NovoSeven RT

NovoSeven RT is used for:

Treating or preventing bleeding episodes in patients with certain bleeding problems.

novoseven novoseven rt price in india

NovoSeven RT is a clotting factor. It works by activating the body’s clotting system.

Do NOT use NovoSeven RT if: you are allergic to any ingredient in NovoSeven RT

Some medical conditions may interact with NovoSeven RT. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are allergic to mouse, hamster, or cow proteins
  • if you have kidney problems, liver problems, heart disease, hardening of the arteries, disseminated intravascular coagulation (DIC), an infection of the blood or tissues, or blood conditions other than hemophilia
  • if you have a blood clot or history of blood clots
  • if you have had surgery and cannot move around much
  • if you have a crush injury

Some MEDICINES MAY INTERACT with NovoSeven RT. Tell your health care provider if you are taking any other medicines, especially any of the following:

Coagulation factor XIII or activated or nonactivated prothrombin complex concentrates because the risk of blood clots may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if NovoSeven RT may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use NovoSeven RT?:

Use NovoSeven RT as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • NovoSeven RT is usually given as an injection at your doctor’s office, hospital, or clinic. If you will be using NovoSeven RT at home, a health care provider will teach you how to use it. Be sure you understand how to use NovoSeven RT. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
    Wash your hands before use.
  • Before giving the injection, let it come to room temperature.
  • Do not heat NovoSeven RT.
  • NovoSeven RT needs to be mixed before use.
  • Do not shake.
  • Use right away after mixing it. If you cannot use NovoSeven RT right away after mixing it, it can be stored at room temperature or refrigerated for up to 3 hours.
  • Do not use NovoSeven RT if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Use the proper technique taught to you by your doctor. Inject into a vein, NOT deep under the skin or into muscle.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of NovoSeven RT, contact your doctor right away.

Ask your health care provider any questions you may have about how to use NovoSeven RT.

Important safety information:

Call the doctor right away if the normal dose does not work as well.
Lab tests, including bleeding time, may be performed while you use NovoSeven RT. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use NovoSeven RT with caution in the ELDERLY and in NEWBORNS; they may be more sensitive to its effects.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using NovoSeven RT while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking NovoSeven RT.

Possible side effects of NovoSeven RT:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with NovoSeven RT. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dizziness; fainting; swelling; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected: Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of NovoSeven RT:

NovoSeven RT is usually handled and stored by a health care provider. If you are using NovoSeven RT at home, store NovoSeven RT as directed by your pharmacist or health care provider. Keep NovoSeven RT out of the reach of children and away from pets.

General information:

  • If you have any questions about NovoSeven RT, please talk with your doctor, pharmacist, or other health care provider.
  • NovoSeven RT is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take NovoSeven RT or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about NovoSeven RT. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to NovoSeven RT. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using NovoSeven RT.

For the Consumer

Applies to coagulation factor viia: intravenous powder for solution

As well as its needed effects, coagulation factor viia (the active ingredient contained in NovoSeven RT) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking coagulation factor viia, check with your doctor or nurse immediately:

More common:

  • Bleeding problems
  • fever
  • high blood pressure
  • joint or muscle pain or stiffness

Less common or rare:

  • Bloating or swelling of the face, hands, lower legs, or feet
  • bluish color of the hands or feet
  • blurred vision
  • changes in facial color
  • chest pain
  • chills
  • cold sweats
  • confusion
  • continuing thirst
  • cough
  • dizziness
  • excessive sweating
  • faintness
  • fast heartbeat
  • hives, itching, or skin rash
  • large flat blue or purplish patches on the skin
  • lightheadedness when getting up suddenly from a lying or
  • sitting position
  • persistent bleeding or oozing from puncture sites or mucous
  • membranes (bowel, mouth, nose, or urinary bladder)
  • puffiness or swelling of the eyelids or around the eyes
  • shakiness
  • slow or irregular heartbeat (less than 50 beats per minute)
  • slurred speech
  • sneezing
  • sore throat
  • sudden decrease in the amount of urine
  • swelling of the face, fingers, feet, or lower legs
  • troubled breathing, tightness in the chest
  • unusual tiredness or weakness
  • unusual weight gain

Minor Side Effects:

Some coagulation factor viia side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common or rare:

  • Burning or stinging at the injection site
  • drowsiness
  • feeling of warmth
  • headache
  • nausea or vomiting
  • pinpoint red or purple spots on the skin
  • redness of the face, neck, arms and occasionally, upper chest

For Healthcare Professionals

Applies to coagulation factor viia: intravenous powder for injection
General

The most common adverse reactions were thrombotic events.

Cardiovascular

  • Common (1% to 10%): Hypertension, thromboembolic events
  • Uncommon (0.1% to 1%): Shock
  • Rare (less than 0.1%): Angina pectoris
  • Postmarketing reports: Intracardiac thrombus, flushing

Specific arterial thromboembolic events (cerebral artery occlusion, cerebrovascular accident), specific venous thromboembolic events (pulmonary embolism, deep vein thrombosis), and angina pectoris were reported with a frequency of common (1% to 10%) in clinical trials of 61 patients with acquired hemophilia.[Ref]
Hematologic

  • Common (1% to 10%): Plasma fibrinogen decreased, acute post-operative hemarthrosis
  • Rare (less than 0.1%): Disseminated intravascular coagulation, D dimer increased, antithrombin decreased, coagulopathy, fibrin degradation products increased, alkaline phosphatase increased, lactate dehydrogenase increased, prothrombin increased
  • Immunologic

Antibody formation against this drug has only been reported in patients with factor VII deficiency.

  • Common (1% to 10%): Antibody formation against this drug
  • Rare (less than 0.1%): Hypersensitivity
  • Postmarketing reports: Anaphylactic reaction
  • Nervous system
  • Common (1% to 10%): Intracranial hypertension, headache
  • Uncommon (0.1% to 1%): Cerebrovascular accident
  • Frequency not reported: Cerebrovascular disorder
  • Local
  • Common (1% to 10%): Localized phlebitis
  • Rare (less than 0.1%): Injection site reaction
  • Common (1% to 10%): Fever
  • Frequency not reported: Pain
  • Dermatologic
  • Uncommon (0.1% to 1%): Rash, pruritus, urticaria
  • Postmarketing reports: Angioedema
  • Gastrointestinal
  • Uncommon (0.1% to 1%): Nausea
  • Respiratory
  • Uncommon (0.1% to 1%): Dyspnea
  • Hepatic

Rare (less than 0.1%): Alanine aminotransferase increased
Frequency not reported: Abnormal hepatic function[Ref]

General

  • NovoSeven RT is intended for intravenous bolus administration only.
  • Evaluation of hemostasis should be used 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.
  • NovoSeven RT should be administered to patients only under the supervision of a physician experienced in the treatment of bleeding disorders.

Hemophilia A or B with Inhibitors

Treatment of Acute Bleeding Episodes

Hemostatic Dosing

90 micrograms/kg given every two hours by bolus infusion until hemostasis is achieved, or until the treatment has been judged to be inadequate.
Doses between 35 and 120 micrograms/kg have been used successfully in clinical trials for hemophilia A or B patients with inhibitors, and both the dose and administration interval may be adjusted based on the severity of the bleeding and degree of hemostasis achieved.1
The minimum effective dose has not been established. 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.

Post-hemostatic Dosing

  • The appropriate duration of post-hemostatic dosing has not been studied.
  • For severe bleeds, dosing should continue at 3-6 hour intervals after hemostasis is achieved, to maintain the hemostatic plug.
  • The biological and clinical effects of prolonged elevated levels of Factor VIIa have not been studied; therefore, the duration of post-hemostatic dosing should be minimized.
  • Patients should be appropriately monitored by a physician experienced in the treatment of hemophilia during this time period.

Dosing for Surgical Interventions

Minor Surgery

An initial dose of 90 micrograms per kg body weight should be given immediately before the intervention and repeated at 2-hour intervals for the duration of the surgery.
For minor surgery, post-surgical dosing by bolus injection should occur at 2-hour intervals for the first 48 hours and then at 2- to 6-hour intervals until healing has occurred.

Major Surgery

An initial dose of 90 micrograms per kg body weight should be given immediately before the intervention and repeated at 2-hour intervals for the duration of the surgery.
For major surgery, post-surgical dosing by bolus injection should occur at 2 hour intervals for 5 days, followed by 4 hour intervals until healing has occurred. Additional bolus doses should be administered if required.

Congenital Factor VII deficiency

The recommended dose range for treatment of bleeding episodes or for prevention of bleeding in surgical interventions or invasive procedures in congenital Factor VII deficient patients is 15-30 micrograms per kg body weight every 4-6 hours until hemostasis is achieved.
Effective treatment has been achieved with doses as low as 10 micrograms/kg.
Dose and frequency of injections should be adjusted to each individual.
The minimum effective dose has not been determined.

Acquired Hemophilia

The recommended dose range for the treatment of patients with acquired hemophilia is 70-90 micrograms/kg repeated every 2-3 hours until hemostasis is achieved.
The minimum effective dose in acquired hemophilia has not been determined.
The majority of the effective outcomes were observed with treatment in the recommended dose range. The largest number of treatments with any single dose was 90 micrograms/kg; of the 15 treated, 10 (67%) were effective and 2 (13%) were partially effective.

Reconstitution

Calculate the NovoSeven RT dosage you will need and select the appropriate NovoSeven RT vial package. The selected package contains 1 vial of NovoSeven RT powder and 1 vial of histidine diluent required to prepare reconstituted NovoSeven RT solution. Reconstitute only with the histidine diluent provided with NovoSeven RT. Do not reconstitute with sterile water or other diluent.

Reconstitution should be performed using the following procedures:

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

After reconstitution with the specified volume of diluent, each vial contains approximately 1 mg/mL NovoSeven RT (1000 micrograms/mL).

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.
Administration

NovoSeven RT is intended for intravenous bolus injection only and should not be mixed with infusion solutions.
Reconstituted NovoSeven RT should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is observed.
Administration should take place within 3 hours after reconstitution.
Any unused solution should be discarded. Do not freeze reconstituted NovoSeven RT or store it in syringes.

Administration should be performed using the following procedures:

Always use aseptic technique.
Draw back the plunger of a sterile syringe (attached to sterile needle) and admit air into the syringe.
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.
Remove and discard the needle from the syringe.
Administer as a slow bolus injection over 2 to 5 minutes, depending on the dose administered.
If line needs to be flushed before or after NovoSeven RT administration, use 0.9% Sodium Chloride Injection, USP.
Discard any unused reconstituted NovoSeven RT after 3 hours.

Applies to the following strength(s): 1000 mcg (1 mg) ; 2000 mcg (2 mg) ; 8000 mcg (8 mg) ; 5000 mcg (5 mg) ; 1200 mcg (1.2 mg) ; 2400 mcg (2.4 mg) ; 4800 mcg (4.8 mg)

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Hemophilia A
Hemophilia B
Factor VII Deficiency
Glanzmann’s Thrombasthenia

Usual Pediatric Dose for:

  • Hemophilia A
  • Hemophilia B
  • Factor VII Deficiency
  • Glanzmann’s Thrombasthenia

Additional dosage information:

  • Renal Dose Adjustments
  • Liver Dose Adjustments
  • Precautions
  • Dialysis

Usual Adult Dose for Hemophilia A

CONGENITAL HEMOPHILIA A OR B WITH INHIBITORS:
Hemostatic:
90 mcg/kg IV bolus injection once every 2 hours (adjustable based on bleeding severity) until hemostasis is achieved or treatment is deemed inadequate

Post-hemostatic:
90 mcg/kg IV bolus injection once every 3 to 6 hours for severe bleeds

Perioperative Management:
Initial: 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 hours for surgery duration (additional bolus doses may be required with major surgery).

Post-surgical:
-Minor surgery: 90 mcg/kg IV bolus injection once every 2 hours for 48 hours, then every 2 to 6 hours until healing occurs.
-Major surgery: 90 mcg/kg IV bolus injection once every 2 hours for 5 days, then every 4 hours until healing occurs.

ACQUIRED HEMOPHILIA:
Non-perioperative Management:
70 to 90 mcg/kg IV bolus injection once every 2 to 3 hours until hemostasis is achieved

Perioperative Management:
70 to 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 to 3 hours for surgery duration and until hemostasis is achieved.
Usual Adult Dose for Hemophilia B

CONGENITAL HEMOPHILIA A OR B WITH INHIBITORS:
Hemostatic:
90 mcg/kg IV bolus injection once every 2 hours (adjustable based on bleeding severity) until hemostasis is achieved or treatment is deemed inadequate

Post-hemostatic:
90 mcg/kg IV bolus injection once every 3 to 6 hours for severe bleeds

Perioperative Management:
Initial: 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 hours for surgery duration (additional bolus doses may be required with major surgery).

Post-surgical:
-Minor surgery: 90 mcg/kg IV bolus injection once every 2 hours for 48 hours, then every 2 to 6 hours until healing occurs.
-Major surgery: 90 mcg/kg IV bolus injection once every 2 hours for 5 days, then every 4 hours until healing occurs.

ACQUIRED HEMOPHILIA:
Non-perioperative Management:
70 to 90 mcg/kg IV bolus injection once every 2 to 3 hours until hemostasis is achieved

Perioperative Management:
70 to 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 to 3 hours for surgery duration and until hemostasis is achieved.
Usual Adult Dose for Factor VII Deficiency

15 to 30 mcg/kg IV bolus injection once every 4 to 6 hours until hemostasis is achieved

Comments: Doses as low as 10 mcg/kg have been effective.
Usual Adult Dose for Glanzmann’s Thrombasthenia

Non-perioperative Management:
90 mcg/kg IV bolus injection once every 2 to 6 hours until hemostasis is achieved in severe bleeding episodes requiring systemic hemostatic therapy

Perioperative Management:
Initial: 90 mcg/kg IV bolus injection immediately before surgery; repeat every 2 hours for procedure duration.
Post-surgical: 90 mcg/kg IV bolus injection once every 2 to 6 hours
Usual Pediatric Dose for Hemophilia A

CONGENITAL HEMOPHILIA A OR B WITH INHIBITORS:
Hemostatic:
90 mcg/kg IV bolus injection once every 2 hours (adjustable based on bleeding severity) until hemostasis is achieved or treatment is deemed inadequate

Post-hemostatic:
90 mcg/kg IV bolus injection once every 3 to 6 hours for severe bleeds

Perioperative Management:
Initial: 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 hours for surgery duration (additional bolus doses may be required with major surgery).
Post-surgical:
-Minor surgery: 90 mcg/kg IV bolus injection once every 2 hours for 48 hours, then every 2 to 6 hours until healing occurs.
-Major surgery: 90 mcg/kg IV bolus injection once every 2 hours for 5 days, then every 4 hours until healing occurs.

ACQUIRED HEMOPHILIA:
Non-perioperative Management:
70 to 90 mcg/kg IV bolus injection once every 2 to 3 hours until hemostasis is achieved

Perioperative Management:
70 to 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 to 3 hours for surgery duration and until hemostasis is achieved.
Usual Pediatric Dose for Hemophilia B

CONGENITAL HEMOPHILIA A OR B WITH INHIBITORS:
Hemostatic:
90 mcg/kg IV bolus injection once every 2 hours (adjustable based on bleeding severity) until hemostasis is achieved or treatment is deemed inadequate

Post-hemostatic:
90 mcg/kg IV bolus injection once every 3 to 6 hours for severe bleeds

Perioperative Management:
Initial: 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 hours for surgery duration (additional bolus doses may be required with major surgery).
Post-surgical:
-Minor surgery: 90 mcg/kg IV bolus injection once every 2 hours for 48 hours, then every 2 to 6 hours until healing occurs.
-Major surgery: 90 mcg/kg IV bolus injection once every 2 hours for 5 days, then every 4 hours until healing occurs.

ACQUIRED HEMOPHILIA:
Non-perioperative Management:
70 to 90 mcg/kg IV bolus injection once every 2 to 3 hours until hemostasis is achieved

Perioperative Management:
70 to 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 to 3 hours for surgery duration and until hemostasis is achieved.
Usual Pediatric Dose for Factor VII Deficiency

15 to 30 mcg/kg IV bolus injection once every 4 to 6 hours until hemostasis is achieved

Comments: Doses as low as 10 mcg/kg have been effective.
Usual Pediatric Dose for Glanzmann’s Thrombasthenia

Non-perioperative Management:
90 mcg/kg IV bolus injection once every 2 to 6 hours until hemostasis is achieved in severe bleeding episodes requiring systemic hemostatic therapy

Perioperative Management:
Initial: 90 mcg/kg IV bolus injection immediately before surgery; repeat every 2 hours for procedure duration.
Post-surgical: 90 mcg/kg IV bolus injection once every 2 to 6 hours
Renal Dose Adjustments

Data not available
Liver Dose Adjustments

Data not available
Precautions

US BOXED WARNING:
-THROMBOSIS: Serious arterial and venous thrombotic events have been reported following administration of this drug. Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive this drug. Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis.

Safety and efficacy have not been established to determine differences among age groups (0 to 16 years); clinical trials were conducted with dosing based on body weight, not age.

Consult WARNINGS section for additional precautions.
Dialysis

Data not available
Other Comments

Administration advice:
-For IV bolus injection only.
-Administer as soon as possible following bleeding onset or immediately before scheduled procedure.
-The manufacturer product information should be consulted.

Storage requirements:
-Prior to reconstitution: Store powder and histidine diluent between 2 and 25C (36 to 77F); do not freeze; protect from light.
-After reconstitution: Store at room temperature or refrigerated up to 3 hours; do not freeze or store in syringes.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

IV compatibility: Do not mix with other infusion solutions.

General:
-Coagulation parameters do not necessarily correlate with or predict effectiveness of this drug; use hemostasis evaluation to determine effectiveness.
-Congenital hemophilia A or B with inhibitors: Outcome decision was made for a majority of patients treated for joint or muscle bleeds within 8 doses; more doses were required for severe bleeds. A majority of patients who reported adverse experiences received more than 12 doses.

Monitoring:
-Monitor for signs or symptoms of activation of the coagulation system or thrombosis.
-Monitor and minimize the duration of any post-hemostatic dosing.
-Monitor prothrombin time (PT) and factor VII coagulant activity in factor VII deficient patients before and after administering this drug.
-Monitor for factor VII antibodies in factor VII deficient patients treated with this drug.

Patient advice:
-Inform patients to seek immediate medical attention if early signs of hypersensitivity occur (e.g., hives, urticaria, chest tightness, wheezing, hypotension, and anaphylaxis).
-Advise patients to seek immediate medical attention if signs of thrombosis occur (e.g., new onset swelling and pain in the limbs or abdomen, new onset chest pain, shortness of breath, loss of sensation or motor power, or altered consciousness or speech).