additional education.

Taking ENSPRYNG

View Transcript

Voice-Over:

The subject of this video is Taking ENSPRYNG. ENSPRYNG is a prescription medicine used to treat neuromyelitis optica spectrum disorder, also known as NMOSD, in adults who are aquaporin-4, also known AQP4, antibody positive. It is not known if ENSPRYNG is safe and effective in children.

ENSPRYNG may cause serious side effects including infections, increased liver enzymes, and low neutrophil counts. All required vaccinations should be completed before starting ENSPRYNG. Do not take ENSPRYNG if you are allergic to satralizumab-mwge or any of the ingredients in ENSPRYNG, have an active hepatitis B infection or have active or untreated inactive (latent) TB.

Please see Important Safety Information at the end of this video. If you have any questions, please talk to your healthcare provider or refer to the ENSPRYNG Prescribing Information and Medication Guide.

This video features a Clinical Education Manager and a real person who is treating her NMOSD with ENSPRYNG.

 

DONNA:

Hello. My name is Donna. I was diagnosed with AQP4 positive NMOSD in 2014. So if you were diagnosed with NMOSD, I know what you’re going through as you look to learn more about this rare disease and consider your treatment options. This is one video in a series. I wish I would have had these videos to turn to when I was first diagnosed.

I’m now going to introduce you to Annette who is a Clinical Education Manager, also known as a CEM. Their job is to provide supplemental injection training to patients who have been prescribed ENSPRYNG and to caregivers when needed.

 

ANNETTE:

Thanks, Donna. Hello there, my name is Annette. I am a CEM with Genentech. I provide supplemental injection training and refresher supplemental injection training to patients and their caregivers, provided of course your doctor says you can self-inject with ENSPRYNG. I have guided many patients through this process. If you have questions or need a refresher, a CEM like me is there to support you during every step of this process.

ENSPRYNG is a monthly self-injectable treatment you can take on the go. You have a voice in how you manage your NMOSD treatment. If your healthcare provider determines it’s appropriate and after proper training, you or your caregiver have the ability to give it in the comfort of your own home or even while traveling, since ENSPRYNG can be stored at room temperature for a total of up to eight days, which don’t need to be eight days in a row.

ENSPRYNG is an injection that is given under the skin once a month via prefilled syringe, which gives the treatment flexibility and control over where you take it. Before and while taking ENSPRYNG, your healthcare provider may order tests and monitor you to ensure ENSPRYNG is still appropriate for you. Now that we’ve spoken about how ENSPRYNG is administered, let’s examine a chart that explains the dosing schedule for ENSPRYNG.

ENSPRYNG is a treatment that is given every four weeks after taking three starting doses in the first month of treatment. Here’s how the starting doses work. For the first four weeks, you are given one dose every two weeks. After that, you take one dose every four weeks. Doses are administered in a prefilled syringe that contain 120 mg of medicine. If a starting dose is missed, you should take it immediately, then maintain the two-week dosing interval from your new starting date until the first three doses are complete and then continue with ongoing doses every four weeks.

If an ongoing dose is missed, you should take it immediately. Wait the four-week interval from your new starting date and then continue with ongoing doses every four weeks.

Of course, you should always consult with your healthcare provider when it comes to administering the treatment they prescribed for you. As a CEM, I am also available to help answer questions you may have about self-injecting with ENSPRYNG.

One common question I get is how to store and handle ENSPRYNG which is the subject of our next slide. Follow these simple rules when storing and handling ENSPRYNG. Store ENSPRYNG in your refrigerator in its original box.

That protects it from light. If needed, unopened ENSPRYNG, can be removed from and returned to your refrigerator prior to administering it. Never freeze or shake the syringe. If for some reason the ENSPRYNG has to be stored at room temperature like when traveling, the total combined time out of the refrigerator should not be more than eight days at a temperature that is higher than 86 degrees Fahrenheit or 30 degrees Celsius.

I hope the information I shared with you today about taking ENSPRYNG was useful. Self-injection with ENSPRYNG can give you the flexibility to take it at a location that’s convenient for you, provided your healthcare provider determines it is appropriate and you have been trained on the proper technique.

Remember, if you are ever unsure and/or need to go over any of these steps again, you can always reach out to your CEM or even your Patient Navigator by calling 1-844-NSPRYNG. If they can’t answer a question, they can always point you in the right direction. Thank you for your time.

Now, let’s go back and get a closing thought from Donna, our Patient Ambassador.

 

DONNA:

Thanks, Annette. Living with NMOSD has brought certain challenges. Putting eye makeup on is not easy nor is playing pickleball. I lacked depth perception so I have a hard time figuring out where the ball is in relation to my paddle.

My sister and I laughed about it until we cried but we had fun trying. Being able to laugh at myself and find joy in everyday life has really made living with NMOSD bearable. After working with my doctor, I’m comfortable self-injecting with ENSPRYNG. For me, it’s empowering. I hope you found this video informative and helpful. Check out all the other videos in the series relating to ENSPRYNG at www.ENSPRYNG.com.

They are a valuable resource you can view any time. You can even watch them more than once as a refresher. Thanks for listening. Stay tuned for additional Important Safety Information.

This video, led by a Clinical Education Manager, provides information about injecting ENSPRYNG and is available in English and Spanish.

Connect your patients with the NMOSD community

Get information or connect with others living with neuromyelitis optica spectrum disorder (NMOSD) through the following organizations†:

The Guthy-Jackson Charitable Foundation

The Sumaira Foundation

The Siegel Rare Neuroimmune Association

Connor B. Judge Foundation

National Organization for Rare Disorders (NORD)

National Institute of Neurological Disorders and Stroke
 

†By selecting any of these links, you will be visiting a site not controlled by or affiliated with Genentech, Inc. Genentech is neither affiliated with nor endorses any of these organizations. We do not make any representation or guarantee as to the accuracy of the information contained on sites we do not own or control. These links are provided for informational purposes only.

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Important Safety Information & Indication

Indication

ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Contraindications

ENSPRYNG is contraindicated in patients with a known hypersensitivity to satralizumab or any of the inactive ingredients, an active hepatitis B infection, or active or untreated latent tuberculosis.

Warnings and Precautions

Infections
An increased risk of infections, including serious and potentially fatal infections, has been observed in patients treated with IL-6 receptor antagonists, including ENSPRYNG. The most common infections reported in a randomized clinical trial of patients treated with ENSPRYNG who were not on other chronic immunosuppressant therapies, and that occurred more often than in patients receiving placebo, were nasopharyngitis (12%) and cellulitis (10%). The most common infections in patients who were on an additional concurrent immunosuppressant, and that occurred more often than in patients receiving placebo, were nasopharyngitis (31%), upper respiratory infection (19%), and pharyngitis (12%). Delay ENSPRYNG administration in patients with an active infection, including localized infections, until the infection is resolved.

Hepatitis B Virus (HBV) Reactivation
Risk of HBV reactivation has been observed with other immunosuppressant therapies. Patients with chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment with ENSPRYNG. Do not administer ENSPRYNG to patients with active hepatitis. For patients who are chronic carriers of HBV [HBsAg+] or are negative for HBsAg and positive for HB core antibody [HBcAb+], consult liver disease experts before starting and during treatment with ENSPRYNG.

Tuberculosis
Tuberculosis has occurred in patients treated with other IL-6 receptor antagonists. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating ENSPRYNG. Consider anti-tuberculosis therapy prior to initiation of ENSPRYNG in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment. Patients should be monitored for the development of signs and symptoms of tuberculosis with ENSPRYNG, even if initial tuberculosis testing is negative.

Vaccinations
Live or live-attenuated vaccines should not be given concurrently with ENSPRYNG because clinical safety has not been established. Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of ENSPRYNG for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of ENSPRYNG for non-live vaccines.

Elevated Liver Enzymes
Mild and moderate elevations of liver enzymes have been observed in patients treated with ENSPRYNG at a higher incidence than in patients receiving placebo. ALT and AST levels should be monitored every 4 weeks for the first 3 months of treatment, followed by every 3 months for one year, and thereafter, as clinically indicated.

Decreased Neutrophil Counts
Decreases in neutrophil counts were observed in patients treated with ENSPRYNG at a higher incidence than placebo. Neutrophil counts should be monitored 4 to 8 weeks after initiation of therapy, and thereafter at regular clinically determined intervals.

Hypersensitivity Reactions
Hypersensitivity reactions, including rash, urticaria, and fatal anaphylaxis, have occurred with other IL-6 receptor antagonists.

Use in Specific Populations

Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ENSPRYNG during pregnancy. Healthcare providers are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-833-277-9338.

There are no adequate data on the developmental risk associated with the use of ENSPRYNG in pregnant women. In an animal reproduction study, no adverse effects on maternal animals or fetal development were observed in pregnant monkeys and their offspring, with administration of ENSPRYNG at doses up to 50 mg/kg/week. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.


Lactation
No information is available on the presence of ENSPRYNG in human milk, the effects of ENSPRYNG on the breastfed infant, or the effects of ENSPRYNG on milk production. ENSPRYNG was excreted in the milk of lactating monkeys administered ENSPRYNG throughout pregnancy. Human IgG is excreted in human milk and the potential for absorption in the infant is unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ENSPRYNG and any potential adverse effects on the breastfed infant from ENSPRYNG or from the underlying maternal condition.

Pediatric Use
Safety and effectiveness in pediatric patients have not been established.

Geriatric Use
Clinical studies of ENSPRYNG did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. However, population pharmacokinetic analyses in patients with NMOSD did not show that age affected the pharmacokinetics of ENSPRYNG. In general, caution should be used when dosing the elderly, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy.

Most Common Adverse Reactions

The most common adverse reactions (≥15% in either trial) were nasopharyngitis (31%), headache (27%), upper respiratory tract infection (19%), rash (17%), arthralgia (17%), extremity pain (15%), gastritis (15%), fatigue (15%), and nausea (15%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

For additional safety information, please see the full Prescribing Information and Medication Guide.

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