Repatha 140mg/ml 1 Pf Syrinj Lat Fr
It is used to lower cholesterol.It is used in some people to lower the chance of heart attack, stroke, some heart procedures, and certain other heart problems.
Drug Class
Antilipemic agent
Pharmacologic Class
PCSK9 inhibitor; Monoclonal antibody
Pregnancy Category
Not available
FDA Approved
Aug 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Repatha is an injectable medicine used to lower 'bad' cholesterol (LDL-C) in your blood. It works by helping your liver remove more LDL-C. It's often used when statins alone aren't enough or if you can't take statins.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh, belly area, or upper arm. If you will be using this medication at home, your doctor or nurse will instruct you on how to administer it properly.
Before using the medication, wash your hands thoroughly. Do not open the packaging until you are ready to use it. Avoid injecting the medication into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site as directed by your doctor, and do not inject into the same location as another shot.
Do not shake the medication. If it has been stored in the refrigerator, allow it to come to room temperature for at least 30 minutes before use. Do not heat the medication. Check the solution for any signs of damage, such as cloudiness, leakage, or particles. The solution should be colorless to faint yellow; do not use it if the color has changed.
When administering the injection, avoid the area within 2 inches (5 cm) of the belly button. The injection may take up to 15 seconds to complete. After use, dispose of the device properly and do not reuse it. Throw away needles in a designated needle/sharp disposal box, and follow local guidelines for disposing of the box when it is full.
Storage and Disposal
Store the medication in the refrigerator, but do not freeze it. If the medication has been frozen, do not use it. Keep the medication in its original container, protected from light. If necessary, you can store the medication at room temperature for up to 30 days. Record the date you remove the medication from the refrigerator, and if it is not used within 30 days, discard it.
Keep the medication away from heat sources, and do not store it in a vehicle's glove box or trunk. Store all medications in a safe location, out of reach of children and pets. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on disposing of medications, and consider participating in local drug take-back programs.
Missed Doses
If you take this medication every 2 weeks and miss a dose, take it as soon as you remember. If it has been more than 7 days since the missed dose, skip it and resume your regular schedule. If you take this medication every month and miss a dose, take it as soon as you remember. If it has been more than 7 days since the missed dose, take the missed dose and start a new schedule based on the date of administration.
For all uses of this medication, do not take two doses at the same time or extra doses. If you are unsure about what to do if you miss a dose, consult your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh, belly area, or upper arm. If you will be using this medication at home, your doctor or nurse will instruct you on how to administer it properly.
Before using the medication, wash your hands thoroughly. Do not open the packaging until you are ready to use it. Avoid injecting the medication into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site as directed by your doctor, and do not inject into the same location as another shot.
Do not shake the medication. If it has been stored in the refrigerator, allow it to come to room temperature for at least 30 minutes before use. Do not heat the medication. Check the solution for any signs of damage, such as cloudiness, leakage, or particles. The solution should be colorless to faint yellow; do not use it if the color has changed.
When administering the injection, avoid the area within 2 inches (5 cm) of the belly button. The injection may take up to 15 seconds to complete. After use, dispose of the device properly and do not reuse it. Throw away needles in a designated needle/sharp disposal box, and follow local guidelines for disposing of the box when it is full.
Storage and Disposal
Store the medication in the refrigerator, but do not freeze it. If the medication has been frozen, do not use it. Keep the medication in its original container, protected from light. If necessary, you can store the medication at room temperature for up to 30 days. Record the date you remove the medication from the refrigerator, and if it is not used within 30 days, discard it.
Keep the medication away from heat sources, and do not store it in a vehicle's glove box or trunk. Store all medications in a safe location, out of reach of children and pets. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on disposing of medications, and consider participating in local drug take-back programs.
Missed Doses
If you take this medication every 2 weeks and miss a dose, take it as soon as you remember. If it has been more than 7 days since the missed dose, skip it and resume your regular schedule. If you take this medication every month and miss a dose, take it as soon as you remember. If it has been more than 7 days since the missed dose, take the missed dose and start a new schedule based on the date of administration.
For all uses of this medication, do not take two doses at the same time or extra doses. If you are unsure about what to do if you miss a dose, consult your doctor.
Lifestyle & Tips
- Continue to follow a cholesterol-lowering diet as recommended by your doctor or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- Maintain a healthy weight.
- Avoid smoking.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once monthly
Dose Range:
140 - 420 mg
Condition-Specific Dosing:
Heterozygous Familial Hypercholesterolemia (HeFH) or Clinical Atherosclerotic Cardiovascular Disease (ASCVD):
140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once monthly
Homozygous Familial Hypercholesterolemia (HoFH):
420 mg subcutaneously once monthly
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Approved for patients ≥10 years old for HoFH (420 mg subcutaneously once monthly) and HeFH (140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once monthly).
Adolescent:
Approved for patients ≥10 years old for HoFH (420 mg subcutaneously once monthly) and HeFH (140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once monthly).
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary
Dialysis:
No dose adjustment necessary; not removed by dialysis
Hepatic Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary
Pharmacology
Mechanism of Action
Evolocumab is a human monoclonal IgG2 antibody that binds to proprotein convertase subtilisin/kexin type 9 (PCSK9). By binding to PCSK9, evolocumab prevents PCSK9 from binding to the low-density lipoprotein receptor (LDLR) on the surface of hepatocytes. This increases the number of available LDLRs to clear LDL-C from the blood, thereby lowering LDL-C levels.
Pharmacokinetics
Absorption:
Bioavailability:
72%
Tmax:
3-4 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
11-17 L
ProteinBinding:
Low (as expected for a monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
11-17 days
Clearance:
Non-linear at lower concentrations, becoming linear at higher concentrations
ExcretionRoute:
Primarily via catabolism; no specific excretion route
Unchanged:
Not applicable (protein catabolism)
Pharmacodynamics
OnsetOfAction:
Within 1 week
PeakEffect:
Approximately 1-2 weeks for maximal LDL-C reduction
DurationOfAction:
Maintained for the dosing interval (2 weeks or 1 month)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Nose or throat irritation
Flu-like symptoms
Signs of a common cold
Back pain
Bruising, redness, or other irritation at the injection site
Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Nose or throat irritation
Flu-like symptoms
Signs of a common cold
Back pain
Bruising, redness, or other irritation at the injection site
Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of a serious allergic reaction: rash, hives, swelling of your face, lips, tongue, or throat, or trouble breathing. Seek immediate medical attention.
- Severe injection site reactions: persistent redness, pain, or swelling at the injection site.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regularly undergo blood tests and other laboratory examinations as instructed by your doctor. Adhere to the dietary plan recommended by your doctor. Be aware that this drug may cause elevated blood sugar levels, potentially leading to the development or worsening of diabetes. If you have a known allergy to latex, consult with your doctor to discuss any necessary precautions. If you are pregnant, planning to become pregnant, or are currently breast-feeding, notify your doctor to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials. Doses up to 1750 mg have been administered without dose-limiting toxicity.
What to Do:
In case of overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Lipid Panel (LDL-C, Total Cholesterol, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and confirm diagnosis of hyperlipidemia or ASCVD.
Timing: Prior to initiation of therapy
Routine Monitoring
Lipid Panel (LDL-C, Total Cholesterol, HDL-C, Triglycerides)
Frequency: 4-12 weeks after initiation or dose adjustment, then periodically as clinically indicated (e.g., every 6-12 months)
Target: Individualized based on patient risk factors and guideline recommendations (e.g., LDL-C <70 mg/dL or <55 mg/dL for very high-risk patients)
Action Threshold: Failure to achieve target LDL-C reduction, or unexpected increase in lipid levels
Signs/Symptoms of Allergic Reactions
Frequency: Ongoing, especially after first few doses
Target: Absence of symptoms
Action Threshold: Development of rash, urticaria, angioedema, or other hypersensitivity reactions (discontinue and treat appropriately)
Injection Site Reactions
Frequency: Ongoing
Target: Absence of severe redness, pain, or swelling
Action Threshold: Persistent or severe injection site reactions (consider alternative injection sites or re-evaluate therapy)
Symptom Monitoring
- Signs of allergic reaction (rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
- Injection site reactions (redness, pain, bruising, swelling)
Special Patient Groups
Pregnancy
Limited human data on evolocumab use in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies have shown no evidence of harm to the fetus. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, no increased risk observed in animal studies.
Second Trimester:
Limited data, no increased risk observed in animal studies.
Third Trimester:
Limited data, no increased risk observed in animal studies.
Lactation
It is unknown whether evolocumab is excreted in human milk. Human IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Repatha and any potential adverse effects on the breastfed infant from Repatha or from the underlying maternal condition.
Infant Risk:
Low risk, but potential for infant exposure to IgG antibodies. Monitor for adverse effects.
Pediatric Use
Approved for Homozygous Familial Hypercholesterolemia (HoFH) and Heterozygous Familial Hypercholesterolemia (HeFH) in patients aged 10 years and older. Safety and effectiveness in pediatric patients with other forms of hyperlipidemia have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between geriatric patients (≥65 years old) and younger patients. No dose adjustment is necessary based on age.
Clinical Information
Clinical Pearls
- Repatha is a biologic agent and should be stored in the refrigerator (2°C to 8°C / 36°F to 46°F) in the original carton to protect from light. Do not freeze. If needed, it can be kept at room temperature (up to 25°C / 77°F) for a maximum of 30 days.
- Allow the syringe or auto-injector to warm to room temperature for at least 30 minutes before injection. Do not warm using heat sources.
- Rotate injection sites (thigh, abdomen, upper arm) with each dose.
- Patients should be educated on proper subcutaneous injection technique.
- Repatha is typically used in addition to diet and maximally tolerated statin therapy, or in patients who are statin intolerant.
- Monitor for hypersensitivity reactions, which can occur within minutes or days of administration.
Alternative Therapies
- Statins (e.g., Atorvastatin, Rosuvastatin)
- Ezetimibe
- Other PCSK9 inhibitors (e.g., Alirocumab)
- siRNA (e.g., Inclisiran)
- Bile acid sequestrants (e.g., Cholestyramine)
- Fibrates (e.g., Fenofibrate, Gemfibrozil)
- Niacin (Nicotinic Acid)
Cost & Coverage
Average Cost:
Highly variable, typically >$500 per 140mg syringe per 140mg/ml prefilled syringe
Insurance Coverage:
Specialty Tier (Tier 3 or 4), often requires prior authorization and step therapy
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.