Rybelsus
Rybelsus（semaglutide）is a medicine for diabetes treatment. It is a glucagon-like peptide-1 (GLP-1) receptor agonist that acts on GLP-1 receptors in brain cells to increase the feeling of fullness and satiety, and, therefore, further suppress appetite. However, it is off-label use for weight management purposes. Rybelsus for body weight loss treatment is not approved by the Ministry of Health, Labour and Welfare of Japan so it is not indicated for Relief Systems for Adverse Drug Reactions if there are any severe side effects that occur after using the medicine.
Weight Loss Effect
| Placebo | 15.7% |
| Rybelsus 3mg | 21.3% |
| Rybelsus 7mg | 28.7% |
| Rybelsus 14mg | 44.3% |
In a study of type 2 diabetes patients, 11% of patients in the 7 mg Rybelsus group and 36% of patients in the 14 mg group lost 5% or more of their body weight at 26 weeks (approximately 6 months), compared with 7% of patients in placebo group. There have been no studies of weight loss in those who were not with type 2 diabetes mellitus.
Treatment duration and weight change after discontinuation
The recommended duration of treatment is 6 to 12 months. Because the long-term risk is unknown and because appetite returns to normal and weight is likely to return after discontinuation of Rybelsus, it is important to combine diet change and exercise to create a habit for long term body weight control.
How to take Rybelsus
Take one tablet with about half a glass of water (no more than 120 mL) on an empty stomach before the first meal or drink of the day. Do not eat or drink for at least 30 minutes after taking Rybelsus. Do not take any other medications 30 minutes after Rybelsus. Do not cut, chew, or take two tablets at the same time.
About the dose of Rybelsus
- The starting dose is 3 mg once per day. After one month, the dose is increased to 7 mg once per day.
- After one moth of 7mg once daily, the dose can be increased to 14mg once daily if the weight loss effect is not satisfactory.
Side effects of Rybelsus
The following are side effects in patients with type 2 diabetes; no studies have been conducted for side effects in patients other than type 2 diabetes.
| side effect | ＞5% | 1～5% | 0.5～1% | Frequency unknown |
|---|---|---|---|---|
| Metabolism, Nutrition | decrease in appetite | |||
| Nerve system | headache | dizziness, impaired taste | ||
| Eye | diabetic retinopathy | |||
| Heart | tachycardia | |||
| Gastrointestinal | nausea, diarrhea | constipation, vomiting, abdominal discomfort, abdominal pain, abdominal distension, GERD | bloating, gastritis, belching | |
| Liver, bile ducts | Gall stone | |||
| General | powerless, malaise | |||
| Blood test | Elevated level of lipase | Elevated level of amylase or CK |
- Gastrointestinal symptoms: Nausea, vomiting, diarrhea, and constipation are the most common side effects. Most are mild to moderate and transient and it will decrease with continued treatment. Please consult your doctor if the symptoms are severe.
- Hypoglycemia (low blood sugar): Hypoglycemia has been reported in patients with type 2 diabetes. If you experience strong hunger, fatigue, cold sweats, tremors, palpitations, or fever, take 10g of sugar or 100mL of juice containing sugar and rest. Please make sure that no hypoglycemic symptoms occur before driving a car, operating machinery, or working at height.
- Acute pancreatitis (0.1%): Seek urgent medical attention if symptoms such as severe abdominal pain, back pain, vomiting, or fever occur.
- Cholelithiasis (gall stone),frequency unknown: abdominal pain may occur after a greasy meal or at the night after overeating. In acute pancreatitis caused by gallstones, the pain begins abruptly and is maximal within minutes. Elevated amylase and lipase are not predictive of the development of pancreatitis, but they are diagnostic indicators when symptoms are present. Seek urgent medical attention if you experience severe abdominal pain.
- Anaphylactic shock/angioedema: An overreaction of immune response (allergic reaction) may cause symptoms such as decreased blood pressure, fainting, edema of the face, lips, and skin, rash, and difficulty breathing due to edema of the airways. If anaphylactic symptoms occur, call an ambulance immediately because injection treatment at a hospital is necessary.
- Intestinal obstruction (frequency unknown): Discontinue use Rybelsus and seek medical attention if any abnormalities such as severe constipation, abdominal distention, persistent abdominal pain, or vomiting occur.
- Medullary thyroid carcinoma: In a 2-year carcinogenicity study in rats and mice using subcutaneous semaglutide, an increased incidence of thyroid C-cell tumors was reported in the patients with usual or lower dose of Rybelsus treatment.
About Rybelsus treatment and pregnancy
Both men and women should discontinue use Rybelsus 2 months prior to the start of planning to be pregnant. Use contraception while taking the drug and do not take it during pregnancy or breast feeding.
Interactions with other drugs or alcohol
If diarrhea or vomiting persists during taking Rybelsus, the absorption of warfarin may be impaired. Avoid combined use with thyroid hormone (thyradin, Levothyroxine Sodium Hydrate). Severe hypoglycemia has been reported when combing with insulin and other diabetic medications. Do not use diabetic medications as diet pills concomitantly if you are prescribed from another hospital. There are no interactions with orlistat (Xenical), although safety with other anti-obesity drugs and diet herbs has not been established.
Although there is no direct interaction between Rybelsus and alcohol, excessive alcohol consumption inhibits glycogen production and glycogenesis in the liver and can cause hypoglycemia alone. Excessive alcohol consumption should be avoided during Rybelsus treatment.
Who cannot undergo Rybelsus treatment
- Patients under 18 years of age or over 75 years of age.
- Patients with diabetes, pancreatitis, cholelithiasis, cholecystitis, severe renal or hepatic dysfunction.
- Patients with a history of abdominal surgery or bowel obstruction.
- Patients with eating disorders, BMI less than 18.5, body fat percentage less than 15% for men and 25% for women.
- Patients with obesity caused by endocrine disorders or drugs such as steroids.
- Patients with thyroid disease or a family history of multiple endocrine neoplasia type 2.
- Those who are planning to be pregnant, who are pregnant or under breast feeding.
- Patients with depression or suicide attempts.
- Those who are allergic to Semaglutide (Rybelsus, Ozempic), additives (Salcaprozate sodium, povidone, crystalline cellulose, magnesium stearate)
Fees（Tax included）
| Fees (Tax included) | |
|---|---|
| Rybelsus 3mg | 30tablets ¥9,900 |
| Rybelsus 7mg | 30tablets ¥22,440 |
| Rybelsus 14mg | 30tablets ¥33,000 |
| Examination fee | Blood test (only when necessary) ¥3,982 Urine test (female on the first visit only) ¥1,056 |
| Others | Anti-nausea medicine for 10 days ¥660 |
※ Consultation fee (first visit ¥3,850、repeat visit ¥1,650) will be charged other than the prescription fee.
※ Blood tests (¥3,982) are required at the first visit, one month after Rybelsus treatment, and once every 3 months thereafter for side effects check. Body weight will also be checked every time during your visit.
