NOVORAPID FlexPen Injection
Insulin Aspart Biphasic
100 IU/ml
Novo Nordisk A/S
| Pack size | 3ml FlexPen x 5 |
|---|---|
| Dispensing mode | POM |
| Source | DENMARK |
| Agent | CITY MEDICAL STORE |
| Retail Price | 297.00 AED |
Available as:
Indications
NOVORAPID FlexPen Injection is used for:
Diabetes mellitus
Adult Dose
Subcutaneous
Diabetes Mellitus
Combination rapid-onset (faster than regular insulin) and intermediate-acting insulins in fixed dose
Typical daily insulin requirements range between 0.5-1 unit/kg
Dose regimen varies among patients depending on metabolic needs;
Administer SC q12hr (ie, before breakfast and evening meal); each dose intended to cover 2 meals or a meal and snack
Dosing Considerations:
Insulin naive patients: For patients with type 2 diabetes, the recommended starting dose of Insulin Aspart 30/70 is 6 Units at breakfast and 6 Units at dinner (evening meal). Insulin Aspart
30/70 can also be initiated once daily with 12 units at dinner (evening meal).
How to intensify: Insulin Aspart 30/70 can be intensified from once daily to twice daily. When using Insulin Aspart 30/70 once daily, it is generally recommended to move to twice daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses.
From Insulin Aspart 30/70 twice daily to thrice daily: If twice daily dosing with Insulin Aspart 30/70 results in recurrent daytime hypoglycaemic episodes, the morning dose can be split into morning and lunchtime doses. The dinner doses remain unchanged.
How to adjust the dose:
- Adjust the dose of Insulin Aspart 30/70 on the basis of the lowest pre-meal blood glucose level from the three previous days
- Dose adjustment can be made once a week until target HbA1c is reached
- The dose should not be increased if hypoglycemia occurred within three days
- Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness
The following titration guideline is recommended for dose adjustments:
Pre-meal blood glucose level Dose adjustment
< 4.4 mmol/l < 80 mg/dl - 2 units
4.4 – 6.1 mmol/l 80 – 110 mg/dl 0
6.2 – 7.8 mmol/l 111 – 140 mg/dl + 2 units
7.9 – 10 mmol/l 141 – 180 mg/dl + 4 units
> 10 mmol/l > 180 mg/dl + 6 units
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment: Dose adjustments may be needed.
Administration
Administer subcutaneously in the upper arm, thigh or abdominal wall. A subcutaneous injection into the abdominal wall results in a faster absorption than from other injection sites.
Contra Indications
Hypoglycaemia.Hypersensitivity to any of the components.
Precautions
Rapid changes in serum glucose may induce symptoms of hypoglycemia
Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions (eg, long duration of diabetes, diabetic nerve disease, use of beta-blockers or intensified diabetes control)
Caution in conditions with decreased insulin requirements (eg, diarrhea, nausea, vomiting, malabsorption, hypothyroidism, renal impairment, hepatic impairment)
Caution in conditions with increased insulin requirements (eg, fever, hyperthyroidism, trauma, infection, surgery)
May cause a shift in potassium from extracellular to intracellular space, possibly leading to hypokalemia; caution when coadministered with potassium-lowering drugs or conditions that may decrease potassium
Frequent glucose monitoring and insulin dose reduction may be required with renal or hepatic impairment; not recommended during periods of rapidly declining renal or hepatic function because of risk for prolonged hypoglycemia
Pregnancy-Lactation
Pregnancy
Available information from published randomized controlled trials during second trimester of pregnancy have not reported association with insulin aspart and major birth defects or adverse maternal or fetal outcomes
Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, still birth, and macrosomia related morbidity
Animal data
In animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to human subcutaneous dose of 1 unit/kg/day, respectively; pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia; these effects were similar to those observed in rats administered regular human insulin
Lactation
There are no data on presence of insulin in human milk, effects on breastfed infant, or on milk production; one small published study reported that exogenous insulin, including insulin aspart, was present in human milk; however, there is insufficient information to determine effects of insulin aspart on breastfed infant; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy, and any potential adverse effects on breastfed infant from drug, or from underlying maternal condition
Interactions
Reduce insulin requirements w/ oral hypoglycemics, octreotide, MAOIs, nonselective ?-adrenergic blockers, ACE inhibitors, salicylates, alcohol, anabolic steroids & sulfonamides; increase insulin requirements w/ OCs, thiazides, glucocorticoids, thyroid hormones, sympathomimetics & danazol. ?-blocking agents may mask the symptoms of hypoglycaemia. Alcohol may intensify & prolong the glucose lowering effect of insulin.
Adverse Effects
Side effects of Insulin Aspart Biphasic :
>10%
Hypoglycemia (47-69%)
Headache (12-35%)
Influenza-like symptoms (12-13%)
1-10%
Headache (9%)
Dyspepsia (9%)
Diarrhea (7-8%)
Back pain (7%)
Pharyngitis (6-7%)
Frequency Not Defined
Insulin resistance
Lipodystrophy
Lipohypertrophy
Local allergic reaction
Hypokalemia
Weight gain
Peripheral edema
Mechanism of Action
Insulin Aspart Biphasic is a biphasic suspension of soluble insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
The blood glucose lowering effect of Insulin Aspart Biphasic is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Soluble insulin aspart which has a rapid onset of action, thus allowing it to be given closer to a meal (within zero to 10 minutes of the meal) when compared to soluble human insulin. The crystalline phase consists of protamine-crystallised insulin aspart, which has an activity profile similar to that of human NPH insulin.
When Insulin Aspart Biphasic is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection. The maximum effect is exerted between 1 and 4 hours after injection. The duration of action is up to 24 hours.
Note
NOVORAPID FlexPen 100 IU/ml Injection manufactured by Novo Nordisk A/S. Its generic name is Insulin Aspart Biphasic. NOVORAPID FlexPen is availble in United Arab Emirates.
Farmaco UAE drug index information on NOVORAPID FlexPen Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.