repatha sureclick 140 mg/ml

Long-term use of Repatha demonstrated a sustained treatment effect as evidenced by reduction of LDL-C in patients with severe familial hypercholesterolaemia (non-HoFH) (see table 5). Repatha has no known effects on the ability to drive or use machines, but as a general precaution, avoid driving soon after you have an injection. Twenty-six paediatric patients with homozygous familial hypercholesterolaemia have been treated with Repatha in clinical studies conducted in patients aged 10 to < 18 years. Nzov produktu poda KL Repatha 140 mg injekn roztok naplnen v injeknom pere sol inj 2x1 ml/140 mg (striek.inj.skl.napl.SureClick v pere) Aplikan forma SOL INJ - Injekn roztok Vrobca Amgen Europe B.V. (NLD) Drite rozhodnutia Amgen Europe B.V. (NLD) Dodvatelia Amgen Slovakia s.r.o. An approximate two to three-fold accumulation was observed in trough serum concentrations (Cmin (SD) 7.21 (6.6)) following 140 mg doses every 2 weeks or following 420 mg doses administered monthly (Cmin (SD) 11.2 (10.8)), and serum trough concentrations approached steady-state by 12 weeks of dosing. Each 1 mL single-use prefilled syringe and single-use prefilled SureClick autoinjector contains 140 mg evolocumab, acetate (1.2 mg), polysorbate 80 (0.1 mg), proline (25 mg) in Water for Injection, USP. Treatment effects of Repatha compared with placebo in paediatric patients with heterozygous familial hypercholesterolaemia mean percent change from baseline to week 24 (%, 95% CI), QM = monthly (subcutaneous); CI =Confidence Interval; LDL-C = low density lipoprotein cholesterol; HDL-C = high density lipoprotein cholesterol; ApoB = apolipoprotein B; ApoA1 = apolipoprotein A1, TC = total cholesterol. Repatha 140 mg solution for injection in pre-filled pen Your total cholesterol is made up mainly of Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) cholesterol. See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects. The most common side effects of Repatha include: runny nose, sore throat, symptoms of the common cold, flu or flu-like symptoms, back pain, high blood sugar levels (diabetes), and redness, pain, or bruising at the injection site. Key: OLE = open-label extension, N (n) = Number of evaluable patients (N) and patients with observed LDL-C values at specific scheduled visit (n) in the severe familial hypercholesterolaemia (non-HoFH) final analysis set. Use this medication regularly to get the most benefit from it. Drug Name Repatha Sureclick. AIMOVIG AUTOINJECTOR 140 MG/ML SUBCUTANEOUS AUTO-INJECTOR Formulary Addition AIMOVIG AUTOINJECTOR 70 MG/ML SUBCUTANEOUS AUTO-INJECTOR Formulary Addition ciprofloxacin 0.3 %-dexamethasone 0.1 % ear drops,suspension . No interaction studies have been performed. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Learn more about the RepathaREADY Support Program Do you have questions? For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia). Information for consumers on prescription, over-the-counter and complementary medicines. Call us toll free at 866-978-1084. Do not inject into any areas of skin that are injured, tender, hard, red, or has scars or stretch marks. Repatha is a sterile, preservative-free solution, clear to opalescent; colourless to yellowish solution for injection, practically free from particles. Keep all your doctor's appointments so that your progress can be checked. Your doctor will help you decide whether to stop breast-feeding, or whether to stop using Repatha, considering the benefit of breast-feeding to the baby and the benefit of Repatha to the mother. Subcutaneous regimens of 140 mg every 2 weeks and 420 mg once monthly were equivalent in average LDL-C lowering (mean of weeks 10 and 12) resulting in -72% to -57% from baseline compared with placebo. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. This narrowing can slow or block blood flow to vital organs such as the heart and brain. Side EffectsRedness, pain, or bruising at the injection site may occur. 2007 - 2022 gmedication.com. Table 5. Repatha is used to treat high cholesterol. you are allergic to evolocumab, or any of the ingredients listed at the end of this leaflet or medicines or other products that are produced by DNA technology using Chinese Hamster Ovary cells. Amgen Australia Pty LtdLevel 11, 10 Carrington StSydney NSW 2000Ph: 1800 803 638www.amgenmedinfo.com.au. Carefully read and learn the Instructions for Use. The cartridge assembly is co-packed with an administration device. The three injections should be given consecutively within 30 minutes. It can raise your HDL cholesterol as well. Effect of evolocumab on LDLC in patients with homozygous familial hypercholesterolaemia - mean percent change from baseline to OLE week 216 (and associated 95% CI). Repatha can also be stored at room temperature (68F to 77F) in its original box for up to 30 days. It is used alone or with other medicines. Store in a refrigerator (2C 8C). Repatha is only part of a complete treatment program that also includes diet, statin medication, and regular blood testing. TAUSSIG was a multicentre, open-label, 5-year extension study to assess the long-term safety and efficacy of Repatha, as an adjunct to other lipid-lowering therapies, in patients with severe familial hypercholesterolaemia (FH), including homozygous familial hypercholesterolaemia. In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements. No formal drug-drug interaction studies have been conducted for Repatha. The required amount of RoActemra concentrate (0.6 mL/kg) should be withdrawn from the vial and placed in the 50 mL infusion bag. The entire contents should be injected. The administration device is designed for use only with the provided 3.5 mL pre-filled cartridge assembly. If you have any questions, ask your doctor or pharmacist. e Assessment of time to hospitalisation for unstable angina was ad-hoc. Who should not take Repatha Sureclick 140 Mg/Ml Subcutaneous Pen Injector Antihyperlipidemic - PCSK9 Inhibitors? Table 9. The primary efficacy endpoint in this trial was percent change from baseline to week 24 in LDL-C. Repatha significantly reduced LDL-C from baseline to mean of weeks 10 and 12 compared with placebo for the rosuvastatin and simvastatin groups and compared with placebo and ezetimibe for the atorvastatin group (p < 0.001). The pharmacokinetics of Repatha were evaluated in 103 paediatric patients aged 10 to < 18 years with heterozygous familial hypercholesterolaemia (HAUSER-RCT). What should I know before I use Repatha? There is no specific treatment for Repatha overdose. Effect of evolocumab on LDL-C in patients with severe familial hypercholesterolaemia (non-HoFH) mean percent change from baseline to OLE week 216 (and associated 95% CI). A risk to breastfed newborns/infants cannot be excluded. No overall differences in safety or efficacy were observed between these patients and younger patients. Help us improve emc by letting us know which of the following best describes you, 2. Enrolled patients were randomized in a 2:1 ratio to receive 24 weeks of subcutaneous once monthly 420 mg Repatha or placebo. Repatha SureClick may also be used for purposes not listed in this medication guide. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines. The initial recommended dose is 420 mg once monthly. 1 mL solution (140 mg/mL evolocumab) in a single use pre-filled syringe made from type I glass with stainless steel needle, supplied as a 1-pack. Some medicines may interfere with Repatha and affect how it works. The administration device is a compact, sterile, single-use, disposable, injection device intended for use only with the provided 3.5 mL pre-filled cartridge assembly; supplied as a 1-pack. What is the medium of administration of the drug? Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. Do not shake this medication. The information was verified by Dr. Vishal Pawar, MD Pharmacology, Contact|Privacy Policy You should consult a doctor about the dosage before using this medicine! Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop. b 2-sided log-rank test stratified by randomisation stratification factors collected via IVRS. Prior to initiating evolocumab, secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded. See additional information under Section 6. To be updated with all the latest news, offers and special announcements. 20 USE COUPON You SAVE $65.51 The needle cover of the glass pre-filled syringe is made from dry natural rubber (a derivative of latex), which may cause severe allergic reactions. If your doctor has prescribed Repatha along with other cholesterol lowering medicines, follow your doctor's instructions on how to take these medicines together. Single-Dose Prefilled SureClick Autoinjector . Before starting Repatha, you should be on a cholesterol lowering diet and regularly exercising to lower your cholesterol. Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or. REPATHA is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous administration. Latest news, evidence and CPD opportunities. If your doctor decides that you or a caregiver can give the injections of Repatha you or your caregiver will receive training on the right way to prepare and inject Repatha. By reporting side effects, you can help provide more information on the safety of this medicine. (6) MENDEL-2 was an international, multicentre, double-blind, randomised, placebo and ezetimibe-controlled, 12-week study of Repatha in 614 patients with primary hypercholesterolaemia and mixed dyslipidaemia. Do Not Freeze or Shake. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Before injecting each dose, clean the injection site with rubbing alcohol. Repatha is available in two strengths: 140 milligrams per milliliter (mg/mL) and 420 mg/3.5 mL. Read the Patient Information Leaflet if available from your pharmacist before you start using evolocumab and each time you get a refill. Start typing to retrieve search suggestions. N PEN PRE-UMPLUT: 140 mg: AMGEN EUROPE B.V. EVOLOCUMABUM: Cutie . It works by improving how well your body gets rid of LDL cholesterol. An independent peer-reviewed journal providing critical commentary on drugs and therapeutics. Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a), and increased HDL-C and ApoA1 at week 52 compared with placebo (p < 0.001) (see table 4). Repatha is used in adults who cannot control their cholesterol levels by cholesterol lowering diet and exercise. Effect on coronary atherosclerotic plaque morphology. ATC code: C10AX13. LDL-C reductions in this study were consistent with previous studies where evolocumab was added to stable lipid-lowering therapy as demonstrated by on-treatment LDL-C levels at week 8 in this study (reflecting steady-state effect of high-intensity statin in both treatment arms) of 0.79 mmol/L (30.5 mg/dL) and 2.06 mmol/L (79.7 mg/dL) in the evolocumab plus atorvastatin and the placebo plus atorvastatin groups, respectively. GAUSS-2 was an international, multicentre, double-blind, randomised, ezetimibe-controlled, 12-week study in 307 patients who were statin-intolerant or unable to tolerate an effective dose of a statin. in the full CMI. Be careful before you drive or use any machines or tools until you know how Repatha affects you. What should I know while using Repatha? If you notice other effects not listed above, contact your doctor or pharmacist. Therefore, no dose adjustments are necessary in patients with severe renal impairment or ESRD receiving haemodialysis. If you become pregnant while using this medicine, tell your doctor immediately. Provides consumers with a way to report and discuss adverse experiences with medicines. This medication belongs to a class of drugs known as monoclonal antibodies. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. Injection: 140 mg/mL solution in a single-use prefilled SureClick auto injector. Keep all medical and lab appointments. In patients with primary hypercholesterolaemia or mixed dyslipidaemia on high dose statin, the systemic exposure of evolocumab was slightly lower than in subjects on low-to-moderate dose statin (the ratio of AUClast 0.74 [90% CI 0.29; 1.9]). It is not known if Repatha will affect your unborn baby. Up to 99% of patients treated with either dose of evolocumab achieved an LDL-C of < 2.6 mmol/L and up to 95% achieved an LDL-C < 1.8 mmol/L at the mean of weeks 10 and 12. Create a FREE Epocrates Online account to access patient medication instructions. Inject this medication under the skin of the thigh, abdomen, or upper arm as directed by your doctor, usually once every 2 weeks, or once every month. The intended pharmacological effect of decreased serum LDL-C and total cholesterol were observed in these studies and was reversible upon cessation of treatment. Reductions in LDL-C and changes in other lipid parameters in 14 adolescent patients (aged 12 to < 18 years) with homozygous familial hypercholesterolaemia are comparable to those in the overall population of patients with homozygous familial hypercholesterolaemia. However, some side effects may need medical attention. Time to a MACE event (composite of CV death, MI, or stroke); 3-year Kaplan-Meier, Effect on LDL-C during acute phase of Acute Coronary Syndromes (ACS). A total of 3,681 patients enrolled in OSLER-2. Follow the instructions in the carton on how to take care of your medicine properly. Are there any side effects?7. Evolocumab was compared to placebo for the rosuvastatin and simvastatin groups and compared with placebo and ezetimibe for the atorvastatin group. For the primary endpoint of absolute change in minimum FCT (fibrous cap thickness) in a matched segment of artery from baseline, least squares (LS) mean (95% CI) increased from baseline by 42.7 m (32.4, 53.1) in the Repatha group and 21.5 m (10.9, 32.1) in the placebo group, an additional 21.2 m (4.7, 37.7) compared to placebo (p = 0.015; 38% difference (p = 0.041)). HAUSER-OLE was an open label, single arm, multicentre, 80 week trial in 12 HofH subjects to evaluate the safety, tolerability and efficacy of Repatha for LDL-C reduction in paediatric patients from aged 10 to < 18 years of age with homozygous familial hypercholesterolaemia. The mutagenic potential of evolocumab has not been evaluated. 140 mg/mL INJECTION SUPPORT 36F - 46F 68F - 77F Storing and traveling with Repatha Store Repatha in the refrigerator (36F to 46F) until you're ready to use it. Enter your ZIP Code to compare discount Repatha Sureclick coupon prices in your area. Watch how to store, use, and discard the Repatha SureClick autoinjector (single-dose prefilled autoinjector). For more information, see Section 5. Treatment of homozygous familial hypercholesterolaemia. Find information on medicines by active ingredient or brand name. Repatha significantly reduced LDL-C compared with ezetimibe (p < 0.001). LDL-C and other lipid parameters returned to baseline within 12 weeks after discontinuation of Repatha at the beginning of OSLER or OSLER-2 without evidence of rebound. Lab and/or medical tests (such as LDL cholesterol levels) should be done while you are using this medication. Carefully read and learn the Instructions for Use. Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9. How to use Repatha SureClick Watch Demo Download the Instructions for Use. Monitoare Oficial; Categorie act; Anul publicarii; Institutii emitente; search Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a) and increased HDL-C from baseline to mean of weeks 10 and 12 as compared to placebo for the rosuvastatin and simvastatin groups (p < 0.05) and significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1 and Lp(a), compared with placebo and ezetimibe for the atorvastatin group (p < 0.001) (see tables 2 and 3). This website uses cookies. Do not freeze. To bookmark a medicine you must sign up and log in. Repatha 420 mg once monthly significantly reduced LDL-C from baseline at 52 weeks compared with placebo (p < 0.001). Changes in unbound PCSK9 and serum lipoproteins were reversible upon discontinuation of evolocumab. Repatha Syringe; Repatha Pushtronex; Form Pen Injection; Dosage 140 MG/ML; Quantity 2 ML. Why am I using Repatha?2. The mean (SE) percent changes in calculated LDL-C from baseline were: -44.4% (1.7%) at week 12, -41.0% (2.1%) at week 48, and -35.2% (2.5%) at week 80. The effects of evolocumab in this patient population were consistent with those observed in previous studies in evolocumab clinical development program and no new safety concerns were noted. Despite very public messaging that the Bluetooth contact-tracing tools for COVID-19 developed by Google and Apple would not track users' locations, You have entered an incorrect email address! Immunoglobulin (Ig) products provide critical therapy for people with immunodeficiencies and immune-type neurological conditions. * Not available in Australia. 11 ofertas a partir de: R$ 1.653,33. . Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1 and Lp(a), from baseline to mean of weeks 10 and 12 compared with both placebo and ezetimibe (p < 0.001) (see table 3). Solution for injection (injection) in pre-filled pen (SureClick). Primary hypercholesterolaemia and mixed dyslipidaemia (including heterozygous familial hypercholesterolaemia), Adults and paediatric patients (aged 10 years and over). This Instructions for Use contains information on how to inject Repatha. No new safety concerns were identified and the safety data in this paediatric population was consistent with the known safety profile of the product in adults with heterozygous familial hypercholesterolaemia. Do not double the dose to catch up. Read the Patient Information Leaflet if available from your pharmacist before you start using evolocumab and each time you get a refill. Patients had to be on a low-fat diet and receiving background lipid-lowering therapy. Sanghai Pharmaceuticals - Offering Repatha Evolocumab 2 sureclicks of 1ml of 140mg/ml, in New Delhi, Delhi. When suggestions are available use up and down arrows to review and ENTER to select. The most frequent injection site reactions were injection site bruising, erythema, haemorrhage, injection site pain, and swelling. Download Once a month Repatha Pushtronex System Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Repatha is given as an injection under the skin (subcutaneous). The 140 mg dose should be delivered using a single pre-filled syringe. If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal. Ongoing education for Aboriginal and Torres Strait Islander health workers and practitioners on quality use of medicines and medical tests, Practical information, tools and resources for health professionals and staff to help improve the quality of health care and safety for patients. Repatha prices without insurance will vary depending on whether you buy the prefilled autoinjectors, the single-use prefilled syringes, or the single-use on-body infusor. Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Repatha. Of the 18,546 patients treated with evolocumab in double-blind clinical studies 7,656 (41.3%) were 65 years old, while 1,500 (8.1%) were 75 years old. Established atherosclerotic cardiovascular disease in adults. Pharmacist not accepting the card? Before using this medication, tell your doctor or pharmacist your medical history. Tell your doctor if you are breast-feeding a baby. This will make the injection more comfortable. Manufactured by: There are limited data available on overdose with RoActemra. If you are using the prefilled syringe/pen, let it warm up to room temperature for at least 30 minutes. After 12 weeks of treatment, dose frequency can be up-titrated to 420 mg once every 2 weeks if a clinically meaningful response is not achieved. More instructions can be found in Section 4. . Repatha Evolocumab 140 mg / mL Injection 1 mL REPATHA, SYR 140MG/ML 1ML RX No Image Compare Features In adults with established cardiovascular disease, REPATHA is indicated to reduce the risk of myocardial infarction, stroke, and coronary revascularization If removed from the refrigerator, Repatha may be stored at room temperature (up to 25C) in the original carton and must be used within 1 month. Patients were randomised 1:1 to either Repatha (140 mg every two weeks or 420 mg once every month) or matching placebo; the mean duration of patient follow-up was 26 months. For more information, including what to do if you have any side effects, see Section 6. The study did not investigate the correlation between atherosclerotic disease regression and cardiovascular events. Are there any side effects? Who should not take 1 ML Repatha SureClick 140 MG/ML Auto-Injector? Repatha Syringe; Repatha Pushtronex; Form Pen Injection; Dosage 140 MG/ML; Quantity 4 ML. Store in the original carton in order to protect from light. Evolocumab is for subcutaneous injection into the abdomen, thigh or upper arm region. If you are using the prefilled syringe/pen, let it warm up to room temperature for at least 30 minutes. Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients aged 10 years and over with heterozygous familial hypercholesterolaemia, as an adjunct to diet: in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or. Key: HoFH = homozygous familial hypercholesterolaemia, QM = once monthly, a nominal p value < 0.001 when compared with placebo, b p value < 0.001 when compared with placebo. In cynomolgus monkeys at exposures much higher than patients receiving 420 mg evolocumab once monthly, no effects on embryo-foetal or postnatal development (up to 6 months of age) were observed. This information is not intended as a substitute for medical advice and should not be exclusively relied on to manage or diagnose a medical condition. Combination with a statin and statin with other lipid-lowering therapies. Do not shake. Do not use this medicine if you notice it is discoloured or contains large lumps, flakes or coloured particles. This is not a complete list of possible side effects. Repatha is a protein (human monoclonal antibody) that lowers cholesterol. In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). RUFINAMIDE 40 MG/ML ORAL SUSPENSION [Banzel] 4: Non-Preferred Drug: 40%: 40%: None: If it is longer than 7 days from the missed dose, skip the missed dose. What Repatha looks like and contents of the pack N = number of patients randomized and dosed in the interim analysis set. HAUSER-OLE was an open-label, single-arm, multicentre, 80 week study of Repatha in 150 paediatric patients aged 10 to 17 years with HeFH that rolled-over from HAUSER-RCT and enrolled 13 de novo paediatric HoFH patients. Ideal for people with no prescription coverage,or drug is not covered by insurance, Everyone can qualify. The more medicines you take, the more difficult it can be to remember important information about them. In Canada - Call your doctor for medical advice about side effects. An approximately 20% increase in the clearance of evolocumab was observed in patients co-administered statins. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Median (Q1, Q3) LDL-C at baseline was 398 (343, 475) mg/dL. ADRUCIL 500 MG/10 ML INTRAVENOUS SOLUTION Removed from Plan Formulary 140 mg dans 1,0 mL (140 mg/mL) 420 mg dans 3,5 mL (120 mg/mL) Anticorps monoclonal dirig contre la . When measured by TAV, atherosclerotic regression was observed in 61.5% (95% CI 56.7, 66.0) and 48.9% (95% CI 44.2, 53.7) of patients who received Repatha or placebo respectively. The effects of Repatha 420 mg once monthly on coronary atherosclerotic plaques as assessed by optical coherence tomography (OCT), were evaluated in a 52 week double-blind, randomised, placebo controlled study including adult patients initiated within 7 days of a non ST segment elevation acute coronary syndrome (NSTEACS) on maximally tolerated statin therapy. Randomisation was stratified by study centre and presence of stable statin treatment within 4 weeks prior to enrolment. Administration of single subcutaneous dose of 140 mg resulted in a Cmax mean (SD) of 13.0 (10.4) g/mL and AUClast mean (SD) of 96.5 (78.7) dayg/mL.

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