Victoza PI Questions

Question 0

WHAT IS THE BLACK BOX WARNING FOR LIRAGLUTIDE?

Answer 0

•Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in rodents. It is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be determined by clinical or nonclinical studies (5.1).

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) (5.1).

Question 1

WHAT IS THE FDA APPROVED INDICATION FOR LIRAGLUTIDE?

Who should it not be used with?

Answer 1

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).

Not recommended as first line with diet and exercise.

Not for T1DM.

Hasn’t been studied with prandial insulin.

Hasn’t been studied in patients with a history of pancreatitis. Consider other options for those with history of pancreatitis.

Question 2

WHAT ARE IMPORTANT LIMITATIONS?

Answer 2

• ​Not recommended as first-line therapy for patients inadequately controlled on diet and exercise (5.1).
• ​Has not been studied sufficiently in patients with a history of pancreatitis. Use caution (5.2).
• ​Victoza® should also not be used in patients with type 1 diabetes, since it requires functioning beta cells to be effective.
• ​Patients with DKA.

Question 3

WHEN SHOULD IT BE ADMINISTERED?

Answer 3

•​Administer once daily at any time of day, independently of meals

Question 4

WHAT IS THE DOSE?

Answer 4

•​Initiate at 0.6 mg per day for one week.

After one week, increase the dose to 1.2 mg.

If the 1.2 mg dose does not result in acceptable glycemic control, the dose can be increased to 1.8 mg.

Question 5

WHY IS LIRAGLUTIDE STARTED AT A LOWER DOSE?

Answer 5

This dose is intended to reduce gastrointestinal symptoms during initial titration, and is not effective for glycemic control.

Question 6

What doses can the FlexPen deliver?

Answer 6

​Solution for subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg (6 mg/mL, 3 mL)

Question 7

LIRAGLUTIDE IS CONTRAINDICATED IN WHAT PATIENTS?

Answer 7

Do not use in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2.

Question 8

HOW MANY CASES OF THYROID C CELL TUMORS WERE SEEN IN HUMANS?

Answer 8

Cases of MTC in patients treated with Victoza have been reported in the postmarketing period; the data are insufficient to establish or exclude a causal relationship.

Question 9

WAS PANCREATITIS SEEN MORE IN VICTOZA OR THE COMPARATORS

Answer 9

•​Pancreatitis: In clinical trials, there were more cases of pancreatitis among Victoza-treated patients than among comparator-treated patients.

There have been 13 cases of pancreatitis among Victoza treated patients and 1 case in the comparator (glimepiride) treated patient.

Question 10

IF A PATIENT HAS PANCREATITIS WHAT SHOULD BE DONE?

Answer 10

If pancreatitis is suspected, Victoza and other potentially suspect drugs should be discontinued. Victoza should not be restarted if pancreatitis is confirmed. Use with caution in patients with a history of pancreatitis.

Question 11

IF VICTOZA IS GIVEN WITH A SECREATAGOGUE WHAT SHOULD BE CONSIDERED?

Answer 11

•​Serious hypoglycemia: Can occur when Victoza is used with an insulin secretagogue (e.g. a sulfonylurea). Consider lowering the dose of the insulin secretagogue to reduce the risk of hypoglycemia.

Question 12

RENAL IMPAIRMENT MAY OCCUR WITH VICTOZA AND IS ASSOCIATED WITH?

Answer 12

​Renal Impairment: Has been reported 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.

Question 13

WHAT IS THE MOST COMMON ADVERSE REACTION WITH VICTOZA?

Answer 13

•​The most common adverse reactions, reported in ≥5% of patients treated with Victoza and more commonly than in patients treated with placebo, are: headache, nausea, diarrhea and anti-liraglutide antibody formation.

Question 14

WHY MIGHT VICTOZA INTERACT WITH SOME DRUGS?

Answer 14

•​Victoza delays gastric emptying. May impact absorption of concomitantly administered oral medications.

Question 15

VICTOZA IS INDICATED FOR WHAT AGE?

Answer 15

There are no data in patients below 18 years of age?

Question 16

VICTOZA IS INDICATED FOR WHAT TYPE OF DIABETES?

Answer 16

•​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.

Question 17

WHEN CAN VICTOZA BE USED AS A MONOTHERAPY?

Answer 17

The indication for Victoza® states that it can be used in addition to diet and exercise for patients with type 2 diabetes. It can therefore be used as monotherapy. Victoza® should not be a first choice, but if, for example, a patient is started on metformin but does not tolerate it, Victoza® can be substituted.

Question 18

CAN VICOTZA BE USED 1ST LINE?

Answer 18

• A limitation of use has been added stating that it should not be used as first-line therapy. Thus, Victoza® should not be a first choice, but if, for example, a patient is started on metformin but does not tolerate it, Victoza® can be substituted.

Question 19

VICTOZA HAS BEEN STUDIED IN COMBINATION WITH WHAT DRUGS?

Answer 19

1. Metformin, 2. Sulfonylurea (SU), 3. Metformin plus an SU, and 4. Metformin plus a thiazolidinedione (TZD). Use in these combinations is approved, even though it is not stated explicitly in the indication.

Question 20

In the clinical trials how did the incidence of pancreatitis compare to the general population with Type 2 diabetes?

Answer 20

The incidence rate was lower than in the general population of patients with type 2 diabetes.

Question 21

WHAT IS THE STARTING DOSE OF VICTOZA?

Answer 21

For all patients, Victoza should be initiated with a dose of 0.6 mg per day for one week. The 0.6 mg dose is a starting dose intended to reduce gastrointestinal symptoms during initial titration, and is not effective for glycemic control. After one week at 0.6 mg per day, the dose should be increased to 1.2 mg. If the 1.2 mg dose does not result in acceptable glycemic control, the dose can be increased to 1.8 mg.

Question 22

HOW SHOULD THE SOLUTION LOOK?

Answer 22

Victoza solution should be inspected prior to each injection, and the solution should be used only if it is clear, colorless, and contains no particles.

Question 23

WHEN IN THE DAY SHOULD VICTOZA BE ADMINISTERED?

Answer 23

Victoza® is dosed once a day, without regard to meals. It is recommended that the dose be given around the same time each day, but the timing can be changed without need for dose adjustment.

Question 24

HOW MANY DAYS WORTH OF VICOTOZA ARE IN A FLEX PEN?

Answer 24

Each pen contains 18 mg of liraglutide in solution, meaning that it can deliver 15 days’ worth of 1.2-mg injections or 10 days’ worth of 1.8-mg injections.

Question 25

VICTOZA IS CONTRAINDICATED IN PATIENTS WITH?

Answer 25

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). In the clinical trials, there have been 4 reported cases of thyroid C-cell hyperplasia among Victoza-treated patients and 1 case in a comparator-treated patient (1.3 vs. 0.6 cases per 1000 patient-years).

Question 26

WHAT IS CONSIDERED A BIOLOGICAL MARKER OF MTC?

Answer 26

Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. Patients with MTC usually have calcitonin values >50 ng/L.

Question 27

HOW MANY PATIENTS ON VICOTZA WERE FOUND TO HAVE MTC?

Answer 27

Important to note that no cases of MTC have been reported in patients taking liraglutide, although one case was reported in a comparator group.

Question 28

HOW MANY CASES OF PANCREATITIS HAVE BEEN SEEN IN CLINICAL TRIALS?

Answer 28

In clinical trials of Victoza, there were 13 cases of pancreatitis among Victoza-treated patients and 1 case among comparator-treated patients (2.2 vs. 0.6 cases per 1000 patient-years). 9 cases were reported as acute pancreatitis and 4 cases with Victoza were reported as chronic pancreatitis.

Question 29

IF PANCREATITIS IS SUSPECTED IN A PATIENT ON VICTOZA WHAT SHOULD HAPPEN?

Answer 29

If pancreatitis is suspected, Victoza® should be discontinued and tests performed. If tests show pancreatitis, Victoza® should not be restarted.

Question 30

IN THE CLINICAL TRIALS WHAT WAS THE INCIDENCE OF WITHDRAWAL FOR VICTOZA VS. COMPARATOR TREATED PATIENTS?

Answer 30

The incidence of withdrawal due to adverse events was 7.8% for Victoza treated patients and 3.4% for comparator-treated patients in the five controlled trials of 26 weeks duration or longer.

Question 31

WHAT WAS THE MOST COMMON CAUSE FOR WITHDRAWL FROM THE CLINICAL TRIALS?

Answer 31

This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza-treated patients and 0.5% of comparator-treated patients. Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials.

Question 32

What is the difference in gastrointestinal adverse effects in the in 26 Week Open-Label Trial versus Exenatide?

Answer 32

In a 26-week study of Victoza versus exenatide, both in combination with metformin and/or sulfonylurea overall gastrointestinal adverse event incidence rates, including nausea, were similar in patients treated with Victoza and exenatide.

Question 33

ANTI-LIRAGLUTIDE ANTIBODIES WERE FOUND IN WHAT % OF PATIENTS IN THE CLINICAL TRIALS?

Answer 33

Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza may develop anti-liraglutide antibodies. Low titers of anti-liraglutide antibodies were detected in 8.6% of these Victoza-treated patients. Liraglutide antibodies had no reduction in HbA1c with Victoza treatment. 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.

Question 34

HOW MANY PATIENTS ON VICOTZA HAD HYPOGLYCEMIA REQUIRING ASSISITANCE?

Answer 34

In the clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza-treated patients (2.6 cases per 1000 patient-years) and in two comparator-treated patients. Six of these patients treated were also taking MET+ sulfonylurea. One patient who injected 10 times the maximum dose of Victoza® had to be hospitalized for severe nausea and vomiting, but did not develop hypoglycemia.

Question 35

DID VICTOZA AFFECT LIVER TESTS?

Answer 35

Elevated serum bilirubin in 4% of patients. Serum bilirubin is a measure of liver function. Bilirubin may therefore reflect decreased liver function. No other liver tests in patients treated with Victoza® were abnormal, so the significance of is unknown.

Question 36

HOW MIGHT VICTOZA CAUSE A DRUG INTERACTION?

Answer 36

The delay in gastric emptying caused by Victoza® could slow the absorption of oral medications, which typically are not absorbed until they enter the small intestine. No such effect has been found in clinical testing, but it cannot be ruled out.

Question 37

WHAT IS THE PREGNANCY CATEGORY OF VICTOZA?

Answer 37

Victoza® is in pregnancy category C. This means that no well-controlled clinical trials have been conducted in pregnant women, but animal studies have shown some effects on fetuses. In general, insulin is recommended for all pregnant women with type 2 diabetes.

Question 38

IS VICTOZA FDA APPROVED FOR USE IN PEDIATRIC PATIENTS?

Answer 38

IS VICTOZA FDA APPROVED FOR USE IN PEDIATRIC PATIENTS? No studies have been conducted in patients under 18 years of age, so Victoza® is not recommended in children. Victoza is not recommended for use in pediatric patients.

Question 39

DOES VICTOZA REQUIRE AN ADJUSTMENT IN DOSE IN OLDER ADULTS?

Answer 39

DOES VICTOZA REQUIRE AN ADJUSTMENT IN DOSE IN OLDER ADULTS? No overall differences in safety or effectiveness were observed between these patients and younger patients. 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.

Question 40

DOES VICTOZA REQUIRE A DOSE ADJUSTMENT IN RENAL OR HEPATIC IMPAIRMENT?

Answer 40

DOES VICTOZA REQUIRE A DOSE ADJUSTMENT IN RENAL OR HEPATIC IMPAIRMENT? No dose adjustment is recommended. For Victoza®, there is only limited experience in patients with hepatic or renal impairment, so the drug should be used with caution, though

Question 41

HOW IS VICTOZA MADE AND HOW IS IT SIMILAR TO ENDOGENOUS GLP-1?

Answer 41

HOW IS VICTOZA MADE AND HOW IS IT SIMILAR TO ENDOGENOUS GLP-1? Liraglutide is 97% homologous to endogenous GLP-1 (7-37). Only two changes have been made. The lysine at position 34 of the protein has been replaced with arginine, and a fatty acid chain has been attached to the other lysine at position 26. This fatty acid chain is called palmitic acid and contains 16 carbon atoms. Palmitic acid is a saturated fatty acid found in palm oil and can be used by the body in fatty acid synthesis. This chain lengthens the lifetime of liraglutide in the body in three ways. •​promoting self-association of liraglutide in the subcutaneous space, slowing uptake into the blood •​binding liraglutide to plasma proteins, because bound liraglutide does not leave the bloodstream or get degraded • Helping to block degradation by DPP-4 and neutral endopeptidases (NEPs)

Question 42

EACH ML OF VICTOZA CONTAINS HOW MUCH LIRAGLUTIDE?

Answer 42

EACH ML OF VICTOZA CONTAINS HOW MUCH LIRAGLUTIDE? Victoza® contains 6 mg of liraglutide in each milliliter of solution.

Question 43

WHAT IS THE MECHANISM OF ACTION OF VICTOZA?

Answer 43

WHAT IS THE MECHANISM OF ACTION OF VICTOZA? Liraglutide activates the GLP-1 receptor in pancreatic beta cells. Liraglutide increases intracellular cyclic AMP (cAMP) leading to 1, Insulin release in the presence of elevated glucose concentrations. This insulin secretion subsides as blood glucose concentrations decrease and approach euglycemia. 2. Liraglutide also decreases glucagon secretion in a glucose-dependent manner. 3. The mechanism of blood glucose lowering also involves a delay in gastric emptying.

Question 44

WHAT IS THE HALF LIFE OF VICTOZA?

Answer 44

WHAT IS THE HALF LIFE OF VICTOZA? Unlike native GLP-1, liraglutide is stable against metabolic degradation by both peptidases and has a plasma half-life of 13 hours after subcutaneous administration. GLP-1(7-37) has a half-life of 1.5-2 minutes due to degradation by the ubiquitous endogenous enzymes, dipeptidyl peptidase IV (DPP-IV) and neutral endopeptidases (NEP). The pharmacokinetic profile of liraglutide, which makes it suitable for once daily administration.

Question 45

COMPARED TO PLACEBO WHAT WAS THE AUC BLOOD GLUCOSE REDUCTION WITH VICTOZA OVER 5 HOURS?

Answer 45

COMPARED TO PLACEBO WHAT WAS THE AUC BLOOD GLUCOSE REDUCTION WITH VICTOZA OVER 5 HOURS? Compared to placebo, the postprandial plasma glucose AUC0-300min was 35% lower after Victoza 1.2 mg and 38% lower after Victoza 1.8 mg.

Question 46

VICTOZA INDUCED INSULIN SECRETION IS DEPENDANT UPON?

Answer 46

VICTOZA INDUCED INSULIN SECRETION IS DEPENDANT UPON? Insulin secretion stimulated by Victoza® in patients with type 2 diabetes increases as blood glucose levels increase. Victoza® does not increase insulin secretion above what the body naturally produces at low blood glucose values, limiting the risk of hypoglycemia. In contrast, glucagon secretion was lowered while insulin was increased, but was not impaired at low blood glucose levels when it is needed.

Question 47

After subcutaneous administration, liraglutide reaches its maximum concentration in the blood (Cmax) after how may hours?

Answer 47

8–12 hours.

Question 48

Total exposure (AUC of the blood concentration vs time graph) was how much lower was given in the thigh compared to the abdomen?

Answer 48

Total exposure (AUC of the blood concentration vs time graph) was how much lower was given in the thigh compared to the abdomen? 22% lower when the injection was made in the thigh compared to the abdomen, but the values for all three injection sites were considered clinically comparable.

Question 49

WHAT IS THE HALF LIFE OF VICTOZA?

Answer 49

Liraglutide is not rapidly metabolized. Its half-life is approximately 13 hours, meaning that half of the total amount of drug in the body is broken down every 13 hours. The long half-life allows Victoza® to be dosed once daily.

Question 50

WHAT EFFECT DOES AGE HAVE ON THE PK OF LIRAGLUTIDE?

Answer 50

WHAT EFFECT DOES AGE HAVE ON THE PK OF LIRAGLUTIDE? Elderly - Age had no effect on the pharmacokinetics of Victoza based on a pharmacokinetic study in healthy elderly subjects (65 to 83 years) and population pharmacokinetic analyses of patients 18 to 80 years of age.

Question 51

WHAT EFFECT DID GENDER HAVE ON THE PK OF LIRAGLUTIDE?

Answer 51

WHAT EFFECT DID GENDER HAVE ON THE PK OF LIRAGLUTIDE? Based on the results of population pharmacokinetic analyses, females have 34% lower weight-adjusted clearance of Victoza compared to males. Based on the exposure response data, no dose adjustment is necessary based on gender.

Question 52

WHAT EFFECT DOES ETHINICITY HAVE ON THE PK OF LIRAGLUTIDE?

Answer 52

WHAT EFFECT DOES ETHINICITY HAVE ON THE PK OF LIRAGLUTIDE? Race and ethnicity had no effect on the pharmacokinetics of Victoza based on the results of population pharmacokinetic analyses that included Caucasian, Black, Asian and Hispanic/Non-Hispanic subjects.

Question 53

WHAT EFFECT DOES BODY WEIGHT HAVE ON THE PK OF LIRAGLUTIDE?

Answer 53

WHAT EFFECT DOES BODY WEIGHT HAVE ON THE PK OF LIRAGLUTIDE? The exposure of liraglutide decreases with an increase in baseline body weight. However, the 1.2 mg and 1.8 mg daily doses of Victoza provided adequate systemic exposures over the body weight range of 40 – 160 kg evaluated in the clinical trials. Liraglutide was not studied in patients with body weight >160 kg.

Question 54

HOW IS THE PK OF LIRAGLUTIDE DIFFERENT IN PEDIATRIC PATIENTS?

Answer 54

HOW IS THE PK OF LIRAGLUTIDE DIFFERENT IN PEDIATRIC PATIENTS? Victoza has not been studied in pediatric patients.

Question 55

WHAT EFFECT DOES RENAL IMPAIRMENT HAVE ON THE PK OF LIRAGLUTIDE?

Answer 55

WHAT EFFECT DOES RENAL IMPAIRMENT HAVE ON THE PK OF LIRAGLUTIDE? Compared to healthy subjects, liraglutide AUC in mild, moderate, and severe renal impairment and in end-stage renal disease was on average 35%, 19%, 29% and 30% lower, respectively. Increased weight, renal impairment, and hepatic impairment all affected its pharmacokinetics, in no case was the effect so large as to necessitate a dose change for the patients in question.

Question 56

WHAT EFFECT DOES HEPATIC IMPAIRMENT HAVE ON THE PK OF LIRAGLUTIDE?

Answer 56

WHAT EFFECT DOES HEPATIC IMPAIRMENT HAVE ON THE PK OF LIRAGLUTIDE? Compared to healthy subjects, liraglutide AUC in subjects with mild, moderate and severe hepatic impairment was on average 11%, 14% and 42% lower, respectively. Increased weight, renal impairment, and hepatic impairment all affected its pharmacokinetics, in no case was the effect so large as to necessitate a dose change for the patients in question.

Question 57

What is the potential for Victoza drug interactions related to the CYP 450 system?

Answer 57

Low potential for pharmacokinetic drug-drug interactions related to cytochrome P450 (CYP) and plasma protein binding. Metabolic interactions can occur when two drugs are metabolized by the same system; for example, the cytochrome P450 enzyme system of the liver metabolizes many drugs.

Question 58

What is the dominant organ for liraglutide metabolism or excretion?

Answer 58

What is the dominant organ for liraglutide metabolism or excretion? Elimination interactions can occur if two drugs are excreted by the same organ (eg, liver or kidney). Neither of these situations is likely to apply to liraglutide because there is no one dominant organ that metabolizes or excretes it.

Question 59

WHAT IS THE MECHANISM FOR LIRAGLUTIDE TO INTERACT WITH ANOTHER DRUG?

Answer 59

WHAT IS THE MOST MECHANISM FOR LIRAGLUTIDE TO INTERACT WITH ANOTHER DRUG? Delayed gastric emptying. This would slow the rate at which orally administered drugs entered the small intestine for absorption. Studies were performed with several common medications (digoxin for heart failure, lisinopril for blood pressure, atorvastatin for high cholesterol, acetaminophen for pain, and griseofulvin for fungal infections) and, in many cases, their pharmacokinetics were indeed affected. But the variations were not great enough to require dosage changes of the affected drugs.

Question 60

WHAT DRUGS WAS LIRAGLUTIDE STUDIED WITH IN THE LEAD STUDIES?

Answer 60

WHAT DRUGS WAS LIRAGLUTIDE STUDIED WITH IN THE LEAD STUDIES? •​Victoza® monotherapy (LEAD-3) •​Victoza® add-on to metformin (LEAD-2) •​Victoza® add-on to SU (LEAD-1) •​Victoza® add-on to metformin + SU (LEAD-5) •​Victoza® add-on to metformin + TZD (LEAD-4) •​Victoza® or exenatide + metformin and/or SU (LEAD-6)

Question 61

HOW IS VICTOZA SUPPLIED?

Answer 61

HOW IS VICTOZA SUPPLIED? 2 x Victoza pen NDC 0169-4060-12 3 x Victoza pen NDC 0169-4060-13

Question 62

HOW LONG DOES A VICTOZA PEN LAST?

Answer 62

HOW LONG DOES A VICTOZA PEN LAST? Victoza® is available in the prefilled Victoza® pen. Each pen contains 18 mg of liraglutide (3 mL of a 6-mg/mL solution). This corresponds to 10 days of 1.8-mg/day therapy or 15 days of 1.2-mg/day therapy. Therefore, a pack of two pens will cover a month of 1.2-mg doses, and a pack of three will cover a month of 1.8-mg doses.

Question 63

WHAT IS THE EXPIRATION DATE FOR VICTOZA?

Answer 63

WHAT IS THE EXPIRATION DATE FOR VICTOZA? Prior to first use store in the refrigerator Until expiration date ——————————————————– After first use Refrigerated or Room Temperature 30 days

Question 64

What was the incidence of pancreatitis compared to the general population with Type 2 diabetes.

Answer 64

Incidence rate was lower than in the general population of patients with type 2 diabetes.

Question 65

What was the incidence of pancreatitis in the clinical trials, Victoza versus the comparators?

Answer 65

More patients had pancreatitis in clinical studies while taking Victoza® than with comparators.

Question 66

True or false? Exenatide (Byetta®) has a stronger warning, because pancreatitis has been seen in its postmarketing studies.

Answer 66

True

Question 67

Can Victoza be used in Type 1 diabetes?

Answer 67

Victoza® should also not be used in patients with type 1 diabetes, since it requires functioning beta cells to be effective, or in patients with DKA.

Question 68

When should Victoza be given?

Answer 68

Victoza® is dosed once a day, without regard to meals.

Question 69

Serum calcitonin levels in studies varied by?

Answer 69

Serum calcitonin levels were increased in patients taking 1.8 mg of liraglutide per day. The 1.2-mg/day dose produced rates of calcitonin increase similar to placebo.

Question 70

What should be done if pancreatitis is suspected?

Answer 70

If pancreatitis is suspected, Victoza® should be discontinued and tests performed. If tests show pancreatitis, Victoza® should not be restarted.

Question 71

Does the dose of Victoza need to be adjusted in renal impairment?

Answer 71

No dosage adjustments are required in patients with renal impairment,

Question 72

Why does Victoza typically not produce hypoglycemia?

Answer 72

Victoza® alone does not typically produce hypoglycemia because GLP-1 stimulates insulin secretion only in the presence of elevated glucose levels.

Question 73

There were 7 cases of severe hypoglycemia in the clinical studies while on Victoza. 6 of 7 patients were on what drug with Victoza?

Answer 73

Seven patients taking Victoza® in clinical studies, but six of them were also taking a sulfonylurea.

Question 74

Has Victoza been studied in children?

Answer 74

No studies have been conducted in patients under 18 years of age, so Victoza® is not recommended in children.

Question 75

Liraglutide reaches its maximum concentration in the blood (Cmax) after _____ hours?

Answer 75

Liraglutide reaches its maximum concentration in the blood (Cmax) after 8–12 hours.

Question 76

What is the half life?

Answer 76

13 hrs

Question 77

One way in which liraglutide was expected to interact with other medications was through ________?

Answer 77

One way in which liraglutide was expected to interact with other medications was through delayed gastric emptying.

Question 78

Liraglutide has been shown to be effective inpatients that weigh between _____ and _______.

Answer 78

40kg and 160kg