Riastap
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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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
RiaSTAP®, Fibrinogen Concentrate (Human) is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
The effectiveness of RiaSTAP is based on maximum clot firmness, which measures the structural integrity of a clot, reflecting the underlying effectiveness of the fibrinogen present to form a fibrin clot (see Clinical Studies [14]).
There are no controlled trials demonstrating a direct benefit on treatment of bleeding episodes with RiaSTAP.
RiaSTAP is not indicated for dysfibrinogenemia.
History
There is currently no drug history available for this drug.
Other Information
RiaSTAP is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma.
Each vial contains 900 to 1300 mg fibrinogen, 400 to 700 mg human albumin, 375 to 660 mg L-arginine hydrochloride, 200 to 350 mg sodium chloride and 50 to 100 mg sodium citrate. Sodium hydroxide and hydrochloric acid may have been used to adjust the pH.
All plasma used in the manufacture of RiaSTAP is tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to HIV-1/2 and HCV. Additionally, the plasma is tested with FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1 and found to be non-reactive (negative). For HBV, an investigational NAT procedure is used; however, the significance of a negative result has not been established. In addition, the plasma has been tested by NAT for HAV and B19V. Only plasma that passed virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL.
RiaSTAP is manufactured from cryoprecipitate into a glycine precipitate, which is then further purified by multiple precipitation/adsorption steps. The manufacturing process has been demonstrated to reduce the risk of virus transmission in an additive manner: cryoprecipitation, Al(OH)3 adsorption/glycine precipitation/Al(OH)3 adsorption, heat treatment (+60ºC for 20 hours in an aqueous solution), and two subsequent glycine precipitation steps (initial and main glycine precipitation steps). These steps have been validated independently in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 1 shows the virus clearance during the manufacturing process for RiaSTAP, expressed as the mean log10 reduction factor (LRF).
| Manufacturing Step | Virus Reduction Factor (log10) | |||||||
|---|---|---|---|---|---|---|---|---|
| Enveloped viruses | Non-enveloped viruses | |||||||
| HIV | BVDV | WNV | HSV-1 | PRV | HAV | CPV | B19V* | |
| BVDV, bovine viral diarrhea virus, model for HCV WNV, West Nile virus HSV-1, herpes simplex virus type 1 CPV, canine parvovirus, model for B19V n.d., not done |
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|
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| Cryoprecipitation | n.d. | n.d. | n.d. | 1.6† | 2.4 | 2.8 | n.d. | |
| Al(OH)3 adsorption/ glycine precipitation/ Al(OH)3 adsorption | (2.8)‡ | (1.5)‡ | n.d. | (0.9)‡ | n.d. | |||
| Heat Treatment | ≥ 5.7 | ≥ 9.1 | ≥ 8.3 | ≥ 8.1 | ≥ 4.3 | 1.6 | ≥ 4.5* | |
| Glycine precipitation (two subsequent steps) |
3.9 | 2.1 | n.d. | 1.0 | (1.0)‡ | (1.6)‡ | n.d. | |
| Cumulative virus reduction (log10) | ≥ 9.6 | ≥ 11.2 | ≥ 8.3 | ≥ 9.1 | 1.6 | ≥ 6.7 | 4.4 | ≥ 4.5 |
Sources
Riastap Manufacturers
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Csl Behring Gmbh
![Riastap (Fibrinogen) Injection, Powder, Lyophilized, For Solution [Csl Behring Gmbh]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Riastap | Lupin Pharmaceuticals, Inc.
Swallow duloxetine delayed-release capsules USP whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. All of these might affect the enteric coating. Duloxetine delayed-release capsules USP can be given without regard to meals. If a dose of duloxetine delayed-release capsules USP is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of duloxetine delayed-release capsules USP at the same time.
2.1 Dosage for Treatment of Major Depressive DisorderAdminister duloxetine delayed-release capsules USP at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. The safety of doses above 120 mg/day has not been adequately evaluated. Periodically reassess to determine the need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.1)].
2.2 Dosage for Treatment of Generalized Anxiety DisorderAdults
For most patients, initiate duloxetine delayed-release capsules USP 60 mg once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Nevertheless, if a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated. Periodically reassess to determine the continued need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.2)].
Pediatric use information for patient's ages 7 to 17 years is approved for Eli Lilly and Company, Inc.'s CYMBALTA® (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2.3 Dosage for Treatment of Diabetic Peripheral Neuropathic PainAdminister duloxetine delayed-release capsules USP 60 mg once daily. There is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated [see CLINICAL STUDIES (14.3)]. For patients for whom tolerability is a concern, a lower starting dose may be considered.
Since diabetes is frequently complicated by renal disease, consider a lower starting dose and gradual increase in dose for patients with renal impairment [see DOSAGE AND ADMINISTRATION (2.6), USE IN SPECIFIC POPULATIONS (8.10), and CLINICAL PHARMACOLOGY (12.3)].
2.5 Dosage for Treatment of Chronic Musculoskeletal PainAdminister duloxetine delayed-release capsules USP 60 mg once daily. Begin treatment at 30 mg for one week, to allow patients to adjust to the medication before increasing to 60 mg once daily. There is no evidence that higher doses confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions [see CLINICAL STUDIES (14.5)].
2.6 Dosing in Special PopulationsHepatic Impairment
Avoid use in patients with chronic liver disease or cirrhosis [see WARNINGS AND PRECAUTIONS (5.14) and USE IN SPECIFIC POPULATIONS (8.9)].
Severe Renal Impairment
Avoid use in patients with severe renal impairment, GFR <30 mL/min [see WARNINGS AND PRECAUTIONS (5.14) and USE IN SPECIFIC POPULATIONS (8.10)].
2.7 Discontinuing Duloxetine Delayed-release CapsulesAdverse reactions after discontinuation of duloxetine delayed-release capsules USP, after abrupt or tapered discontinuation, include: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [see WARNINGS AND PRECAUTIONS (5.7)].
2.8 Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric DisordersAt least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with duloxetine delayed-release capsules USP. Conversely, at least 5 days should be allowed after stopping duloxetine delayed-release capsules USP before starting an MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS (4)].
2.9 Use of Duloxetine Delayed-release Capsules with Other MAOIs such as Linezolid or Methylene BlueDo not start duloxetine delayed-release capsules USP in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see CONTRAINDICATIONS (4)].
In some cases, a patient already receiving duloxetine delayed-release capsules USP therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, duloxetine delayed-release capsules USP should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with duloxetine delayed-release capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see WARNINGS AND PRECAUTIONS (5.4)].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with duloxetine delayed-release capsules is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUTIONS (5.4)].
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