NovoSeven - instructions for use, analogs, reviews and release forms (injections in ampoules for injection of lyophilizate) drugs for the treatment of hemorrhages in hemophilia and other disorders of blood clotting in adults, children and during pregnancy. Composition

In this article, you can read the instructions for using the drug NovoSeven. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of NovoSeven in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of NovoSeven in the presence of existing structural analogues.Use for the treatment of bleeding in hemophilia, thrombocytopenia and other disorders of blood clotting in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

NovoSeven recombinant clotting factor 7a. In therapeutic doses, it binds to a large amount of tissue factor, forming a complex that enhances the initial activation of factor 10. In the presence of calcium ions and anionic phospholipids, it is able to activate the factor 10 on the surface of activated platelets, bypassing the coagulation cascade system. It works only at the site of damage and does not cause systemic activation of the coagulation process.

Composition

Eptakog alpha + excipients.

Indications

• bleeding and prevention of massive bleeding during surgical operations in patients with hereditary or acquired hemophilia with inhibitors to coagulation factor 8 and coagulation factor 9;
• hereditary deficiency of factor 7;
• hereditary deficiency of other coagulation factors;
• qualitative platelet defects;
• thrombocytopenia;
• other specified hemorrhagic conditions, including Glantzman's thrombastenia.

Forms of release

Lyophilizate for the preparation of a solution for intravenous administration of 1 mg, 2 mg and 5 mg complete with a solvent (injections in ampoules for injection).

Instructions for use and dosing regimen

As soon as possible, the drug NovoSeven after the onset of bleeding is shown. The recommended initial dose administered intravenously is 90 μg per 1 kg of body weight of the patient. After the first injection, the NovoSeven preparation can be repeated. The duration of treatment and the interval between drug administration are determined by the severity of the bleeding or by the nature of the invasive procedure / surgical intervention.

The medication should be administered every 2-3 hours until reaching hemostasis. If there are indications for continuing treatment after stopping bleeding, the intervals between drug administration can be sequentially increased to 4, 6, 8 or 12 hours for the entire treatment period according to the indications.

With bleeding of mild and moderate severity (articular, muscular and from mucous tissue), the most effective early administration of the drug is most effective. One of the following dose regimens is recommended.The first - from two to three injections in a dose of 90 mcg per 1 kg of body weight after 3 hours, to maintain the effect, another dose of NovoSeven is prescribed at a rate of 90 mcg per 1 kg of body weight. The second mode is a single injection at a rate of 270 micrograms per 1 kg of body weight. Clinical experience of using the drug in a dose of 270 μg per 1 kg of body weight in elderly patients is absent.

The duration of outpatient treatment should not exceed 24 hours.

For severe bleeding, the recommended initial dose is 90 μg per 1 kg of body weight and can be administered during the transport phase to a hospital where this patient is usually treated. The scheme of further therapy depends on the type and severity of the bleeding. At the beginning of the treatment, the drug is injected every 2 hours before the onset of clinical improvement. In the presence of indications for the continuation of therapy, the intervals between administrations can be increased to 3 hours within 1-2 days. Subsequently, the intervals between administration of the drug can be increased to 4, 6, 8 or 12 hours for the entire treatment period according to the indications. The duration of treatment of severe bleeding can be 2-3 weeks and even more if there are clinical indications.

Patients with inhibitory haemophilia A or B and frequent bleeding (4 or more episodes per month) to reduce the frequency of bleeding NovoSeven can be administered at a dose of 90 micrograms per 1 kg of body weight once a day. Duration of treatment - up to 3 months.

In case of invasive procedures and surgical operations, an initial dose of 90 μg per kg of body weight of the patient is administered immediately before the intervention. The second dose is given after 2 hours, and then the drug is administered at 2-3-hour intervals during the first 24-48 hours, depending on the intervention and the clinical condition of the patient. In large operations, treatment lasts 6-7 days with 2-4-hour intervals between administration of the drug at the recommended dose. During treatment for the next 2 weeks, the intervals between drug administration can be increased to 6-8 hours. The total duration of the drug after a large operation can be 2-3 weeks until the wound is healed.

With acquired hemophilia (including outpatient treatment), as early as possible the administration of NovoSeven after the onset of bleeding is shown.The recommended initial dose administered intravenously is 90 μg per 1 kg of body weight of the patient. After the first injection, the NovoSeven preparation can be repeated if necessary. The duration of treatment and the interval between drug administration are determined by the severity of the bleeding or by the nature of the invasive procedure / surgical intervention. When the initial dose is administered, the interval should be 2-3 hours. After achieving hemostasis, the intervals between drug administration for the entire treatment period can be increased to 4, 6, 8 or 12 hours.

If there is a deficiency of blood coagulation factor 7, the recommended dose for stopping bleeding during surgical interventions or invasive procedures is 15-30 micrograms per 1 kg of body weight. The drug is injected every 4-6 hours until reaching hemostasis. Doses and frequency of administration are specified on an individual basis.

With Glanzman thrombasthenia, the recommended dose for monitoring and preventing bleeding during surgical interventions or invasive procedures is 90 μg (80-120 μg) per 1 kg of body weight. The drug is administered every 2 hours (1.5-2.5 hours). To ensure persistent hemostasis, at least 3 doses are required.An intravenous bolus route of administration is recommended, as the effectiveness of the drug may decrease with drop administration. In patients with thrombastenia Glanzmann without refractoriness, the drug of choice is platelet mass.

Side effect

• chills;
• headache;
• nausea, vomiting;
• weakness;
• increased sweating;
• change in blood pressure;
• redness of the skin and itchy skin;
• kidney failure;
• ataxia (partial or complete loss of coordination of voluntary muscle movements); impaired liver function;
• disorders of cerebral circulation;
• angina (clinical syndrome, characterized by a feeling or a sense of discomfort behind the sternum);
• supraventricular tachycardia (heart palpitations);
• thrombophlebitis (inflammation of the vein wall with the formation of a thrombus closing its lumen);
• pulmonary embolism;
• DIC-syndrome (disseminated intravascular coagulation).

Contraindications

• increased sensitivity to proteins of mice, hamsters and cows.

Application in pregnancy and lactation

In pregnancy, NovoSeven is used only in cases of extreme necessity.

It is not known whether the active substance is excreted in breast milk.During lactation apply with caution, it is better to stop breastfeeding during the treatment.

Use in children

Currently available clinical experience does not allow to offer a differentiated dosing regimen for children and adults, although it is known that the clearance in children is higher. Therefore, in pediatric practice, it may be necessary to use higher doses of NovoSeven to achieve a drug concentration in plasma similar to plasma concentration in adult patients.

special instructions

In cases of severe bleeding, the drug should be administered in a hospital. Bleeding of mild or moderate severity can be treated at home in close cooperation with a hemophilic center or a hematologist, but no longer than 24 hours. If bleeding can not be stopped, hospitalization is mandatory.

Particular care should be taken if the patient undergoes a surgical operation, he has a smashed wound, severe atherosclerosis or thrombotic complications, septicemia.

It should avoid simultaneous use of concentrates prothrombin complex (activated or not activated).

Drug Interactions

Do not inject NovoSeven in one syringe with any other medicines.

Analogues of medicinal product NovoSeven

Structural analogs for the active substance:

• Coagil-7;
• Eptakog alpha (activated).

Analogues of the NovoSeven drug for the pharmacological group (coagulants, including blood coagulation factors, hemostatics):

• Agamphil A;
• Agamphil B;
• Advait;
• Aimafiks;
• Antigemophilic factor of man-M;
• Batroksobin;
• Bériate;
• Vikasol;
• Vilata;
• Wilfactin;
• Gelaspon;
• Hemomectin;
• Highlander pepper herb;
• The sponge is haemostatic collagenic;
• Dicycin;
• Zheplastane;
• Immunate;
• Immunine;
• Innonfactor;
• Caprol;
• Collagen;
• Collatamp;
• Stinging nettle leaves;
• Nettle Extract
• Cryoprecipitate;
• LongEight;
• Mononayn;
• NewEight;
• Nuwick;
• Octavie;
• Octaneine;
• Octaplex;
• Octofactor;
• Shepherd's grass bag;
• Shepherd's bag extract;
• Polyhemostat;
• Protagem;
• Protamine;
• Recombinant;
• Ricksubis;
• Hemostatic napkins;
• Spray hemostatic;
• Tachokomb;
• Thysukol Kit;
• Tobarpin;
• Thrombin;
• Yarrow grass;
• Fundi;
• Feiba;
• Pheracril;
• Hemate P;
• An applet;
• Eptakog alpha;
• Etamsylate.

Review of a hematologist

In our department is not often, but patients with haemophilia with rather heavy bleeding. I would like to note that if the patient was introduced the first dose of NovoSeven during the transportation to the hospital, the clinical improvement is much quicker than if the first injection was made to him in the department. As a rule, during the first, rarely the second day (with the introduction of the drug every 2-3 hours) it is possible to achieve a stop of bleeding. I do not remember that any of the patients had adverse reactions to the drug NovoSeven.

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