Novoseven

Name: Novoseven

Side effects

Fever, headache, pain/redness/irritation at the injection site, dizziness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: swelling ankles/feet, new or worsening bleeding/bruising, new or worsening joint pain/swelling.Get medical help right away if any of these rare but very serious side effects occur: pain/swelling/redness/weakness of the arms or legs, calf pain/swelling that is warm to the touch, shortness of breath, coughing up blood, chest/jaw/left arm pain, fast/slow heartbeat, sudden vision changes, weakness on one side of the body, slurred speech, confusion, change in the amount of urine.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Storage

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Reviewed on 4/16/2014 References

What should i discuss with my healthcare provider before receiving coagulation factor viia (novoseven rt)?

You should not receive coagulation factor VIIa if you are allergic to it.

If possible before you receive coagulation factor VIIa, tell your doctor if you have:

  • coronary artery disease (hardening of the arteries);
  • a history of stroke or heart attack;
  • a severe injury or infection;
  • liver disease; or
  • if you are allergic to mouse, hamster, or cow proteins.

In an emergency situation it may not be possible to tell your caregivers about your health conditions. Make sure any doctor caring for you afterward knows you have received this medicine.

FDA pregnancy category C. It is not known whether coagulation factor VIIa will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether coagulation factor VIIa passes into breast milk or if it could harm a nursing baby. You should not breast-feed while receiving this medicine.

In an emergency situation it may not be possible to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

What should i avoid after receiving coagulation factor viia (novoseven rt)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

  • Advate
  • Adynovate
  • Alprolix
  • Bebulin VH
  • Coagadex
  • Idelvion
  • Novoeight
  • Nuwiq
  • Profilnine
  • Rixubis

© Novoseven Patient Information is supplied by Cerner Multum, Inc. and Novoseven Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Commonly used brand name(s)

In the U.S.

  • Novoseven
  • NovoSeven RT

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Hemostatic

Uses For Novoseven

Factor VIIa is used to treat and prevent bleeding episodes in patients with Hemophilia A or B who have formed antibodies against other clotting proteins (eg, Factor VIII or Factor IX) that help bleeding to stop. It is also used to treat or prevent bleeding in patients with acquired hemophilia, congenital Factor VII deficiency, or Glanzmann's thrombasthenia (a bleeding disorder that is caused by a blood abnormality) that has been treated with platelet transfusions but did not work well.

Factor VIIa is a man-made protein produced to replicate the naturally occurring activated factor VII (factor VIIa) in the body. It is used to stop bleeding of injuries for patients with hemophilia by helping the blood to clot.

Factor VIIa is to be given only by or under the direct supervision of your doctor.

Before Using Novoseven

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Factor VIIa in children.

Geriatric

Adequate and well-controlled studies have not been done on the relationship of age to the effects of Factor VIIa in geriatric patients.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Factor XIII
  • Prothrombin Complex

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood clots or a history of medical problems caused by blood clots or
  • Heart disease (eg, coronary heart disease), history of or
  • Infection or
  • Injury (crush) or
  • Liver disease—These conditions may increase the risk of developing blood clots.

For the Consumer

Applies to coagulation factor viia: intravenous powder for solution

Along with its needed effects, coagulation factor viia (the active ingredient contained in NovoSeven RT) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking coagulation factor viia:

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

Some side effects of coagulation factor viia may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions 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.[Ref]

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[Ref]

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[Ref]

Immunologic

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

Common (1% to 10%): Antibody formation against this drug
Rare (less than 0.1%): Hypersensitivity
Postmarketing reports: Anaphylactic reaction[Ref]

Nervous system

Common (1% to 10%): Intracranial hypertension, headache
Uncommon (0.1% to 1%): Cerebrovascular accident
Frequency not reported: Cerebrovascular disorder[Ref]

Local

Common (1% to 10%): Localized phlebitis
Rare (less than 0.1%): Injection site reaction[Ref]

Other

Common (1% to 10%): Fever
Frequency not reported: Pain[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, pruritus, urticaria
Postmarketing reports: Angioedema[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Nausea[Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea[Ref]

Hepatic

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

Some side effects of NovoSeven RT may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

(web3)