Victoza

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Victoza (liraglutide [rDNA origin]) is a GLP-1 analog indicated for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise, to improve glycemic control in adults. Common side effects of Victoza include:

• headache,
• dizziness,
• nausea,
• vomiting,
• upset stomach,
• indigestion,
• loss of appetite,
• diarrhea,
• constipation,
• cold symptoms (stuffy nose, sneezing, sinus pain, sore throat),
• back pain,
• tired feeling,
• skin rash,
• upper respiratory tract infection, or
• redness or rash where the medicine was injected.

Tell your doctor if you have serious side effects of Victoza including:

• swelling or a lump in your throat,
• hoarse voice,
• trouble swallowing,
• shortness of breath,
• urinating less than usual or not at all,
• weakness,
• confusion,
• increased thirst,
• loss of appetite,
• pounding heartbeats or fluttering in your chest,
• swelling,
• weight gain,
• pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, fast heart rate),
• signs of infection (such as fever, chills, sore throat, flu symptoms),
• easy bruising or bleeding (nosebleeds, bleeding gums),
• mouth sores, or
• unusual weakness.

Victoza should be injected subcutaneously in the abdomen, thigh, or upper arm once daily at any time of day. The injection site and timing can be changed without dose adjustment. Patients should be advised that Victoza delays gastric emptying and may impact the absorption of concomitantly administered oral medications especially oral diabetes medications (Glucotrol, Metaglip, Amaryl, Avandaryl, Duetact, DiaBeta, Micronase, Glucovance, and others). Tell your doctor all medications and supplements you use. 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. It is not known if Victoza passes into breast milk. The patient and her healthcare provider should decide if Victoza will be taken or if the patient will breastfeed instead. Patients should not do both without consulting their healthcare providers first. Abrupt withdrawal of Victoza may lead to nausea and vomiting.

Victoza (liraglutide [rDNA origin]) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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;
• urinating less than usual or not at all;
• weakness, confusion, increased thirst, loss of appetite, pounding heartbeats or fluttering in your chest;
• swelling, weight gain, feeling short of breath;
• pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, fast heart rate; or
• signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), mouth sores, unusual weakness.

Less serious side effects may include:

• headache, dizziness;
• upset stomach, loss of appetite;
• nausea, vomiting;
• diarrhea, constipation;
• cold symptoms such as stuffy nose, sneezing, sinus pain, sore throat;
• back pain;
• tired feeling;
• mild skin rash; or
• redness or rash where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Victoza (Liraglutide [rDNA] Injection)

SIDE EFFECTS

The following serious adverse reactions are described below or elsewhere in the prescribing information:

• Risk of Thyroid C-cell Tumors [see WARNINGS AND PRECAUTIONS]
• Pancreatitis [see WARNINGS AND PRECAUTIONS]
• Use with Medications Known to Cause Hypoglycemia [see WARNINGS AND PRECAUTIONS]
• Renal Impairment [see WARNINGS AND PRECAUTIONS]
• Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]

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]. 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

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

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], 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 Victozatreated 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].

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 26week 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.

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]
• Dehydration resulting from nausea, vomiting and diarrhea. [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION]
• Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis. [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION]
• Angioedema and anaphylactic reactions. [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Patient counseling Information]
• Allergic reactions: rash and pruritus
• Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death [see WARNINGS AND PRECAUTIONS]
• Hepatobiliary disorders: elevations of liver enzymes, hyperbilirubinemia, cholestasis, hepatitis [see Clinical Trials Experience]

Read the entire FDA prescribing information for Victoza (Liraglutide [rDNA] Injection)

© Victoza Patient Information is supplied by Cerner Multum, Inc. and Victoza Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.