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Sevenfact

Last reviewed on RxList: 4/8/2020
Sevenfact Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Sevenfact?

Sevenfact [coagulation factor VIIa (recombinant)-jncw] is a coagulation factor VIIa concentrate indicated for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors.

What Are Side Effects of Sevenfact?

Side effects of Sevenfact include:

  • headache,
  • dizziness,
  • infusion-site discomfort,
  • infusion-site bleeding,
  • infusion-related reactions, and
  • fever

Dosage for Sevenfact

The dose of Sevenfact for mild or moderate bleeds is 75 mcg/kg repeated every 3 hours until hemostasis is achieved OR an initial dose of 225 mcg/kg. If hemostasis is not achieved within 9 hours, additional 75 mcg/kg doses may be administered every 3 hours as needed to achieve hemostasis. The dose of Sevenfact for severe bleeds is 225 mcg/kg, followed if necessary 6 hours later with 75 mcg/kg every 2 hours.

Sevenfact In Children

Limited clinical data for Sevenfact in the pediatric population were collected in an adult and adolescent study. A total of 5 subjects aged 12 to 18 years of age (range 13-17 years) were dosed with Sevenfact. These 5 subjects were treated for a total of 79 bleeding episodes (all mild or moderate) that occurred while subjects were still under 18 years of age. Hemostatic efficacy in this subgroup (n=5) was comparable to efficacy observed in the overall population.

What Drugs, Substances, or Supplements Interact with Sevenfact?

Sevenfact may interact with other medicines such as:

Tell your doctor all medications and supplements you use.

Sevenfact During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Sevenfact; it is unknown how it would affect a fetus. It is unknown if Sevenfact passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Sevenfact [coagulation factor VIIa (recombinant)-jncw] Lyophilized Powder for Solution, for Intravenous Use 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.

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.

SLIDESHOW

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Sevenfact Professional Information

SIDE EFFECTS

The most common adverse reactions (incidence ≥1%) reported in clinical trials for SEVENFACT were headache, dizziness, infusion-site discomfort, infusion-site hematoma, infusion-related reaction, and fever.

Clinical Trials Experience

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 the clinical trials of another drug and may not reflect the rates observed in practice.

In two studies of SEVENFACT in patients with Hemophilia A or B with or without inhibitors, 42 subjects (27 subjects in Study 1 and 15 subjects in Study 2) have been exposed to SEVENFACT .

Study 1: The safety of SEVENFACT has been evaluated in a safety and efficacy study of 27 subjects with Hemophilia A or B with inhibitors, which included treatment of 468 bleeding episodes. As described in Table 2, a total of seven adverse reactions were observed in two subjects (7.4%) treated with SEVENFACT. One episode of fever occurred in a 12-year-old subject, lasted two days, and was managed symptomatically.

Study 2: In a study with 15 subjects evaluating the safety and pharmacokinetics of three escalating doses of SEVENFACT (25 mcg/kg, 75 mcg/kg and 225 mcg/kg), a total of three (20%) subjects experienced four adverse reactions (Table 2).

One subject developed an infusion reaction immediately following the infusion of the first dose of 75 mcg/kg; the reaction lasted 45 minutes. Signs and symptoms included flushing, chest tightness, shakiness, transient tachycardia, and mild hypotension. Symptoms resolved without any intervention and did not recur with subsequent administration at 225 mcg/kg dose.

Adverse reactions reported in the two clinical studies are shown in Table 2.

Table 2 : Adverse Reactions Occurring in the Two Clinical Studies

Preferred TermsNumber of Adverse Reactions in Study 2
(N=15)
Number of Adverse Reactions in Study 1
(N=27)
Infusion site discomfort-4
Infusion site hematoma-2
Dizziness2-
Headache1-
Body temperature increased-1
Infusion related reaction1-

Immunogenicity

In Study 1, two out of 27 subjects had a positive screening assay for anti-SEVENFACT antibody at baseline, prior to exposure to SEVENFACT, and at follow-up visits. One of these two subjects had a transient SEVENFACT antibody with an additional confirmatory test for anti-SEVENFACT antibody, which was confirmed as non-neutralizing.

In Study 2, five of 15 subjects tested positive for anti-SEVENFACT antibody using a screening assay. The confirmatory assay was negative for all subjects at all time points.

No subject developed anti-rabbit milk protein antibodies during treatment with SEVENFACT.

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibodies 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. For these reasons, comparison of the incidence of antibodies to SEVENFACT with the incidence of antibodies to other products may be misleading.

Read the entire FDA prescribing information for Sevenfact (Coagulation factor VIIa (recombinant)-jncw for Injection)

QUESTION

What is hemophilia? See Answer
Related Resources for Sevenfact

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

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