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Drug overview for REPATHA SURECLICK (evolocumab):
Generic name: EVOLOCUMAB (E-voe-LOK-ue-mab)
Drug class: Antihyperlipidemic - PCSK9 Inhibitors
Therapeutic class: Cardiovascular Therapy Agents
Evolocumab, a fully human IgG2 monoclonal antibody that binds to proprotein convertase subtilisin kexin type 9 (PCSK9), is an antilipemic agent.
No enhanced Uses information available for this drug.
Generic name: EVOLOCUMAB (E-voe-LOK-ue-mab)
Drug class: Antihyperlipidemic - PCSK9 Inhibitors
Therapeutic class: Cardiovascular Therapy Agents
Evolocumab, a fully human IgG2 monoclonal antibody that binds to proprotein convertase subtilisin kexin type 9 (PCSK9), is an antilipemic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for REPATHA SURECLICK (evolocumab) have been approved by the FDA:
Indications:
Heterozygous familial hypercholesterolemia
Homozygous familial hypercholesterolemia
Hypercholesterolemia
Increased cardiovascular event risk
Professional Synonyms:
Elevated blood cholesterol level
Familial heterozygous hypercholesterolemia
Familial homozygous hypercholesterolemia
Heterozygous familial elevated blood cholesterol
Indications:
Heterozygous familial hypercholesterolemia
Homozygous familial hypercholesterolemia
Hypercholesterolemia
Increased cardiovascular event risk
Professional Synonyms:
Elevated blood cholesterol level
Familial heterozygous hypercholesterolemia
Familial homozygous hypercholesterolemia
Heterozygous familial elevated blood cholesterol
The following dosing information is available for REPATHA SURECLICK (evolocumab):
No enhanced Dosing information available for this drug.
Evolocumab is administered subcutaneously. The drug is administered as an every-2-week or once-monthly dosing regimen. Evolocumab is commercially available as a prefilled syringe, prefilled auto-injector, and on-body infusor pump with prefilled cartridge.
Patients and/or their caregivers should be trained on the proper techniques for preparation and administration of evolocumab using these devices. If the on-body infusor with prefilled cartridge is used in pediatric patients 10-17 years of age, adult supervision is necessary. A monthly evolocumab dose of 420 mg can be administered using the on-body infusor with prefilled cartridge or by consecutively administering three 140-mg subcutaneous injections within 30 minutes using the prefilled syringes or auto-injectors.
Patient preference for dosing frequency and injection volume should be considered when determining the method of administration. Prior to use, all commercially available dosage forms of evolocumab (prefilled syringes and auto-injectors, on-body infusors with prefilled cartridges) should be stored at 2-8degreesC in their original carton to protect from light; the drug should not be frozen or shaken. Alternatively, patients may store these products at room temperature at 20-25degreesC; however, the drug must be used within 30 days or otherwise discarded if stored under these conditions.
Prior to administration, evolocumab prefilled syringes and auto-injectors should be allowed to warm to room temperature for at least 30 minutes, and the on-body infusor with prefilled cartridge should be allowed to warm to room temperature for at least 45 minutes. Evolocumab injection should be inspected visually prior to administration and should not be used if the solution is discolored, cloudy, or contains particulate matter. Commercially available evolocumab injection contains no preservatives and is intended for single use only.
Evolocumab should be administered subcutaneously into the abdomen (except for the 2-inch area around the navel), thigh, or upper arm; injection sites should be rotated. Areas that are tender, bruised, red, or indurated, or that have scars or stretch marks should be avoided. The on-body infusor should be securely attached to a clean, firm, and flat skin surface that is less likely to have body hair or on which the body hair can be trimmed; it should not be used on areas with wrinkles, skin folds, moles, or excessive hair.
Injection of the drug using a prefilled syringe or auto-injector may take up to 15 seconds to complete; injection of the drug using the on-body infusor with prefilled cartridge takes about 5 minutes to complete. Evolocumab should not be administered with other drugs at the same injection site. If a dose of evolocumab is missed, the missed dose should be administered as soon as possible within 7 days.
If a dose of evolocumab is missed in a patient receiving the every-2-week regimen and the missed dose is not administered within 7 days, the dose should be withheld and the next dose should be administered at the regularly scheduled time. If a dose of evolocumab is missed in a patient receiving the once-monthly regimen and the missed dose is not administered within 7 days, the dose should be administered and a new dosing schedule should be initiated starting on that date.
Patients and/or their caregivers should be trained on the proper techniques for preparation and administration of evolocumab using these devices. If the on-body infusor with prefilled cartridge is used in pediatric patients 10-17 years of age, adult supervision is necessary. A monthly evolocumab dose of 420 mg can be administered using the on-body infusor with prefilled cartridge or by consecutively administering three 140-mg subcutaneous injections within 30 minutes using the prefilled syringes or auto-injectors.
Patient preference for dosing frequency and injection volume should be considered when determining the method of administration. Prior to use, all commercially available dosage forms of evolocumab (prefilled syringes and auto-injectors, on-body infusors with prefilled cartridges) should be stored at 2-8degreesC in their original carton to protect from light; the drug should not be frozen or shaken. Alternatively, patients may store these products at room temperature at 20-25degreesC; however, the drug must be used within 30 days or otherwise discarded if stored under these conditions.
Prior to administration, evolocumab prefilled syringes and auto-injectors should be allowed to warm to room temperature for at least 30 minutes, and the on-body infusor with prefilled cartridge should be allowed to warm to room temperature for at least 45 minutes. Evolocumab injection should be inspected visually prior to administration and should not be used if the solution is discolored, cloudy, or contains particulate matter. Commercially available evolocumab injection contains no preservatives and is intended for single use only.
Evolocumab should be administered subcutaneously into the abdomen (except for the 2-inch area around the navel), thigh, or upper arm; injection sites should be rotated. Areas that are tender, bruised, red, or indurated, or that have scars or stretch marks should be avoided. The on-body infusor should be securely attached to a clean, firm, and flat skin surface that is less likely to have body hair or on which the body hair can be trimmed; it should not be used on areas with wrinkles, skin folds, moles, or excessive hair.
Injection of the drug using a prefilled syringe or auto-injector may take up to 15 seconds to complete; injection of the drug using the on-body infusor with prefilled cartridge takes about 5 minutes to complete. Evolocumab should not be administered with other drugs at the same injection site. If a dose of evolocumab is missed, the missed dose should be administered as soon as possible within 7 days.
If a dose of evolocumab is missed in a patient receiving the every-2-week regimen and the missed dose is not administered within 7 days, the dose should be withheld and the next dose should be administered at the regularly scheduled time. If a dose of evolocumab is missed in a patient receiving the once-monthly regimen and the missed dose is not administered within 7 days, the dose should be administered and a new dosing schedule should be initiated starting on that date.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| REPATHA 140 MG/ML SURECLICK | Maintenance | Adults inject 1 milliliter (140 mg) by subcutaneous route every 2 weeks in the abdomen, thigh, or outer area of upper arm (rotate sites) |
No generic dosing information available.
The following drug interaction information is available for REPATHA SURECLICK (evolocumab):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for REPATHA SURECLICK (evolocumab):
Drug contraindication overview.
*History of serious hypersensitivity reaction to evolocumab or any ingredient in the formulation.
*History of serious hypersensitivity reaction to evolocumab or any ingredient in the formulation.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for REPATHA SURECLICK (evolocumab):
Adverse reaction overview.
Adverse effects reported in >5% of patients receiving evolocumab and occurring more frequently than with placebo in clinical studies of adults with primary hyperlipidemia include nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. Adverse effects reported in >5% of patients receiving evolocumab and occurring more frequently than with placebo in adults with established cardiovascular disease include diabetes mellitus, nasopharyngitis, and upper respiratory tract infection.
Adverse effects reported in >5% of patients receiving evolocumab and occurring more frequently than with placebo in clinical studies of adults with primary hyperlipidemia include nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. Adverse effects reported in >5% of patients receiving evolocumab and occurring more frequently than with placebo in adults with established cardiovascular disease include diabetes mellitus, nasopharyngitis, and upper respiratory tract infection.
There are 3 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Diabetes mellitus Hypertension |
| Rare/Very Rare |
|---|
|
Angioedema |
There are 26 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Back pain Influenza Injection site sequelae Pharyngitis Upper respiratory infection |
Arthralgia Bruising Cough Diarrhea Dizziness Fatigue Gastroenteritis Headache disorder Memory impairment Muscle spasm Musculoskeletal pain Myalgia Nausea Pain in oropharynx Sinusitis Urinary tract infection |
| Rare/Very Rare |
|---|
|
Eczema Erythema Flu-like symptoms Skin rash Urticaria |
The following precautions are available for REPATHA SURECLICK (evolocumab):
Safety and efficacy of evolocumab have not been established in pediatric patients with types of hyperlipidemia other than homozygous familial hypercholesterolemia or heterozygous familial hypercholesterolemia. In addition, safety and efficacy of evolocumab have not been established in pediatric patients <10 years of age with homozygous familial hypercholesterolemia or heterozygous familial hypercholesterolemia. The principal efficacy study of evolocumab in patients with homozygous familial hypercholesterolemia included 7 pediatric patients >=13 years of age who received the drug in combination with diet and other LDL-cholesterol lowering therapies; in addition, 19 pediatric patients >=11 years of age with homozygous familial hypercholesterolemia received evolocumab in open-label trials. In a 24-week, randomized, placebo-controlled, double-blind trial in pediatric patients >=10 years of age with heterozygous familial hypercholesterolemia, 104 patients received evolocumab 420 mg subcutaneously once monthly and 53 patients received placebo; 39 patients (25%) were 10-11 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Available data from clinical trials and postmarketing reports on evolocumab in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Adverse embryofetal or postnatal developmental effects have not been observed in monkeys exposed to evolocumab during the period of organogenesis through parturition at dose exposures up to 12 times the maximum recommended human dosage; however, studies with another proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor demonstrated some evidence of humoral immune suppression in infant monkeys exposed to the drug in utero. To monitor pregnancy outcomes in pregnant women exposed to evolocumab, a pregnancy safety study has been established.
Clinicians and patients are encouraged to call 800-772-6436 or visit https://wwwext.amgen.com/products/global-patient-safety/adverse-event-repor ting to report evolocumab exposure in pregnant women.
Clinicians and patients are encouraged to call 800-772-6436 or visit https://wwwext.amgen.com/products/global-patient-safety/adverse-event-repor ting to report evolocumab exposure in pregnant women.
It is not known whether evolocumab is distributed into human milk. Human IgG is distributed into human milk; however, published data suggest that the IgG antibodies present in human milk are not substantially distributed into the circulation of neonates and infants. The potential adverse effects of evolocumab on the infant should be weighed against the known benefits of breastfeeding, taking into account the importance of the drug to the woman.
In clinical studies, 41% of patients who received evolocumab were 65 years of age or older and 8% were 75 years of age or older. Although no overall differences in safety or efficacy have been observed between geriatric patients and younger adults in controlled studies or in other clinical experience, the possibility of increased sensitivity to evolocumab in some geriatric patients cannot be ruled out.
The following prioritized warning is available for REPATHA SURECLICK (evolocumab):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for REPATHA SURECLICK (evolocumab)'s list of indications:
| Heterozygous familial hypercholesterolemia | |
| E78.01 | Familial hypercholesterolemia |
| Homozygous familial hypercholesterolemia | |
| E78.01 | Familial hypercholesterolemia |
| Hypercholesterolemia | |
| E78.0 | Pure hypercholesterolemia |
| E78.00 | Pure hypercholesterolemia, unspecified |
| E78.01 | Familial hypercholesterolemia |
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