Levemir Information
Levemir (Insulin) Description
Levemir (Insulin) (insulin detemir [rDNA origin] injection) is a sterile solution of insulin detemir for use as an injection. Insulin detemir is a long-acting basal insulin analog, with up to 24 hours duration of action, produced by a process that includes expression of recombinant DNA in followed by chemical modification.
Insulin detemir differs from human insulin in that the amino acid threonine in position B30 has been omitted, and a C14 fatty acid chain has been attached to the amino acid B29. Insulin detemir has a molecular formula of C HONS and a molecular weight of 5916.9. It has the following structure:
Levemir (Insulin) is a clear, colorless, aqueous, neutral sterile solution. Each milliliter of Levemir (Insulin) contains 100 U (14.2 mg/mL) insulin detemir, 65.4 mcg zinc, 2.06 mg m-cresol, 16.0 mg glycerol, 1.80 mg phenol, 0.89 mg disodium phosphate dihydrate, 1.17 mg sodium chloride, and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. Levemir (Insulin) has a pH of approximately 7.4.
Levemir (Insulin) Clinical Pharmacology
The primary activity of insulin detemir is the regulation of glucose metabolism. Insulins, including insulin detemir, exert their specific action through binding to insulin receptors.
Receptor-bound insulin lowers blood glucose by facilitating cellular uptake of glucose into skeletal muscle and fat and by inhibiting the output of glucose from the liver. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.
Insulin detemir is a soluble, long-acting basal human insulin analog with a relatively flat action profile. The mean duration of action of insulin detemir ranged from 5.7 hours at the lowest dose to 23.2 hours at the highest dose (sampling period 24 hours).
The prolonged action of Levemir (Insulin) is mediated by the slow systemic absorption of insulin detemir molecules from the injection site due to strong self-association of the drug molecules and albumin binding. Insulin detemir is distributed more slowly to peripheral target tissues since insulin detemir in the bloodstream is highly bound to albumin.
Figure 1 shows glucose infusion rate results from a glucose clamp study in patients with type 1 diabetes.
Figure 1: Activity Profiles in Patients with Type 1 Diabetes in a 24-hour Glucose Clamp Study
Figure 2 shows glucose infusion rate results from a 16-hour glucose clamp study in patients with type 2 diabetes. The clamp study was terminated at 16 hours according to protocol.
Figure 2: Activity Profiles in Patients with Type 2 Diabetes in a 16-hour Glucose Clamp Study
For doses in the interval of 0.2 to 0.4 U/kg, Levemir (Insulin) exerts more than 50% of its maximum effect from 3 to 4 hours up to approximately 14 hours after dose administration.
In a glucose clamp study, the overall glucodynamic effect (AUC) [mean mg/kg ± SD (CV)] of four separate subcutaneous injections in the thigh was 1702.6 ± 489 mg/kg (29%) in the Levemir (Insulin) group and 1922.8 ± 765 mg/kg (40%) for NPH. The clinical significance of this difference has not been established.
Levemir (Insulin) Clinical Studies
The efficacy and safety of Levemir (Insulin) given once-daily at bedtime or twice-daily (before breakfast and at bedtime, before breakfast and with the evening meal, or at 12-hour intervals) was compared to that of once-daily or twice-daily NPH human insulin or once-daily insulin glargine in non-blinded, randomized, parallel studies of 6004 patients with diabetes (3724 with type 1, and 2280 with type 2). In general, patients treated with Levemir (Insulin) achieved levels of glycemic control similar to those treated with NPH human insulin or insulin glargine, as measured by glycosylated hemoglobin (HbA).
In one non-blinded clinical study (Study A, n=409), adult patients with type 1 diabetes were randomized to treatment with either Levemir (Insulin) at 12-hour intervals, Levemir (Insulin) morning and bedtime or NPH human insulin morning and bedtime. Insulin aspart was also administered before each meal. At 16 weeks of treatment, the combined Levemir (Insulin) -treated patients had similar HbA and fasting plasma glucose (FPG) reductions to NPH-treated patients (Table 1). Differences in timing of Levemir (Insulin) administration (or flexible dosing) had no effect on HbA, FPG, body weight, or risk of having hypoglycemic episodes.
Overall glycemic control achieved with Levemir (Insulin) was compared to that achieved with insulin glargine in a randomized, non-blinded, clinical study (Study B, n=320) in which patients with type 1 diabetes were treated for 26 weeks with either twice-daily (morning and bedtime) Levemir (Insulin) or once-daily (bedtime) insulin glargine. Insulin aspart was administered before each meal. Levemir (Insulin) -treated patients had a decrease in HbA similar to that of insulin glargine-treated patients.
In a randomized, controlled clinical study (Study C, n=749), patients with type 1 diabetes were treated with once-daily (bedtime) Levemir (Insulin) or NPH human insulin, both in combination with human soluble insulin before each meal for 6 months. Levemir (Insulin) and NPH human insulin had a similar effect on HbA.
In a non-blinded, randomized, controlled clinical study (Study D, n=347), pediatric patients (age range 6 to 17) with type 1 diabetes were treated for 26 weeks with a basal-bolus insulin regimen. Levemir (Insulin) and NPH human insulin were administered once- or twice-daily (bedtime or morning and bedtime) according to pretrial dose regimen. Bolus insulin aspart was administered before each meal. Levemir (Insulin) -treated patients had a decrease in HbA similar to that of NPH human insulin.
In a 24-week, non-blinded, randomized, clinical study (Study E, n=476), Levemir (Insulin) administered twice-daily (before breakfast and evening) was compared to a similar regimen of NPH human insulin as part of a regimen of combination therapy with one or two of the following oral antidiabetes agents (metformin, insulin secretagogue, or α–glucosidase inhibitor). Levemir (Insulin) and NPH similarly lowered HbA from baseline (Table 3).
In a 22-week, non-blinded, randomized, clinical study (Study F, n=395) in adults with Type 2 diabetes, Levemir (Insulin) and NPH human insulin were given once- or twice-daily as part of a basal-bolus regimen. As measured by HbA or FPG, Levemir (Insulin) had efficacy similar to NPH human insulin.
Levemir (Insulin) Indications And Usage
Levemir (Insulin) is indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia.
Levemir (Insulin) Contraindications
Levemir (Insulin) is contraindicated in patients hypersensitive to insulin detemir or one of its excipients.
Levemir (Insulin) Precautions
Inadequate dosing or discontinuation of treatment may lead to hyperglycemia and, in patients with type 1 diabetes, diabetic ketoacidosis. The first symptoms of hyperglycemia usually occur gradually over a period of hours or days. They include nausea, vomiting, drowsiness, flushed dry skin, dry mouth, increased urination, thirst and loss of appetite as well as acetone breath. Untreated hyperglycemic events are potentially fatal.
Levemir (Insulin) is not intended for intravenous or intramuscular administration. The prolonged duration of activity of insulin detemir is dependent on injection into subcutaneous tissue. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia. Absorption after intramuscular administration is both faster and more extensive than absorption after subcutaneous administration.
Levemir (Insulin) should not be diluted or mixed with any other insulin preparations
Mixing of Insulins
Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Lipodystrophy and hypersensitivity are among potential clinical adverse effects associated with the use of all insulins.
As with all insulin preparations, the time course of Levemir (Insulin) action may vary in different individuals or at different times in the same individual and is dependent on site of injection, blood supply, temperature, and physical activity.
Adjustment of dosage of any insulin may be necessary if patients change their physical activity or their usual meal plan.
As with all insulin preparations, hypoglycemic reactions may be associated with the administration of Levemir (Insulin) . Hypoglycemia is the most common adverse effect of insulins. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control (see PRECAUTIONS, ). Such situations may result in severe hypoglycemia (and, possibly, loss of consciousness) prior to patients’ awareness of hypoglycemia.
The time of occurrence of hypoglycemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen or timing of dosing is changed. In patients being switched from other intermediate or long-acting insulin preparations to once- or twice-daily Levemir (Insulin) , dosages can be prescribed on a unit-to-unit basis; however, as with all insulin preparations, dose and timing of administration may need to be adjusted to reduce the risk of hypoglycemia (see , Changeover to Levemir (Insulin) ).
As with any insulin therapy, lipodystrophy may occur at the injection site and delay insulin absorption. Other injection site reactions with insulin therapy may include redness, pain, itching, hives, swelling, and inflammation. Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions. Reactions usually resolve in a few days to a few weeks. On rare occasions, injection site reactions may require discontinuation of Levemir (Insulin) .
In some instances, these reactions may be related to factors other than insulin, such as irritants in a skin cleansing agent or poor injection technique.
Systemic allergy: Generalized allergy to insulin, which is less common but potentially more serious, may cause rash (including pruritus) over the whole body, shortness of breath, wheezing, reduction in blood pressure, rapid pulse, or sweating. Severe cases of generalized allergy, including anaphylactic reaction, may be life-threatening.
Levemir (Insulin) must only be used if the solution appears clear and colorless with no visible particles (see DOSAGE AND ADMINISTRATION, ). Patients should be informed about potential risks and advantages of Levemir (Insulin) therapy, including the possible side effects. Patients should be offered continued education and advice on insulin therapies, injection technique, life-style management, regular glucose monitoring, periodic glycosylated hemoglobin testing, recognition and management of hypo- and hyperglycemia, adherence to meal planning, complications of insulin therapy, timing of dosage, instruction for use of injection devices and proper storage of insulin. Patients should be informed that frequent, patient-performed blood glucose measurements are needed to achieve effective glycemic control to avoid both hyperglycemia and hypoglycemia. Patients must be instructed on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, or skipped meals. Refer patients to the Levemir (Insulin) "" circular for additional information.
As with all patients who have diabetes, the ability to concentrate and/or react may be impaired as a result of hypoglycemia or hyperglycemia.
Patients with diabetes should be advised to inform their health care professional if they are pregnant or are contemplating pregnancy (see PRECAUTIONS, ).
A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring.
The following are examples of substances that may reduce the blood-glucose-lowering effect of insulin: corticosteroids, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives).
The following are examples of substances that may increase the blood-glucose-lowering effect of insulin and susceptibility to hypoglycemia: oral antidiabetic drugs, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, propoxyphene, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics.
Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine, and reserpine, the signs of hypoglycemia may be reduced or absent.
The results of and protein binding studies demonstrate that there is no clinically relevant interaction between insulin detemir and fatty acids or other protein bound drugs.
If Levemir (Insulin) is mixed with other insulin preparations, the profile of action of one or both individual components may change. Mixing Levemir (Insulin) with insulin aspart, a rapid acting insulin analog, resulted in about 40% reduction in AUC() and C for insulin aspart compared to separate injections when the ratio of insulin aspart to Levemir (Insulin) was less than 50%.
Levemir (Insulin) should NOT be mixed or diluted with any other insulin preparations.
Levemir (Insulin) Adverse Reactions
Adverse events commonly associated with human insulin therapy include the following:
In trials of up to 6 months duration in patients with type 1 and type 2 diabetes, the incidence of severe hypoglycemia with Levemir (Insulin) was comparable to the incidence with NPH, and, as expected, greater overall in patients with type 1 diabetes (Table 4).
In trials of up to 6 months duration in patients with type 1 and type 2 diabetes, Levemir (Insulin) was associated with somewhat less weight gain than NPH (Table 4). Whether these observed differences represent true differences in the effects of Levemir (Insulin) and NPH insulin is not known, since these trials were not blinded and the protocols (e.g., diet and exercise instructions and monitoring) were not specifically directed at exploring hypotheses related to weight effects of the treatments compared. The clinical significance of the observed differences has not been established.
Levemir (Insulin) Overdosage
Hypoglycemia may occur as a result of an excess of insulin relative to food intake, energy expenditure, or both. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid reoccurrence of hypoglycemia.
Levemir (Insulin) Dosage And Administration
Levemir (Insulin) can be administered once- or twice-daily. The dose of Levemir (Insulin) should be adjusted according to blood glucose measurements. The dosage of Levemir (Insulin) should be individualized based on the physician’s advice, in accordance with the needs of the patient.
Levemir (Insulin) should be administered by subcutaneous injection in the thigh, abdominal wall, or upper arm. Injection sites should be rotated within the same region. As with all insulins, the duration of action will vary according to the dose, injection site, blood flow, temperature, and level of physical activity.
Levemir (Insulin) How Supplied
Levemir (Insulin) is available in the following package sizes: each presentation containing 100 Units of insulin detemir per mL (U-100).
*Levemir (Insulin) PenFillcartridges are for use with Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery devices and NovoFine disposable needles.
Levemir (Insulin) Recommended Storage
Unused Levemir (Insulin) should be stored between 2° and 8°C (36° to 46° F). .
After initial use, vials should be stored in a refrigerator, never in a freezer. If refrigeration is not possible, the in-use vial can be kept unrefrigerated at room temperature, below 30°C (86°F), for up to 42 days, as long as it is kept as cool as possible and away from direct heat and light.
Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.
After initial use, a cartridge (PenFill) or a prefilled syringe (including FlexPen or InnoLet) may be used for up to 42 days if it is kept at room temperature, below 30°C (86°F). In-use cartridges and prefilled syringes in-use must NOT be stored in a refrigerator and must NOT be stored with the needle in place. Keep all cartridges and prefilled syringes away from direct heat and sunlight.
Not in-use (unopened) Levemir (Insulin) PenFill, FlexPen or InnoLet can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused cartridges and prefilled syringes in the carton so they will stay clean and protected from light.
The storage conditions are summarized in the following table:
Date of issue: July 15, 2009
Version: 5
© 2005/2009 Novo Nordisk Inc.
Levemir (Insulin) is covered by US Patent Nos. 5,750,497; 5,866,538; 6,011,007; 6,869,930 and other patents pending.
FlexPen is covered by US Patent Nos. 6,004,297; 6,235,004; 6,582,404 and other patents pending.
Manufactured for:
Novo Nordisk Inc.
Princeton, NJ 08540
www.novonordisk-us.com
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark
Levemir (Insulin) Patient Information
(insulin detemir [rDNA origin] injection)
Make sure you know the type and strength of insulin prescribed for you.
Read the Patient Information that comes with Levemir (Insulin) before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your diabetes or your treatment. Make sure that you know how to manage your diabetes. Ask your healthcare provider if you have any questions about managing your diabetes.
Levemir (Insulin) is a man-made long-acting insulin that is used to control high blood sugar in adults and children with diabetes mellitus.
Only use Levemir (Insulin) if it appears clear and colorless. There may be air bubbles. This is normal. If it looks cloudy, thickened, or colored, or if it contains solid particles do not use it and call Novo Nordisk at 1-800-727-6500.
Levemir (Insulin) comes in:
These are not all of the possible side effects from Levemir (Insulin) . Ask your healthcare provider or pharmacist for more information.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Medicines are sometimes prescribed for conditions that are not mentioned in the patient leaflet. Do not use Levemir (Insulin) for a condition for which it was not prescribed. Do not give Levemir (Insulin) to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about Levemir (Insulin) . If you would like more information about Levemir (Insulin) or diabetes, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Levemir (Insulin) that is written for healthcare professionals. Call 1-800-727-6500 or visit www.novonordisk-us.com for more information.
Helpful information for people with diabetes is published by the American Diabetes Association, 1701 N Beauregard Street, Alexandria, VA 22311 and on www.diabetes.org.
Levemir (Insulin) ingredients include:
All Levemir (Insulin) vials and Levemir (Insulin) FlexPen are latex free.
Date of Issue: May 22, 2009
Version: 4
Levemir (Insulin) is covered by US Patent Nos. 5,750,497, 5,866,538, 6,011,007, 6,869,930, and other patents pending.
FlexPen is covered by US Patent Nos. 6,582,404, 6,004,297, 6,235,004, and other patents pending.
PenFill is covered by US Patent Nos. 6,126,646, 5,693,027, DES 347894, and other patents pending.
© 2005-2009 Novo Nordisk Inc.
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark
For information about Levemir (Insulin) contact:
Novo Nordisk Inc.
100 College Road West,
Princeton, New Jersey 08540
* Levemir (Insulin) PenFill cartridges are for use with Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery devices and NovoFine disposable needles.
Levemir (Insulin) InnoLet is a disposable dial-a-dose insulin delivery system able to deliver 1 to a maximum of 50 units. The dose can be adjusted in increments of 1 unit. Levemir (Insulin) InnoLet is designed for use with NovoFine single-use needles. Levemir (Insulin) InnoLet is not recommended for the blind or severely visually impaired patients without the assistance of a sighted individual trained in the proper use of the product.
a. Pull off the cap.
b. Wipe the rubber membrane with an alcohol swab.
c. Remove the protective tab from the disposable needle and screw the needle onto the InnoLet (see diagram ). Never place a disposable needle on your InnoLet until you are ready to give an injection. Remove the needle from InnoLet immediately after the use. If the needle is not removed, some liquid may leak from the Levemir (Insulin) InnoLet.
d.
Small amounts of air may collect in the needle and insulin reservoir during normal use. dial 2 units by turning the dose selector clockwise. Hold the Levemir (Insulin) InnoLet with the needle pointing up and tap the Levemir (Insulin) InnoLet gently with your finger so any air bubbles collect in the top of the reservoir. Remove both the plastic outer and inner needle cap.
e. With the needle pointing up, press the push button as far as it will go and the dose selector returns to zero. See if a drop of insulin appears at the needle tip (see Figure ). If not, repeat the procedure until insulin appears.
Always check that the push button is fully depressed and the dose selector is set at 0. Hold the Levemir (Insulin) InnoLet in front of you and dial the dose selector clockwise to set the required dose. Do not put your hand over the push button when dialing the dose. If the button is not allowed to rise freely, insulin will be pushed out of the needle. You will hear a click for every single unit dialed. Do not rely on the clicking sound as a means for setting your dose. If you have set a wrong dose, simply dial the dose selector forward or backwards until the right number of dose has been set.
Use the injection technique recommended by your doctor or health care professionals.
Always check that the push button is fully depressed before using the Levemir (Insulin) InnoLetagain. If not, turn the dose selector until the push button is completely down. Then proceed as stated in steps 1-3.
The numbers on the insulin reservoir can be used to estimate the amount of insulin left in the Levemir (Insulin) InnoLet. Do not use these numbers to measure the insulin dose. You cannot set a dose greater than the number of units remaining in the reservoir.
If you think that your Levemir (Insulin) InnoLet is not working properly, follow this procedure:
a. Screw on a new NovoFine needle
b. Perform air shot as described in
c. Put the outer needle cap onto the needle
d. Dispense 20 units into the needle cap.
The insulin will fill the lower part of the cap (as shown in the figure above).
If the Levemir (Insulin) InnoLet has released too much or too little insulin, repeat the test. If it happens again, do not use your Levemir (Insulin) InnoLet and contact Novo Nordisk at 1-800-727-6500.
Please read the following instructions carefully before using your Levemir (Insulin) FlexPen.
Levemir (Insulin) FlexPen is a disposable dial-a-dose insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. Levemir (Insulin) FlexPen is designed to be used with NovoFine needles.
Make sure you have the following items:
Wash your hands with soap and water. Before you start to prepare your injection, check the label to make sure that you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin. Levemir (Insulin) should look clear.
Wipe the rubber stopper with an alcohol swab.
Remove the protective tab from a disposable needle.
Screw the needle tightly onto your FlexPen. It is important that the needle is put on straight (see diagram B).
Never place a disposable needle on your Levemir (Insulin) FlexPen until you are ready to take your injection.
Before each injection small amounts of air may collect in the cartridge during normal use. To avoid injecting air and to ensure proper dosing:
A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.
If you do not see a drop of insulin after 6 times, do not use the Levemir (Insulin) FlexPen and contact Novo Nordisk at 1-800-727-6500.
A small air bubble may remain at the needle tip, but it will not be injected.
Check and make sure that the dose selector is set at 0.
The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer (see diagram H). When turning the dose selector, be careful not to press the push-button as insulin will come out.
You cannot select a dose larger than the number of units left in the cartridge.
You will hear a click for every single unit dialed. Do not set the dose by counting the number of clicks you hear.
Do the injection exactly as shown to you by your healthcare provider. Your healthcare provider should tell you if you need to pinch the skin before injecting.
Inject the dose by pressing the push-button all the way in until the 0 lines up with the pointer (see diagram I). Be careful only to push the button when injecting.
Turning the dose selector will not inject insulin.
This will make sure that the full dose has been given. You may see a drop of Levemir (Insulin) at the needle tip. This is normal and has no effect on the dose you just received. If blood appears after you take the needle out of your skin, press the injection site lightly with a finger.
The Levemir (Insulin) FlexPen prevents the cartridge from being completely emptied. It is designed to deliver 300 units.
If your Levemir (Insulin) FlexPen is not working the right way, follow the steps below:
The insulin should fill the lower part of the big outer needle cap (see diagram L). If Levemir (Insulin) FlexPen has released too much or too little insulin, do the function check again. If the same problem happens again, do not use your Levemir (Insulin) FlexPen and contact Novo Nordisk at 1-800-727-6500.
Your FlexPen is designed to work accurately and safely. It must be handled with care. Avoid dropping your FlexPen as it may damage it. If you are concerned that your FlexPen is damaged, use a new one. You can clean the outside of your FlexPen by wiping it with a damp cloth. Do not soak or wash your FlexPen as it may damage it. Do not refill your FlexPen.
Insulin detemir (rDNA origin) injection
NDC 0169-3687-12
List 368712
100 units/mL (U-100)
10 mL
For subcutaneous use only
Rx Only
novo nordisk
NDC 0169-3439-10
List 643910
Insulin detemir (rDNA origin) injection
For use with NovoFine disposable needles.
Keep in a cool place.
Store at 2 - 8C (36 - 46F).
Avoid freezing.
Protect from light.
novo nordisk
