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Xulotophy PI > Xultophy PI > Flashcards

Xultophy PI Flashcards

1
Q

What are the contents of Xultophy?

A

Degludec 100/3.6 of Liraglutide

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2
Q

When was Xultophy approved by the FDA/

A

2016

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3
Q

What are the 2 topics of the boxed warning?

A

1) Thyroid C cell tumors caused in rodents. Unknown if Xultophy causes thyroid C cell tumors or MTC in humans.
2) Xultophy CONTRAINDICATED in pts with personal or family history of MTC or MEN 2.

Counsel pts on potential risks of MTC & s/s thyroid tumors.

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4
Q

What is the indication for Xultophy?

A

Adjunct to diet and exercise.
Improve glycemic control of pts T2 DM adults:
1)inadequately controlled less than 50 units/day basal insulin or
2)Liraglutide 1.8mg

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5
Q

What are the 5 limitation for Xultophy use?

A

1) not recommended as 1st line therapy for pts not controlled w/diet & exercise
2) has not been studied in pts w/pancreatitis; if pt has hx pancreatitis, use something else
3) not recommended in combo with Lira or other GLP-1 RA
4) not for treatment T1DM or ketoacidosis
5) has not been studied with prandial insulin

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6
Q

DOSAGE & ADMINISTRATION:

What if pt is on Lira (or other GLP-1RA) & basal insulin prior to X initiation?

A

DC both before starting Xultophy

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7
Q

What is the recommended starting dose of Xultophy?

A

16 units - dosed per degludec = starting dose:

16 units degludec = 0.58mg of liraglutide

Dose daily SQ

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8
Q

What time of day is best to administer Xultophy?

A

Once daily same time each day

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9
Q

Does Xultophy has to be given with food?

A

Xultophy can be given with or without food.

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10
Q

What is the maximum daily dose of Xultophy?

A

Degludec 50mg + Liraglutide 1.8mg

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11
Q

What is the range of Xultophy which can be delivered from the pen?

A

Xultophy can deliver doses from 10-50 units (degludec) with each injection.

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12
Q

How much Liraglutide is contained in 1 unit of degludec?

A

Lira = 0.036mg per 1 unit Degludec

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13
Q

When should alternative antidiabetic products be used when Xultophy reaches what doses?

A

1) deg doses persistently below 16 units/day or

2) deg doses over 50 units/day

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14
Q

What 3 areas does PI suggest Degludec be injected?

A

Thigh
Upper arm
Abdomen

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15
Q

What are the dosage forms and strengths of Xultophy?

A

Injection - SQ, given once daily

Deg 100units + 1.8 mg Liraglutide in 3ml SINGLE PT use

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16
Q

What are the 3 contra-indications for Xultophy use?

A

1) pts with personal/family hx of medullary thyroid CA or pts with MEN 2
2) pts with prior, serious hyper-sensitivity rxn to Xultophy, its components or excipients
3) during episodes of hypoglycemia

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17
Q

Warnings & Precautions - 10

A

1) Thyroid C cell tumors - see boxed warning
2) Pancreatitis - post marketing reports: fatal & non-fatal hemorrhagic or necrotizing pancreatitis have been reported w/lira. DC if pancreatitis suspected.
3) Never share pen between pts - even if needle changed
4) Hyper or Hypo with changes in Xultophy regimen: close medical supervision and increase frequency of bld glucose monitoring.
5) overdose due to medication errors: a)have pt check label to avoid mix up with insulin pens; b) do not exceed max dose (50/1.8); do not give addn GLP-1RA products w/Xultophy.

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18
Q

Warnings and Precautions cont (6-10)

A

6) hypoglycemia - may be life-threatening. Increase monitoring with changes to: a) dose; b) co-admin of glucose lowering agents; c) meal pattern; d) physical activity; e) renal impairment or hypoglycemia unawareness.
7) Acute Kidney Injury -has been reported post-marketing, assoc with N/V/diarrhea/dehydration- may require hemodialysis. Advise pts of risk of dehydration due to GI ADRs; pts should avoid fluid depletion.

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19
Q

Hypersensitivity and Allergic Rxns:

Severe, life threatening generalized allergy, anaphylaxis, angioedema, brochospasm, hypotension, shock can occur. What is the recommendation if a hypersensitivity occurs?

A

Discontinue medication and tx per standard of care.

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20
Q

What is the recommendation for hypokalemia?

A

May be life-threatening.

Monitor K levels for pts at risk, treat if needed.

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21
Q

Fluid retention and CHF with use of TZDs.

What is the recommendation?

A

Observe pt for s/s heart failure. Consider decreasing dose orDC if HF occurs.

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22
Q

Macrovascular outcomes:

What do these studies report with Xultophy use?

A

No studies estab conclusive evidence of macrovascular risk reduction with Xultophy.

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23
Q

Adverse Rxns:

List most common SE (7) seen with Xultophy use. (In > 5% pts)

A

1) nasopharyngitis
2) HA
3) N
4) V
5) diarrhea
6) increased lipase
7) URI

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24
Q

List the 3 drug interactions:

A

1) drugs affecting glucose metabolism
2) anti-adrenergic drugs (beta blockers, clonidine, guanethidine, reserpine)
3) may have hypoglycemic unawareness

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25
Q

What are the effects of delayed Gastric Emptying on oral meds?

A

May impact absorption of concomitantly admin oral meds.

26
Q

Can Xultophy be used in pregnancy?

A

Only if potential benefit justifies potential risk to fetus.

27
Q

How do you titration Xultophy?

A

After beginning dose of 16 units, titration up or down by 2 units every 3-4 days.

28
Q

What if pts need less than 16 units?

A

May use less than 16 units to start, however, if dose continues to be 16 units or less, DC Xultophy and use another agent.

29
Q

When should you consider changing the dose of Xultophy?

A

To avoid hyper or hypoglycemia may change dose Xultophy:

1) changes physical activity, meals
2) changes renal/hepatic function
3) acute illness
4) use with other meds

30
Q

What is the recommended titration schedule for Xultophy and how often should doses be modified?

A

2-0-2

Every 3-4 days modify

31
Q

What is the recommendation if a dose is missed?

A

1) tell pts to resume dose at next scheduled time
2) do not take extra doses or increase dose to make up
3) if more than 3 days have passed since last dose - restart dose at 16 units again. (to avoid GI upse)

32
Q

What is the appearance of Xultophy in the pen ?

A

Clear and colorless

33
Q

Can the dose of Xultophy be split?

A

No

34
Q

Since cases of MTC have been reported in pts treated with Lira postmarketing, has a causal relationship between MTC and Lira use in humans been supported?

A

Data have been insufficient to establish or exclude a causal relationship between MTC & Lira use in humans.

35
Q

What are some of the listed s/s of thyroid tumors?

A

1) mass in the neck
2) dysphagia
3) dyspnea
4) persistent hoarseness

36
Q

Is routine monitoring of calcitonin or using thyroid ultrasound recommended in PI to detect MTC?

A

Routine monitoring of calcitonin - uncertain use for early detection of MTC and may increase risk of unnecessary procedures due to:

1) low specificity of serum calcitonin (alot of things can increase level)
2) high background incidence of thyroid disease

37
Q

What are usual calcitonin levels found in pts with MTC?

A

> 50 ng/ml

38
Q

Does Lira use cause pancreatitis?

A

Spontaneous postmarketing reports w/Lira:

1) acute pancreatitis
2) fatal & non-fatal hemorrhagic or necrotizing pancreatitis

39
Q

How many cases of pancreatitis have been reported in Lira clinical trials?

A

1) 13 cases in Lira group
a) 9 = acute pancreatitis
b) 4 = chronic pancreatitis
* - one case w/necrosis led to death
2) 1 case in comparator group )glimepiride)
Clinical causality could not be established

40
Q

In cases of reported pancreatitis in clinical trials - what were some of the other risk factors noted? (2)

A

History of:

1) cholelithiasis
2) alcohol abuse

41
Q

If a pt develops pancreatitis and it is stopped, can Xultophy be restarted?

A

NO, use other agents

42
Q

Why can’t Xultophy be used for multiple pts?

A

Risk of transmitting blood borne diseases.

43
Q

Since hypoglycemia is one of the most common ADR of insulin, name some of the SE.

A

1) severe - seizures
2) life threatening
3) death
4) others: can impair concentration ability and reaction time (driving or operating machinery)

44
Q

Acute Kidney Injury

Post marketing reports w,Lira use have included acute renal failure & worsening of chronic renal failure - may require hemodialysis. What were some of the common s/s of these pts?

A

Pts experienced:

1) N
2) V
3) diarrhea
4) dehydration
5) COUNSEL pts to AVOID dehydration

45
Q

List the severe, life-threatening ADRs which were reported with Xultophy use.

A

1) anaphylaxis
2) anagioedema
3) bronchospasm
4) hypotension
5) shock
DC Xultophy & give supportive care

46
Q

Can a pt be given Xultophy with a hx of angioedema?

A

Use caution with these pts.

Xultophy is Contra-indicated in pts have hypersensitivity rxns to deg, lira, or excipients.

47
Q

Why is there a caution about hypokalemia?

A

All insulin products can cause shift in K from extra to intracellular space – which can lead to hypokalemia (respiratory paralysis, ventricular arrhythmia, death).

Monitor K levels in pts at risk for hypoKalemia.

48
Q

Fluid retention & CHF

Does Xultophy cause fluid retention?

A

No, but other products can cause fluid retention if used with insulin: PPAR - gamma agonist.

1) CHF
2) decrease or DC dose of PPAR gamma

49
Q

CLINICAL TRIAL EXPERIENCE - TABLE 3

n = 1881
Mean duration exposure = 33 wks
Meanage 5 yo
>75 yo = 2.8%
53% male
75% white
6% AA
16% Hispanic
Mean BMI ~ 32 kg/m2
Mean dur DM 8.7 yr
Mean baseline A1C = 8.2% 
Mean baseline eGFR = 88.3 ml/min/1.73m2
6.24% pts had eGFR < 60 ml/min/1.73m2
A

What was the greatest ADR seen?

Nasopharyngitis = 9.6%

50
Q

How were events of severe hypoglycemia defined in Phase 3 clinical programs?

A

episode requiring assistance of another person to administer CHO, glucagon, or resuscitate

51
Q

Where there any clinically important difference in risk of severe hypo between Xultophy & comparators?

A

No - no clinically important differences in risk of severe hypoglycemia were observed in clinical trials.

52
Q

List the % of pts in each study who reported Severe Hypoglycemia. (A, B, C)

A = vs Lira (Dual III 3851)
B = vs Deg (Dual II 3912 3a)
C = vs Glar (Dual V 3952)
A

A vs Lira = severe hypo: n=291, hypo = 0.3%

B vs Deg, n= 199, hypo = 0.5%

C vs Glar, n = 278, hypo 0%

53
Q

Malignancy - Victoza

What was the rate of malignancies in pooled analysis of Lira clinical trials?

A

Per 1000 to yrs of malignant neoplasms:

1) 10.9% Lira
2) 6.3% PCB
3) 7.2% for active comparator

54
Q

Were there malignant events reported beyond 1 yr of exposure to Lira?

A 
Yes
1) 7 malignant neoplasm events :
A) 6 events in Lira pts (4 colon, 1 prostate, 1 nasopharyngeal)
B) PCB = no events
C) active comparator = 1 event (colon)
NO CAUSALITY ESTABLISHED.
55
Q

Papillary Thyroid CA - Victoza

How many cases of papillary thyroid CA in Lira pts were reported?

A

1) 7 cases papillary thyroid CA in Lira pts
2) 1 case in comparator group

(Equals 1.5 vs 0.5 cases per 1000 pt yrs)

(Most of papillary thyroid CA were < 1 cm diameter)

56
Q

Cholelithiasis & cholecystitis - Lira (Victoza & Saxenda):

What was the incidence of each in Lira trials?

A

1) Choleithiasis = 0.3% in Lira & PCB groups
= 1.5% Lira. 0.6% PCB group (Saxenda)

2) Cholecystitis = 0.2% in Lira & PCB groups
= 0.5% in Lira & 0.2% PCB groups

(The Lira group pts w/above - majority required cholecystectomy)

57
Q

Is there any effect on DM retinopathy with use of Xultophy?

A

In general, rapid improvement in glucose control has been associated with transitory, reversible ophthalmologic refraction disorder, worsening of DM retinopathy, & acute painful peripheral neuropathy.

58
Q

Can use of Xultophy cause lipodystrophy?

A

Long term use of any insulin can cause lipodystrophy at sites of repeated injections, which may affect absorption.

1) Lipodystrophy - thickening of fat tissue
2) Lipoatrophy - thinning of fat tissue

59
Q

Can Xultophy cause peripheral edema?

A

Insulin can cause sodium retention & edema, particularly if previously poor metabolic control is improved rapidly by intensified therapy.

60
Q

Did Xultophy cause weight gain in clinical trials?

A

Use of any insulin can cause wt gain.

In Study A - 26 wks, pts converting from Lira to Xultophy had mean increase in bwt of 2 kg.

61
Q

Injection site reactions -

What was the rate of injection site reactions in pts in Xultophy studies?

A

Site reactions in pts treated in Xultophy group = 2.6%.

Injection site rxns:
Hematoma
Pain
Hemorrhage
Erythema
Nodules
Swelling
Discoloration
Priorities
Warmth
Mass

Xulotophy PI (1 decks)

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