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Novoseven

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Novoseven

Novoseven Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

NovoSeven (coagulation factor Vlla recombinant) is a blood coagulant compound. NovoSeven is prescribed for the prevention and treatment of bleeding in hemophilia A or B, patients with inhibitors to Factor VIII or Factor IX, and acquired hemophilia, Side effects include but are not limited to fever; headache; pain, redness, or irritation at the site of injection; dizziness, nausea; or vomiting. Serious side effects may occur. Drug interaction and all side effect information should be reviewed prior to administering NovoSeven.

NovoSeven is supplied in a variety of strengths, depending on the patient's condition. Simultaneous use of activated prothrombin complex concentrates or prothrombin complex concentrates should be avoided. There are no adequate and well-controlled studies in pregnant women. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance or the drug to the mother. The safety and effectiveness of NovoSeven was not determined to be different in various age groups, from infants to adolescents (0 to 16 years of age).

NovoSeven (coagulation factor Vlla recombinant) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Novoseven in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • fever;
  • little or no urinating;
  • a feeling that you might pass out; or
  • any bleeding that will not stop.

Common side effects may include:

  • mild headache;
  • joint pain;
  • nausea, vomiting;
  • swelling;
  • mild itching or rash; or
  • pain, redness, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Novoseven (Coagulation Factor VIIa (Recombinant)) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Novoseven Overview - Patient Information: Side Effects

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.

Read the entire patient information overview for Novoseven (Coagulation Factor VIIa (Recombinant))»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Novoseven FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most serious adverse reactions observed in patients receiving NovoSeven (coagulation factor viia (recombinant)) are thrombotic events, however the extent of the risk of thrombotic adverse events after treatment with NovoSeven (coagulation factor viia (recombinant)) in individuals with hemophilia and inhibitors is considered to be low. (See WARNINGS)

The most common adverse reactions observed in clinical studies for all labeled indications of NovoSeven (coagulation factor viia (recombinant)) are pyrexia, hemorrhage, injection site reaction, arthralgia, headache, hypertension, hypotension, nausea, vomiting, pain, edema and rash.

The following sections describe the adverse event profile observed during clinical studies for each of the labeled indications. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug product cannot be directly compared to rates in clinical trials of another drug, and may not reflect rates observed in practice.

Hemophilia A or B Patients with Inhibitors

The table below lists adverse events that were reported in ≥ 2% of the 298 patients with hemophilia A or B with inhibitors that were treated with NovoSeven (coagulation factor viia (recombinant)) for 1, 939 bleeding episodes. The events listed are considered to be at least possibly related or of unknown relationship to NovoSeven (coagulation factor viia (recombinant)) administration.

Body System
Event
# of episodes
reported
(n=1,939 treatments)
# of unique
patients
(n=298 patients)
Body as a whole
  Fever 16 13
Platelets, Bleeding, and Clotting
  Hemorrhage NOS 15 8
  Fibrinogen plasma decreased 10 5
Skin and Musculoskeletal
  Hemarthrosis 14 8
Cardiovascular
  Hypertension 9 6

Events which were reported in 1% of patients and were considered to be at least possibly or of unknown relationship to NovoSeven (coagulation factor viia (recombinant)) administration were: allergic reaction, arthrosis, bradycardia, coagulation disorder, DIC, edema, fibrinolysis increased, headache, hypotension, injection site reaction, pain, pneumonia, prothrombin decreased, pruritus, purpura, rash, renal function abnormal, therapeutic response decreased, and vomiting.

Serious adverse events that were probably or possibly related, or where the relationship to NovoSeven (coagulation factor viia (recombinant)) was not specified, occurred in 14 of the 298 patients (4.7%). Six of the 14 patients died of the following conditions: worsening of chronic renal failure, anesthesia complications during proctoscopy, renal failure complicating a retroperitoneal bleed, ruptured abscess leading to sepsis and DIC, pneumonia, and splenic hematoma and GI bleeding. Thrombosis was reported in two of the 298 patients with hemophilia.

Surgery Studies

In Study C, six patients experienced serious adverse events: two of these patients had events which were considered probably or possibly related to study medication (acute post-operative hemarthrosis, internal jugular thrombosis). No deaths occurred during the study.

In Study D, seven of 24 patients had serious adverse events (4 for bolus injection, 3 for continuous infusion). There were 4 serious adverse events which were considered probably or possibly related to rFVIIa treatment (2 events of decreased therapeutic response in each treatment arm). No deaths occurred during the study period.

Congenital Factor VII Deficiency

Data collected from the compassionate/emergency use programs, the published literature, a pharmacokinetics study, and the HTRS registry showed that at least 75 patients with Factor VII deficiency had received NovoSeven (coagulation factor viia (recombinant)) - 70 patients for 124 bleeding episodes, surgeries, or prophylaxis regimens; 5 patients in the pharmacokinetics trial.

In the compassionate/emergency use programs, 28 adverse events in 13 patients and 10 serious adverse events in 9 patients were reported. Non-serious adverse events in the compassionate/emergency use programs were single events in one patient, except for fever (3 patients), intracranial hemorrhage (3 patients), and pain (2 subjects). The most common serious adverse event in the compassionate/emergency programs was serious bleeding in critically ill patients. All nine patients with serious adverse events died. One adverse event (localized phlebitis) was reported in the literature. No adverse events were reported in the pharmacokinetics reports or for the HTRS registry. No thromboembolic complications were reported for the 75 patients included here. Isolated cases of factor VII deficient patients developing antibodies against factor VII were reported after treatment with NovoSeven (coagulation factor viia (recombinant)) . These patients had previously been treated with human plasma and/or plasma-derived factor VII. In some cases the antibodies showed inhibitory effect in vitro.

Acquired Hemophilia

Data collected from four compassionate use programs, the HTRS registry, and the published literature showed that 139 patients with acquired hemophilia received NovoSeven (coagulation factor viia (recombinant)) for 204 bleeding episodes, surgeries and traumatic injuries.

Of these 139 patients, 10 experienced 12 serious adverse events that were of possible, probable, or unknown relationship to treatment with NovoSeven (coagulation factor viia (recombinant)) . Thrombotic serious adverse events included cerebral infarction, cerebral ischemia, angina pectoris, myocardial infarction, pulmonary embolism and deep vein thrombosis. Additional serious adverse events included shock and subdural hematoma.

Data collected for mortality in the compassionate use programs, the HTRS registry and the publications spanning a 10 year period, was overall 32/139 (23%). Deaths due to hemorrhage were 10, cardiovascular failure 4, neoplasia 4, unknown causes 4, respiratory failure 3, thrombotic events 2, sepsis 2, arrhythmia 2 and trauma 1.

Postmarketing Experience

The following post marketing adverse events are reported voluntarily from a population of uncertain size; hence, it is not possible to estimate their frequency or establish a causal relationship to exposure.

The following additional adverse events were reported following the use of NovoSeven (coagulation factor viia (recombinant)) in both labeled indications and unlabeled indications that included individuals with situational coagulopathy and without known coagulopathy: high D-dimer levels and consumptive coagulopathy, thromboembolic events including myocardial infarction, myocardial ischemia, cerebral infarction and/or ischemia, thrombophlebitis, arterial thrombosis, deep vein thrombosis and related pulmonary embolism, and isolated cases of hypersensitivity reactions including anaphylactic reactions. (See WARNINGS and PRECAUTIONS)

Evaluation and interpretation of these post marketing events is confounded by underlying diagnoses, concomitant medications, pre-existing conditions, and inherent limitations of passive surveillance. A causal relationship has not been established for the above events.

Additional data on the adverse event profile in general and regarding the frequency of thrombotic events in particular is being collected through a postmarket surveillance program. The Hemophilia and Thrombosis Research Society (HTRS) Registry surveillance program is designed to collect data on all uses of NovoSeven (coagulation factor viia (recombinant)) to expand the base of experience regarding the use of NovoSeven (coagulation factor viia (recombinant)) . 12 All prescribers can obtain information regarding contribution of patient data to this program by calling 1-877-362-7355.

Read the entire FDA prescribing information for Novoseven (Coagulation Factor VIIa (Recombinant)) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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