Victoza 6 mg / ml solution for injection in pre-filled pen

Victoza 6 mg / ml solution for injection in pre-filled pen 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

Victoza 6 mg / ml solution for injection in pre-filled pen is similar to a hormone that occurs naturally in the body and helps control blood sugar, insulin levels, and digestion.

The Victoza 6 mg / ml solution for injection in pre-filled pen brand of Victoza 6 mg / ml solution for injection in pre-filled pen is used together with diet and exercise to treat type 2 diabetes. Victoza 6 mg / ml solution for injection in pre-filled pen is usually given after other diabetes medicines have been tried without success. Victoza 6 mg / ml solution for injection in pre-filled pen is not for treating type 1 diabetes.

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

Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen 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.

Victoza 6 mg / ml solution for injection in pre-filled pen 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.

Victoza 6 mg / ml solution for injection in pre-filled pen can be added to existing sulfonylurea or to a combination of metformin and sulfonylurea therapy or a basal insulin. When Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen. However, when initiating treatment with Victoza 6 mg / ml solution for injection in pre-filled pen 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). Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen in children and adolescents below age 18 have not been established. No data are available.

Administration: Victoza 6 mg / ml solution for injection in pre-filled pen must not be administered intravenously or intramuscularly.

Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen?

You should not use Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen, 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 Victoza 6 mg / ml solution for injection in pre-filled pen.

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.

Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen refilled. Ask your doctor, nurse, or pharmacist any questions that you may have about this information.
• Use Victoza 6 mg / ml solution for injection in pre-filled pen with or without food.
• A health care provider will teach you how to use Victoza 6 mg / ml solution for injection in pre-filled pen. Be sure you understand how to use Victoza 6 mg / ml solution for injection in pre-filled pen. 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 Victoza 6 mg / ml solution for injection in pre-filled pen into a vein or muscle.
• Do not use Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen with the needle attached. Doing so may increase the risk that Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen.
• 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 Victoza 6 mg / ml solution for injection in pre-filled pen on a regular schedule to get the most benefit from it.
• If you miss a dose of Victoza 6 mg / ml solution for injection in pre-filled pen, 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 Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen.

Use: Labeled Indications

Chronic weight management (Victoza 6 mg / ml solution for injection in pre-filled pen): 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 (Victoza 6 mg / ml solution for injection in pre-filled pen): 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 Victoza 6 mg / ml solution for injection in pre-filled pen?

In vitro, Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen may influence absorption of concomitantly administered oral medicinal products. Interaction studies did not show any clinically relevant delay of absorption. Few patients treated with Victoza 6 mg / ml solution for injection in pre-filled pen reported at least 1 episode of severe diarrhoea. Diarrhoea may affect the absorption of concomitant oral medicinal products.

Paracetamol: Victoza 6 mg / ml solution for injection in pre-filled pen 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: Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen. Atorvastatin C_max was decreased by 38% and median t_max was delayed from 1 hr to 3 hrs with Victoza 6 mg / ml solution for injection in pre-filled pen.

Griseofulvin: Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen; 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 Victoza 6 mg / ml solution for injection in pre-filled pen treatment in patients on warfarin more frequent monitoring of International Normalised Ratio (INR) is recommended.

Insulin: Combination of Victoza 6 mg / ml solution for injection in pre-filled pen with insulin has not been evaluated.

Incompatibilities: Substances added to Victoza 6 mg / ml solution for injection in pre-filled pen may cause degradation of Victoza 6 mg / ml solution for injection in pre-filled pen. In the absence of compatibility studies, Victoza 6 mg / ml solution for injection in pre-filled pen must not be mixed with other medicinal products.

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What are the possible side effects of Victoza 6 mg / ml solution for injection in pre-filled pen?

Summary of the Safety Profile: In five large long-term clinical trials over 2,500 patients have received treatment with Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen as monotherapy, rates of hypoglycemia reported with Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen used as monotherapy. Major hypoglycemia may occur uncommonly and has primarily been observed when Victoza 6 mg / ml solution for injection in pre-filled pen is combined with a sulfonylurea (0.02 events/patient year). Very few episodes (0.001 events/patient year) were observed with administration of Victoza 6 mg / ml solution for injection in pre-filled pen in combination with oral antidiabetics other than sulfonylureas. The risk of hypoglycemia is low with combined use of basal insulin and Victoza 6 mg / ml solution for injection in pre-filled pen (1.0 events per patient year, see

Pharmacology: Pharmacodynamic under Actions).

Gastrointestinal Adverse Reactions: When combining Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen reported a greater occurrence of nausea in the initial weeks of therapy (14%), compared with glimepiride (3%).

The proportion of Victoza 6 mg / ml solution for injection in pre-filled pen - 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 Victoza 6 mg / ml solution for injection in pre-filled pen. 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 Victoza 6 mg / ml solution for injection in pre-filled pen.

Withdrawal: The incidence of withdrawal due to adverse reactions was 7.8% for Victoza 6 mg / ml solution for injection in pre-filled pen-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 Victoza 6 mg / ml solution for injection in pre-filled pen-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 Victoza 6 mg / ml solution for injection in pre-filled pen 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 Victoza 6 mg / ml solution for injection in pre-filled pen. Pancreatitis was also reported post-marketing.

Allergic Reactions: Allergic reactions including urticaria, rash and pruritus have been reported from marketed use of Victoza 6 mg / ml solution for injection in pre-filled pen.

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

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.

Victoza 6 mg / ml solution for injection in pre-filled pen 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.