FDA approves Repatha

The U.S. Food and Drug Administration (FDA) has approved Repatha (evolocumab) injection, a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C.
Repatha is an injectable prescription medicine called a PCSK9 inhibitor. It is used:
along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart or blood vessel problems, who need additional lowering of LDL cholesterol.
along with diet and other LDL lowering therapies in people with homozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL), who need additional lowering of LDL cholesterol.
The effect of Repatha on heart problems such as heart attacks, stroke, or death is not known.
It is not known if Repatha is safe and effective in children with homozygous familial hypercholesterolemia (HoFH) who are younger than 13 years of age or in children who do not have HoFH.
Do not use Repatha if you are allergic to evolocumab or to any of the ingredients. See the end of this leaflet for a complete list of ingredients.
Before you start treatment, tell your healthcare provider about all your medical conditions, including allergies, and if you:
are allergic to rubber or latex. The needle covers on the single-use prefilled syringes and within the needle caps on the single-use prefilled SureClick autoinjectors contain dry natural rubber.
are pregnant or plan to become pregnant. It is not known if Repatha will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment.
are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will use Repatha or breastfeed. You should not do both without talking to your healthcare provider first. Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.
Repatha side effects
Repatha can cause side effects including:
allergic reactions. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, severe itching, a swollen face, or trouble breathing.
The most common side effects include: runny nose, sore throat, symptoms of the common cold, flu or flu-like symptoms, back pain, and redness, pain, or bruising at the injection site.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects. Ask your healthcare provider or pharmacist for more information.
Ingredients in Repatha
Active Ingredient: evolocumab
Inactive Ingredients: proline, glacial acetic acid, polysorbate 80, water for injection, and sodium hydroxide.
Source: drugs.com

FDA approves Repatha

The U.S. Food and Drug Administration (FDA) has approved Repatha (evolocumab) injection, a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C. Repatha is an injectable prescription medicine called a PCSK9 inhibitor. It is used: along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart or blood vessel problems, who need additional lowering of LDL cholesterol. along with diet and other LDL lowering therapies in people with homozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL), who need additional lowering of LDL cholesterol. The effect of Repatha on heart problems such as heart attacks, stroke, or death is not known. It is not known if Repatha is safe and effective in children with homozygous familial hypercholesterolemia (HoFH) who are younger than 13 years of age or in children who do not have HoFH. Do not use Repatha if you are allergic to evolocumab or to any of the ingredients. See the end of this leaflet for a complete list of ingredients. Before you start treatment, tell your healthcare provider about all your medical conditions, including allergies, and if you: are allergic to rubber or latex. The needle covers on the single-use prefilled syringes and within the needle caps on the single-use prefilled SureClick autoinjectors contain dry natural rubber. are pregnant or plan to become pregnant. It is not known if Repatha will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment. are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will use Repatha or breastfeed. You should not do both without talking to your healthcare provider first. Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies. Repatha side effects Repatha can cause side effects including: allergic reactions. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, severe itching, a swollen face, or trouble breathing. The most common side effects include: runny nose, sore throat, symptoms of the common cold, flu or flu-like symptoms, back pain, and redness, pain, or bruising at the injection site. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects. Ask your healthcare provider or pharmacist for more information. Ingredients in Repatha Active Ingredient: evolocumab Inactive Ingredients: proline, glacial acetic acid, polysorbate 80, water for injection, and sodium hydroxide. Source: drugs.com