‘Labeling’ Tagged Posts

Syrup Bottle sticker labeling machine and Bottle Inspection Machine, Flip Desk

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Rituxan Labeling Up to date With Observe Up Remedy Data for Sufferers With GPA/MPA

 

October 19, 2018

Rituxan is a CD20-directed cytolytic antibody

Rituxan is a CD20-directed cytolytic antibody

The Food and Drug Administration (FDA) has approved updated labeling for Rituxan (rituximab; Genentech) to include information on follow up treatment for patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) who have achieved disease control with induction therapy. Rituxan, a CD20-directed cytolytic antibody, was initially approved for GPA and MPA, in combination with glucocorticoids, in 2011.

The approval for follow up treatment was based on data from an open-label, prospective, active-controlled study (MAINRITSAN) involving 115 patients in disease remission (86 with GPA, 24 with MPA, 5 with renal-limited ANCA-associated vasculitis). Patients were randomized to receive azathioprine or rituximab; the primary endpoint of the study was the occurrence of major relapse, defined by the reappearance of clinical or laboratory signs of vasculitis activity that could lead to organ failure or damage, or could be life-threatening, through month 28.

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Results showed the observed cumulative incidence rate of first major relapse during the 28 months was lower in patients treated with rituximab compared with azathioprine (5% vs 29%, respectively). In addition, the safety profile was found to be consistent with that previously seen in this patient population.

“Options for continued treatment in GPA and MPA, chronic autoimmune diseases in which patients experience periods of flares, are currently limited,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “As part of our commitment to support people living with rare diseases, we are pleased to provide updated prescribing information for Rituxan to help physicians make more informed decisions about therapeutic options for patients who have achieved disease control with induction treatment.”

For more information visit Gene.com.

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Labeling for Hereditary Issue X Deficiency Remedy Coagadex Up to date

 
The FDA has approved an expanded indication for perioperative management of bleeding

The FDA has approved an expanded indication for perioperative management of bleeding

The Food and Drug Administration (FDA) has approved updated labeling for Coagadex (coagulation factor X [human]; Bio Products Laboratory) to remove age restrictions for the currently approved indications and to add an indication for routine prophylaxis to prevent or reduce the frequency of bleeding episodes. In addition, the FDA has approved an expanded indication for perioperative management of bleeding to include patients with moderate hereditary Factor X deficiency.

Coagadex is now indicated in adults and children with hereditary Factor X deficiency for:

In an open-label, non-randomized clinical trial, the use of Coagadex in routine prophylaxis of bleeding episodes was evaluated in 9 children <12 years of age. Investigators’ assessment following 6 months of routine prophylaxis was rated “excellent” (no minor or major bleeds during the study period) in all 9 subjects. In addition, 22 infusions were given to treat a bleed, equivalent to 2.1 bleeds per subject per year; all bleeds were treated with a single infusion and recorded efficacy ratings were categorized as “excellent” (ie, bleeding stopped with 12 hours).

Labeling for A number of HIV Meds Up to date to Embody Interplay Knowledge With DOACs

 

August 14, 2018

Both Genvoya and Stribild are expected to increase exposures of some direct oral anticoagulants

Each Genvoya and Stribild are anticipated to extend exposures of some direct oral anticoagulants

The Meals and Drug Administration (FDA) has accredited labeling updates for Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide; Gilead), Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate; Gilead) and Tybost (cobicistat; Gilead) to incorporate new drug-drug interplay knowledge. 

Genvoya and Stribild are mixture antiretrovirals indicated as an entire routine for the therapy of HIV-1 an infection in particular sufferers. Tybost, a pharmacokinetic enhancer, is meant to extend systemic publicity of atazanavir or darunavir (once-daily) together with different antiretroviral brokers. 

Each Genvoya and Stribild are anticipated to extend exposures of the next direct oral anticoagulants: apixaban, rivaroxaban, betrixaban, dabigatran, and edoxaban. For concomitant apixaban, the dosing directions within the apixaban label relating to coadministration with CYP3A and P-gp inhibitors must be adopted. Concomitant rivaroxaban with Genvoya or Stribild shouldn’t be advisable as a consequence of a doubtlessly elevated threat for bleeding. For concomitant betrixaban, dabigatran, and edoxaban, dosing suggestions with Genvoya or Stribild depend upon the particular anticoagulant indication and renal perform; clinicians ought to seek advice from the prescribing info for these direct oral anticoagulants for dosing directions with P-gp inhibitors.

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If Tybost is given with atazanavir or darunavir, coadministration with rivaroxaban shouldn’t be advisable as a consequence of a doubtlessly elevated bleeding threat. When given with apixaban, the dosing suggestion will depend on the apixaban dose; clinicians ought to seek advice from the prescribing info for apixaban relating to concomitant robust CYP3A and P-gp inhibitors.

If Tybost is given with atazanavir, the dosing suggestions for concomitant betrixaban, dabigatran, or edoxaban depend upon the direct oral anticoagulant indication and renal perform; clinicians ought to seek advice from the direct oral anticoagulant prescribing info for dosing directions with P-gp inhibitors. No dose adjustment is required for betrixaban, dabigatran, or edoxaban when given with Tybost + darunavir. 

For extra info name (888) 463-6332 or go to FDA.gov.

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Cytovene-IV Labeling Up to date to Embrace Further Fertility Impairment Information

 
Patients should be advised that fertility may be impaired with the use of Cytovene-IV.

Sufferers must be suggested that fertility could also be impaired with using Cytovene-IV.

The Meals and Drug Administration (FDA) has permitted revisions to the Cytovene-IV (ganciclovir sodium; Genentech) labeling to incorporate an up to date Boxed Warning relating to impairment of fertility. 

Cytovene-IV, a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor, is indicated to deal with CMV retinitis in immunocompromised adults, together with sufferers with AIDS. It’s also indicated to stop CMV illness in grownup transplant recipients in danger for CMV illness.

The up to date warning states that primarily based on animal knowledge and restricted human knowledge, using Cytovene-IV on the really useful human dose could trigger short-term or everlasting inhibition of spermatogenesis in males and suppression of fertility in females. Sufferers must be suggested that fertility could also be impaired with using Cytovene-IV. 

In a small, open-label, non-randomized scientific research, grownup male renal transplant sufferers receiving valganciclovir (the prodrug of ganciclovir) for CMV prophylaxis for as much as 200 days post-transplantation had been in comparison with an untreated management group; sufferers had been adopted up for six months after discontinuing valganciclovir. The imply sperm density on the finish of remedy decreased by 11 million/mL from baseline within the valganciclovir group (N=24) whereas the management group (N=14) had a rise of 33 million/mL. On the follow-up go to, the imply sperm density was related within the valganciclovir group to that of the management group (41 million/mL vs 43 million/mL enhance from baseline, respectively). 

Cytovene-IV is provided as 500mg power lyophilized powder for reconstitution in 10mL vials. Every carton incorporates 5 vials.