Saxenda 6mg/ml

Saxenda 6mg/ml is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of

Limitations of Use

Saxenda 6mg/ml is similar to a hormone that occurs naturally in the body and helps control blood sugar, insulin levels, and digestion.

The Saxenda 6mg/ml brand of Saxenda 6mg/ml is used together with diet and exercise to treat type 2 diabetes. Saxenda 6mg/ml is usually given after other diabetes medicines have been tried without success. Saxenda 6mg/ml is not for treating type 1 diabetes.

The Saxenda 6mg/ml brand of Saxenda 6mg/ml is used together with diet and exercise to help people lose weight when they have certain health conditions. Saxenda 6mg/ml is not for treating type 1 or type 2 diabetes. Saxenda 6mg/ml is not a weight-loss medicine or appetite suppressant.

Saxenda 6mg/ml may also be used for purposes not listed in this medication guide.

Posology: To improve gastro-intestinal tolerability, the starting dose is 0.6 mg Saxenda 6mg/ml daily. After at least one week, the dose should be increased to 1.2 mg. Some patients are expected to benefit from an increase in dose from 1.2 mg to 1.8 mg and based on clinical response, after at least one week the dose can be increased to 1.8 mg to further improve glycemic control. Daily doses higher than 1.8 mg are not recommended.

Saxenda 6mg/ml can be added to existing metformin or to a combination of metformin and thiazolidinedione therapy. The current dose of metformin and thiazolidinedione can be continued unchanged.

Saxenda 6mg/ml can be added to existing sulfonylurea or to a combination of metformin and sulfonylurea therapy or a basal insulin. When Saxenda 6mg/ml is added to sulfonylurea therapy or basal insulin, a reduction in the dose of sulfonylurea or basal insulin should be considered to reduce the risk of hypoglycemia. Self-monitoring of blood glucose is not needed in order to adjust the dose of Saxenda 6mg/ml. However, when initiating treatment with Saxenda 6mg/ml in combination with a sulfonylurea or a basal insulin, blood glucose self-monitoring may become necessary to adjust the dose of the sulfonylurea or the basal insulin.

Special Populations: Elderly (>65 years old): No dose adjustment is required based on age. Therapeutic experience in patients ≥75 years of age is limited.

Patients with Renal Impairment: No dose adjustment is required for patients with mild or moderate renal impairment (creatinine clearance 60-90 mL/min and 30-59 mL/min, respectively). There is no therapeutic experience in patients with severe renal impairment (creatinine clearance below 30 mL/min). Saxenda 6mg/ml can currently not be recommended for use in patients with severe renal impairment including patients with end-stage renal disease.

Patients with Hepatic Impairment: The therapeutic experience in patients with all degrees of hepatic impairment is currently too limited to recommend the use in patients with mild, moderate or severe hepatic impairment.

Pediatric Population: The safety and efficacy of Saxenda 6mg/ml in children and adolescents below age 18 have not been established. No data are available.

Administration: Saxenda 6mg/ml must not be administered intravenously or intramuscularly.

Saxenda 6mg/ml is administered once daily at any time, independent of meals, and can be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site and timing can be changed without dose adjustment. However, it is preferable that Saxenda 6mg/ml is injected around the same time of the day, when the most convenient time of the day has been chosen. For further instructions on administration.

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What is the most important information I should know about Saxenda 6mg/ml?

You should not use Saxenda 6mg/ml if you are allergic to it, or if you have multiple endocrine neoplasia type 2 (tumors in your glands), a personal or family history of medullary thyroid cancer, insulin-dependent diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin)

Before using Saxenda 6mg/ml, tell your doctor if you have stomach problems causing slow digestion, kidney or liver disease, high blood pressure, high triglycerides, or if you have ever had pancreatitis, gallstones, or alcoholism.

You should not breast-feed while using Saxenda 6mg/ml.

Never share an injection pen with another person. Sharing injection pens can allow disease such as hepatitis or HIV to pass from one person to another.

Call your doctor at once if you have a serious side effect such as swelling or a lump in your throat area, hoarse voice, trouble swallowing, feeling short of breath, severe pain in your upper stomach spreading to your back, nausea and vomiting, or signs of infection such as fever, chills, sore throat, flu symptoms, mouth sores, or easy bruising or bleeding.

Saxenda 6mg/ml is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar.

Use Saxenda 6mg/ml as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Saxenda 6mg/ml comes with an extra patient information sheet called a Medication Guide. It also comes with an extra patient leaflet with detailed instructions for use. Read them carefully. Read them again each time you get Saxenda 6mg/ml refilled. Ask your doctor, nurse, or pharmacist any questions that you may have about this information.
• Use Saxenda 6mg/ml with or without food.
• A health care provider will teach you how to use Saxenda 6mg/ml. Be sure you understand how to use Saxenda 6mg/ml. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Use the proper technique taught to you by your health care provider. Inject deep under the skin, in the stomach area (abdomen), upper leg (thigh), or upper arm, as directed by your doctor. Do NOT inject Saxenda 6mg/ml into a vein or muscle.
• Do not use Saxenda 6mg/ml if it contains particles, is cloudy or discolored, or if the pen is cracked or damaged.
• Remove the needle after each injection and dispose of it properly. Do not store Saxenda 6mg/ml with the needle attached. Doing so may increase the risk that Saxenda 6mg/ml will leak or that germs will enter your medicine.
• Do not share pen or cartridge devices with another person even if the needle has been changed. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
• Check with your doctor to see if you should drink extra fluids while you are taking Saxenda 6mg/ml.
• Remove the needle after each injection. Store this device without a needle on it.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse or share needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• Use Saxenda 6mg/ml on a regular schedule to get the most benefit from it.
• If you miss a dose of Saxenda 6mg/ml, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. If you miss taking Saxenda 6mg/ml for 3 days or more, contact your health care provider before you start to take it again.

Ask your health care provider any questions you may have about how to use Saxenda 6mg/ml.

Use: Labeled Indications

Chronic weight management (Saxenda 6mg/ml): As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of ≥30 kg/m (overweight) in the presence of at least 1 weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, dyslipidemia).

Diabetes mellitus, type 2 (Saxenda 6mg/ml): As an adjunct to diet and exercise to improve glycemic control in children ≥10 years of age, adolescents, and adults with type 2 diabetes mellitus; risk reduction of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.

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What other drugs will affect Saxenda 6mg/ml?

In vitro, Saxenda 6mg/ml has shown very low potential to be involved in pharmacokinetic interactions with other active substances related to cytochrome P450 and plasma protein-binding.

The small delay of gastric emptying with Saxenda 6mg/ml may influence absorption of concomitantly administered oral medicinal products. Interaction studies did not show any clinically relevant delay of absorption. Few patients treated with Saxenda 6mg/ml reported at least 1 episode of severe diarrhoea. Diarrhoea may affect the absorption of concomitant oral medicinal products.

Paracetamol: Saxenda 6mg/ml did not change the overall exposure of paracetamol following a single dose of 1000 mg. Paracetamol C_max was decreased by 31% and median t_max was delayed up to 15 min. No dose adjustment for concomitant use of paracetamol is required.

Atorvastatin: Saxenda 6mg/ml did not change the overall exposure of atorvastatin to a clinical relevant degree following single dose administration of atorvastatin 40 mg. Therefore, no dose adjustment of atorvastatin is required when given with Saxenda 6mg/ml. Atorvastatin C_max was decreased by 38% and median t_max was delayed from 1 hr to 3 hrs with Saxenda 6mg/ml.

Griseofulvin: Saxenda 6mg/ml did not change the overall exposure of griseofulvin following administration of a single dose of griseofulvin 500 mg. Griseofulvin C_max increased by 37% while median t_max did not change. Dose adjustments of griseofulvin and other compounds with low solubility and high permeability are not required.

Lisinopril and Digoxin: Single dose administration of lisinopril 20 mg or digoxin 1 mg with Saxenda 6mg/ml showed a reduction of lisinopril and digoxin AUC by 15% and 16%, respectively; C_max decreased by 27% and 31%, respectively. Lisinopril median t_max was delayed from 6 hrs to 8 hrs with Saxenda 6mg/ml; whereas digoxin median t_max was delayed from 1 hr to 1.5 hrs. No adjustment of lisinopril or digoxin dose is required based on these results.

Oral Contraceptives:

Warfarin: No interaction study has been performed. Upon initiation of Saxenda 6mg/ml treatment in patients on warfarin more frequent monitoring of International Normalised Ratio (INR) is recommended.

Insulin: Combination of Saxenda 6mg/ml with insulin has not been evaluated.

Incompatibilities: Substances added to Saxenda 6mg/ml may cause degradation of Saxenda 6mg/ml. In the absence of compatibility studies, Saxenda 6mg/ml must not be mixed with other medicinal products.

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What are the possible side effects of Saxenda 6mg/ml?

Summary of the Safety Profile: In five large long-term clinical trials over 2,500 patients have received treatment with Saxenda 6mg/ml alone or in combination with metformin, a sulfonylurea (with or without metformin) or metformin plus rosiglitazone.

The most frequently reported adverse reactions during clinical trials were gastrointestinal disorders: Nausea and diarrhea were very common, whereas vomiting, constipation, abdominal pain and dyspepsia were common. At the beginning of the therapy, these gastrointestinal adverse reactions may occur more frequently. These reactions usually diminish within a few days or weeks on continued treatment. Headache and nasopharyngitis were also common.

Furthermore, hypoglycemia was common and very common when Saxenda 6mg/ml is used in combination with a sulfonylurea. Major hypoglycemia has primarily been observed when combined with a sulfonylurea.

Tabulated List of Adverse Reactions: Table 3 lists adverse reactions reported in long term phase 3 controlled trials and spontaneous (postmarketing) reports. Frequencies for related spontaneous reports (postmarketing) have been calculated based on their incidence in phase 3 clinical trials.

Frequencies are defined as: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Description of Selected Adverse Reactions: In a clinical trial with Saxenda 6mg/ml as monotherapy, rates of hypoglycemia reported with Saxenda 6mg/ml were lower than rates reported for patients treated with active comparator (glimepiride). The most frequently reported adverse reactions were gastrointestinal disorders, infections and infestations.

Hypoglycemia: Most episodes of confirmed hypoglycemia in clinical trials were minor. No episodes of major hypoglycemia were observed in the trial with Saxenda 6mg/ml used as monotherapy. Major hypoglycemia may occur uncommonly and has primarily been observed when Saxenda 6mg/ml is combined with a sulfonylurea (0.02 events/patient year). Very few episodes (0.001 events/patient year) were observed with administration of Saxenda 6mg/ml in combination with oral antidiabetics other than sulfonylureas. The risk of hypoglycemia is low with combined use of basal insulin and Saxenda 6mg/ml (1.0 events per patient year, see

Pharmacology: Pharmacodynamic under Actions).

Gastrointestinal Adverse Reactions: When combining Saxenda 6mg/ml with metformin, 20.7% of patients reported at least one episode of nausea, and 12.6% of patients reported at least one episode of diarrhea. When combining Saxenda 6mg/ml with a sulfonylurea, 9.1% of patients reported at least one episode of nausea and 7.9% of patients reported at least one episode of diarrhea. Most episodes were mild to moderate and occurred in a dose-dependent fashion. With continued therapy, the frequency and severity decreased in most patients who initially experienced nausea.

In monotherapy, patients treated with both doses of Saxenda 6mg/ml reported a greater occurrence of nausea in the initial weeks of therapy (14%), compared with glimepiride (3%).

The proportion of Saxenda 6mg/ml - treated patients with nausea declined over time and after 16 weeks the proportion was similar to glimepiride-treated patients.

Patients >70 years may experience more gastrointestinal effects when treated with Saxenda 6mg/ml. Patients with mild and moderate renal impairment (creatinine clearance 60-90 mL/min and 30-59 mL/min, respectively) may experience more gastrointestinal effects when treated with Saxenda 6mg/ml.

Withdrawal: The incidence of withdrawal due to adverse reactions was 7.8% for Saxenda 6mg/ml-treated patients and 3.4% for comparator-treated patients in the long-term controlled trials (26 weeks or longer). The most frequent adverse reactions leading to withdrawal for Saxenda 6mg/ml-treated patients were nausea (2.8% of patients) and vomiting (1.5%).

Injection Site Reactions: Injection site reactions have been reported in approximately 2% of patients receiving Saxenda 6mg/ml in long-term (26 weeks or longer) controlled trials. These reactions have usually been mild.

Pancreatitis: Few cases (<0.2%) of acute pancreatitis have been reported during long-term clinical trials with Saxenda 6mg/ml. Pancreatitis was also reported post-marketing.

Allergic Reactions: Allergic reactions including urticaria, rash and pruritus have been reported from marketed use of Saxenda 6mg/ml.

Few cases of anaphylactic reactions with additional symptoms such as hypotension, palpitations, dyspnea and edema have been reported with marketed use of Saxenda 6mg/ml. Few cases (0.05%) of angioedema have been reported during all long-term clinical trials with Saxenda 6mg/ml.

Reporting of Suspected Adverse Reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

Each mL of solution contains Liraglutide 6 mg^* . One pre-filled pen contains Liraglutide 18 mg in 3 mL.

Saxenda 6mg/ml also contains the following excipients: Disodium phosphate dihydrate, propylene glycol, phenol and water for injections.

It has a pH of 8.15.

^*human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA technology in Saccharomyces cerevisiae.