Repatha Surclk 140mg/ml Inj Latex
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
Lipid-lowering agent
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 blocking a protein called PCSK9, which helps your liver remove more LDL-C from your blood. This can reduce your risk of heart attack, stroke, and certain heart procedures.
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.
Preparation and Administration
Before using this medication, wash your hands thoroughly. Do not open the packaging until you are ready to use it. 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, and do not administer the medication into the same location as another injection. Do not shake the medication.
If the medication 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. Do not use the medication if it has been dropped, broken, or if the solution is cloudy, leaking, or contains particles. The medication should be 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.
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, 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 to protect it 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.
Protect the medication from heat, and do not store it in a vehicle's glove box or trunk. Keep all medications in a safe place, 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. 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 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.
Preparation and Administration
Before using this medication, wash your hands thoroughly. Do not open the packaging until you are ready to use it. 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, and do not administer the medication into the same location as another injection. Do not shake the medication.
If the medication 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. Do not use the medication if it has been dropped, broken, or if the solution is cloudy, leaking, or contains particles. The medication should be 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.
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, 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 to protect it 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.
Protect the medication from heat, and do not store it in a vehicle's glove box or trunk. Keep all medications in a safe place, 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. 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 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 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:
Primary Hyperlipidemia and Mixed Dyslipidemia:
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 procedure.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for general use. For HeFH/HoFH: 10 years and older.
Adolescent:
For Heterozygous Familial Hypercholesterolemia (HeFH) and Homozygous Familial Hypercholesterolemia (HoFH) aged 10 years and older: 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once monthly. For HoFH, 420 mg once monthly, administer after apheresis if applicable.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed (limited data, monitor LDL-C)
Dialysis:
No adjustment needed (limited data, monitor LDL-C). For HoFH patients on apheresis, administer after apheresis procedure.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed (limited data, monitor LDL-C)
Confidence:
Medium
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 LDL-C from the blood, thereby lowering LDL-C levels.
Pharmacokinetics
Absorption:
Bioavailability:
72%
Tmax:
3-4 days (subcutaneous)
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 11-17 L
ProteinBinding:
Not applicable (monoclonal antibody, not typically protein bound in the same way as small molecules)
CnssPenetration:
Limited
Elimination:
HalfLife:
11-17 days (after single subcutaneous dose)
Clearance:
Not available (primarily catabolized)
ExcretionRoute:
Not applicable (catabolized into small peptides and amino acids)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Within 1 week (significant LDL-C reduction)
PeakEffect:
1-2 weeks (maximal LDL-C reduction)
DurationOfAction:
2-4 weeks (based on dosing interval)
Confidence:
Medium
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 immediately or seek emergency 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 symptoms that bother you or persist, contact your doctor for advice:
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 immediately or seek emergency 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 symptoms that bother you or persist, contact your doctor for advice:
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: swelling of your face, lips, mouth, or tongue; breathing problems; severe rash; hives. Seek immediate medical attention.
- Severe injection site reactions that do not go away or worsen.
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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and laboratory tests should be conducted as directed by your doctor to monitor your condition. Adhere to the dietary plan recommended by your doctor to ensure optimal management of your health.
Be aware that this medication may cause high blood sugar levels, which can lead to the development of new-onset diabetes or worsen existing diabetes. If you have a known allergy to latex, consult your doctor to discuss any potential risks.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the benefits and risks of this medication with your doctor. This will enable you to make an informed decision about your treatment, considering the potential effects on both you and your baby.
Be aware that this medication may cause high blood sugar levels, which can lead to the development of new-onset diabetes or worsen existing diabetes. If you have a known allergy to latex, consult your doctor to discuss any potential risks.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the benefits and risks of this medication with your doctor. This will enable you to make an informed decision about your treatment, considering the potential effects on both you and your baby.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported with evolocumab due to its mechanism of action and subcutaneous administration.
What to Do:
In case of suspected overdose, contact a poison control center (1-800-222-1222) or seek emergency medical attention. Treatment should be supportive and directed at the symptoms.
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 familial hypercholesterolemia.
Timing: Prior to initiation of therapy
Routine Monitoring
Lipid Panel (LDL-C)
Frequency: 4-12 weeks after initiation, then periodically as clinically indicated
Target: Individualized based on patient risk factors and treatment goals (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/Symptoms of Allergic Reactions
Frequency: Regularly, especially after initial doses
Target: Absence of symptoms
Action Threshold: Discontinue if severe allergic reaction occurs.
Injection Site Reactions
Frequency: Regularly
Target: Absence of severe reactions
Action Threshold: Manage symptomatically; if persistent or severe, consult healthcare provider.
Symptom Monitoring
- Signs of allergic reaction (e.g., rash, hives, swelling, difficulty breathing)
- Injection site reactions (e.g., redness, pain, bruising, swelling)
- Flu-like symptoms (e.g., fever, body aches)
- Upper respiratory tract infection symptoms (e.g., runny nose, sore throat)
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. Monoclonal antibodies are transported across the placenta in increasing amounts during the third trimester, so potential effects on the fetus are likely to be greater during the third trimester. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical low risk.
Second Trimester:
Limited data, theoretical low risk.
Third Trimester:
Potential for increased fetal exposure and theoretical risk of altered immune function in the newborn due to placental transfer of IgG antibodies.
Lactation
No data are available on the presence of evolocumab in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal 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. Consider the half-life of evolocumab (11 to 17 days) when advising lactating women.
Infant Risk:
Low risk, but potential for infant exposure to IgG antibody. Monitor for adverse effects.
Pediatric Use
Approved for pediatric patients aged 10 years and older with Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH). Safety and effectiveness in pediatric patients younger than 10 years have not been established.
Geriatric Use
No dosage adjustment is required in elderly patients. No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Clinical Information
Clinical Pearls
- Repatha is a biologic agent administered via subcutaneous injection, typically self-administered by patients or caregivers.
- It is often used in combination with statins or other lipid-lowering therapies when maximal tolerated statin therapy does not achieve adequate LDL-C reduction.
- Patients should be trained on proper injection technique and storage (refrigerated, protect from light).
- The 420 mg monthly dose can be given as three 140 mg injections consecutively within 30 minutes at different injection sites.
- Evolocumab significantly reduces LDL-C and has demonstrated cardiovascular outcome benefits in clinical trials.
- Common side effects include nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.
Alternative Therapies
- Other PCSK9 inhibitors (e.g., Alirocumab (Praluent), Inclisiran (Leqvio))
- Statins (e.g., Atorvastatin, Rosuvastatin)
- Ezetimibe (Zetia)
- Bempedoic acid (Nexletol)
- Bile acid sequestrants (e.g., Cholestyramine)
- Fibrates (e.g., Fenofibrate, Gemfibrozil)
Cost & Coverage
Average Cost:
$500 - $600 per 140mg/ml single-use prefilled syringe or autoinjector
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 promptly. To ensure safe and effective treatment, 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.