Enter drug's generic or brand name below. Results will appear here. Note: all drug related information obtained on this page is provided by RX List.
Using the RX LIST database:
(1) Enter the drug name in the search box below and hit ENTER
(2) The rx list web site will open here with the drug search completed. Next, scroll down the page to locate the link to the drug you are searching for and then click on the link.
Novoeight®,
Antihemophilic Factor
(Recombinant) Lyophilized Powder for Intravenous Injection
Novoeight® is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight® is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight® is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight® is approximately 8340 IU per milligram of protein.
The active ingredient in Novoeight® is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight® is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa.
Novoeight® is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight®.
Novoeight®, Antihemophilic Factor (Recombinant), is indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency or classic hemophilia) for:
Novoeight® is not indicated for the treatment of von Willebrand disease.
For intravenous injection after reconstitution only.
Dosage (IU) = Body Weight (kg)
× Desired Factor VIII
Increase (IU/dL or % normal) × 0.5
The final dose calculated is expressed as IU
A guide for dosing Novoeight® for the control and prevention of bleeding episodes is provided in Table 1. Dosing should aim at maintaining a plasma factor VIII activity level at or above the plasma levels (in % of normal or in IU/dL) outlined in Table 1.
Table 1: Dosing for Control
and Prevention of Bleeding Episodes
| Type of Bleeding Episodes | Factor VIII Level Required (IU/dL or % of normal) | Frequency of Doses (hours) | Duration of Therapy (days) |
| Minor | |||
| Early hemarthrosis, minor muscle or oral bleeding | 20-40 | 12-24 | At least 1 day until bleeding resolution is achieved |
| Moderate | |||
| Muscle bleeding, bleeding into the oral cavity or mild head trauma | 30-60 | 12-24 | Until pain and acute disability are resolved (approximately 3-4 days) |
| Major | |||
| Life or limb threatening hemorrhage, Gastrointestinal bleeding, intracranial, intra-abdominal or intrathoracic bleeding, fractures | 60-100 | 8-24 | Until resolution of bleed (approximately 7-10 days) |
A guide for dosing Novoeight® during surgery (perioperative management) is provided in Table 2. Consideration should be given to maintaining a plasma factor VIII activity level at or above the plasma levels (in % of normal or in IU/dL) outlined in Table 2.
Table 2: Dosing for
Perioperative Management
| Type of Surgery | Factor VIII Level Required (IU/dL or % of normal) | Frequency of Doses (hours) | Duration of Therapy (days) |
| Minor | |||
| Including tooth extraction | 30-60 | 24 | At least 1 day until healing is achieved |
| Major | |||
| Intracranial, intraabdominal, intrathoracic, or joint replacement surgery | 80-100 (pre-and post-operative) | 8-24 | Until adequate wound healing, then continue therapy for at least 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL) |
A guide for dosing Novoeight® for routine prophylaxis is included below in Table 3.
Table 3: Dosing for Routine
Prophylaxis
| Patient Population | Factor VIII Dose Required (IU/kg) | Frequency of Doses |
| Adults and adolescents ( ≥ 12 years) | 20-50 | 3 times weekly |
| 20-40 | Every other day | |
| Children ( < 12 years) | 25-60 | 3 times weekly |
| 25-50 | Every other day |
 |
The instructions below serve as a general guideline for preparation and reconstitution of Novoeight®. For full instructions, refer to the FDA-approved patient information and Instructions for Use.
1. Bring the Novoeight® vial and the pre-filled diluent syringe to room temperature.
Figure A
 |
2. Remove the plastic cap from the Novoeight® vial.
Figure B
 |
3. Wipe the rubber stopper on the vial with a sterile alcohol swab and allow it to dry prior to use.
4. Remove the protective paper from the vial adapter. Do not remove the vial adapter from the protective cap.
Figure C
 |
5. Place the vial on a flat and solid surface. While holding the protective cap, place the vial adapter over the Novoeight® vial and press down firmly on the protective cap until the vial adapter spike penetrates the rubber stopper.
Figure D
 |
6. Remove the protective cap from the vial adapter.
Figure E
 |
7. Grasp the plunger rod as shown in the diagram. Attach the plunger rod to the syringe by holding the plunger rod by the wide top end. Turn the plunger rod clockwise into the rubber plunger inside the pre-filled diluent syringe until resistance is felt.
Figure F
 |
8. Break off the syringe cap from the pre-filled diluent syringe by snapping the perforation of the cap.
Figure G
 |
9. Connect the pre-filled diluent syringe to the vial adapter by turning it clockwise until it is secured.
Figure H
 |
10. Push the plunger rod to slowly inject all the diluent into the vial.
Figure I
 |
11. Without removing the syringe, gently swirl the Novoeight® vial until all of the powder is dissolved. The reconstituted solution should be inspected visually for particulate matter before administration. Do not use if particulate matter or discoloration is observed.
Figure J
 |
12. Use the Novoeight® solution immediately. If not, store the solution in the vial with the vial adapter and the syringe attached, at room temperature ≤ 86°F (30°C) for no longer than 4 hours.
For intravenous injection only.
1. Invert the Novoeight® vial and slowly draw the solution into the syringe.
Figure K
 |
2. Detach the syringe from the vial adapter by turning the syringe counterclockwise.
3. Attach the syringe to the luer end of an infusion needle set.
4. Inject the reconstituted Novoeight® intravenously slowly over 2 to 5 minutes.
5. After injection, safely dispose of the syringe with the infusion set, the vial with the vial adapter, any unused Novoeight® and other waste materials.
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 Novoeight® through incompatible needleless connectors, withdraw the reconstituted product into a standard 10 mL sterile Luer-lock plastic syringe.
If you encounter any problems with attaching the pre-filled sodium chloride diluent syringe to any Luer-lock compatible device, please contact Novo Nordisk at (844) 303-4448.
Novoeight® is available as a white lyophilized powder in single-use vials containing 250, 500, 1000, 1500, 2000 and 3000 international units per vial.
After reconstitution with 4 mL of 0.9% sodium chloride solution, each mL of reconstituted solution contains approximately 62.5, 125, 250, 375, 500 or 750 international units of Novoeight®, respectively.
| Presentation (Nominal Product Strength) | Carton Number | Components |
| 250 International Units | NDC 0169 7825 01 |
|
| 500 International Units | NDC 0169 7850 01 |
|
| 1000 International Units | NDC 0169 7810 01 |
|
| 1500 International Units | NDC 0169 7815 01 |
|
| 2000 International Units | NDC 0169 7820 01 |
|
| 3000 International Units | NDC 0169 7830 01 |
|
Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark. Revised: Sep 2015
The most frequently reported adverse reactions ( ≥ 0.5%) were injection site reactions, increased hepatic enzymes, and pyrexia.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.
During the clinical development of Novoeight®, 214 male previously treated patients (PTPs; exposed to a factor VIII-containing product for ≥ 150 days) with severe hemophilia A (factor VIII level ≤ 1%) received at least one dose of Novoeight® as part of either routine prophylaxis, on-demand treatment of bleeding episodes, perioperative management of major and minor surgical, dental, or other invasive procedures, or pharmacokinetic evaluation of Novoeight®. Thirty-one subjects (14%) were < 6 years of age, 32 (15%) were 6 to < 12 years of age, 16 (7%) were adolescents (12 to < 16 years of age), and 135 (63%) were adults (16 years of age and older). The subjects received a total of 33,272 injections with a median of 127 injections of Novoeight® (range 1-442) per subject, and had a total of 32,929 exposure days during prevention and treatment of bleeds.
The most frequently reported adverse reactions in previously treated patients was injection site reactions (2.3%), increased hepatic enzymes (1.4%), and pyrexia (0.9%).
Subjects were monitored for neutralizing antibodies to factor VIII and binding antibodies to CHO and murine protein. No subjects developed confirmed neutralizing antibodies to factor VIII. One twenty-two month old child had a positive neutralizing antibody to factor VIII of 1.3 [BU] in the Bethesda assay after 15 exposure days that was not confirmed when checked after 20 exposure days. In vivo recovery was normal for this child and no clinical adverse findings were observed.
No patients developed de novo anti-murine antibodies. Nineteen subjects were positive for anti-Chinese hamster ovary (CHO) cell protein antibodies. Two of these subjects changed from anti-CHO negative to anti-CHO positive and 6 subjects changed from anti-CHO positive to anti-CHO negative. The remaining 11 subjects were either positive throughout the trials (n=6), negative at baseline and end-of trial but with transient positive samples (n=2), or positive at baseline and end-of trial but with negative samples in between (n=3). No clinical adverse findings were observed in any of these subjects.
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.
No information provided.
Included as part of the PRECAUTIONS section.
Hypersensitivity reactions, including anaphylaxis, are possible with Novoeight®. Novoeight® contains trace amounts of hamster proteins. Patients treated with this product may develop hypersenÂsitivity to these non-human mammalian proteins. Early signs of hypersensitivity reactions that can progress to anaphylaxis include angioedema, chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if allergic- or anaphylactic-type reactions occur.
Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of Novoeight®. Monitor all patients for the development of inhibitors by appropriate clinical observation and laboratory testing. If the expected plasma levels of factor VIII activity are not attained, or if bleeding is not controlled with an appropriate dose, perform testing for factor VIII inhibitors.
Long-term studies in animals to evaluate the carcinogenic potential of Novoeight®, or studies to determine the effects of Novoeight® on genotoxicity or fertility have not been performed. An assessment of the carcinogenic potential of Novoeight® was completed, and no carcinogenic risk from product use has been identified.
As hemophilia mainly affects males, there are no adequate and well-controlled studies using Novoeight® in pregnant women to determine whether there is a drug-associated risk. Animal reproduction studies have not been conducted with Novoeight®.
In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. There is no reliable data on the incidences specific to the hemophilia A population.
There is no information regarding the presence of Novoeight® in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Novoeight® and any potential adverse effects on the breastfed infant from Novoeight® or from the underlying maternal condition.
Children have shorter half–life and lower recovery of factor VIII than adults. Because clearance (based on per kg body weight) has been demonstrated to be higher in the pediatric population, higher or more frequent dosing based on body weight may be needed. [See CLINICAL PHARMACOLOGY]
Safety and efficacy studies have been performed in 79 previously treated pediatric patients < 16 years of age. Thirty-one of these subjects (39%) were < 6 years of age, 32 (41%) were 6 to < 12 years of age, and 16 (20%) were adolescents (12 to < 16 years of age). All subjects received preventive treatment every other day or three times weekly at the dose levels described in Table 3. A total of 244 bleeds in 54 subjects were treated with Novoeight®. The majority of the bleeds (91%) were of mild/moderate severity, 41% of the bleeds were spontaneous and 58% of the bleeds were localized in joints. Of these 244 bleeds, 210 (86%) were rated excellent or good in their response to treatment with Novoeight® and 3 (1.2%) were rated as having no response. A total of 222 (91%) of the bleeds were resolved with one or two injections of Novoeight®. Routine prophylactic treatment has been shown to reduce joint bleeding. [See Clinical Studies]
Clinical studies of Novoeight® did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
No information provided.
Novoeight® is contraindicated in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components (including traces of hamster proteins).
Novoeight® temporarily replaces the missing clotting factor VIII that is needed for effective hemostasis.
The activated partial thromboplastin time (aPTT) is prolonged in patients with hemophilia A. Determination of aPTT is a conventional in vitro assay for the biological activity of FVIII. Treatment with Novoeight® normalizes the aPTT over the effective dosing period.
All pharmacokinetic studies with Novoeight® were conducted in previously treated patients with severe hemophilia A (factor VIII ≤ 1%). Analysis of plasma samples was conducted using both the one-stage clotting assay and the chromogenic assay.
In a multi-center, multi-national, open-label, single dose pharmaÂcokinetic study, 23 patients with severe hemophilia A received 50 international units/kg of Novoeight® intravenously. Two patients were below the age of 18 years (13 and 17 years). The pharmaÂcokinetic parameters for 20 patients who completed the study are summarized in Table 4.
Table 4: Pharmacokinetics of
Novoeight® in 20 adult and adolescent patients with hemophilia A
| Parameters | Clotting Assay | Chromogenic Assay |
| Mean (SD) | Mean (SD) | |
| Incremental Recovery (IU/mL)/(IU/kg) | 0.020 (0.002) | 0.028 (0.006) |
| AUC (IU*h/mL) | 14.2 (3.8) | 18.7 (5.1) |
| CL (mL/h/kg) | 3.74 (0.95) | 2.87 (0.80) |
| M (h) | 10.8 (4.9) | 12.0 ( 9.3) |
| Vss (mL/kg) | 53.4 (10.9) | 44.3 (28.2) |
| Cmax (IU/mL) | 1.07 (0.16) | 1.54 (0.29) |
| MRT (h) | 15.4 (6.4) | 16.4 (10.1) |
In a separate pharmacokinetic study, 28 pediatric patients with severe hemophilia A (14 patients were below 6 years of age and 14 patients were between 6 to < 12 years of age) received a single dose of 50 international units/kg Novoeight®. The pharmacokinetic parameters of Novoeight® are summarized in Table 5 for both age groups.
Table 5: Pharmacokinetics of
Novoeight® in 28 pediatric patients with hemophilia A
| Parameters | Clotting Assay | Chromogenic Assay | ||
| 0 to < 6 years | 6 to < 12 years | 0 to < 6 years | 6 to < 12 years | |
| Mean (SD) | Mean (SD) | |||
| Incremental Recovery (IU/mL)/(IU/kg) | 0.018 (0.007) | 0.020 (0.004) | 0.022 (0.006) | 0.025 (0.006) |
| AUC (IU*h/mL) | 9.9 (4.1) | 11.1 (3.7) | 12.2 (4.4) | 14.4 (3.5) |
| CL (mL/h/kg) | 6.26 (3.73) | 5.02 (1.67) | 4.60 (1.75) | 3.70 (1.00) |
| t½ (h) | 7.7 (1.8) | 8.0 (1.9) | 10.0 (1.7) | 9.4 (1.5) |
| Vss (mL/kg) | 57.3 (26.8) | 46.8 (10.6) | 55.8 (23.7) | 41.2 (6.0) |
| Cmax (IU/mL) | 1.00 (0.58) | 1.07 (0.35) | 1.12 (0.31) | 1.25 (0.27) |
| MRT (h) | 9.7 (2.5) | 9.9 (2.6) | 12.1 (1.9) | 11.6 (2.3) |
The pharmacokinetic parameters were comparable between younger (0 to < 6 years) and older (6 to < 12 years) children. The mean clearance of Novoeight® in younger and older children was 67% and 34% higher (based on per kg body weight) than in adults (3.74 mL/h/ kg) when using the clotting assay, and 60% and 29% higher than in adults (2.87 mL/h/kg) when using the chromogenic assay. The mean half–life of Novoeight® in younger and older children was 29% and 26% shorter than in adults (10.8 hours) when using the clotting assay, and 16% and 21% shorter than in adults (12 hours) when using the chromogenic assay.
Three multi-center, open-label, non-controlled trials have been conducted to evaluate the safety and efficacy of Novoeight® in the control and prevention of breakthrough bleeds, routine prophylaxis and perioperative management in previously treated patients with hemophilia A. The analysis included 213 exposed subjects: 150 adolescents or adult subjects from the age of 12 years ( ≥ 150 exposure days) and 63 pediatric subjects below the age of 12 years ( ≥ 50 exposure days). Immunocompetent patients with severe hemophilia A (factor VIII activity ≤ 1%) and no history of FVIII inhibitors were eligible for the trials. A total of 187 out of 213 subjects continued in the safety extension trial. All subjects received preventive treatment every other day or three times weekly at the dose levels described in Table 3. Breakthrough bleeds were treated at the investigator's discretion aiming for a FVIII activity level above 0.5 IU/mL. Treatment during surgery was at the investigator's discretion aiming for a FVIII trough activity level above 0.5 IU/mL.
A total of 991 bleeds in 158 subjects were treated with Novoeight®. The majority of the bleeds (89%) were of mild/moderate severity, 62% of the bleeds were spontaneous and 72% of the bleeds were localized in joints.
An overall assessment of efficacy was performed by the subject (for home treatment) or study site investigator (for treatment under medical supervision) using a four-point scale of excellent, good, moderate, or none. If the hemostatic response was rated as “excellent” or “good”, the treatment of the bleed was considered a success. If the hemostatic response was rated as “moderate or none” the treatment was considered a failure. Of these 991 bleeds, 838 (84%) were rated excellent or good in their response to treatment with Novoeight® and 17 (1.7%) were rated as having no response. A total of 898 (91%) of the bleeds were resolved with one or two injections of Novoeight®.
Clinical trials of Novoeight® included 79 previously treated patients between one to 16 years of age. The hemostatic efficacy in treatment of bleeds was rated as either “excellent” or “good” on a pre-specified rating scale for 86% of the 244 bleeds reported in 54 subjects.
All 213 subjects received Novoeight® for routine prophylaxis. The prophylactic regimen for the 150 adolescent and adult subjects consisted of 20-40 IU/kg every other day or 20-50 IU/kg three times per week. The prophylactic regimen for the 63 pediatric subjects consisted of 25-50 IU/kg every other day or 25-60 IU/kg three times per week. The majority of the subjects ( > 80%) were treated with the three times per week regimen.
The median annualized bleeding rates are provided in Table 6.
Table 6: Annualized Bleeding
Rate in All Patients
| Small children 0 - < 6 years | Older children 6 - < 12 years | Adolescents 12 - < 16 years | Adults ≥ 16 years | Total | |
| Annualized bleeding rate (median) (IQR) | 2.9 (6.3) | 4.1 (8.6) | 4.4 (6.9) | 3.1 (5.6) | 3.1 (7.3) |
A total of 68 subjects were treated with Novoeight® for at least 12 months, including seven subjects < 12 years. The ABR was similar for the subjects treated for 12 months when compared to the ABR for the total trial population.
A total of 11 surgeries were performed in 11 previously treated subjects between 14 and 55 years of age, of which 10 were major surgeries (five synovectomies, two total hip arthroplasties, one knee replacement, arthroscopy, and circumcision), and one was minor (tooth extraction).
The investigator's ratings of intra- and post-operative quality of hemostasis for these subjects were “excellent” or “good” for all cases.
Novoeight®
(NNO-vo-eyt) Antihemophilic Factor (Recombinant) Lyophilized Powder for
Intravenous Injection
Read the Patient Product Information and the Instructions For Use that come with Novoeight® before you start taking this medicine and each time you get a refill. There may be new information.
This Patient Product Information does not take the place of talking with your healthcare provider about your medical condition or treatment. If you have questions about Novoeight® after reading this information, ask your healthcare provider.
What is the most important information I need to know about Novoeight®?
Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia center.
You must carefully follow your healthcare provider's instructions regarding the dose and schedule for infusing Novoeight® so that your treatment will work best for you.
What is Novoeight®?
Novoeight® is an injectable medicine used to replace clotting factor VIII that is missing in patients with hemophilia A. Hemophilia A is an inherited bleeding disorder that prevents blood from clotting normally.
Novoeight® is used to control and prevent bleeding in people with hemophilia A.
Your healthcare provider may give you Novoeight® when you have surgery.
Novoeight® is not used to treat von Willebrand Disease.
Who should not use Novoeight®?
You should not use Novoeight® if you
Tell your healthcare provider if you are pregnant or nursing because Novoeight® might not be right for you.
What should I tell my healthcare provider before I use Novoeight®?
You should tell your healthcare provider if you
How should I use Novoeight®?
Treatment with Novoeight® should be started by a healthcare provider who is experienced in the care of patients with hemophilia A.
Novoeight® is given as an injection into the vein.
You may infuse Novoeight® at a hemophilia treatment center, at your healthcare provider's office or in your home. You should be trained on how to do infusions by your hemophilia treatment center or healthcare provider. Many people with hemophilia A learn to infuse the medicine by themselves or with the help of a family member.
Your healthcare provider will tell you how much Novoeight® to use based on your weight, the severity of your hemophilia A, and where you are bleeding.
You may need to have blood tests done after getting Novoeight® to be sure that your blood level of factor VIII is high enough to clot your blood. This is particularly important if you are having major surgery.
Your healthcare provider will calculate your dose of Novoeight® (in international units, IU) depending on your condition and body weight.
Call your healthcare provider right away if your bleeding does not stop after taking Novoeight®.
Development of factor VIII inhibitors
Your body can also make antibodies called “inhibitors” against Novoeight®, which may stop Novoeight® from working properly.
If your bleeding is not adequately controlled, it could be due to the development of factor VIII inhibitors. This should be checked by your healthcare provider. You might need a higher dose of Novoeight® or even a different product to control bleeding. Do not increase the total dose of Novoeight® to control your bleeding without consulting your healthcare provider.
Use in children
Novoeight® can be used in children. Your healthcare provider will decide the dose of Novoeight® you will receive.
If you forget to use Novoeight®
Do not inject a double dose to make up for a forgotten dose. Proceed with the next injections as scheduled and continue as advised by your healthcare provider.
If you stop using Novoeight®
If you stop using Novoeight® you are not protected against bleeding. Do not stop using Novoeight® without consulting your healthcare provider.
If you have any further questions on the use of this product, ask your healthcare provider.
What if I take too much Novoeight®?
Always take Novoeight® exactly as your healthcare provider has told you. You should check with your healthcare provider if you are not sure. If you inject more Novoeight® than recommended, tell your healthcare provider as soon as possible.
What are the possible side effects of Novoeight®?
Common Side Effects Include:
Other Possible Side Effects:
You could have an allergic reaction to coagulation factor VIII products. Call your healthcare provider right away and stop treatment if you get any of the following signs of an allergic reaction:
These are not all of the possible side effects from Novoeight®. Ask your healthcare provider for more information. You are encouraged to report side effects to FDA at 1-800-FDA-1088.
Tell your healthcare provider about any side effect that bothers you or that does not go away.
What are the Novoeight® dosage strengths?
Novoeight® comes in six different dosage strengths. The actual number of international units (IU) of factor VIII in the vial will be imprinted on the label and on the box. The six different strengths are as follows:
Dosage strength of approximately 250 IU per vial
Dosage strength of approximately 500 IU per vial
Dosage strength of approximately 1000 IU per vial
Dosage strength of approximately 1500 IU per vial
Dosage strength of approximately 2000 IU per vial
Dosage strength of approximately 3000 IU per vial
Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your doctor.
How should I store Novoeight®?
Prior to Reconstitution:
Store in original package in order to protect from light. Do not freeze Novoeight®.
Novoeight® vials can be stored in the refrigerator (36–46°F [2°C–8°C]) for up to 30 months or up to the expiration date, or at room temperature (up to 86°F [30°C]) for a single period not exceeding 12 months.
If you choose to store Novoeight® at room temperature:
Do not use this medicine after the expiration date which is on the outer carton and the vial.
The expiration date refers to the last day of that month.
After Reconstitution (mixing the dry powder in the vial with the diluent):
The reconstituted Novoeight® should appear clear to slightly unclear without particles.
The reconstituted Novoeight® should be used immediately.
If you cannot use the Novoeight® immediately after it is mixed, it should be used within 4 hours when stored at ≤ 86°F (30°C). Store the reconstituted product in the vial.
Keep this medicine out of the sight and out of reach of children.
What else should I know about Novoeight® and hemophilia A?
Medicines are sometimes prescribed for purposes other than those listed here. Do not use Novoeight® for a condition for which it is not prescribed. Do not share Novoeight® with other people, even if they have the same symptoms that you have.
Instructions on how to use
Novoeight®
MixPro®
READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOEIGHT®.
Novoeight® is supplied as a powder. Before injection (administration) it must be mixed (reconstituted) with the liquid diluent supplied in the syringe. The liquid diluent is a sodium chloride solution. The mixed Novoeight® must be injected into your vein (intravenous injection). The equipment in this package is designed to mix and inject Novoeight®.
You will also need an infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze pads, and bandages.
Don't use the equipment without proper training from your doctor or nurse.
Always wash your hands and ensure that the area around you is clean.
When you prepare and inject medication directly into the veins, it is important to use a clean and germ free (aseptic) technique. Improper technique can introduce germs that can infect the blood.
Don't open the equipment until you are ready to use it.
Don't use the equipment if it has been dropped, or if it is damaged. Use a new package instead.
Don't use the equipment if it is expired. Use a new package instead. The expiration date is printed on the outer carton and on the vial, the vial adapter and the pre-filled syringe.
Don't use the equipment if you suspect it is contaminated. Use a new package instead.
Don't dispose of any of the items until after you have injected the mixed solution.
The equipment is for single use only.
Content
The package contains:
 |
1. Prepare the vial and the syringe
Figure A
 |
Figure B
 |
2. Attach the vial adapter
Figure C
 |
Figure D
 |
Lightly squeeze the protective cap with your thumb and index finger as shown. Remove the protective cap from the vial adapter. Don't lift the vial adapter from the vial when removing the protective cap.
Figure E
 |
3. Attach the plunger rod and the syringe
Figure F
 |
Don't touch the syringe tip under the syringe cap. If you touch the syringe tip germs from your fingers can be transferred.
If the syringe cap is loose or missing, don't use the pre-filled syringe.
Figure G
 |
Figure H
 |
4. Mix the powder with the diluent
Figure I
 |
Figure J
 |
Novoeight® is recommended to be used immediately after it is mixed. This is because if left, the medicine may no longer be sterile and could cause infections.
If you cannot use the mixed Novoeight® solution immediately, it should be used within 4 hours when stored at ≤ 86°F (30°C). Store the reconstituted product in the vial.
Do not freeze mixed Novoeight®solution or store it in syringes.
Figure K
 |
Don't touch the syringe tip. If you touch the syringe tip germs from your fingers can be transferred.
Figure L
 |
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®).
The use of these needleless connectors can damage the connector and affect administration.
To administer Novoeight®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 sodium chloride diluent syringe to any Luer-lock compatible device, please contact Novo Nordisk at (844) 303-4448.
5. Inject the mixed solution
Novoeight® is now ready to inject into your vein.
Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or subcutaneous port:
The peel-off label found on the Novoeight® vial can be used to record the lot number.
Disposal
Don't throw it out with the ordinary household trash.
Figure M
 |
Don't disassemble the vial and vial adapter before disposal.
Don't reuse the equipment.
Important information
Contact your healthcare provider or local hemophilia treatment center if you experience any problems.
For full Prescribing Information please read the other insert included in this package.
