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Weightloss Compounding Medications

Weight Management

RX Compound Store Pharmacy’s main objective is to provide physicians & other health experts with some resources they may need to help their patients acquire & maintain their ideal body weight.

RxCompoundStore fills prescriptions for weight loss drugs that contain semaglutide or
tirzepatide as their active ingredient. These prescriptions are compounded in RxCompoundStore’s
sterile room and taken by injection.

What is semaglutide?
Semaglutide is an injectable glucagon-like peptide-1 (GLP-1) agonist that’s administered once weekly. It
was originally approved by the FDA in a drug to help control blood sugar in Type 2 diabetes in 2017. A
number of patients over time demonstrated that those taking the semaglutide drug for blood sugar
control also lost weight as an additional benefit.


Within a few years, the FDA approved a semaglutide-based drug for weight loss. It can be prescribed for
use by adults with a body mass index (BMI) greater than or equal to 30 mg/kg² alone or 27 mg/kg² with
at least one condition related to weight (e.g., high blood pressure, high cholesterol, Type 2 diabetes).
Semaglutide should be used together with lifestyle changes, including a healthy diet and exercise.

How does semaglutide work for weight loss?
GLP-1 is an incretin hormone released by your digestive tract that contributes to your appetite and
digestion. Your digestive system releases incretins after you’ve eaten a meal. They assist in lowering
your blood sugar by triggering insulin release and blocking the production of sugar. They also ensure
that gastric emptying (the emptying of your stomach) occurs at a slow pace. As a result of the foregoing,
you feel full for a longer period of time, which lowers your appetite and causes you to eat less and lose
weight. GLP-1 agonists are referred to as “incretin mimetics” because they “mimic” the effects of
incretin hormones.


How is semaglutide dosed?
Semaglutide is prescribed as a single-use, disposable injection pen that is pre-measured with the correct
dose. You administer the injection once each week, on the same day of the week. You can administer
the injection any time of day, with or without food.


To administer Semaglutide, you inject yourself just under the skin in your abdomen, upper arm, or thigh.
You should avoid injecting yourself in the same spot repeatedly. Instead, change your injection site with
each dose, even if it’s a different site in the same body part.


You may experience side effects, such as nausea and vomiting because semaglutide slows down how
quickly your stomach empties itself of food. Due to the potential for side effects, your prescriber will
probably start you at a low dose and slowly increase your dose every 4 weeks, which should prevent or
mitigate the side effects.


What do we know about semaglutide side effects?
The most common side effects of semaglutide are nausea, diarrhea, and vomiting. These side effects are
more likely when you first begin semaglutide and when your prescriber increases your dose.
Other potential side effects include:

  • Constipation
  • Stomach pain
  • Headache
  • Fatigue
  • Indigestion
  • Dizziness
  • Bloating
  • Burping
    Serious side effects
    Semaglutide may cause more serious side effects in some people and has a boxed warning — the most serious warning label the FDA uses — due to a potential risk for thyroid C-cell tumors, something that has been observed in animal studies but not confirmed in humans. In spite of the lack of confirmation of the risk in humans, you shouldn’t take semaglutide if you have a personal or family history of certain thyroid tumors.
    Other potential serious side effects include:
  • Pancreatitis (inflamed pancreas)
  • Cholelithiasis (gallbladder disease)
  • Kidney damage
  • Low blood sugar (hypoglycemia)
  • Allergic reactions (including swelling of the face, tongue, or throat; difficulty breathing)
  • Certain eye problems in people with Type 2 diabetes
  • Fast heart rate
  • Suicidal thoughts and behaviors
    Tell your healthcare provider right away if you’re experiencing any changes in mood or behavior, or if
    you’re having suicidal thoughts.
  • Can semaglutide interact with other medications?
    Because semaglutide can lower your blood sugar, it can interact with other medications that lower
    blood sugar, like insulin and medications that cause insulin to be released, such as sulfonylureas.
    Combining any of these medications with semaglutide can result in dangerously low blood sugar levels.
  • Semaglutide can potentially affect oral medications because it slows down how quickly food leaves your stomach. This may affect how certain oral medications are absorbed by your body. Your prescriber can manage potential interactions with oral medications, so it’s important to always advise your health care provider of all medications you take.


How does semaglutide compare to other weight loss medications?


One of the reasons for the headlines about semaglutide is the amount of weight people lost during
clinical trials. With other weight loss medications, weight loss of 5%-10% has been common in trials. The
largest clinical trial of semaglutide in adults resulted in an average weight loss of about 15% of initial
body weight over 68 weeks (almost 16 months).


What is tirzepatide?


The FDA approved a drug with tirzepatide as its main ingredient in May 2022 for Type 2 diabetes. It is
an incretin mimetic like GLP-1, but it also mimics another incretin called glucose-dependent
insulinotropic polypeptide (GIP). Tirzepatide has effects similar to semaglutide, but it’s the first
medication in its class to be approved by the FDA.


A comparison clinical trial between semaglutide and tirzepatide in people with Type 2 diabetes
demonstrated that tirzepatide was more effective for long-term blood sugar control, and people taking
it lost more weight compared to semaglutide.


On November 8, 2023, the FDA approved the first prescription medication with tirzepatide as its active ingredient for weight loss, meaning medications with tirzepatide as their active ingredient are now approved for both type 2 diabetes and weight loss in those who are obese (with a body mass index of 30 kilograms per square meter (kg/ m2) or greater) or those who are overweight (body mass index of 27 kg/m2 or greater) with at least one weight-related condition (such as high blood pressure, type 2 diabetes or high cholesterol).

How does tirzepatide work?

Tirzepatide is the first combination of two classes of medications: a glucagon-like peptide-1 (GLP-1)
receptor agonist (like semaglutide) and a glucose-dependent insulinotropic polypeptide (GIP) receptor
agonist. As a result, tirzepatide is referred to as a dual GLP-1/GIP receptor agonist.
GLP-1 and GIP are both incretin hormones, which are released after eating. Tirzepatide works by
mimicking their effects, resulting in the release of insulin from the pancreas after eating and the
diminution of the amount of glucose produced by the liver. These processes help you feel full, slow
down digestion, and lower blood sugar, similar to the effects of semaglutide.
Other similar injectable weight loss medications such as semaglutide only mimic one incretin — GLP-1.
Because tirzepatide acts like two incretins, it may cause more weight loss than current alternatives.

Can you take tirzepatide for weight loss?

On November 8, 2023, the FDA approved the first prescription medication with tirzepatide as its active ingredient for weight loss, meaning medications with tirzepatide as their active ingredient are now approved for both type 2 diabetes and weight loss in those who are obese (with a body mass index of 30 kilograms per square meter (kg/ m2) or greater) or those who are overweight (body mass index of 27 kg/m2 or greater) with at least one weight-related condition (such as high blood pressure, type 2 diabetes or high cholesterol).  Talk to your doctor if you believe you may be in one of the groups described in the FDA approval who could benefit from a prescription for tirzepatide.    

What do we know about tirzepatide side effects?

Like any medication, tirzepatide can cause side effects. These seem to be most prevalent when initially
starting it or immediately after increasing the dose. Most side effects are mild and resolve with time.
Common side effects include:
– Nausea
– Vomiting
– Diarrhea
– Loss of appetite
– Stomach pain
– Constipation
– Upset stomach

If these side effects are severe or ongoing, discuss them with your healthcare provider.

Is it dangerous to use tirzepatide for weight loss?

There are potentially serious side effects that can be caused by tirzepatide. These include:
– Allergic reaction. An allergic reaction can result in a rash and breathing difficulties, and any
allergic reaction requires immediate medical attention.
– Pancreatitis. This can cause severe stomach or back pain, vomiting, and fevers, and requires
immediate medical attention.
– Thyroid cancer. Your healthcare provider may recommend avoiding tirzepatide if you or a close
family member has a history of certain types of thyroid cancer.
– Gallbladder problems. This can include gallstones, which can occur in people who lose weight
rapidly. There are prescription drugs available to minimize the risk of developing gall stones.
– Low blood sugar (hypoglycemia). This is more likely if tirzepatide is combined with another drug
that lowers blood sugar.

Tirzepatide can also interact with other medications. Make sure you review your medications with your
healthcare provider and pharmacist.

How does RxCompoundStore legally obtain semaglutide and tirzepatide and fulfill prescriptions with
them?


Sections 503A and 503B of the Food, Drug, and Cosmetic Act set conditions under which compounded
human drug products are exempt from certain federal requirements, such as pre-market drug approval.
One of the conditions of section 503A restricts compounded drugs that are essentially copies of
commercially available drugs, but FDA does not consider a drug to be commercially available when it
appears on FDA’s drug shortages list. If a drug is not in shortage, “copies” can be compounded under
section 503A as long as the compounding is not done “regularly or in inordinate amounts.” All other
conditions of section 503A would have to be met, including compounding based on a valid prescription
for an identified individual patient (https://www.fda.gov/drugs/human-drug-compounding/drug-
compounding-and-drug-shortages).


Drugs containing semaglutide and tirzepatide are on the FDA’s drug shortages list. As a result,
RxCompoundStore is able to fill the need that exists due to the shortages. RxCompoundStore only uses the same active ingredients found in brand name prescriptions. It does not use the ingredient about
which the FDA has sent warnings (https://a4pc.org/files/FDA-to-NABP-Semaglutide-letter_April-27-2023.pdf).

The team at RX Compound Store Pharmacy offers great support and advice for your prescription needs in your treatment of weight loss.  You can reach us by phone at 786-803-8947or contact us with your weight loss questions.

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