Approval was based on results of the SUSTAIN trial (n = 198), in which the median annual VOC rate was 1.63 for those receiving crizanlizumab 5 mg/kg, compared to 2.98 in the placebo group (indicating a 45.3% lower rate in the crizanlizumab group, p = 0.01). Sickle cell disease is rare, and Adakveo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 9 August 2012. You may report side effects to FDA at 1-800-FDA-1088. received an overall rating of 0 out of 10 stars from 0 reviews. The lowest GoodRx price for the most common version of Adakveo is around $9,355.68, 17% off the average retail price of $11,314.28. What other drugs will affect crizanlizumab? What other drugs will affect crizanlizumab? What other drugs will affect crizanlizumab? Infusion reactions may happen within 24 hours of receiving an infusion of Adakveo. side effects or any other side effects bother you or do not go away: Upset stomach. You may report side effects to FDA at 1-800-FDA-1088. Crizanlizumab is used in people with sickle cell disease to reduce how often certain episodes (vaso-occlusive crises) occur. 13.2 Animal Toxicology and/or Pharmacology In the 26-week repeat-dose toxicity study, administration of crizanlizumab-tmca in cynomolgus monkeys at dose levels up to 50 mg/kg/dose once every 4 weeks resulted in inflammation of the vessels in multiple tissues in 2 out of 10 animals. In the event of a severe reaction, crizanlizumab should be discontinued and appropriate therapy should be instituted. Some side effects may occur within 24 hours after you receive this medicine. What other drugs will affect crizanlizumab? What is the most important information I should know about crizanlizumab? You may report side effects to FDA at 1-800-FDA-1088. You've been a warrior fighting sickle cell disease. Call your doctor for medical advice about side effects. What is the most important information I should know about crizanlizumab? The active drug in Adakveo is crizanlizumab. Adakveo was approved by the Food and Drug Administration (FDA) in November 2019. Tell your caregiver if you feel dizzy, nauseated, tired, itchy, chilled, sweaty, or have a fever, wheezing, or shortness of breath. Crizanlizumab is the first targeted therapy approved for sickle cell disease. Back pain. Get information on Crizanlizumab injection including uses, dosage details, medication side-effects and drug interaction facts from Cleveland Clinic's health library. ADAKVEO ® (crizanlizumab-tmca) reduced pain crises by nearly half (45%) vs placebo in a 1-year study (based on a median annual rate of 1.63 pain crises with ADAKVEO vs 2.98 with placebo). The most common side effects with Adakveo (which may affect more than 1 in 10 people) are joint pain, nausea, back pain, fever and abdominal (belly) pain. Other drugs may affect crizanlizumab, including prescription … Other drugs may affect crizanlizumab, including prescription … Some side effects may occur within 24 hours after you receive this medicine. Special instructions for crizanlizumab. You may report side effects to FDA at 1-800-FDA-1088. DESCRIPTION. For the full list of side effects and restrictions, see the package leaflet. These are not all of the possible side effects of Adakveo. CRIZANLIZUMAB is a selectin blocker. Vaso-occlusive crisis is a common and painful complication of sickle cell disease that occurs when blood circulation is blocked by sickled red blood cells and may lead to organ damage. on its own in patients for whom hydroxycarbamide does not work well enough or causes too many side effects. Joint pain. CORONAVIRUS: DELAYS FOR ROUTINE SURGERIES, VISITOR RESTRICTIONS + COVID-19 TESTING. The committee noted that, because crizanlizumab had no effect on haemoglobin or measures of haemolysis in the SUSTAIN trial (the main clinical trial; see section 3.3), combining it with blood transfusions could potentially benefit people with sickle cell disease. What other drugs will affect crizanlizumab? The clinical expert FDA approval. 13.2 Animal Toxicology and/or Pharmacology In the 26-week repeat-dose toxicity study, administration of crizanlizumab-tmca in cynomolgus monkeys at dose levels up to 50 mg/kg/dose once every 4 weeks resulted in inflammation of the vessels in multiple tissues in 2 out of 10 animals. The most common side effects (incidence > 10%) were arthralgia, nausea, back pain, pyrexia, and abdominal pain. crizanlizumab alongside regular blood transfusions to prevent VOC. You may report side effects to your national health agency. Call your doctor for medical advice about side effects. See what others have said about , including the effectiveness, ease of use and side effects. Some side effects may occur within 24 hours after you receive this medicine. You may report side effects to FDA at 1-800-FDA-1088. Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome): back pain. Crizanlizumab (SEG101), Novartis‘ investigational compound for sickle cell disease (SCD), received breakthrough therapy designation from the U.S. Food and Drug Administration for its potential to prevent vaso-occlusive crises (VOCs).. There were no adverse effects of crizanlizumab-tmca on male or female reproductive organs. In case of a severe side effect or reaction, call the doctor, nurse or pharmacist at 901-595-3300. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. There were no adverse effects of crizanlizumab-tmca on male or female reproductive organs. Last Updated: 11/6/2020 If you are outside the Memphis area, dial toll-free 1-866-2STJUDE (1-866-278-5833). * Efficacy for crizanlizumab-tmcawas evaluated in 198 patients with sickle cell disease in SUSTAIN (NCT01895361), a 52-week, randomised, multicentre, placebo-controlled, double-blind trial. Other drugs may affect crizanlizumab, including prescription … You may report side effects to FDA at 1-800-FDA-1088. Tell your doctor if any of these symptoms are severe or do not go away: nausea back or joint pain fever redness, pain, swelling, or burning at the site where the injection was given Learn more about Crizanlizumab-tmca These are not all of the side effects that may occur. You may report side effects to FDA at 1-800-FDA-1088. Tell your caregiver if you feel dizzy, nauseated, tired, itchy, chilled, sweaty, or have a fever, wheezing, or shortness of breath. Tell your caregiver if you feel dizzy, nauseated, tired, itchy, chilled, sweaty, or have a fever, wheezing, or shortness of breath. Indication ... Adakveo may cause serious side effects, including infusion reactions. Crizanlizumab may also be used for purposes not listed in this medication guide. Crizanlizumab-tmca - Get up-to-date information on Crizanlizumab-tmca side effects, uses, dosage, overdose, pregnancy, alcohol and more. Some side effects may … What other drugs will affect crizanlizumab? Other drugs may affect crizanlizumab, including prescription … ... an unusual or allergic reaction to crizanlizumab, other medicines, foods, dyes or preservatives. pregnant or trying to … Crizanlizumab trials in Africa are expected to start in 2020. Clazakizumab (formerly ALD518 and BMS-945429), an investigational drug, is an aglycosylated, humanized rabbit monoclonal antibody against interleukin-6. Before receiving crizanlizumab, tell your care … Crizanlizumab-tmca injection is used to prevent vaso-occlusive crisis in patients with sickle cell disease. Some side effects may occur within 24 hours after you receive this medicine. Crizanlizumab is for use in adults and children at least 16 years old. 800.223.2273 You may report side effects to FDA at 1-800-FDA-1088. Other drugs may affect crizanlizumab, including prescription … You may report side effects to FDA at 1-800-FDA-1088. What are the possible side effects of crizanlizumab? If you notice other side effects that you think are caused by this medicine, tell your doctor Call your doctor for medical advice about side effects. Vaso-occlusive crisis is a common and painful complication of sickle cell disease that occurs when blood circulation is blocked by sickled red blood cells and may lead to organ damage. What is the most important information I should know about crizanlizumab (Adakveo)? Adakveo contains the active substance crizanlizumab. For more information, ask your healthcare provider or pharmacist. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Crizanlizumab-tmca injection is used to prevent vaso-occlusive crisis in patients with sickle cell disease. This medicine is used to reduce how often sickle cell crises happen. What is the most important information I should know about crizanlizumab? These side effects may go away during treatment as your body adjusts to the medicine. Other drugs may affect crizanlizumab, including prescription … The power of protection against pain crises with ADAKVEO. If you have questions about side effects, call your doctor. Severe joint pain or fever may occur in around 1 in 100 people.