Repatha Srclk 140mg/ml Inj Latex 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, PCSK9 Inhibitor
Pharmacologic Class
Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor
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 body remove more LDL-C. It's often used when diet and statin medicines aren't enough to lower cholesterol, or for people with certain genetic conditions that cause very high cholesterol.
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 administer the medication into the same location as another injection.
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. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this 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, dispose of it properly.
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 the 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. Check with 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 administer the medication into the same location as another injection.
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. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this 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, dispose of it properly.
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 the 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. Check with 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.
- Engage in regular physical activity.
- Maintain a healthy weight.
- Do not stop taking Repatha or other cholesterol medications without consulting your doctor.
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. For patients on apheresis, consider 420 mg every 2 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (for general use)
Adolescent:
For Homozygous Familial Hypercholesterolemia (HoFH) in patients 10 years and older: 420 mg subcutaneously once monthly.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Dialysis:
No dose adjustment needed
Hepatic Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
Not studied; caution advised
Pharmacology
Mechanism of Action
Evolocumab is a human monoclonal antibody that binds to proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes, leading to degradation of the LDLR. By inhibiting the binding of PCSK9 to LDLR, evolocumab increases the number of LDLRs available 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:
Approximately 11-17 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
11-17 days
Clearance:
Not readily quantifiable due to catabolic degradation
ExcretionRoute:
Primarily non-renal catabolism
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Within 1 week
PeakEffect:
Approximately 1-2 weeks after initial dose
DurationOfAction:
Maintained throughout dosing interval (2 weeks or 1 month)
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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 minor 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 about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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 minor 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 about side effects, contact your doctor for medical advice. 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 (e.g., rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, dizziness, feeling faint). Seek immediate medical attention.
- Unusual muscle pain or weakness (though rare with PCSK9 inhibitors, important to report if experienced with other lipid-lowering agents).
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 existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dosage 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 existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dosage 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 directed by your doctor. Adhere to the dietary plan recommended by your doctor. Be aware that this drug may cause high blood sugar levels, potentially leading to the development or worsening of diabetes. If you have a known allergy to latex, consult your doctor to discuss any necessary precautions. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials.
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).
Drug Interactions
Monitoring
Baseline Monitoring
Lipid Panel (LDL-C, Total Cholesterol, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and assess the need for therapy.
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 (e.g., every 6-12 months) as clinically indicated
Target: LDL-C reduction goals vary based on patient risk (e.g., <70 mg/dL or <55 mg/dL for very high-risk patients)
Action Threshold: If LDL-C goals are not met, consider adherence, dose adjustment (if applicable), or combination therapy.
Signs and symptoms of adverse reactions (e.g., nasopharyngitis, upper respiratory tract infection, flu, back pain, injection site reactions, allergic reactions)
Frequency: Regularly during therapy
Target: Absence of severe or persistent adverse effects
Action Threshold: Report any severe or persistent adverse effects to healthcare provider. Discontinue if severe allergic reaction occurs.
Symptom Monitoring
- Symptoms of allergic reactions (e.g., rash, urticaria, swelling, difficulty breathing)
- Symptoms of infection (e.g., fever, sore throat, cough, body aches)
- Injection site reactions (e.g., redness, pain, bruising)
Special Patient Groups
Pregnancy
Limited data on evolocumab use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Monoclonal antibodies, like evolocumab, are transported across the placenta, particularly during the third trimester. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data, animal studies showed no direct harm.
Second Trimester:
Limited human data, animal studies showed no direct harm.
Third Trimester:
Potential for fetal exposure due to placental transfer of IgG antibodies.
Lactation
It is not known whether evolocumab is excreted in human milk. Consider the developmental and health benefits of breastfeeding 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:
Unknown. Large proteins like antibodies are generally poorly absorbed orally by infants, but caution is advised.
Pediatric Use
Approved for Homozygous Familial Hypercholesterolemia (HoFH) in patients 10 years and older. Safety and effectiveness in pediatric patients with HeFH or ASCVD have not been established. Safety and effectiveness in pediatric patients with HoFH younger than 10 years have not been established.
Geriatric Use
No dose adjustment is necessary in elderly patients (≥65 years old). No overall differences in safety or effectiveness were observed between elderly and younger patients.
Clinical Information
Clinical Pearls
- Repatha is administered via subcutaneous injection. Patients or caregivers can be trained to administer the injection at home.
- Store Repatha in the refrigerator (2°C to 8°C / 36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.
- Allow Repatha to reach room temperature for at least 30 minutes before injection. Do not warm in any other way.
- Rotate injection sites (thigh, abdomen, or upper arm). Do not inject into areas where the skin is tender, bruised, red, or hard.
- Repatha is often used in combination with statins and/or other lipid-lowering therapies.
- Patients should continue to follow a cholesterol-lowering diet during treatment.
Alternative Therapies
- Alirocumab (Praluent) - another PCSK9 inhibitor
- Inclisiran (Leqvio) - an siRNA PCSK9 inhibitor
- Statins (e.g., Atorvastatin, Rosuvastatin)
- Ezetimibe (Zetia)
- Bile Acid Sequestrants (e.g., Cholestyramine)
- Fibrates (e.g., Fenofibrate)
- Niacin
Cost & Coverage
Average Cost:
Highly variable, typically >$500 per 140mg syringe per 140mg/ml prefilled syringe or auto-injector
Insurance Coverage:
Specialty Tier (requires prior authorization, often step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.