Patient Informed Consent for Treatment
Weight-Loss Medications
Before you choose to use the services of the practitioner, you must read the following information fully and
carefully:
The main benefits may include:
1. Semaglutide (Semaglutide) is 94% similar to natural human GLP-1 and therefore acts as a
physiological regulator of appetite and thereby reducing food intake by reducing feelings of hunger
and increasing feelings of fullness/satiety.
2. Semaglutide is a newly licensed medication indicated for the treatment of type-2 diabetes. It is
currently undergoing clinical trial to gain a license for the treatment of obesity. In the meantime, your
medical practitioner may prescribe this medication for you 'off-label'
3. For long term success the treatment needs to be combined with lifestyle changes including
nutritional, exercise and behavioral habits.
4. Weight loss can lead to secondary benefits by improving weight loss related health problems
such as cardiovascular risk factors (including hypertension, blood glucose levels and waist
circumference) and physical health-related Quality of Life.
I understand that I have the right to be informed of the procedure, any feasible alternative options,
and the risks and benefits. Except in emergencies, procedures are not performed until I have had
an opportunity to receive such information and to give my informed consent.
Since every human being is unique, we cannot guarantee any specific result from Semaglutide
treatment. Medication and or medical conditions may have a negative impact on the outcomes as
well as lifestyle factors. Treatment should be discontinued after 12 weeks if the patient has not lost
at least 5% of their initial body weight.
Patients need to follow the instructions carefully as provided separately in the patient instruction
sheet. Patients must agree to notify their practitioner of any contraindications or side effects of the
treatment.
HEALTH CONCERNS: If you suffer from a medical or pathological condition, you need to consult
with an appropriate healthcare provider such as your GP or Consultant. If you are under the care of
another healthcare provider, it is important that you inform your other healthcare providers of your
use of Semaglutide. If you are using medications of any kind, you are required to alert us of.
Note: If you have any physical or emotional reaction to semaglutide treatment, discontinue use
immediately, and contact your PRACTITIONER to ascertain if the reaction is adverse or an
indication of the natural course of the body's adjustment to the treatment.
Laboratory testing may be done to any patient identified at risk to determine areas of
dysfunction, not to diagnose or treat. Potential blood tests:
1. Full blood count
Restore Medical Clinic, Inc. • Dr. Michael Woo-Ming, MD
1501 Westcliff Dr. Suite 303 • Newport Beach, CA 92660 • 949-209-8850
info@restoremedclinic.com • www.restoremedclinic.com
2. Liver function test
3. Kidney Function Tests
4. Cholesterol levels, HbA1c, Glucose
Patient groups who may require blood test monitoring at additional cost:
5.
6.
7.
8.
Age 50 or above
High blood pressure
Pre-Diabetics
Any significant medical problem
COMMUNICATION: Every client is an individual, and it is not possible to determine in advance
how your system will react to the treatment. It is sometimes necessary to adjust your program as
we proceed. It is your responsibility to do your part by following healthy dietary guidelines, exercise
your body and make necessary behavioural modifications.
1. Alternatives to Semaglutide therapy are surgical procedures, oral medical treatments
(including Orlistat) and / or dietary and lifestyle changes alone.
2. Several weeks to months of treatment may be required depending on your individual response.
3. If a missed dose is more than 5 days late, the missed dose should not be taken, and the
next dose should be taken at the normal time.
4. It is essential to combine eating, exercise and behavioural modifications with Semaglutide.
5. Semaglutide should not be used in combination with another GLP-1 receptor agonist, insulin or
insulin secretagogues (such as sulfonylureas) due to the risk of hypoglycaemia.
6. Upon initiation of Semaglutide treatment in patients on warfarin or other coumarin derivatives
more frequent monitoring of International Normalised Ratio (INR) is recommended.
7. Semaglutide causes a delay of gastric emptying and has the potential to impact the absorption
of concomitantly administered oral medications. Monitor for potential consequences of
delayed absorption of oral medications concomitantly administered with Semaglutide
8. There are several special warnings and precautions for use of Semaglutide including warnings
on pancreatitis, cholelithiasis and cholecystitis, thyroid disease, heart rate, dehydration
and hypoglycaemia in people with type 2 diabetes.
9. Thyroid adverse events, such as goitre have been reported in particular in patients with preexisting thyroid disease. Semaglutide should therefore be used with caution in patients with thyroid
disease.
10. A higher rate of cholelithiasis and cholecystitis (gallstone and gallbladder disease) has
been observed in patients treated with semaglutide. Cholelithiasis and cholecystitis may lead
to hospitalisation and cholecystectomy (surgery to remove the gallbladder Patients should be aware
of the characteristic symptoms of cholelithiasis and cholecystitis.
11. Signs and symptoms of dehydration, including renal impairment and acute renal failure, have
been reported in patients treated with Semaglutide. Patients treated with semaglutide should be
Restore Medical Clinic, Inc. • Dr. Michael Woo-Ming, MD
1501 Westcliff Dr. Suite 303 • Newport Beach, CA 92660 • 949-209-8850
info@restoremedclinic.com • www.restoremedclinic.com
advised of the potential risk of dehydration in relation to gastrointestinal side effects and take
precautions to avoid fluid depletion. Patients should also be aware of the symptoms of increased
heart rate.
12. Acute pancreatitis has been observed with the use of Semaglutide. Patients and their carers
should be told how to recognise signs and symptoms of acute pancreatitis and advised to seek
immediate medical attention if symptoms develop. If pancreatitis is suspected, semaglutide
should be discontinued; if acute pancreatitis is confirmed, semaglutide should not be restarted.
13. Semaglutide may cause dose-dependent and Itreatment-duration-dependent thyroid C-cell
tumours at clinically relevant exposures in both genders of rats and mice. It is unknown
whether Semaglutide causes thyroid C-cell tumours, including medullary thyroid carcinoma (cancer,
MTC), in humans, as the human relevance of semaglutide-induced rodent thyroid C-cell tumours
has not been determined. Patients should be aware of symptoms of thyroid tumours (such as a
mass in the neck, difficulty swallowing, difficulty breathing or shortness of breath, persistent
hoarseness
•
The most common semaglutide side effects are:
o Nausea
o constipation
o decresed appetite
o dizziness
o hypoglycemia
o vomiting
o dyspepsia
o abdominal pain
o diarrhea
o headache
o fatigue
o increaded lipase
Nausea is the most common side effect when first starting semaglutide, but decreases over time for
most people as their body gets used to the medicine. The dosing schedule is designed to reduce
the likelihood of gastrointestinal symptoms. Tell your health care professional if you have any side
effect that bothers you or that does not go away.
Risks of Semaglutide treatment include but not limited to:
a. Common or very common, reported in 5%: Dysgeusia (altered sense of taste), dry
mouth, insomnia, asthenia; burping; constipation; diarrhea; dizziness; dry mouth;
gallbladder disorders; gastrointestinal discomfort; gastrointestinal disorders; insomnia; nausea;
vomiting, hypoglycemia, dyspepsia, gastritis, gastro-esophageal reflux disease, flatulence,
eructation, upper abdomen pain, abdomen distension, cholelithiasis, injection site reactions,
fatigue, increased lipase and increased amylase.
b. Uncommon: Malaise; pancreatitis; tachycardia; urticaria
c. Rare: Renal impairment, allergic reaction, anaphylaxis
Do not take Semaglutide if any of the below contraindications apply to you:
a. Aged under 18 or above 75
Restore Medical Clinic, Inc. • Dr. Michael Woo-Ming, MD
1501 Westcliff Dr. Suite 303 • Newport Beach, CA 92660 • 949-209-8850
info@restoremedclinic.com • www.restoremedclinic.com
b. Severe renal/kidney impairment (with eGFR of 15 or below) or a history of renal disease
c. Severe hepatic/liver impairment
d. Personal or family history of medullary thyroid cancer (MTC)
e. Hypersensitivity to Semaglutide or to any of the excipients: disodium phosphate
dihydrate, propylene glycol, phenol and water for injection. f. Concurrent treatment with any
other products for weight management
g. Weight problems related to endocrinological or eating disorders h. Concurrent insulin or
sulfonylurea
i. Patients on warfarin (more frequent INR monitoring required)
j. Concurrent use of any medicinal products with may cause weight gain
k. Pregnancy, breastfeeding or trying to/planning to become pregnant.
l. Congestive heart failure
m. History of pancreatitis, gallbladder disease, inflammatory bowel disease, diabetic
gastroparesis.
n. Patients with a personal or family history of MEN 2 (Multiple Endocrine Neoplasia
syndrome
The below drugs interact with Semaglutide and treatment of Semaglutide should not be
used concurrently. Drug interactions:
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
Alogliptin
Biphasic insulin aspart
Biphasic insulin lispro
Biphasic isophane insulin
Canagliflozin
Dapagliflozin
Dulaglutide
Empagliflozin
Exenatide
Glibenclamide
Gliclazide
Glimepiride
Glipizide
Any insulin including aspart, degludec, detemir, glargine, glulisine, lispro, isophane,
zinc suspension
Nateglinide
Pioglitazone
Repaglinide Saxagliptin, Sitagliptin, Vildagliptin
Tolbutamide
Restore Medical Clinic, Inc. • Dr. Michael Woo-Ming, MD
1501 Westcliff Dr. Suite 303 • Newport Beach, CA 92660 • 949-209-8850
info@restoremedclinic.com • www.restoremedclinic.com
I am aware that other unforeseeable complications could occur. I do not expect the clinic
to anticipate and or explain all risk and possible complications. I rely on them to exercise
judgment during the course of treatment. I understand the risks and benefits of the treatment and
have had the opportunity to have all of my questions answered.
I understand that I have the right to consent to or refuse any proposed treatment at any time prior to its
performance. At any stage during the treatment, I have the right to request that the procedure is terminated,
however l accept that l will not be reimbursed once supply has commenced.
__ I am clear about the risks of using this medication
__ I am clear about the expected weight loss outcomes of this program
__ I am clear about the diet, exercise, and behavioral changes I need to make
Patient Informed Consent for Weight-Management Medications
Procedure & Alternatives
I authorize Restore Medical Clinic and its affiliate physicians to assist me in my weight-reduction efforts. I
understand my treatment may involve, but is not necessarily limited to, the use of weight management
medications for more than 12 weeks and when indicated in higher doses than the dosage indicated in the
medication’s labeling.
I have read and understand my doctor’s statements that follow:
“All prescription medication has labeling determined between its manufacturer and the U. S. Food and Drug
Ad- ministration. This labeling contains among other things suggestions for use. Weight-management
medication labeling suggestions are generally based on shorter term studies (up to 12 weeks) using the
dosage indicated on the label.
“As an obesity medicine specialist, I have found the weight-management medication helpful for periods much
longer than 12 weeks and when indicated at an increased dosages than those suggested on the labeling. As a
physician, I am not required to use the medication as the labeling suggests, but I do use the labeling as a
source of information along with my own experience, the experience of my colleagues, recent longer-term
studies and recommendations of university based investigators. Based on these, I have chosen, when
indicated, to use the weight-management medications for longer periods of time and at times and when
indicated at increased dosages. Such usage has not been as systematically studied as that suggested in the
labeling and it is possible, as with most other medications, that there could be serious side effects (as noted
below).
“As an obesity medicine specialist, I believe that the probability of such side effects is outweighed by the
benefit of the weight-management medication being used for longer periods of time and when indicated at
increased dosages. However, you must decide if you are willing to accept the risks of side effects, even if they
might be serious, for the possible help that the medication used in this manner may give.”
I understand it is my responsibility to follow the instructions carefully and to report to the physician treating
me for my weight any significant medical problems that I think may be related to my weight-control program,
as soon as reason- ably possible. Also, I will notify the physician of all medication I am taking, including antidepressant medications and herbal supplements.
Restore Medical Clinic, Inc. • Dr. Michael Woo-Ming, MD
1501 Westcliff Dr. Suite 303 • Newport Beach, CA 92660 • 949-209-8850
info@restoremedclinic.com • www.restoremedclinic.com
I understand the purpose of this treatment is to assist me in my desire to decrease my body weight and to
maintain this weight loss. I understand that my continuing to receive the weight-management medication will
be dependent on my progress in weight reduction and weight maintenance.
I understand there are other programs that can assist me in my desire to decrease my body weight and to
maintain this weight loss. In particular, a balanced-calorie counting program or an exchange-eating program
without the use of the weight-management medication likely may prove successful if followed, even though I
probably will be hungrier without the use of a weight-management medication.
No Guarantees
I understand that much of the success of the program will depend on my efforts and that there are no
guarantees or assurances that the program will be successful. I also understand that I will have to continue
monitoring my weight all of my life, if I am to be successful.
Consent
I have read and fully understand this consent form and I realize I should not sign this form if all items have not
been explained, or any questions have not been answered to my complete satisfaction. I acknowledge that I
have been given time to completely read and understand this form, as well as discuss with my physician the
risks associated with the proposed treatment and other treatments not involving weight-management
medications.
Patient Warning
If you have any questions as to the risks or hazards of the proposed treatment, or any questions concerning
the pro- posed treatment or other possible treatments, please ask your provider now before signing this
consent form.
Patient’s Name (print)
Signature (or person with authority to consent for patient) Date
I. Physician Declaration:
I have explained the contents of this document to the patient and have answered all the patient’s related
questions, and, to the best of my knowledge, I feel the patient has been adequately informed concerning the
benefits and risks associated with the use of the weight-management medications, the benefits and risks
associated with alternative therapies, and the risks of obesity. After being adequately informed, the patient
has consented to therapy involving the weight-management medications, if indicated, in the aforementioned
manner.
Physician’s Signature
Restore Medical Clinic, Inc. • Dr. Michael Woo-Ming, MD
1501 Westcliff Dr. Suite 303 • Newport Beach, CA 92660 • 949-209-8850
info@restoremedclinic.com • www.restoremedclinic.com