At our clinic, we stopped prescribing Saxenda and replaced it with a more effective once-weekly injection called Ozempic and Wegovy(semaglutide).
Please refer to the following page for information about the Ozempic and Wegovy.
Saxenda® is a weight management medication (obesity treatment drug) produced by Novo Nordisk. The generic name of the drug is liraglutide, which belongs to a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists.
It is approved as a treatment for obesity by the U.S. FDA (for patients with a BMI of 30 or higher, or with a BMI of 27 or higher and obesity-related diseases).
Saxenda acts on GLP-1 receptors in brain cells to increase satiety and decrease hunger, thereby suppressing appetite and reducing body weight.
It is not approved in Japan and is not covered by the pharmaceuticals and medical devices compensation scheme as an unapproved drug.
Body weight loss rate
In a study of 3731 obese individuals injected with Saxenda versus placebo for 56 weeks (approximately 13 months), 92% of patients injected with Saxenda lost an average of 8.4 kg (2.8 kg for placebo) of body weight.
|Percentage of weight loss||＞5%||＞10%||＞15％|
|Percentage of patients||63.2%||33.1%||14.4%|
Treatment duration and body weight change after discontinuation
The recommended duration of treatment is 4-13 months, but long-term treatment is also possible. After discontinuation of Saxenda injection, appetite returns to normal and body weight may regain easily. It is important to combine diet change and exercise to create a habit for long term body weight control.
Directions for use and storage
- Store unused Saxenda in a refrigerator but please avoid freezing it. Used Saxenda should be used within 30 days at room temperature (2-30°C), avoiding exposure to sunlight. You may continue to store it in the refrigerator after use.
- Inject once a day at the same time subcutaneously at the abdomen, thigh, or upper arm before breakfast. Do not inject into a muscle or vein. Please be sure to read the attached procedure manual and the video (Click here to watch.) and follow the instructions for use.
- Start with 0.6 mg daily to get used to the side effects, then increase by 0.6 mg every week up to a maximum of 3.0 mg. If the effect is significant or side effects such as nausea persist, do not increase the dose and continue at the same dose.
|First week||Second week||Third week||Fourth week||After 5th week|
Injection method (video)
For the method of injecting Saxenda, please refer to the following video.
If you miss a dose of Saxenda injection
- If you missed Saxenda injection for less than 12 hours, inject the missed dose as soon as possible, and continue the next dose of Saxenda at the scheduled time.
- If the missed Saxenda injection for more than 12 hours, please don’t inject the missed dose and skip Saxenda once. At the next scheduled injection time, inject the dose of the previous (missed) dose. Please do not inject double doses at once.
- If you stop Saxenda injection for more than 3 days, please restart with 0.6 mg, as nausea and other symptoms are more likely to occur when resuming.
Side effects of Saxenda
|Metabolism, Nutrition||low level of blood sugar||dehydration, high cholesterol|
|Nerve system||headache||dizziness, impaired taste|
|Cardiovascular||low blood pressure||tachycardia|
|Gastrointestinal||nausea, vomiting, diarrhea, constipation||thirsty, indigestion, gastritis, GERD, upper abdominal pain, abdominal distension, belch||pancreatitis, delayed stomach, emptying|
|Liver, bile ducts||Gall stone||cholangitis|
|Kidney||Acute renal failure, Renal function impairment|
|General||(Injection site)redness, rash, pain, internal bleeding, induration, etc.|
|Blood test||Elevated level of amylase or lipase||anemia, Elevated level of liver function tests|
- Gastrointestinal symptoms: Nausea, vomiting, diarrhea, and constipation are the most common side effects. Most are mild to moderate and transient. The symptoms subside with continued treatment.
- Hypoglycemia (low blood sugar): No severe hypoglycemia has been reported in patients without type 2 diabetes; hypoglycemic symptoms have been reported in 1.6% of patients (1.1% placebo). If you experience strong hunger, 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.
- Pancreatitis (inflammation of pancreas), cholelithiasis(gallstones), cholecystitis (inflammation of gallbladder): If symptoms such as severe abdominal pain, back pain, vomiting, or fever occur, seek medical attention immediately. Removal of the gallbladder might be necessary and it might be fatal if untreated. Cholelithiasis can cause abdominal pain at the night after a greasy meal or overeating. In acute pancreatitis caused by gallstones, the pain begins suddenly 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.
- Dehydration and renal dysfunction: Renal failure and renal dysfunction can occur from dehydration related to gastrointestinal side effects such as diarrhea and vomiting. When diarrhea or vomiting occurs, be sure to keep hydrated.
- Anaphylactic shock and angioedema: An excessive immune response (allergic reaction) may cause symptoms such as decreased blood pressure, fainting, swelling 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 emergent treatment at a hospital is necessary.
- Intestinal obstruction (frequency unclear): Discontinue use and seek medical attention if severe constipation, abdominal distention, persistent abdominal pain, vomiting, or other abnormalities are observed.
- Depression and suicide attempts: Although the causal relationship is unknown, anxiety, weakness, difficulty concentrating, depression, irritability, mood swings, and suicidal thoughts have been reported with 0.3% patients with Saxenda treatment compared to 0.1% in placebo group. If symptoms occur, discontinue the medication and consult your doctor.
- Heart conduction disorders: Clinical studies have reported that 0.3% of patients experienced first degree atrioventricular block, right bundle branch block, or left bundle branch block, but the causal relationship with Saxenda is unknown.
- Thyroid disorders: Goiter has been reported in a study in patients with type 2 diabetes. Please be sure to consult your doctor if you experience symptoms such as swelling or lumps in the thyroid gland (on the front side of the neck, below the throat). Non-fatal thyroid C-cell tumors (medullary thyroid carcinoma) have been reported in a 2-year carcinogenicity study in rats and mice. Papillary thyroid carcinoma (0.2%) has also been reported in Saxenda clinical studies.
- Breast cancer: Clinical trials have reported breast cancer 0.2% in placebo vs. 0.7% in Saxenda treatment group, but the number of cases is small and a causal relationship has not been proven. Subsequent studies have also found no association between Saxenda and risk of breast cancer.
- Colorectal neoplasms: Benign colorectal neoplasms have been reported 0.4% in placebo vs. 0.6% in Saxenda treatment group, and malignant colorectal neoplasms (colorectal cancer) in 0.1% placebo vs. 0.2% Saxenda, but the number of cases is small and the causal relationship is unknown.
- Pancreatic cancer: pancreatic cancer has been reported, but the causal relationship with Saxenda is unknown.
Interactions with other drugs and alcohol
If you suffer from persistent diarrhea or vomiting during Saxenda treatment, the efficacy of warfarin may be impaired. Severe hypoglycemia has been reported when combing Saxenda with insulin and other diabetes medications. Although safety with other anti-obesity drugs and diet herbs has not been established, there is no evidence showed interactions between Saxenda and Orlistat (Xenical).
Although there is no direct interaction with alcohol, excessive alcohol consumption inhibits glycogen production and gluconeogenesis in the liver and can cause hypoglycemia. Excessive alcohol consumption should be avoided while using Saxenda.
Precautions during travelling
- In most cases, a medical certificate is not required for domestic flights but we still can provide it in case you need it. Please note that a medical certificate in Japanese will cost \3,300 (tax included） and a medical certificate in English will cost \5,500 (tax included）.
- Please inject Saxenda at the same time as the scheduled injection time when you were in Japan, even if there is a time difference. If the scheduled injection time in Japan falls on your bedtime during travelling, please inject before bedtime or upon waking up, and return to the original scheduled injection time upon your return to Japan.
Saxenda and pregnancy
Saxenda cannot be used during pregnancy or breast feeding. Due to the lack of safety data, both men and women must use contraception during treatment and discontinue use one month before start planning to be pregnant.
Who cannot use Saxenda
- 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 pregnant or under breast feeding.
- Patients with depression or suicide attempts.
- Those who are allergic to disodium hydrogen phosphate di-hydrate, propylene glycol, phenol
Fees of Saxenda (tax included)
At our clinic, we stopped prescribing Saxenda and replaced it with a more effective once-weekly injection called Ozempic (semaglutide).
Please refer to the following page for information about the Ozempic.
|Fees (tax included)|
|Saxenda (18mg)||1 injection pen (18mg/3mL)|
|Examinations||Blood test (only when necessary) ¥3,982|
Urine test (female on the first visit only) ¥1,056
|Others||70 needles ¥2,860|
100 alcohol cotton swabs ¥660
Needle disposal container (disposal fee included) ¥440
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 Saxenda treatment, and once every 3 months thereafter for side effects check.
※ The needle disposal container is designed so that once the lid is closed, it cannot be opened. Please be sure to put the used needle in the container, and close the lid only before bringing it to our clinic. For needles prescribed by other hospitals, please take them to the medical institution that prescribed them for you. If you wish to dispose of needles at our clinic, please purchase our needle disposal container and bring it to our clinic in the container. However, there is a risk that the needle may penetrate and cause needlestick injuries (infection) so please do not use anything other than the designated container. Please note that a medical waste fee will be charged for the disposal of needles other than the needle disposal containers prescribed by our clinic.
※ Please note that even in the case of side effects, etc., returns and refunds are not accepted after prescription.
Number of Saxenda is needed for 30 days
|Injection dose||Number of Saxenda is needed for 30 days|
|0.6mg||1 injection pen|
|1.2mg||2 injection pens|
|1.8mg||3 injection pens|
|2.4mg||4 injection pens|
|3.0mg||5 injection pens|
※ If you start with 0.6mg and increase the dose every week from 1.2mg → 1.8mg → 2.4mg → max 3.0mg, 3 injection pens of Saxenda are enough for 32 days.
List of references/websites
- Novo Nordisk Inc. “Saxenda liraglutide injection 3mg” https://www.saxenda.com/
- Pi-Sunyer X, (2015) “A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management.” N Engl J Med. 2015 Jul 2;373(1):11-22. doi: 10.1056/NEJMoa1411892. PMID: 26132939
- Novo Nordisk Australia. “Saxenda Consumer Medicine Information” https://www.novonordisk.com.au/content/dam/australia/affiliate/www-novonordisk-au/Patients/Documents/Saxenda%20cmi3.pdf
- American Diabetes Association. “Evidence-Based Nutrition Principles and Recommendations for the Treatment and Prevention of Diabetes and Related Complications” J Am Diet Assoc. 2002 Jan;102(1):109-18. DOI: 10.1016/s0002-8223(02)90031-3 PMID: 11794490
- FDA. “SAXENDA (liraglutide injection)” https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206321Orig1s000lbl.pdf
- Novo Nordisk Inc. “Saxenda – Safty” https://www.saxendapro.com/safety/gastrointestinal-side-effects.html 最終アクセス 2020.09.18
- Novo Nordisk Inc. “Prescribing Information for Saxenda” https://www.novo-pi.com/saxenda.pdf
- Michael A. Nauck, (2018) “Neoplasms Reported With Liraglutide or Placebo in People With Type 2 Diabetes: Results From the LEADER Randomized Trial” Diabetes Care 2018 Aug; 41(8): 1663-1671. https://doi.org/10.2337/dc17-1825
- Funch D, (2019) “Liraglutide use and evaluation of pancreatic outcomes in a US commercially insured population.” Diabetes Obes Metab. 2019 Aug;21(8):1837-1848. doi: 10.1111/dom.13739. Epub 2019 May 24. PMID: 30945402
- Ran Lu, (2018) “Synergistic anti-tumor effects of liraglutide with metformin on pancreatic cancer cells” PLoS One. 2018; 13(6): e0198938. doi: 10.1371/journal.pone.0198938 PMID: 29897998
- Ligumsky H, (2012) “The peptide-hormone glucagon-like peptide-1 activates cAMP and inhibits growth of breast cancer cells.” Breast Cancer Res Treat. 2012 Apr;132(2):449-61. doi: 10.1007/s10549-011-1585-0. Epub 2011 Jun 3. PMID: 21638053
- Koehler JA, (2011) “Glucagon-like peptide-1 receptor activation inhibits growth and augments apoptosis in murine CT26 colon cancer cells.” Endocrinology. 2011 Sep;152(9):3362-72. doi: 10.1210/en.2011-1201. Epub 2011 Jul 19. PMID: 21771884
- le Roux CW, (2017) “3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial.” Lancet. 2017 Apr 8;389(10077):1399-1409. doi: 10.1016/S0140-6736(17)30069-7. Epub 2017 Feb 23. PMID: 28237263
- Novo Nordisk Inc. “Saxenda – Sustained Weight Loss” https://www.saxendapro.com/efficacy/maintaining-significant-weight-loss.html
- William M. Steinberg, “Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Pooled Data From the SCALE Clinical Development Program” Diabetes Care 2017 Jul; 40(7): 839-848. https://doi.org/10.2337/dc16-2684
- NICE. “Obese, overweight with risk factors: liraglutide (Saxenda)” Evidence summary Published date: June 2017 https://www.nice.org.uk/advice/es14/chapter/Key-points
- “ビクトーザ皮下注18mg” 添付文書 https://www.info.pmda.go.jp/go/pack/2499410G1021_1_10/ 2020/01/05アクセス
- 薬事日報 “【GLP-1アナログ製剤「ビクトーザ」】ブルーレター配布へ‐糖尿病性ケトアシドーシス発症受け指示” 2010年10月14日 2019/12/28アクセスhttps://www.yakuji.co.jp/entry20845.html
- 富士フイルム富山化学株式会社 “サノレックス錠0.5mg” https://www.info.pmda.go.jp/go/pack/1190008F1020_4_02 2019/12/28アクセス
- Madsbad S. (2015) “Review of head-to-head comparisons of glucagon-like peptide-1 receptor agonists.” Diabetes Obes Metab. 2016 Apr;18(4):317-32. doi: 10.1111/dom.12596. Epub 2015 Dec 29. PMID: 26511102
- Marso SP, (2016) “Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.” N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13. PMID: 27295427
- Nana Li, (2016) “Liraglutide ameliorates palmitate-induced endothelial dysfunction through activating AMPK and reversing leptin resistance” Biochem Biophys Res Commun. 2016 Sep 9;478(1):46-52. doi: 10.1016/j.bbrc.2016.07.095. PMID: 27457805
- Tom Lamb. “Drug Injury Watch” posted on January 30th, 2018 https://www.drug-injury.com/druginjurycom/2018/01/saxenda-pancreatic-cancer-risks-liraglutide-side-effects-victoza-pancreas-malignancy-incretin-mimetics-drug-class.html
- Donnie Funch, (2018) “Is there an association between liraglutide use and female breast cancer in a real-world setting?” Diabetes Metab Syndr Obes. 2018; 11: 791–806. doi: 10.2147/DMSO.S171503 PMID: 30538516