use the Repatha SureClick autoinjector after the expiration date. Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. For homozygous familial hypercholesterolaemia the recommended starting dose is 420 mg once monthly. pounding in the ears. What are the benefits of this drug? Repatha contains the active drug evolocumab, which is a biologic medication. Biologics are made from parts of living organisms. Also began experiencing extreme night . Step 2: Injection of Repatha SureClick Autoinjector. Repatha; Descriptions. The recommended dose for adults with high cholesterol and heart disease to reduce the risk of heart attack, stroke and certain heart procedures is either 140 mg every two weeks or 420 mg once monthly. INJECTION SUPPORT. More common side effects in people using Repatha to reduce the risk of stroke, heart attack, and certain heart surgeries include: runny nose. sore throat . To learn more about Repatha's uses, talk with your doctor. REPATHA (evolocumab) injection, for subcutaneous use . You'll take Repatha as an injection under your skin. REPATHA lowers LDL cholesterol. Description and Brand Names. Hogyan kell alkalmazni a Repatha-t? After 12 weeks . You may also store Repatha in the original carton at cool room temperature, away from light and heat. 3. 1. Read the full instructions before you inject!. The most common . The cartridges are to be used together with an automated dosing device called a mini-doser. Evolocumab injection is used together with a proper diet, alone or together with other medicines (eg, ezetimibe, statins), to treat patients with heterozygous familial hypercholesterolemia (also called primary hyperlipidemia) or with homozygous familial hypercholesterolemia (HoFH . Part of the Repatha SureClick autoinjector may be broken even if you cannot see the break. Repatha is an injection used to reduce LDL bad cholesterol levels which in turn reduces your risk of having a heart attack or stroke. Use the medicine within 30 days if it is kept at room temperature. Repatha (evolocumab) is a new cholesterol lowering injection developed by Amgen that was approved by US Food and Drug Administration (FDA) as an adjunctive treatment for adults with heterozygous familial and homozygous familial hypercholesterolemia (HoFH) in August 2015. Both Praluent and Repatha are liquid solutions given as a subcutaneous injection. : 125522 Approval Date: 08/27/2015. I had never used an. REPATHA is an injection that is given under the skin in the thigh, abdomen, or upper arm. Do not heat a syringe or injection device. In the Repatha arm, post-baseline new binding antibodies were detected in 43 patients (0.3 percent) and neutralizing antibodies in none. This is "Repatha "SureClick"" by Center City Film & Video on Vimeo, the home for high quality videos and the people who love them. 1 This video series is sponsored by Amgen Inc. It is the second PCSK9 inhibitor approved by the FDA. Use a new Repatha SureClick autoinjector, and call 1-844­ REPATHA (1-844-737-2842). Dropping an injection device can cause it to break. Prefilled Syringe § A single-use prefilled syringe is also available. Repatha is a prescribed medication for dramatically lowering cholesterol. Other side effects not listed may also occur in some patients. MORE INFO. It can only be prescribed by a licensed physician. Amennyiben nem biztos az adagolást illetően, kérdezze meg . Blinded administration of ezetimibe was also included as an active control. Detailed results from the Repatha cognitive function study (EBBINGHAUS) will be presented in a separate Late-Breaking Clinical Trial Session . Instead, evolocumab comes . Repatha is available as a solution for injection in pre-filled syringes, pre-filled pens and cartridges. Linkedin; Pin it; Email; Print; Company: Amgen, Inc. Repatha "SureClick" 4 years ago. What are the benefits of . Injections are given under the skin of the abdomen, thigh or upper arm. Repatha is given as an injection under the skin (subcutaneous). Detailed results from the Repatha cognitive function study (EBBINGHAUS) will be presented in a separate Late-Breaking Clinical Trial Session . You may also store Repatha SureClick in the original carton at cool room temperature, away from light and heat. Storing and traveling with Repatha ® Store Repatha ® in the refrigerator (36°F to 46°F) until you're ready to use it. A Repatha nátriumot tartalmaz A gyógyszer kevesebb mint 1 mmol (23 mg) nátriumot tartalmaz adagonként, azaz gyakorlatilag "nátriummentes", és nincs hatással a beállított nátriumtartalmú étrendre. How much to use. Injection site reactions were more common with Repatha than with placebo (2.1 percent Repatha; 1.6 percent placebo). REPATHA ® safely and effectively. This is an injection . Do not use an injection device that has been dropped onto a hard surface, even if you cannot see a . Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha At the selected skin injection side with thumb and fingers about two inches apart pinch the skin to form a firm surface, or instead stretch the skin between thumb and fingers to form a firm area of skin . back pain. It can only be prescribed by a lice. A total of 4 trials evaluated the use of Repatha in adult patients. At the selected skin injection side with thumb and fingers about two inches apart pinch the skin to form a firm surface, or instead stretch the skin between thumb and fingers to form a firm area of skin . Patients were randomly assigned to receive subcutaneous injections of Repatha 140 mg every 2 weeks, Repatha 420 mg once monthly, or placebo for 12 weeks. Watch how to store, use, and discard the Repatha® SureClick® autoinjector (single-dose prefilled autoinjector). Repatha is available as a solution for injection in pre-filled syringes, pre-filled pens and cartridges. Step 2: Injection of Repatha SureClick Autoinjector. Initial U.S. Approval: 2015 -----RECENT MAJOR CHANGES-----Indications and Usage (1) 02/2021 . But unlike generics, which are made for non-biologic drugs, biosimilars are made for biologic drugs.) Repatha ® SureClick ® Interactive Learning Tool for Community Pharmacists is sponsored by Amgen, Inc. For this activity, you will be tasked with watching an instructional video, followed by 8 questions on how to properly prepare and use the Repatha ® Single-Dose Prefilled SureClick ® Autoinjector. Dosage and Administration (2.2) 05/2020 . Warnings and Precautions (5.1) 02/2021 . After 12 weeks . The recommended dose for adults with mixed dyslipidaemia or atherosclerotic . Use the medicine within 30 days if it is kept at room temperature. "[Repatha] over about two years of study, reduced the risk of cardiovascular events, including heart attacks and stroke, by about 15 percent. When you are ready to inject, remove the orange cap. Call your doctor for medical advice about side effects. Amgen said they are reducing the price of evolocumab to "improve affordability by lowering patient copays, especially for Medicare patients." Earlier this year, Regeneron and Sanofi, the makers of the other PCSK9 inhibitor on the . REPATHA (evolocumab) injection, for subcutaneous use . Do not use an injection device that has been dropped onto a hard surface, even if you cannot see a . Initial U.S. Approval: 2015 -----RECENT MAJOR CHANGES-----Indications and Usage (1) 02/2021 . The recommended dose for adults with high cholesterol and heart disease to reduce the risk of heart attack, stroke and certain heart procedures is either 140 mg every two weeks or 420 mg once monthly. nervousness. See full prescribing information for REPATHA. Repatha (evolocumab) injection. This is "Repatha "SureClick"" by Center City Film & Video on Vimeo, the home for high quality videos and the people who love them. A gyógyszert mindig a kezelőorvosa által elmondottaknak megfelelően alkalmazza. Part of the Repatha SureClick autoinjector may be broken even if you cannot see the break. Contraindications (4) 02/2021 . slow or fast heartbeat. REPATHA ® safely and effectively. Application No. swollen joints. Repatha® in the Community Pharmacy video series Designed to help you support high-risk patients along their journey to lower LDL-C and reduce the risk of another myocardial infarction, stroke, or coronary revascularization with Repatha ® added to a statin. From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha ®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. When you are ready to inject, remove the orange cap. Use the medicine within 30 days if it is kept at room temperature. Two trials evaluated the role of Repatha in primary . First injection of Repatha. Repatha is given as an injection under the skin (subcutaneous). reactions at Repatha injection sites, such as bruising, redness, or pain; back pain; joint pain ; muscle pain* Mild side effects of many drugs may go away within a few days or a couple of weeks . Repatha is supplied as a 140 mg/ mL-prefilled single-use syringe or SureClick autoinjector. See full prescribing information for REPATHA. (Biosimilars are like generic drugs. To give the 420-mg dose, three 140-mg injections should be administered consecutively within 30 minutes. Amgen's Repatha clears blocked arteries, shows study. Share; Tweet; Linkedin; Pin it; More sharing options. 68°F - 77°F. Repatha, a PCSK9 inhibitor for the treatment of cholesterol problems. pain or tenderness around the eyes and cheekbones. Do not heat a syringe or injection device. back pain. Clinical Trials. More common side effects in people using Repatha to reduce the risk of stroke, heart attack, and certain heart surgeries include: runny nose. You may also store Repatha in the original carton at cool room temperature, away from light and heat. sore throat . Approval Letter(s) (PDF) Printed Labeling (PDF) Summary Review (PDF) Officer/Employee List . Drug information provided by: IBM Micromedex US Brand Name. Handle this medicine carefully. Overall, the mean age at baseline was 53 years (range: 20 to 80 years), 18% were ≥ 65 years old, 66% were women, 83% White, 7% Black, and 9% Asian; 11% identified . How much to use. injection site reactions*. The recommended dose for adults with mixed dyslipidaemia or atherosclerotic . For about every 66 people treated, one person . Repatha is a prescribed medication for dramatically lowering cholesterol. Repatha, a PCSK9 inhibitor for the treatment of cholesterol problems. Repatha Evolocumab Injection ₹ 16,000/ Piece Get Latest Price REPATHA is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor indicated: in adults with established cardiovascular disease (CVD) to reduce the risk of myocardial infarction, stroke, and coronary revascularization (1) as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol Warnings and Precautions (5.1) 02/2021 . Drug forms and administration. Use a new Repatha SureClick autoinjector, and call 1-844­ REPATHA (1-844-737-2842). FDA has approved Repatha (evolocumab) injection as an add-on treatment to diet alone or together with certain other therapies for patients aged 10 years and older with heterozygous familial . Injections are given under the skin of the abdomen, thigh or upper arm. Injection site reactions were more common with Repatha than with placebo (2.1 percent Repatha; 1.6 percent placebo). Repatha "SureClick" 4 years ago. Do not. 36°F - 46°F. Do not use an injection device that has been dropped onto a hard surface, even if you . Handle this medicine carefully. The cap should only off the device a maximum of 5 minutes as the medicine can dry out. use the Repatha SureClick autoinjector if it has been dropped on a hard surface. Dropping an injection device can cause it to break. Three days after injection began experiencing difficulty swallowing with increased mucus production. Amgen has presented clinical data indicating that its PCSK9 inhibitor Repatha could help to reverse heart disease by removing atherosclerotic plaques, showing for the first time that the effect of this class of drugs may go further than reducing cholesterol alone. Self-injection with one click injector. Contraindications (4) 02/2021 . Download and read instructions before using; Watch the demo video § 140 mg/mL. This is a quick video on how to inject Repatha. No issues with injection. This is a quick video on how to inject Repatha. reactions at Repatha injection sites, such as bruising, redness, or pain; back pain; joint pain ; muscle pain* Mild side effects of many drugs may go away within a few days or a couple of weeks . From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha-treated and placebo-treated patients, respectively. In the Repatha arm, post-baseline new binding antibodies were detected in 43 patients (0.3 percent) and neutralizing antibodies in none. Self-injection with one click injector. use the Repatha SureClick autoinjector after the expiration date. Evolocumab, the powerful cholesterol-fighting injection sold as Repatha, offers a 25% reduction in cardiovascular (CV) death, heart attack, or stroke after the first year, giving the PCSK9 . Repatha ® can also be stored at room temperature . Amgen announced yesterday they have reduced the list price of evolocumab (Repatha) by 60%, cutting the cost of the drug from over $14,500 to $5,850 per year. Do not. use the Repatha SureClick autoinjector if it has been dropped on a hard surface. Repatha ® SureClick ® Interactive Learning Tool for Community Pharmacists is sponsored by Amgen, Inc.. For this activity, you will be tasked with watching an instructional video, followed by 8 questions on how to properly prepare and use the Repatha ® Single-Dose Prefilled SureClick ® Autoinjector.. After answering each question, you will be prompted to view a knowledge check to confirm . Repatha isn't available in a biosimilar form. Dosage and Administration (2.1, 2.3) 02/2021 . Dropping an injection device can cause it to break. The cartridges are to be used together with an automated dosing device called a mini-doser. Watch the demo video . For homozygous familial hypercholesterolaemia the recommended starting dose is 420 mg once monthly. injection site reactions*. Dosage and Administration (2.2) 05/2020 . Do not heat a syringe or injection device. Repatha is used as an adjunctive therapy … If you notice any other effects, check with your healthcare professional. Handle this medicine carefully. Dosage and Administration (2.1, 2.3) 02/2021 . muscle stiffness. The cap should only off the device a maximum of 5 minutes as the medicine can dry out.

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