Spakinect completes GFEs for the FDA approved brand name Zepbound only.
We DO NOT prescribe any medications and will not be prescribing Zepbound, the prescription will need to come from the on-site medical director/prescriber.
Tirzepatide = Generic name for Zepbound, which is a prescription drug manufactured by eli lilly. Zepbound is approved for weight loss. (Other brands of the drug or generic compounds do not have this FDA indication)
Clients will need standing orders/protocols from their medical directors to utilize ANY form of Zepbound, but if they plan to use a generic, compounded, or other brand of the drug this should be outlined in their SOPs.
Spakinect recommends that the patient be monitored throughout the entire process.
Zepbound FAQs:
What is Zepbound?
Zepbound® (Tirzepatide) injection is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of ≥30 kg/m2 (obesity) or ≥27 kg/m2 (overweight) in the presence of at least 1 weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia).
Can we add generic Tirzepatide or Mounjaro as a treatment?
Great question! Currently our providers are completing GFEs for weight loss utilizing the FDA approved Zepbound (Tirzepatide). While our clearance is for the brand name of this drug, if you plan to use generic substitutes or compounded substances, you would need to ensure that your medical director is aware of this and has policies or standing orders that allow for this. Unfortunately we are not able to complete an evaluation for generic Tirzepatide and/or Mounjaro, since Spakinect evaluates for FDA approved products/treatments and are unable to validate the ingredients from medications that come from a compounded pharmacy. All off label use or use of other brands and/or compounded substances should also be established by your MD through your medical spas standard operating procedures.
Why not generic Tirzepatide?
We are unable to guarantee the exact ingredients and dosages if the medication is obtained from a compounding pharmacy. All off label use or use of other brands and/or compounded substances should also be established by your MD through your medical spas SOPs.
Why not Mounjaro?
Currently, Mounjaro is indicated for treatment of type II Diabetes. While it does also aid in weight loss, and the ingredients are the same as Zepbound, it is not FDA approved for this indication of weight loss. Since our clearance is for Zepbound, If you decide to substitute this for a different brand this needs to be established in a policy by your spa’s medical director.
Will you ever add generic Tirzepatide?
Currently we provide approval for the brand name of the medication Zepbound (Tirzepatide) specifically, as it is FDA approved as a weight loss treatment.Unfortunately, because we are unable to guarantee the exact ingredients and dosages of generic or compounded Tirzepatide, we will not likely be adding this to our database. However, please check with your respective state medical board about best practices for generic substitutes. We recommend that all off label use or use of other brands and/or compounded substances should be established by your MD through your medical spas’ policies and protocols.
Why do we need to verify Height/Weight/BMI?
OPTION 1: While our providers will ask patients for a weight and calculate a BMI during the visit, all required ongoing monitoring including blood work and BMI verification should also be facilitated by your onsite MD or Medical Director through your established protocols and policies.
OPTION 2: Since this is an FDA approved weight loss treatment it is important to obtain and document an accurate starting BMI as well as to monitor throughout the course of the treatment to ensure patient safety. Each of our Zepbound approvals are conditional upon the weight being verified on site prior to, and throughout, the duration of treatment.
Can you prescribe Zepbound and/or how do we prescribe it?
At this time Spakinect does not prescribe any medications, so the prescription will come for your own MD. Any medication’s administration instructions, dose, frequency and route will need to be specified and documented in your clinic’s protocols/SOPs by your MD or Medical director.
Do I need to do a GFE everytime a patient wants a Zepbound injection?
Our evaluations for Zepbound (Tirzepatide) GFE approval are valid within 12 months of the timestamp documented on the GFE. Should there be any changes in the patient's clinical status within the 12 month timeframe, the GFE is null and void and a new GFE must be completed prior to administration of the requested medication. This can be found in the treatment plan for Zepbound.
I am implementing this in my medical spa. Can you provide guidance on what medical screening should be occurring?
All information about prescribing including dosages, administration frequencies, and route, should be established by your MD. Recommend they contact their Zepbound rep and reference the full prescribing information.
Does Spakinect help patients get approved for Zepbound by their insurances?
If a patient would like to get Zepbound approved by insurance, they need to provide documentation from their primary care physician with the necessary ICD-10 diagnosis codes for insurance approval, which should be managed either by the physician responsible for the monitoring of the patient or by their PCP.
What is involved in the Zepbound screening process?
The Zepbound screening process involves a thorough examination by healthcare providers, including a review of the individual's medical history, current medications, and contraindications to treatment, as well as calculation of Body Mass Index (BMI). The specifics of the monitoring required during the screening process may vary based on the physician who is responsible for monitoring the patient's progress throughout their treatment with Zepbound. Additionally, the full prescribing information for Zepbound can be found on their website, and patients can also contact the Zepbound drug representative for further information and support.
Any other questions regarding Zepbound or any of our other treatments we clear for please send and email to clincialsupport@spakinect.com to get in touch with our clinical department.
Medication GFE Duration Reference *Please note Spakinect providers do not prescribe medications, all medication prescriptions should be written by the medical spa/clinic staff as indicated.* ACUTE WELLNESS/AESTHETIC MEDICATIONS GFE Duration Decadron ...