Repatha 140mg/ml 1 Pf SR 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
Antilipemic Agent; Proprotein Convertase Subtilisin/Kexin Type 9 (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 blocking a protein called PCSK9, which helps your body remove more bad cholesterol. It's often used when diet and statin medicines aren't enough to lower cholesterol, especially for people with certain genetic conditions or a history of 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 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, and do not administer into the same location as another injection. Do not shake the medication.
If the medication has been refrigerated, allow it to reach room temperature for at least 30 minutes before use. Do not heat the medication. Do not use if the medication has been dropped, broken, or if the solution is cloudy, leaking, or contains particles. The solution should be colorless to faint yellow; do not use if the color has changed. Avoid injecting 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 and do not reuse. Throw away needles in a designated sharps disposal container and follow local guidelines for disposal when the container is full. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store the medication in the refrigerator, but do not freeze. 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 not used within 30 days, discard the medication. Protect the medication from heat and do not store in a vehicle's glove box or trunk. Keep all medications out of reach of children and pets, and dispose of unused or expired medications properly. Do not flush down the toilet or pour down the drain unless instructed to do so. Check with your pharmacist for guidance on disposal and potential drug take-back programs in your area.
Missed Dose Instructions
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 the dose 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 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 in case of a missed 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 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, and do not administer into the same location as another injection. Do not shake the medication.
If the medication has been refrigerated, allow it to reach room temperature for at least 30 minutes before use. Do not heat the medication. Do not use if the medication has been dropped, broken, or if the solution is cloudy, leaking, or contains particles. The solution should be colorless to faint yellow; do not use if the color has changed. Avoid injecting 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 and do not reuse. Throw away needles in a designated sharps disposal container and follow local guidelines for disposal when the container is full. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store the medication in the refrigerator, but do not freeze. 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 not used within 30 days, discard the medication. Protect the medication from heat and do not store in a vehicle's glove box or trunk. Keep all medications out of reach of children and pets, and dispose of unused or expired medications properly. Do not flush down the toilet or pour down the drain unless instructed to do so. Check with your pharmacist for guidance on disposal and potential drug take-back programs in your area.
Missed Dose Instructions
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 the dose 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 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 in case of a missed 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.
- Quit smoking if you smoke.
- Manage other cardiovascular risk factors (e.g., blood pressure, diabetes).
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 ASCVD:
140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once monthly
Homozygous Familial Hypercholesterolemia (HoFH):
420 mg subcutaneously once monthly; if a clinically meaningful response is not achieved in 12 weeks, the dosage may be increased to 420 mg every 2 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For Heterozygous Familial Hypercholesterolemia (HeFH) and HoFH in patients ≥10 years: 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once monthly. For HoFH, if a clinically meaningful response is not achieved in 12 weeks, the dosage may be increased to 420 mg every 2 weeks.
Adolescent:
For Heterozygous Familial Hypercholesterolemia (HeFH) and HoFH in patients ≥10 years: 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once monthly. For HoFH, if a clinically meaningful response is not achieved in 12 weeks, the dosage may be increased to 420 mg every 2 weeks.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary (limited data, monitor closely)
Dialysis:
No specific dose adjustment recommended; Evolocumab is not renally eliminated.
Hepatic Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
Caution advised; no specific dose adjustment recommended, but systemic exposure may be higher. Monitor closely.
Pharmacology
Mechanism of Action
Evolocumab is a human monoclonal antibody (IgG2) 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 the degradation of LDLRs and reduced clearance of LDL-C from the blood. By inhibiting PCSK9 from binding to LDLR, evolocumab increases the number of available LDLRs to clear LDL-C, 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 16 L
ProteinBinding:
Not applicable (monoclonal antibody, not expected to bind to plasma proteins in a specific manner)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 11 to 17 days
Clearance:
Clearance is saturable at low concentrations and linear at higher concentrations. At the recommended doses, the primary clearance pathway is non-linear, likely mediated by target-binding (PCSK9).
ExcretionRoute:
Not renally or hepatically eliminated in the traditional sense; degraded into small peptides and amino acids.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Within 1 week (significant LDL-C reduction)
PeakEffect:
Approximately 1-2 weeks after initial dose
DurationOfAction:
Maintained throughout 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 immediately or seek 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 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 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 immediately or seek 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 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 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 allergic reaction: severe rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing.
- Severe injection site reactions (though usually mild and transient).
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 assess potential interactions between this medication and other substances.
Any existing health problems, as this medication may interact with certain conditions.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to ensure your safety while taking 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor assess potential interactions between this medication and other substances.
Any existing health problems, as this medication may interact with certain conditions.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to ensure your safety while taking 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 personalized diet 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 potential risks and alternatives.
If you are pregnant, planning to become pregnant, or are currently 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 potential risks and alternatives.
If you are pregnant, planning to become pregnant, or are currently 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 in clinical trials. Doses up to 840 mg have been administered subcutaneously 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) for further guidance.
Drug Interactions
Monitoring
Baseline Monitoring
Lipid Panel (LDL-C, Total Cholesterol, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and confirm eligibility for therapy based on guidelines.
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 (e.g., every 6-12 months)
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 dose adjustment (for HoFH) or adherence counseling.
Symptom Monitoring
- Symptoms of allergic reactions (e.g., rash, urticaria, swelling, dyspnea)
- Injection site reactions (e.g., erythema, pain, bruising)
- Muscle pain or weakness (though less common than with statins)
Special Patient Groups
Pregnancy
Limited human data on evolocumab use in pregnancy are insufficient to inform a drug-associated risk of adverse developmental outcomes. Monoclonal antibodies are transported across the placenta, especially during the third trimester. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data; animal studies did not show direct harm.
Second Trimester:
Limited data; animal studies did not show direct harm.
Third Trimester:
Potential for fetal exposure due to placental transfer of IgG antibodies; potential effects on fetal lipid metabolism are unknown.
Lactation
It is unknown 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 evolocumab are generally not well absorbed orally by infants, but potential for exposure exists.
Pediatric Use
Approved for HeFH and HoFH in patients aged 10 years and older. Safety and effectiveness in pediatric patients younger than 10 years have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between geriatric patients (≥65 years) and younger patients. No dose adjustment is necessary based on age.
Clinical Information
Clinical Pearls
- Repatha 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.
- Allow the Repatha prefilled syringe or autoinjector to warm to room temperature for at least 30 minutes before injecting. Do not warm in any other way (e.g., microwave, hot water).
- Administer subcutaneously into the abdomen, thigh, or upper arm. Rotate injection sites with each dose.
- Patients should be trained on proper injection technique by a healthcare professional.
- Repatha is typically used in combination with diet and maximally tolerated statin therapy, or other lipid-lowering therapies if statins are not tolerated or contraindicated.
- Patients should be advised to report any signs of allergic reaction immediately.
Alternative Therapies
- Statins (e.g., atorvastatin, rosuvastatin)
- Ezetimibe
- Bempedoic acid (Nexletol, Nexlizet)
- Inclisiran (Leqvio) - another PCSK9 inhibitor, administered every 6 months
- Fibrates (e.g., fenofibrate, gemfibrozil)
- Niacin (nicotinic acid)
- Bile acid sequestrants (e.g., cholestyramine, colesevelam)
- LDL apheresis (for severe cases, especially HoFH)
Cost & Coverage
Average Cost:
$5,850 - $6,900 per 28-day supply (2 x 140mg/ml pens or 1 x 420mg/3.5ml cartridge)
Insurance Coverage:
Tier 4 (Specialty Drug) - Requires prior authorization and often 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 be sure 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.