Repatha Pushtronex 420mg/3.5ml Crtg
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
Monoclonal Antibody, 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 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 cholesterol from your body. This can help reduce your risk of heart attack, stroke, and other heart problems.
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 how to use it properly.
Preparation and Administration
1. Wash your hands before and after handling the medication.
2. If stored in the refrigerator, allow the medication to reach room temperature for at least 45 minutes before use. Do not heat the medication.
3. Do not open the packaging until you are ready to use it.
4. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
5. Use the medication within 5 minutes of inserting the cartridge into the on-body injector, as it will dry out and become ineffective if you wait longer.
6. Do not push the start button until the on-body injector is ready and placed on the skin. This button can only be pressed once.
7. Keep the device dry and avoid getting it wet.
8. Avoid injecting into moles, scars, or bruised areas, as well as skin with excessive hair.
9. The injection process may take up to 5 minutes to complete.
10. Keep electronic devices, such as cell phones, at least 12 inches away from the product during injection.
11. Rotate the injection site as directed by your doctor, and avoid injecting into the same area as another shot.
Important Safety Precautions
Do not use the medication if it has been dropped, broken, or if the solution is cloudy, leaking, or contains particles.
The medication is colorless to faint yellow; do not use it if the solution changes color.
Avoid injecting into skin within 2 inches (5 cm) of the belly button.
If you suspect the device has not worked correctly, or if the On-body Injector comes off before or during a dose, is leaking, or has a wet sticky part, contact your doctor immediately.
If the light on the On-body Injector flashes red, contact your doctor right away.
Disposal and Storage
Dispose of the used device and any needles in a needle/sharp disposal box. Do not reuse needles or other items.
When the disposal box is full, follow local regulations for proper disposal.
Store the medication in the refrigerator, but do not freeze. If needed, you can store it at room temperature for up to 30 days. Record the date you remove it from the refrigerator, and discard it if not used within 30 days.
* Store the medication in its original container to protect it from light.
Missed Dose
If you 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 when the dose is given. Do not take two doses at the same time or extra doses. If you are unsure what to do if you miss a 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 how to use it properly.
Preparation and Administration
1. Wash your hands before and after handling the medication.
2. If stored in the refrigerator, allow the medication to reach room temperature for at least 45 minutes before use. Do not heat the medication.
3. Do not open the packaging until you are ready to use it.
4. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
5. Use the medication within 5 minutes of inserting the cartridge into the on-body injector, as it will dry out and become ineffective if you wait longer.
6. Do not push the start button until the on-body injector is ready and placed on the skin. This button can only be pressed once.
7. Keep the device dry and avoid getting it wet.
8. Avoid injecting into moles, scars, or bruised areas, as well as skin with excessive hair.
9. The injection process may take up to 5 minutes to complete.
10. Keep electronic devices, such as cell phones, at least 12 inches away from the product during injection.
11. Rotate the injection site as directed by your doctor, and avoid injecting into the same area as another shot.
Important Safety Precautions
Do not use the medication if it has been dropped, broken, or if the solution is cloudy, leaking, or contains particles.
The medication is colorless to faint yellow; do not use it if the solution changes color.
Avoid injecting into skin within 2 inches (5 cm) of the belly button.
If you suspect the device has not worked correctly, or if the On-body Injector comes off before or during a dose, is leaking, or has a wet sticky part, contact your doctor immediately.
If the light on the On-body Injector flashes red, contact your doctor right away.
Disposal and Storage
Dispose of the used device and any needles in a needle/sharp disposal box. Do not reuse needles or other items.
When the disposal box is full, follow local regulations for proper disposal.
Store the medication in the refrigerator, but do not freeze. If needed, you can store it at room temperature for up to 30 days. Record the date you remove it from the refrigerator, and discard it if not used within 30 days.
* Store the medication in its original container to protect it from light.
Missed Dose
If you 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 when the dose is given. Do not take two doses at the same time or extra doses. If you are unsure what to do if you miss a dose, contact your doctor.
Lifestyle & Tips
- Continue to follow a heart-healthy diet (low in saturated and trans fats, cholesterol)
- Engage in regular physical activity as recommended by your doctor
- Maintain a healthy weight
- Quit smoking if you smoke
- Manage other cardiovascular risk factors (e.g., high blood pressure, diabetes)
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
420 mg subcutaneously once monthly (Pushtronex on-body infusor)
Dose Range:
420 - 420 mg
Condition-Specific Dosing:
Primary Hyperlipidemia (including Heterozygous Familial Hypercholesterolemia - HeFH):
420 mg subcutaneously once monthly
Homozygous Familial Hypercholesterolemia (HoFH):
420 mg subcutaneously once monthly
Established Atherosclerotic Cardiovascular Disease (ASCVD):
420 mg subcutaneously once monthly
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for general use; for HoFH: 10 years and older, 420 mg subcutaneously once monthly
Adolescent:
For HoFH: 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; no data for patients on dialysis
Hepatic Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No data available; use with caution
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 LDLRs available to clear low-density lipoprotein cholesterol (LDL-C) from the blood, thereby lowering LDL-C levels.
Pharmacokinetics
Absorption:
Bioavailability:
72%
Tmax:
3 to 4 days
FoodEffect:
Not applicable for subcutaneous administration
Distribution:
Vd:
3.3 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
11 to 17 days (effective half-life for LDL-C reduction is longer due to target-mediated drug disposition)
Clearance:
Not typically reported as a single value for biologics; cleared via catabolism
ExcretionRoute:
Not via renal or hepatic excretion in the traditional sense
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
LDL-C reduction observed within 1 week
PeakEffect:
Maximum LDL-C reduction typically within 1 to 2 weeks
DurationOfAction:
Sustained LDL-C reduction for the dosing interval (e.g., 1 month for 420mg dose)
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 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 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 unusual 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, 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 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 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 unusual 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, 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 an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
- Severe injection site reactions (e.g., persistent redness, swelling, pain, bruising)
- Unusual muscle pain or weakness (though rare with this class)
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, any of 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.
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 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, any of 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.
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 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 high blood sugar levels, including the development of new-onset diabetes or worsening of existing diabetes. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Before undergoing a magnetic resonance imaging (MRI) procedure, consult with your doctor. Additionally, if you plan to travel to high-altitude areas (above 11,483 feet or 3,500 meters), discuss this with your doctor to ensure your safety.
Be aware that this drug may cause high blood sugar levels, including the development of new-onset diabetes or worsening of existing diabetes. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Before undergoing a magnetic resonance imaging (MRI) procedure, consult with your doctor. Additionally, if you plan to travel to high-altitude areas (above 11,483 feet or 3,500 meters), discuss this with your doctor to ensure your safety.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials.
What to Do:
In case of overdose, treat the patient symptomatically and institute supportive measures as required. Contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Fasting Lipid Panel (LDL-C, Total Cholesterol, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and confirm indication for therapy
Timing: Prior to initiation of therapy
Routine Monitoring
Fasting Lipid Panel (LDL-C)
Frequency: 4 to 8 weeks after initiation, then periodically (e.g., every 6-12 months or as clinically indicated)
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: If target LDL-C not achieved, consider adherence, concomitant therapies, or re-evaluation of treatment plan
Symptom Monitoring
- Injection site reactions (e.g., erythema, pain, bruising)
- Hypersensitivity reactions (e.g., rash, urticaria, angioedema)
- Nasopharyngitis
- Upper respiratory tract infection
- Influenza
- Back pain
- Arthralgia
- Headache
- Symptoms of new-onset diabetes mellitus (rare)
Special Patient Groups
Pregnancy
Available data from clinical trials and postmarketing reports are insufficient to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Insufficient data
Second Trimester:
Insufficient data
Third Trimester:
Insufficient data
Lactation
No data are available regarding the presence of evolocumab in human milk, the effects on the breastfed infant, or the effects on milk production. 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. Evolocumab is a large protein, and oral absorption by an infant is unlikely.
Infant Risk:
Unknown; likely low due to large molecular weight and poor oral absorption
Pediatric Use
Approved for Homozygous Familial Hypercholesterolemia (HoFH) in patients 10 years and older. Safety and effectiveness have not been established in pediatric patients with other forms of hyperlipidemia or in patients younger than 10 years with HoFH.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients. No dose adjustment is needed based on age.
Clinical Information
Clinical Pearls
- Repatha Pushtronex is an on-body infusor designed for hands-free, slow subcutaneous administration over approximately 9 minutes, which may improve patient comfort compared to rapid injections.
- It is typically used in combination with statins or other lipid-lowering therapies when those therapies alone are insufficient to achieve target LDL-C levels.
- Patients should be instructed on proper storage (refrigerated, protect from light) and administration techniques, including allowing the device to warm to room temperature before use.
- Repatha significantly reduces LDL-C levels and has demonstrated a reduction in major adverse cardiovascular events in patients with established ASCVD.
- Patients should continue to adhere to a heart-healthy diet and lifestyle modifications while on Repatha therapy.
Alternative Therapies
- Statins (e.g., atorvastatin, rosuvastatin, simvastatin)
- Ezetimibe
- Bempedoic acid (Nexletol, Nexlizet)
- Fibrates (e.g., fenofibrate, gemfibrozil)
- Niacin
- Bile acid sequestrants (e.g., cholestyramine, colesevelam)
- Inclisiran (Leqvio) - a small interfering RNA (siRNA) targeting PCSK9
Cost & Coverage
Average Cost:
Typically several thousand dollars per month per 420mg/3.5ml cartridge
Insurance Coverage:
Specialty tier; often requires prior authorization and may have specific criteria for coverage (e.g., high LDL-C despite maximally tolerated statin therapy, history of ASCVD, 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 safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.