Novo Nordisk

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Novo Nordisk Drugs

Tresiba

Tresiba

2.1 Important Administration Instructions
• Always check insulin labels before administration [see Warnings and Precautions (5.4) ]. • Inspect visually for particulate matter and discoloration. Only use TRESIBA if the solution appears clear and colorless. • Train patients on proper use and injection technique before initiating TRESIBA. Training reduces the risk of administration errors such as needle sticks and incomplete dosing. • Inject TRESIBA subcutaneously into the thigh, upper arm, or abdomen. • Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy [see Adverse Reactions (6.1)]. • DO NOT administer TRESIBA intravenously, intramuscularly or in an insulin infusion pump. • DO NOT dilute or mix TRESIBA with any other insulin products or solutions. • DO NOT transfer TRESIBA from the TRESIBA pen into a syringe for administration [see Warnings and Precautions (5.4)].
2.2 General Dosing Instructions
• Inject TRESIBA subcutaneously once-daily at any time of day. • Individualize and titrate the dose of TRESIBA based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal. • The recommended days between dose increases is 3 to 4 days. • Dose adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness to minimize the risk of hypoglycemia or hyperglycemia [see Warnings and Precautions (5.3)]. • Instruct patients who miss a dose of TRESIBA to inject their daily dose during waking hours upon discovering the missed dose. Instruct patients to ensure that at least 8 hours have elapsed between consecutive TRESIBA injections. • DO NOT perform dose conversion when using the TRESIBA U-100 or U-200 FlexTouch pens. The dose window for both the TRESIBA U-100 and U-200 FlexTouch pens shows the number of insulin units to be delivered and NO conversion is needed.
2.3 Starting Dose in Insulin Naïve Patients

Type 1 Diabetes Mellitus:

The recommended starting dose of TRESIBA in insulin naïve patients with type 1 diabetes is approximately one-third to one-half of the total daily insulin dose. The remainder of the total daily insulin dose should be administered as a short-acting insulin and divided between each daily meal. As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin naïve patients with type 1 diabetes.

Type 2 Diabetes Mellitus:

The recommended starting dose of TRESIBA in insulin naïve patients with type 2 diabetes mellitus is 10 units once daily.

2.4 Starting Dose in Patients Already on Insulin Therapy

Type 1 and Type 2 Diabetes Mellitus:

Start TRESIBA at the same unit dose as the total daily long or intermediate-acting insulin unit dose.
Prandimet

Prandimet

Recommended Dosing

The dosage of PrandiMet should be individualized on the basis of the patient's current regimen, effectiveness and tolerability. PrandiMet can be administered 2 to 3 times a day up to a maximum daily dose of 10 mg repaglinide/2500 mg metformin HCl. No more than 4 mg repaglinide/1000 mg metformin HCl should be taken per meal. Initiation and maintenance of combination therapy with PrandiMet should be individualized to the patient, and at the discretion of the health care provider. Blood glucose monitoring should be performed to determine the therapeutic response to PrandiMet.

PrandiMet doses should usually be taken within 15 minutes prior to the meal but the timing can vary from immediately preceding the meal up to 30 minutes before the meal. Patients who skip a meal should be instructed to skip the PrandiMet dose for that meal.

Patients Inadequately Controlled with Metformin HClMonotherapy

If therapy with a combination tablet containing repaglinide and metformin HCl is considered appropriate for a patient with type 2 diabetes mellitus inadequately controlled with metformin HCl alone, the recommended starting dose of PrandiMet is 1 mg repaglinide/500 mg metformin HCl administered twice daily with meals, with gradual dose escalation (based on glycemic response) to reduce the risk of hypoglycemia with repaglinide.

Patients Inadequately Controlled with MeglitinideMonotherapy

If therapy with a combination tablet containing repaglinide and metformin HCl is considered appropriate for a patient with type 2 diabetes mellitus inadequately controlled with repaglinide alone, the recommended starting dose of the metformin HCl component of PrandiMet should be 500 mg metformin HCl twice a day, with gradual dose escalation (based on glycemic response) to reduce gastrointestinal side effects associated with metformin HCl.

Patients Currently Using Repaglinide and Metformin HCl Concomitantly

For patients switching from repaglinide co-administered with metformin HCl, PrandiMet can be initiated at the dose of repaglinide and metformin HCl similar to (but not exceeding) the patient's current doses, then may be titrated to the maximum daily dose as necessary to achieve targeted glycemic control.

No studies have been performed examining the safety and efficacy of PrandiMet in patients previously treated with other oral antihyperglycemic agents and switched to PrandiMet. Any change in therapy should be undertaken with care and with appropriate monitoring as changes in glycemic control can occur.
Novolin R

Novolin R

2.1 Dosing

The dosage and timing of Novolin R must be individualized. Blood glucose monitoring is essential for all patients receiving insulin therapy.

Total daily insulin requirements vary and are usually between 0.5 and 1.0 units/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered medications.

2.2 Subcutaneous Injection

Novolin R should generally be injected approximately 30 minutes prior to the start of a meal.

Novolin R given by subcutaneous injection should generally be used in regimens that include an intermediate or long-acting insulin [see How Supplied/Storage and Handling (16.1, 16.2)].

Novolin R should be administered by subcutaneous injection in the abdominal region, buttocks, thigh, or the upper arm. Subcutaneous injection into the abdominal wall is generally associated with faster absorption than other injection sites. Injection sites should be rotated within the same region to reduce the risk of lipodystrophy. Injection into a lifted skin fold minimizes the risk of intramuscular injection.

2.3 Intravenous Use

Novolin R can be administered intravenously under medical supervision for glycemic control, with close monitoring of blood glucose and potassium concentrations to avoid hypoglycemia and hypokalemia [see Warnings and Precautions (5.2, 5.3), How Supplied/Storage and Handling (16.1, 16.2)].

Intravenous administration of insulin is commonly used in the treatment of diabetic ketoacidosis, peri-operative management of diabetes, and maintenance of glycemic control during labor in pregnant diabetic women. For intravenous use, Novolin R should be used at concentrations from 0.05 units/mL to 1.0 unit/mL in infusion systems using polypropylene infusion bags. Novolin R can be used with the following infusion fluids: 0.9% sodium chloride, 5% dextrose, or 10% dextrose with 40 mmol/L potassium chloride.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Never use Novolin R if it has become viscous or cloudy; use Novolin R only if it is clear and colorless. Vials should not be used if leakage is observed. Novolin R should not be used after the printed expiration date.

The onset of action of Novolin R, when administered intravenously, is more rapid in comparison to subcutaneous administration.

2.4 Use in Insulin Pumps

Use of Novolin R in insulin pumps is not recommended because of the risk of precipitation.
Vagifem

Vagifem

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer.

A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions (5.3, 5.15)].

Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

2.1 Treatment of Atrophic Vaginitis due to Menopause

Vagifem should be administered intravaginally using the supplied applicator: 1 tablet daily for 2 weeks, followed by 1 tablet twice weekly (for example, Tuesday and Friday). Generally, women should be started at the 10 mcg dosage strength.
Prandin

Prandin

There is no fixed dosage regimen for the management of type 2 diabetes with PRANDIN.

The patient's blood glucose should be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood glucose-lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels are of value in monitoring the patient's longer term response to therapy.

Short-term administration of PRANDIN may be sufficient during periods of transient loss of control in patients usually well controlled on diet.

PRANDIN doses are usually taken within 15 minutes of the meal but time may vary from immediately preceding the meal to as long as 30 minutes before the meal.

Starting Dose

For patients not previously treated or whose HbA1c is < 8%, the starting dose should be 0.5 mg with each meal. For patients previously treated with blood glucose-lowering drugs and whose HbA1c is ≥ 8%, the initial dose is 1 or 2 mg with each meal preprandially (see previous paragraph).

Dose Adjustment

Dosing adjustments should be determined by blood glucose response, usually fasting blood glucose. Postprandial glucose levels testing may be clinically helpful in patients whose pre-meal blood glucose levels are satisfactory but whose overall glycemic control (HbA1c) is inadequate. The preprandial dose should be doubled up to 4 mg with each meal until satisfactory blood glucose response is achieved. At least one week should elapse to assess response after each dose adjustment.

The recommended dose range is 0.5 mg to 4 mg taken with meals. PRANDIN may be dosed preprandially 2, 3, or 4 times a day in response to changes in the patient’s meal pattern. The maximum recommended daily dose is 16 mg.

Patient Management

Long-term efficacy should be monitored by measurement of HbA1c levels approximately every 3 months. Failure to follow an appropriate dosage regimen may precipitate hypoglycemia or hyperglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy including hypoglycemia. When hypoglycemia occurs in patients taking a combination of PRANDIN and a thiazolidinedione or PRANDIN and metformin, the dose of PRANDIN should be reduced.

Patients Receiving Other Oral Hypoglycemic Agents

When PRANDIN is used to replace therapy with other oral hypoglycemic agents, PRANDIN may be started on the day after the final dose is given. Patients should then be observed carefully for hypoglycemia due to potential overlapping of drug effects. When transferred from longer half-life sulfonylurea agents (e.g., chlorpropamide) to repaglinide, close monitoring may be indicated for up to one week or longer.

Combination Therapy

If PRANDIN monotherapy does not result in adequate glycemic control, metformin or a thiazolidinedione may be added. If metformin or thiazolidinedione monotherapy does not provide adequate control, PRANDIN may be added. The starting dose and dose adjustments for PRANDIN combination therapy is the same as for PRANDIN monotherapy. The dose of each drug should be carefully adjusted to determine the minimal dose required to achieve the desired pharmacologic effect. Failure to do so could result in an increase in the incidence of hypoglycemic episodes. Appropriate monitoring of FPG and HbA1c measurements should be used to ensure that the patient is not subjected to excessive drug exposure or increased probability of secondary drug failure.
Victoza

Victoza

Victoza can be administered once daily at any time of day, independently of meals, and can be injected subcutaneously in the abdomen, thigh or upper arm. The injection site and timing can be changed without dose adjustment.

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.

When initiating Victoza, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycemia [see Warnings and Precautions (5.4) and Adverse Reactions (6)].

When using Victoza with insulin, administer as separate injections. Never mix. It is acceptable to inject Victoza and insulin in the same body region but the injections should not be adjacent to each other.

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.

If a dose is missed, the once-daily regimen should be resumed as prescribed with the next scheduled dose. An extra dose or increase in dose should not be taken to make-up for the missed dose.

Based on the elimination half-life, patients should be advised to reinitiate Victoza at 0.6 mg if more than 3 days have elapsed since the last Victoza dose. This approach will mitigate any gastrointestinal symptoms associated with reinitiation of treatment. Upon reinitiation, Victoza should be titrated at the discretion of the prescribing healthcare provider.
Novolin N

Novolin N

How should I take Novolin® N?

Only use Novolin® N if it appears cloudy or milky. There may be air bubbles. This is normal. If the precipitate (the white deposit at the bottom of the vial) has become lumpy or granular in appearance or has formed a deposit of solid particles on the wall of the vial, do not use it, and call Novo Nordisk at 1-800-727-6500. This insulin should not be used if the liquid in the vial remains clear after the vial has been gently rotated.

Novolin® N comes in:
• 10 mL vials (small bottles) for use with syringe
Novolin 7030

Novolin 7030

How should I take Novolin® 70/30?

Only use Novolin® 70/30 if it appears cloudy or milky. There may be air bubbles. This is normal. If the precipitate (the white deposit at the bottom of the vial) has become lumpy or granular in appearance or has formed a deposit of solid particles on the wall of the vial, do not use it, and call Novo Nordisk at 1-800-727-6500. This insulin should not be used if the liquid in the vial remains clear after the vial has been gently rotated.

Novolin® 70/30 comes in:
• 10 mL vials (small bottles) for use with syringe
Glucagen Hypokit

Glucagen Hypokit

For GlucaGen HypoKit:

2.1 Treatment of severe hypoglycemia
1. Using the supplied prefilled syringe, carefully insert the needle through the rubber stopper of the vial containing GlucaGen powder and inject all the liquid from the syringe into the vial. 2. Shake the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted fluid should be clear and of water-like consistency. 3. The reconstituted GlucaGen gives a concentration of approximately 1 mg/mL glucagon. 4. The reconstituted GlucaGen should be used immediately after reconstitution. 5. Inject 1 mL (adults and children, weighing more than 55 lbs (25 kg)) or 0.5 mL (children weighing less than 55 lbs (25 kg)) subcutaneously, intramuscularly, or intravenously. If the weight is not known: children younger than 6 years should be given a 0.5 mL and children 6 years and older should be given 1 mL. 6. Discard any unused portion. 7. Emergency assistance should be sought immediately after subcutaneous or intramuscular injection of glucagon. 8. The glucagon injection may be repeated using a new kit while waiting for emergency assistance. 9. Intravenous glucose MUST be administered if the patient fails to respond to glucagon. 10. When the patient has responded to the treatment, give oral carbohydrates to restore the liver glycogen and prevent recurrence of hypoglycemia. For GlucaGen Diagnostic Kit and the GlucaGen 10-pack:
2.2 Use as a diagnostic aid

1. GlucaGen should be reconstituted with 1 mL of Sterile Water for Reconstitution (if supplied) or 1 mL of Sterile Water for Injection, USP. Using a syringe, withdraw all of the Sterile Water for Reconstitution (if supplied) or 1 mL Sterile Water for Injection, USP and inject into the GlucaGen vial.

2. Shake the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted fluid should be clear and of water-like consistency.

3. The reconstituted GlucaGen gives a concentration of approximately 1 mg/mL glucagon.

4. The reconstituted GlucaGen should be used immediately after reconstitution.

5. GlucaGen must be administered by medical personnel.

6. Discard any unused portion.

7. Onset of action after an injection will depend on the organ under examination and route of administration [see Pharmacodynamics (12.2)].

8. The usual diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small bowel is 0.2 mg to 0.5 mg given intravenously or 1 mg given intramuscularly; the usual dose to relax the colon is 0.5 mg to 0.75 mg intravenously and 1 mg to 2 mg intramuscularly [see Pharmacodynamics (12.2)].

9. After the end of the diagnostic procedure, give oral carbohydrates to patients who have been fasting, if this is compatible with the diagnostic procedure applied.

The GlucaGen Diagnostic Kit and the GlucaGen 10-pack presentations are intended only for use by healthcare providers as a diagnostic aid. The GlucaGen Diagnostic Kit and the GlucaGen 10-pack presentations are not intended for use by patients to treat severe hypoglycemia because they are not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility.
Levemir

Levemir

2.1 Dosing

LEVEMIR is a recombinant human insulin analog for once- or twice-daily subcutaneous administration.

Patients treated with LEVEMIR once-daily should administer the dose 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.

The dose of LEVEMIR must be individualized based on clinical response. Blood glucose monitoring is essential in all patients receiving insulin therapy.

Patients adjusting the amount or timing of dosing with LEVEMIR should only do so under medical supervision with appropriate glucose monitoring [see Warnings and Precautions (5.2)].

In patients with type 1 diabetes, LEVEMIR must be used in a regimen with rapid-acting or short-acting insulin.

As with all insulins, injection sites should be rotated within the same region (abdomen, thigh, or deltoid) from one injection to the next to reduce the risk of lipodystrophy [see Adverse Reactions (6.1)].

LEVEMIR can be injected subcutaneously in the thigh, abdominal wall, or upper arm. As with all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by exercise and other variables, such as stress, intercurrent illness, or changes in co-administered medications or meal patterns.

When using LEVEMIR with a glucagon-like peptide (GLP)-1 receptor agonist, administer as separate injections. Never mix. It is acceptable to inject LEVEMIR and a GLP-1 receptor agonist in the same body region but the injections should not be adjacent to each other.

2.2 Initiation of LEVEMIR Therapy

The recommended starting dose of LEVEMIR in patients with type 1 diabetes should be approximately one-third 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.

The recommended starting dose of LEVEMIR in patients with type 2 diabetes inadequately controlled on oral antidiabetic medications is 10 Units (or 0.1-0.2 Units/kg) given once daily in the evening or divided into a twice daily regimen.

The recommended starting dose of LEVEMIR in patients with type 2 diabetes inadequately controlled on a GLP-1 receptor agonist is 10 Units given once daily in the evening.

LEVEMIR doses should subsequently be adjusted based on blood glucose measurements. The dosages of LEVEMIR should be individualized under the supervision of a healthcare provider.

2.3 Converting to LEVEMIR from Other Insulin Therapies

If converting from insulin glargine to LEVEMIR, the change can be done on a unit-to-unit basis.

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)].

As with all insulins, close glucose monitoring is recommended during the transition and in the initial weeks thereafter. Doses and timing of concurrent rapid-acting or short-acting insulins or other concomitant antidiabetic treatment may need to be adjusted.
Good Sense All Day Alle...

Good Sense All Day Allergy

The recommended dosage of Saxenda is 3 mg daily. The dose escalation schedule in Table 1 should be used to reduce the likelihood of gastrointestinal symptoms. If patients do not tolerate an increased dose during dose escalation, consider delaying dose escalation for approximately one additional week. Saxenda should be discontinued, however, if a patient cannot tolerate the 3 mg dose, as efficacy has not been established at lower doses (0.6, 1.2, 1.8, and 2.4 mg).

Table 1. Dose Escalation Schedule

Week

Daily Dose

1

0.6 mg

2

1.2 mg

3

1.8 mg

4

2.4 mg

5 and onward

3 mg

Saxenda should be taken once daily at any time of day, without regard to the timing of meals. Saxenda can be injected subcutaneously in the abdomen, thigh, or upper arm. The injection site and timing can be changed without dose adjustment. Saxenda must not be administered intravenously or intramuscularly.

When initiating Saxenda in patients taking insulin secretagogues (such as sulfonylureas), consider reducing the dose of the insulin secretagogue (for example, by one-half) to reduce the risk for hypoglycemia, and monitor blood glucose. Saxenda and insulin should not be used together [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)]. Conversely, if discontinuing Saxenda in patients with type 2 diabetes, monitor for an increase in blood glucose.

Evaluate the change in body weight 16 weeks after initiating Saxenda and discontinue Saxenda if the patient has not lost at least 4% of baseline body weight, since it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.

If a dose is missed, the once-daily regimen should be resumed as prescribed with the next scheduled dose. An extra dose or increase in dose should not be taken to make up for the missed dose. If more than 3 days have elapsed since the last Saxenda dose, patients should reinitiate Saxenda at 0.6 mg daily and follow the dose escalation schedule in Table 1, which may reduce the occurrence of gastrointestinal symptoms associated with reinitiation of treatment.

Prior to initiation of Saxenda, patients should be trained by their healthcare professional on proper injection technique. Training reduces the risk of administration errors such as needle sticks and incomplete dosing. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations.

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

BMI is calculated by dividing weight in (kilograms) by height (in meters) squared. A chart for determining BMI based on height and weight is provided in Table 2.

Table 2. BMI Conversion Chart
Novolog

Novolog

2.1 Dosing

NovoLog is an insulin analog with an earlier onset of action than regular human insulin. The dosage of NovoLog must be individualized. NovoLog given by subcutaneous injection should generally be used in regimens with an intermediate or long-acting insulin [see Warnings and Precautions (5), How Supplied/Storage and Handling (16.2)]. The total daily insulin requirement may vary and is usually between 0.5 to 1.0 units/kg/day. When used in a meal-related subcutaneous injection treatment regimen, 50 to 70% of total insulin requirements may be provided by NovoLog and the remainder provided by an intermediate-acting or long-acting insulin. Because of NovoLog’s comparatively rapid onset and short duration of glucose lowering activity, some patients may require more basal insulin and more total insulin to prevent pre-meal hyperglycemia when using NovoLog than when using human regular insulin.

Do not use NovoLog that is viscous (thickened) or cloudy; use only if it is clear and colorless. NovoLog should not be used after the printed expiration date.

2.2 Subcutaneous Injection

NovoLog should be administered by subcutaneous injection in the abdominal region, buttocks, thigh, or upper arm. Because NovoLog has a more rapid onset and a shorter duration of activity than human regular insulin, it should be injected immediately (within 5-10 minutes) before a meal. Injection sites should be rotated within the same region to reduce the risk of lipodystrophy. As with all insulins, the duration of action of NovoLog will vary according to the dose, injection site, blood flow, temperature, and level of physical activity.

NovoLog may be diluted with Insulin Diluting Medium for NovoLog for subcutaneous injection. Diluting one part NovoLog to nine parts diluent will yield a concentration one-tenth that of NovoLog (equivalent to U-10). Diluting one part NovoLog to one part diluent will yield a concentration one-half that of NovoLog (equivalent to U-50).

2.3 Continuous Subcutaneous Insulin Infusion (CSII) by External Pump

NovoLog can also be infused subcutaneously by an external insulin pump [see Warnings and Precautions (5.9, 5.10), How Supplied/Storage and Handling (16.2)]. Diluted insulin should not be used in external insulin pumps. Because NovoLog has a more rapid onset and a shorter duration of activity than human regular insulin, pre-meal boluses of NovoLog should be infused immediately (within 5-10 minutes) before a meal. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen. Although there is significant interpatient variability, approximately 50% of the total dose is usually given as meal-related boluses of NovoLog and the remainder is given as a basal infusion. Change the NovoLog in the reservoir at least every 6 days, change the infusion sets and the infusion set insertion site at least every 3 days.

The following insulin pumps† have been used in NovoLog clinical or in vitro studies conducted by Novo Nordisk, the manufacturer of NovoLog:
• Medtronic Paradigm® 512 and 712 • MiniMed 508 • Disetronic® D-TRON® and H-TRON®
Before using a different insulin pump with NovoLog, read the pump label to make sure the pump has been evaluated with NovoLog.

2.4 Intravenous Use

NovoLog can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia [see Warnings and Precautions (5), How Supplied/Storage and Handling (16.2)]. For intravenous use, NovoLog should be used at concentrations from 0.05 U/mL to 1.0 U/mL insulin aspart in infusion systems using polypropylene infusion bags. NovoLog has been shown to be stable in infusion fluids such as 0.9% sodium chloride.

Inspect NovoLog for particulate matter and discoloration prior to parenteral administration.
Novolog Mix 7030

Novolog Mix 7030

2.1 Dosing

NovoLog Mix 70/30 is an insulin analog with an earlier onset and intermediate duration of action in comparison to the basal human insulin premix. The addition of protamine to the rapid-acting aspart insulin analog (NovoLog) results in insulin activity that is 30% short-acting and 70% long-acting. NovoLog Mix 70/30 is typically dosed on a twice-daily basis (with each dose intended to cover 2 meals or a meal and a snack). The dosage of NovoLog Mix 70/30 must be individualized. The written prescription for NovoLog Mix 70/30 should include the full name, to avoid confusion with NovoLog (insulin aspart) and Novolin 70/30 (human premix).

NovoLog Mix 70/30 should appear uniformly white and cloudy. Do not use it if it looks clear or if it contains solid particles. NovoLog Mix 70/30 should not be used after the printed expiration date.

NovoLog Mix 70/30 should be administered by subcutaneous injection in the abdominal region, buttocks, thigh, or upper arm. NovoLog Mix 70/30 has a faster onset of action than human insulin premix 70/30 and should be dosed within 15 minutes before meal initiation for patients with type 1 diabetes. For patients with type 2 diabetes, dosing should occur within 15 minutes before or after meal initiation. Injection sites should be rotated within the same region to reduce the risk of lipodystrophy. As with all insulins, the duration of action may vary according to the dose, injection site, blood flow, temperature, and level of physical activity.

NovoLog Mix 70/30 should not be administered intravenously or used in insulin infusion pumps. Dose regimens of NovoLog Mix 70/30 will vary among patients and should be determined by the health care professional familiar with the patient’s recommended glucose treatment goals, metabolic needs, eating habits, and other lifestyle variables.

2.2 Resuspension

NovoLog Mix 70/30 is a suspension that must be visually inspected and resuspended immediately before use. The NovoLog Mix 70/30 vial should be rolled gently in your hands in a horizontal position 10 times to mix it. The rolling procedure must be repeated until the suspension appears uniformly white and cloudy. Inject immediately. Resuspension is easier when the insulin has reached room temperature.

The NovoLog Mix 70/30 FlexPen should be rolled 10 times gently between your hands in a horizontal position. Thereafter, turn the NovoLog Mix 70/30 FlexPen upside down so that the glass ball moves from one end of the reservoir to the other. Do this at least 10 times. The rolling and turning procedure must be repeated until the suspension appears uniformly white and cloudy. Inject immediately. Before each subsequent injection, turn the disposable NovoLog Mix 70/30 FlexPen upside down so that the glass ball moves from one end of the reservoir to the other at least 10 times and until the suspension appears uniformly white and cloudy. Inject immediately.
Activella

Activella

Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

Activella therapy consists of a single tablet to be taken once daily for the treatment of moderate to severe vasomotor symptoms due to menopause.
• Activella 1 mg/0.5 mg • Activella 0.5 mg/0.1 mg
2.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause

Activella therapy consists of a single tablet to be taken once daily for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
• Activella 1 mg/0.5 mg
2.3 Prevention of Postmenopausal Osteoporosis

Activella therapy consists of a single tablet to be taken once daily for the prevention of postmenopausal osteoporosis.
• Activella 1 mg/0.5 mg • Activella 0.5 mg/0.1 mg
Novoseven Rt

Novoseven Rt

For intravenous bolus administration only

2.1 Dose
• Treatment with NovoSeven RT should be initiated under the direction of a qualified healthcare professional experienced in the treatment of bleeding disorders. • Use hemostasis evaluation to determine the effectiveness of NovoSeven RT and to provide a basis for modification of the NovoSeven RT treatment schedule. • Coagulation parameters do not necessarily correlate with or predict the effectiveness of NovoSeven RT.
Treatment of Acute Bleeding Episodes

NovoSeven RT dosing for the treatment of acute bleeding episodes is provided in Table 1.

Table 1: Dosing for Treatment of Acute Bleeding Episodes
Dose* and Frequency Duration of Therapy Additional Information * The minimum effective dose has not been determined
Congenital Hemophilia A or B with Inhibitors

Hemostatic

90 mcg/kg every two hours, adjustable based on severity of bleeding

Post-Hemostatic

90 mcg/kg every 3-6 hours for severe bleeds

Until hemostasis is achieved, or until the treatment has been judged to be inadequate

After hemostasis is achieved to maintain the hemostatic plug

The appropriate duration of post-hemostatic dosing has not been studied

Acquired Hemophilia

70-90 mcg/kg every 2-3 hours

Until hemostasis is achieved

Congenital Factor VII Deficiency

15-30 mcg/kg every 4-6 hours

Until hemostasis is achieved

Effective treatment has been achieved with doses as low as 10 micrograms per kg body weight.

Adjust dose and frequency of injections to each individual patient

Glanzmann’s Thrombasthenia

90 mcg/kg every 2-6 hours

In severe bleeding episodes requiring systemic hemostatic therapy until hemostasis is achieved

Platelet transfusions are the primary treatment in patients with Glanzmann’s Thrombasthenia without refractoriness to platelets or in patients without platelet-specific antibodies

Congenital Hemophilia A or B with inhibitors
• Dose and administration interval may be adjusted to the individual patient based on the severity of the bleeding. 1 • For patients treated for joint or muscle bleeds, a decision on outcome was reached for a majority of patients within eight doses although more doses were required for severe bleeds. A majority of patients who reported adverse experiences received more than twelve doses. Monitor and minimize the duration of any post-hemostatic dosing.
Perioperative Management

NovoSeven RT dosing for prevention of bleeding in surgical interventions or invasive procedures (perioperative management) is provided in Table 2.

Table 2: Dosing for Perioperative Management
Type of Surgery Dose and Frequency Additional Information * The minimum effective dose has not been determined.
Congenital Hemophilia A or B with Inhibitors

Minor

Initial: 90 mcg/kg immediately before surgery and repeat every 2 hours for the duration of the surgery

Post surgical:

90 mcg/kg every 2 hours for 48 hours then every 2-6 hours until healing occurs

Major

Initial:

90 mcg/kg immediately before surgery and repeat every 2 hours for the duration of the surgery

Post surgical:

90 mcg/kg every 2 hours for 5 days then every 4 hours until healing occurs

Additional bolus doses should be administered if required

Acquired Hemophilia

Minor or Major

70-90 mcg/kg immediately before surgery and repeat every 2-3 hours for the duration of the surgery and until hemostasis is achieved*

Congenital Factor VII Deficiency

Minor or Major

15-30 mcg/kg immediately before surgery and repeat every 4-6 hours for the duration of the surgery and until hemostasis is achieved*

Adjust dose and frequency of injections to each individual patient

Effective treatment has been achieved with doses as low as 10 micrograms per kg body weight

Glanzmann’s Thrombasthenia

Minor or Major

Initial:

90 mcg/kg immediately before surgery and repeat every 2 hours for the duration of the procedure*

Post surgical:

90 mcg/kg every 2-6 hours to prevent post-operative bleeding*

Higher average infused doses (median dose was 100 micrograms per kg (IQR 90-140)) were noted for surgical patients who had clinical refractoriness with or without platelet-specific antibodies compared to those with neither

2.2 Reconstitution
• Follow the procedures below for the preparation and reconstitution of NovoSeven RT. For questions regarding reconstitution, please contact Novo Nordisk at 1-877-NOVO-777. • Calculate the NovoSeven RT dosage and select the appropriate NovoSeven RT package provided with either 1 histidine diluent vial or 1 pre-filled histidine diluent syringe. • Reconstitute only with the histidine diluent provided with NovoSeven RT.
NovoSeven RT package containing 1 vial of NovoSeven RT powder and 1 vial of histidine diluent:
1. Always use aseptic technique. 2. Bring NovoSeven RT (white, lyophilized powder) and the specified volume of histidine (diluent) to room temperature, but not above 37°C (98.6° F). The specified volume of diluent corresponding to the amount of NovoSeven RT is as follows: 1 mg (1000 micrograms) vial + 1.1 mL Histidine diluent 2 mg (2000 micrograms) vial + 2.1 mL Histidine diluent 5 mg (5000 micrograms) vial + 5.2 mL Histidine diluent 8 mg (8000 micrograms) vial + 8.1 mL Histidine diluent 3. Remove caps from the NovoSeven RT vials to expose the central portion of the rubber stopper. Cleanse the rubber stoppers with an alcohol swab and allow to dry prior to use. 4. Draw back the plunger of a sterile syringe (attached to sterile needle) and admit air into the syringe. It is recommended to use syringe needles of gauge size 20-26. 5. Insert the needle of the syringe into the Histidine diluent vial. Inject air into the vial and withdraw the quantity required for reconstitution. 6. Insert the syringe needle containing the diluent into the NovoSeven RT vial through the center of the rubber stopper, aiming the needle against the side so that the stream of liquid runs down the vial wall (the NovoSeven RT vial does not contain a vacuum). Do not inject the diluent directly on the NovoSeven RT powder. 7. Gently swirl the vial until all the material is dissolved. The reconstituted solution is a clear, colorless solution which may be stored either at room temperature or refrigerated for up to 3 hours after reconstitution. After reconstitution with the specified volume of diluent, each vial contains approximately 1 mg per mL NovoSeven RT (1000 micrograms per mL).
NovoSeven RT package containing 1 vial of NovoSeven RT powder and 1pre-filled histidine diluent syringe with vial adapter for needleless reconstitution:
1. Always use aseptic technique. 2. Bring NovoSeven RT (white, lyophilized powder) and the specified volume of histidine (diluent) to room temperature, but not above 37°C (98.6° F). The specified volume of diluent corresponding to the amount of NovoSeven RT is as follows: 1 mg (1000 micrograms) vial + 1 mL Histidine diluent in pre-filled syringe 2 mg (2000 micrograms) vial + 2 mL Histidine diluent in pre-filled syringe 5 mg (5000 micrograms) vial + 5 mL Histidine diluent in pre-filled syringe 8 mg (8000 micrograms) vial + 8 mL Histidine diluent in pre-filled syringe 3. Remove cap from the NovoSeven RT vial. Cleanse the rubber stopper with an alcohol swab and allow to dry prior to use. 4. Peel back the protective paper from the vial adapter. Do not remove the vial adapter from the package. 5. Place the NovoSeven RT vial on a flat surface. While holding the vial adapter package, place the vial adapter over the NovoSeven RT vial and press down firmly on the package until the vial adapter spike penetrates the rubber stopper. 6. Attach the plunger rod to the syringe. Turn the plunger rod clockwise into the plunger inside the pre-filled diluent syringe until resistance is felt. Remove the syringe cap from the pre-filled diluent syringe and screw onto the vial adapter. 7. Push the plunger rod to slowly inject all the diluent into the vial. Keep the plunger rod pressed down and swirl the vial gently until the powder is dissolved. The reconstituted solution is a clear, colorless solution which may be stored fully assembled either at room temperature or refrigerated for up to 3 hours after reconstitution. After reconstitution with the specified volume of diluent, each vial contains approximately 1 mg per mL NovoSeven RT (1000 micrograms per mL).
2.3 Administration

For intravenous bolus injection only
• Inspect the reconstituted NovoSeven RT visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is observed. • Do not freeze reconstituted NovoSeven RT or store it in syringes. • Administer within 3 hours after reconstitution. • Do not mix with other infusion solutions. • Discard any unused solution.
Perform the following procedures immediately prior to administration:

NovoSeven RT package containing 1 vial of NovoSeven RT powder and 1 vial of histidine diluent:

1. Always use aseptic technique.

2. Draw back the plunger of a sterile syringe (attached to sterile needle) and admit air into the syringe.

3. Insert needle into the vial of reconstituted NovoSeven RT. Inject air into the vial and then withdraw the

appropriate amount of reconstituted NovoSeven RT into the syringe.

4. Remove and discard the needle from the syringe.

NovoSeven RT package containing 1 vial of NovoSeven RT powder and 1 pre-filled histidine diluent syringe with vial adapter for needleless reconstitution:

1. Always use aseptic technique.

2. Invert the NovoSeven RT vial. Stop pushing the plunger rod and let it move back on its own while the mixed

solution fills the syringe. Pull the plunger rod slightly downwards to draw the mixed solution into the syringe. Tap

the syringe to remove air bubbles and withdraw the required dose amount of reconstituted NovoSeven RT into the

syringe.

3. Unscrew the vial adapter with the vial. Discard the empty NovoSeven RT vial with the vial adapter attached.

Caution:
• The pre-filled diluent syringe is made of glass with an internal tip diameter of 0.037 inches, and is compatible with a standard Luer-lock connector. • Some needleless connectors for intravenous catheters are incompatible with the glass diluent syringes (for example, certain connectors with an internal spike, such as Clave ® /MicroClave ®, InVision-Plus ®, InVision-Plus CS ®, InVision-Plus ® Junior ®, Bionector ®), and their use can damage the connector and affect administration. To administer product through incompatible needleless connectors, withdraw reconstituted product into a standard 10 mL sterile Luer-lock plastic syringe. • If you have encountered any problems with attaching the pre-filled histidine diluent syringe to any Luer-lock compatible device, please contact Novo Nordisk at (877) 668-6777.
Administer NovoSeven RT using the following procedures:

1. Administer as a slow bolus injection over 2 to 5 minutes, depending on the dose administered.

2. If line needs to be flushed before or after NovoSeven RT administration, use 0.9% Sodium Chloride Injection,

USP.

3. Discard any unused reconstituted NovoSeven RT after 3 hours.
Tretten

Tretten

For intravenous use only.

2.1 Dose
• Treatment should be initiated under the supervision of a physician experienced in the treatment of rare bleeding disorders. • The dose for routine prophylaxis for bleeding in patients with congenital factor XIII (FXIII) A-subunit deficiency is 35 international units (IU) per kilogram body weight once monthly to achieve a target trough level of FXIII activity at or above 10% using a validated assay. • Consider dose adjustment if adequate coverage is not achieved with the recommended 35 IU/kg dose.
A pharmacokinetic study was conducted in the FXIII congenitally deficient population evaluating five dose cohorts (2, 7, 24, 60 and 89 IU/kg) with blood sampling at 0.5, 1, 4, 8, 24, 48, 72 hours, and 7, 14, and 28 days. Samples were tested for FXIII activity by a chromogenic assay and for FXIII A2B2 tetramer levels by an ELISA, as well as for other analytes. It was found that FXIII tetramer levels were proportional to the observed FXIII activity up to the point of replacement of 100% of normal FXIII activity, but there was no increase in FXIII tetramer levels at higher levels of FXIII activity. A dose of 35 IU/kg is sufficient to replace 100% of FXIII activity in this population, and higher doses may not increase the levels of tetrameric Factor XIII.

2.2 Reconstitution

Reconstitute only with sterile water for injection (provided with TRETTEN). The product can be reconstituted using the vial adapter included or a needle.

Reconstitute using the following procedures:
1. Use aseptic technique. 2. Wash hands before starting. 3. Bring TRETTEN (white lyophilized powder) and sterile water for injection (diluent) to room temperature, but not above 25°C (77°F). 4. Remove the plastic caps from the two vials. 5. Clean the rubber stoppers on the vials with sterile alcohol swabs and allow them to dry before use. 6. Remove the protective paper from the vial adapter, but do not unscrew the protective cap. Attach the vial adapter to the diluent vial, without taking the vial adapter out of the protective cap. Once attached, remove the protective cap from the vial adapter by lightly squeezing the protective cap with your thumb and index finger as shown on the figure below. 7. Draw back the plunger of the sterile syringe and admit a volume of 3.2 mL air into the syringe. 8. Screw the syringe onto the vial adapter on the diluent vial. 9. Inject the air from the syringe into the diluent vial until resistance is felt. Then hold the syringe with the diluent vial upside down and withdraw 3.2 mL water into the syringe. 10. Remove the empty diluent vial by tipping the syringe with the attached vial adapter. 11. Attach the syringe with the vial adapter to the powder vial. Hold the syringe slightly tilted with vial facing downwards. Push the plunger slowly to inject all water (3.2 mL) into the powder vial. Do not inject the diluent directly on the TRETTEN powder to avoid foaming. 12. Gently swirl the vial until all material is dissolved . Do not shake the vial. The reconstituted TRETTEN is a clear and colorless solution. Use the reconstituted TRETTEN immediately. If not, store the solution refrigerated or at room temperature not to exceed 25°C (77°F) for up to three hours. Discard after three hours. NOTE: • For larger dose that requires multiple vials of TRETTEN, reconstitute each additional vial using the same procedure with a separate syringe. • For smaller dose that requires less than the full volume in the vial, reconstituted TRETTEN may be diluted with 0.9% sodium chloride to facilitate measurement of small volumes. Discard remaining product. • For home administration, any such changes should be communicated by the pharmacist or healthcare provider to the patient or family.
2.3 Administration
• Inspect the reconstituted TRETTEN visually for particulate matter and discoloration prior to administration. Do not use if particulate matter or discoloration is observed. • Administer at a rate not exceeding 1-2 mL per minute. • Do not administer with other infusion solutions. • Do not administer as drip.
Norditropin

Norditropin

For subcutaneous injection.

Therapy with Norditropin should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with GHD, Noonan syndrome, Turner syndrome or SGA, and adult patients with either childhood onset or adult onset GHD.

2.1 Dosing of Pediatric Patients

General Pediatric Dosing Information

The Norditropin dosage and administration schedule should be individualized based on the growth response of each patient. Serum insulin-like growth factor I (IGF-I) levels may be useful during dose titration.

Response to somatropin therapy in pediatric patients tends to decrease with time. However, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human GH (rhGH).

Treatment with Norditropin for short stature should be discontinued when the epiphyses are fused.

Pediatric Growth Hormone Deficiency (GHD)

A dosage of 0.024 to 0.034 mg/kg/day, 6 to 7 times a week, is recommended.

Pediatric Patients with Short Stature Associated with Noonan Syndrome

Not all patients with Noonan syndrome have short stature; some will achieve a normal adult height without treatment. Therefore, prior to initiating Norditropin for a patient with Noonan syndrome, establish that the patient does have short stature.

A dosage of up to 0.066 mg/kg/day is recommended.

Pediatric Patients with Short Stature Associated with Turner Syndrome

A dosage of up to 0.067 mg/kg/day is recommended.

Pediatric Patients with Short Stature Born Small for Gestational Age (SGA) with No Catch-up Growth by Age 2 to 4 Years

A dosage of up to 0.067 mg/kg/day is recommended.

Recent literature has recommended initial treatment with larger doses of somatropin (e.g., 0.067 mg/kg/day), especially in very short children (i.e., HSDS < -3), and/or older/pubertal children, and that a reduction in dosage (e.g., gradually towards 0.033 mg/kg/day) should be considered if substantial catch-up growth is observed during the first few years of therapy. On the other hand, in younger SGA children (e.g., approximately < 4 years) (who respond the best in general) with less severe short stature (i.e., baseline HSDS values between -2 and -3), consideration should be given to initiating treatment at a lower dose (e.g., 0.033 mg/kg/day), and titrating the dose as needed over time. In all children, clinicians should carefully monitor the growth response, and adjust the rhGH dose as necessary.

2.2 Dosing of Adult Patients

Adult Growth Hormone Deficiency (GHD)

Either of two approaches to Norditropin dosing may be followed: a non-weight-based regimen or a weight-based regimen.

Non-weight based — based on published consensus guidelines, a starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) may be used without consideration of body weight. This dose can be increased gradually every 1 to 2 months by increments of approximately 0.1-0.2 mg/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor I (IGF-I) concentrations. The dose should be decreased as necessary on the basis of adverse events and/or serum IGF-I concentrations above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person, and between male and female patients.

Weight-based — based on the dosing regimen used in the original adult GHD registration trials, the recommended dosage at the start of treatment is not more than 0.004 mg/kg/day. The dose may be increased to not more than 0.016 mg/kg/day after approximately 6 weeks according to individual patient requirements. Clinical response, side effects, and determination of age- and gender-adjusted serum IGF-I concentrations should be used as guidance in dose titration.

A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen. In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women.

2.3 Preparation and Administration

Norditropin® FlexPro® 5 mg/1.5 mL, 10 mg/1.5 mL, 15 mg/1.5 mL and 30 mg/3 mL:

Instructions for delivering the dosage are provided in the PATIENT INFORMATION and INSTRUCTIONS FOR USE leaflets enclosed with the Norditropin FlexPro prefilled pen.

Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Norditropin MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. Use it only if it is clear and colorless.

Injection sites should always be rotated to avoid lipoatrophy.

Novo Nordisk

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