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Victoza Prescribing Information

This information is not for clinical use. These highlights do not include all the information needed to use Victoza safely and effectively. Before taking Victoza please consult with your doctor. See full prescribing information for Victoza.

Warning

WARNING: RISK OF THYROID C-CELL TUMORS • Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether VICTOZA causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions (5.1) and Nonclinical Toxicology (13.1)]. • VICTOZA is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of VICTOZA and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with VICTOZA [see Contraindications (4) and Warnings and Precautions (5.1)]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether VICTOZA causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1). • VICTOZA is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors (4, 5.1).

Indications And Usage

VICTOZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. VICTOZA is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1). Important Limitations of Use (1.1): •Not recommended as first-line therapy for patients inadequately controlled on diet and exercise (5.1). •Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis (5.2). •Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. •Has not been studied in combination with prandial insulin. 1.1 Important Limitations of Use •VICTOZA is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of the rodent C-cell tumor findings to humans. Prescribe VICTOZA only to patients for whom the potential benefits are considered to outweigh the potential risk [see Warnings and Precautions (5.1)]. •Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with VICTOZA. VICTOZA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using VICTOZA. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. •VICTOZA is not a substitute for insulin. VICTOZA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. •The concurrent use of VICTOZA and prandial insulin has not been studied.

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Dosage Forms And Strengths

Injection: 6 mg/mL solution in a pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg. •Injection: 6 mg/mL solution in a pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg (3).

Contraindications

• Medullary Thyroid Carcinoma VICTOZA is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). • Hypersensitivity VICTOZA is contraindicated in patients with a prior serious hypersensitivity reaction to VICTOZA or to any of the product components. VICTOZA is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (4). VICTOZA is contraindicated in patients with a prior serious hypersensitivity reaction to VICTOZA or any of the product components (4).

Warning and Cautions

• Thyroid C-cell Tumors: See Boxed Warning (5.1). • Pancreatitis: Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis (5.2). • Never share a VICTOZA pen between patients, even if the needle is changed (5.3). • Serious Hypoglycemia: When VICTOZA is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin, consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia (5.4). • Renal Impairment: Postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of VICTOZA in patients with renal impairment (5.5). • Hypersensitivity: Postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema). Discontinue VICTOZA and other suspect medications and promptly seek medical advice (5.6). • Macrovascular Outcomes: There have been no studies establishing conclusive evidence of macrovascular risk reduction with VICTOZA or any other antidiabetic drug (5.7). 5.1 Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice [see Nonclinical Toxicology (13.1) ]. Malignant thyroid C-cell carcinomas were detected in rats and mice. It is unknown whether VICTOZA will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. Cases of MTC in patients treated with VICTOZA have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and VICTOZA use in humans. VICTOZA is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of VICTOZA and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with VICTOZA. Such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated. 5.2 Pancreatitis Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with VICTOZA. After initiation of VICTOZA, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, VICTOZA should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, VICTOZA should not be restarted. Consider antidiabetic therapies other than VICTOZA in patients with a history of pancreatitis. In clinical trials of VICTOZA, there have been 13 cases of pancreatitis among VICTOZA-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with VICTOZA were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a VICTOZA-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. 5.3 Never Share a VICTOZA Pen Between Patients VICTOZA pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens. 5.4 Use with Medications Known to Cause Hypoglycemia Patients receiving VICTOZA in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin [see Dosage and Administration (2.2), Adverse Reactions (6.1)]. 5.5 Renal Impairment VICTOZA has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in VICTOZA-treated patients [see Adverse Reactions (6.2)]. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration [see Adverse Reactions (6.1)]. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including VICTOZA. Use caution when initiating or escalating doses of VICTOZA in patients with renal impairment [see Use in Specific Populations (8.6)]. 5.6 Hypersensitivity Reactions There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with VICTOZA. If a hypersensitivity reaction occurs, the patient should discontinue VICTOZA and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with VICTOZA. 5.7 Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with VICTOZA or any other antidiabetic drug.

Adverse Reactions

The following serious adverse reactions are described below or elsewhere in the prescribing information: •Risk of Thyroid C-cell Tumors [see Warnings and Precautions (5.1)] •Pancreatitis [see Warnings and Precautions (5.2)] •Use with Medications Known to Cause Hypoglycemia [see Warnings and Precautions (5.4) ] •Renal Impairment [see Warnings and Precautions (5.5) ] •Hypersensitivity Reactions [see Warnings and Precautions (5.6) ] •The most common adverse reactions, reported in ≥5% of patients treated with VICTOZA are: nausea, diarrhea, headache and vomiting (6.1). •Immunogenicity-related events, including urticaria, were more common among VICTOZA-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials (6.2). To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-877-484-2869 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Common Adverse Reactions The data in Table 1 are derived from 5 placebo-controlled clinical trials [see Clinical Studies (14)]. These data reflect exposure of 1673 patients to VICTOZA and a mean duration of exposure to VICTOZA of 37.3 weeks. The mean age of patients was 58 years, 4% were 75 years or older and 54% were male. The population was 79% White, 6% Black or African American, 13% Asian; 4% were of Hispanic or Latino ethnicity. At baseline the population had diabetes for an average of 9.1 years and a mean HbA1c of 8.4%. Baseline estimated renal function was normal or mildly impaired in 88.1% and moderately impaired in 11.9% of the pooled population. Table 1 shows common adverse reactions, excluding hypoglycemia, associated with the use of VICTOZA. These adverse reactions occurred more commonly on VICTOZA than on placebo and occurred in at least 5% of patients treated with VICTOZA. Table 1 Adverse reactions reported in ≥ 5% of VICTOZA-treated patients Placebo N=661 Liraglutide 1.2 mg N= 645 Liraglutide 1.8 mg N= 1024 Adverse Reaction (%) (%) (%) Nausea 5 18 20 Diarrhea 4 10 12 Headache 7 11 10 Nasopharyngitis 8 9 10 Vomiting 2 6 9 Decreased appetite 1 10 9 Dyspepsia 1 4 7 Upper Respiratory Tract Infection 6 7 6 Constipation 1 5 5 Back Pain 3 4 5 Cumulative proportions were calculated combining studies using Cochran-Mantel-Haenszel weights In an analysis of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed in Table 1. Other Adverse Reactions Gastrointestinal Adverse Reactions In the pool of 5 placebo-controlled clinical trials, withdrawals due to gastrointestinal adverse reactions, occurred in 4.3% of VICTOZA-treated patients and 0.5% of placebo-treated patients. Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Injection site reactions Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of VICTOZA-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of VICTOZA-treated patients discontinued due to injection site reactions. Hypoglycemia Hypoglycemia requiring the assistance of another person in placebo-controlled trials In 5 placebo-controlled clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 8 VICTOZA-treated patients (7.5 events per 1000 patient-years). Of these 8 VICTOZA-treated patients, 7 patients were concomitantly using a sulfonylurea. Table 2 Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in 26-Week Combination Therapy Placebo-controlled Trials Placebo Comparator VICTOZA Treatment Add-on to Metformin Placebo + Metformin (N = 121) VICTOZA + Metformin (N = 724) Patient not able to self-treat 0 0.1 (0.001) Patient able to self-treat 2.5 (0.06) 3.6 (0.05) Add-on to Glimepiride Placebo + Glimepiride (N = 114) VICTOZA + Glimepiride (N = 695) Patient not able to self-treat 0 0.1 (0.003) Patient able to self-treat 2.6 (0.17) 7.5 (0.38) Not classified 0 0.9 (0.05) Add-on to Metformin + Rosiglitazone Placebo + Metformin + Rosiglitazone (N = 175) VICTOZA + Metformin + Rosiglitazone (N = 355) Patient not able to self-treat 0 0 Patient able to self-treat 4.6 (0.15) 7.9 (0.49) Not classified 1.1 (0.03) 0.6 (0.01) Add-on to Metformin + Glimepiride Placebo + Metformin + Glimepiride (N = 114) VICTOZA + Metformin + Glimepiride (N = 230) Patient not able to self-treat 0 2.2 (0.06) Patient able to self-treat 16.7 (0.95) 27.4 (1.16) Not classified 0 0 “Patient not able to self-treat” is defined as an event requiring the assistance of another person for treatment Malignancy In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for VICTOZA, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions (6.1)], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among VICTOZA-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Papillary thyroid carcinoma In clinical trials of VICTOZA, there were 7 reported cases of papillary thyroid carcinoma in patients treated with VICTOZA and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Cholelithiasis and cholecystitis In clinical trials of Saxenda (liraglutide at doses up to 3 mg), 1.5% and 0.6% of Saxenda-treated patients reported adverse events of cholelithiasis and cholecystitis versus 0.5% and 0.2% of placebo-treated patients. The majority of Saxenda-treated patients with adverse events of cholelithiasis and cholecystitis required cholecystectomy. In clinical trials of VICTOZA, the incidence of cholelithiasis was 0.3% in both VICTOZA-treated and placebo-treated patients. The incidence of cholecystitis was 0.2% in both VICTOZA-treated and placebo-treated patients. Laboratory Tests Bilirubin In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of VICTOZA-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Calcitonin Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. At the end of the clinical trials, adjusted mean serum calcitonin concentrations were higher in VICTOZA-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. Between group differences in adjusted mean serum calcitonin values were approximately 0.1 ng/L or less. Among patients with pretreatment calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of VICTOZA-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients. The clinical significance of these findings is unknown. Lipase and Amylase In one placebo-controlled trial in renal impairment patients, a mean increase of 33% for lipase and 15% for amylase from baseline was observed for VICTOZA-treated patients while placebo-treated patients had a mean decrease in lipase of 3% and a mean increase in amylase of 1%.The clinical significance of these changes is unknown. Vital signs VICTOZA did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with VICTOZA compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established [see Warnings and Precautions (5.7) ]. 6.2 Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with VICTOZA may develop anti-liraglutide antibodies. Approximately 50-70% of VICTOZA-treated patients in five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these VICTOZA-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the VICTOZA-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the VICTOZA-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the VICTOZA-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the VICTOZA-treated patients in the double-blind 26-week add-on combination therapy trials. Among VICTOZA-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative VICTOZA-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among VICTOZA-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of VICTOZA-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative VICTOZA-treated, placebo-treated and active-control-treated patients, respectively. Among VICTOZA-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative VICTOZA-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of VICTOZA when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with VICTOZA treatment. In five double-blind clinical trials of VICTOZA, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of VICTOZA-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for VICTOZA-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. 6.3 Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of VICTOZA. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. •Medullary thyroid carcinoma [see Warnings and Precautions (5.1)] •Dehydration resulting from nausea, vomiting and diarrhea. [see Warnings and Precautions (5.5) and Patient Counseling Information (17)] •Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis. [see Warnings and Precautions (5.5) and Patient Counseling Information (17)] •Angioedema and anaphylactic reactions. [see Contraindications (4), Warnings and Precautions (5.6), Patient Counseling Information (17) ] •Allergic reactions: rash and pruritus •Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death [see Warnings and Precautions (5.2)] •Hepatobiliary disorders: elevations of liver enzymes, hyperbilirubinemia, cholestasis, hepatitis [see Adverse Reactions (6.1)]

Drug Interactions

•VICTOZA delays gastric emptying. May impact absorption of concomitantly administered oral medications. (7). 7.1 Oral Medications VICTOZA causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials, VICTOZA did not affect the absorption of the tested orally administered medications to any clinically relevant degree. Nonetheless, caution should be exercised when oral medications are concomitantly administered with VICTOZA.

Use In Specific Populations

•Renal Impairment: No dose adjustment recommended (2.3, 8.6, 12.3). 8.1 Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies of VICTOZA in pregnant women. VICTOZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Liraglutide has been shown to be teratogenic in rats at or above 0.8 times the human systemic exposures resulting from the maximum recommended human dose (MRHD) of 1.8 mg/day based on plasma area under the time-concentration curve (AUC). Liraglutide has been shown to cause reduced growth and increased total major abnormalities in rabbits at systemic exposures below human exposure at the MRHD based on plasma AUC. Female rats given subcutaneous doses of 0.1, 0.25 and 1.0 mg/kg/day liraglutide beginning 2 weeks before mating through gestation day 17 had estimated systemic exposures 0.8-, 3-, and 11-times the human exposure at the MRHD based on plasma AUC comparison. The number of early embryonic deaths in the 1 mg/kg/day group increased slightly. Fetal abnormalities and variations in kidneys and blood vessels, irregular ossification of the skull, and a more complete state of ossification occurred at all doses. Mottled liver and minimally kinked ribs occurred at the highest dose. The incidence of fetal malformations in liraglutide-treated groups exceeding concurrent and historical controls were misshapen oropharynx and/or narrowed opening into larynx at 0.1 mg/kg/day and umbilical hernia at 0.1 and 0.25 mg/kg/day. Pregnant rabbits given subcutaneous doses of 0.01, 0.025 and 0.05 mg/kg/day liraglutide from gestation day 6 through day 18 inclusive, had estimated systemic exposures less than the human exposure at the MRHD of 1.8 mg/day at all doses, based on plasma AUC. Liraglutide decreased fetal weight and dose-dependently increased the incidence of total major fetal abnormalities at all doses. The incidence of malformations exceeded concurrent and historical controls at 0.01 mg/kg/day (kidneys, scapula), ≥ 0.01 mg/kg/day (eyes, forelimb), 0.025 mg/kg/day (brain, tail and sacral vertebrae, major blood vessels and heart, umbilicus), ≥ 0.025 mg/kg/day (sternum) and at 0.05 mg/kg/day (parietal bones, major blood vessels). Irregular ossification and/or skeletal abnormalities occurred in the skull and jaw, vertebrae and ribs, sternum, pelvis, tail, and scapula; and dose-dependent minor skeletal variations were observed. Visceral abnormalities occurred in blood vessels, lung, liver, and esophagus. Bilobed or bifurcated gallbladder was seen in all treatment groups, but not in the control group. In pregnant female rats given subcutaneous doses of 0.1, 0.25 and 1.0 mg/kg/day liraglutide from gestation day 6 through weaning or termination of nursing on lactation day 24, estimated systemic exposures were 0.8-, 3-, and 11-times human exposure at the MRHD of 1.8 mg/day, based on plasma AUC. A slight delay in parturition was observed in the majority of treated rats. Group mean body weight of neonatal rats from liraglutide-treated dams was lower than neonatal rats from control group dams. Bloody scabs and agitated behavior occurred in male rats descended from dams treated with 1 mg/kg/day liraglutide. Group mean body weight from birth to postpartum day 14 trended lower in F2 generation rats descended from liraglutide-treated rats compared to F2 generation rats descended from controls, but differences did not reach statistical significance for any group. 8.3 Nursing Mothers It is not known whether VICTOZA is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for liraglutide in animal studies, a decision should be made whether to discontinue nursing or to discontinue VICTOZA, taking into account the importance of the drug to the mother. In lactating rats, liraglutide was excreted unchanged in milk at concentrations approximately 50% of maternal plasma concentrations. 8.4 Pediatric Use Safety and effectiveness of VICTOZA have not been established in pediatric patients. VICTOZA is not recommended for use in pediatric patients. 8.5 Geriatric Use In the VICTOZA clinical trials, a total of 797 (20%) of the patients were 65 years of age and over and 113 (2.8%) were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 8.6 Renal Impairment No dose adjustment of VICTOZA is recommended for patients with renal impairment [see Clinical Pharmacology (12.3)]. The safety and efficacy of VICTOZA was evaluated in a 26-week clinical study that included patients with moderate renal impairment (eGFR 30 to 60 mL/min/1.73m2) [see Clinical Studies (14.3)]. There is limited experience with VICTOZA in patients with severe renal impairment including end stage renal disease.There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis [see Warnings and Precautions (5.5) and Adverse Reactions (6.2)]. Use caution in patients who experience dehydration. 8.7 Hepatic Impairment There is limited experience in patients with mild, moderate or severe hepatic impairment. Therefore, VICTOZA should be used with caution in this patient population. No dose adjustment of VICTOZA is recommended for patients with hepatic impairment [see Clinical Pharmacology (12.3)]. 8.8 Gastroparesis VICTOZA slows gastric emptying. VICTOZA has not been studied in patients with pre-existing gastroparesis.

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SAVINGS OF 70%! "When I first used my card, both the pharmacist and I were amazed! She took the information from it for herself and then compared the costs to what my prices would have been had I gone through my insurance (I had none at the time I 1st used my card), and I still saved a lot of money!! They entered the new info. into their system and in the meantime I`ve told lots of friends and family members about how to save.....THANK YOU SO VERY MUCH!!!!!" Elizabeth H.
SAVINGS OF 70%! "My beloved Border Collie - named Mickey - was recently diagnosed with a form of plasmacytoma cancer and is on both Melphalan and Prednisone drugs as part of his monthly treatment. I printed out the prescription savings card and took it to my local pharmacist. I was so pleasantly surprised to know that the card indeed will save us money! I was able to buy the Melphalan chemotherapy drug for $34 less than the last 2 months, since we started treatment! Thanks so much!" Mary L.
SAVINGS OF 70%! "Wow! I can`t believe this actually worked. I have no insurance at this time and have to pay
I lost my insurance coverage and went online seeking help and found this CARD! It worked and saved me money $$$$$ very 1st time. There are others out there but with less coverage and a smaller list of drugs or they charge you a monthly fee. I am so happy I take 3 prescriptions a month forever and at times more and I will save over 78% as I figured it out, and that is great tell everybody you know as I am doing."
David B.
SAVINGS OF 70%! "My husband and I lost our insurance. This is the card to use to save money. His blood pressure medicine is $55. I now can get it for $13.44. That is quite a difference!" Candace
SAVINGS OF 70%! "Thank you SO MUCH! My patients have saved so much money using these cards." Danielle <br/>Primary Care Coalition<br/>primarycarecoalition.org
SAVINGS OF 70%! "While I am blessed to be a Medicaid patient, I know plenty of people which could include me if I didn’t have Medicaid who rely heavily on the WalMart and Target $4 lists. After comparing prices on this and other sites I have seen that there is the greatest free drug card savings potential on this site. I have already printed out 3 cards for loved ones." Jacques M.
SAVINGS OF 70%! "I have been using the RX card for almost a year now. In that time, it has saved my family over $4000. We have no insurance, and the RX card has been a God send. My husband and I are both disabled, and my 65-year old mother is almost blind and diabetic, so we would have simply had to do without. The RX card enabled us to have the meds we need. Thank you so very much!" Sharon H.
SAVINGS OF 70%! "Today, on three different prescriptions, I saved over $70!!! Thank you so much." Susan

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