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Levemir PI Questions Flashcards

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0
Q

WHAT IS THE INDICATION FOR LEVEMIR?

A

WHAT IS THE INDICATION FOR LEVEMIR? LEVEMIR is a long-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

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1
Q

LEVEMIR IS NOT RECOMMENDED FOR PATIENTS WITH?

A

LEVEMIR IS NOT RECOMMENDED FOR PATIENTS WITH? Not recommended for treating diabetic ketoacidosis

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2
Q

WHEN AND HOW SHOULD LEVEMIR BE ADMINISTERED?

A

WHEN AND HOW SHOULD LEVEMIR BE ADMINISTERED? -Administer subcutaneously once daily or in divided doses twice daily. -Once daily administration should be given with the evening meal or at bedtime. -Patients who require twice-daily dosing can administer the evening dose with the evening meal, at bedtime, or 12 hours after the morning dose.

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3
Q

HOW IS LEVEMIR SUPPLIED?

A

HOW IS LEVEMIR SUPPLIED? Solution for injection 100 Units/mL (U-100) in -3 mL LEVEMIR FlexPen¨ -10 mL vial (3)

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4
Q

CAN LEVEMIR BE MIXED WITH OTHER INSULINS OR SOLUTIONS?

A

CAN LEVEMIR BE MIXED WITH OTHER INSULINS OR SOLUTIONS Administration: Do not dilute or mix with any other insulin or solution.

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5
Q

CAN LEVEMIR BE ADMINISTERED VIA AN INSULIN PUMP?

A

CAN LEVEMIR BE ADMINISTERED VIA AN INSULIN PUMP? Do not administer subcutaneously via an insulin pump, intramuscularly, or intravenously because severe hypoglycemia can occur

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6
Q

WOULD RENAL OR HEPATIC IMPAIRMENT REQUIRE A DOSAGE ADJUSTMENT OF LEVEMIR?

A

WOULD RENAL OR HEPATIC IMPAIRMENT REQUIRE A DOSAGE ADJUSTMENT OF LEVEMIR? Renal or hepatic impairment: May require adjustment of the LEVEMIR dose.

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7
Q

SIGNS OF HYPOGLYCEMIA MAY BE REDUCED IN PATIENTS ON WHICH DRUGS?

A

SIGNS OF HYPOGLYCEMIA MAY BE REDUCED IN PATIENTS ON WHICH DRUGS? The signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).

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8
Q

What type of pediatric patients has Levemir not been studied in?

A

-Pediatric: Has not been studied in children with type 2 diabetes. -Has not been studied in children with type 1 diabetes < 6 years of age.

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9
Q

In a Type 1 diabetic what proportion of the total daily dose should be LEVEMIR?

A

1/3 of the total daily insulin requirements. Rapid-acting or short-acting, pre-meal insulin should be used to satisfy the remainder of the daily insulin requirements

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10
Q

HOW SHOULD LEVEMIR BE INITIATED IN TYPE 2 DIABETICS?

A

HOW SHOULD LEVEMIR BE INITIATED IN TYPE 2 DIABETICS? The recommended starting dose of LEVEMIR in patients with type 2 diabetes who are not currently treated with insulin is 10 Units (or 0.1-0.2 Units/kg) given once daily in the evening or divided into a twice daily regimen.

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11
Q

HOW SHOULD GLARGINE BE CONVERTED TO LEVEMIR?

A

HOW SHOULD GLARGINE BE CONVERTED TO LEVEMIR? If converting from insulin glargine to LEVEMIR, the change can be done on a unit-to-unit basis.

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12
Q

HOW SHOULD NPH BE CONVERTED TO LEVEMIR?

A

HOW SHOULD NPH BE CONVERTED TO LEVEMIR? If converting from NPH insulin, the change can be done on a unit-to-unit basis. However, some patients with type 2 diabetes may require more LEVEMIR than NPH insulin, as observed in one trial [see Clinical Studies (14)]. Doses and timing of concurrent rapid-acting or short-acting insulins or other concomitant antidiabetic treatment may need to be adjusted.

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13
Q

LEVEMIR IS AVAILABLE IN WHAT DOSAGE FORMS AND STRENGTHS?

A

LEVEMIR IS AVAILABLE IN WHAT DOSAGE FORMS AND STRENGTHS? LEVEMIR solution for injection 100 Unit per mL is available as: 3 mL LEVEMIR FlexPen¨ 10 mL vial

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14
Q

HOW SHOULD LEVEMIR BE ADMINISTERED?

A

HOW SHOULD LEVEMIR BE ADMINISTERED? -LEVEMIR should only be administered subcutaneously. -Do not administer LEVEMIR intravenously or intramuscularly.

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15
Q

CAN LEVEMIR BE USED IN AN INSULIN INFUSION PUMP?

A

CAN LEVEMIR BE USED IN AN INSULIN INFUSION PUMP? -Do not use LEVEMIR in insulin infusion pumps.

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16
Q

WHAT IS THE MOST COMMON ADVERSE REACTION OF LEVEMIR?

A

WHAT IS THE MOST COMMON ADVERSE REACTION OF LEVEMIR? Severe hypoglycemia requiring the assistance of another person or parenteral glucose infusion, or glucagon administration has been observed in clinical trials with insulin, including trials with LEVEMIR. The prolonged effect of subcutaneous LEVEMIR may delay recovery from hypoglycemia.

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17
Q

WHAT IMPACT DID RENAL IMPAIRMENT HAVE ON THE PHARMACOKINETICS OF LEVEMIR?

A

WHAT IMPACT DID RENAL IMPAIRMENT HAVE ON THE PHARMACOKINETICS OF LEVEMIR? No difference was observed in the pharmacokinetics of insulin detemir between non-diabetic individuals with renal impairment and healthy volunteers.

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18
Q

WHAT IMPACT DID HEPATIC IMPAIRMENT HAVE ON THE PHARMACOKINETICS OF LEVEMIR?

A

WHAT IMPACT DID HEPATIC IMPAIRMENT HAVE ON THE PHARMACOKINETICS OF LEVEMIR? Non-diabetic individuals with severe hepatic impairment had lower systemic exposures to insulin detemir compared to healthy volunteers. However, some studies with human insulin have shown increased circulating insulin concentrations in patients with liver impairment.

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19
Q

IN THE CLINICAL TRIALS WHAT WAS THE INCIDENCE OF HYPOGLYCEMIA IN LEVEMIR COMPARED TO NON-LEVEMIR TREATED PATIENTS?

A

IN THE CLINICAL TRIALS WHAT WAS THE INCIDENCE OF HYPOGLYCEMIA IN LEVEMIR COMPARED TO NON-LEVEMIR TREATED PATIENTS? The rates of hypoglycemia in the LEVEMIR clinical trials were comparable between LEVEMIR-treated patients and non-LEVEMIR-treated patients.

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20
Q

WHAT EFFECT CAN TIGHT GLUCOSE CONTROL HAVE SHORT TERM ON RETINOPATHY?

A

WHAT EFFECT CAN TIGHT GLUCOSE CONTROL HAVE SHORT TERM ON RETINOPATHY? RAPID IMPROVEMENTS IN GLUCOSE CONTROL CAN RESULT IN A TRANSITORY WORSENING OF RETINOPATHY. LONG TERM RETINOPATHY IMPROVES WITH TIGHT GLUCOSE CONTROL.

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21
Q

CAN LEVEMIR CAUSE WEIGHT GAIN?

A

Weight gain can occur with insulin therapy, including LEVEMIR, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

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22
Q

WHAT WAS THE IMPACT OF ANTIBODIES ON GLUCOSE CONTROL IN THE LEVEMIR CLINICAL TRIALS?

A

WHAT WAS THE IMPACT OF ANTIBODIES ON GLUCOSE CONTROL IN THE LEVEMIR CLINICAL TRIALS? All insulin products can elicit the formation of insulin antibodies. These insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose. In phase 3 clinical trials of LEVEMIR, antibody development has been observed with no apparent impact on glycemic control.

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23
Q

WHAT MEDICATIONS MAY INCREASE THE BLOOD GLUCOSE EFFECT OF LEVEMIR?

A

WHAT MEDICATIONS MAY INCREASE THE BLOOD GLUCOSE EFFECT OF LEVEMIR? May increase the blood-glucose-lowering effect of LEVEMIR: diabetic medications, pramlintide acetate, angiotensin converting enzyme (ACE) inhibitors, , fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, propoxyphene, pentoxifylline, salicylates, somatostatin analogs, and sulfonamide antibiotics.

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24
Q

WHAT MEDICATIONS MAY DECREASE THE BLOOD GLUCOSE EFFECT OF LEVEMIR?

A

WHAT MEDICATIONS MAY DECREASE THE BLOOD GLUCOSE EFFECT OF LEVEMIR? Corticosteroids, niacin, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), glucagon, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), protease inhibitors and atypical antipsychotic medications (e.g. olanzapine and clozapine).

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25
Q

WHAT PREGNANCY CATEGORY IS LEVEMIR?

A

WHAT PREGNANCY CATEGORY IS LEVEMIR? Pregnancy Category B

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26
Q

HAS LEVEMIR BEEN STUDIED IN PEDIATRIC TYPE 2 DIABETICS?

A

HAS LEVEMIR BEEN STUDIED IN PEDIATRIC TYPE 2 DIABETICS? LEVEMIR has not been studied in pediatric patients with type 2 diabetes.

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27
Q

WHAT AGE GROUP AND TYPE OF DIABETES WAS LEVEMIR STUDIED IN PEDIATRIC PATIENTS?

A

WHAT AGE GROUP AND TYPE OF DIABETES WAS LEVEMIR STUDIED IN PEDIATRIC PATIENTS? Age 6 to 17 years with type 1 diabetes.

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28
Q

WHAT DIFFERENCES WERE SEEN IN OLDER ADULTS IN TERMS OF SAFETY AND EFFECTIVENESS OF LEVEMIR?

A

WHAT DIFFERENCES WERE SEEN IN OLDER ADULTS IN TERMS OF SAFETY AND EFFECTIVENESS OF LEVEMIR? No overall differences in safety or effectiveness were observed between these patients and younger patients,

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29
Q

HOW CAN LEVEMIR BE DESCRIBED? (ROUTE OF ADMINISTRATION, DURATION OF ACTION).

A

HOW CAN LEVEMIR BE DESCRIBED? (ROUTE OF ADMINISTRATION, DURATION OF ACTION). LEVEMIR (insulin detemir [rDNA origin] injection) is a sterile solution of insulin detemir for use as a subcutaneous injection. Insulin detemir is a long-acting (up to 24-hour duration of action) recombinant human insulin analog. LEVEMIR is produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification.

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30
Q

HOW DOES LEVEMIR DIFFER FROM HUMAN INSULIN, HOW WAS IT MODIFIED?

A

Modified by: C14 fatty acid chain has been attached to the amino acid B29, Amino acid threonine in position B30 has been omitted. LEVEMIR is a clear, colorless, aqueous, neutral sterile solution.

31
Q

EACH ML OF LEVEMIR CONTAINS HOW MUCH INSULIN DETEMIR?

A

EACH ML OF LEVEMIR CONTAINS HOW MUCH INSULIN DETEMIR? Each milliliter of LEVEMIR contains 100 units (14.2 mg/mL) insulin detemir,

32
Q

WHAT IS THE MECHANISM OF ACTION OF INSULIN DETEMIR?

A

WHAT IS THE MECHANISM OF ACTION OF INSULIN DETEMIR? Binding to insulin receptors facilitating cellular uptake of glucose into skeletal muscle and adipose tissue and by inhibiting the output of glucose from the liver. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.

33
Q

DOES LEVEMIR PD HAVE A PEAK?

A

DOES LEVEMIR PD HAVE A PEAK? The pharmacodynamic profile of LEVEMIR is relatively constant with no pronounced peak.

34
Q

WHY IS THE DISTRIBUTION OF INSULIN DETEMIR SLOWED?

A

WHY IS THE DISTRIBUTION OF INSULIN DETEMIR SLOWED? -Slowed systemic absorption of insulin detemir. -Binding to albumin.

35
Q

WHEN IS THE CMAX OF LEVEMIR REACHED?

A

WHEN IS THE CMAX OF LEVEMIR REACHED? (Cmax) reached between 6-8 hours post-dose.

36
Q

WHAT IS THE HALF LIFE?

A

WHAT IS THE HALF LIFE? Insulin detemir has a terminal half-life of 5 to 7 hours

37
Q

WHAT AGE GROUPS WITH TYPE 1 DIABETES HAS LEVEMIR BEEN STUDIED?

A

WHAT AGE GROUPS WITH TYPE 1 DIABETES HAS LEVEMIR BEEN STUDIED? Children 2-12 years adolescents (13-17 years), and adults with type 1 diabetes.

38
Q

HOW IS LEVEMIR PK DIFFERENT AMONG AGE GROUPS?

A

HOW IS LEVEMIR PK DIFFERENT AMONG AGE GROUPS? There was no difference in pharmacokinetics between adolescents and adults.

39
Q

HOW IS THE AUC OF LEVEMIR DIFFERENT IN THE ELDERLY COMPARED TO THE YOUNG?

A

HOW IS THE AUC OF LEVEMIR DIFFERENT IN THE ELDERLY COMPARED TO THE YOUNG? AUC was up to 35% higher among the elderly subjects due to reduced clearance.

40
Q

HOW DOES RENAL IMPAIRMENT AFFECT THE PK OF LEVEMIR?

A

WHAT IS THE DIFFERENCE IN THE PK OF LEVEMIR In this study, there were no differences in the pharmacokinetics of LEVEMIR between healthy subjects and those with renal impairment.

41
Q

WHAT IMPACT DOES HEPATIC IMPAIRMENT HAVE ON LEVEMIR AUC?

A

WHAT IMPACT DOES HEPATIC IMPAIRMENT HAVE ON LEVEMIR AUC? AUC decreased with increasing degrees of hepatic impairment with a corresponding increase in apparent clearance.

42
Q

WHAT IS THE EXPIRATION OF UNUSED UNOPENED REFRIGERATED LEVEMIR?

A

WHAT IS THE EXPIRATION OF UNUSED UNOPENED REFRIGERATED LEVEMIR? Unused (unopened) LEVEMIR can be kept until the expiration date printed on the label if it is stored in a refrigerator.

43
Q

WHAT IS THE EXPIRATION OF UNUSED UNOPENED ROOM TEMPERATURE LEVEMIR?

A

WHAT IS THE EXPIRATION OF UNUSED UNOPENED ROOM TEMPERATURE LEVEMIR? Unrefrigerated LEVEMIR should be discarded 42 days after it is first kept out of the refrigerator, even if the FlexPen or vial still contains insulin.

44
Q

WHAT IS THE EXPIRATION DATE OF OPENED REFRIGERATED LEVEMIR?

A

WHAT IS THE EXPIRATION DATE OF OPENED REFRIGERATED LEVEMIR? Refrigerated LEVEMIR vials should be discarded 42 days after initial use. Unrefrigerated LEVEMIR vials should be discarded 42 days after they are first kept out of the refrigerator.

45
Q

AFTER INITIAL USE HOW SHOULD LEVEMIR FLEXPENS BE STORED?

A

AFTER INITIAL USE HOW SHOULD LEVEMIR FLEXPENS BE STORED? Keep the opened (in use) LEVEMIR FlexPen away from direct heat and light at room temperature, below 30¡C (86¡F).

46
Q

WHAT IS THE EXPIRATION DATE OF A LEVEMIR FLEXPEN UN-REFRIGERATED?

A

WHAT IS THE EXPIRATION DATE OF A LEVEMIR FLEXPEN UN-REFRIGERATED? Unrefrigerated LEVEMIR FlexPens should be discarded 42 days after they are first kept out of the refrigerator. *The total time allowed at room temperature (below 30¡C) is 42 days regardless of whether the product is in-use or not in-use.

47
Q

Insulin-naïve patients with type 2 diabetes who are not achieving glycemic targets on OADs alone can begin treatment with Levemir® at what dose?

A

Insulin-naïve patients with type 2 diabetes who are not achieving glycemic targets on OADs alone can begin treatment with Levemir® at 10 U once or twice daily.

48
Q

Levemir® should only be administered through what route?

A

Levemir® should only be administered subcutaneously. Infusion pumps should not be used to administer Levemir®, nor should it be mixed with any other insulin or solution.

49
Q

Compare the incidence of adverse effects of Levemir with other insulins?

A

The adverse events observed with Levemir® are comparable to those observed with any insulin therapy.

50
Q

Compare the incidence of severe hypoglycemia in patients on Levemir to NPH for Type 1 and Type 2 diabetes.

A

The incidence of severe hypoglycemia was similar for both Levemir® and NPH in patients with type 1 or type 2 diabetes

51
Q

Levemir® may be used in pediatric patients starting at what age?

A

Levemir® may be used in pediatric patients with type 1 diabetes ≥6years of age.

52
Q

To create Levemir®, what was modified?

A

To create Levemir®, the B30 threonine in human insulin was removed, and a 14-carbon (C-14) fatty acid chain was attached to amino acid B29.

53
Q

The long-acting effects of Levemir® are due to:

A

Slow absorption from the SC injection site and its binding to albumin in the bloodstream. When Levemir® is injected just under the skin, it forms a depot of insulin that is absorbed slowly into the bloodstream over a period of up to 24hours.

54
Q

Injection of Levemir® resulted in higher AUC levels in:

A

Injection of Levemir® resulted in higher AUC levels in children and elderly patients in comparison to adolescents and adults.

55
Q

To obtain FDA approval, the studies cited in the PI were designed to show:

A

Equal efficacy (noninferiority) rather than greater efficacy (superiority).

56
Q

Treatments with Levemir®, NPH, and insulin glargine (rDNA origin) injection (Lantus®) have been compared in efficacy and safety studies. What was the difference in efficacy?

A

The efficacy of all three insulins in reducing A1C levels was comparable, with no clinically relevant differences. Treatments with Levemir®, NPH, and insulin glargine (rDNA origin) injection (Lantus®) have been compared in efficacy and safety studies. Levemir® and NPH were administered either once or twice daily, while insulin glargine was administered only once daily. A1C levels were used to evaluate glycemic control.

57
Q

Studies A and B used NovoLog® as the bolus insulin, and Study C used regular human insulin for bolus doses. Study A compared the A1C and FPG values of treatment with Levemir® to that of NPH as basal insulin; similarly, Study C compared the A1C values following treatment with Levemir® or NPH. Study B compared the A1C values following treatment with Levemir® or insulin glargine. What results for efficacy were observed?

A

Results from all three studies demonstrated comparable reductions in A1C for Levemir®, NPH, and insulin glargine.

58
Q

Study D in the PI, corresponds to the Robertson study. Levemir® and NPH were evaluated in a basal-bolus regimen for pediatric patients with type 1 diabetes. What were the results of the study?

A

A1C reductions in patients treated with Levemir® were comparable to those seen in patients treated with NPH.

59
Q

Study E, corresponds to the Hermansen study. In this treat-to-target trial, glycemic response was evaluated in adult patients with type 2 diabetes. The basal insulin, either Levemir® or NPH, was administered twice daily in combination with OADs. What were the results of the study?

A

Levemir® and NPH were effective enough to help a majority of patients, 70% and 74%, respectively, reach that goal.

60
Q

Study F corresponds to the Raslova study. Glycemic control was evaluated from a basal-bolus treatment with either Levemir® plus NovoLog® or NPH plus regular human insulin. How does LEVEMIR compare to NPH?

A

Levemir® demonstrated A1C and FPG reductions similar to those of NPH.

61
Q

The results from Studies E and F suggest what?

A

Levemir® effectively controls glucose levels in adults with type 2 diabetes as part of a basal-bolus treatment or as an add-on insulin to OAD therapy.

62
Q

What is the half life?

A

5-7hrs

63
Q

What’s the onset of action?

A

2 hrs

64
Q

When is the peak?

A

3-15hrs

65
Q

What is the bioavailability

A

60%

66
Q

What is the peak?

A

3-15hrs

67
Q

What is the duration?

A

6-23 hrs

68
Q

For Levemir Study A 1. Who was the author 2. What population 3. What was the competitor 4. What was the bolus insulin

A
  1. Home 2. DM1 Adults 3. Vs. NPH 4. Aspart
69
Q

For Levemir Study B 1. Who was the author 2. What population 3. What was the competitor 4. What was the bolus insulin

A
  1. Pieber 2. DM1 Adults 3. Glargine (B Product) 4. Aspart
70
Q

For Levemir Study C 1. Who was the author 2. What population 3. What was the competitor 4. What was the bolus insulin

A
  1. Russell-Jones 2. DM1 Adults 3. NPH 4. Regular Insulin
71
Q

For Levemir Study D 1. Who was the author 2. What population 3. What was the competitor 4. What was the bolus insulin

A
  1. Robertson*** 2. Peds Ages 6-17 3. NPH 4. Aspart
72
Q

For Levemir Study I 1. Who was the author 2. What population 3. What was the competitor 4. What was the bolus insulin

A
  1. Thalange*** 2. DM1 Peds, age 2-16 yo*** 3. NPH 4. Aspart
73
Q

For Levemir Study E 1. Who was the author 2. What population 3. What was the competitor 4. What was the bolus insulin

A
  1. Hermansen 2. DM2 Adults 3. NPH with OADs 4. None, used with oral antidiabetic agents
74
Q

For Levemir Study F 1. Who was the author 2. What population 3. What was the competitor 4. What was the bolus insulin

A
  1. Raslova 2. DM2 Adults 3. NPH 4. Aspart
75
Q

For Levemir Study H 1. Who was the author 2. What population 3. What were the groups 4. What were the results

A
  1. Rosenstock 2. DM2 patients, patients who did not achieve A1c < 7% after 12 weeks of tx with lira and MET, added QD detemir for 26 weeks 3. Lira+ Met withour detemir 4. Extra 0.5% A1c reduction, weight loss 0.3 kg

Levemir (2 decks)

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