Xyosted Prefilled Autoinjector for Subcutaneous Testosterone Administration

Thread starter #1
Conclusion
Authentic needle and drug-containing devices were used in order to provide a realistic assessment of the potential for limitations of usability with the SCTE-AI device. Results of this usability validation study indicate the low potential for physical harm associated with use of the device. Results of the study indicate that there is residual risk of (i) not checking the expiration date and (ii) holding the device in place long enough to ensure a complete dose.

The SCTE-AI is intended for use in the at-home setting by the patient or a non-patient caregiver. It may also be used in hospitals, clinics, long-term care and home care settings on adult patients by health care professionals that includes nurses or home health care professionals who may assist patients to use the device in clinical care or home settings. Compared to trained participants, success rates were lower in untrained users who did not read the IFU (reading the IFU improved success rates). From a clinical perspective, these results suggest that it is ideal for each newly prescribed patient to be provided with a first-use in-office specific training on how to use the SCTE-AI. Subsequent to the first-use training, our results suggest a success rate >80% for patients or caregivers with use of the SCTE-AI with minimal use errors.

Overall, the testing in this study is regarded as successful in demonstrating the objective of minimizing the occurrence of preventable use errors. The SCTE-AI device is safe and intuitive to use; is associated with a high rate of injection success, regardless of prior training or experience; and provides patients with an alternative to IM/topical T formulations.
 

Attachments

Thread starter #2
AUTOINJECTOR1-s2.0-S1743609518312165-gr1_lrg.jpg

Figure 1. A, Diagram of the parts of the subcutaneous testosterone enanthate autoinjector device. Image obtained from the instructions for use. B, Subcutaneous testosterone enanthate autoinjector packaging for the 3 different testosterone enanthate dose levels (50, 75, and 100 mg).
 
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Thread starter #3
AUTOINJECTOR1-s2.0-S1743609518312165-gr2_lrg.jpg

Figure 2. A, Patient vs caregiver error and close call rates for the first and second injections. B, Experienced vs naïve error and close call rates for the first and second injections. C, Trained vs untrained use error and close call rates for the first and second injections.
 
Thread starter #4
AUTOINJECTOR1-s2.0-S1743609518312165-gr3_lrg.jpg
Figure 3. First and second injection hold times by study participants (% of total users). The majority of injection hold times were >10 seconds for each injection. The average user hold time for the first injection during the study was 10.42 ± 4.78 seconds, and the average hold time for the second injection was 10.27 ± 4.41 seconds.
 
Thread starter #5
AUTOINJECTOR1-s2.0-S1743609518312165-gr4_lrg.jpg

Figure 4. Use error and close call rates for untrained users (left) or trained users (right) who read the instructions for use vs users who did not read the instructions for use. Both left and right panels show first injections
 

Nelson Vergel

Founder, ExcelMale.com
#13
To be honest, I am very happy about the approval of this option. For the first time, doctors will be educated by pharma reps and CME classes about the fact that TRT can be prescribed as a subq injection. As insurance pre-authorization letters are becoming more prevalent, some doctors will opt to prescribe regular subcutaneous injections using insulin syringes.

This option starts a new conversation among doctors that take insurance.
 
#14
To be honest, I am very happy about the approval of this option. For the first time, doctors will be educated by pharma reps and CME classes about the fact that TRT can be prescribed as a subq injection. As insurance pre-authorization letters are becoming more prevalent, some doctors will opt to prescribe regular subcutaneous injections using insulin syringes.

This option starts a new conversation among doctors that take insurance.
Looking from this point of view you are right. But damn what a profit!!
 
Thread starter #15
To be honest, I am very happy about the approval of this option. For the first time, doctors will be educated by pharma reps and CME classes about the fact that TRT can be prescribed as a subq injection. As insurance pre-authorization letters are becoming more prevalent, some doctors will opt to prescribe regular subcutaneous injections using insulin syringes.

This option starts a new conversation among doctors that take insurance.

Great points and at least we have more studies and a lengthy one (52 weeks) to prove the effectiveness of sub-q injections for trt as many doctors are still misinformed.
 
#16
I have been on the xyosted free option for 3 weeks. I really like it and feel better than the gel I was on before. Much more convenient and very easy to use. Problem though is insurance will not cover and as stated here before it is extremely expensive. Would love to know if others had endo's prescribe injections but allow you to inject subcutaneously without it being xyosted? My doctor said no to that with no real good explanation. Do most endo's not allow or advise on subconscious injections? Just looking to find a way to do this sub q with the insurance covering. Thanks in advance for any advice.
C
 

Nelson Vergel

Founder, ExcelMale.com
#17
I have been on the xyosted free option for 3 weeks. I really like it and feel better than the gel I was on before. Much more convenient and very easy to use. Problem though is insurance will not cover and as stated here before it is extremely expensive. Would love to know if others had endo's prescribe injections but allow you to inject subcutaneously without it being xyosted? My doctor said no to that with no real good explanation. Do most endo's not allow or advise on subconscious injections? Just looking to find a way to do this sub q with the insurance covering. Thanks in advance for any advice.
C
If your doctor said no, I would change doctors. That is so strange! You can get testosterone cheaply from Empower Pharmacy to inject subcutaneously. They also send syringes. I wonder why a doctor would say no. Relationship with pharma company?

You can also try to use a copay card

STEADYCare Support Program :: XYOSTED
 
#19
I received more of an explanation from my endo why he will not prescribe testosterone for sub q injection...he said the testosterone they use for IM injections is formatted differently than the used with sub q and xyosted injections? Is the testosterone for those who do sub q injections formatted differently than the testosterone for IM injections?
Thanks,
C
 

Nelson Vergel

Founder, ExcelMale.com
#20
I received more of an explanation from my endo why he will not prescribe testosterone for sub q injection...he said the testosterone they use for IM injections is formatted differently than the used with sub q and xyosted injections? Is the testosterone for those who do sub q injections formatted differently than the testosterone for IM injections?
Thanks,
C
Wow, I bet that is what he is hearing from pharmaceutical reps.
 
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