Repatha Srclk 140mg/ml Pf Auto Inj
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
Pregnancy Category
Not available
FDA Approved
Aug 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Repatha is an injectable medicine that helps lower 'bad' cholesterol (LDL-C) in your blood. It works by blocking a protein called PCSK9, which allows your liver to remove more LDL-C from your blood. It's used for people with high cholesterol who haven't reached their goals with other medicines, or for those with specific genetic conditions causing 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 self-administering at home, your doctor or nurse will provide guidance on proper technique.
Before using, wash your hands thoroughly. Do not open the packaging until you are ready to administer the medication. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site as directed by your doctor to minimize the risk of adverse reactions. Do not administer into the same location as another injection.
Preparation and Administration
Do not shake the medication. If it has been refrigerated, allow it to come to room temperature for at least 30 minutes before use. Do not heat the medication. Check the solution for any visible particles, cloudiness, or leakage before use. The solution should be colorless to faintly yellow; do not use if the color has changed. Do not inject within 2 inches (5 cm) of the belly button. The injection process may take up to 15 seconds to complete.
Disposal
After use, dispose of the device and needle in a designated sharps container. Do not reuse needles or other components. When the container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Handling
Store the medication in its original container, protected from light, in the refrigerator. Do not freeze. If necessary, you may store at room temperature for up to 30 days; record the date you remove it from the refrigerator. If not used within 30 days, discard the medication. Keep it away from heat sources and do not store in a vehicle's glove box or trunk. Ensure all medications are kept out of reach of children and pets.
Missed Dose
If you take this medication every 2 weeks and miss a dose, administer it as soon as you remember. If more than 7 days have passed since the missed dose, skip it and resume your regular schedule. If you take this medication every month and miss a dose, administer it as soon as you remember. If more than 7 days have passed, take the missed dose and start a new schedule based on the date of administration. For all schedules, do not take extra doses or double up on doses. If you are unsure about what to do in case of a missed dose, contact 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 self-administering at home, your doctor or nurse will provide guidance on proper technique.
Before using, wash your hands thoroughly. Do not open the packaging until you are ready to administer the medication. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site as directed by your doctor to minimize the risk of adverse reactions. Do not administer into the same location as another injection.
Preparation and Administration
Do not shake the medication. If it has been refrigerated, allow it to come to room temperature for at least 30 minutes before use. Do not heat the medication. Check the solution for any visible particles, cloudiness, or leakage before use. The solution should be colorless to faintly yellow; do not use if the color has changed. Do not inject within 2 inches (5 cm) of the belly button. The injection process may take up to 15 seconds to complete.
Disposal
After use, dispose of the device and needle in a designated sharps container. Do not reuse needles or other components. When the container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Handling
Store the medication in its original container, protected from light, in the refrigerator. Do not freeze. If necessary, you may store at room temperature for up to 30 days; record the date you remove it from the refrigerator. If not used within 30 days, discard the medication. Keep it away from heat sources and do not store in a vehicle's glove box or trunk. Ensure all medications are kept out of reach of children and pets.
Missed Dose
If you take this medication every 2 weeks and miss a dose, administer it as soon as you remember. If more than 7 days have passed since the missed dose, skip it and resume your regular schedule. If you take this medication every month and miss a dose, administer it as soon as you remember. If more than 7 days have passed, take the missed dose and start a new schedule based on the date of administration. For all schedules, do not take extra doses or double up on doses. If you are unsure about what to do in case of a missed dose, contact 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.
- Avoid smoking.
- Limit alcohol intake.
- Adhere to all other prescribed medications for cholesterol or cardiovascular health.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For primary hyperlipidemia and established atherosclerotic cardiovascular disease (ASCVD): 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once monthly.
Dose Range:
140 - 420 mg
Condition-Specific Dosing:
Primary Hyperlipidemia and 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, administer after apheresis.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for general use. For HoFH: 420 mg subcutaneously once monthly for patients 10 years and older.
Adolescent:
For HoFH: 420 mg subcutaneously once monthly for patients 10 years and older.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Dialysis:
No dose adjustment necessary. For HoFH patients on apheresis, administer after apheresis.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary (limited data, but not expected to alter pharmacokinetics significantly).
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 available LDLRs to clear LDL-C from the blood, thereby lowering LDL-C levels.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 72%
Tmax:
3 to 4 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 11 to 17 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
11 to 17 days
Clearance:
Not specifically reported as a single rate, but clearance is dose-dependent and decreases with increasing dose.
ExcretionRoute:
Primarily via non-specific proteolytic degradation.
Unchanged:
Not applicable (metabolized)
Pharmacodynamics
OnsetOfAction:
Within 1 week (significant LDL-C reduction)
PeakEffect:
Approximately 1 to 3 weeks
DurationOfAction:
Maintained for the dosing interval (2 weeks or 1 month) due to long half-life.
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
+ Difficulty 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
+ Frequent urination
+ Flushing
+ Rapid 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 unusual symptoms that bother you or persist, contact your doctor for guidance:
Nose or throat irritation
Flu-like symptoms
Common cold symptoms
Back pain
Bruising, redness, or irritation at the injection site
Headache
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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
+ Difficulty 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
+ Frequent urination
+ Flushing
+ Rapid 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 unusual symptoms that bother you or persist, contact your doctor for guidance:
Nose or throat irritation
Flu-like symptoms
Common cold symptoms
Back pain
Bruising, redness, or irritation at the injection site
Headache
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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 the face, lips, tongue, or throat, difficulty breathing or swallowing, dizziness, feeling faint.
- Severe injection site reactions that do not resolve.
- Unexplained muscle pain or weakness (though rare with evolocumab, it's a general concern with lipid-lowering therapies).
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 allergic reaction you experienced, including any symptoms that occurred.
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 this medication can be taken safely with all your other 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 allergic reaction you experienced, including any symptoms that occurred.
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 this medication can be taken safely with all your other 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 work and other laboratory tests as instructed 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 with your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials. Doses up to 1050 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) or seek immediate medical attention.
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 to 12 weeks after initiation or dose adjustment, then periodically as clinically indicated.
Target: LDL-C goals vary based on patient risk (e.g., <70 mg/dL or <55 mg/dL for very high-risk patients per guidelines).
Action Threshold: If LDL-C goals are not met, consider adherence, dose adjustment, or combination therapy.
Symptom Monitoring
- Injection site reactions (redness, pain, bruising)
- Symptoms of allergic reactions (rash, hives, swelling, difficulty breathing)
- Symptoms of nasopharyngitis, upper respiratory tract infection, or influenza
- Muscle pain or weakness (though less common than with statins)
- Back pain
- Arthralgia
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of evolocumab in pregnant women. Monoclonal antibodies are known to cross the placental barrier. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data. Animal studies showed no adverse developmental effects at exposures up to 300 times the human exposure.
Second Trimester:
Limited human data. Monoclonal antibodies are generally transferred across the placenta more during the third trimester.
Third Trimester:
Limited human data. Potential for fetal exposure and effects on the developing immune system, though specific risks are unknown.
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 evolocumab and any potential adverse effects on the breastfed infant from evolocumab or from the underlying maternal condition.
Infant Risk:
Risk is unknown. Monoclonal antibodies are large proteins and are generally poorly absorbed orally by infants. However, potential for infant exposure exists.
Pediatric Use
Safety and effectiveness have been established in pediatric patients aged 10 years and older with HoFH. Safety and effectiveness have not been established in pediatric patients with other forms of hyperlipidemia or in patients younger than 10 years of age.
Geriatric Use
No dose adjustment is necessary in geriatric patients. No overall differences in safety or effectiveness were observed between geriatric and younger patients.
Clinical Information
Clinical Pearls
- Evolocumab is a highly effective LDL-C lowering agent, often used in patients who cannot achieve lipid goals with statins or have statin intolerance, or in those with very high cardiovascular risk.
- It is administered subcutaneously, and patients should be trained on proper injection technique.
- Storage: Refrigerate at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Allow to warm to room temperature for at least 30 minutes before injection.
- Patients should continue lifestyle modifications and other lipid-lowering therapies (e.g., statins, ezetimibe) as prescribed, as evolocumab is often used in combination.
- Consider patient assistance programs due to the high cost of the medication.
Alternative Therapies
- Other PCSK9 inhibitors (e.g., Alirocumab)
- HMG-CoA reductase inhibitors (Statins, e.g., Atorvastatin, Rosuvastatin)
- Cholesterol absorption inhibitors (e.g., Ezetimibe)
- Adenosine triphosphate-citrate lyase (ACL) inhibitors (e.g., Bempedoic acid)
- Small interfering RNA (siRNA) targeting PCSK9 (e.g., Inclisiran)
- Bile acid sequestrants (e.g., Cholestyramine)
- Fibrates (e.g., Fenofibrate)
- Niacin
Cost & Coverage
Average Cost:
Very high (e.g., ~$500-$600 per 140mg syringe/autoinjector, ~$1500-$1800 per 420mg monthly dose) per 140mg/ml prefilled syringe/autoinjector or 420mg/3.5ml cartridge
Insurance Coverage:
Tier 4 or Specialty Tier (requires prior authorization, step therapy, and often documentation of high cardiovascular risk or familial hypercholesterolemia)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. It is also important to note that some medications may come with additional patient information leaflets, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance and support. 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 detailed information about the overdose, including the type and amount of medication taken, as well as the time it was taken.