product news
F I RST COMPLETE REG IMEN I NJ ECT I ON FOR H I V APPROVED
TABLETS FOR OVERACT I VE BLADDER (OAB)
warning that “Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV- 1 RNA greater than 50 copies/milliliter).” This is by no means an inclusive list of side effects. Patients should receive these injections under a provider’s care and closely monitored. Source: https://www.fda.gov/news-events/press-announcements/ fda-approves-first-extended-release-injectable-drug-regimen-adults-living-hiv https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics
Health experts estimate that more than 30 million Americans suffer from overactive bladder (OAB) symptoms. Patients with OAB often experience difficultly controlling urinary symptoms such as frequent urge to urinate, frequent urination, bedwetting, bladder spasm, or leaking of urine. In addi- tion to being a major inconvenience, OAB may also be a source of embarrassment. Causes of OAB are hard to pinpoint but can include weak muscles, nerve damage, use of medications, alcohol or caffeine, infection, and being overweight. Lifestyle changes, self-care, and kegel exercises have helped many people. Additionally, some medica- tions can treat OAB as well. Most patients report tolerating these medications well with some showing some improvement in reducing symptoms, although others do not. Recently, the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for the first new oral branded OAB medication since 2012. Once- daily Gentasa Gemtesa 75 mg (vibegron) is a beta-3 adrenergic receptor (β3) agonist used for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. Vibegron, a small-molecule β3 ago- nist, helps relax the detrusor bladder muscle so that the bladder can hold more urine. Furthermore, Gemtesa is the first beta 3-ago- nist available as a once-daily pill that does not require dose titration, a major benefit for patients who can more easily understand and comply with dosing instructions. In clinical trials, Gemtasa at 75mg once- daily dosing showed that it clearly treated clinical symptoms of OAB by reduc- ing urinary frequency, urge urinary incontinence, and urgency. In addition, data specifically showing a reduction in urgency episodes are included in Gemtesa’s prescribing information, which is unique among currently available OAB treatments. The most common adverse reactions to Gemtesa from a double-blind, placebo-con- trolled study in ≥2% of patients included headache, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infections. Gemtasa may also cause serious side effects such as the inabil- ity to empty the bladder. Urovant, the manufacturer of Gemtesa, plans to launch this OAB drug soon in the United States.
Statistics showed that in 2018, approximately 1.2 million people were living in the United States with HIV. Moreover, one in seven were unaware of their status and were in need of testing. In 2018 alone, 36,400 new HIV infections occurred in the United States. HIV patients in treatment may have to take pills daily, sometimes taking more than one or combination drugs to manage their condition. But now, Cabenuva (cabotegravir and rilpivirine, injectable formulation) offers another alternative. Cabenuva is the first FDA- approved injectable, complete regimen for HIV-infected adults that is administered once a month. Cabenuva is a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults that replaces current antiretroviral regimens in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. Vocabria (cabotegravir, 30 mg tablet formulation) was approved by the FDA as it is taken in unison with oral rilpovirine (Edurant) for a time period of one month prior to beginning treatment with Cabenuva in order to certify that the medications are functioning well together before shifting to an extended-release injectable formulation. Initial injections begin on the last day of oral therapy. Cabenuva (cabotegravir extend- ed-release injectable suspension; rilpivirine extended-release injectable suspension) is co- packaged for intramuscular use. The initial kit contains capotegravir 600mg/rilpirivine 900mg as this is only a one-time first dose given as gluteal intramuscular injections. Following monthly injections are for 400mg Cabenuva gluteal intra-muscular injection and a single 600 mg gluteal intramuscular injection of rilpivirine at each visit. Cabenuva was safely and efficiently administered in two randomized and controlled clinical trials, resulting in participants from both trials continuing to show signs of virologic suppression at the end of each study. The most common reactions to the Cabenuva injections were “fever (pyrexia), fatigue, headaches, musculoskeletal pain, nausea, sleep disorders, dizziness, and rashes” according to the FDA. Listed within the FDA’s new release, there is a
GENER I C SUN I T I N I B AVA I LABLE
Glenmark Pharmaceuticals Limited has received FDA approval for Sutib, a generic version of Sunitinib that is used to treat kidney cancer. Brand name Sutent, which is manufactured by Pfizer, was approved in 2006. However, all of the medicine’s patents expire in 2021, leaving the door open for generics. In 2010, Mylan submitted a generic Sutent; however, Pfizer sued, alleging patent infringement and winning exclusivity until 2021. Sunitinib is an oral multi-kinase inhibitor (MKI). It works by blocking several enzymes that promote cell growth. It is used for the treatment of certain patients with gastrointestinal stromal tumors (GIST) and advanced renal cell carcinoma. Additionally, it is approved for patients with certain types of pancreatic neuroendocrine tumors. Sunitinib may also be used for metastatic kidney cancer that has progressed after a trial of immunotherapy and has been shown to reduce the risk of kidney cancer progression by 58%. Pfizer’s Sutent has an estimated cost of $5,917 for a supply of 28 capsules at a dosage of 12.5mg, depending on the pharmacy. One major benefit of this new generic is the cost, which is about 96% lower than the Pfizer brand. For kidney cancer or a GIST, sunitinib is dosed at once a day for four weeks, followed by two weeks without the drug. This makes up a cycle of treatment that lasts for six weeks. Sutib is available as oral capsules in doses of 50 mg, 25 mg, and 12.5 mg. A sunitinib 10 mg/mL oral suspension may be prepared with capsules and a 1:1 mixture of Ora-Sweet and Ora-Plus using three sunitinib 50 mg capsules. This suspension maintains an average concentration of 96% to 106% (of the original concentration) at room temperature or refrigerated for up to 60 days in plastic, amber prescription bottles. As with any antineoplastic agent, numerous side effects can occur when taking this medication, which has a black box warning. Patients being treated with sunitinib are closely monitored with dosages, which may need to be changed at times. Capsules are stored at 20°C to 25°C (68°F to 77°F).
Source: https://www.drugs.com/newdrugs/fda-approves-gemtesa-vibegron-pa- tients-overactive-bladder-oab-5415.html
Source: https://www.glenmarkpharma.com/sites/default/files/PressRelease_ Glenmark_Lanuches_SUTIB_in_India.pdf
CPhT CONNECT www.pharmacy technician.org
7
Made with FlippingBook - Online Brochure Maker