Helixate Fs
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Side Effects & Adverse Reactions
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Helixate® FS is a recombinant antihemophilic factor indicated for:
- •
- Control and prevention of bleeding episodes in adults and children with hemophilia A.
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- Surgical prophylaxis in adults and children with hemophilia A.
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- Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage.
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- Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.
Helixate FS is not indicated for the treatment of von Willebrand disease.
History
There is currently no drug history available for this drug.
Other Information
Helixate FS Antihemophilic Factor (Recombinant) is a coagulation factor VIII produced by recombinant DNA technology. It is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII gene has been introduced.8 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Helixate FS is a purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as factor VIII derived from human plasma. No human or animal proteins, such as albumin, are added during the purification and formulation processes of Helixate FS.
The purification process includes a solvent/detergent virus inactivation step in addition to the use of the purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant factor VIII and remove contaminating substances.
Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.9-13 Several of the individual production and raw material preparation steps in the Helixate FS manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. These TSE reduction steps include the Fraction II+III separation step for HPPS (6.0 log10) and an anion exchange chromatography step (3.6 log10).
Helixate FS is formulated with the following as stabilizers (see Table 6) in the final container and is then lyophilized. The final product does not contain any preservative. It is a sterile, nonpyrogenic powder preparation for intravenous injection. Intravenous administration of sucrose contained in Helixate FS will not affect blood glucose levels.
| Stabilizer | 250 IU, 500 IU, 1000 IU | 2000 IU, 3000 IU |
|---|---|---|
| Sucrose |
0.9–1.3% |
0.9–1.2% |
| Glycine |
21–25 mg/mL |
20–24 mg/mL |
| Histidine |
18–23 mmol/L |
17–22 mmol/L |
Table 7 lists the inactive ingredients/excipients also contained in the final product.
| Inactive Ingredient/Excipient | 250 IU, 500 IU, 1000 IU | 2000 IU, 3000 IU |
|---|---|---|
| Sodium |
27–36 mEq/L |
26–34 mEq/L |
| Calcium |
2.0–3.0 mmol/L |
1.9–2.9 mmol/L |
| Chloride |
32–40 mEq/L |
31–38 mEq/L |
| Polysorbate 80 |
64–96 μg/mL |
64–96 μg/mL |
| Sucrose |
28 mg/vial |
52 mg/vial |
| Imidazole, tri-n-butyl phosphate, and copper |
Trace amounts |
Trace amounts |
Sources
Helixate Fs Manufacturers
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Csl Behring Llc
![Helixate Fs (Antihemophilic Factor, Recombinant) Kit [Csl Behring Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Helixate Fs | Genentech, Inc.
2.1 Recommended DosingThe recommended dose of XENICAL is one 120-mg capsule three times a day with each main meal containing fat (during or up to 1 hour after the meal).
The patient should be on a nutritionally balanced, reduced-calorie diet that contains approximately 30% of calories from fat. The daily intake of fat, carbohydrate, and protein should be distributed over three main meals. If a meal is occasionally missed or contains no fat, the dose of XENICAL can be omitted.
Because XENICAL has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene, patients should be counseled to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition [see Warnings and Precautions (5.1)]. The vitamin supplement should be taken at least 2 hours before or after the administration of XENICAL, such as at bedtime.
For patients receiving both XENICAL and cyclosporine therapy, administer cyclosporine 3 hours after XENICAL.
For patients receiving both XENICAL and levothyroxine therapy, administer levothyroxine and XENICAL at least 4 hours apart. Patients treated concomitantly with XENICAL and levothyroxine should be monitored for changes in thyroid function.
Doses above 120 mg three times a day have not been shown to provide additional benefit.
Based on fecal fat measurements, the effect of XENICAL is seen as soon as 24 to 48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48 to 72 hours.
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