bPrior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics. SKYRIZI and its design are registered trademarks of AbbVie Biotechnology Ltd. North Chicago, IL: AbbVie Inc. Turner D, Ricciuto A, Lewis A, et al. This is the most important information to know about SKYRIZI. 17 PATIENT COUNSELING INFORMATION AbbVie Provides Update Regarding SKYRIZI (risankizumab-rzaa) for the Treatment of Moderate to Severe Crohn's Disease in the U.S. PR Newswire NORTH CHICAGO, Ill., Feb. 28, 2022 NORTH CHICAGO, Ill.,. The sections evaluated on endoscopy are the: rectum, sigmoid and left colon, transverse colon, right colon and ileum (per SESCD assessment). Week 0, CDAI=Crohn's disease activity index; IV=intravenous; SC=subcutaneous; SES-CD=simple endoscopic score for Crohn's disease, IV=intravenous; SES-CD=simple endoscopic score for Crohn's disease, CDAI=Crohn's disease activity index; SC=subcutaneous; SES-CD=simple endoscopic score for Crohn'sdisease. With Prime Featured, display your headline and ticker symbol on the pages where our users live. Lipid Elevations: Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12 in patients treated with SKYRIZI in Crohns disease. (min,max) 45% SKYRIZI vs 25% placebo, p<0.001, 48% OF TOTAL PATIENTS DEMONSTRATED ENDOSCOPIC RESPONSE WITH SKYRIZI AT WEEK 52, REGARDLESS OF BIOLOGIC EXPERIENCE1,4, Co-Primary Endpoints for FORTIFY: It is not known if SKYRIZI passes into your breast milk. Endoscopic Response: Decrease in SESCD >50% from baseline as scored by a central reviewer. 15 in april 2019, skyrizi received u.s. food and drug administration approval Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. For more information about AbbVie, please visit us atwww.abbvie.com. Presented at the 17th Congress of the European Crohns and Colitis Organisation (ECCO 2022) Virtual, February 16-19, 2022. 57% SKYRIZI vs 46% placebo (induction responders), p<0.05. (min,max) 2 skyrizi is approved in the u.s. to treat moderate to severe plaque psoriasis in adults 2021. ClinicalTrials.gov. Patient 1: Failed a Biologic and Presented With SevereCD ON ENDOSCOPY (SES-CD OF 27)9,10, Patient received 600 mg IV (induction) and 360mgSC (maintenance). AbbVie has completed two positive Phase III trials in PsA (PASI 90 and physical function at week 24 versus placebo) and three positive trials in CD (clinical remission and endoscopic response at week 12 versus placebo). Condition: Crohns Type: drug Learning Zones Currently approved indications for Skyrizi are not affected by this extension. SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally. SES-CD=simple endoscopic score for Crohn's disease. The following information on important labeling revisions does not include all changes; please refer to the SKYRIZI Full Prescribing Information. Assessment used non-responder imputation for missing data due to COVID-19 (NRI-NC); analysis used the Cochran-Mantel-Haenszel test. The agency decided to extend the Prescription Drug User Fee Act (PDUFA) action date for the indication by three months to review additional data submitted from the sponsor related in part to an on-body injector. Moskovitz DN, Daperno M, Van Assche G. Defining and validating cut-offs for thesimple endoscopic score for Crohn's disease. Endoscopic Response: Decrease in SES-CD >50% from baseline as scored by a central reviewer. IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI (risankizumab-rzaa) 1 Indications. 1,2 il-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis. Skyrizi PDUFA date for Crohn's disease extended three months due to additional data submitted by ABBV during the BLA review:. aEndoscopic response was defined as a decrease in SES-CD >50% from baseline as scored by a central reviewer. Endoscopic Remission AT WEEK52: Last year, sales of the drug were $2.939 billion internationally. Call your doctor for medical advice about side effects. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility. Follow @abbvie onTwitter,Facebook,LinkedInorInstagram. SFET Ferrante M, Panaccione R, Baert F, et al. Risankizumab induces early clinical remission and response in patients with moderate-to-severe Crohns disease: results from the phase 3 ADVANCE and MOTIVATE studies. This endpoint was not statistically significant under the prespecified multiple testing procedure. have recently received or are scheduled to receive an immunization (vaccine). Hypersensitivity Reactions On January 21, 2022, the Prescribing Information and Medication Guide for SKYRIZI (risankizumab-rzaa) was updated to add a Contraindication and a new Warning and Precaution for Serious Hypersensitivity Reactions. median Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI. MARI Data Limitations:Data was not multiplicity controlled, and not powered to demonstrate statistical difference in treatment effect for SKYRIZI vs placebo (induction responders). Data Limitations: Endoscopic remission and sub-group data at Week52 could not be tested for multiplicity control, and cannot demonstrate a statistically significant difference in treatment effect for SKYRIZI vs placebo (induction responders). Nov 8, 2022 11:06 AM, Worldwide Crypto Based Exchange Traded Products AUM Rose 7.5% in October 2 Call your doctor for medical advice about side effects. It is not known if SKYRIZI can harm your unborn baby. Nov 7, 2022 8:23 AM, ARway Corp. A No-Code Augmented Reality Wayfinding Solution is Now Trading in the USA Under The Stock Symbol: ARWYF Analysis is not multiplicity or placebo controlled, subjects were not restratified at Week12 for Week24 assessment and are not counted in the efficacy or safety analysis at Week52. 2021. March 3, 2022 Medical Devices Regulatory Affairs The FDA has extended its review period for AbbVie's and Boehringer Ingelheim's Skyrizi (risankizumab-rzaa) for the treatment of moderate-to-severe Crohn's disease in patients age 16 years and older, calling for details of the injector device. Use SKYRIZI exactly as your healthcare provider tells you to use it. Efficacy and safety of risankizumab as maintenance therapy in patients with Crohn's disease: 52 week results from the phase 3 FORTIFY study. Another step forward for Skyrizi in Crohn's disease 03-06-2021 Print. ClinicalTrials.gov. Data Limitations:Post hoc analyses of SF and APS at Weeks 1-3 were not powered or tested to demonstrate a statistical significant difference in treatment effect for SKYRIZI vs. placebo. cThe bio-nave subpopulation includes patients who were bio-exposed but did not have an inadequate response, loss of response, or intolerance to biologics (5%). Skyrizi is indicated for: Most common (1%) adverse reactions associated with SKYRIZI in plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. No conclusions regarding these comparisons can be made. Do you know about Skyrizi's immunomodulatorimmuno- November 30, 2022; FDA is planning to hold an advisory committee meeting in October 2022 to discuss the application. Interim efficacy and safety of RZB maintenance treatment from the OLE, up to 2 years, are reported. WELL-STUDIED Safety Profile? *The bio-nave subpopulation includes patients who were bio-exposed but did not have an inadequate response, loss of response, or intolerance to biologics (13%). ClinicalTrials.gov. Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100)* to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study. (Total Population): CD=Crohn's disease; CDAI=Crohn's disease activity index; IL-23=interleukin-23; SES-CD=simple endoscopic score for Crohn'sdisease, CDAI=Crohn's disease activity index; IV=intravenous, CD=Crohn's disease; CDAI=Crohns disease activity index; SES-CD=simple endoscopic score for Crohnsdisease. Available at: BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment. Skyrizi is also used to treat moderate to severe Crohn's disease in adults. Prior to initiating SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines. SKYRIZI was approved in the U.S. in 2019 to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. Risankizumab-rzaa (Skyrizi) will not be used concomitantly with apremilast, tofacitinib, or other biologic DMARDs (e.g., adalimumab, infliximab). We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections. You may get infections more easily. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. EMOR Nov 9, 2022 9:04 AM, Mullen Enters Into Agreement With Newgate Motor Group, One of Ireland's Most Recognized Auto Groups, to Distribute Mullen I-GO in Ireland and United Kingdom The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. RXMD AbbVie has also filed an application with the European Medicines Agency asking for approval of Skyrizi to treat patients at least 16 years with moderate to severe Crohn's disease. Schreiber S, Ferrante M, Panaccione R, et al. See "What is the most important information I should know about SKYRIZI?". Products or treatments described on this site are available in the U.S. but may not be available in all other countries. If you are having difficulty paying for your medicine, AbbVie may be able to help. Most common (>3%) adverse reactions associated with SKYRIZI in Crohn's disease are upper respiratory infections, headache, and arthralgia in induction and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection in maintenance. Nov 9, 2022 7:13 AM, Progressive Care Announces Shareholder Conference Call and Business Update on November 14, 2022 Shares of UK and USA-based clinical stage biotech F-star Therapeutics were up 11% at $8.15 pre-market, as it revealed it has entered into an exclusive licensing agreement with AstraZeneca,, under which the Anglo-Swedish pharma major will receive global rights to research, develop and commercialize next generation Stimulator . BLEG 08-07-2021. 1,2 il-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis. The regulatory filing seeks approval for Skyrizi both as a 600mg intravenous ("IV") induction and 360mg subcutaneous ("SC") maintenance therapy in patients aged 16 years and older with CD. Interleukin-23 (IL-23) is a cytokine involved in inflammatory processes that is thought to be linked to a number of chronic immune-mediated diseases, including plaque psoriasis, psoriatic arthritis, and Crohn's disease. Available at: A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis. 24% of total patients demonstrated endoscopic remission with SKYRIZI at Week121, Ranked Secondary Endpoint for ADVANCE: hs-CRP, BLA for MS: PDUFA date December 28, 2022. See the SES-CD Criteria, All patients may have received concomitant conventional therapies that included, IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mg, Subcutaneous injection of risankizumab-rzaa 180 mg. SKYRIZI [package insert]. All rights reserved. Skyrizi (risankizumab) is the first IL-23-selective drug to be cleared for the inflammatory bowel disease - ahead of rivals like Johnson & Johnson's Tremfya (guselkumab), and Sun Pharma's. Nov 4, 2022 11:17 AM, Branded Legacy, Inc. Signs Letter Of Intent to Purchase Total Refinement Solutions, LLC AbbVie. Hypersensitivity Reactions, Infections, Tuberculosis (TB), Hepatotoxicity in Treatment of Crohn's Disease, Administration of Vaccines. Nov 8, 2022 8:00 AM, E-commerce Customers Recognize Safe-T Group's Enterprise Privacy Unit, NetNut, in Time for November Shopping Events Call your doctor for medical advice about side effects. skyrizi is an interleukin-23 (il-23) inhibitor that selectively blocks il-23 by binding to its p19 subunit. BTDG If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves. Presented at the 16th Congress of the European Crohns and Colitis Organisation (ECCO 2021) Virtual, July 2-3 and 8-10, 2021. risankizumab-rzaa or any of the excipients. SKYRIZI is a prescription medication for adults with moderate to severe Crohn's disease. dClinical response was defined as a reduction of CDAI score 100 points from baseline. All patients with insufficient data were counted as non-responders for, Endoscopic improvement should be measured by, Turner D, Ricciuto A, Lewis A, et al. The sections evaluated on endoscopy are the: rectum, sigmoid and leftcolon, transverse colon, right colon and ileum (per SESCD assessment). AbbVie announces US FDA extend PDUFA action date by 3 months to review for Skyrizi to treat Crohn's disease North Chicago, Illinois , Wednesday, March 2, 2022, 14:00 Hrs [IST] AbbVie announced that the US Food and Drug Administration (FDA) has extended its review period for Skyrizi (risankizumab-rzaa) for the treatment of moderate to severe . Most common (>3%) adverse reactions associated with SKYRIZI in Crohns disease are upper respiratory infections, headache, and arthralgia in induction and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection in maintenance. Ferrante M, Panaccione R, Feagan B, et al. Prior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics. No statistical or clinical conclusions can be drawn from this presentation and the results should be interpreted with caution. Risankizumab as maintenance therapy formoderately to severely active Crohns disease: results from the multicentre, randomised, double-blind. The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to review additional data submitted by AbbVie, including information about the on-body injector, for this new proposed indication. Introduction Adults with moderate-to-severe Crohn's disease (CD) who responded to risankizumab (RZB) in the phase 2 induction and maintenance study (Feagan, 2017) could enroll in an open-label extension (OLE) study. BLO FNQQF Skyrizi is used to treat active psoriatic arthritis in adults. AbbVie (NYSE:ABBV) has announced that the FDA will prolong the review period for Skyrizi (risankizumab-rzaa) to treat moderate to severe Crohns disease in patients 16 years and older. AbbVie announces US FDA extend PDUFA action date by 3 months to review for Skyrizi to treat Crohn's disease: North Chicago, Illinois Wednesday, March 2, 2022, 14:00 Hrs [IST] . February 28, 2022 - 4:15 pm. To View This Article: Login No statistical or clinical conclusions can be made. The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections. Skyrizi works to reduce inflammation by binding to excess IL-23. Endoscopic Response AT WEEK 52: Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Nov 7, 2022 7:51 AM, FDCTech's Quarterly Release for the Third Quarter (FY22 Q3) Results Nov 7, 2022 11:06 AM, Kona Gold Beverage, Inc Rolls Out Ooh La Lemin Lemonades in over 250 Walmart stores across 12 States In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. gClinical response was defined as a reduction of CDAI score 100 points from baseline. Call your doctor for medical advice about side effects. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately. 1 Now, health providers may prescribe it for adults with moderately to severely active Crohn's disease. CDAI=Crohn's disease activity index; SES-CD=simple endoscopic score for Crohn'sdisease. AbbVie has also filed an application with the European Medicines Agency asking for approval of Skyrizi to treat patients at least 16 years with moderate to severe Crohns disease. 2021. Themean half-life of SKYRIZI is approximately 21days for patients with CD which may have contributed to these rates. About AbbVieAbbVie's mission is to discover and deliver innovative medicines that solve serious health issuestoday and address the medical challenges of tomorrow. By selecting "Yes" below, you certify that you are a Healthcare Professional and that you wish to proceed to the Healthcare Professionals Only section on the AbbVie Medical Information site. The most common side effects of SKYRIZI in people treated for Crohn's Disease include: upper respiratory . No clinical or statistical inferences can be made due to the exploratory nature of the assessment and should be interpreted withcaution. The US Food and Drug Administration (FDA) approved it to treat moderate to severe Crohn's disease in adults. You must be logged in to give a plus1 award. ARWYF That number . Please see Important Safety Information, including BOXED WARNING on Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis. Fainting, dizziness, feeling lightheaded (low blood pressure), Swelling of your face, eyelids, lips, mouth, tongue, or throat. Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults. The. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 16, 2023. . Most common (>3%) adverse reactions associated with SKYRIZI in Crohn's disease are upper respiratory infections, headache, and arthralgia in induction and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection in maintenance. NORTH CHICAGO, Ill., Feb. 28, 2022 /PRNewswire/ --AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has extended its review period for SKYRIZI (risankizumab-rzaa) for the treatment of moderate to severe Crohn's disease in patients 16 years and older. These are not all the possible side effects of SKYRIZI. SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to For more information, talk to your HCP. Week 0, Nov 9, 2022 8:11 AM, Progressive Care Announces Integration With Salesforce What are the possible side effects of SKYRIZI?SKYRIZI may cause serious side effects. Colombel J, Schreiber S, D'Haens G, et al. You are encouraged to report negative side effects of prescription drugs to the FDA. The Pharma Letter provides subscribers with daily, up-to-date news, business intelligence, comment and analysis for the pharmaceutical, biotechnology and generics sectors of the health . Clinical Remission AT WEEK 52: Risankizumab as induction therapy for Crohns disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Development and validation of a new, simplified endoscopic activity score for Crohns disease: the SES-CD. *The four endoscopic variables are scored from 0 to 3 in each bowel segment (rectum, sigmoid and left colon, transverse colon, right colon and ileum). FDCT Clinical Remission: Defined as a CDAI score of <150 points. Endoscopic Response AT WEEK 52: AbbVie announced that the US Food and Drug Administration (FDA) approved risankizumab-rzaa (Skyrizi) to treat moderately to severely active Crohn disease (CD) in adults, making the drug the first specific interleukin-23 (IL-23) inhibitor labeled for this population in the US, according to a company press statement. Available at: BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. Continuation criteria The member (18 years of age or older) has a documented diagnosis of active moderate to severe chronic plaque psoriasis and is a candidate for systemic therapy or phototherapy; and . are pregnant or plan to become pregnant. Data Limitations: Endoscopic remission sub-group data at Week 52 was not tested formultiplicity control, and cannot demonstrate a statistically significant difference in treatment effect for SKYRIZI vs placebo (induction responders). SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. DHaens G, Panaccione R, Baert F, et al. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Clinical Remission AT WEEK 12: Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. BASELINE OF INDUCTION (ADVANCE, MOTIVATE), MAINTENANCE OF CLINICAL REMISSION DATA AT WEEK 52, CRITERIA FOR ENDOSCOPIC RESPONSE AND ENDOSCOPIC REMISSION, SEE COMBINED CLINICAL RESPONSE DATA (CR-100) FOR INITIAL AND DELAYED RESPONDERS, SES-CD is a Recommended Measure of Disease Activity by STRIDE-II. The IL-23 inhibitor from AbbVie indicated for the treatment of moderately to severely active Crohn's disease (CD) in adults. The most common side effects of SKYRIZI include upper respiratory infections, feeling tired, fungal skin infections, headache, and injection site reactions. Then, in January, it won an indication for adults with active psoriatic arthritis. The total population in the ADVANCE and MOTIVATE studies includes patients dosed with risankizumab-rzaa 1200 mg IV, which did not demonstrate additional treatment benefit over the 600 mg dose and is not a recommended regimen. median CDAI=Crohn's disease activity index; SC=subcutaneous. AbbVie announced positive top-line results from the Phase III maintenance study, FORTIFY, showing Skyrizi (risankizumab) 360 mg subcutaneous [SC]; administered every eight weeks, achieved the co-primary endpoints of endoscopic response and clinical remission at one year in adult patients with moderate to severe Crohn's disease. 2021. have an infection that does not go away or that keeps coming back. Earlier this year, the FDA approved SKYRIZI to treat active psoriatic arthritis in adults.1. Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. modulator use, n(%), Baseline Quoted in the announcement . The IL-23 inhibitor from AbbVie indicated for the treatment of moderately to severely active Crohn's disease (CD) in adults.1.
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